Based on the results of the state health technology assessment, the Center recommends considering the possibility of negotiating managed access agreements for the medicinal product brentuximab vedotin for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma in combination with cyclophosphamide, doxorubicin and prednisone (CHP).
Malignant neoplasms are one of the most complex and important challenges for the healthcare sector. The constant growth in cancer incidence, the difficulties associated with early-stage diagnosis, and the high cost and complexity of treatment make the issue of malignant neoplasms extremely relevant.
The mechanism of action of this medicinal product is that it delivers an antineoplastic agent to CD30-positive tumor cells, leading to their apoptotic death. According to study data, the medicinal product brentuximab vedotin demonstrates clinical benefits in progression-free survival and overall survival in combination with CHP chemotherapy compared with standard chemotherapy (CHOP regimen: cyclophosphamide, doxorubicin, vincristine, prednisone).
Taking into account the recommendations of international clinical guidelines and protocols and the results of the assessment of clinical efficacy and safety based on high-quality evidence, the Authorized Body for state HTA recommended considering the possibility of negotiating managed access agreements for the medicinal product brentuximab vedotin for the indication of treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma, positive or negative for the anaplastic lymphoma kinase gene (ALK+ or ALK-), in combination with chemotherapy (cyclophosphamide, doxorubicin and prednisone, CHP), with a view to its further inclusion in the list of medicinal products, medical devices and auxiliary equipment procured with public funds for the implementation of healthcare programs and centralized measures under the area “Chemotherapeutic products, radiopharmaceuticals and supportive products for the treatment of cancer patients”.
The conclusion of the state HTA on the medicinal product brentuximab vedotin can be reviewed in detail on the Center’s website at http://surl.li/ylurcz
