OBJECTIVES: To assess the budget impact in 5 years of incorporating venetoclax in combination with rituximab (VR) to the minimum mandatory coverage list of the Agência Nacional de Saúde Suplementatar (ANS) for treating relapsed or refractory Chronic Lymphocytic Leukemia (R/R CLL) compared to ibrutinib.

METHODS: The economic analysis compares the two treatment options based exclusively on their list prices (PF18%), according to Brazilian Health Regulatory Agency (Anvisa) price-data. Based on the number of adult beneficiaries of health insurance in Brazil, it was applied epidemiological premises to determine the total number of eligible patients for treatment. The National Institute for Health and Clinical Excellence (NICE) premises on time on treatment were considered for VR (22 months) and ibrutinib (56 months). The model simulated the market penetration assumption for VR, reaching 100% in 5 years. A sub-analysis of 17p deletion patients was developed, once this is the only R/R CLL population currently in the ANS’ mandatory coverage list. Scenarios considered: scenario 1 (total incidence per year and no discontinuation rate); scenario 2 (total incidence per year and annual discontinuation according to clinical trials); and scenario 3 (total incidence per year, the annual discontinuation according to clinical trials and a technology adoption curve on patients without 17p deletion). A coverage expansion analysis was also developed.

RESULTS: Over 5 years, in scenario 1, the total incremental cost saving was R$ 300,170,524; in scenario 2 R$ 221,480,973; and scenario 3 R$ 238,385,678. The incremental cost saving generated by VR solely in the 17p deletion population would allow access expansion for treating 60% of patients without 17p deletion each year.

CONCLUSIONS: Venetoclax in combination with rituximab generates the least budgetary impact compared to ibrutinib for treating relapsed or refractory Chronic Lymphocytic Leukaemia (R/R CLL) in the Brazilan private heathcare system.