GVS advice inclisiran (Leqvio®) for the treatment of hypercholesterolemia

Registered indication

Inclisiran is indicated in adults with primary hypercholesterolemia (familial and non-familial) and sufficiently high risk. Hypercholesterolemia is also known as high cholesterol. Inclisiran (Leqvio®) can be used as an addition to a diet: 

• In combination with a statin or a statin with other lipid-lowering treatments in patients who do not reach their LDL-C target with a maximum tolerance dose of a statin, or 
• alone or in combination with other lipid-reducing treatments for patients who do not tolerate statins or for whom a statin is contraindicated.

Review of interchangeability

The National Health Care Institute has come to the final conclusion that inclisiran has an equal value compared to the other medicinal products in the GVS cluster 0C10AXAP V, which includes: alirocumab and evolocumab.

The National Health Care Institute's advice

The National Health Care Institute advises the minister to include inclisiran in List 1A in cluster 0C10AXAP V. The standard dose of inclisiran can be set at 1.56 mg per day. The National Health Care Institute points out to the minister that a financial arrangement has been concluded for alirocumab (Praluent®) and evolocumab (Repatha®), to ensure the accessibility and affordability of the health care package. The National Health Care Institute does not have an understanding of the agreements made, but the starting point for inclusion of inclisiran in the GVS should be that there are no additional costs, compared to alirocumab and evolocumab. We therefore recommend the minister to renegotiate for inclisiran (Leqvio®).

Condition for inclisiran (Leqvio®)

If the application of inclisiran (Leqvio®) is included in the package after a successful price negotiation, the National Health Care Institute recommends the following reimbursement conditions. 

In adult patients with hypercholesterolemia (familial and non-familial) and sufficiently high risk, if a maximum tolerable statin 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 or;
• in combination with only ezetimibe in case 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.

Patients with sufficiently high risk are defined as one of the following groups:

1. patients with heterozygous familial hypercholesterolemia; 
2. patients who have experienced a cardiovascular event and have had a recurring cardiovascular event; 
3. patients with diabetes mellitus type 2 who have experienced a cardiovascular event; 
4. patients who have experienced a cardiovascular event and an actual statin intolerance that has been established and documented.

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