Package advice for the lock procedure for evinacumab (Evkeeza®) for the treatment of a rare form of elevated cholesterol
The National Health Care Institute has assessed whether the medicinal product evinacumab (Evkeeza®) can be reimbursed from the basic health care package. Evinacumab can be used to treat certain patients with homozygous familial hypercholesterolaemia (HoFH). The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to reimburse evinacumab from the basic health care package for the mentioned condition after price negotiations.
Condition for which reimbursement is requested
Evinacumab can be used for the treatment of adult and adolescent patients aged 12 years and older with HoFH. HoFH is a rare genetic disorder in which patients have a significantly increased level of low-density lipoprotein cholesterol (LDL-C) in the blood. LDL-C is a protein that transports cholesterol in the blood and causes cholesterol to be deposited on the walls of blood vessels.
Long-term high blood cholesterol can lead to cardiovascular disease, such as myocardial infarction, cardiac cramp, a stroke, a transient ischaemic attack (TIA) or claudication. Patients with HoFH have such high LDL cholesterol levels that they experience vein calcification at an early age and may die prematurely.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister to reimburse evinacumab for the disorder mentioned from the basic health care package after price negotiations. We conclude that evinacumab meets the established medical science and medical practice for the treatment of the rare form of high cholesterol mentioned. This means that the treatment is effective. The price must not exceed that of the existing treatment with lomitapide.
Lock procedure for expensive medicinal products
The Minister has placed evinacumab 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) 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.