GVS advice icosapent-ethyl (Vazkepa®)
The National Health Care Institute has completed its assessment whether the product icosapent-ethyl (Vazkepa®) can be included in the Medicine Reimbursement System (GVS). Icosapent-ethyl is indicated for reducing the risk of cardiovascular events in adult statin-treated patients with high cardiovascular risk with elevated triglycerides and diagnosed cardiovascular disease or diabetes with at least one cardiovascular risk factor. The National Health Care Institute advises the Minister to include icosapent-ethyl on List 1B of the GVS with further conditions.
Indication for which reimbursement is requested
Icosapent-ethyl (Vazkepa®) is indicated for reducing the risk of cardiovascular events in adult statin-treated patients with high cardiovascular risk with elevated triglycerides and diagnosed cardiovascular disease or diabetes with at least one cardiovascular risk factor.
The National Health Care Institute's advice
The National Health Care Institute advises the Minister to include icosapent-ethyl on List 1B. For the complete registered indication, icosapent-ethyl has an added value compared to the standard treatment. As far as cost effectiveness is concerned, there is a large difference between the ‘primary prevention’ and ‘secondary prevention’ subgroups. Therefore, the National Health Care Institute recommends that icosapent-ethyl should only be reimbursed for ‘secondary prevention’; i.e. statin-treated patients with high cardiovascular risk with elevated triglycerides and a diagnosed cardiovascular disease. Since icosapent-ethyl with the current price for the treatment of these patients is not cost effective, the National Health Care Institute recommends negotiating a 30% discount.
If the application of icosapent-ethyl is included in the package after successful price negotiations, the National Health Care Institute recommends the following reimbursement conditions.