Blog November 14, 2018

A Crowded Field for Migraine Therapies, Where Recently There Were None

migraineBack in March, when we first wrote about migraine drug development, there were no approved therapies addressing the underlying mechanisms of these painful, sometimes chronic, headaches — the most prevalent neurological disorder worldwide. Now, three such drugs have reached the market.


The three drugs — Aimovig (erenumab) from Amgen/Novartis, Ajovy (fremanezumab) from Teva Pharmaceuticals, and Emgality (galcanezumab) from Eli Lilly — are quite similar. All are monoclonal antibodies that target CGRP (calcitonin gene-related peptide), a molecule that plays a role in how patients experience migraine pain. All are administered by monthly subcutaneous injection, although Ajovy can also be given as quarterly shots. All appear to be similarly effective, reducing migraine frequency by half in about 50% of patients, and by a third in 75% of those treated, while also reducing the intensity of the headaches in treated patients overall. All have also shown good safety profiles, with mild constipation being the most serious side effect.


The three drugs have likewise been similarly priced, at least for now. Lilly has set a U.S. list price for Emgality, the most recently approved migraine treatments, of $575 per month, or $6,900 annually — in line with the pricing set for both Aimovig and Ajovy. Lilly has also established a patient support program that enables patients with commercial insurance to receive the drug free of charge for up 12 months. Amgen and Teva have similarly offered price breaks for commercially insured patients: Amgen allows such patients to access Aimovig for a small $5 per month co-pay, and Teva is making Ajovy available free until the end of 2019, when it plans to re-evaluate its patient assistance program.


Competition within the field of migraine drug therapy continues to grow. Allergan is planning to file for approval of an oral CGRP inhibitor in Q1 2019. Unlike the three marketed injectables, which are intended to prevent migraine attacks, Allergan’s treatment is designed for as-needed use, potentially in combination with a preventative drug (including Allergan’s own Botox treatment, which was approved for migraine prevention in 2010).  Alder Pharmaceuticals has an infused CGRP antibody, and Biohaven has an oral CGRP drug, both of which will be submitted to the FDA in 2019. Alder is also developing a second migraine drug that targets a different protein involved in mediating the initiation of migraine headaches.


A big question is, how will drug developers differentiate their offerings and effectively compete in an increasingly crowded field of similarly safe and effective treatments? One strategy is to offer patients more tools and support for managing their condition. Novartis has taken the lead in partnering with technology developers to create such patient management aids in the neurology space. For instance, they have partnered with Healint to create a migraine tracking application that helps patients identify triggers of migraine attacks, track the course of their attacks, and gain overall insight into their condition.


A second question is what the ultimate effect of increasing competition will be on pricing and reimbursement. ExpressScripts has already decided to cover both Lilly and Amgen/Novartis’s drugs in its formulary, and to exclude Teva’s product, presumably because of Teva’s insufficient discount to ExpressScripts.


Others are also focusing on lowering the pricing for migraine drugs. A new start-up, Thirty Madison, just raised a $15.3 million Series A financing towards building an end-to-end, direct-to-consumer healthcare brand that offers diagnosis, treatment, and ongoing patient management for a variety of chronic conditions, with an early focus on migraine. The company’s goal is to lower healthcare costs by connecting patients to knowledgeable licensed physicians for online consultations using diagnostic frameworks developed by leading experts. Thirty Madison says they will then cut out the “pharma middlemen” to provide FDA-approved treatments to consumers at a fraction of the prices charged at local pharmacies.


Given the crowded market, how will companies in the field effectively compete, especially if it remains difficult to differentiate products based on performance? Will prices drop further as more products reach the marketplace, giving payers more leverage in what they cover — and don’t? And what effect might a company like Thirty Madison have on the field and on the pricing of these products, given their mission of lowering costs?