GVS advice for the extension of the List 2 conditions for evolocumab (Repatha®) and alirocumab (Praluent®) for excessively high cholesterol
The National Health Care Institute has assessed whether the PCSK9 inhibitors evolocumab (Repatha®) and alirocumab (Praluent®) can be included in the Medicine Reimbursement System (GVS). A medicinal product becomes eligible for reimbursement once it has been included in the GVS. Evolocumab and alirocumab can be used for treating certain patients with excessively high cholesterol levels. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to amend the List 2 conditions for evolocumab and alirocumab but believes that the price should be reduced by at least 65%.
Indication for which reimbursement is requested
The PCSK9 inhibitors evolocumab (Repatha®) and alirocumab (Praluent®) can be used in patients with hypercholesterolaemia (both familial and non-familial). Hypercholesterolaemia patients have excessively high levels of cholesterol.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the minister of VWS to amend the List 2 conditions for evolocumab (Repatha®) and alirocumab (Praluent®) but believes that the price should be reduced by at least 65%. We therefore recommend attaching the following conditions to reimbursement.
Medicine Reimbursement System (GVS)
PCSK9 inhibitors evolocumab (Repatha®) and alirocumab (Praluent®) are extramural drugs. Extramural drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.