Clinical and economic assessment of an extended release lanreotide formulation (Somatuline® Autogel®) in patients with gastrointestinal neuroendocrine tumors

Objective: To conduct a comparative pharmacoeconomic assessment of the use of extended release formulations of lanreotide and octreotide in adult patients (over 18 years of age) with gastrointestinal neuroendocrine tumors (GI NETs) in the Russian healthcare system in 2025. Material and methods. A comparative analysis of clinical trial data, including randomized controlled trials and retrospective cohort studies, was conducted on the efficacy and safety profiles of lanreotide and octreotide. The focus was on overall survival, progressionfree survival, and the incidence of adverse events. Next the study employed the methods involving the calculation of the costeffectiveness ratio (CER) and the incremental cost-effectiveness ratio (ICER), as well as sensitivity analysis. Economic parameters (costs, CER, ICER) are presented both in absolute values (rubles) and as relative measures (%). Results . The average costs of drug therapy with lanreotide for 10 years per patient comprised 7,213,219.59 rubles, compared to 4,279,437.69 rubles for a course of extended release octreotide (a difference of 40.67%). At the same time, the costs of treating adverse events were lower for lanreotide compared to octreotide, equaling 24,604.01 and 59,203.81 rubles, respectively (a difference of 58.4%). Direct medical costs for a 10-year course of lanreotide therapy in one patient with GI NETs were 7,237,823.60 rubles, compared to 4,338,641.50 rubles for a course of octreotide, with the difference comprising 2,899,182.10 rubles (40.06%). When calculating CER, the cost of 1 month of extended life with lanreotide therapy was 63,825.60 rubles, compared to 48,046.97 rubles using octreotide (a difference of 32,83%). When recalculated to annual costs, the cost of 1 year of extended life with lanreotide therapy was 765,907.26 rubles, compared to 576,563.65 rubles using octreotide (a difference of 24.73%). ICER for lanreotide was 1,506,068.62 rubles per year, which is within the limits of justified economic costs, being significantly lower than the willingness to pay for the Russian Federation (about 3,350,000 rubles per year). Results of a one-way sensitivity analysis showed that the benefit of lanreotide is achieved with a 25% increase in the price of octreotide or a 33% increase in overall survival with lanreotide. Conclusion. The use of lanreotide in adult patients with GI NETs is both a clinically justified and economically feasible choice in the context of Russian healthcare.