At the request of the Minister of Health, Welfare and Sport (VWS), The National Health Care Institute will assess whether the conditions for reimbursement of empagliflozin (Jardiance®) can be extended. Empagliflozin is already included in the Medicine Reimbursement System (GVS) with reimbursement conditions and can be used in certain patients with diabetes or heart failure.
Indication for which extension of List 2 conditions is requested
The marketing authorisation holder is now requesting reimbursement for adults with symptomatic (NYHA II-IV) chronic heart failure with moderate or sustained ejection fraction (LVEF>40%).
Heart failure is a disorder in which the heart's pumping power is reduced. This causes patients to 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 moderate ejection fraction, the heart's squeezing function is less effective. This results in less blood than normal being pumped out when the heart beats.
- For patients with type 2 diabetes mellitus who cannot be treated with the combination of metformin and a sulphonylurea derivative, do not use insulin and use this medicinal product as a dual combination with metformin or triple treatment in combination with metformin and/or a sulphonylurea derivative;
- For patients aged 18 years and older with symptomatic (NYHA II-IV) chronic heart failure with reduced ejection fraction (LVEF <40%); or
- For patients aged 18 years and older with type 2 diabetes mellitus with a very high risk of cardiovascular disease:
a. with previously proven cardiovascular diseases; and/or
b. chronic kidney damage with
- eGFR 30-44 ml/min per 1,73m2 without albuminurie,
- eGFR 30-59 ml/min per 1,73m2 with moderately elevated albuminuria (ACR > 3 mg/mmol) or
- eGFR ≥ 60 ml/min per 1,73m2 with severely increased albuminuria (ACR > 30 mg/mmol).
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister to adjust the current List 2 condition (for symptomatic (NYHA II-IV) chronic heart failure with reduced ejection fraction (LVEF < 40%) as follows:
- For adult patients with symptomatic (NYHA II-IV) chronic heart failure.
Medicine Reimbursement System (GVS)
Empagliflozine 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 on 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.