Based on the results of the state health technology assessment, the Center recommends considering negotiations on managed access agreements (MAAs) for the medicinal product acalabrutinib, indicated as monotherapy for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.
These include, in particular, patients with an unsatisfactory somatic status and intolerance/inadvisability of therapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) and bendamustine in combination with rituximab (BR).
Chronic lymphocytic leukemia is a malignant lymphoproliferative disease characterized by the progressive accumulation of phenotypes of mature malignant B-lymphocytes in the bone marrow, peripheral blood and secondary lymphoid organs. The mean age at diagnosis is 72 years, which means that most patients are elderly people characterized by concomitant diseases (comorbid conditions). This is precisely why standard chemoimmunotherapy regimens, such as FCR and BR, are considered much less effective, more toxic and outdated for such patients, and may be contraindicated due to intolerance.
Based on the results of the analysis of the clinical efficacy of the medicinal product, the following was established:
- acalabrutinib prolongs progression-free survival compared with the combination of chlorambucil + rituximab and reduces the risk of progression or death by 92%, the result is statistically significant.
- acalabrutinib reduces the risk of death by 62% compared with the chlorambucil+rituximab regimen, with a statistically significant difference.
It is expected that an innovative therapy may become available to patients with CLL and comorbidities, which will significantly improve their quality of life.
Detailed information on the HTA conclusion can be found on the Center’s website at the link https://surl.li/mwofua
