The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse glofitamab (Columvi®) in combination with gemcitabine and oxaliplatin (GemOx) from the basic health insurance package only after price negotiations. This medicinal product can be used in certain patients with lymphoma. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. This is a reassessment of an earlier advice from 2024.
Current state of affairs: advice sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health insurance package.
Glofitamab is intended for certain people with lymphoma
Glofitamab is the active substance. The brand name is Columvi®. Gemcitabine and oxaliplatin (GemOx) are medicines used as chemotherapy. Glofitamab and GemOx are administered by infusion in the hospital.
The medicinal product can be used for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This is an aggressive form of lymphoma. 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. The marketing authorisation holder has requested reimbursement for adult patients with R/R DLBCL who are not eligible for autologous stem cell transplantation. In a stem cell transplant, a patient is given healthy stem cells via the blood. Autologous means a patient’s own stem cells.
Advice from the National Health Care Institute on the reimbursement of glofitamab
The National Health Care Institute advises the Minister of VWS to reimburse glofitamab (Columvi®) in combination with gemcitabine and oxaliplatin (GemOx) from the basic health insurance package only after price negotiations. In June 2024, the National Health Care Institute advised the Minister of VWS not to reimburse glofitamab from the basic health insurance package. At the time, we concluded that glofitamab does not meet the legal criterion of 'established medical science and medical practice' for said group of patients. In other words, it has not been sufficiently demonstrated that the treatment works better than the current treatment, The National Health Care Institute was able to make a new assessment, since a new study has been published in the meantime in which glofitamab was studied in combination with GemOx. That investigation led to this advice.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing package advice. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health insurance package.
Explanation of the package lock procedure for expensive medicinal products
The Minister has placed glofitamab for this indication in the lock procedure for expensive medicinal products. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health insurance package until:
- there is a positive reimbursement advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.