GVS advice extension further conditions for dapagliflozin (Forxiga®)
The National Health Care Institute has completed its assessment whether the further conditions for dapagliflozin (Forxiga®) could be extended. Dapagliflozin is indicated for the treatment of chronic kidney disease for adults. The National Health Care Institute advises the Minister to extend the List 2 conditions of dapagliflozin.
Indications for requested reimbursement
Forxiga® is registered for the treatment of type 2 diabetes mellitus and is listed in the Medicine Reimbursement System (GVS) on List 1A along with other SGLT2 inhibitors in cluster 0A10BXAO V, with further conditions on List 2. The current application is related to an extension of the reimbursement conditions based on the newly licensed indication. The recommended dosage is 10 mg dapagliflozin per day, added to the standard background treatment for chronic kidney disease.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to extend the reimbursement conditions of dapagliflozin for adult patients with chronic kidney disease.
Reimbursement conditions for dapagliflozin
Only for insured persons:
- with type 2 diabetes mellitus who cannot be treated with the combination of metformin and a sulfonylurea derivative, who do not use insulin and use this medicinal product as a dual or triple treatment in combination with metformin and/or a sulfonylurea derivative,
- aged 18 and older with symptomatic (NYHA II-IV) chronic heart failure with reduced ejection fraction (LVEF <40%),
- aged 18 and older with type 2 diabetes mellitus with a very high risk of cardiovascular disease and previously diagnosed cardiovascular disease, or
- aged 18 and older with chronic kidney disease.