Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States.

Background: Galcanezumab (GMB) improved quality of life and reduced disability of patients with episodic (EM) and chronic migraine (CM) in Phase 3 trials. Aim: To estimate indirect cost savings associated with GMB treatment in patients with migraine in the United States (US). Methods: We analyzed data of patients from the US from three randomized, Phase 3, double-blind, placebo (PBO)-controlled GMB studies: EVOLVE-1 and EVOLVE-2 (EM patients), REGAIN (CM patients). Annual indirect costs were calculated using items of Migraine Disability Assessment (MIDAS) questionnaire: lost time/productivity at work/school, household work, and leisure time. All costs were annualized and expressed in 2019 US dollars. While the main analysis considered lost time/productivity at work/school and household work as a full day, a sensitivity analysis was performed by discounting them by half. For EM, annual indirect costs savings were estimated using mixed model repeated measures analysis. For CM, ANCOVA models were used to estimate annual indirect costs savings as change from baseline. Results: The analysis included 805 patients with EM (mean age = 41.4y; PBO = 534; GMB = 271) and 423 patients with CM (mean age = 38.9y; PBO = 279; GMB = 144). Compared to PBO, GMB significantly reduced annual indirect costs among patients with EM at 3 months (least square mean [95% confidence interval] work/school=$1883.6 [603.64, 3163.65], p = 0.0040, household work=$628.9 [352.95, 904.88], p < 0.0001, and leisure activity=$499.17 [42.36, 955.98], p = 0.0323) and 6 months (work/school=$2382.29 [1065.48, 3699.10], p = 0.0004, household work=$559.45 [268.99, 849.90], p = 0.0002, and leisure activity=$753.81 [334.35, 1173.27], p = 0.0004), whereas significant difference was not observed among patients with CM. Sensitivity analysis results were similar to primary analysis results. Conclusions: GMB treatment versus PBO resulted in significantly greater indirect cost savings in patients with EM through improved productivity at work/school, household work, and leisure days. Patients with CM receiving GMB versus PBO attained greater cost savings, although not statistically significant, through reduced lost productivity at work/school.