Headaches Still Evident in Migraine Market Elizabeth Krutoholow and Curt Wanek

Bloomberg Intelligence analysts

Doctors Chime in on Migraine Drugs; Marketing, Payer Access Key

Clinical data on a long-awaited new class of migraine treatments is promising, yet there are still overhangs, based on historical hurdles. Even if efficacy data remain on par with other migraine treatments, doctors are excited to give their patients an option that targets the calcitonin gene-related peptide. They are also wary about the commercial side, given historical problems with formulary access with triptans and Botox. Phase III data are needed before the full potential of the class can be assessed.

Safety will be key to watch in Phase III trials, given Merck’s telcagepant, now discontinued, didn’t show signs of liver toxicity until Phase III. Allergan, Amgen-Novartis, Eli Lilly, Alder and Teva are all developing anti-calcitonin gene-related peptide treatments for migraines.

Marketing May Give Bigger Benefit Than First-Mover in CGRP Race

Amgen and Eli Lilly are neck-and-neck to introduce the first CGRP receptor agonist, yet marketing may be more important than a first-mover advantage. For migraine specialists, a good patient support system and marketing is key, said Dr. Robert Cowan, director of the Stanford Headache Clinic. This may help secure payer coverage and lower the cost for patients. Allergan, Amgen-Novartis, Eli Lilly and Teva should find patient support and marketing easier than Alder, which lacks commercial experience.

CGRPs Show Marginal Benefits but Novel Mechanism Wins Doctors

CGRP agonists are only slightly better than existing therapies in reducing migraine days vs. placebo. Intravenous and subcutaneous delivery may induce an elevated placebo response, according to Dr. Audrey Halpern of NYU Langone Medical Center. Amgen showed a 6.6-day reduction in headache days per month but only a 2.4-day benefit over placebo. Even though the difference is low, it’s still effective in terms of its standalone benefit, Halpern said.

Even if the CGRPs achieve lower-than-expected efficacy, as long as it’s statistically significant, doctors are still excited about giving their patients another treatment option with a new mechanism of action.

Amgen, Teva CGRP’s May Face Same Formulary Scrutiny as Botox

A new class of migraine treatments being developed by Amgen, Teva, Eli Lilly, Alder and Allergan may face difficulty getting covered by payers if they prove to be marginally better than placebo in Phase III trials. Currently, they appear as effective as Botox with two migraine days less than placebo. It is challenging to get payers to pay for Botox for chronic migraine, according to Dr. Robert Cowan, director of the Stanford Headache Clinic. Out-of-pocket costs for patients may be $1,500 every three months.

Eli Lilly Strategy to Early Market in Cluster Headache May Fail

Eli Lilly’s plans to beat its peers in the CGRP antibody space to market by gaining approval for galcanezumab in cluster headache may not be successful since it is unlikely that neurologists would be able to use the drug in episodic or chronic headache off label, said Dr. Robert Cowan, director of the Stanford Headache Clinic. Several neurologists said that payer pushback for migraine coverage can be a hurdle for use.

Lilly plans to submit an application in cluster headache in 2017, which would allow for 2018 approval, potentially beating peers such as Amgen to market.

Teva, Allergan May Have Edge in CGRP Commercialization

Teva and Allergan may have an edge against peers vying for a share of the CGRP migraine market, given expertise in neurology and their existing sales relationships. Unless Phase III trials show very differentiating factors, most anti-CGRPs in development appear similar in efficacy with slight differences in side-effect profiles and modes of administration. Their success is more likely to be tied to marketing, said Dr. Robert Cowan, director of the Stanford Headache Clinic.

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