Package advice on the lock procedure medicinal product tafasitamab (Minjuvi®) for the treatment of lymphoma
The National Health Care Institute has assessed whether the medicinal product tafasitamab (Minjuvi®) can be reimbursed from the basic health care package. Tafasitamab is used in the treatment of certain patients with an aggressive form of lymphoma. The reason for this advice was the placing of the product in the so-called ‘lock procedure’ for expensive medications’. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to reimburse tafasitamab (Minjuvi®) from the basic health care package for this indication after price negotiations.
Indication for which reimbursement is requested
Reimbursement has been requested for the treatment of people with an aggressive form of lymphatic cancer, better known as relapsed/refractory diffuse large cell B-cell lymphoma (R/R DLBCL). This is a type of lymphoma that is part of the group of non-Hodgkin lymphomas. Relapsed means that the cancer has come back, after first having disappeared partially or completely. Refractory means that the tumour did not respond to earlier treatment.
Tafasitamab can be used in combination with lenalidomide, followed by tafasitamab only. This is called monotherapy. These are patients who are not eligible for autologous stem cell transplantation. In an autologous stem cell transplant, the patient gets stem cells from their own blood or bone marrow.
Recommendations from the National Health Care Institute
The National Health Care Institute concludes that tafasitamab (Minjuvi®) meets the 'established medical science and medical practice' for the treatment of the mentioned form of lymphoma. This means that the treatment is effective. However, the National Health Care Institute also concluded that the price of the product is too high. The price must not exceed that of the existing treatment with Polivy®. We advise the Minister to reimburse tafasitamab (Minjuvi®), after price negotiations, for the mentioned condition from the basic health care package.
Lock procedure for expensive medicinal products
The Minister has placed trastuzumab-deruxtecan (Enhertu) for this indication in the ‘lock procedure for expensive medicinal products’. A medication in this lock procedure will not be eligible for reimbursement from the basic health care package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the manufacturer.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The Minister ultimately decides whether or not to reimburse the medicinal product from the basic health care package.