Based on the results of the state health technology assessment, the Center recommends including crovalimab in the lists of medicinal products procured with state funds using the managed access agreements procedure.
The medicinal product is intended for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and children aged 12 years and older – a rare chronic blood disease in which red blood cells are destroyed. This can lead to anemia, blood clot formation, impaired kidney function and the need for frequent blood transfusions.
Crovalimab blocks a specific protein of the part of the immune system involved in their destruction.
The medicinal product belongs to modern targeted therapies and is currently the only medicinal product registered in Ukraine that directly affects this mechanism of PNH development.
What did the studies show?
According to the results of a network meta-analysis (Bührer et al., 2023), compared with best supportive care, patients receiving crovalimab:
- more often did not require red blood cell transfusions;
- required on average 8 fewer blood transfusions;
- more often achieved a stable hemoglobin level;
- reported better well-being and less fatigue.
The Center's recommendation to include crovalimab in state procurement is based on a comprehensive assessment of its clinical efficacy, safety, cost-effectiveness and budget impact.
For Ukrainian patients with paroxysmal nocturnal haemoglobinuria, this may expand treatment options, reduce the need for blood transfusions and improve quality of life.
The HTA conclusion can be reviewed in detail on the Center's website at the link https://surl.li/befcfm
