GVS advice bempedoic acid (Nilemdo®) for use in adults with primary hypercholesterolaemia or mixed dyslipidaemia

The National Health Care Institute has completed its assessment whether bempedoic acid is interchangeable with another medicinal product included in the Medicine Reimbursement System (GVS). Bempedoic acid is indicated for the use of cholesterol-lowering treatments for patients with non-familial hypercholesterolaemia or mixed dyslipidaemia. The National Health Care Institute advises the Minister to reimburse bempedoic acid in the package after successful price negotiations.

Indication for which reimbursement is requested

Partly based on a statement by the physicians’ association, reimbursement is being requested for an indication that is narrower than the registered indication. This refers to adults with non-familial hypercholesterolaemia or mixed dyslipidaemia with a high or very high cardiovascular risk. It is specifically regarding the following patients:

  • who do not achieve the LDL cholesterol treatment goals through diet and maximum possible dosages of statins and ezetimibe, including patients who are statin-intolerant, or for whom a statin is contraindicated;
  • and who are not eligible for treatment with a PCSK9 inhibitor.

National Health Care Institute's advice

The National Health Care Institute advises the Minster to include bempedoic acid on List 1B of the GVS. The medicinal product has added therapeutic value compared to usual care. Because there are uncertainties about the cost-effectiveness, the National Health Care Institute advises the Minister to first negotiate the price. The National Health Care Institute recommends a price discount of 50%. It may be possible to renegotiate in the future if long-term data shows that effects are achieved at hard endpoints. If the application of bempedoic acid (Nilemdo®) is included in the package after successful price negotiations, the National Health Care Institute recommends the reimbursement conditions.

Reimbursement conditions for bempedoic acid

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:

  1. In combination with both a statin and ezetimibe as a daily dose or;
  2. In combination with ezetimibe alone as a daily dose in cases of documented statin intolerance: statin-associated muscle pain has been determined for at least three different statins according to the flow chart and criteria described by EAS/ESC consensus (European Heart Journal 2015; 36: 1012-1022).

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.