GVS advice dapagliflozin (Forxiga®) extension of List 2 conditions
The National Health Care Institute has assessed whether the reimbursement conditions for dapagliflozin (Forxiga®) can be extended. Dapagliflozin is already included in the Medicine Reimbursement System (GVS) with reimbursement conditions and can be used in certain patients with diabetes or heart failure. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to extend the List 2 conditions for certain patients.
Indication for which reimbursement is requested
Dapagliflozin is already included in the GVS with further conditions, the so-called List 2 conditions. The marketing authorisation holder is now requesting reimbursement for adults with symptomatic (NYHA II-IV) chronic heart failure with mildly reduced or preserved ejection fraction (LVEF>40%).
Heart failure is a disorder that reduces the heart's pumping power. This causes patients to quickly feel tired and short of breath during exertion. In patients with heart failure and a sustained ejection fraction, the heart muscle does not relax sufficiently, causing the heart to be insufficiently filled with blood. In patients with heart failure and mildly reduced or preserved ejection fraction, the heart's squeezing function is less effective. This results in less blood than normal being pumped out when the heart beats.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of VWS to extend the List 2 conditions for dapagliflozin as follows.
We advise the Minister of VWS to adjust the second condition as follows:
2. Patients aged 18 years or older with symptomatic (NYHA II-IV) chronic heart failure.
Medicine Reimbursement System (GVS)
Dapagliflozin is an outpatient medicinal product. Outpatient medicinal products are medicinal products for home use available at the pharmacy on prescription from a physician. They are only reimbursed from the basic health care package if they are included 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 on 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 on whether or not to reimburse the medication from the basic health care package.