following a second resubmission:
dapagliflozin (Forxiga) is accepted for restricted use within NHSScotland.
Indication under review: In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
SMC restriction: in triple therapy in combination with metformin and sulphonylurea, as an alternative to a dipeptidyl peptidase-4 (DPP-4) inhibitor.
SMC has previously accepted dapagliflozin for use:
- as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.
- in combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.
Dapagliflozin is also licensed for use as monotherapy but the company’s resubmission did not relate to its use in this setting. SMC cannot recommend the use of dapagliflozin as monotherapy.
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Medicine details
- Medicine name:
- dapagliflozin (Forxiga)
- SMC ID:
- 799/12 (c)
- Indication:
In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Endocrine system
- Submission type
- Resubmission
- Date advice published
- 07 July 2014
SMC has previously accepted dapagliflozin for use:
- as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.
- in combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.
This advice remains valid.