The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to expand the reimbursement conditions for bempedoic acid (Nilemdo®) and bempedoic acid with ezetimibe (Nustendi®). These medicines are already in the Medicine Reimbursement System (GVS) for the treatment of certain patients with high cholesterol. If the Minister adopts our advice, this medicine will also be reimbursed from the basic healthcare package for another patient group with high cholesterol.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of Health, Welfare and Sport (VWS). The Minister makes the final decision whether or not to extend the conditions of reimbursement.
Bempedoic acid is intended for certain people with high cholesterol
Bempedoic acid is the active substance. The brand name is Nilemdo®. Bempedoic acid can also be given in combination with ezetimibe. The brand name is then Nustendi®. The medicine is a tablet to be swallowed entirely.
The medicines can be used in people with hypercholesterolaemia, mixed dyslipidaemia and cardiovascular disease. Patients with hypercholesterolaemia have high cholesterol levels in the blood. Dyslipidaemia is a collective name for a variety of fat metabolism disorders. In the blood, we see this as increased levels of total cholesterol, LDL cholesterol, triglycerides and decreased HDL cholesterol. People with hypercholesterolaemia or dyslipidaemia are at higher risk of cardiovascular disease, such as myocardial infarction or stroke.
Advice from the National Health Care Institute on the expansion of the reimbursement conditions for bempedoic acid and bempedoic acid with ezetimibe
The National Health Care Institute advises the Minister of VWS to extend the reimbursement conditions for bempedoic acid (Nilemdo®) and bempedoic acid with ezetimibe (Nustendi®) for certain patients with high cholesterol. These are the so-called List 2 conditions.
For more information on the GVS and lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines’.
Expand the conditions for the reimbursement of bempedoic acid and bempedoic acid with ezetimibe
Bempedoic acid is already being reimbursed for certain patients with high cholesterol who are not eligible for a PCSK9 inhibitor. We advise the Minister to extend the List 2 conditions as follows:
We advise the Minister to extend the conditions as follows:
Only for an insured person with hypercholesterolaemia or mixed dyslipidaemia who does not reach the LDL-C target with a statin and ezetimibe at the maximum tolerated dose.
Only for an insured person with hypercholesterolaemia or mixed dyslipidaemia who does not reach the LDL-C target with a statin at the maximum tolerated dose.
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?
The Minister of Health, Welfare and Sport (VWS) asks the National Health Care Institute to carry out an assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Bempedoic acid and bempedoic acid with ezetimibe 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 healthcare package if they are listed in the GVS.