The State Expert Center has completed the state health technology assessment of the medicinal product trifluridine/tipiracil for the treatment of adult patients with metastatic colorectal cancer.
The corresponding conclusion is published on the Center's website: http://surl.li/tseds
Disease priority: for which patients is it important?
Malignant neoplasms of the colon rank fourth among women and fifth among men in the structure of overall cancer incidence in Ukraine. In Europe, the incidence of rectal cancer is 35% of all cases of colorectal cancer, i.e., 15-25 patients per 100 thousand population per year; mortality from this pathology is 4-10 cases per 100 thousand per year.
Cancer treatment is one of the priority areas of healthcare development for 2023–2025 (MoH of Ukraine order of 07.10.2022 No. 1832).
About the medicinal product under assessment
Based on the analysis of the comparative clinical efficacy of trifluridine/tipiracil, clinical benefits were confirmed compared with best supportive care (placebo) in patients with metastatic colorectal cancer who had previously been treated with the available types of chemotherapy.
With the use of the investigational medicinal product, the risk of death is reduced by 33% and the risk of disease progression by 54%. Trifluridine/tipiracil received a score of 3 points (moderate benefit) on the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (based on the RECOURSE study).
UO recommendations
It is recommended to consider holding negotiations on managed entry agreements for the medicinal product trifluridine/tipiracil (film-coated tablets of 15 mg and 20 mg), as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with available therapies, taking into account the conditions specified in the opinion.
