The Center recommends including the medicinal product Emicizumab in the lists of medicinal products procured with state funds using the CDA procedure for routine prophylaxis of bleeding episodes in adult patients with hemophilia A without inhibitors to factor VIII and with difficult venous access – a conclusion from the state health technology assessment has been published.
Why is this important for patients?
Severe hemophilia A is accompanied by a high risk of recurrent bleeding, in particular joint bleeding, which over time leads to chronic pain, joint damage and loss of functional activity. For some patients, an additional problem is difficult venous access (approximately 36,7% of patients), which significantly complicates regular intravenous administration of factor VIII for the prophylaxis of bleeding.
What is the clinical advantage?
Emicizumab for the prophylaxis of bleeding in hemophilia A is administered subcutaneously and allows reducing dependence on frequent intravenous injections.
Based on the results of the analysis, it was established that prophylaxis with Emicizumab provides a statistically and clinically significant reduction in the frequency of bleeding compared with treatment with factor VIII products "on demand". The annual frequency of treated bleeding decreased by more than 95% compared with the absence of prophylaxis.
You can read the state HTA conclusion in detail on the Center's website at the link https://surl.li/hztrlf
It is worth noting that Emicizumab has already been the subject of a state health technology assessment and is currently provided by the state payer in Ukraine for routine bleeding prophylaxis. It is used for the treatment of adult patients with hemophilia A with the formation of inhibitors to factor VIII, as well as in children with hemophilia A, starting from birth, with or without the formation of inhibitors.
The published state HTA conclusion supplements the existing decisions and expands the possibilities for treating patients with this severe orphan disease.
