— Lasmiditan, rimegepant, and ubrogepant all perform better than placebo, but evidence is not adequate to distinguish among them; generic triptans remain the most effective option for acute treatment for most patients requiring prescription medications —

— At prices anticipated by analysts, all three drugs would exceed common thresholds for cost-effectiveness —

BOSTON, January 10, 2020 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine: lasmiditan (Reyvow™, Eli Lilly), rimegepant (Biohaven), and ubrogepant (Ubrelvy™, Allergan).

“These new therapies appear to be less effective overall than triptans and are expected to be much more expensive,” said David Rind, MD, ICER’s Chief Medical Officer. “However, for those patients who are unable to take triptans or who don’t get adequate benefit from them, the evidence does demonstrate that all three new therapies improve or relieve migraine symptoms in 10-20% more patients than respond to placebo. To reach commonly cited thresholds of cost-effectiveness, these therapies would require prices significantly below what some analysts are currently projecting.”

This Evidence Report will be reviewed at an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in Chicago, IL on January 23, 2020. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. Register here to attend the Midwest CEPAC meeting in person or to watch by live webcast.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect 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 Clinical Findings

For people with acute migraine who can tolerate triptans, the evidence provides moderate certainty that lasmiditan, rimegepant, and ubrogepant all offer either a comparable or inferior net health benefit to triptans. Therefore, triptans will likely remain first-line therapy for this patient population.

For those people with migraine who are not able to take triptans, results from clinical trials show that lasmiditan, rimegepant, and ubrogepant all decrease symptoms of migraine attacks and improve function compared with placebo. This evidence provides moderate certainty that all three treatments offer a small or substantial net health benefit, with high certainty of at least a small net health benefit.

The evidence also suggests that all three treatments provide comparable net health benefits to each other. Lasmiditan may provide slightly greater pain relief at two hours than rimegepant and ubrogepant, but it has significantly higher rates of dizziness and discontinuation.

Key Cost-Effectiveness Findings

ICER’s value-based price benchmark range for lasmiditan, rimegepant, and ubrogepant is $2,200-$3,200 per year. While the actual prices for the treatments are not yet known, each would need to be priced well below branded sumatriptan (Imitrex®, GlaxoSmithKline) to reach these benchmarks.

ICER’s value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with a treatment’s added benefits for patients over their lifetime. The ranges reflect commonly cited cost-effectiveness thresholds between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. Prices at or below these thresholds help ensure that the health benefits gained by patients using new treatments are not outweighed by health losses due to long-term cost pressures that lead individuals to abandon care or lose health insurance.

Because none of these treatments has been shown to extend patients’ lives, ICER did not calculate what prices would be needed to reach alternative cost-effectiveness thresholds based on Equal Value of Life Years Gained (evLYG).

Potential Budget Impact

At an assumed annual placeholder price of $4,515 for each of three new therapies, only between 10-18% of eligible patients who are not able to take triptans could be treated before crossing ICER’s potential budget impact threshold of $819 million per year. In lieu of an actual price for any of the three therapies, this placeholder price is based on an analyst estimate that the new therapies could be priced approximately 20% higher than branded sumatriptan.

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.