Package advice lock procedure product emicizumab (Hemlibra®) for the treatment of moderate haemophilia A
The National Health Care Institute has assessed whether emicizumab (Hemlibra®) can be reimbursed from the basic health care package for patients with moderate haemophilia A and a high risk of bleeding episodes. This is a coagulation disorder in which the blood does not clot properly. The reason for this advice was the placing of the product in the so-called ‘lock procedure’ for expensive medications. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to reimburse emicizumab from the basic health care package for the mentioned condition after price negotiations.
Condition for which reimbursement is requested
Emicizumab can be used as a preventive measure to prevent bleeding episodes (prophylaxis) in patients with moderate haemophilia A without coagulation factor VIII inhibitors and with severe bleeding phenotype. Haemophilia is a coagulation disorder in which the blood does not clot properly. A person with haemophilia has a higher risk of bleeding, bruising and continued bleeding after surgery. Patients with haemophilia A lack or have insufficient coagulation factor VIII in their blood. A coagulation factor is a protein that plays an important role in blood clotting.
Advice from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include emicizumab in the basic health care package for the above indication after price negotiations. These negotiations with the marketing authorisation holder should ensure that the net price of emicizumab prophylaxis does not exceed the net price of the current treatment: treatment with factor VIII prophylaxis.
Lock procedure for expensive medicinal products
The Minister has placed emicizumab 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’.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise 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.