GVS assessment empagliflozin (Jardiance®) for the treatment of adults with chronic heart failure
The National Health Care Institute has completed its assessment whether the further condition of empagliflozin (Jardiance®) could be extended. It is currently included on List 1A in the Medicine Reimbursement System (GVS) for the treatment of a specific group of patients with type 2 diabetes mellitus. The National Health Care Institute recommends the Minister for Medical Care to extend the reimbursement condition for the treatment of a certain group of adults with chronic heart failure.
Download "GVS assessment empagliflozin (Jardiance®) for the treatment of adults with chronic heart failure"
Indication for which reimbursement is requested
Empagliflozin is an oral blood glucose reducing agent that selectively inhibits the sodium/glucose cotransporter 2 (SGLT2) in the renal tubuli.
It is currently included on List 1A in the GVS in cluster 0A10BXAO V, along with the other SGLT2 inhibitors canagliflozin, empagliflozin and ertugliflozin. The reimbursement is arranged through a List 2 condition:
- only for an insured person with type 2 diabetes mellitus who cannot be treated with the combination of metformin and sulfonylurea derivative, does not use insulin and uses this medicinal product as a dual or triple treatment in combination with metformin and/or a sulfonylurea derivative.
- For the treatment of people 18 years and older with type 2 diabetes mellitus with a very high risk of cardiovascular disease:
- With previously proven cardiovascular diseases; and/or
- Chronic kidney damage with:
- eGFR 30-44 ml/min per 1.73m2 without albuminuria;
- 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).
The National Health Care Institute’s advice
The National Health Care Institute recommends the Minister to extend the reimbursement condition for empagliflozin, as was previously done for dapagliflozin, with the following condition:
- For adult patients with symptomatic (NYHA II-IV) chronic heart failure with reduced ejection fraction (LVEF<40%).