GVS advice SGLT-2 inhibitors
The National Health Care Institute has completed its assessment the further conditions of SGLT-2 inhibitors canagliflozin (Invokana®), dapagliflozin (Forxiga®), empagliflozin (Jardiance®), ertugliflozin (Steglatro®), could be extended. The National Health Care Institute's advice is to extend the List 2 conditions of the SGLT-2 inhibitors canagliflozin, dapagliflozin and empagliflozin, but not those of ertugliflozin.
Registered indication
The extension requested, in addition to the current List 2 conditions, is for patients with diabetes mellitus type 2 who have a very high risk of cardiovascular disease, as an addition to the standard treatment.
Assessment of therapeutic value
The National Health Care Institute has concluded that the SGLT-2 inhibitors canagliflozin, dapagliflozin and empagliflozin in the treatment of patients with diabetes mellitus type 2 (DM2) and a very high risk of cardiovascular disease have a therapeutic added value compared to placebo. They are thus part of the established medical science and medical practice. Ertugliflozin does not meet the established medical science and medical practice.
The National Health Care Institute's advice
The National Health Care Institute advises the minister to extend the List 2 conditions of the SGLT-2 inhibitors canagliflozin (Invokana®), dapagliflozin (Forxiga®) and empagliflozin (Jardiance®) with the following condition:
For the treatment of adults with diabetes mellitus type 2 with a very high risk of cardiovascular disease:
- established cardiovascular diseases; and/or
- chronic kidney damage with
- eGFR 30-59 ml/min per 1.73m2, with moderately increased albuminuria (ACR> 3 mg/mmol/l); or
- eGFR ≥ 60 ml/min per 1.73m2 with severely increased albuminuria (ACR>30 mg/mmol).