The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse marstacimab (Hympavzi®) from the basic healthcare package following price negotiations. This medicinal product can be used for certain patients with haemophilia A or haemophilia B. These are hereditary conditions in which the blood does not clot properly. The reason for this advice was the placement of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products’.
This is the ninth medicinal product that the Medicines Evaluation Board (CBG) and the National Health Care Institute have assessed in a parallel procedure.
Current status: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister will make the final decision on whether or not the medicinal product will be reimbursed from the basic healthcare package.
Marstacimab is intended for certain people with haemophilia A or B
Marstacimab is the active substance. The brand name is Hympavzi®. The medicinal product is an injection.
Marstacimab can be used for people with severe haemophilia A or haemophilia B who do not have inhibitors against factor VIII or factor IX. Haemophilia A and B are hereditary conditions in which the blood does not clot properly:
- In haemophilia A, l coagulation factor VIII is missing or present in insufficient amounts in in the blood.
- In haemophilia B, coagulation factor IX is missing or present in insufficient amounts in the blood.
A coagulation factor is a protein that plays an important role in blood clotting. Because of the lack of the coagulation factor, the blood does not clot properly, causing a person to bleed more easily and for a longer time after an injury or medical procedure. In severe haemophilia, bleeding can also occur spontaneously, for example in joints and the brain. To restore coagulation and prevent bleeding, patients are treated with coagulation factors. A treatment aimed at preventing a disease is called prophylaxis. Some patients start making antibodies (inhibitors) against the administered coagulation product after such a treatment.
Advice from the National Health Care Institute advice on reimbursing marstacimab
The National Health Care Institute advises the Minister of VWS to reimburse marstacimab (Hympavzi®) from the basic healthcare package following price negotiations. After successful negotiations, the net price for marstacimab should not exceed the net price of the standard treatment.
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 this advice come about?
The National Health Care Institute advises the Minister after issuing a package advice. The final decision on whether or not the medical product will be reimbursed from the basic healthcare package rests with the Minister of Health, Welfare and Sport (VWS).
Explanation of the package lock procedure for expensive medicinal products
The Minister has placed marstacimab in the 'lock procedure for expensive medicinal products' for this indication. A medicine in this lock procedure will not be eligible for reimbursement from the basic healthcare package until:
- The National Health Care Institute has issued a positive advice;
- Appropriate arrangements and safeguards have been established;
- Successful price reductions have been negotiated with the marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.
CBG - National Health Care Institute Parallel Procedure
The assessment of marstacimab took place in the parallel procedure of the CBG and the National Health Care Institute. In this procedure, they simultaneously assess a medicine’s admission to the Dutch market and the reimbursement from the basic healthcare package. This will give patients access to new medicines as soon as possible.