In final 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. Prolonged, poorly controlled diabetes can, among other things, increase the likelihood of atherosclerosis (a condition involving the furring and narrowing of the blood vessels). This may result in a poor blood supply to the heart, causing angina (a dull, heavy or tight pain in the chest). It also increases the chance that a blood vessel in the heart or brain will become blocked, leading to a heart attack or stroke. Complications of type 2 diabetes can also lead to problems with the eyes (retinopathy[i]), nerves (neuropathy[ii]), and kidneys (nephropathy[iii]).

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-inhibitors[iv] in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). The guidance also recommends dapagliflozin in combination with insulin as an option for treating type 2 diabetes.

Dapagliflozin, in combination with metformin and sulfonylurea, another blood-sugar-lowering drug, is not recommendedfor 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: “Type 2 diabetes is a serious problem which is becoming more common in the UK. Some people with the condition need to take more than one medication to help control their blood sugar. NICE is, therefore, pleased to recommend dapagliflozin in combination therapy for some people with type 2 diabetes, which will provide another treatment option for 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.

The final guidance can be found on the NICE website.

Ends.

Notes to Editors

References

i. Diabetic retinopathy is the result of leakage from or abnormal growth of the blood vessels that supply the retina, the light-sensitive and vision-essential region at the back of the eye.

ii. Neuropathy affects the body's nerves, often manifesting as leg and foot problems. Common symptoms of neuropathy include tingling, numbness, and pain--which can become excruciating--but some people experience no symptoms at all. Neuropathy can develop into ulcers, which when untreated can lead to amputation.

iii. Nephropathy, or kidney disease, develops when nephrons--the clusters of blood vessels in the kidneys that filter out waste from the body--lose their filtering capacity. In severe cases, the kidneys can fail, leading to a need for dialysis or a kidney transplant.

iv. 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.

About the guidance

1. The final guidance can be found on the NICE website from 00:01hrs Wednesday 26 June.

2. 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.

3. 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.

4. 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.

5. 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.

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

7. 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).

8. 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).

9. 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.

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

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

12. 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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