The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to not reimburse venetoclax (Venclyxto®) with obinutuzumab from the basic health insurance package. This medicinal product can be used in certain patients with previously untreated chronic lymphocytic leukaemia. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. At the present time, the price of the medicinal product is too high. Only if price negotiations lead to a lower price can the medicine be reimbursed.
Current state of affairs: advisory report 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 healthcare package.
Venetoclax with obinutuzumab is intended for certain people with previously untreated leukaemia
Venetoclax is the active substance. The brand name is Venclyxto®. The medicine is a tablet to be swallowed. Venetoclax is combined with the medicine obinutuzumab. Obinutuzumab is administered directly into the bloodstream through an intravenous line.
The combination of venetoclax with obinutuzumab can be used in people with chronic lymphocytic leukaemia (CLL). CLL is the most common type of blood cancer. In CLL, malignant white blood cells, the B-lymphocytes, accumulate in the body. This can cause symptoms. CLL is a chronic disease, which means that the disease almost never goes away. However, people may live with it for a very long time. The disease is not treated until the patient starts having symptoms. Examples of symptoms include infections, fatigue, spontaneous bleeding, unexplained bruising, swelling of the lymph glands, upper abdominal pain and night sweats.
The National Health Care Institute advice on the reimbursement of venetoclax
The National Health Care Institute advises the Minister of VWS not to reimburse venetoclax (Venclyxto®) from the basic health insurance package. At the moment, the price of the medicine is too high. Only if the medicine's price is reduced by at least 51% can it be reimbursed.
Reassessment
In July 2025, the National Health Care Institute advised the Minister of VWS not to reimburse venetoclax for a specific subgroup from the basic health insurance package. We concluded that venetoclax for this patient group does meet the legal criterion of 'established medical science and medical practice'. This means it has been demonstrated that the treatment works better than the current standard treatment. However, at the time we were unable to determine whether this very expensive medicinal product was worth the asking price. The marketing authorisation holder had not provided all the necessary information.
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) advises 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 venetoclax 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 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’.