Based on the results of the state health technology assessment (HTA), the State Expert Center of the Ministry of Health of Ukraine recommends including the medicinal product darolutamide in the lists of medicinal products procured with state funds using the managed access agreements procedure.
The medicinal product is indicated for patients with non-metastatic castration-resistant prostate cancer at high risk of developing metastases (PSA-DT < 10 months) in combination with androgen deprivation therapy.
Prostate cancer is one of the most common oncological diseases among men worldwide. About 1,6 million new cases of the disease and more than 366 thousand deaths are registered annually. Although the five-year survival rate of patients exceeds 98%, in the event of metastatic disease this figure drops to 31%. Therefore, timely treatment is key to preventing disease progression.
Based on the results of the comparative clinical efficacy analysis, using data from the ARAMIS study, the use of darolutamide in combination with androgen deprivation therapy, compared with androgen deprivation therapy alone:
- reduces the risk of developing metastases by 59% (p<0,001);
- reduces the risk of death by 31% (p=0,003).
The Center's recommendation to include darolutamide in state procurement is based on a comprehensive assessment of its clinical efficacy, safety, economic feasibility and budget impact.
For Ukrainian patients, this is an opportunity to receive modern treatment that helps control the disease, delay its spread and preserve quality of life.
The full conclusion of the state health technology assessment can be found at the link https://surl.li/ibvuhm
