In final draft guidance published today, NICE has recommended dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) for some people with type 2 diabetes.

Type 2 diabetes is a long-term condition that causes a person's blood sugar level to become too high. It occurs when the body does not produce enough insulin for it to function properly, or when the body's cells do not use insulin properly. Insulin is a hormone made by the pancreas, and is central to regulating blood sugar and fat metabolism in the body.

Dapagliflozin is recommended in combination therapy with blood-sugar-lowering drug metformin as an option for treating type 2 diabetes, if it is used as described for DPP4-inhibitorsⁱ in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). The draft guidance also recommends dapagliflozin in combination with insulin as an option for treating type 2 diabetes.

Dapagliflozin in a triple therapy regimen in combination with metformin and sulfonylurea, another blood-sugar-lowering drug, is not recommended for treating type 2 diabetes, except in the context of research as part of a clinical trial.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: “We are pleased to recommend dapagliflozin for some people with type 2 diabetes. It is a serious problem in the UK and dapagliflozin provides another treatment option for some people with this condition.”

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor that blocks the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine.

Following the consultation on the draft recommendations in February, NICE requested further clarification and information from the manufacturers. NICE also asked the decision support unitⁱⁱ to further review the economic analysis provided by the manufacturer and to perform exploratory analyses for dapagliflozin in dual therapy and as an add-on to insulin therapy.

The final draft guidance (final appraisal determination / FAD) can be found from 00:01hrs on Thursday 30 May on the NICE website

NICE has not yet issued final guidance to the NHS; these decisions may change in the event of an appeal.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is expected to be published in June 2013.

Ends

Notes to Editors

References

i. DPP-4 inhibitors lower blood sugar levels by blocking an enzyme known as dipeptidyl peptidase IV (DPP-4), which is responsible for breaking down the proteins that stimulate the insulin-producing cells, and slows gastric emptying time after a meal.

ii. The Decision Support Unit is commissioned by the NICE to provide a research and training resource to support the Institute's Technology Appraisal Programme. Further information on the NICE Decision Support Unit.

About the guidance

1. The final draft guidance (final appraisal determination / FAD) can be found from 00:01hrs Thursday 30 May

Embargoed copies are available on request; please contact the press office.

2. Final guidance is expected in June 2013.

3. In preliminary draft recommendations (appraisal consultation document / ACD) published in February 2013, NICE were minded not to recommend dapagliflozin in combination therapy for treating type 2 diabetes, and asked for further clarification and information from the manufacturer.

4. Dapagliflozin in a triple therapy regimen is currently being studied as an add-on to 2 other oral agents. The Committee considered that the cost-effectiveness analyses should be considered as exploratory in nature.

5. Dapagliflozin has a UK marketing authorisation ‘in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:

• monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance
• add-on combination therapy with other glucose-lowering agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control'.

The subject of this appraisal is the add-on therapy indication.

6. The manufacturers' submission states that the cost of dapagliflozin is £36.59 for 28 5-mg or 10-mg tablets (excluding VAT). Dapagliflozin is administered orally as a single dose of 10 mg per day. Costs may vary in different settings because of negotiated procurement discounts.

7. A patient access scheme has not been submitted by the manufacturer.

8. Diabetes currently affects almost 3 million people in the UK, of which about 90% will have type 2 diabetes. This is estimated to rise to 5 million - that is, nearly 10% of the population - by 2025. (Diabetes UK).

9. Diabetes is a major risk factor for cardiovascular disease and stroke among people of working age. An estimated 850,000 people in the UK may have diabetes but don't know it and may remain undiagnosed. Many more may have blood glucose levels above the normal range, (impaired glucose regulation) but not high enough for a diabetes diagnosis. (Diabetes UK).

10. For dapagliflozin as add-on to insulin, the Committee noted that in all the analyses conducted by the DSU the estimate of the ICER for dapagliflozin compared with DPP-4 inhibitors was below £20,000 per QALY.

11. Dapagliflozin is accepted for restricted use within NHS Scotland as a treatment option of type 2 diabetes in adults aged 18 and over.

12. NICE technology appraisals apply across the NHS in England and Wales.

13. Further details on NICE technology appraisals

Related NICE guidance

Published

• Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes. NICE technology appraisal guidance 248 (2012).
• Liraglutide for the treatment of type 2 diabetes mellitus. NICE technology appraisal guidance 203 (2010).
• Type 2 diabetes: the management of type 2 diabetes (partial update of CG66). NICE clinical guideline 87 (2009).
• Type 2 diabetes: the management of type 2 diabetes (partially updated by CG87). NICE clinical guideline 66 (2008).
• Diabetes in pregnancy: management of diabetes and its complications from pre-conception to the postnatal period. NICE clinical guideline 63 (2008).
• Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus (review). NICE technology appraisal guidance 151 (2008).
• Type 2 diabetes: prevention and management of foot problems. NICE clinical guideline 10 (2004).

About NICE

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