Фармакоекономічний аналіз застосування пертузумабу в терапії метастатичного HER2-позитивного раку молочної залози в Україні

Abstract

ABSTRACT Background. The incidence of breast cancer tends to be increasing worldwide in recent years. It is characterized by various clinical manifestations and potential treatment approaches. The choice of treatment strategy, its sequence as well as the efficiency of administered chemotherapy is quite relevant these days. Purpose – assessing economic feasibility of targeted therapy with pertuzumab (Perjeta®) in patients with metastatic HER2+ BC from the perspective of the health care system of Ukraine. Materials and methods. The treatment outcomes as well as related costs were determined by means of Markov analytical modelling based on a randomized multicenter open clinical study of CLEOPATRA phase III [2]. The model time horizon was 20 years. The alternative schemes of frontline therapy of metastatic HER2+ breast cancer were compared: PTD regimen pertuzumab + trastuzumab + docetaxel and TD regimen trastuzumab + docetaxel. Based on Markov modelling, pharmacoeconomic analysis by means of cost-effectiveness and cost-utility methods was carried out. As an efficiency criterion, LYG amount was used, as a utility criterion − QALY indicator. Direct medical costs were counted, the structure of which had been determined according to the current Protocol. The cost of drugs was calculated in accordance with the Register of wholesale prices for pharmaceuticals of the Ministry of Health of Ukraine; the cost of treatment procedures was determined in accordance with the available price lists of paid medical services provided by licensed medical institutions. Discounting at the level of 3 % per year was applied. Sensitivity analysis of the outcomes was carried out before pertuzumab price changed. Results. According to the modelling, the average life expectancy of patients with HER2+ BC, receiving PTD scheme is 15.69 years compared to 13.95 years in the TD group. Along with prolonging life, associated with PTD scheme, its quality increases. Patients in the TD group gain 7.8 QALY on average, while in the PTD group it is 9.24. The total expenses for the simulated (involved into modeling) study period in the PTD group averaged UAH 1 970 369.6 per patient, in the TD group − UAH 732 517.7. ICER (cost of 1 additional life year) and ICUR (cost of 1 additional quality-adjusted life year) incremental coefficients amounted to UAH 710924.6 and UAH 861175.4 respectively.