The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse avapritinib (Ayvakyt®) from the basic healthcare package after price negotiations. This medicine can be used for certain patients with mast cell disease, a very rare, aggressive blood disease. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products.
Advice - reimburse avapritinib (Ayvakyt®) for the treatment of a rare blood disease
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse avapritinib (Ayvakyt®) from the basic healthcare package after price negotiations. This medicine can be used for certain patients with mast cell disease, a very rare, aggressive blood disease. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products.
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.
Avapritinib is intended for certain people with a rare, aggressive blood disease
Avapritinib is the active substance. The brand name is Ayvakyt®. The medicine is a tablet to be swallowed.
Avapritinib can be used in people with advanced systemic mastocytosis. People with mastocytosis have too many mast cells in the body. Mast cells are white blood cells. The mast cells contain substances that can be released. These can cause symptoms such as itching, nausea, diarrhoea and abdominal pain. Systemic mastocytosis means that there are too many mast cells in the entire body. Due to the accumulation of the mast cells throughout the body, cancer and organ damage are common in people with systemic mastocytosis.
The National Health Care Institute’s advice on reimbursement of avapritinib
The National Health Care Institute advises the Minister of VWS to reimburse avapritinib (Ayvakyt®) from the basic healthcare package after price negotiations. The National Health Care Institute advises that the price should decrease by at least 75%.
Conditions for reimbursement of avapritinib
For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis in combination with haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy. ASM, SM-AHN and MCL are all three forms of advanced systemic mastocytosis.
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 avapritinib in the package lock procedure for expensive medicinal products for this indication. A medication 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’.