GVS advice on the re-assessment of vericiguat (Verquvo®) for the treatment of adults with chronic heart failure
The National Health Care Institute has assessed whether the medicinal product vericiguat (Verquvo®) can be included in the Medicine Reimbursement System (GVS). A medicinal product becomes eligible for reimbursement once it has been included in the GVS. Vericiguat is used in the treatment of certain patients with an aggressive form of heart failure. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to include vericiguat on List 1B of the GVS.
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Condition for which the medicinal product can be applied
Vericiguat is registered for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction, who are stabilised after a recent decompensation event (heart failure) requiring IV therapy (via a blood vessel with an infusion needle).
Heart failure is a disorder that reduces the heart's pump force. In symptomatic heart failure, people show symptoms during normal exertion or even at rest. Common symptoms include excessive fatigue, palpitations and shortness of breath. A reduced ejection fraction means that the squeeze function of the heart is less effective. This results in less blood than normal being pumped out when the heart beats. IV therapy means the administration of a medicine into a vein.
Previous evaluation by the National Health Care Institute
In February 2022, the National Health Care Institute determined that vericiguat has no added value in the registered indication as an addition to the standard treatment. Based on new study data, the marketing authorisation holder then asked us to re-evaluate vericiguat.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to include vericiguat (Verquvo®) on List 1B of the GVS under conditions.
Conditions for reimbursement
Only for an adult insured person with symptomatic (NYHA II-IV) chronic heart failure and reduced ejection fraction (LVEF ≤ 40%) (HFrEF) with an NT-proBNP value of ≤5314 pg/ml,
- who cannot be adequately treated with combination therapy of an ACE inhibitor or angiotensin II receptor blocker (ARB) or sacubitril/valsartan, a beta-blocker and an aldosterone antagonist and
- who is not taking an SGLT2 inhibitor.
Medicine Reimbursement System (GVS)
Vericiguat 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.