Abstract

Immunotherapy treatments have transformed cancer care, offering improved outcomes in a range of indications, greater quality of life, survival benefits and regimen tolerability, and have markedly improved treatment efficacy. The rapid expansion of immuno-oncology (IO) treatment options and their use may potentially put healthcare budgets under strain. The objective of this study is to describe an approach developed to inform decision makers and payers of the potential health outcomes and economic impact of PD-1/PD-L1 inhibitors in Bulgaria. Budget impact analysis and partitioned survival modelling were used to estimate key clinical and economic outcomes in a world with and without PD-1/PD-L1 inhibitors in 11 oncology indications: adjuvant and metastatic melanoma, first- and second-line non-small cell lung cancer, metastatic triple-negative breast cancer, urothelial carcinoma, renal cell carcinoma, first- and second-line head and neck squamous cell carcinoma, small cell lung cancer and gastric cancer. Outcomes were estimated over a five-year time horizon (2019-2023). Drug acquisition costs and market share assumptions were based on publicly available information, while efficacy and adverse events data were taken from the clinical trials. Indirect costs were also included in the model. In 2019, it was estimated that 22.2% (BGN 88 million) of Bulgarian expenditure on cancer medicines was attributable to PD-1/PD-L1 inhibitors. The average annual economic impact of PD-1/PD-L1 inhibitors is estimated to be BGN 179 million over five years. For this investment, 1,711 additional life years, 1,546 progression-free life years and 1,429 quality-adjusted life years are expected to be gained over five years by using PD-1/PD-L1 inhibitors in Bulgaria. A reduction of 626 high-grade adverse events is also expected. PD-1/PD-L1 inhibitors can deliver significant survival benefits in cancer patients, with less severe side effects. The budgetary effects for Bulgaria are manageable but increasing usage of PD-1/PD-L1 inhibitors will require additional budget planning.

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