Amarin Corp Plc (AMRN)

[dogn]

From Healthcare Institute Netherlands

GVS advice icosapent-ethyl (Vazkepa®) in the treatment of adults at high risk of cardiovascular disease

The National Health Care Institute has tested whether icosapent-ethyl (Vazkepa®) can be included in the drug reimbursement system (GVS). A medicine is eligible for reimbursement as soon as it is included in the GVS. The Zorginstituut advises the Minister of Health, Welfare and Sport (VWS) to include icosapent-ethyl (Vazkepa®) in the GVS on Appendix 1B under certain conditions. Appendix 1B contains the list of medicines in the GVS that are not mutually replaceable.

Download 'GVS advice icosapent-ethyl (Vazkepa®) in the treatment of adults at high risk of cardiovascular disease'
PDF document | 131 pages | 16.4MB
Advice | 16-09-2022

Condition in which the product can be applied
The active ingredient icosapent ethyl is available as a medicine under the brand name Vazkepa. This is a highly purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA). The drug is licensed to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides and established cardiovascular disease or diabetes with at least one cardiovascular risk factor. This means that they have an increased risk of cardiovascular disease.

Advice from the Healthcare Institute
The Zorginstituut advises the Minister of Health, Welfare and Sport to include icosapent-ethyl in appendix 1B of the GVS. For the full registered indication, icosapent-ethyl has added value compared to standard treatment. With regard to cost-effectiveness, there is a big difference between the subgroups 'primary prevention' and 'secondary prevention'. Primary prevention involves preventing disease. Secondary prevention means early detection of diseases or abnormalities in people who are ill, at increased risk or who have a certain genetic predisposition. The disease can therefore be treated earlier, so that it heals sooner or does not get worse.

Due to the large difference in cost-effectiveness, the Zorginstituut recommends that icosapent-ethyl be reimbursed only in the context of 'secondary prevention'. These include statin-treated patients at high cardiovascular risk with elevated triglycerides and established cardiovascular disease. Since icosapent-ethyl is not cost-effective at the current price for the treatment of these patients, the Zorginstituut recommends negotiating a discount of 30%. If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug. the Zorginstituut advises to negotiate a discount of 30%.

If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug. the Zorginstituut advises to negotiate a discount of 30%. If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug.

Conditions for reimbursement of icosapent-ethyl
Only for an insured person with an established cardiovascular condition:

being treated with a statin;
have a high cardiovascular risk;
with elevated triglycerides (at least 1.7 and at most 5.6 mmol/l).

Drug Reimbursement System (GVS)
Icosapent-ethyl is an outpatient drug. Extramural medicines are medicines for home use, which are available at the pharmacy with a prescription from a doctor. They are only reimbursed from the basic health insurance package if they are listed in the GVS. The amount of the compensation depends on the list on which they appear. Mutually replaceable medicines are clustered on Appendix 1A. A reimbursement limit may apply for this. Unique medicines are listed in Appendix 1B. There is no reimbursement limit for this. Additional conditions may also apply to reimbursement. Then a medicine will also be added to Appendix 2.

The Scientific Advisory Council (WAR) and the Package Advisory Committee (ACP) advise the Zorginstituut in the assessment. Based on the assessment, the Zorginstituut sends a recommendation to the Minister of Health, Welfare and Sport. The minister makes the final decision whether or not to reimburse the medicine from the basic health insurance package.

Attachments
ACP advice icosapent ethyl (Vazkepa®) for the treatment of adults at high risk of cardiovascular disease
ACP advice to the Board of Directors of the National Health Care Institute on icosapent ethyl (Vazkepa®) for reducing the risk of ...
Advice | 19-08-2022

https://www.zorginstituutnederland.nl/publicaties/adviezen/2022/09/16/gvs-advies-icosapent-ethyl-vazkepa