GVS advice on sacubitril/valsartan (Entresto®)
At the request of the Minister of Health, Welfare and Sport (VWS), the National Health Care Institute has carried out an assessment regarding the extension of the current List 2 conditions for the medicinal product sacubitril/valsartan (Entresto®). This medicinal product is used to treat patients with symptomatic (NYHA II–IV) chronic heart failure. The National Health Care Institute advises the Minister to extend the List 2 conditions to include the patient group for which added therapeutic value has been established.
Extension of the List 2 conditions
Sacubitril/valsartan (Entresto®) has already been included in the Medicine Reimbursement System (GVS) with further conditions, referred to as ‘List 2 conditions’. It concerns a request from the marketing authorisation holder to extend the existing List 2 conditions.
Heart failure is a disorder that reduces the heart’s pump force. This causes patients to feel tired and short of breath during exertion.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister to extend the current List 2 conditions to include the patient group for which added therapeutic value has been established. In addition, we would advise the Minister that patients who are undergoing treatment with sacubitril/valsartan under the aforementioned leniency scheme should also qualify for reimbursement. Thus, the new condition is as follows.
Medicine Reimbursement System (GVS)
Sacubitril/valsartan is an extramural drug. Extramural drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.