Impact of Ibrutinib and Idelalisib on the Pharmaceutical Cost of Treating Chronic Lymphocytic Leukemia at the Individual and Societal Levels

PURPOSE: To evaluate the impact of approval of ibrutinib and idelalisib on pharmaceutical costs in the treatment of chronic lymphocytic leukemia (CLL) at the societal level and assess individual out-of-pocket costs under Medicare Part D. METHODS: Average wholesale price of commonly used CLL treatment regimens was ascertained from national registries. Using the population of Olmsted County, Minnesota, we identified the proportion of patients with newly diagnosed CLL who experience progression to the point of requiring treatment. Using these data, total pharmaceutical cost over a 10-year period after diagnosis was estimated for a hypothetic cohort of 100 newly diagnosed patients under three scenarios: before approval of ibrutinib and idelalisib (historical scenario), after approval of ibrutinib and idelalisib as salvage therapy (current scenarios A and B), and assuming use of ibrutinib as first-line treatment (potential future scenario). RESULTS: Estimated 10-year pharmaceutical costs for 100 newly diagnosed patients were as follows: 4, 565, 929 (approximately 45, 659 per newly diagnosed patient and 157, 446 per treated patient) for the historical scenario, 7, 794, 843 (approximately 77, 948 per newly diagnosed patient and 268, 788 per treated patient) for current scenario A, 6, 309, 162 (approximately 63, 092 per newly diagnosed patient and 217, 557 per treated patient) for current scenario B, and 16, 414, 055 (approximately 164, 141 per newly diagnosed patient and 566, 002 per treated patient) for the potential future scenario. Total out-of-pocket cost for 100 patients with newly diagnosed CLL under Medicare Part D increased from 9, 426 under the historical scenario (approximately 325 per treated patient) to 363, 830 and 255, 051 under current scenarios A and B (approximately 8, 800 to 12, 500 per treated patient) and to 1, 031, 367 (approximately 35, 564 per treated patient) under the future scenario. CONCLUSION: Although ibrutinib and idelalisib are profound treatment advances, they will dramatically increase individual out-of-pocket and societal costs of caring for patients with CLL. These cost considerations may undermine the potential promise of these agents by limiting access and reducing adherence.