Advice - expansion of the reimbursement conditions for inclisiran (Leqvio®) and bempedoic acid (Nilemdo®)
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to amend the List 2 conditions for inclisiran (Leqvio®) and bempedoic acid (Nilemdo®). Inclisiran can be used to treat excessive cholesterol levels. Bempedoic acid can be used to treat fat metabolism disorders. These medicinal products have already been included in the Medicine Reimbursement System (GVS) and are therefore reimbursed for certain groups of patients.
Disorders for which the medicinal product can be used
Inclisiran can be used to treat certain people with excessive cholesterol levels. Bempedoic acid can be used to treat certain people with fat metabolism disorders.
Advice from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to mend the List 2 conditions for inclisiran (Leqvio®) and bempedoic acid (Nilemdo®). Under the new conditions, patients who do not tolerate ezetimibe no longer have to use ezetimibe in order to be eligible for reimbursement of bempedoic acid or inclisiran.
Conditions for reimbursement of inclisiran and bempedoic acid.
In patients with hypercholesterolemia (both familial and non-familial) and sufficiently high risk, if a maximum tolerable statin dosage in combination with ezetimibe does not reach the treatment objective in accordance with the guidelines accepted in the Netherlands by the relevant physicians’ associations, inclisiran can be used as follows:
in combination with both a statin and ezetimibe at the maximum tolerable dosage;
or in combination with ezetimibe alone at the maximum tolerable dosage in the event of documented statin intolerance: statin-associated muscle pain for at least 3 different statins has been determined according to the flow chart and criteria described by EAS/ESC consensus (European Heart Journal 2015; 36:1012-1022).
Patients at sufficiently high risk are defined as one of the following groups:
patients who have experienced a cardiovascular event and have had a recurring cardiovascular event;
patients with diabetes mellitus type 2 who have also experienced a cardiovascular event; or
patients who have experienced a cardiovascular event and have an actual statin intolerance that has been established and documented.
Bempedoic acid can be used as follows, exclusively for an insured person with non-familial hypercholesterolaemia or mixed dyslipidaemia and high or very high cardiovascular risk, if a maximum tolerable statin dosage combined with ezetimibe does not achieve the treatment objective in accordance with the guidelines accepted in the Netherlands by the relevant physicians’ associations; and the patient is not eligible for treatment with a PCSK9 inhibitor:
in combination with both a statin and ezetimibe at the maximum tolerable dosage; or
in combination with ezetimibe alone at the maximum tolerable dosage in the event of documented statin intolerance: statin-associated muscle pain for at least 3 different statins has been determined according to the flow chart and criteria described by EAS/ESC consensus (European Heart Journal 2015; 36:1012-1022).
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?
For this advice, the National Health Care Institute has consulted with Zorgverzekeraars Nederland (ZN). The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.
Explanation about the reimbursement of medicinal products
Inclisiran and bempedoic acid are extramural medicinal products. Extramural means: medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic health care package if they are listed in the GVS.
This report is a summary of recommendations by the National Health Care Institute
