— Clinical benefits similar to other new CGRP inhibitors included in review —

— Despite favorable long-term cost-effectiveness, June 14th public meeting will address how to manage short-term affordability if these agents are widely prescribed —

 BOSTON – May 31, 2018 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks: erenumab (Aimovig™, Amgen/Novartis), fremanezumab (Teva), and galcanezumab (Eli Lilly). Erenumab was approved earlier this month. The other two agents remain under FDA review.

ICER’s report found that the CGRP inhibitors prevented approximately one to three days of migraine per month, on average. Cost-effectiveness analyses for erenumab and fremanezumab, using an estimated annual net price of $5,000, found that the price of the therapies aligns with the value to patients for whom other preventive treatments have failed. The drugs were not found to be cost-effective, however, if used to treat patients who had not already tried existing preventive treatments, which are far less expensive.

ICER’s previously released Draft Evidence Report used a placeholder price of $8,500 per year; however, following the announcement of erenumab’s list price of $6,900 annually, ICER updated these analyses. Assuming a 27% discount reflective of typical rebates and discounts to reach a net price of $5,000, cost-effectiveness findings became substantially more favorable than in the draft report.

This Evidence Report will be the subject of an upcoming public meeting of the California Technology Assessment Forum (CTAF) in Los Angeles, CA on June 14, 2018. CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

“CGRP inhibitors appear to offer modest improvements in outcomes for patients with chronic migraine and frequent episodic migraine. For individuals for whom prior preventive therapies have not been effective or tolerated, the price of erenumab after expected discounts seems to align with those added benefits for patients,” noted David Rind, MD, MSc, ICER’s Chief Medical Officer. “However, as with any new class of medication only tested in trials of several months’ duration, concerns remain about unanticipated harms. Additionally, migraine is common, and there may be concerns about affordability and access. While the therapies are cost-effective in the long-term, CGRP inhibitors could potentially have a significant impact on short-term health budgets. During our public meeting in June, we will convene stakeholders from all perspectives to identify opportunities to ensure access for those patients for whom these therapies are appropriate, while balancing the need to maintain affordability.”

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report reflects changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Report Findings

For patients with either chronic or episodic migraine who are eligible to receive preventive therapy with oral agents or onabotulinum toxin A (the latter for chronic migraine only), evidence was insufficient to show a net health benefit of either erenumab or fremanezumab over those options. In patients for whom prior preventive therapy has failed, evidence suggested a comparable or better net health benefit of both therapies in chronic migraine and was promising but inconclusive in episodic migraine. Conclusions about net health benefit were limited by remaining uncertainty regarding the long-term safety profile of CGRP inhibitors.

Given the limited data currently available for galcanezumab, evidence was found to be insufficient in all populations.

When used for patients with chronic and episodic migraine for whom prior preventive treatments have failed, ICER estimated a fair annual price of $3,700 to $5,300 for erenumab and $3,700 to $5,200 for fremanezumab. For erenumab, this represents a discount of 23% to 46% off the announced list price. At an assumed net price of $5,000, ICER estimates that of all eligible patients (those for whom at least one preventive therapy has failed), 16% could be treated with erenumab and 22% could be treated with fremanezumab, annually, without raising concerns about affordability. It is unknown at this time how many individuals within the eligible population will be prescribed a CGRP inhibitor.

During the June public meeting, pre-registered stakeholders will provide brief oral comments on the report and its findings, the CTAF panel will vote on key questions raised in the report, and a roundtable of experts will discuss recommendations for applying the evidence to policy and practice. Requests to make an oral comment were accepted during the public comment period on the Draft Evidence Report and are now closed.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.