OBJECTIVES: Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. Its cost-effectiveness for the prevention of chronic (CM) and episodic migraine (EM) was examined.

METHODS: A semi-Markov cost-effectiveness model (CEM) was developed with a 4-week cycle and 10-year analysis time horizon. Costs and benefits were discounted at 3.0% annual rates. Treatment efficacy was incorporated as reduction in mean migraine days (MDs)/28 days. Patient cohorts were distributed among MD categories (0–28 MDs/28 days) based on mean MD levels. The CEM estimated costs (fremanezumab acquisition and MD-related costs [direct and indirect]) and health-related quality of life (MD- and treatment status–based utilities) for fremanezumab and no-treatment arms. Only background mortality was modeled. Outcome measures were costs, reduction in MDs, and quality-adjusted life-years (QALYs). Analyses were performed on a combined CM-EM population (67% CM, 33% EM). The incremental cost-effectiveness ratio (ICER) was reported as cost/QALY gained between fremanezumab and no treatment. In the base-case analysis, randomized clinical trial (RCT) fremanezumab MDs/28 days were compared with constant no-treatment MD profiles. Fremanezumab was also compared with RCT-sourced placebo-arm MD profiles.

RESULTS: In the base-case 10-year analysis time horizon, monthly fremanezumab treatment resulted in a cost/QALY ICER of $17,755, with average incremental costs of $3,642/patient, incremental QALYs of 0.205, and a 146.0-day reduction in MDs. Excluding indirect costs, fremanezumab treatment resulted in a cost/QALY ICER of $44,748, with average incremental costs of $9,180/patient. Where placebo effects were included, fremanezumab treatment resulted in a cost/QALY ICER of $114,259, with average incremental costs of $10,491/patient, incremental QALYs of 0.092, and a 46.8-day reduction in MDs. Similar results were achieved using cost estimates for quarterly dosing.

CONCLUSIONS: Based on current pricing and RCT results, fremanezumab treatment is cost effective versus no treatment.