Based on the results of the state health technology assessment, the Center recommends considering negotiations on managed access agreements for the medicinal product enzalutamide for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of progression.
The mechanism of action of the medicinal product is that it blocks several stages of the androgen receptor signaling pathway, inhibits the growth of cancer cells, and can induce their death and tumor regression.
Enzalutamide demonstrates clinical benefits in metastasis-free survival and overall survival compared with placebo: a reduction in metastasis by 71%; an additional 21,9 months of median metastasis-free survival; a reduction in the risk of death by 27%; an additional 10,7 months of median overall survival.
Taking into account the recommendations of international clinical guidelines and protocols and the results of the assessment of clinical effectiveness and safety based on high-quality evidence, the authorized state HTA body has been recommended to consider conducting negotiations on managed access agreements for the medicinal product enzalutamide, with a view to its further inclusion in the list of medicinal products, medical devices, and auxiliary equipment procured with public funds for the implementation of healthcare programs and centralized measures in the area of "Chemotherapeutic drugs, radiopharmaceuticals, and supportive care drugs for the treatment of oncology patients."
Detailed information on the state HTA conclusion for the medicinal product enzalutamide is available on the Center’s website at the link http://surl.li/hngtgx
For your information, in Ukraine prostate cancer ranks second in the structure of morbidity and mortality among men. Prostate cancer in its development passes through several successive stages – from a localized process to the formation of metastases. One of the intermediate stages requiring special attention from specialists is nmCRPC. A change in treatment tactics can significantly prolong the patient's survival.
