Clinical and economic impact of modern pharmaceuticals on reducing mortality from hormone-sensitive prostate cancer with high-volume disease

Background. One of the modern standards of treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC) is second-generation androgen receptor inhibitors enzalutamide and apalutamide used in combination with androgen deprivation therapy (ADT), as well as darolutamide used in combination with docetaxel and ADT.

Aim. To evaluate clinical and economic effects of using novel pharmaceuticals for treating patients with mHSPC and high-volume disease on reducing prostate cancer mortality in Russia.

Materials and methods. A mathematical model based on overall survival and progression-free survival data from clinical trials and network meta-analysis has been developed. The model describes duration of therapy and treatment outcomes in a 3-year period for combinations darolutamide + docetaxel + ADT, enzalutamide + ADT, apalutamide + ADT, docetaxel + ADT and ADT monotherapy in current practice. Four additional scenarios were considered: Darolutamide, Enzalutamide, and Apalutamide, in which all patients were treated with corresponding pharmaceutical, as well as the Rational scenario, in which the frequency of prescriptions for each considered option was determined by expert consensus. The model was used to estimate the number of lives saved and healthcare system costs when transitioning from the current practice to different scenarios of the proposed practice over a 3-year horizon considering the number of adult patients with mHSPC and high-volume disease who may start the considered therapy annually in Russia.

Results. Every year in Russia, up to 9,092 patients with mHSPC and high-volume disease can initiate therapy with the considered options. Compared to the current practice, in the Darolutamide scenario within 3-year horizon it is possible to reduce mortality from prostate cancer by 2,159 cases (22–39 % reduction in mortality from malignant tumors necessary to achieve the “Health Development” state program goal); in the Enzalutamide scenario by 787 cases (9–14 % reduction); in the Apalutamide scenario by 382 cases (5–7 % reduction); and in the Rational scenario by 1,115 cases (11–20 % reduction). The cost of saving one life in the Darolutamide scenario amounts to 17.8 million rubles, in the Enzalutamide scenario to 61.2 million rubles, in the Apalutamide scenario to 65.5 million rubles, in the Rational scenario to 18.6 million rubles.

Conclusion. The use of second-generation androgen receptor inhibitors in patients with mHSPC and high-volume disease has a significant and quantifiable impact on reducing cancer-related mortality in Russia. Darolutamide is the most cost-effective option among all the considered ones.

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