GVS advice dapagliflozin (Forxiga®) extension of further condition

Extension of the indication

Dapagliflozin (as propanediol monohydrate) 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 sulfonylurea derivative.

The current application is related to an extension of the reimbursement condition based on the newly registered indication: for use in adults for the treatment of symptomatic chronic heart failure with reduced injection fraction. The recommended dosage in that case is 10 mg per day, added to the default background treatment for heart failure.

The National Health Care Institute's advice

On the basis of the considerations mentioned in the report, the National Health Care Institute advices the minister to extend the reimbursement condition for dapagliflozin with the following condition:

• In adult patients with symptomatic (NYHA II-IV) chronic heart failure with reduced ejection fraction (LVEF≤40%).

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.