Eli Lilly, Allergan and Biohaven have a lot riding on their forthcoming migraine launches, and now cost-effectiveness watchdog ICER has come out with some less-than-stellar findings from data supporting the drugs.
The Institute for Clinical and Economic Review's new draft report on Eli Lilly’s Reyvow, Allergan’s ubrogepant and Biohaven’s rimegepant concludes with “moderate certainty” the drugs provide a “small or substantial” health benefit for patients who can’t take or haven't responded to triptans, a class of older migraine treatments.
But for those who can, ICER rated ubrogepant and rimegepant as “comparable or inferior” to the existing meds. And Lilly’s Reyvow is likely to perform worse than the existing options, the group said.
Eli Lilly won FDA approval for Reyvow last month, but the drugmaker can’t launch until it receives Drug Enforcement Agency classification for the new med. The company hasn’t released the drug's list price.
And that number, of course, is a key variable. “Pricing of these drugs will determine whether they are cost-effective at commonly used thresholds in patients who cannot take triptan medications,” the report added.
Going by expected pricing for the new meds, ICER concluded triptans would “provide a greater benefit at a lower total cost," at least for those who respond and can tolerate them.
Importantly, the report is in draft form and subject to change as the assessment continues.
Biohaven CEO Vlad Coric said via email that more than 4 million patients don’t respond to triptans or can’t take those medicines due to CV risks. He said a new option “such as Rimegepant clearly will be an important addition to these patients.”
Further, ICER’s report didn’t emphasize that Biohaven ran a head-to-head trial comparing rimegepant against sumatriptan, Coric said. The study found a “clear advantage” for Biohaven's drug 48 hours after treatment without having to redose and without adverse effects.
Lilly said in a statement it’s “disappointed” with the review “as we feel it does a disservice to patients and practitioners by utilizing flawed methodologies that do not reflect” the entire U.S. healthcare system. Reyvow has a unique mechanism of action and is an important option for patients, the company said.
“We will work with payers to ensure access to our new treatment and, once available in January 2020, Lilly will provide commercially insured patients with a co-pay card program to ensure access to Reyvow," the company added.
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The report comes as each drugmaker gears up for its respective launch. Allergan’s ubrogepant is set for an FDA decision in December, followed by rimegepant’s deadline in the first quarter of 2020. Both drugs are expected to launch next year if approved.
Meanwhile, Eli Lilly and other drugmakers are already competing in the CGRP migraine prevention field. Lilly won approval for Emgality last year, trailing Amgen’s Aimovig and Teva’s Ajovy into the market, but has since grabbed a nice chunk of the market. Lilly also recently scored a cluster headache nod for its entrant.
RELATED: Biohaven, sporting new data, moves closer to CGRP finish line—and maybe M&A
ICER typically releases evidence reports on drugs around launch time to inform stakeholders on decisions about new meds, VP of communications and outreach David Whitrap previously told FiercePharma.
It follows a report on new rheumatoid arthritis meds that ICER said offered “marginal” benefits. After releasing the report, the group withdrew its findings to reevaluate its approach.
ICER has had a contentious history with pharma companies, who have frequently blasted its methodology and have said ICER is biased. Whitrap recently said relations have been improving and that more drugmakers are cooperating in the reviews.
Coric said that his company looks “forward to continuing to work with ICER to refine the evaluation of these important new agents for patients seeking treatment options and believe that rimegepant will have important differentiation from triptans not reflected in the ICER draft document."
Editor's note: This story was updated with comments from Biohaven CEO Vlad Coric and Eli Lilly. A clarification was added to indicate the report is still a draft and subject to changes.