New Treatments for Migraine: Therapeutic Ratings and Comparative Coverage in the US, Canada, and Europe

Although the FDA and EMA broadly approved 3 CGRP-targeted migraine therapies (erenumab, fremanezumab, galcanezumab) for preventive treatment, French and German health technology assessment agencies rated all 3 as providing no added benefit over existing treatments for their general indications, rating the therapies as providing “considerable added benefit” only for patients who had failed all other prophylactic therapies. Comparator countries and the US VA have also restricted coverage far more narrowly than the FDA indication, consistent with evolving clinical guidelines and cost-effectiveness analyses suggesting price reductions of 23-46% would be needed for these drugs to meet standard value thresholds.