The State Expert Center of the Ministry of Health of Ukraine continues to provide scientifically substantiated assessment of medicinal products under the state health technology assessment (HTA) procedure. This is one of the important elements of the process of adopting state decisions on providing patients with innovative treatment.
Based on the results of the HTA, the Center recommends including the medicinal product daratumumab in the lists of medicines procured with state budget funds using the managed access agreements procedure.
Multiple myeloma is a severe oncological disease of the bone marrow. It most often affects older people. The disease manifests as bone pain, anemia, weakness and kidney damage. After standard treatment, relapse or resistance to therapy often occurs. Therefore, access to modern treatment methods is critically important for patients.
Daratumumab is recommended by Ukrainian industry standards and international clinical guidelines for the treatment of patients with multiple myeloma who have received at least one line of therapy, as part of combination therapy with bortezomib and dexamethasone.
The results of the randomized controlled CASTOR trial demonstrated that adding daratumumab to standard therapy:
- more than doubles progression-free survival – 16,7 months versus 7,1 months;
- reduces the risk of disease progression or death by 69%;
- prolongs overall survival – 49,6 months versus 38,5 months;
- reduces the risk of death by 26%.
Thus, the conclusion of the state HTA can become an important step towards expanding patients' access to modern treatment at the expense of the state budget, which has been proven to prolong life expectancy and delay disease progression.
Let us recall that managed access agreements are a mechanism that enables the procurement of innovative medicinal products on special terms. It provides patients with access to modern treatment, and the state with the efficient use of budget funds.
The full conclusion of the state health technology assessment can be found at the link https://surl.li/gihlxw
