The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse etranacogene dezaparvovec (Hemgenix®) from the basic health care package after price negotiations. This medicinal product can be used in certain patients with haemophilia B. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products. For this assessment, the National Health Care Institute collaborated with other countries in the Beneluxa initiative.
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 medication from the basic health care package.
Etranacogene dezaparvovec is intended for certain patients with haemophilia B
Etranacogene dezaparvovec is the active substance. The brand name is Hemgenix®. The medicinal product consists of a single IV administration.
The medicinal product can be used for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
Haemophilia is a hereditary disorder caused by a lack of one of the clotting factors in the blood. This may be due to a defect in the gene for these coagulation factors. In haemophilia B, the patient has a lack of coagulation factor IX. Because of the lack of coagulation factor IX, the blood does not clot properly, causing a person to bleed faster and any bleeding is prolonged.
Advice from the National Health Care Institute on the reimbursement of etranacogene dezaparvovec
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse etranacogene dezaparvovec (Hemgenix®) from the basic health care package after price negotiations.
Joint assessment of etranacogene dezaparvovec: the Beneluxa initiative
The marketing authorisation holder for Hemgenix® is CSL Behring. They are requesting reimbursement for this medicinal product in several European countries at the same time. For this dossier, the Netherlands and Belgium collaborate within the so-called Beneluxa Initiative.
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 about the assessment. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.
Lock procedure for expensive medicinal products
The Minister has placed etranacogene dezaparvovec 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’.