The National Health Care Institute has advised the Minister of Health, Welfare and Sport (hereinafter also “VWS”) not to reimburse epcoritamab (Tepkinly®) through the basic healthcare package. This medicinal product can be used in certain patients with an aggressive form of lymphoma. The reason for this advice was the placing of the medicinal product in what is known as the ‘lock procedure for expensive medicinal products’. It has not been demonstrated that this medicinal product has an added value for patients.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advisory report to the Minister of Health, Welfare and Sport. The minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Epcoritamab is intended for people who have lymphoma
Epcoritamab is the active substance; the brand name is Tepkinly®. The medicinal product is for injecting into a vein.
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 manufacturer has applied for reimbursement for adult patients with R/R DLBCL who have received at least 2 prior systemic treatments. Systemic therapy works on the whole body.
Advice from the National Health Care Institute on reimbursing epcoritamab
The National Health Care Institute advises the Minister of VWS not to reimburse epcoritamab (Tepkinly®) through the basic healthcare package. The National Health Care Institute has determined that epcoritamab does not meet the legal criterion of ‘established medical science and medical practice’ for this disorder.
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 final decision as to whether or not reimbursement from the basic healthcare package will take place lies with the Minister.
Explanation of the package lock procedure for expensive medicinal products
The Minister has placed epcoritamab for this indication in the ‘lock procedure for expensive medicinal products’. A medicine in this lock procedure will not be eligible for reimbursement from the basic healthcare 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 marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.