The National Health Care Institute has advised the Minister of Health, Welfare and Sport (WVS) not to reimburse daratumumab (Darzalex®) in combination with bortezomib (Velcade®), cyclophosphamide, and dexamethasone from the basic health care package. This combination of medicinal products can be used in certain patients with a form of severe AL amyloidosis. This is a disease in which the body does not handle a certain type of protein well. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. The information provided by the marketing authorisation holder does not provide sufficient insight as to whether the medicinal product is worth the high asking price.
Daratumumab is intended for certain people with a form of AL amyloidosis
Daratumumab is the active substance. The brand name is Darzalex®. The medicine is an injection given under the skin (subcutaneously).
It can be used in combination with bortezomib, cyclophosphamide and dexamethasone in people with AL amyloidosis. This is an acquired form of AL amyloidosis. Acquired means that the disease is not congenital, but that the patient has developed the disease during their life. AL amyloidosis is a disease in which the body does not handle a certain type of protein well. These proteins build up in the organs, leading to organ damage. This organ damage is the cause of the symptoms associated with the disease. AL amyloidosis is a progressive disease. This means that the symptoms increase and expand over time. The number of symptoms, the type of symptoms and the course of the disease vary per patient. As a result, the diagnosis can often only be established at a late stage. AL amyloidosis can affect all organs, but the damage to the heart in particular affects the life expectancy of patients.
Advice from the National Health Care Institute on the reimbursement of daratumumab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to not reimburse daratumumab (Darzalex®) from the basic health care package. The information provided by the marketing authorisation holder about the cost-effectiveness does not provide sufficient insight as to whether the medicinal product is worth the high asking price. Therefore, the National Health Care Institute cannot give advice about a socially acceptable price. The National Health Care Institute requests the marketing authorisation holder to update and re-submit the 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 a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.
Lock procedure for expensive medicinal products
The Minister has placed daratumumab 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 health care 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 manufacturer.
For more information, see the page ‘Lock procedure for expensive medicinal products’.