The Center recommends considering the possibility of negotiating managed access agreements (MAAs) for the medicinal product palbociclib for the treatment of advanced HR(+), HER2(-) breast cancer, stage IV, without life-threatening visceral involvement, in postmenopausal patients who have not previously received treatment for metastases.
According to study data, the product demonstrates clinical advantages in efficacy and safety in combination with letrozole compared with letrozole monotherapy. Palbociclib acts by inhibiting cyclin-dependent kinases CDK4/6, which reduces cell proliferation by blocking the transition from the G1 phase to the S phase of the cell cycle.
Taking into account the results of the assessment of clinical effectiveness and cost-effectiveness, safety and prevalence of the nosology, the authorized body for state HTA recommended considering the possibility of holding negotiations on managed entry agreements for the medicinal product palbociclib with a view to its further inclusion in the list of medicinal products, medical devices and ancillary equipment for them, procured with public funds to implement health care programs and centralized measures in the area of “Chemotherapeutic agents, radiopharmaceuticals and supportive care agents for the treatment of cancer patients.”
Of note, breast cancer ranks first in incidence among women aged 30-74 years and in mortality among women aged 30-75+ years. According to the National Cancer Registry of Ukraine, a high incidence rate (20,2-104,3 per 100 thousand population) is recorded in cohorts of women of reproductive age. Prevention, diagnosis, and treatment of oncological diseases are among the priority areas of healthcare development for 2023-2025 years.
Detailed information on the conclusion of the state HTA on the medicinal product palbociclib can be found on the Center’s website at http://surl.li/uucwzu
