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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 Dynamics

New 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 Burdens

In 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: Toujeo

Company: 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: Tresiba

Company: 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: Ozempic

Company: 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