GVS assessment of evolocumab (Repatha®) for the treatment of primary hypercholesterolaemia
Evolocumab is currently included on List 1A, together with the medicinal product alirocumab (Praluent®). Conditions have been attached to the reimbursement of evolocumab (and of alirocumab), whereby reimbursement is limited to very high-risk groups of patients. The marketing authorisation holder has submitted a dossier, based on the results of new studies, to substantiate broadening the risk population to include non-familial hypercholesterolemia for which evolocumab will be reimbursed (alteration in List 2 condition). The National Health Care Institute's advises the Minister of VWS against altering the List 2 condition. Reimbursement according to the current conditions can continue.
Current place in the Medicine Reimbursement System (GVS)
Evolocumab is currently included on List 1A, together with the medicinal product alirocumab (Praluent®), which also belongs to the class of PCSK9 antibodies. Conditions have been attached to the reimbursement of evolocumab (and of alirocumab), whereby reimbursement is limited to very high-risk groups of patients.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute advises the Minister against altering the List 2 condition. Reimbursement according to the current conditions can continue.
Condition
For patients with hypercholesterolemia (familial and non-familial) and sufficiently high risk, if maximum tolerated oral lipid-lowering therapy (statin, ezetimibe) does not achieve the treatment objective in accordance with the guidelines that have been accepted by the professional group concerned in the Netherlands, evolocumab can be used as follows:
- in combination with maximum tolerated oral lipid-lowering therapy, i.e. statin and/or ezetimibe;
- in combination with ezetimibe alone, in the event of documented statinintolerance: statin-associated myalgia for at least three different statins, established based on the flow diagram and the criteria described by the EAS/ESC consensus (European Heart Journal 2015; 36: 1012-1022).
Patients with sufficient high risk are defined as one of the following groups:
- Homozygous familial hypercholesterolaemic patients who are not LDL-receptor-negative.
- Heterozygous familial hypercholesterolaemic patients.
- Patients who have suffered a cardiovascular event (CVE) and one relapsed CVE.
- Patients with diabetes mellitus type 2 and who have suffered a CVE.
- Patients who have suffered a CVE and whose statin-intolerance has been established and documented.
Future developments
The National Health Care Institute will continue to evaluate the use of alirocumab en evolocumab.