The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to partially reimburse venetoclax (Venclyxto®) in combination with obinutuzumab after price negotiations from the basic healthcare package. This medicinal product can be used in certain patients with previously untreated leukaemia. Leukaemia is cancer in the white blood cells. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’.
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 another medicine: obinutuzumab. Obinutuzumab is administered directly into the bloodstream through an intravenous line.
The combination of venetoclax and obinutuzumab can be used in people with chronic lymphocytic leukaemia (CLL). CLL is a form of blood cancer. It is the most common form of leukaemia. 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 can often live with it for many years, even decades. 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 or night sweats.
Advice of the National Health Care Institute on the reimbursement of venetoclax in combination with obinutuzumab
The National Health Care Institute has evaluated the medicinal product for 3 subtypes of chronic lymphocytic leukaemia (CLL). We advise the Minister of VWS to reimburse venetoclax in combination with obinutuzumab from the basic healthcare package for 1 of the 3 subtypes under certain conditions.
The National Health Care Institute advises to reimburse venetoclax in combination with obinutuzumab for:
- Fit, previously untreated patients with CLL and mutated IGHV status, without 17p depletion or TP53 mutation. A condition is that the net price of the medicinal products is equal to the net price of the current standard treatment. The assessment indicates that the medicinal products are as effective for these patients as the current standard of treatment.
The National Health Care Institute advises not to reimburse venetoclax in combination with obinutuzumab for the following 2 subtypes:
- Fit, previously untreated patients with CLL and an unmutated IGHV status, without 17p depletion or TP53 mutation. For this patient group, the National Health Care Institute cannot assess whether venetoclax is worth the high asking price. The marketing authorisation holder has not carried out the economic analyses requested by the National Health Care Institute, which makes it insufficiently clear whether the asking price is in proportion to the health benefit for the patients. Reliable data is required to advise the Minister on a reasonable price for reimbursement. The National Health Care Institute calls on the marketing authorisation holder to carry out the required analyses.
- Previously untreated patients with 17p depletion or TP53 mutation. The marketing authorisation holder’s scientific studies have not shown a survival benefit for this patient group.
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 a 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 venetoclax in the 'lock procedure for expensive medicinal products' for this indication. 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’.