Objectives: Pegvisomant is an established and effective medication for patients with acromegaly, who have had an inadequate response to surgery, radiation therapy or treatment with somatostatin analogues. Currently pegvisomant is not included in the Vital and Essential Drug List (VEDL) in Russia, which limits access to this therapy for patients with limited treatment options. This pharmacoeconomic evaluation compared pegvisomant with best supportive care (BSC) from the Russian healthcare system perspective. Methods: Markov model of acromegaly progression on pegvisomant or BSC was developed. Model included 3 states: normal level of IGF-I concentration, elevated level of IGF-I concentration and death. Transition probabilities between the first two states were derived from the 12-week randomized clinical trial that compared three pegvisomant regimens vs placebo. After 12 weeks we assumed no transitions between normal and elevated IGF-I concentration states and only considered mortality, which was higher in the elevated IGF-I concentration state, according to earlier meta-analysis. Costs of medication and patient monitoring were considered. We used a lifetime time horizon and calculated incremental cost-effectiveness ratio (ICER) as difference in costs of pegvisomant vs BSC derived by difference in life-years gained (LYG). Results: Pegvisomant was associated with 26.65 LYG vs 21.60 LYG on BSC. Yearly medication costs of pegvisomant were US$44,524 per patient. Lifetime medical costs associated with pegvisomant treatment were US$496,971 per patient. ICER for pegvisomant vs BSC was US$98,318 per one LYG. This value is within the actual ICER range for antineoplastic drugs, approved for the VEDL in 2017 in Russia. Sensitivity analyses showed that results were robust to variations in model assumptions. Conclusions: Pegvisomant is a cost-effective option of acromegaly treatment, compared to BSC, and should be recommended for inclusion into VEDL in Russia.
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