Budget Impact of Venetoclax for Newly Diagnosed Patients with Acute Myeloid Leukemia Aged ≥ 75 Years or with Comorbidities Precluding Intensive Chemotherapy in the United States.

[INTRODUCTION] Venetoclax plus azacitidine or decitabine is approved in the US for treatment of newly diagnosed patients with acute myeloid leukemia (AML) aged ≥ 75 years or who have comorbidities precluding use of intensive chemotherapy. As novel targeted regimens expand treatment options for AML, this study evaluated the budget impact of adopting venetoclax combinations for this population from a US third-party payer perspective to inform affordability and access at the health plan level.

[METHODS] The model estimated the 3-year budget impact of adopting venetoclax combinations in a hypothetical US health plan with 1 million members (60% commercial, 40% Medicare). Eligible patients were estimated using public data. Market share projections assumed venetoclax + azacitidine or decitabine captured a 53% and 15% share, respectively, from existing treatments (azacitidine, low-dose cytarabine [LDAC], decitabine, ivosidenib, gemtuzumab ozogamicin, glasdegib + LDAC, and ivosidenib + azacitidine). The model considered costs associated with drug acquisition/administration, adverse events, hospitalization, disease monitoring, blood transfusions, and subsequent AML management (2024 USD). Clinical inputs for venetoclax combinations were informed by final VIALE-A and M14-358 data, respectively. Incremental budget impact was calculated as per-member-per-month (PMPM), with one-way sensitivity analyses performed.

[RESULTS] In a 1-million-member health plan, 48 patients were eligible for venetoclax combinations. Annual costs of venetoclax + azacitidine ($258,498) or decitabine ($259,921) were lower than those of the highest-cost comparators, ivosidenib + azacitidine ($477,520) and ivosidenib ($404,869). Drug acquisition costs of adopting venetoclax combinations were offset by lower subsequent AML management costs, resulting in savings of $0.0476 PMPM in years 1-3. Results remained robust in sensitivity analyses. In a 100% Medicare scenario, 117 patients were eligible for venetoclax combinations, with savings of $0.1137 PMPM over years 1-3.

[CONCLUSION] Inclusion of venetoclax combinations for newly diagnosed patients with AML aged ≥ 75 years or with comorbidities precluding intensive chemotherapy reduced the budget impact, providing potential financial benefits for US payers.