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 Guide for Life Sciences Companies

Modernize the Patient Access Experience. Transform Your Pharmaceutical Brand.

Consumer expectations continue to evolve in the world of pharma. The pandemic unleashed disruption and innovation in healthcare.

Why the Pharmacy Matters: A Guide for Life Sciences Manufacturers

The pharmacy has an outsized impact on whether your brand is covered by payers and whether patients adhere to therapy - your access partner plays a key role in this process.

Upcoming Events

Webinar: Tech Enabled Patient Access: Enhanced Patient Experience, Insights and Brand Outcomes

Successfully commercializing a specialty-lite therapy in today’s competitive environment is a high-stakes affair. As the complexity of the patient journey increases and the bar to address payer utilization management requirements stretch higher, commercial leaders would be wise to consider commercialization partners that leverage technology to remove friction in the drug channel. Innovative platforms can simplify the patient experience, convert access to covered dispenses, and deliver actionable insights.Hosted by Fierce Pharma in partnership with Syneos Health, Merck, and Impel Pharmaceuticals, we invite you to join us for a webinar:Date: Thursday, October 27th, 2022 Time: 12pm ET / 9am PT Duration: 60 MinutesRegister here

Case Studies

LOE: 3x Refill Adherence vs. Retail

Providing end-to-end visibility into the prescription life cycle, we unlock coverage and maximize reimbursement for brands while integrating into the lives and workflows of patients and providers.

Launch: Fast Adoption and Coverage

Phil unlocked access and coverage to enable a successful launch for a novel migraine therapy.

Mid-Cycle: 90% of Dispenses Covered

Learn how Phil unlocked payer coverage for 90% of this women's health brands's dispenses with formulary placement transforming their brand trajectory

Phil Blog

Developing a Distribution Strategy that Optimizes Gross to Net

Downward pressure on net sales is an ongoing problem for pharmaceutical and life sciences companies. It’s crucial to understand the gross-to-net (GNT) challenges that manufacturers are facing and how they can leverage their distribution strategies to optimize GTN.Understanding the challenges surrounding GTNNumerous factors impact a life science company’s GTN, which is the difference between the wholesaler acquisition cost (WAC) – also known as the drug’s list price – and the manufacturer’s net sales. Distributor chargebacks and rebates, 340B Drug Pricing Program rebates, negotiated price reductions, and copay assistance can significantly reduce the net revenue manufacturers realize for their brand-name drugs. The fact is, many companies today are experiencing declining net drug revenue as they offer larger rebates to offset increases in list prices, as depicted in this chart from Drug Channels:There are two major changes in the pharmaceutical environment that underly the GTN challenges companies are facing:1. Consumer expectationsInnovations, fueled by mobile technologies, over the last decade or so have removed a lot of friction from buying experiences and have enabled more informed decision-making, which has become part of the standard purchasing experience today.Consumers expect to know upfront how much a product or service costs, how conveniently they can obtain it, and when they can expect to receive it.For most things consumers buy today, they are getting that clarity, except when it comes to their prescription drugs. The pharmaceutical industry is decades behind when it comes to meeting consumer expectations. Failing to deliver that frictionless, consumer-centric experience creates barriers that keep patients from starting on or properly adhering to their prescribed therapies, which for any manufacturer, is going to add up to poor gross to net.2. Prescription coverageAs drug and patient out-of-pocket costs have continued to rise, payers have instituted stricter formulary requirements – particularly for more expensive specialty drugs – that must be met before they approve and cover a therapy. In these cases, the prescriber must follow a prior authorization process to get the patient started on their therapy.While the technology to create “back office” efficiencies around administrative workflows is prevalent across many industries, this is not necessarily the case in healthcare. The lack of process optimization and streamlining means that a smaller percentage of prescription drugs get covered by payers because of the friction involved in the approval process. This means that the manufacturer often ends up subsidizing a greater percentage of scripts than would have otherwise been covered in a streamlined process. Now that the financial burden is borne by the manufacturer, nowhere does it show up more clearly than in GTN.The impact of both these challenges combined is multiplicative. If a company loses a few scripts due to a friction-prone path to coverage, it is also losing the subsequent refills. And if a percentage of those scripts or scripts overall are not covered and the manufacturer steps in to subsidize at a much higher percentage than planned, together, these factors represent a greater magnitude of diminished net revenue to pharma brands.Why manufacturers need a value-aligned distribution channelMultiple entities are involved in getting a patient on therapy between the manufacturer and the payer. The better manufacturers understand that distribution channel, the more effectively they can employ various mechanisms and measures to help patients get started on therapy faster, stay on their treatment, and access it more affordably.Surprisingly, many prescription models are antiquated and misaligned with the needs of today's patients and prescribers. As a result, some of the manufacturer's distribution costs may not be commensurate with the value added. In other words, some entities capture disproportionately more value than they contribute. This means that fewer dollars are available for manufacturers to improve patient access.Manufacturers have very little pricing power in the highly competitive, highly regulated world of pharma. Cost inflation is typically due to how the distribution channel operates. Due to a lack of visibility, manufacturers may not realize that one-sixth or one-seventh of their brand's value is captured by an entity adding zero value.Pharmaceutical manufacturers budget a certain amount of capital to help patients access their prescribed therapy. When they can track what is happening within the distribution channel in real-time, they can design programs so that most of that capital goes to its intended purpose.It's essential that the distribution channel aligns with the value each stakeholder contributes to achieving the end goal of ensuring patients receive the right therapy at the right time and at the right price.Achieving a GTN-optimized distribution strategyThere are three key considerations when designing a distribution strategy to optimize GTN:1. Always put the patient-turned-consumer at the centerBeyond a traditional patient-centered approach, manufacturers must recognize that the patient is also a consumer who wants a more modern way to access their medications and be informed as to what’s happening behind the scenes. Equip them with the digital-based tools and user experiences that are familiar to them, and that assist them with accessing and staying on therapy.2. Address the healthcare provider experienceMake sure providers have modern tools to streamline and facilitate their efforts to meet payer requirements so they can help their patients get started and adhere to prescribed medications.3. Create an incentive-aligned distribution channelAll entities and stakeholders along your distribution channels should be working toward the common goals of getting scripts covered and making sure that most patient access dollars go to the patient to underwrite the cost of their care.It’s time to embrace innovationMany pharma companies today are not taking full advantage of digital technology. The good news is that while technology has failed the industry for several decades, in the last five to six years, there have been clear strides, especially with consumer- and prescriber-facing innovations. The new technology hype cycle is behind us, and solutions are now production-worthy in a way and at a scale that they’re able to impact lives. It may take a new mindset, but by embracing innovation and implementing the right tools, pharmaceutical manufacturers can improve clinical, financial, and operational outcomes.Phil can be a game-changer for life science companies looking to meet patient expectations and positively impact outcomes while optimizing GTN. With a digital, frictionless experience, providers can more easily meet payer criteria and get their patients on therapy quicker. Patients can better access, adhere to, and afford their medications while staying informed along the way.The platform also provides a holistic end-to-end view of what is happening along the entire patient-prescription journey. Most importantly, data and insights are delivered in real-time, so manufacturers can course correct as necessary. Without a very high commitment hurdle, smaller companies can try it out at a level that best fits their requirements and then scale as needed. Learn more about Phil.

Providers are doubling down on software investments, report finds

Editor's Note: The consensus amongst healthcare industry experts is that the COVID-19 pandemic accelerated the shift to a more digital and consumer centric healthcare environment. With the shift underway and investment in healthcare technologies booming, many tout this as a silver lining of the pandemic. Despite this well found optimism, rapid technological change always unleashes unintended consequences. One of the consequences of the digital health revolution is the upending of provider workflows from a largely in-person care delivery model to a blended care model. Providers are busier than ever juggling synchronous and asynchronous care evidenced by their efforts to double down on software investments to reduce their operational burden. Pharma brands would be wise to consider this as they develop HCP engagement plans and access strategies to overcome PA obstacles. PHIL was purposefully designed to make it easy for prescribers to utilize our platform by seamlessly integrating into existing workflows and enabling “1-click” PA submissions. As you develop your go to market strategy, we can help you drive adoption amongst your target populations while protecting your Gross to Net.Dive Brief: Healthcare providers are continuing to invest heavily in software as the COVID-19 pandemic continues, despite a precarious operating environment, according to a new report by KLAS Research and Bain. About 45% of providers increased their software investments over the past year, the report found. Providers are focusing their investments mostly in revenue cycle management, patient intake and cybersecurity. Providers are also streamlining tech stacks and looking to their electronic health record providers and other existing vendors for new tools before turning to other offerings, the report found. Dive Insight: Macroeconomic uncertainty has led health tech companies to issue dismal projections for the remainder of the year, but the new report suggests providers are still spending big on software. Only 10% of providers decelerated their spending in the past year, according to KLAS and Bain. Software is a top-five strategic priority for almost 80% of providers, and a top-three priority for almost 40%. Over the next year, more than 95% of providers expect to make new investments in software, with one-third planning to spend more than usual. The high level of spending comes despite ongoing cost pressures, especially for providers. The coronavirus pandemic, which kicked the digitization of healthcare into overdrive, has resulted in organizations regrouping and becoming more focused with their investments, KLAS and Bain said. In addition, clinician shortages and wage inflation are actually driving demand for tools to improve productivity and ameliorate labor strains. Almost 80% of providers upping software spending cited those factors as top catalysts for doing so. However, not all organizations are increasing IT investment. Roughly 30% or respondents said they’ll likely spend less over the next year than they would during a time of more favorable market conditions. For those investing in software, revenue cycle management is often a top priority, as providers look to automate labor-intensive processes and bring more cash in the door, the report found. That’s especially the case for smaller providers. Security and privacy are another top investment priority, as cyberattacks increase in frequency and severity. From 2018 to 2021, the number of data breaches reported to the HHS has roughly doubled, and data suggests the breaches are becoming costlier, too. A recent high-profile attack on CommonSpirit has thrown the issue into the limelight. The health system — one of the largest in the U.S. — is still working to get its systems back online more than a week after it first disclosed it was grappling with an unspecified IT incident. Competition in the provider IT space shows no sign of cooling down, with early-stage capital, big tech and large EHR players continuing to expand their software offerings, the report said. As a result, it’s critical for vendors to understand their customers’ investment postures and articulate software values in order to remain competitive, according to KLAS and Bain. KLAS and Bain based their report on secondary market research, financial information and interviews with industry participants. This article was written by Rebecca Pifer from Healthcare Dive and was legally licensed through the Industry Dive Content Marketplace. Please direct all licensing questions to legal@industrydive.com.

5 FDA decisions to watch in the fourth quarter

Though 2022 has been a down year for the biotechnology sector, notable decisions from the Food and Drug Administration have provided a few bright spots.Two gene therapies came to market, providing a lift for a field that’s been slowed by recent setbacks. The cancer drug Enhertu was approved for a newly defined tumor type known as “HER2-low.” The regulator also cleared a new medicine for ALS and a first-of-its-kind inflammatory disease drug.The fourth quarter could yield some other medical milestones. An Alzheimer’s drug that unexpectedly succeeded in a large trial last week is under review. So are what could be the first treatment for a common form of vision loss, a closely watched HIV drug, and a type of anemia pill the FDA has already turned back twice.Here are 5 FDA decisions to watch:Covis’ Makena for prevention of preterm birthsIn the decade since the FDA made Makena available for the prevention of preterm births, the treatment has become a flashpoint in the debate over speedy drug approvals.Makena was developed by AMAG Pharmaceuticals and granted accelerated approval in 2011 based on a study showing it reduced the risk of preterm births — which can jeopardize a baby’s health — in women with a history of delivering early.A study meant to confirm Makena’s benefits took years to complete, however. When the results did arrive in 2019, Makena didn’t perform meaningfully better than a placebo. Since then, the fate of Makena has been the subject of a fight between the FDA, AMAG and the drug’s current owner, Covis Pharma, which acquired AMAG in 2020. After an FDA advisory panel in 2019 recommended the regulator pull Makena from the market, the agency proposed doing so, arguing “the available evidence does not show Makena is effective” for its approved use.Its developers, as well as some patient advocates and outside experts, have countered that doing so would be a mistake, claiming the drug still may help Black women at high risk of early births, who made up a larger portion of participants in the original trial than the confirmatory study.A hearing on the issue has been delayed several times amid legal wrangling, extending the drug’s time on market while its benefit remains unclear. The FDA specifically cited the case as “an example of how lengthy and burdensome the withdrawal process may be” when a company disagrees with the agency, according to a report on accelerated approvals published last week by the U.S. Department of Health and Human Services.The back-and-forth could come to a conclusion this quarter. A three-day hearing of an FDA advisory panel will begin on Oct. 17 and feature discussions on the available confirmatory evidence as well as “whether FDA should allow Makena to remain on the market.”GSK’s daprodustat for anemia from kidney diseaseGSK’s daprodustat is the third anemia drug of its kind to be reviewed by the FDA. If the rejections of the first two are any indication, daprodustat could have a tough time when the agency’s expert advisers meet to review it on Oct. 26.Daprodustat is intended to be an oral alternative to injectable biologics like Epogen and Aranesp that boost red blood cell production and are used to treat anemia in patients with damaged kidneys. Those medicines have been standard treatments for years, but their use has been restricted because of the risk of heart problems.GSK’s drug is also meant to increase red blood cell levels, but by tricking the body into thinking it’s in a low-oxygen environment. The approach is meant to be both safer and more convenient for patients, and has spawned daprodustat as well as drugs from FibroGen and Akebia Therapeutics. All three are approved in Japan, and FibroGen’s is cleared for use in Europe.But none are available in the U.S., where regulators have taken a tougher stance. In a meeting last year, the FDA and its expert reviewers challenged claims that FibroGen’s drug is safer than its injectable competitors. The agency rejected that medicine and demanded another trial. It then did the same to Akebia’s treatment in March.GSK believes it has a better case. Unlike its rivals, daprodustat didn’t perform worse than injectable drugs on measures of heart safety in the key studies supporting its application. There are still concerns, however. An editorial published in the New England Journal of Medicine alongside GSK’s two large studies flagged the risk of cancer, and questioned the drug’s benefit in patients who aren’t on dialysis, a group that makes up the majority of people with chronic kidney disease.Apellis’ pegcetacoplan for geographic atrophyPeople with the “wet” form of age-related macular degeneration, a leading cause of vision loss, have many effective treatment options. The estimated 5 million people across the globe with geographic atrophy — an irreversible eye disease that results from AMD — don’t. That could change if the FDA approves Apellis Pharmaceuticals’ pegcetacoplan later this year, however.Pegcetacoplan is an injectable drug that blocks activation of the complement system, a part of the body’s innate immune response. In clinical testing, it’s shown the potential to slow growth of the lesions, or scar tissue, found in the eyes of people with geographic atrophy.Yet Apellis doesn’t have a clear-cut case. The drug missed statistical significance in one of its two Phase 3 studies. Apellis also hasn’t yet proven that slowing lesion growth directly translates to improved vision. In August, the company reported patients in its late-stage trials didn’t experience a visual acuity benefit after two years of treatment.Apellis executives have expressed confidence the drug’s benefit will become apparent with longer follow-up. “We have trouble imagining a scenario where lesion size doesn’t inevitably correlate with function,” wrote Evercore ISI analyst Umer Raffat, in a research note.A green light from the FDA could yield a drug that Jefferies analysts estimate could generate as much as $6 billion in yearly sales at its peak. A rejection or delay, meanwhile, could cost Apellis a chance to be first to market, as Iveric Bio plans to file for approval of a similar drug early next year.The FDA will make a decision by Nov. 26.Mirati’s adagrasib for non-small cell lung cancerFor three years, analysts and investors have debated whether a cancer drug developed by Mirati Therapeutics, a small San Diego biotech, can top a rival one from Amgen that's become the crown jewel of the larger company's oncology business.The two companies have traded clinical trial readouts showing their drugs can effectively shrink tumors driven to growth by mutations in a gene, called KRAS, that for decades was considered undruggable. Last spring, Amgen turned its positive data into a first-of-its-kind approval for its drug, now sold as Lumakras.Now it's Mirati's turn in front of the FDA, as its drug adagrasib is under review with a decision deadline of Dec. 14. Should it win approval, Mirati would compete for market share with Amgen, which has the benefit of recent data confirming its drug beat chemotherapy in a larger study of patients with non-small cell lung cancer.But Lumakras failed to show it could extend patients’ lives, leaving an opening for Mirati to do better. The company is currently enrolling a bigger trial that's meant to confirm adagrasib's benefit.Gilead’s lenacapavir for HIVBy Dec. 27, Gilead Sciences should know whether its second attempt at getting a key HIV drug approved in the U.S. has succeeded.The first try ended with an FDA rejection because of concerns about potential adverse interactions between the drug, known as lenacapavir, and the specific glass vials in which it was contained. Gilead said it has since addressed those manufacturing-related issues by using vials made from a different glass. The treatment won its first approval in Europe in September.A similar outcome in the U.S. would bolster the commercial prospects for an important addition to Gilead’s arsenal of HIV medicines. Lenacapavir has a unique way of binding to the protein shell that surrounds the virus, and its benefits appear long-lasting. In a small study, an injection of the drug every six months, in combination with other antivirals, kept the virus in check for heavily pretreated patients who had developed resistance to multiple therapies.Gilead has been evaluating potential combinations of lenacapavir and other drugs, including Merck & Co.’s islatravir, although that latter therapy has raised safety concerns over the last year. Gilead is also testing whether its drug works as a preventive treatment.In a note to clients earlier this year, RBC Capital Markets analyst Brian Abrahams wrote that his team expects the FDA to approve lenacapavir for heavily pretreated HIV patients — a “relatively small indication” that could generate peak annual sales of about $200 million in the U.S.But given lenacapavir’s various advantages, including the ability to be combined with other treatments and administered in multiple ways, the RBC team argues the drug could become “the backbone” of Gilead’s HIV franchise within several years and ultimately achieve more than $4 billion in yearly sales at its apex.BONUS: Eisai and Biogen’s lecanemab for Alzheimer’sWill lecanemab, an experimental Alzheimer's drug that succeeded in a large clinical trial last week, become a backbone therapy for the neurodegenerative disease? Doctors and researchers aren't yet sure, as only limited data have been disclosed by lecanemab's developers, Eisai and Biogen.They'll get much more information Nov. 29, when the companies present fuller study results at a medical meeting in San Francisco. The results are likely to be pored over and debated, as they represent the first clearly positive data from a Phase 3 trial of a drug meant to treat Alzheimer's underlying cause.They’re also likely to help the FDA decide whether to approve lecanemab on an accelerated basis. Using data from an earlier study, Eisai filed an application earlier this year, and a decision is expected by Jan. 6 on the basis of the treatment’s ability to clear toxic plaques from the brain.The new trial results were meant to confirm those preliminary findings. Now that they’re positive, Eisai has a stronger case and the FDA a potentially easier judgment call.This article was written by Jonathan Gardner, Ben Fidler, Delilah Alvarado, Jacob Bell and Ned Pagliarulo from Biopharma Dive and was legally licensed through the Industry Dive Content Marketplace. Please direct all licensing questions to legal@industrydive.com.

Are Traditional Hub Providers Keeping Pace with Today’s Consumers and Providers?

The seismic changes in consumer behavior and expectations brought on by mobile devices and cloud computing seem to have happened overnight, but they’ve been years in the making. The popularity of user-friendly services offered by the likes of Amazon, Uber, and Apple Pay has driven innovation and disruption across industries. The COVID-19 pandemic further accelerated the shift to digital tools, especially in healthcare.Most healthcare organizations have implemented secure Software-as-a-Service (SaaS) applications to deploy cloud-based EHRs, telehealth, and revenue cycle management. So providers are now accustomed to using these solutions to reduce administrative burden and offer more convenience to their patients.For many pharmaceutical specialty brands, hub services represent a major touchpoint with patients and healthcare providers (HCPs). With consumer demands for choice, convenience, and transparency at an all-time high, life science companies must ensure their hub providers aren’t stuck in the past.What is a “traditional” hub?Over the last two decades, hub services arose from the need to effectively commercialize brands in the high-growth specialty medication categories, which treat smaller patient populations and require “high-touch” patient support services.The National Council for Prescription Drug Programs (NCPDP) defines hub services – also called Patient Services or Patient Services Support – as “manufacturer-sponsored programs that assist patients and prescribers in the areas of access, affordability and adherence services providing efficient distribution of medication improving patient compliance.”A “traditional” hub is a comprehensive, full-service patient services model. The core of this model is the call center. A team of care coordinators, reimbursements specialists, nurses, and others works via telephone to enroll patients, perform benefit investigations, obtain prior authorizations, and support patients with therapy administration and adherence.Even though the traditional hub model is expensive, cumbersome, difficult to customize, and may be overkill for some therapies, a 2021 survey of life sciences companies found that most still rely on traditional hubs:89% utilize a call center as part of their patient services team91% outsource their nurse/clinical educator team to a hub71% use a hub for reimbursement supportMost hub services are misaligned with consumer and provider needsWhile a hub can be a great tool to positively impact the patient journey, it can also be a costly endeavor that results in a poor return on investment – particularly if it’s not aligned with consumer and HCP preferences.Hub service providers can play an integral role in the commercialization of specialty drugs; however, those that fall under the “traditional” model may not be keeping pace with consumer and HCP demands. Responses from a recent survey found that patients had similar “pharma” experience expectations across various disease areas, characterized as personal, trustworthy, accurate, and simple.The results also revealed that:Services that patients need the most – patient support enrollment, patient support services, medication reminders, checking the status of treatment, and resources to manage health – all rated poorlyPatients who have a poor experience are twice as likely to search for a new treatment optionPatients who have great experiences are three times as likely to enroll in a program or serviceThe 3 questions you should be askingOffering patient access and support services is the most tangible way for life sciences companies to connect and engage with patients. Accordingly, consumer experience can be a significant differentiator for specialty brands today.Before product launch and throughout the product life cycle, commercial teams should be asking the following three questions to determine if potential hub providers are delivering a modern, consumer-centered experience that can help them meet their objectives:How well does the prescribing process integrate into HCP workflows? Prescribing your brand should be as easy for the provider as writing for a generic. However, specialty therapies present challenges. A 2020 survey found that 80% of providers have trouble starting patients on specialty therapies and 75% spend at least one hour per patient per week completing the work required to initiate treatment. It’s crucial to ensure that providers can stay within their EHR using an easy-to-use technology interface that streamlines the prior authorization (PA) process, minimizes administrative burden, and helps them better serve their patients. A better prescriber experience will translate to a higher adoption rate and a better consumer experience. Do they deliver a seamless and personalized experience for patients? The delivery experience of patient support should be a frictionless, consumer-centric digital experience like other industries. That’s often not the case – 57% of healthcare consumers think retailers or financial services are better at providing personalized omnichannel experiences. Look for easy-to-use digital tools, tailored content delivery, and two-way communications based on each patient’s healthcare needs and preferences. A frictionless patient experience leads to better enrollment rates and medication adherence. Are patients (and HCPs) kept informed? Healthcare Information and Management Systems Society (HIMMS) recommends that digital patient engagement platforms feature capabilities that deploy regular communications to bridge knowledge gaps. Providing greater transparency – in real time – around out-of-pocket costs, financial assistance, PA status, and prescription and refill status results in better decision-making, higher satisfaction, less prescription abandonment, improved adherence, and better outcomes.Patient services can reduce the patient’s disease burden and improve their experience. For companies that market a specialty therapy, the dilemma should not be whether to offer these services but determining if their commercialization partner delivers a solution that meets today’s consumer and provider expectations. Download our whitepaper to learn more about transforming your brand’s performance with a modern patient access experience.About the AuthorRick Salazar is a VP Of Business Development at Phil. He is a senior patient services and distribution leader with expertise helping patients, providers and manufacturers overcome barriers to access and and use via a technology driven platform supporting both buy and bill and pharmacy benefit drugs.

Tech Enabled Patient Access Webinar: Key Takeaways

“Patient access begins at the moment that a drug is prescribed and encompasses everything that goes with getting a drug into a patient’s hand.” said Len Paolillo, CCO of Impel Pharmaceuticals, during last Thursday’s webinar focused on how the right technology can meaningfully improve the chances a therapy will actually be taken as prescribed. As the life sciences industry faces strong access headwinds in 2022 due to evolving consumer expectations and stricter payer utilization management requirements, the conversation was timely and important. Mr. Paolillo, alongside Deepak Thomas, Founder and CEO of Phil and Kim Plesnarski, VP, Market Access Solutions at Syneos Health, offered relevant insights for life science companies looking to improve their patient access strategy. The conversation touched on a range of hot-button topics ranging from the importance of timely channel insights to how tech, like the Phil Platform, has matured to the point where brands need to rely on it if they hope to reach their commercial goals.Here are key takeaways from the webinar for life sciences companies to consider:Increasing channel complexity is driving a greater demand for patient support services, yet the legacy access model is broken “Basically every launch today requires investment in access and support services. That wasn’t the case just ten years ago.” said Ms. Plesnarski when unpacking why the industry is witnessing 16% yoy growth in patient support services. The consensus among the panelists was that the legacy solutions; expensive, call center driven HUB providers,and specialty pharmacy networks are ill-equipped to respond to this increasing complexity. According to Len Paolillo, brands must avoid falling into the trap of relying on their past launches and need to treat each launch as a fresh start to evaluate the current state of the channel and what needs to be done to drive access with each individual patient. If they don’t, it’s inevitable that they’ll see limited prescriber adoption and will over rely on subsidies to keep patients on therapy. Patients are consumers and want the same purchase experience they’ve grown accustomed to in other industries - life sciences needs to deliver Mr. Thomas advised that brands would be wise to treat their target patient population first and foremost as consumers. Thus, they should be developing patient journeys that are responsive to consumer preferences and behavior in 2022 and on par with what consumers experience when making other significant purchase decisions. However, due to bolt on technology and the antiquated approaches of legacy access models, patients often feel like their pharma purchase experience is stuck in the past. This results in frustration, alienation of core constituents, and high rates of medication non adherence that contribute to poor health outcomes. Mr. Paolillo noted that one of the reasons he partnered with Phil to support Impel’s flagship launch in a competitive category was that the platform offered patients frictionless onboarding and refill experience that met patients where they are at - on their smartphone. He noted that “I was looking for a consistent patient experience that fit into their lives and stood out in its simplicity.” Brands should have a realistic view of their payer timeline at launch and look for partners that can quickly respond to formulary wins The panelists agreed that strategic planning is paramount to ensure conversion of market access to covered dispenses - a must for brands looking to optimize their gross to net. Noting the impact that access partners can have on a brand’s overall commercial trajectory, Deepak shared his view that the choice of access partner at launch is perhaps the most important decision a brand has to make. He emphasized that brands would be wise to balance the patient experience with the pursuit of coverage as this can ultimately make or break a brands financials. Further noting that there is a key distinction between an access partner that can deliver on driving pull through and one that will sacrifice the pursuit of coverage for pull through at all cost. Len underscored that if brands want sustainable growth, that they need to have good insight into the channel data to be able to understand when payer lives are going to come on so that they can quickly roll them off free goods into reimbursement. Patients shouldn’t know and don’t care when quickstart ends and coverage begins, but it’s important for brands to be able to make these changes quickly to tightly manage their finances. Life sciences companies need holistic pharmacy strategies that recognize that pharmacy incentives can be at odds with the patient & manufacturer Pharmacies typically have a singular mission and that’s to get patients on therapy noted Ms. Plesnarski. To succeed in today’s environment, brands can no longer rely on the notion that a pharmacy’s job is to help patients get on formulary. Brands should take a more strategic and proactive approach given that many pharmacies are not structured to deliver responsive patient experiences, or often do so at the expense of the manufacturer.  As there are meaningful differences in the various pharmacy formats, brands would be wise to consider the value that pharmacies provide and whether or not their incentives are aligned with their own. Misaligned incentives have resulted in a growing gap between positioning on formulary and a brand’s ability to convert that access into payer coverage at the point of dispense.Thus, many brands find themselves over subsidizing patient access for much longer than they had anticipated at launch and falling into a mid cycle crisis. If you don’t have clear, visible data into patient, physician, and HCP behavior, you won’t be able to adjust your access strategy effectively “Insights eat data for lunch”, Deepak quipped. All panelists were in agreement that timely data is essential to navigate the complexities of the drug channel in 2022. However, they were frank in suggesting that most access partners fall short in delivering the actionable insights brands need to be able to grow sustainably.  Without insights there is not much a brand can do with the information. Mr. Paolillo underscored the value of data, noting that if you can’t map the data back to the friction points of key stakeholders, there is not much you can do to reduce abandonment and the data doesn’t have much value. He shared that one of the benefits of the Phil platform is that paired data and insights have allowed Impel to adjust business rules around copay and shipping to help patients start and adhere to therapy. The bottom line is that data & insights can be a key difference maker for brands.Unlock the value of your productSuperior clinical trial results do not guarantee commercial success. A robust clinical profile is no longer enough – you need a value proposition supported by real-time data and a go-to-market strategy that optimizes market access and patient and provider engagement. If you are interested in learning more about what the Phil Platform can do for your brand, contact us to get started.

Phil, Inc. Forges Strategic Partnership with Syneos Health

SAN FRANCISCO, Calif. – October 25, 2022 – Phil Inc., a patient access platform company that revolutionizes life science product commercialization with technology to improve patient prescription access, today announced an exclusive partnership with Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization. Through the strategic partnership, Phil will serve as Syneos Health’s hub partner, creating an end-to-end commercialization solution for life sciences organizations to ensure patients can seamlessly start and adhere to therapy and receive and refill medicines quickly, easily and affordably.Under the terms of the agreement, Phil will exclusively provide Syneos Health with HUB-related services. Syneos Health will serve as Phil’s preferred provider for outsourced services, including field teams, engagement center, market access, field reimbursement, nurse navigator, and other services. “We’re honored to partner with Syneos Health to modernize patient access to prescriptions with a solution that addresses the pain points of providers, insurers and biopharma companies,” said Deepak Thomas, founder and chief executive officer at Phil, Inc. “Our combined solution provides hands-on, high touch service, aided by the best Silicon Valley technology and tools, to remove friction from every step of the prescription process. By removing barriers to accessing medication, we can help patients receive and adhere to the prescriptions they need and create exponentially better health outcomes.”“Syneos Health is excited to collaborate with Phil to transform the patient experience for prescription management,” said Deanne Melloy, Chief Commercial Officer, Deployment Solutions, Syneos Health. “Leveraging our deep commercialization expertise and market knowledge, coupled with Phil’s proven platform, we can offer customers a new service that ensures patients get the therapeutics prescribed by their care providers, creating  an end-to-end patient services unit that complements our long-standing offerings. About Syneos HealthSyneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically integrating clinical development, medical affairs and commercial capabilities to address modern market realities.We bring together more than 29,000 minds, across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcastAbout Phil, Inc.Phil, Inc. revolutionizes life science product commercialization with technology to improve prescription access. Our patient access platform removes barriers to medication access and ensures patients can seamlessly start and adhere to therapy. Providing end-to-end visibility into the prescription life cycle, we unlock coverage and maximize reimbursement for brands while integrating into the lives and workflows of patients and providers. We combine a Silicon Valley mindset and deep pharma expertise with data insights and software-driven platform customization to create exponentially better patient outcomes, improve provider experience and elevate brand value. ContactKatie BeachEvoke CanaleKatherine.Beach@canalecomm.com ###

How Pharmaceutical Manufacturers can Leverage Phil’s Technology to Improve Patient Access to Their Therapies

Many patients struggle to navigate healthcare effectively, inhibiting access to prescribed therapies. Patrick Leary, Chief Commercial Officer at Phil, shares how technology can break down many of the barriers patients experience, enabling them to better afford and adhere to their medications. Q: What are the most significant challenges patients face today when affording the medications their providers prescribe? Pat: Over the last few decades, healthcare has shifted toward having patients take on greater financial responsibility for their medical services and products. I believe the impetus was to encourage patients to be better consumers; however, the shift hasn’t manifested in that way. It has often resulted in creating barriers to care. High coinsurance and high deductible health plans result in financial toxicity for many patients. Formulary requirements often dictate that patients use a “preferred” or generic brand to get coverage, even if a provider prescribes a “non-preferred” therapy that they think is best for a specific patient. Ultimately, there has just been a shift of cost from payers to patients, making it difficult for many people to afford the medicine they need to treat their health conditions effectively. Q: What role can technology play in easing the patient financial burden related to accessing their prescribed therapies? Pat: Technology helps reduce the financial burden in a couple of ways. First, from manufacturers and providers to payers and pharmacies, it can remove many administrative costs associated with processing prescriptions. These cost savings can be passed on to patients. Second, and quite frankly the biggest opportunity, is that technology can ensure that patients take advantage of any available copay programs to reduce out-of-pocket and utilize in-network pharmacies to maximize prescription coverage. Third, it can ensure that all of the administrative hoops required to gain payer approval for prescription coverage are addressed. It used to take an army of people calling payers, pharmacies, and foundations to determine what financial resources were available for patients and how they could take advantage of them. The same was often true related to gaining payer coverage of prescribed therapies. Now, by automating many of these processes, technology can efficiently and effectively funnel patients to the best financial outcome possible for their prescribed therapy. Q: Why is speed to therapy important? Pat: Speed to therapy is crucial for better outcomes. The faster a patient’s medical treatment initiates, the more likely it will be efficacious and prevent or slow down disease progression. With rare exceptions, that’s universally true for any disease state. Also, when patients must delay getting started – for example, while waiting for prior authorization – they get frustrated, and the likelihood of prescription abandonment escalates. This generally means a diluted patient experience and a reduction of brand loyalty. Another perspective is that of the providers. If they find getting their patient on therapy too time-consuming, they may decide to try another treatment even though it’s not optimal for that patient. Q: What hurdles slow the process of getting a patient started on their therapy? Pat: There are tremendous hurdles between patients and their prescribed therapies. I refer to them as hoops to jump through. Today, they are more like flaming hoops in the form of formulary and non-formulary lists, prior authorization requirements, and step therapy, where patients must first try and fail certain drugs. Payers have erected significant financial barriers for medications that are not preferred or off formulary. These barriers to therapy access are designed to steer patients away from specific therapies that payers deem too expensive. Q: How can pharmaceutical companies proactively increase speed to therapy? Pat: They need to make the prescribing process as easy, familiar, and light a lift as possible for providers and patients. That means meeting them where they are by modernizing the process. For patients, send texts with a link. Simplify forms by pre-filling the patient information you already have. For physicians, ensure the prior authorization process works within current workflows and attaches clinical information. Stay within their EHR so they don’t have to learn to navigate another website or portal. Make it as easy to prescribe your brand as a generic, and providers will do it more often. Suppose you can give providers an easy-to-use technology embedded in a familiar process that helps reduce patients’ financial burden. In that case, you will be able to get many more patients started on therapy more quickly. Q: Given the correlation between medication adherence and clinical outcomes, how can pharma manufacturers use technology to improve adherence? Pat: Manufacturers can use automated communication technology to make staying on therapy as easy as possible. For example: Sending out messages that inform patients of the benefits of the therapy Reminding them of how to take their medication and the potential side effects Setting patients up on automated refills Informing of an upcoming refill and giving them the option to change the date It’s crucial to communicate with patients in the ways they prefer. Some people want to talk to a live person; others prefer a text reminder. When they sign up for therapy support, enable them to opt-in to receive text reminders. Give them choices to receive emails or phone calls. Then you can set up a cadence around the expectations for a particular therapy. Some nurse communications can be automated while allowing the patient to choose to talk to a nurse if they have additional questions. This approach will retain patients at a much higher level because they know what to expect, are more comfortable with the form of communication, and know they have resources when needed. Q: Can you share a real-world example? Pat: Absolutely! Phil is designing a technology-driven patient access program with a large pharma manufacturer. The program involves enrolling patients into the company’s nursing support program. We’re automating the front-end enrollment. With a large team of nurses making calls to enroll patients, the enrollment rates had been low. The underlying issue is that when people see an 800 number they don’t recognize, they don’t answer the phone. Our technology interacts with patients in ways they prefer, which results in much higher enrollment rates. Not only are patients happier, but so are nurses. And rather than calling and leaving messages all day, the nurses can focus on what they’re best at – helping patients adhere to their treatment. Q: How does the Phil Platform improve patient access to manufacturer’s brands?Pat: Phil reduces the friction many patients encounter when accessing their prescribed therapy. Our technology does all the things I’ve talked about and more: For prescribers, utilizing the Phil hub platform and pharmacy network is as easy as prescribing a generic – they just go in, select “Phil Rx” in their EHR, and send it to us. For patients, Phil captures all the relevant patient information from the EHR and prefills the electronic benefits verification form. The patient can confirm their insurance information on their mobile browser on their phone – we make that as simple as possible. If they don’t complete the mobile enrollment process (less than 5% of all patients) or want to talk to someone, we offer the opportunity to engage live via phone. They can call or request someone to call them. And this is all done in the patient’s preferred language. If the prescribed therapy needs prior authorization, Phil takes care of it. The platform prefills the information into required PA forms and sends a fax to the prescriber’s office to have them verify, add any missing information, and electronically submit. Every approved prescription is routed to a pharmacy that is best suited from a coverage perspective, meaning it has a contract with the payer. This eliminates out-of-network coverages. The platform automatically applies any manufacturer coupons or copay buydowns and collects credit card information to pay any difference. Patients receive a text to opt-in to the support services program to receive adherence reminders, clinical messaging, and support. Phil’s enrollment rate is over 90% compared to 30% for prescriptions that go through the traditional retail process. Opted-in patients are kept informed throughout the process, receiving updates about the status of their prior authorization, if they’ll be receiving some meds through a bridge program until approval, what their copay will be, etc. No more frustration because they are left in the dark about what is happening with their prescription. They can also choose to have their medication delivered to their home and to set up automatic shipments. The bottom line is that by streamlining the whole prescription process, the Phil platform achieves higher patient enrollment, more coverage for enrolled patients, and lower out-of-pocket. This trifecta translates to better medication access and adherence.

From the ‘go-go days’ to a bubble crunch — the biotech sector faces its next challenge

Editor's Note: In 2022, Biotechs face a challenging macroeconomic environment that has limited their access to growth capital supplied by investors. As many biotechs have leveraged investor capital to fuel growth, the drying up of available funding will have a material impact on their commercial operations. Biotechs with weaker cash positions will face more pressure to carefully evaluate spend and look for more sustainable growth pathways. Commercial stage biotech companies would be wise to evaluate new strategies and partnerships that help them to unlock payer coverage of their innovative therapies to reduce pressure on their gross to net margins and allow them to invest profits in growing their brands. Phil has extensive experience partnering with biotech companies at all stages of the commercial life cycle. Our platform is purposefully designed to improve patient access, ensure the highest % of dispenses are being covered by insurance, and provides unprecedented insights into the prescription lifecycle.Bubbles burst. Consider the U.S. housing bubble in 2008. The dot-com bubble in the early 2000s. Or go as far back as the Dutch tulip bubble in 1637. For biotech markets, though, a deflation from the heights of early 2021 has so far looked more like a leaky tire at cruising speed than a full-on highway blowout.The pinnacle of the biotechnology index known as the XBI — or the SPDR S&P Biotech exchange-traded fund — hit more than $160 in February 2021. Since then, the index fell below $70 at its nadir in June this year — a noteworthy drop in value for 16 months, but not one that is particularly concerning as a long-term proposition for the industry, some say. Since that low point, the XBI has been on a mostly upward trajectory to above $80 this month.That's still a long way down from the apex, though."If the bubble didn't pop, it certainly deflated," says Troy Wilson, CEO of the public biotech Kura Oncology. "In particular, what we saw was a drawdown and a pullback in asset values." Some of the downhill momentum can be attributed to larger forces such as inflation, interest rates and the fear of recession, Wilson says."It's not at the heights it was a couple years ago — it's not at the depths it was six months ago," Wilson says. "But I do think people are still a little bit on pins and needles."More likely than not, the recent dip is more of a correction than a major dive from the heights of the biotech boom, says Lance Minor, principal and life sciences national co-leader at accounting firm BDO. The sector will likely return to its apogee, Minor says, but when and how it gets there is important."I do believe we will get back to those heights, but I'm hoping that it's a more measured growth and not as reactionary or as driven by the pandemic surge," Minor says.Technologies like mRNA that led to COVID-19 vaccine innovation will carry on into new therapeutic areas to treat some of the more stubborn diseases of the past, for instance. What fed the biotech bubble in the first place and what led to its demise, however temporary, is complicated, but understanding its implications can offer insights into what's ahead for the industry.'The go-go days'One of the contributors to the overheated biotech market was investors’ fears of missing out during the rapid rise in valuations that accompanied the beginning of the COVID-19 pandemic.Wilson calls these times the "go-go days.""You had very easy monetary policy from the [Federal Reserve], so investors could borrow money at essentially zero and put it into high-risk assets — the Fed intentionally or unintentionally created a series of asset bubbles," Wilson says. "We saw it in biotech, we saw it in cryptocurrency, we saw it to a certain extent in tech, we saw it in housing — investors were borrowing and making outrageous returns and the cycle repeats itself."During these go-go days, biotechs were presenting reams of positive clinical data and attracting investors. And like a forest fire creates its own weather systems, Wilson says, so too do risky capital markets. In this case, it created a surge in demand for new companies, which inflated the bubble that quickly grew as startups that were still years away from demonstrative clinical data were going public with successful IPOs."A lot of investors were making outsized returns in biotech using cheap dollars, and so an ample supply of entrepreneurs and venture capitalists were willing to take companies public, and it was raising the amount of new companies that were coming to market," Wilson says.As the supply of public company stock rose, the demand leaked out, bringing asset values down, which led investors to liquidate their positions, Wilson says. Essentially, there were more companies than there was investor support. "We didn't see a crash," Wilson says. "What we saw was just the air coming out of the balloon." There is still rampant inflation and the likelihood that the U.S. economy is either in a recession or entering one, Wilson says. And now, something’s got to give."There are more companies than the market can reasonably sustain — we don’t need seven companies pursuing the same therapeutic target," Wilson says. "Whether it's M&A activity, whether it's bankruptcies, you're going to see consolidation and you're going to see that this naturally corrects itself."Investors are looking for the 20 to 30 companies that are going to become the next marquee names, and Wilson suspects about half of them will be in oncology.Still, the window into the future isn't entirely fogless."It could take well into next year before we have clarity on where the macro picture is," Wilson says.Cash on hand, you can standLance Minor, BDO principal and life sciences national co-leader Permission granted by Lance Minor/BDO The companies at most risk during this deflationary time are those that are tight on cash, Minor says. Conversely, companies with some financial runway will have an easier time riding the wave back up."With cash reserves tightening and a reduction in the issuance of debt, it means firms need to be smarter with how they're spending money," Minor says. Of course, that biotech bubble was critical to the therapies and vaccines that were quickly approved during the pandemic — the risk taken early on paid off, even though it was an expensive way to pursue development, he says. From an executive standpoint, Wilson agrees that the companies best positioned to snag a spot in a potential upcoming boom are companies that have a lot of cash and data catalysts before the end of the year. The calendar year is particularly important for Wall Street's fund managers, whose annual bonus depends on their position at the end of December.On the other side of the spectrum, companies with less than two years of cash on hand and no clear data catalysts aren't attracting the attention they once did in better times."The pendulum swung all the way in the opposite direction, so preclinical data is really not derisking anymore in the minds of investors — they need clinical derisking events," Wilson says. "You're seeing a separation of the haves and the have-nots." Companies who may have hit the IPO button too early during the bubble period and have struggled to show timely clinical data are now seeing Wall Street's waning interest.Kura's IPO came through in 2015, and that was a good time to cash in, Wilson says."When people are handing out hors d'oeuvres, use both hands," he says. "We were fortunate to be able to access the capital markets in late 2020 to raise about $300 million." Kura has planned inflection points coming within the next few years and their cash position gives them leeway to not depend on raising more capital.New tech, meet big moneyThe biotech boom brought about many technology advances that fed the current slate of hopefuls, and those promises can help feed the larger biopharma industry as bigger companies look to bolster their own pipelines."Economic growth, particularly in biotech, was quite high, driven by new technology and new innovation," Minor says. "Most notably around COVID — monoclonal antibody therapeutic treatments and vaccines brought in billions."Platforms for cell and gene therapy have also given rise to a wave of innovation that lends value to the overall sector, he says. This is where consolidation is likely to come into play, as biotechs have fallen in value to the point where cash-rich pharma giants can scoop them up for a bargain."Tightening cash, tight runways for development, lower valuations of the smaller companies, the large cash supply that larger companies have stockpiled — it all means the smaller companies are ripe for M&A," Minor says.The number of IPOs has dropped from their heyday during the height of the bubble, and a recent wave of deals washing upon the biotech shores of late promises better times ahead, Wilson says. In particular, rumors of a potential acquisition of cancer drugmaker Seagen by pharma giant Merck & Co. would help push that along."If that were to happen, it would be a great thing for two reasons," Wilson says. "It would further validate for investors this thesis that a large pharma is willing to pay a premium for innovation, and it would unlock $40 billion in capital that could then be redeployed and reinvested into other companies."For now, the best advice Wilson has for these more meager times in biotech: "Don't assume the market is going to step in and rescue you."The outlook for biotech could improve in 2023 — but it also could be worse, Wilson says."You have to have a game plan that says, I can still be successful if the go-go days don't come back," Wilson says. "I hope we return to those halcyon days, but I think we're going to see more pain in the economy before things get better."This article was written by Michael Gibney from PharmaVoice and was legally licensed through the Industry Dive Content Marketplace. Please direct all licensing questions to legal@industrydive.com.

3 Ways for Pharmaceutical Companies to Improve the Probability of Launch Success

Launching a successful pharmaceutical brand is no easy task. It takes significant stakeholder alignment across many strategic fronts to successfully transition from FDA approval to product adoption and growth. And even with a sizable base and formulary placement, it doesn’t necessarily follow that a brand will overcome the “Coverage Hurdle'' that requires a brand to jump through hoops to convert market access to a high % of covered dispenses. With the stakes at brand launch at an all-time high as a result of soaring drug development costs and the prospect of slipping into a mid-cycle crisis an ever present reality - brands would be wise to adopt new paradigms at launch.While the need to adopt new launch models is essential, it remains to be seen whether such a paradigm shift is currently present in the marketplace.This question is particularly salient as it relates to smaller sized organizations whose share of launches has been increasing as % of annual new products introduced to the marketplace. Recent McKinsey research suggests their share of successful launches is well below that of experienced launchers:While this trend can’t be attributed to any one factor given all launches are dynamic and unique, one cause identified that is contributing to this disparity is that leaner organizations often rely on relationships with a few key opinion and trial-site leaders to inform their thinking on critical decisions like pricing, sales-force deployment, and partnerships. This should come as no surprise as smaller, capital constrained organizations inevitably have limited human capital to support commercial efforts. While larger companies typically deploy specialists in key areas such as marketing, access, and sales, it’s not uncommon for key executives at smaller organizations to serve as generalists that make decisions across these essential areas. In time constrained launch phases, commercial leaders often fall back on previously utilized partnerships and paradigms that are not necessarily fit to succeed in today’s dynamic drug channel. With insights gleaned from over 100 access programs across therapeutic areas, here are some of Phil’s key learnings that that can be applied to brand launches to help brand’s realize their unique potential:Prioritize Brand Loyalty over New Patient Starts - During a brand’s launch phase, commercial teams are often laser focused on generating a head of steam with HCPs and patients to get patients on therapy. From a tactical standpoint, this generally means a significant marketing effort directed at HCPs to educate them on the efficacy of their product and subsidizing access to therapy with a bridge program while the brand expands formulary placement. While getting patients on therapy is essential, generating a loyal base requires more than driving new prescriptions with manufacturer subsidies. To create lasting brand loyalty, brands must think holistically about their goals during a launch, and this should start with prioritizing the overall patient experience with their brand to ensure patients are able to easily access, afford, and adhere to therapy. If long term affordability and adherence are out of reach, brands will struggle to maintain loyalty over the long run even with a clinically differentiated product. This will result in diminished confidence with HCPs and patients which in return stunts their chances for sustained growth.Weight Market and Patient Access Equally - While most brands lack significant market access with top tier payers at launch, brands that have demonstrated differentiated clinical efficacy can reasonably expect to sign some major payor contracts. When this happens, the prevailing expectation is that these contracts will unlock patient access translating to meaningful coverage of dispenses. Commercial executives understand that this is essential for sustained growth as manufacturers can’t subsidize their brands with access dollars forever. Yet, it’s increasingly common for brands to be frustrated to find that their formulary placement isn’t flipping the script on the overall percentage of covered dispenses. The cause for this is typically related to challenges with prior authorization requirements as well as the misaligned incentives at the pharmacy counter that contribute to manufacturer coupon overutilization. Brands should shift their thinking further upstream from simply generating market access to orchestrating covered dispenses. This can be accomplished by choosing the right access partner to cultivate patient access strategies that facilitate a high probability of coverage success.Choosing the Right Access Partner is Critical - As pharmaceutical companies prepare for launch, they need to make critical decisions regarding their partner ecosystems that can help them realize commercial goals. There are two leading factors that have made this process more challenging for brands. First, as the size of the pharmaceutical market has expanded, so has the number of potential vendors. More choice has made the decision-making process more complex given that many solution providers look the same, talk the same, and make the same promises. Second, the complexities of the drug channel have increased dramatically, and the overall pace of change and disruption is increasing. This has translated into a need for larger partner ecosystems and diluted effectiveness of legacy access partners. Therefore, it’s essential for brands to ask the right questions when evaluating potential partners. Brands should press hard to determine if organizations are:Positioned to respond to rapidly shifting consumer and HCP expectationsStructured to operate with aligned financial incentivesAble to corroborate their claims and results with robust data & referencesCapable of making sense of data to provide actionable insights to inform strategyInvesting in innovation that will result in long term benefits in an evolving channelThe bottom line is that launching a successful brand is a more challenging proposition than ever, particularly for smaller pharmaceutical companies. By prioritizing a more holistic and innovative approach that can be realized with the right partners, brands can meaningfully improve their probability of high adoption and reaching their expected value.Through its next-generation patient access platform, Phil partners with pharmaceutical manufacturers to remove barriers to medication access and adherence. A seamless patient experience allows those who need them to be able to benefit from their prescribed drug therapies. Visit our website to learn more. About the Author:Dan is the Director of Product Marketing at Phil. He supports the organization’s growth by driving go to market strategy, crafting compelling content, and leading sales enablement. He has an extensive background in healthcare big and small and is passionate about the ability of technology to improve health outcomes.

Why Your Channel Strategy Matters

Channel strategy underpins the deployment of a life science company’s overall commercialization strategy. A company’s channel strategy is the tie that binds the market access, patient access, marketing, trade, and sales strategies to meet brand goals effectively. Ideally, it tightly integrates the processes for managing the logistics of getting products from the manufacturer to patients, implementing services to support patient access and medication adherence, and capturing channel data to measure success and inform decision-making.Getting your channel strategy is essential to ensure patients can access and adhere to therapy – here are four ways channel strategy can positively impact your brand’s success:1. Differentiating your productWith the pharmaceutical industry facing diminishing returns on development investment, and increased payer utilization management controls, the stakes are high. Strategic product differentiation, particularly in competitive categories is a must key to mitigate risk and improve the probability of success. The promise of positive patient outcomes alone is insufficient alone. Payers require manufacturers to prove the real-world value of their brands, which means that patients need to be able to access and adhere to therapy.Your channel strategy essentially creates a post-launch infrastructure to substantiate the value of a product beyond efficacy and when applied correctly can differentiate it from competing therapies that may struggle to generate significant adoption. When data is an integral part of your strategy, you can gain a deeper understanding of patient needs and show how your brand uniquely solves unmet problems, such as enhanced tolerability, convenience, greater safety, or reduced healthcare costs.2. Improving patient experienceConsumerization is one of the biggest healthcare trends impacting pharmaceutical commercialization today. Patients want the same experience they get from other industries, such as retail, consumer technology, and banking. At the same time, healthcare providers are busier than ever and under the gun to improve the quality of care and manage new blended care models. A poor prescriber experience often results in reduced brand loyalty.A well refined and modern channel strategy can improve patient and provider experience by minimizing the complexity associated with patient access, ultimately generating a stronger value proposition by:● Improving outcomes by accelerating speed-to-therapy●  Limiting healthcare costs resulting from non-adherence●  Reducing the burden placed on prescribers to address lengthy PA requirements●  Minimizing poor outcomes due to prescription abandonment3. Expanding coverage and reimbursement Getting a prescribed therapy from manufacturer to patient – effectively and efficiently – is crucial to hitting sales forecasts and, ultimately, brand success. Multiple studies have shown that broad payer coverage correlates with better outcomes, so it makes sense to ensure favorable coverage in today's value-based system. However, manufacturers would be wise to consider the fact that broad coverage doesn’t always translate into a high % of covered dispenses.A key element of a company's channel strategy is the design of its drug distribution model. Each plan's coverage, coding, and payment criteria determine whether a therapy is covered and at what price. Pricing and reimbursement systems are notoriously complex to navigate. Failure to optimize your distribution network can lead to poor coverage and reimbursement outcomes, undermining commercialization efforts even if your market access team has signed payer contracts.Life science companies – particularly those in certain therapeutic categories or that are smaller or startups – can generate a substantial competitive advantage and avoid a product mid-life cycle crisis with a streamlined distribution model that offers comprehensive coverage and high reimbursement rates.4. Accelerating therapy startsAlthough the negative consequences of delayed therapy are well documented, medication delays are common. In a 2021 report, 82% of patients experienced delays accessing their medications for various reasons, including cost and insurance challenges.More and more payers are implementing utilization management measures, such as prior authorizations (PAs), to stem rising healthcare costs, especially related to specialty medications. In fact, 79% of medical practices report that PA requirements increased between 2021 and 2022. The PA process, by design, is a significant barrier to medication access – it can leave patients waiting for days or weeks for approval, and coverage can be denied despite being appropriately prescribed.A pharmaceutical company’s channel strategy can be instrumental in accelerating patient access to therapy. Integrating technology to simplify and automate the PA process for pharmacies and providers can effectively reduce medication access delays.Getting your channel strategy rightYour channel strategy is essential to the patient journey and should be as unique as your product and the patients it treats. It can make or break your brand’s success. Watch Phil’s on-demand webinar to discover vital considerations for your channel strategy and how to evaluate channel partners so you can build a channel strategy that will have the most significant impact on your patients and your bottom line.

3 Ways Healthcare Technology is Improving Medication Adherence

One of the most significant burdens on the U.S. healthcare system is nonadherence to drug therapy. Not only does this issue exact a severe toll on patients’ health and quality of life, but the related healthcare costs are also staggering. Studies show that up to 60% of patients struggle with medication adherence, and failure to take prescribed treatment causes an estimated 125,000 avoidable deaths and $100 billion in preventable healthcare costs each year.For years pharmaceutical companies have tried to address nonadherence by making medications more manageable and convenient to take through drug formulation and delivery method improvements. The latest technologies hold great potential to solve this deep-seated problem. By connecting siloed and fragmented data from key stakeholders, like providers, pharmacies, and payers, and using mobile applications to communicate with patients, the tech sector is stepping with data-driven applications to support and improve medication adherence. Here are three examples:1. Reminders: Many patients have difficulties understanding and remembering how to take their medications correctly. Complicated medication schedules due to dosing or polypharmacy are common reasons for nonadherence. Patient-friendly mobile applications can use pharmacy data to send out timely automated reminders, such as push notifications, texts, and video messages that help patients stick to prescribed treatments. Additional reminders that a prescription is about to run out help patients stay proactive and further support adherence.2. Patient education: An easy-to-access patient prescription information portal can offer educational materials on how a medication works, potential side effects, proper drug storage and administration, dosing, what treatment benefits to expect if taken as prescribed, and encouragement to contact their prescriber if anything unexpected occurs. Patient portal technologies can drive health literacy, which impacts treatment adherence and patient outcomes.3. Motivation: Technology can help motivate patients to stick with their prescribed therapy. Consistent encouragement to complete various therapeutic steps combined with informative tools that drive a better understanding of how those steps pave the way to a meeting patients’ health goals can boost adherence. A 2017 study concluded that gamification – applying video game elements, such as virtual rewards for completing tasks, in a non-gaming environment – was a “valuable technique to motivate people to adhere to medication regimens.” In fact, the healthcare gamification market is forecasted to grow at an annual rate of 11.9% from 2019 to 2026. The bottom line is that personalized electronic correspondence promotes patient engagement and empowers patients to strive for therapy independence and self-management.Healthcare technology applications create opportunities to boost adherence to long-term therapies. While technology cannot replace the relationship between a patient and clinician, it can facilitate better partnerships between healthcare providers, pharmaceutical manufacturers, pharmacies, and patients to enhance outcomes.Through its next-generation patient access platform, Phil partners with pharmaceutical manufacturers to remove barriers to medication adherence. A seamless online experience empowers patients to access and benefit from their prescribed drug therapies. Visit our website to learn more.

Where's the Data? The Healthcare Data You Need to Drive Commercialization

What matters most for life sciences companies is not the amount of data but knowing how to use it. A Forrester report revealed that data-driven companies experience an annual average growth rate of over 30%. Pharma companies that invest in capabilities to capture and analyze the best data to make informed commercialization decisions will realize better business outcomes and a competitive advantage.Understanding the value of data Data alone hold negligible value because it reveals very little meaningful information. The true value of data comes from analyzing the data to enable actionable insights. These insights can help pharma companies boost market access, improve business operations, and strengthen customer relationships. Using a data-driven approach for pharma commercialization can generate substantial returns, including a 5-10 percent net revenue improvement and 10-20 percent spend reduction/reallocation. By basing decisions on accurate information backed by validated data, pharma companies avoid moving in the wrong direction. Data-supported decisions eliminate political influence, bias, and following “gut feelings” that can lead to poor decision-making and waste valuable resources.Not all data is equal in its ability to contribute to sound business decisions. Data must be current and accurate when decisions are made. The healthcare environment is constantly evolving, so pharma companies should not rely on initial data sets that are likely to be no longer relevant. Continually collecting and analyzing data is key to effective commercialization strategies.Data sources for pharmaceutical commercializationThere are various sources from which commercialization teams can leverage real-world data – post-launch data collected outside of a clinical trial – to make strategic, informed decisions, including: Electronic health records (EHRs) and e-prescribing systemscontain current, accurate patient-based data from prescribers.Retail pharmaciescollect a wide range of data on the prescriptions they fill and dispense, which offer a clearer picture of a patient’s medication use and barriers to adherence.Supply-chain operationsgenerate data across the entire product lifecycle, which can help identify vulnerabilities and bottlenecks that negatively impact market access.Payer claimscan provide medical claims data and data around enrollment and engagement in health plans and optional programs.Patient-reported outcomesdata comes from surveys in which patients independently report the status of their health conditions during treatment.Digital devices and mobile health applicationscontain a wealth of patient-generated data on health habits and disease outcomes.Disease registriescollect data on patient populations diagnosed with specific conditions, which may reveal the quality of life and financial burden issues as well as other challenges not found in EHRs.Customer relationship management (CRM) systemsprovide customer, customer engagement, and sales activity data that can drive commercialization objectives. 11 data-driven opportunities for pharmaceutical commercialization Data-driven decision-making offers many opportunities for pharmaceutical commercialization teams, including the ability to: Demonstrate the value of treatments to payersEnable outcomes-based pricingAchieve a better formulary positionDrive medication adherenceIdentify new opportunities for existing brandsInform the design of patient servicesIdentify underdiagnosed patientsGrow sales and improve processesDevelop point-of-care clinical decision supportStrengthen provider, payer, and patient engagementHarness the full power of digital technology investmentsUnlocking the power of dataUnlocking the power of data should be at the forefront of pharmaceutical manufacturers’ efforts to align business goals and outcomes. Faced with an overwhelming amount of data and a complex healthcare ecosystem, many pharma commercialization teams find that getting a holistic – and timely – view of stakeholders is a significant hurdle. Data analytics can help companies quickly respond and adapt to market changes and obtain a competitive advantage with the right commercialization partner. Phil is an end-to-end commercialization partner that provides an integrated approach to data analytics across the patient journey giving life science commercialization teams real-time visibility and control over their distribution channels. Get in touch today to discover how you can drive market access with deeper data insights.   

How to Streamline Pharmaceutical Commercialization

Developing a new drug is an incredibly costly, time-consuming, and high-risk venture. In the 21st century, it typically takes ten years and over $2.6 billion for a pharmaceutical manufacturer to move a drug from its initial discovery into the marketplace.While getting an innovative treatment approved for patient use is a major milestone, it’s just the beginning and certainly does not ensure the brand’s commercial success. It takes an extensive, coordinated effort to successfully take a new drug from FDA approval into patients’ hands. Given that a considerable investment has already been made to make the drug available to patients, it's up to the commercial team to develop a go-to-market model that delivers the best ROI possible. Pharmaceutical manufacturers would be wise to strategically reduce commercialization inefficiencies and improve margins through outsourcing, Lean initiatives, and data analytics.Outsource your drug commercializationAs research and development costs continue to soar, life sciences companies are under increasing pressure to optimize revenue generation for their brands. Since go-to-market strategies can be complex, resource intensive, and expensive, outsourcing pharmaceutical drug commercialization to third-party experts can yield significant cost savings and operational efficiencies while enhancing the probability of commercial success. Pharmaceutical companies can avoid major infrastructure, software, and personnel investments by adopting vendor solutions that integrate their marketing and commercialization processes. This strategy enables them to focus their budget on building and maximizing the value propositions of their brands by:Creating a seamless patient experienceAccelerating time-to-therapyImproving medication adherenceOptimizing market accessApply a Lean approach to commercializationThe successful implementation of “Lean Manufacturing” at Toyota inspired organizations worldwide to adopt a Lean management approach. The Lean Enterprise Institute describes the concept as “a way of thinking about creating needed value with fewer resources and less waste.” According to the Virginia Mason Institute, Lean healthcare is about “implementing processes that add value from a patient perspective - and eliminating or improving those that don’t.” The organization also points out that while “cost savings aren’t the focus of Lean management, they are often an outcome.”Many U.S. healthcare organizations have successfully executed lean management principles, reporting better patient outcomes, lower costs of care, higher patient experience scores, and improvements in productivity.The pharmaceutical sector, however, has been a late adopter of the approach, with many companies struggling to sustain their Lean initiatives. This challenge is partly because the focus has been primarily on manufacturing operations, and an entrenched silo mentality has limited the potential value of lean practice.By adopting Lean principles across the entire supply chain, pharma manufacturers can realize significant efficiency benefits that will give them a competitive edge. For emerging life science companies that want to commercialize their own products, using a Lean approach can help with identifying the best areas to focus internal resources and where it makes the most sense to outsource.Leverage technology and data analyticsPharma supply chains generate large volumes of data – historical sales data, supplier performance data, insurance coverage data, point of sale consumer data, and much more – from which commercialization teams can glean insights to drive down costs and increase revenue. However, these data sources are often underutilized. According to data from IBM, 84% of chief supply chain officers report that their biggest challenge is a lack of supply chain visibility.From drug discovery and development to manufacturing, distribution, and fulfillment, advances in digital technology and analytics are opening opportunities at every stage of the pharmaceutical product’s life cycle.When pharma and life science companies leverage the latest digital technologies to analyze their supply chain data in real-time, they gain a clearer picture of what’s happening across the supply chain. Greater visibility will enable teams to identify inefficiencies and opportunities to reduce costs. Leaders can then make informed decisions to improve efficiency, decrease waste, reduce operational risks, and enhance the experience for all stakeholders.Is your brand reaching its full commercialization potential?Excellent clinical trial results do not guarantee commercial success. You need a go-to-market strategy that optimizes your ROI and ensures your product reaches its full commercialization potential.Phil’s “channel-in-a-box” solution enables life science companies to optimize the commercialization of their drugs effectively and efficiently. For more information on partnering with Phil, visit phil.us/manufacturers.

Optimizing your Drug Distribution Model

The primary objective of a drug distribution model is to ensure patients receive the medications they need when they need them. A manufacturer’s strategy for getting their product from manufacturer to patient – effectively and efficiently – is crucial to the success of a therapy. The complexity of the distribution process has been exacerbated as a result of the pandemic. In addition to considering the range of physical, financial, and logistical challenges, life science companies would be wise to evaluate the needs and preferences of key stakeholders. Commercial teams can take the following steps to optimize their distribution process across a brand’s life cycle.Understand your distribution network optionsA pharmacy network is a group of pharmacies that a health plan contracts with to provide medication at a discounted price. The most impactful decision commercialization teams must make is whether to leverage an open or limited distribution pharmacy network, as this decision hinges on balancing market access with the cost of distribution. Here are the pros and cons of the two most common distribution networks:Limited distribution network: In a limited distribution network, a drug manufacturer contracts with only one or a very limited number of pharmacies. This option is commonly used for specialty therapies as it often presents a number of strategic advantages for brands. According to the 2019 State of Specialty Pharmacy Report, almost 85% of manufacturers manage some or all their products through this model.Pros: More oversight over the distribution process and better medication adherence stemming from the high-toucher clinical care. This may also lower distribution costs.Cons: Payer network coverage may be limited leading to lower coverage approval rates and over subsidization of medications to ensure patients can accessOpen distribution network: This is the traditional distribution option in which a pharmaceutical company makes its drug broadly accessible through a major wholesaler and various dispensing pharmacies, including retail, specialty, and mail order. A 2019 report by Deloitte estimates that 92% of total prescription drug sales go through wholesale distributors.Pros: Larger geographical and health plan coverage, economies of scale, and reduced risk.Cons: Less control over and visibility into distribution processes. Diluted patient experience and limited support for prior authorizations.Evaluate your distribution model for gapsThe stakes are high for life science companies when it comes to establishing the “best fit” drug distribution model for a brand. Failure to develop an optimal distribution strategy can result in poor prescriber uptake, reduced speed-to-therapy, lower rx coverage approvals, prescription abandonment, poor medication adherence, inability to demonstrate value – and ultimately commercial failure.It’s not unusual for manufacturers to adjust distribution models as brands mature in the market. If your brand is in the middle of its lifecycle and underperforming, it may be time to evaluate your current distribution channel and consider transitioning to a different model that can help you achieve your business goals.The following six questions can help you identify gaps and weaknesses in your company’s distribution process:1. Is your current distribution model enabling equal or better access to your brand vs. competitors? 2. Is your current process flexible, allowing your distribution to adapt to changes in the marketplace that may influence growth? 3. Does your return on investment justify the expenses you are incurring such as third-party logistics, transportation, limited distributor service fees, hub, and specialty pharmacy network? 4. Do you have visibility into channel data to inform critical commercial decisions? 5. Do you have the right level of pharmacy network coverage for the patient population size, geographical area, utilization patterns, and outcome goals? Does your pharmacy network have the contracts required to effectively drive coverage?Meet the needs of the four PsA decade ago, a column in Reuters Events dubbed the customers that pharmaceutical companies should be focusing on as the “Four Ps”: prescribers, patients, payers, and pharmacies. The article made the point that “patients often have to make substantial co-payments and are increasingly informed and anxious to participate in the choice of their therapies, allotting them some of the prescriber and payer roles; Prescribers are suffering penalties for over-prescribing, making them payers to some degree; payers are involved in treatment guidelines, making them deciders... and so on.” The bottom line was that the four Ps determined the fate of pharma manufacturers’ drugs.Ensuring your distribution model meets the interconnected needs of these four key stakeholders is as relevant as ever today. Some relevant examples include:Prescribers:Provide patient financial assistance programs, prior authorization support, and medication adherence supportPatients: Support medication access, adherence, education, financial assistance, and home delivery to deliver a seamless experiencePayers:Offer competitive pricing, contracting support, and outcomes reportingPharmacies:Support compliance management, patient education, reimbursement coordination, and billing assistance Streamline the product journeyA seamless product journey is tantamount to optimizing your probability of success. All too often, life science companies find themselves entrenched in an overly complex and underperforming distribution model that lacks the flexibility to adapt to a changing marketplace and continue to meet the needs of stakeholders. Manufacturers can navigate distribution complexity by leveraging technology and data analytics to better connect patients to therapy. When life sciences companies partner with Phil, they gain access to a nationwide pharmacy network with 98% plan coverage that enables patients to receive their prescribed therapies quickly and effectively. Real-time insights ensure a consistent, predictable experience for providers and pharmacies across the network. This ensures that manufacturers are able to continue to grow their brands in a sustainable way.Read this case study to learn how one manufacturer partner changed its distribution model and transformed an underperforming mid-cycle specialty product into a successful brand.

Determining the Optimal Channel Strategy for Your Pharma Brand

In this on-demand webinar, Patrick Leary, Phil’s Chief Commercial Officer, discusses challenges pharmaceutical brands are facing and how a well-thought-out channel strategy is essential to these key success factors:- Speed-to-therapy - Payer Coverage (Approvals of Rx) - Pull-through to First Fill - Adherence to Therapy - Reimbursement A fragmented commercialization strategy poses significant risks to brand growth and threatens things like the patient and prescriber experience, rates of prescription coverage and pull through, medication adherence, and ultimately, profit margins and commercial success.In this webinar, you’ll learn some of the market factors impacting channel strategy, such as payer cost control measures, out-of-pocket costs, and patient consumerization, along with seven important channel strategy considerations and eight components of channel partner evaluation. You will also see a case study on one brand’s successful launch where they exceeded their commercial and access targets with:A 95% enrollment rate50% of Trx covered in the first month3x average adherence vs other channels4x + net sales vs other channels

Technology Trends Shaping the Future of the Pharmaceutical Commercialization

Due to its highly regulated, high-risk environment, the pharmaceutical industry has traditionally been slow to adopt new technologies. A conservative approach to technology implementation means that pharma companies may be missing out on the advantages digital technologies offer and have lagged behind other industries in creating rich customer experiences; however, the Covid-19 pandemic significantly accelerated digital transformation throughout the industry.The latest healthcare technologies promise to transform the development and delivery of innovative pharmaceutical therapies and elevate the experience for patients and providers. Digital transformation is “the process of using digital technologies to create new – or modify existing – business processes, culture, and customer experiences to meet changing business and market requirements.” Here are four of the biggest health technology trends shaping pharma's future.AutomationFrom employee on-boarding and clinical-trial management to launch monitoring and sales operations planning, automated processes streamline workflows for pharmaceutical companies, saving them valuable time and money. Automated processes can also improve the patient experience in ways such as identifying all drug financial assistance programs for which patients are eligible and helping them successfully initiate and stay on therapy.According to the 2021 CAQH Index, automation has reduced the annual cost of healthcare administrative transactions, such as eligibility and benefit authorizations and prior authorizations, by $166 billion. And there’s a huge opportunity to save an additional $20 billion simply by transitioning fully to electronic transactions. Advanced analyticsAdvanced analytics, which also includes artificial intelligence (AI), machine learning, deep learning, and natural language processing, helps companies draw insights from their vast data to make more informed and strategic decisions.recent report forecasts that the global healthcare analytics market is expected to grow at an annual rate of 28.8%, reaching $93.3 billion by 2027. The report attributes the rapid expansion to “the development of advanced analytical solutions tailored to the specific needs of healthcare organizations and facilities providing financial, operational, clinical, and administrative services.”Pharma companies sit on a wealth of data. With advanced analytics, they can make use of real-world data to analyze medication adherence rates, clinical outcomes, social determinants of health (SDOH), and cost savings that can inform how they respond to a rapidly evolving patient experience. This can empower pharma companies to employ personalized, data-driven interventions to drive medication adherence and demonstrate value to payers among other use cases.Digital platformsAccording to a recent report from Gartner, digital life science platforms will be mainstream within five to ten years, which will enable companies to “nimbly adapt their business and operating models in response to external disruption and change in business strategy.”A digital platform handles end-to-end business processes to optimize operations and improve the experience for both internal and external stakeholders. Ideally, it enables a data-driven ecosystem that cuts across organizational information silos and technology investments. In addition to enhancing patient engagement, digital platforms can help pharmaceutical companies: Strengthen commercial and marketing operationsDeliver the experiences patients expect and demandOptimize distribution and drug fulfillment channelsBiosensors and wearable devicesDriven by technological advances in mobile devices, remote patient monitoring, and disease detection and diagnosis, the global wearable biosensors market is expected to surpass $49 billion by 2027. The potential of wearable technologies to collect real-world data, enable personalized care, and improve patient outcomes presents significant opportunities for the pharmaceutical industry. McKinsey & Company gives an excellent example of how a digitally enabled approach to patient care using biosensor technologies may “improve outcomes to the extent that they could become a condition of reimbursement, particularly for expensive specialty drugs”:“A care plan for a Parkinson's patient might include a medication regimen with "chip on a pill" technology to monitor drug taking along with a smartwatch that monitors the patient's condition, sends him or her reminders to adhere to the prescribed treatment, and sends the neurologist compliance and health-status reports. The neurologist can then coach patients on lifestyle changes or even customize therapy remotely.” Are you ready for the future?Automated and secure data systems with next-generation analytics are vital to capitalizing on opportunities in healthcare. To ensure the commercial success of their life saving therapies, life sciences organizations would be wise to consider partnerships with technology vendors that can help them enhance their use of data to elevate the patient experience and drive overall brand value. As an end-to-end commercialization partner, Phil delivers a digital platform that streamlines medication access and adherence while providing an integrated approach to data analytics across the prescription journey. Get in touch today to discover how you can drive market access with deeper data insights. 

Migraine - Post Approval Insights

Migraine is a neurological disorder that affects approximately 1 in 6 Americans and leads to over 1 million emergency department visits in the US annually. Just like many neurological conditions, the treatment landscape of triptans, opioids and NSAIDs has fallen short of providing a sustainable solution for migraine patients with drugs that have subpar efficacy and intolerable side-effects. The condition has been difficult to study and characterize due to varying levels of severity, causes and symptoms and traditional therapies have not specifically addressed the disease pathology of migraines. However, due to the high disease burden impacting schools, workplaces, social settings and healthcare systems, pharmaceutical companies have prioritized the development of migraine therapies with a new class of drugs called calcitonin gene-related peptide (CGRP) antagonists. These CGRP antagonists were designed to target a substance that is elevated in the blood during migraine episodes and they can be administered to prevent migraine attacks.Several CGRP antagonists have been approved since 2018, with slight nuances in drug target, method of administration and dosing frequency. Clinical studies and meta-analyses have confirmed meaningful reductions in migraine headache days, yet the nuanced differences between CGRP antagonists requires a delicate assessment for individual patients. Meanwhile, these specialty medications come at a much higher price compared to existing standard of care options.The high price has meant that payers require migraine patients to jump through a number of medical and administrative hurdles before getting access to CGRP antagonists and this requires step therapy to prove no benefit on less expensive non-specialty agents, while prior authorization is required on the basis of migraine frequency and severity. For some clinicians and physicians, prior authorization hurdles to access CGRP antagonists can be a deterrent to the pursuit of these newer and more effective therapies as patients can't afford the wait times, while the stress of the authorization process can often be counterintuitive to the management of migraine symptoms.Manufacturers have the opportunity to work with Phil to improve market penetration of migraine therapies by offering an enhanced patient and clinician experience, detailed education on the nuanced benefits of these specialty medications, along with assistance in bypassing prior authorization hurdles.Here are some examples of recently approved CGRP antagonists and how they’ve fared on the market thus far.AimovigCompany: Amgen/NovartisGeneric: erenumab-aooeIndication: For the preventative treatment of migraineApproval date: 17 May 2018Analyst peak sales forecast: $1 billion by 2026Full year 2021 sales: $313 million (US); $532 million (global)Market Reception: The first CGRP-antagonist to hit the market created a high demand among physicians and patients to gain access to the once-monthly injection. However, with first-to-market status also comes the burden of navigating uncharted payer waters. Aimovig was able to get onto some large formularies, but with the 2018 approvals of CGRP competitors from Teva and Eli Lilly, a three-way battle emerged for PBM coverage. Overall sales have steadily increased, with global 2018 sales of $119 million rising to $542 million in 2020. However, 2021 saw sales stagnate, possibly due to competitive pressure, particularly the approval of Biohaven’s Nurtec ODT as both a migraine prevention and a treatment.AjovyCompany: Teva Pharmaceuticals/OtsukaGeneric: fremanezumabIndication: For the preventive treatment of migraine in adultsApproval date: 14 September 2018Analyst peak sales forecast: $536 million by 2023Full year 2021 sales: $112 million (global)Market Reception: Ajovy became the second CGRP antagonist to hit the market, and this time offered patients with either quarterly or monthly doses. However, a new competitive  landscape, combined with data showing no clear competitive edge, made it tough for Teva to compete with its rivals. After its approval, while Ajovy made it onto CVS's formulary, the drug suffered some large PBM setbacks, failing to make the preferred coverage lists of  Express Scripts and OptumRx. The drug still requires failure on other cheaper therapies to be covered by any provider. Sales have been slower for Ajovy, making $164 million in 2020, only to see that drop by $40 million in 2021.EmgalityCompany: Eli LillyGeneric: galcanezumabIndication: For the preventive treatment of migraine in adultsApproval date: 27 September 2018Analyst peak sales forecast: $1.27 billion by 2025Full year 2021 sales: $435 million (US); $577 million (global)Market Reception: While Lilly’s Emgality entered a three-way race with Amgen’s Aimovig and Teva’s Ajovy, Emgality produced some impressive clinical results combined with a convenient administration pen and offered patients a 12-month free drug program to speed-up access. The drug received coverage from all top 3 PBMs – Express Scripts, OptumRx and CVS – and in 2019, Emgality was able to hit $163 million in global sales, which was the highest first year of sales for a CGRP-antagonist. The drug also received an additional boost with a 2019 approval for cluster headaches in adults.UbrelvyCompany: AbbvieGeneric: ubrogepantIndication: To treat acute treatment of migraine with or without aura in adultsApproval date: 23 December 2019Analyst peak sales forecast: $1.18 billion by 2026Full year 2021 sales: $552 million (US/global)Market Reception: Originally discovered by Merck and later developed and registered by Allergan, Ubrelvy became the first oral CGRP approved to treat migraines as they happen. It received a favorable review in 2020 from US pricing watchdog ICER. However, despite a strong cost-effectiveness assessment, coverage still requires step therapy and prior authorizations. For example, some providers require therapy failure for a minimum of 30 days on two other triptans and authorization lasts for 12 months, requiring reauthorization thereafter. Ubrelvy generated $141 million in 2020, $552 million in 2021, while sales are expected to double in 2022.Nurtec ODTCompany: BiohavenGeneric: rimegepantIndication: To treat and prevent migraineApproval Date: 27 February 2020 (treatment); 27 May 2021 (prevention)Analyst peak sales forecast: $1.64 billion by 2025Full year 2021 sales: $463 million (US/global)Market Reception: Nurtec is the first drug to receive approvals for both treatment and prevention, and as an oral once-daily option, it has commanded a clear edge over its CGRP competitors. The drug received a similar ICER cost-effectiveness assessment to Ubrelvy, however, during its 3Q21 earnings in November 2021, Biohaven said it had 57% of the oral GCRP market share vs Ubrelvy’s 43%. While Nurtec made $64 million in 2020, the drug saw stronger uptake in 2021, generating $463 million, but Nurtec still requires a similar step-therapy prior authorization process before coverage by many insurers, similar to Ubrelvy. In May, Pfizer announced a definitive agreement to acquire Biohaven for approximately $11.6 billion, a deal largely centered around the commercialization of Nurtec and Biohaven’s other CGRP assets.Innovative and new therapies will inevitably face access challenges as they launch. Patients face delays starting new therapies due to difficulties with prior authorization, reimbursement, and delivery. Phil works with migraine therapy manufacturers such as Impel Pharmaceuticals to improve patient outcomes by easing access to their prescribed medication. After achieving over a 90% enrollment rate and 3x better therapy adherence versus other dispensing channels, Phil holds the majority share of scripts for Impel’s acute migraine treatment, Trudhesa. For more information on how Phil works with manufacturers to streamline patient access, visit us at phil.usSales data taken from biomedtracker.com

3 Patient Engagement Technology Myths

A recent survey by Boston Consulting Group, exploring what patients want from pharma companies and how well companies are meeting those needs, revealed a deficiency in patient engagement. The growing demand for improved and more efficient communication between patients and healthcare entities has created an opportunity for pharmaceutical manufacturers to promote patient engagement through digital tools. However, three common myths may be holding them back.Older adults do not prefer technologyEven though older adults stand to benefit the most from technology-driven patient engagement, pharma manufacturers are often reluctant to gear patient support platforms to older populations. Older adults are not digital natives – people who are viewed as tech-savvy because they grew up in the digital age, so there is a general assumption that this demographic does not use health technology. The reality contradicts this stereotypeAs of 2021, 3 out of 4 people aged 65 and older are using the internet.  Data from 2016 showed that patients in their 60s were just as likely to register for online patient portals as younger people,  and  a  2020 study found that people over the age of 85 had high portal use, particularly around therapy questions, medication refills, scheduling, and billing. The AARP 2021 Tech Trends Report revealed that the pandemic has driven even greater digital technology adoption among seniors. Technology-driven patient engagement can enhance medication adherence. For example, as part of a patient engagement strategy, manufacturers can provide pharmacies with appointment-based medication synchronization (ABMS) support that decreases medication non-adherence by more actively engaging patients in their treatment plans and simplifying pharmacy workflow.  Technology will replace the human touchEmpathy is the foundation of patient-centered care. Many stakeholders share the concern that digital health technologies take the human connection out of the patient journey, depriving patients of empathy. So how can an algorithm possibly deliver empathy? It’s essential to keep in mind that empathy in healthcare is inextricably linked to patient-centricity and patient experience. A well-designed patient engagement platform elevates engagement, personalizes the experience, and enables high-quality patient-centered care. In fact, The Future Health Index 2019 found that 82% of people with access to their digital health records described their personal experience of care as good, very good, or excellent, compared to 66% of those without access. The aim of automation shouldn’t be to replace personal engagement. It should be to bring more value to healthcare by making each patient encounter more meaningful. In pharma, a patient engagement platform can provide opportunities for improving medication access, driving medication adherence, and delivering data insights to optimize patient care and demonstrate value.  Patient engagement technology is expensiveIt is true that developing a technology solution from scratch is indeed an expensive undertaking. Life science companies already heavily invested in drug development may not have the resources to build and maintain digital technology, such as a patient engagement platform. There are many direct and indirect costs related to in-house software development, including:Project planning, development, and managementInfrastructureUser interface (U/I) and user experience (U/X) designSize and complexityCybersecurityTrainingTroubleshooting and supportMaintenanceHowever, implementing a successful patient engagement platform can be affordable. By outsourcing, pharma manufacturers can pay a fraction of the cost it takes to configure one in-house. Return on investment (ROI) should always be considered, so evaluating prospective platforms and determining the anticipated ROI is crucial. The bottom lineThe evolving healthcare landscape is altering expectations across the continuum of care. Pharma companies are struggling with how to engage patients in this complex environment, and misconceptions may be preventing them from embracing digital tools. However, it’s time to appreciate the power of technology-driven patient engagement to build trust, a competitive advantage, and value. Adopting new technologies is not something to be taken lightly. Discover how Phil’s commercialization platform improves patient experience while driving better business outcomes here.

6 Healthcare Trends Impacting Pharma Commercialization

What commercialization strategies should life sciences companies focus on as they look ahead? It’s crucial to monitor trends closely to navigate the evolving healthcare landscape better and build winning strategies. Here are the top six healthcare trends affecting pharma commercialization today:1. Patient financial responsibilityHealthcare costs are increasingly burdensome for many patients. In 2021, total out-of-pocket patient obligations amounted to about $91.6 billion, up 10% from the previous year. What’s more, patient financial responsibility is expected to increase annually by 9.9%, hitting $800 billion by 2026. Already, 3 out of 10 Americans cite high out-of-pocket costs as a barrier to obtaining care. An estimated 13 million U.S. adults fail to fill their prescriptions due to affordability issues. Pharmaceutical manufacturers will need to adopt pricing strategies and meaningful interventions to address patient financial obligations and drive medication adherence2. Value-based paymentThe U.S. healthcare industry is under extreme pressure to contain soaring costs, particularly as the population ages. In the fight to manage unsustainable healthcare costs, policymakers and payers are focusing on value-based payment models. Value-based payment is “a concept by which purchasers of health care (government, employers, and consumers) and payers hold the health care delivery system at large accountable for both quality and cost of care.” The shift from fee-for-service has led to payers establishing treatment protocols, such as tiered drug formularies. The Department of Health and Human Services (HHS) recently announced a plan to curb drug prices through value-based payments. As pay-for-performance escalates, pharma companies need to be prepared to demonstrate value to payers3. Consumerization The rise of digital technologies over the last decade fueled the growth of consumerization within healthcare. The COVID-19 pandemic has only accelerated this trend. Patients-turned-consumers are demanding the same access, convenience, and transparency they experience in other industries. Today’s patient is in the driver’s seat – they are more informed and more proactive about their care. Pharma manufacturers can take advantage of this trend by finding innovative ways to engage and empower patients. 4. Big data and analyticsBig data refers to the vast amounts of data that inundate businesses and organizations every day. According to the Healthcare Information and Management Systems Society (HIMSS), big data and analytics are top trends in healthcare. Currently, big data is categorized by what is known as the five V’s: Volume: There is more data than ever collected from various sources, such as smart devices, transactions, social media, medical equipment, and more. Velocity: Data streams are coming in at an unprecedented speed – often in real-time – from Apps, patient portals, and electronic health records.Variety: Data comes in all types of structured and unstructured formats. Veracity: Verifying the quality of data is essential to ensuring its credibility. Value: What data brings to an organization, such as improving health outcomes, defines its value.       According to McKinsey & Company, the application of big data analytics in the pharma industry can lead to better decision-making and a value generation of $100 billion across the U.S. healthcare system. Manufacturers have the opportunity to leverage data analytics to drive market access5. Artificial intelligenceBig data is the foundation of artificial intelligence (AI), which according to IBM, “leverages computers and machines to mimic the problem-solving and decision-making capabilities of the human mind.” AI offers health science companies opportunities to address many challenges, including finding new ways to lower costs, improve outcomes, and design effective commercialization, marketing, and post-launch strategies. Recent research finds that about 50 percent of global healthcare companies plan to implement AI strategies and broadly adopt this advanced technology by 2025. In fact, the size of the global AI healthcare market is expected to reach $67.4 billion by 20276. Specialty drugs Specialty drug development is a rapidly expanding area in pharma, and the utilization of these medications is expected to grow exponentially in the coming years. In fact, nearly two-thirds of all new FDA drug approvals have been for specialty drugs over the past several years, with many more in the pipeline. Advanced medical technologies are driving the demand for curative therapies, such as cell and gene therapies. Specialty drugs – while expensive – often offer the most effective and possibly only treatment for diseases that historically had few treatment options. Payers are closely scrutinizing these medications because of their high cost. Specialty drug manufacturers will need to work closely with payers and formulary decision-makers to prove the value their brands bring to patients and healthcare.     As pharmaceutical markets, pipelines, and policies continue to evolve, life science companies of all sizes need an agile and flexible approach to optimize commercialization. Commercialization strategies are highly complex, costly, and cumbersome to execute – learn how Phil can help your company here.  

Is Your Life Science Company Taking Full Advantage of Digital Technology?

The pharmaceutical industry generates immense volumes of data, so it would make sense that pharma companies are ahead of the curve by leveraging the latest technologies to transform their operations across the value chain. However, historically, the pharmaceutical sector has been slow to embrace digital technologies.In a highly regulated, high-risk environment, it is no surprise that pharma companies tend to be risk averse. A McKinsey analysis notes that “new technology often faces strong organizational barriers, such as mind-sets that resist IT change and conservative cultures that base decisions on perceived risks.” Digital transformation, which involves implementing new technologies, talent, and processes to improve business operations and meet stakeholder needs, accelerated across the pharma industry during the COVID-19 pandemic. Investments in digital innovation to ensure continued access to medications became the priority. Even those companies that had previously adopted technologies that failed to deliver the value promised needed to adopt digitally-enabled solutions to overcome the challenges posed by the pandemic. As life science companies look toward the future, it’s crucial to address the barriers to digital transformation so they can take advantage of the commercialization opportunities modern technologies have to offer.   Barriers to digital transformationMany life science companies get bogged down by obstacles that keep them from achieving their digital transformation goals. These are the six most significant barriers: Business silos: Many departments and functions work in silos, which impedes digital transformation. To reap the full benefits of advanced technology, cross-functional teams need to collaborate efficiently. Company culture: A risk-averse culture is a significant barrier to technology adoption. A change management approach to digital transformation can help companies anticipate resistance, take steps to gain buy-in, and facilitate employee engagement. Lack of tech talent and resources:A lack of technical expertise and appropriate funding can undermine the adoption of emerging pharma technologies. In a Deloitte survey of biopharma companies, 78% agreed they needed new leaders, and 54% said they needed more funding to succeed in the digital age. Only 20% revealed they are developing capable leaders to help in a digital environment. Cybersecurity:As more companies become reliant on technology and more information moves to the cloud, data protection and security are foundational to successful technology implementation and digital transformation.  Legacy systems:Continuing to rely on outdated legacy IT systems, particularly if they do not integrate with advanced technologies, can prevent a company from realizing the value of new digital solutions.  Data quality:Access to timely and accurate data is essential to successfully executing technology transformation. Outdated, inaccurate information hampers informed decision-making and makes it difficult to measure progress on digital initiatives.Opportunities for tech-enabled commercializationFrom drug discovery and development to manufacturing, distribution, and fulfillment, advances in digital technology and analytics are opening opportunities at every stage of the pharmaceutical product’s life cycle. There are a plethora of commercialization opportunities for life science companies that adopt modern digital technologies, including:     Capturing meaningful post-launch real-world data on a drug’s efficacy, safety, and adherenceFinding new ways to support patients through their treatment journeysSupporting value-based contracts with payers by demonstrating the value of your brandInforming the drug lifecycle with deeper insights into disease progression, clinical characteristics, and outcomesProviding personalized and relevant clinical and educational resources to meet patients where they areStrengthening healthcare provider and payer engagement and relationshipsEstablishing a feedback loop that connects patient experiences with specific productsFacilitating targeted marketing campaigns The pandemic forced life science companies to pivot to digital innovation across every aspect of operations. Now, they need to ensure their digital transformation efforts bring a competitive advantage and drive their businesses forward. Many companies leverage external partners to support their digital initiatives for commercialization. Learn how Phi, Inc. can help you get closer to the patient with real-time visibility and control over your channels here

Meet Catherine Hill, VP, Marketing Phil

Catherine HillCatherine Hill is the Vice President of Marketing at Phil. She joined the company at a pivotal time of growth. In this article Catherine shares what attracted her to Phil as a healthcare outsider and how her personal connection to healthcare drew her to the mission to get patients on life saving therapies.What was it about Phil that caught your attention initially?There were a few things, but initially my interest in Phil stemmed from personal experience as both a patient with chronic illness and watching my parents experience barriers with getting access to much needed treatment. I have spent most of my career in tech and I was starting to feel unfulfilled by the products I was working on. The prospect of a company built to benefit patient lives by assisting with access to critical therapies was really appealing. Phil offered a unique combination of excellent product-market fit, a strong mission and a world-class team. What inspired you to join a company in the healthcare industry given that you have a strong marketing background in industries outside of healthcare?I have seen “what good looks like” from a product-market fit and team perspective in the fast growth companies I had the privilege of working for in the past. And Phil has it. The combination of a product that is solving a real pain in the market with a team that is talented and passionate about the mission was incredibly appealing. I knew that my strong enterprise marketing background, combined with my experience marketing directly to consumers would allow me to build marketing programs that target the enterprise pharma manufacturers, as well as the consumers - prescribers and patients - in a really unique and robust way. What do you think makes a company “marketable”?Ultimately, a company is marketable when it is solving a real pain. When a company is solving a problem in a way that makes a noticeable difference in people’s lives, marketing is easier. Phil solves real problems for pharma manufacturers, physicians and patients. My job in marketing is to make sure those audiences know that there is a solution to their challenges.  Is there a formula to how you approach marketing and are there any marketing strategies you will apply at Phil that are unique or new?I think there are best practices and structures that can be applied that cover about 80% of our marketing but there is a substantial portion that is unique to the situation at a given point in time. For Phil we have a demand-drives-demand strategy supported by a strong content marketing program. We will focus on driving awareness across all of our target audiences with thought leadership and industry focused content that will help make our sales and demand generation activities more efficient. Where do you see the marketing team at Phil in the next two years?We are in a period of fast growth as a company and we are building a marketing function to support that growth. My goal is to build a world class marketing team to communicate how Phil solves problems across all of our target audiences. In two years we will have learned a lot, done a lot of brand building, and worked with a lot of customers to build out case studies. I expect that we’ll be taking those learnings and scaling out the winners as we continue to test and iterate.

Is Your Pharma Product at Risk for a Mid-Life Cycle Crisis?

Commercial launch is an expensive and risky endeavor, especially for small life science companies. According to a recent report, about half of all the drugs launched in the last fifteen years underperformed market expectations by more than 20%. In fact, over half failed to reach $250 million in peak U.S. sales.As the pharmaceutical market shifts toward value-based pricing, gaining market access and sustaining profitability have become more significant challenges. To mitigate the risk for stagnant growth post launch, it’s critical to understand and address the challenges of a product’s mid-life cycle.     Pharma product mid-life cycle challengesThe life cycle for a pharmaceutical product consists of a series of stages that begin at the drug’s conception and end when the brand is withdrawn from the market. There are three distinct stages of a pharmaceutical drug’s lifecycle: The early or pre-marketing stage involves a pre-clinical discovery phase and three clinical trial phases required for FDA approval. It takes an average of ten years and over $2.6 billion for a manufacturer to move a drug from initial discovery into the marketplace.The middle or commercialization stage is when a manufacturer can recoup the costs incurred during the early stage and start making a profit. Revenue generation for this stage is typically represented as a bell curve beginning with a product’s introduction to the market (launch) and moving through growth, maturity, and decline phases. This stage lasts about twelve to sixteen years for most brand-name drug manufacturers.The late stage commences with a brand’s loss of market exclusivity as its patent expires and generic competition hits the market. The commercialization stage is fraught with risks that can negatively impact sales and market share growth, including increased competition, shrinking timeframe to hit peak sales, declining reimbursement, cost pressures, value-based pricing, and expiring patents. Small pharma hurdlesSmall life science companies are playing a larger role in the market. The share of drug launches by emerging companies more than tripled between 2006 and 2018, and in 2020, small biopharma companies originated and launched 40% of all new drugsWhile small companies shine when it comes to innovating and developing novel treatments, they face more hurdles when it comes to commercializing their products. Unquestionably, the growing influence of payers, intense competition, and limited access to prescribers can make it difficult for life sciences companies with fewer resources to compete against big pharma. Recent findings from L.E.K. reveal that large companies have the advantages of size and scale when commercializing new products: Average peak revenues are 50% higher for large pharma companies Smaller biopharma companies are more likely to underperform market expectationsAn even greater proportion of small manufacturers underperform in diseases driven by primary care channelsAddressing mid-cycle commercialization challengesAccording to a Deloitte analysis, the top reasons product launches falter include limited market access, inadequate or incomplete understanding of the market and customer needs, poor product differentiation, and low prioritization and resource allocation. The report also notes that “if a product fails to meet launch year expectations, its probability of recovering revenue in subsequent years declines sharply.” Ensuring your product reaches its full commercialization potential requires innovative approaches to market intelligence and customer engagement to address the factors that lead to poor performance: Seek early input to clarify the priorities and decision-making processes of payer drug formulariesUse post-launch data and services to differentiate your product from the competition   Invest in analytical tools to help you better understand key stakeholders and identify new market opportunitiesTap into real-world data insights to demonstrate value to payers Leverage data analytics to boost market accessEmploying data-driven, technology-based interventions to improve medication adherenceConsider the value of a commercialization partnerUnlock the value of your productSuperior clinical trial results do not guarantee commercial success. A robust clinical profile is no longer enough – you need a value proposition supported by real-time data and a go-to-market strategy that optimizes market access and patient and provider engagement. Read this case study to discover how a specialty brand overcame the mid-cycle challenge by adopting Phil’s commercialization platform. 

Prior Authorization Hurdles Don’t Discriminate By Disease

Experts have called for major reform to the existing prior authorization processes with suggestions such as: Streamlining of administrative stepsTighter turnaround times for prescription authorizationWidespread automation and digitization of processes Integration of health and administrative systemsNationwide coverage   The lack of standardization among current approval processes are resulting in treatment delays, poor patient and physician experiences, low adherence rates, script abandonment, and in many cases, increased healthcare spending as disease progression worsens. Below are some examples that illustrate the burden of prior authorizations within specific therapeutic areas. CardiologyThe cardiovascular treatment landscape significantly expanded in 2015 with a new game-changing class of drugs, PCSK9 inhibitors, which are intended to manage cholesterol-related cardiovascular disease. PA requirements were placed on PCSK9s (alirocumab and evolocumab) due to their high cost, and PA documentation is highly variable among insurance providers. National insurance data from 2017 suggested that coverage was denied at an 80% initial rejection rate, and appeals were able to get half of these prescriptions  eventually approved, but not without heavy administrative burdens. A lack of understanding of  the value of PCSK9s for high-risk groups led to negative implications on overall patient outcomes. A  2019 model study found improved approval rates for PCSK9 inhibitors with the adoption of a standardized evaluation process, proper documentation of insurance coverage, a transition from paper to electronic formats for insurance applications and improved communication with payors in response to denials.DermatologyFor many dermatologists, prior authorizations have become a significant barrier to care with the number of dermatology drugs requiring PAs increasing and a greater variability in what documentation different insurers require for approval. Medications subject to prior authorisations include topical creams, retinoids, topical steroids, immunomodulators and biologics. Common indications affected by PAs include psoriasis, atopic dermatitis and acne. Patients with complex dermatologic conditions, often requiring off-label treatments, face particularly significant insurance barriers. One study found that the average time to a final PA decision was 9.4 days and medications requiring PAs had lower treatment initiation rates, while PA denials were associated with lower rates of disease improvement. Gastroenterology The treatment of inflammatory bowel diseases – including ulcerative colitis and Crohn’s disease – has been associated with delays in biologic therapy initiation as a direct result of denied prior authorizations. Most common biologics for both UC and Crohn’s disease include adalimumab and infliximab, among others. A recent pediatric study showed median biologic initiation time was 21 days, while PAs and complex PAs (requiring appeals, step therapy or peer-to-peer review) were associated with 10.2 day and 24.6 day increases in biologic initiation time, respectively. As a result, PA requirements and denials increased the likelihood of IBD-related healthcare utilization and a dependence on older generation therapies with side effects such as corticosteroids.OncologyThe last decade has seen considerable advancement in the oncology field with the approval of several high cost medications. As a result, PA’s have been implemented for many aspects of cancer care including infusional and oral antineoplastic agents as well as supportive care medications. Experts have questioned whether PA’s are effectively reducing healthcare expenditures in oncology, particularly when delays to one treatment may lead to greater spending on other treatments or hospitalizations. Prior authorizations and coverage denials/appeals appear to be draining precious hours of oncologist’s time and PAs are the main reason for delays in oncology care. While there is more of a clear rationale to require PAs for newer cutting-edge medications such as immunotherapies, payers also require PA approval for supportive care or antineoplastic medicines that are cheap, clearly fit into ASCO treatment guidelines and have been on the market for a long time. These unnecessary barriers can substantially reduce adherence rates, promote therapy abandonment and worsen outcomes for oncology patients.Pulmonology Monoclonal antibodies (such as omalizumab, benralizumab, mepolizumab and dupilumab), have proven effective treatments for patients with severe allergic asthma. However, delays to treatment imposed by the prior authorization process has put patients at high risk of exacerbations during wait periods. One study revealed an average 44 day timeframe between prescription and first dose available for monoclonal antibody injection. This was composed of a mean 21.5 days days for insurance approval and 22.8 days for a specialty pharmacy to fill the medication. High risk patients required prednisone to reduce exacerbations while waiting for their biologic medications, which has side effects that could  have been avoided with a more abbreviated timeline to treatment.How does Phil’s platform help with prior authorizations burdens?Prescribers and patients have access to an integrated digital platform Prescribers get alerts to log-in online for a digital PA submission Field reimbursement teams are able to gain visibility into PA metrics real-timeNational pharmacy network and wholesale supply offers shorter time to therapyReal-time (PHI-blind) data allows manufacturers to better predict initiation, adherence and refillsFor more information on how Phil works with manufacturers to streamline the patient access channel, visit us at phil.us.ReferencesCardiology https://pubmed.ncbi.nlm.nih.gov/31331186/ https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.118.314191 Oncology https://ascopubs.org/doi/full/10.1200/JOP.18.00428 Pulmonology  https://pubmed.ncbi.nlm.nih.gov/33404389/ Dermatology https://www.jaad.org/article/S0190-9622(20)32296-9/fulltext#back-bib2 Gastroenterology (IBD) https://pubmed.ncbi.nlm.nih.gov/35190811/ General https://www.jacc.org/doi/pdf/10.1016/j.jaccas.2020.05.095 https://www.jfas.org/article/S1067-2516(19)30011-0/pdf

How small pharma manufacturers can optimize drug commercialization through outsourcing

One of the most important considerations for any pharmaceutical manufacturer is determining the internal capabilities and capital needed to support drug commercialization. The reality is that small- and medium-sized life sciences companies lack the resources to match the commercialization strategies of big pharma. Fortunately, today, there are opportunities for small pharmaceutical companies to execute a go-to-market strategy through outsourcing.Market-driven opportunities Over the last decade, the pharmaceutical industry has changed – a lot. According to a McKinsey analysis, the share of drug launches by emerging life sciences companies more than tripled between 2006 and 2018. In 2020, small biopharma companies originated and launched 40% of all new drugs, according to an IQVIA reportThree key market factors have driven opportunities for small manufacturers to launch and commercialize their products:Favorable business conditions: Strong economic growth, low-interest rates, and a wealth of venture capital investment combined with high valuations for life sciences companies have provided the monetary resources to launch independently.More options for outsourcing: Technology advancements have opened the door for more vendors to provide sophisticated and specialized solutions that enable companies to effectively outsource commercialization capabilities to avoid investing in a large organizational footprint.  Shift to niche therapeutic areas:Over the next five years, specialty drugs are projected to account for at least half of all revenue generated by pharmacies. Most of these new therapies focus on treating rare – often referred to as “orphan” – diseases. Niche drugs do not require a substantial commercial scale because they benefit smaller, more targeted patient populations.  The benefits of commercial outsourcingSmaller manufacturers are typically very lean organizations, which on the upside, enables them to be very agile and innovative. However, while large companies may turn to a service provider to fill a specific capability, capacity, or technology gap, smaller firms often need more comprehensive outsourcing support across the drug development and supply chain. And managing multiple vendors is complex and can be a challenge for lean companies. Traditionally, when emerging life science companies wanted to commercialize a pharmaceutical drug, they had two options: invest in and develop internal capabilities to go it on their own or license the product commercialization to large pharma. They have a third option now: outsource needed go-to-market capabilities to a third party. This approach can empower smaller drug companies to achieve commercial success on their own by leveraging external technology, infrastructure, and expertise. Strategic outsourcing can benefit the commercialization process by helping drug manufacturers:  Increase operational efficiencies and reduce costsScale up or down rapidly Fill gaps in knowledge and skillsGain visibility and control over distribution channelsElevate brand awarenessImprove medication adherenceOptimize drug fulfillmentDemonstrate value to payersManage payer relationships more effectively Tips for outsourcing success Commercial outsourcing can create more challenges than it solves, including increasing risk and decreasing profits if not done well. Here are some five for getting it right:Consider working with a third party that offers a broad range of commercialization solutions that can be customized for your needs to minimize the number of vendor relationships you need to manage.   Choose a vendor that approaches the relationship as an alliance and partnership that fosters trust and accountability. Establish and track metrics to assess commercialization success and work closely with the vendor to course correct as issues arise.    Look for a partner with an integrated and flexible technology platform that provides a broad range of data and analytics capabilities. Ensure your commercialization partner aligns with a nationwide dispense network and offers a high level of managed plan coverage, high reimbursement rates, and excellent compliance.Reaping the benefits of drug commercialization Commercialization strategies and efforts are highly complex, costly, and cumbersome to execute. As pharmaceutical markets, pipelines, and policies continue to evolve, life science companies of all sizes need an agile and flexible approach to optimize commercialization. Outsourcing drug commercialization to a third-party service provider can help emerging life science companies reap the benefits of successfully bringing their treatments to the market. The secret to success is to develop a strategic commercialization partnership.  Phil’s “channel-in-a-box” solution enables lean and emerging life science companies to optimize the commercialization of their drugs effectively and efficiently. For more information on how Phil can help your company, visit us at phil.us/manufacturers

Is Your Market Access Strategy Meeting the Needs of Drug Formulary Decision Makers?

Drug formularies are a driving force for patient access to prescribed medication. A pharmaceutical brand’s inclusion and positioning on drug formularies are often reflective of the market access strategy’s level of success. To remain competitive, pharma manufacturers must understand how formulary management and the influence of payers are evolving and take steps to optimize market access.What is a drug formulary?A drug formulary is a list of pharmaceutical drug products – both generic and brand name – covered by payers. A multidisciplinary Pharmacy and Therapeutics (P&T) Committee, comprised of physicians, clinician prescribers, pharmacists, nurses, health plan administrators, and other medical experts, determines which medications are part of the formulary. Formulary selection involves the evaluation of a drug’s efficacy, real-world clinical performance, and cost. Based on the committee’s clinical judgment, those products that fail to show adequate clinical differentiation or benefit to justify the cost will have limited or no coverage. How do drug formularies work? Formulary lists are powerful tools used by insurers to influence which medications beneficiaries use. The structure of a formulary impacts the coverage provided for each drug and how much patients will have to pay out-of-pocket:    Closed Formulary: Prescription drugs not on the formulary list are not reimbursed by the payer. There may be exception policies based on medical necessity. Closed formularies have a stronger preference for generics over branded drugs. Often, the number of products in each drug class is limited.Open Formulary: The payer reimburses for formulary and non-formulary drugs. Specific drug classes may be excluded from coverage, such as those for cosmetic use. Patients may have to pay additional out-of-pocket expenses for a non-formulary prescription, and physicians are encouraged to prescribe medications on the formulary.   Many health plans use a tiered pharmacy benefit design. After clinical review, drugs are assigned a formulary ranking that correlates with the coverage level provided. A typical tiered plan would be as follows: Tier 1 medications are the most cost-effective agents, usually generics, with the lowest out-of-pocket costs for patients.Tier 2 medications are preferred brands that are still cost-effective but require a higher out-of-pocket obligation.Tier 3 medications are non-preferred brands that offer either no coverage or the highest out-of-pocket costs. Managed care organizations (MCOs) often add utilization management measures to optimize patient outcomes and reduce unnecessary medication use and cost, particularly for higher-cost specialty drugs. The most common requirements are:  Prior authorizationQuantity limitsStep therapyMandatory generic substitutionTrends impacting formulary coverageClearly, payers have extensive influence on which pharma brands are covered and the level of coverage provided – staying competitive hinges on keeping up on what is happening in the market that will impact formulary selection and coverage. Here are four trends that are impacting a brand’s formulary selection and coverage. Pharmacy benefits managers (PBMs) often serve as intermediaries, negotiating discounts and rebates from pharma manufacturers on behalf of insurers. The PBM market’s rapid consolidation is strengthening its negotiating power. Just three PBMs – OptumRx, Express Scripts, and CVS Caremark – control over 70% of the prescriptions processed in the U.S.Formulary exclusions, which are the drugs that payers do not cover, have skyrocketed since 2014. In 2022, the three biggest PBMs collectively had excluded about 1,410 from their formularies.   Payers are adding higher tiers with cost-sharing formulas to defray costs related to specialty drugs.     Federal and state policies under consideration and intense public scrutiny around PBM pricing and rebate practices will likely force payers to make changes in their drug formulary structure.Optimizing market accessAligning your market access strategy based on payer priorities is the best bet for achieving desired formulary positioning. Steps your market access team can take include:  Understand how different payers leverage formulary tools to influence market access in your therapeutic area Identify gaps in data sets and insights and find a commercialization partner that can fill those gaps  Approach and engage with payers as partners in achieving better patient outcomes and lowering costsImplement value-based contracts for new medications and high-cost treatmentsDevelop payer-centric value messages  Use real-world data and evidence to demonstrate value and product differentiation in clinical outcomes Offer patient-centered services to facilitate patient access and medication adherenceDifferentiate your brand by highlighting how it boosts patient experience Ready to optimize market access? Our end-to-end commercialization solution helps pharmaceutical manufacturers support their brand value to payers while facilitating patient access to therapy with the lowest possible out-of-pocket costs. Learn more about the Phil Platform here.

Diabetes - Post Approval Insights

According to the National Diabetes Statistics Report from the CDC, around 37.3 million people have diabetes in the US, while 96 million have prediabetes. Type 2 diabetes remains the most prevalent in the US (90-95% of diagnosis), while both subtypes represent chronic illnesses that require rigorous self management of therapies for effective disease control. The increased prevalence of diabetes over the last 20 years unleashed a multibillion dollar pharmaceutical market that has pushed drug developers to aggressively pursue life-saving treatments for both type 1 and type 2 diabetes.While pharma has made great strides with the approval of many blockbuster drugs over the last two decades, incremental improvements to therapy have been clinically significant given the high disease prevalence across the globe. However, more options don’t equate to easy access for patients requiring medications. As new competitive therapies emerge, the diabetes treatment landscape has become more complex. A therapy’s commercial success in diabetes isn’t always reflective of the therapy’s benefits but rather how easy it is for patients to access it. Factors affecting patient’s ability to access prescribed diabetes medications include:Pricing DynamicsNew and more expensive drugs offering incremental improvements to available treatments are competing with lower cost generics and cost benefits are often difficult to justify.Administrative BurdensIn the US, prior authorizations (PAs) have been put in place to ensure many approved diabetes drugs and devices are being prescribed and used correctly. While a well intended process, PAs have historically delayed access to prescription drugs, to the point where some patients aren’t receiving them in time to keep up with therapy schedules. Access Hurdles Existing specialty drug distribution channels experience different administrative and commercial roadblocks when processing prescriptions – resulting in the switching of medications and many patients not receiving the drug they were originally prescribed. These challenges lead to long term script abandonment and so manufacturers stand to benefit from higher refill rates and greater revenue predictability if they can work with payers and distributors to improve patient access to their therapies as they come to market. Here’s a snapshot of some high profile diabetes drug approvals and how they’ve fared in the US market in recent years.Drug: ToujeoCompany: Sanofi Generic: insulin glargine injection Indication: To improve glycemic control in adults with type 1 and type 2 diabetes. Approval date: 25 February 2015 Analyst peak sales forecasts: $1.3 billion by 2022 Full year 2021 sales: $284 million (US); $1.1 billion (global)Market reception: Toujeo was a long-acting follow-up to Sanofi’s mega blockbuster Lantus, which was approaching its patent cliff in 2015. However, Toujeo didn’t quite live up to Sanofi’s expectations as it struggled to position the drug as therapeutically superior to Lantus (which made over $7 billion in 2014). It also faced competitive pressure from Novo Nordisk’s diabetes franchise. While Toujeo missed original peak sales expectations of $1.5 billion by 2018 (only hitting $923 million globally in that year), its sales have steadily increased, with expectations for the drug to hit $1.3 billion in 2022. Additionally, Toujeo is expected to keep above the $1 billion annual sales threshold until 2026. Drug: TresibaCompany: Novo Nordisk Generic: insulin degludec injection Indication: To improve blood sugar (glucose) control in adults with diabetes mellitus Approval date: 25 September 2015 Analyst peak sales forecasts: $2 billion by 2025 Full year 2021 sales: $560 million (US); $1.4 billion (global)Market reception: Novo Nordisk’s goal with Tresiba was to usurp Sanofi’s mega blockbuster Lantus and it hoped that nuanced head-to-head hypoglycemia data in 2016 would give it a bonafide edge over Lantus. Data on lower blood sugar episodes in 2017 and a cardiovascular safety study the same year gave it additional competitive armory to challenge Lantus. Sales were quite strong since its launch, hitting over $1 billion in sales from 2017 until this 2021, but never coming close to Lantus’ status given Toujeo was also taking some of the market share. In the end, Tresiba missed its primary endpoint in a head-to-head study with Toujeo in 2019, failing to cut down the number of hypoglycemic events when compared with Toujeo over a 36-week maintenance period. However, Tresiba sales are still expected to steadily increase until 2025.Drug: Soliqua Company: Sanofi Generic: insulin glargine and lixisenatide injection Indication: To improve glycemic control in adults with type 2 diabetes  Approval date: 21 November 2016 Analyst peak sales forecasts: $288 million by 2026 Full year 2021 sales: $126 million (US); $214 million (global)Market reception: Soliqua entered the diabetes market with big promises as a fixed-dose combination therapy of insulin (Lantus) and a GLP-1 medicine (Adlyxin) in a once-daily regimen. Sanofi was racing with Novo Nordisk’s Xultophy to an approval and launch of a similar combination and despite launching first, Soliqua generated underwhelming sales since its launch. However, recent data vs premixed insulin released in 2021 moved Sanofi executives to vocalize expectations for “a lot of interest” among doctors.Drug: Xultophy Company: Novo Nordisk Generic: insulin degludec and liraglutide injection Indication: To improve glycemic control in adults with type 2 diabetes  Approval date: 21 November 2016 Analyst peak sales forecasts: $715 million by 2025 Full year 2021 sales: $76 million (US); $392 million (global) Market reception: While Xultophy received approval on the same day as Soliqua, Novo Nordisk was behind Sanofi with its launch of its combination therapy, setting it back on 2017 sales. However, some additional data in 2017 on hypoglycemia and weight reduction gave it a slight competitive edge. From 2018 onward, Xultophy has performed marginally better on the global scale vs Soliqua, though Soliqua has had a slight edge over Xultophy with sales in the US.Drug: OzempicCompany: Novo Nordisk Generic: semaglutide injection Indication: To improve glycemic control in adults with type 2 diabetes mellitus Approval date: 05 December 2017 Analyst peak sales forecasts: $12.1 billion by 2027 Full year 2021 sales: $3.4 billion (US); $5 billion (global)Market reception: Novo’s Ozempic, a once-weekly injection of semaglutide, had some great expectations leading up to its approval and has proven to be the star performer Novo Nordisk had hoped for and more. The drug was seen as a standout success at the time of its FDA review, receiving a 16-0 vote in favor of its approval with convincing clinical data on HbA1c reductions vs a number of established competitors. It also notably helped patients to lose weight. Original reported forecasts for 2022 were $2.2 billion, but the drug surpassed that figure in 2020, generating $3.1 billion globally that year. With expectations to exceed $12 billion in 2027, Ozempic is truly Novo Nordisk’s unicorn. The active ingredient semaglutide was also approved for obesity as Wegovy in June 2021, with analysts expecting the obesity drug to hit an additional $5 billion in global sales by 2027.Innovative and new therapies will inevitably face reimbursement and access challenges as they launch. The process of getting medications in the hands of the patient can be cumbersome due to difficulties with prior authorization, reimbursement, and delivery. Phil dramatically improves patient outcomes by tackling these access hurdles to enable patients to get on life saving medications faster. For more information on how Phil works with manufacturers to streamline the patient access channel, visit us at phil.us. Sales data taken from biomedtracker.com

Does Your Pharmaceutical Brand’s Data Demonstrate Value to Payers?

The traditional route to pharmaceutical market access focuses on successful clinical trials and meeting regulators' safety and efficacy data requirements. In the past, this same data was sufficient for payers to determine that the drug was worth covering at the price point set by the manufacturer. But times have changed. With payers playing a more influential role in market access and the availability of data to provide a more accurate picture of how medications perform after approval, pharmaceutical manufacturers need to prove the real-world value of their brands. Payers: gatekeepers to market accessAn increasingly competitive market, the advent of specialty therapies, and the rise of value-based care have altered the dynamics of market access in the United States. The influence of insurers has escalated to the point that they are considered gatekeepers, acting as the middleman between patients and medication access. In fact, in a survey of pharmaceutical industry experts published in the Journal of Market Access and Health Policy, payers were named as the second most important stakeholder in market access following patients. The market access role of payers - spanning from formulary tiering and drug utilization reviews to implementation of specific access barriers – translates to substantial impacts on treatment decisions, quality of care, and cost savings. Additionally, insurers are shifting toward value-based contracting in favor of volume-based agreements, particularly in the specialty drugs market. As payer influence continues to evolve and grow, market access leaders need to provide payers with the full picture of the value their brands bring to healthcare delivery.   Real-world data: the game changerWith healthcare costs under the microscope, pharmaceutical manufacturers have growing pressure to deliver clinical trial results in the real world. Real-world data (RWD) – data collected in the context of routine care delivery rather than with the controlled environment of a clinical trial – is playing a progressively more central role in drug decision-making. In today’s value-driven marketplace, RWD can be a gamechanger for pharmaceutical market access.  Potential sources for RWD includeElectronic health records (EHRs)Administrative claimsPatient-reported outcomes (PROs)Medical product and device registriesCondition-specific or disease registriesEnvironmental factors and social determinants of healthReal-world evidence (RWE), which the FDA defines as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data," can bridge gaps in evidence not addressed by clinical trials. In December 2021, the FDA issued guidance for evaluating RWD to support marketing applications after drug approval, such as a new indication.  While randomized clinical trials are still considered the gold standard for formulary decision-making, payers use real-world data to validate clinical trial results further and help make coverage decisions across therapeutic areas. Additionally, more and more payers are tying payment for treatment to both short- and long-term effectiveness measures. Health plans are also turning to RWD to gain insights into drug safety, utilization, costs, and value. Generating real world data insights that demonstrate value to payersPharmaceutical marketers have been using RWD for decades to inform their decision-making, respond to external stakeholders, and improve their brands’ market positioning. With the evolution of data analytics, there are greater opportunities to provide RWD to payers around long-term efficacy, safety in real-world settings, head-to-head comparisons, cost analyses for formulary placements, medication use and adherence patterns, and patient-reported outcomes and experiences – ultimately demonstrating the actual value of a therapy.  In a 2017 Deloitte survey, more than half of life sciences companies polled planned to increase their RWE capabilities significantly. According to the findings, access to the right RWD was a common issue, and new channels for data, including external partnerships, would be needed to improve overall capabilities. The authors of the study pointed out that the FDA’s push to expand the use of RWE and “the growing imperative for life sciences companies to demonstrate product value is helping to drive commercialization strategies that result in broader insurance coverage, optimal pricing, and optimal formulary placement." The bottom lineAchieving real-world insight from the point of care throughout the patient journey is ideal for demonstrating how your medication can improve outcomes and reduce costs. Life sciences companies should consider a commercialization partner that provides high-quality, timely, and actionable RWD to ensure a brand's post-approval market access. With over 120 real-time data points across the patient access journey and customizable market access reports, Phil provides its life science company partners with RWD and insights to support their brand value to payers. Learn more about the Phil Platform here

Antivirals - Post-Approval Insights

Antiviral drug approvals over the last decade have been dominated by drugs aimed at treating Hepatitis C (HCV) and human immunodeficiency virus (HIV). An estimated 2.4 million to 4.7 million people are living with HCV in the US, while about 1.2 million people in the US live with HIV.While these are both huge markets that continue to attract big pharma development efforts, the competitive landscape has become multi-layered and complex with long-standing therapies being evaluated alongside newly approved combinations. While better options become available to patients – even a possible cure for HCV patients – research shows that the prior authorization process is the biggest factor contributing to delayed treatment for patients suffering from both HIV and HCV. This becomes a material factor for overall patient outcomes as delayed treatments – while an obvious inconvenience and frustration for patients – can also contribute to viral resistance and disease worsening. For manufacturers, eventual sales aren’t always a reflection of therapeutic merit as a more laborious authorization process can often translate to lower sales. As the treatment paradigm grows, there is a high unmet need to improve processes within healthcare systems to match eligible patients to the most appropriate treatments in a seamless and timely manner. Here’s a snapshot of some of the blockbuster HIV and HCV drugs with annual sales over $1 billion, that were approved between 2015 - 2018 and how they’ve fared on the market over recent years.Drug: GenvoyaCompany: GileadGeneric: fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideIndication: Complete regimen for HIV treatment for adults and pediatrics over 12Approval date: 5 November 2015Analyst peak sales forecasts: $4 billion by 2021Actual peak sales: $3.6 billion (US); $4.7 billion (global) in 2018Full year 2021 sales: $2.9 billionMarket reception: Genvoya had a strong launch which continued in its first few years on the market, but the entry of Gilead’s other HIV drug Biktarvy, approved in 2018, chipped away at Genvoya’s market share. While sales in 2021 were still impressive, the two-drug regimen has greater contraindications to competition and may have a lower barrier to viral resistance.Drug: ZepatierCompany: MerckGeneric: elbasvir and grazoprevirIndication: chronic HCV genotypes 1 and 4 in adultsApproval date: 28 January 2016Analyst peak sales forecast: $2 billion by 2020Actual peak sales: $772 million (US); $1.6 billion (global) in 2017Full year 2021 sales: not materialMarket reception: Initially expected to be a bigger blockbuster drug, Zepatier suffered stiff competition from a couple of game-changing drug approvals (see below) in its first two years after launch. Its market was also limited in that it was only indicated for two HCV genotypes. In 2018, Merck cut the price of Zepatier by 60%.Drug: EpclusaCompany: GileadGeneric: sofosbuvir and velpatasvirIndication: HCVApproval date: 28 June 2016Actual peak sales: $2.4 billion (US); $3.5bn in 2017 (global)Full year 2021 sales: $815 million (US); $1.46 billion (global)Market reception: Epclusa was a major advance in the HCV space, indicated for all six HCV genotypes. The drug reached an impressive blockbuster status a year after its launch, however sales began to decline faster than expected, again due to yet another market improvement.Drug: MavyretCompany: AbbvieGeneric: glecaprevir and pibrentasvirIndication: chronic HCV for all adultsApproval date: 3 August 2017Actual peak sales: $1.6 million (US); $3.44 billion (global) in 2018Full year 2021 sales: $754 million (US); $1.7 billion (global)Market reception: Mavyret represented yet another incremental improvement for patients with HCV, with a reduced 8-week regimen compared to Epclusa’s 12-week regimen, whilst it was also offered at a discount to existing options. With recent HCV therapies offering patients a cure, the decline in sales after its first year was a reflection of the overall HCV market peaking in 2015. Generic options of earlier approved drugs have also put pressure on Mavyret’s market penetration. Drug: BiktarvyCompany: GileadGeneric: bictegravir, embitcitabine, tenofovir alafenamideIndication: HIVApproval date: 7 February 2018Analyst peak sales forecast: $11 billion by 2024Full year 2021 sales: $7 billion (US)  $8.6 billion (Global)Market reception: With a competitive safety profile and a high barrier to viral resistance, Biktarvy, the three-drug combo, has reared itself as the poster child of HIV drugs. It superseded records made by Gilead’s predecessor (Genvoya) and is also beating out GSK’s triple and doublet therapies. Biktarvy’s sales grew 19% from 2020 and shows no signs of stopping. The drug remains the leading prescribed treatment for naive and switch patients in the US.Innovative and new therapies will inevitably face reimbursement and access challenges as they launch. The process of getting medications in the hands of the patient can be cumbersome due to difficulties with prior authorization, reimbursement, and delivery. Phil dramatically improves patient outcomes by enabling access to life saving medications. For more information on how Phil works with manufacturers to streamline the patient access channel, visit us at phil.usSales data taken from biomedtracker.com

Leveraging Data Analytics to Boost Pharmaceutical Market Access

Specialty drugs comprise a growing share of the pharmaceutical market. According to an industry report by Drug Channels, total prescription revenues surpassed $500 billion in 2021, with specialty drugs accounting for almost 40 percent of outpatient prescription revenues and an even larger share of payers’ net prescription costs. Over the next five years, these therapies are projected to account for at least half of all revenue generated by the pharmacy industry.To remain competitive in this space, manufacturers need to work with their channel and commercialization partners to access real-time data and meaningful insights to drive market- and patient access.The promise of data-driven insights Pharmaceutical companies have historically relied on data across the product life cycle to fuel decisions related to go-to-market approaches, resource allocation, marketing mix, pricing strategies, and customer segmentation. However, conventional data sources, such as claims, often lack critical details necessary to draw meaningful insights.    Today, manufacturers should be expecting richer, more granular data sets. In a complex and rapidly evolving specialty marketplace, they need timely, relevant data that can be acted upon now. The quality of insights that can be gleaned from data today create value and bring tremendous opportunity for commercial strategies. In fact, a McKinsey analysis determined that leveraging advanced analytics can improve the EBITDA of pharmaceutical companies by anywhere from 45 to 75 percent.    With the evolution of data analytics, life science companies can better understand stakeholder influences, preferences, and behaviors. The true potential of these data-driven insights lies in the ability to leverage them to improve care delivery, accelerate patient access and demonstrate real-world drug efficacy – and ultimately, patient outcomes.    Metrics hold valuable insights for market accessWhen implemented well, data capture and management offer visibility into the patient journey and insight into market activities around product movement and usage. Examples of data and metrics that hold valuable market- and patient-access insights for pharma manufacturers include:Diagnosis and off-label useThe time between diagnostic test results and therapy selectionPrescriber affiliations with IDNs Insurance coverage and reimbursementPrior authorization requirementsPatient assistance program usagePatient out-of-pocket obligations Time to fillFill and refill ratesReferral and adjudication statusDenials and appealsNew medication startsMedication stops and reasons why Medication switchingMedication adherenceAdverse eventsThe key to unlocking the value of captured data is to ensure it is translated into meaningful insights and actions that align with commercialization strategies while still complying with applicable regulations. Aligning data analytics with commercialization strategyData has the power to help pharmaceutical companies identify gaps and opportunities with their current market- and patient-access efforts. To truly tap into this power, manufacturers must prioritize access to integrated data and insights that align with their market access strategies. Quality, real-time insights that accurately characterize the entire patient journey – from the provider visit to prescription processing to the patient receiving their medication from the pharmacy – will help manufacturers achieve their commercial objectives. Manufacturers can positively impact market access and minimize patient access barriers by employing advanced analytics to support:  Personalized patient engagementTailored provider and partner digital communications Faster time to therapyMedication adherenceNetwork and distribution optimizationUnderstanding of real-world clinical outcomesContract negotiationsField force effortsA value-oriented data-driven approach can generate substantial returns, including a 5-10 percent net revenue improvement and 10-20 percent spend reduction/reallocation.   Tapping into the full potential of pharma data analyticsPharmaceutical and life sciences companies have access to a vast amount of data but often lack the tools to tap into its full potential. Automated and secure data systems with next-generation analytics are vital to capitalizing on opportunities in the marketplace. Finding a commercialization partner to capture impactful data and then help leverage and scale the analytics to inform efficient and effective decision-making will drive your brand's success.As an end-to-end commercialization partner, Phil provides an integrated approach to data analytics across the patient journey giving manufacturers real-time visibility and control over their distribution channels. Get in touch today to discover how you can drive market access with deeper data insights.

3 Ways a Patient Access Platform Breaks Through Barriers to Medication

There was a time when the path from a physician prescribing to the patient starting drug therapy was straightforward. With the rise of value-based healthcare and novel specialty treatments, that’s no longer the case. Today, rigorous payer requirements and increasing out-of-pocket obligations frequently hinder patient access. Up to one-third of patients report they experience difficulties getting their prescription drugs due to delays, denials, and costs. At the same time, one in ten fail to take medications as prescribed solely because of financial constraints.For specialty drug manufacturers, patient access services have become as vital to a brand’s success as efficacy and price. Here are three ways manufactures can maximize the support they provide patients  with a patient access  platform: 1.  Streamline benefits and reimbursement workflowsSpecialty and specialty-lite medication reimbursements are complicated by strict patient authorization (PA) and step-therapy criteria. There are a multitude of financial assistance programs from manufacturers and foundations that patients qualify for if they meet certain conditions. Managing insurance coverage, prior authorizations, reimbursements, and patient assistance program enrollments are labor- and time-intensive and can extend the time to therapy by days or weeks when done manually. It is well-established that impeding speed to therapy dramatically increases the risk of therapy abandonment and is detrimental to patient outcomes. Manual patient support workflows translate to missed opportunities; however, a patient  access platform alleviates pressure on patients, providers, and pharmacies. Electronic benefits verification (eBV) and prior authorizations (ePAs) can be initiated at the point of care, decreasing delays, accelerating time to therapy, and minimizing patient out-of-pocket costs. By streamlining the entire patient access process, all stakeholders achieve better outcomes.    2.  Enable data-driven decision-making Unlocking and leveraging data have been at the forefront of pharmaceutical manufacturers’ efforts to align business goals and outcomes for decades. With an over-abundance of data and a complex healthcare ecosystem, getting a holistic – and timely – view of stakeholders is more important than ever. Visibility into performance, real-time connectivity, and flexibility will enable the most accurate insights and best decisions to improve patient access. To drive better insights, manufacturers should be looking for the following elements in a patient access services platform:  Real-time data reporting that provides an accurate view of what’s happening across the patient access journeyThe flexibility to support rapid onboarding, response to changes in reimbursement criteria or other data requirements, and scaling of support services up or down Data integration and aggregation capabilities that offer a more comprehensive look at the effectiveness of and gaps within programsEase of use with customizable dashboards and reportsInteroperability with other systems along the supply chain Security features that include encryption of health data and compliance with HIPAA guidelines  3.  Deliver a patient-centered experiencelarge survey of U.S. healthcare consumers revealed that 59 percent expect a digital experience similar to online retailers like Amazon and Apple. Seventy-four percent felt improvement was needed when it comes to filling prescriptions. And this was before the Covid-19 pandemic. Undoubtedly, the consumerization of healthcare has accelerated over the last several years. Patients today expect simple and reliable digital interactions to help them get the care they want when they need it. A well-designed eHub  platform  delivers the patient-centered experience that healthcare consumers prefer and should include supplementing digital interactions with call-based support for those who prefer that route. While many patients may not want to talk on the phone and will  rarely answer a call from an unknown number, a patient access platform has tech-enabled tools that connect with patients through their preferred communication channels. They can also support patients with automated reminders to take their medication or refill a  prescription.   A digitally enabled platform not only enhances dialogue with patients, but also personalizes their experience and increases engagement, all of which will help sustain medication adherence.Elevating your brand’s success Pharmaceutical manufacturers face substantial hurdles to enabling access to their brands – and they cannot afford to miss a piece of the puzzle when it comes to patient support services. A patient access platform can be an effective and efficient way to manage the complexities of patient access. It’s crucial to implement a strong patient support services program that aligns with your business goals and delivers on your brand objectives while helping patients access their therapy as conveniently and reliably as possible. Phil partners with life sciences and pharmaceutical companies to support the commercialization of their brands in a complex and ever-changing marketplace. Our next-generation patient access platform improves outcomes and experience by enabling speed to therapy with the lowest possible out-of-pocket burden. Learn more here.

How to choose the best commercialization partner to drive patient access

Is a pharmaceutical hub the best solution for commercializing your therapies?For well over a decade, pharmaceutical hub services have played a pivotal role in supporting patient access to life-saving and life-altering advanced drug therapies. Unfortunately, hubs tend to be a partner with low customer satisfaction rates and lower than ideal coverage and adherence. So, what is the best way to support patient access to critical therapies? Amid the shift to value-based care, patients’ prescription out-of-pocket burden has increased, particularly for specialty tier drugs. Out-of-pocket cost is a big factor in prescription abandonment and medication adherence. A 2019 Kaiser Family Foundation Health Tracking Poll revealed 1 in 5 patients did not fill a prescription and 3 in 10 did not take their medication as prescribed due to cost. Close to 60 percent reported they had difficulty affording $100 or more per month on prescriptions.In response to market changes, hub models evolved to consist of a broad array of services that support market and patient access across prescription drug tiers. When contemplating patient access services for your brand, it’s essential to consider the value of a commercialization partner, determine what level of services will offer the best fit, and evaluate five other key factors.

Case Study: Defying the Mid-Cycle Curse for Specialty Pharma

Mid-cycle specialty products often face challenges when it comes to reaching patients several years after launch.Case Study: Women’s Health ProductPhil was able to assist our client with turning around a tumultuous post-approval journey. Reimbursement challenges led to poor uptake and the pharma manufacturer brought on a telemedicine company to help with the prescribing and authorization process. However, additional changes to patient eligibility criteria led to prescriber confusion, low coverage rates and limited patient access. Before PhilInitially, patients were offered a limited two-month free supply, but once that ended, many patients stopped therapy because they couldn’t get their medications authorized for further coverage. There were multiple reasons for this, but the main reason was that prior authorization (PA) forms were not submitted correctly or in a timely manner. There was a lack of education and training among healthcare providers on patient eligibility criteria and how to correctly submit the PAs, while the telemedicine company handling the majority of the prescriptions was taking several days to submit PAs with very little follow up. A contract with a specialty pharmacy hindered patient enrollment as patients failed to engage with automated calls to enroll. The pharmacy also had limited contracts with payers – around 60% of commercial plans, very few regional plans and no contracts with state medicaid plans.  As a result, only 12% of TRx were covered by payers despite good formulary. For a therapeutic that required long-term adherence, the average refill rate per patient was no better than 2.5 fills and the company was losing money with every script. The company sought help from Phil to improve its patient access and saw immediate results after adopting the platform.The HCPsThe Phil portal was more user-friendly for physicians and healthcare providers, eliminating the need for physicians to fill in spreadsheets and reply to emails. HCPs were better educated on the process, which held them accountable to complete authorizations. After Phil’s platform was adopted, 98% of PAs were submitted on the same dayThe Patients Patient engagement was notably improved with the help of text messages to guide the patient through every step of the process. From the seamless 1 minute onboarding to the post-dispense texts tailored to the patient’s clinical journey, Phil was able to remove most of the administrative burdens and allow for a greater focus on the promotion of therapy adherence. Scripts covered by payers quadrupled in just 18 months – from 12% to 55% – with the refill rate adherence increasing by 45%.The CoveragePhil was able to enroll 90% of patients through its intuitive platform and scripts were dispensed across a large network of pharmacies that have contracts in place with 98% of all US plans, commercial, medicare and medicaid.The CompanyMonth over month sales growth driven by Phil has meant that the company is now profitable. The sharp increase in volume and revenues has attracted additional venture funding for growth, while profits have enabled the company to invest more in a digital marketing campaign to drive profits up further. The program continues to grow at 66% CAGR more than a year after launching with Phil. For more information visit phil.us.

Meet Deepak Thomas, the Founder of Phil

Deepak Thomas is the founder and CEO of Phil. He started the company as patient zero after being diagnosed with a chronic illness in the late 90s and struggled to navigate his own care within the complex US healthcare system. Several years later, he applied his experience in tech to build a solution that expands and simplifies patient access to specialty drugs, while aligning economic incentives for therapy manufacturers. Today, Deepak describes his journey in starting Phil as a “team of one” to working with some of the largest manufacturers such as Bausch Health.Why did you have the idea/vision to create Phil?In the late 90s, a few months after moving to the US, I was diagnosed with chronic Lyme disease and it was very difficult to navigate access to therapies. Even though Lyme disease is a complex condition to treat, I found it astounding how “stacked against the patient” the US healthcare system is when it comes to navigating care. I had to spend a lot of lunch hours calling doctors and insurers and paid several thousands of dollars out of pocket to fund therapies as I waited for insurance to kick in. As I progressed through my professional career, with more exposure to the tech sector, I saw an opportunity to create a platform that might alleviate patient burdens when accessing their meds.How did your professional background help navigate launching Phil?I come from a technology and business background and over the last decade it became clear that tech was creating significant consumer value across sectors. There was a clear opportunity for someone to come in and create a solution able to reduce consumer (patient) friction and deliver well-informed access to medications particularly for complex conditions. While the healthcare industry is complicated and can’t simply be fixed by “tech,” understanding the business and economic shortcomings of the healthcare industry spurred me to envision what a tech solution might look like. What were the initial steps to get the idea for Phil off the ground?The major challenge was getting a good understanding and perspective of the healthcare system in its entirety. At first I thought the major setback for the system was at the pharmacy level. I quickly came to the conclusion that the problem was far greater, and it was the disconnect between all the stakeholders involved in the process – the manufacturers, prescribers, insurers, pharmacies and patients. I thought “if only everybody involved knew what they needed to do at the appropriate point of time,” so that patients can receive therapies in a timely and painless manner. My goal was to create workflow efficiencies to connect the entire process and all the key players. Essentially that would involve the automation of certain processes to save time and money, combined with bespoke human intervention for troubleshooting and the more personal/one-on-one aspects of the care delivery process. I started the company as a team of one, I learnt how to code again and built a framework for the company over 8-9 months. From that point, I was able to raise funding and started building out the team, starting with my cofounder up to 155 employees today.What types of companies/products typically benefit from Phil’s offering?Specialty lite and specialty drugs are the niche that we serve across all therapeutic areas (TAs). Around 80% of drugs out there are generics and those don’t have significant access issues because they are not expensive. The more expensive therapies have significant hurdles to access and adherence. Right now Phil is breaking down access barriers for both specialty lite and specialty drugs in women’s and men’s health, dermatology, neurology, rheumatology, immunology, gastroenterology, infectious diseases, pediatrics, antiviral and cardiovascular indications among others and there is no aspect that ties Phil’s offering to a specific TA. See how Phil helped improve patient access to a women’s health drugWhat are the main reasons (problems) spurring companies to seek Phil’s help?The patient experience is the main frustration for manufacturers. They have built cutting edge science, expended capital to create awareness among prescribers, but when it comes to getting patients on therapy, the system is failing the patient. Anybody who has walked into a retail pharmacy knows there is more to be desired from that experience. Where do you see the company in the next couple of years?Currently most of the manufacturers we work with are in the specialty lite segment, and we aim to strengthen our offering to manufacturers in the biologics and specialty segments. Those are tougher problems to solve, but our platform is built to work well across both segments. There is an expansion opportunity in specialty and biologics and we aim to have a strong presence there in the future.

Ready to learn more?

Our consultants will work with you to analyze your current channel strategy and make recommendations for how to improve patient access and increase the percentage of scripts getting covered by insurance.