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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.

Aimovig

Company: Amgen/Novartis

Generic: erenumab-aooe

Indication: For the preventative treatment of migraine

Approval date: 17 May 2018

Analyst peak sales forecast: $1 billion by 2026

Full 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.

Ajovy

Company: Teva Pharmaceuticals/Otsuka

Generic: fremanezumab

Indication: For the preventive treatment of migraine in adults

Approval date: 14 September 2018

Analyst peak sales forecast: $536 million by 2023

Full 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.

Emgality

Company: Eli Lilly

Generic: galcanezumab

Indication: For the preventive treatment of migraine in adults

Approval date: 27 September 2018

Analyst peak sales forecast: $1.27 billion by 2025

Full 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.

Ubrelvy

Company: Abbvie

Generic: ubrogepant

Indication: To treat acute treatment of migraine with or without aura in adults

Approval date: 23 December 2019

Analyst peak sales forecast: $1.18 billion by 2026

Full 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 ODT

Company: Biohaven

Generic: rimegepant

Indication: To treat and prevent migraine

Approval Date: 27 February 2020 (treatment); 27 May 2021 (prevention)

Analyst peak sales forecast: $1.64 billion by 2025

Full 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.us

Sales data taken from biomedtracker.com