The Institute for Clinical and Economic Review revised its previous assessment of two new migraine drugs, determining that they meet its long-term cost-effectiveness thresholds — after previously ruling the cost of the medicines was too high. The final evidence report concluded that Allergan's Ubrelvy, which costs $4,896 a year, and Biohaven's rimegepant meet the cost-effectiveness threshold.
The revised analysis of Allergan and Biohaven's drugs came after ICER "work[ed] closely with Allergan to identify high-quality evidence demonstrating additional clinical benefits for ubrogepant beyond the two-hour time point required by the FDA for the clinical trials." The trials submitted for approval compared the drugs to placebo two hours after patients took the medicine.
Use older meds first: Despite the revised cost-effectiveness assessments ICER says it would be "reasonable" for insurers to require prior authorization for these drugs, since they did not demonstrate superiority to older, less-expensive medicines. ICER encouraged the companies to conduct long-term trials that directly compare the migraine treatments as the clinical trials of the new drugs compared the medicines to placebo.
ICER has experienced a lot of pushback from the drug industry and patient groups who argue the assessments don't fully consider the various benefits of a drug. The new ICER assessment drew mixed reviews from two migraine focused groups — the Coalition for Headache and Migraine Patients and Headache & Migraine Policy Forum. "We continue to have concerns that the ICER approach under-counts the real economic costs of migraine disease and under-values the benefits of these new medicines," they said. They are pushing ICER to analyze the drugs again using a framework the group is switching to that will place greater weight on societal benefits of a drug.