Фармакоекономічний аналіз використання олапарибу (препарату Лінпарза®) для підтримуючої терапії пацієнтів із BRCA-мутованим чутливим до препаратів платини рецидивуючим раком яєчників

Among women, one of the common localizations of malignant tumors is ovarian cancer (OC). Two genes have been identified, and their mutations lead to hereditary forms of breast and ovarian cancer – BRCA1 and BRCA2. Women with BRCA-associated OC respond better to targeted drugs and have better survival rates against specific treatments. Targeted drugs for the treatment of BRCA-mutated OC are specific inhibitors of enzymes of the group poly- (ADP-ribose) polymerase (PARP). Currently, the only PARP inhibitor registered in Ukraine is olaparib (Linparza ® drug, AstraZeneca, United Kingdom). Aim. To assess the economic feasibility of the targeted olaparib therapy (Linparza ® drug) for patients with BRCA mutated platinum-sensitive recurrent ovarian cancer (BRCA-MPS ROC) from the standpoint of the Ukrainian healthcare system. Materials and methods. Determination of treatment outcomes and associated costs was performed using Markov analytical modeling based on the results of a randomized multicenter, open-label phase II clinical trial D0810C0019-Study 19. The model time horizon is 15 years. Clinical efficacy and safety of olaparib and placebo (WW strategy) were compared as the supportive therapy for patients with BRCA-MPS ROC. Based on the results of Markov simulation the methods of “cost-effectiveness” and “cost-utility” were used. Years of the saved life (LYG) were used as a criterion of efficiency. The QALY index was used as a criterion of utility. The cost of direct medical expenses, which structure was determined in accordance with the current Protocol, was taken into account. The cost of medical treatment was determined according to the register of the Ministry of Health of Ukraine as of 7.08.2019. The cost of medical services was determined according to the available price lists. The cost of correction of side effects of the chemotherapy was also considered. Discounting was determined at the level of 5 % annually. The sensitivity analysis of the results was performed on the price and dose of olaparib and the observation horizon. Results. According to the simulation, the average life expectancy of patients with BRCA mutated platinum-sensitive recurrent ovarian cancer when using olaparib (Linparza ® drug) as a supportive antitumor therapy is 4.8 LYG compared to 2.56 LYG in the WW strategy group. The olaparib supportive care strategy provides the patient with 3.61 years of quality of life compared to 1.87 years in the WW group. Thus, the use of olaparib provides the patient with an additional 2.24 years of life and 1.74 additional QALY. The total costs for the simulated period in the group of olaparib averaged 1893410.7 UAH, and in the WW group – 47466.9 UAH. The incremental coefficients of ICER (cost of 1 additional year of life) and ICUR (cost of 1 additional year of quality life) amounted to 824564,4 UAH, and 1063162.2 UAH, respectively. Conclusions. The pharmacoeconomic analysis based on Markov modeling and cost-effectiveness and cost-utility calculations has shown that olaparib (Linparza ® drug) is highly effective in the treatment of BRCA-mutated platinum-sensitive recurrent ovarian cancer; it almost doubles the patients’ survival without recurrence. At the same time, olaparib is an expensive drug. The transition of half of the patients with BRCA-mutated platinum-sensitive recurrent ovarian cancer from the “watch-and-wait” strategy to the treatment with olaparib requires an additional annual cost of 10,548,250.3 UAH.