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In preliminary recommendations published recently (18 October) by NICE, exenatide prolonged release suspension for injection (Bydureon, Eli Lilly) is recommended in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedioneⁱ) as a treatment option for people with type 2 diabetes, when control of blood glucose remains or becomes inadequate (HbA_1cⁱⁱ of 7.5% or above, or other higher level agreed with the individual), and the person has:

• a body mass index (BMI) of 35 kg/m² or higher in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or
• a BMI below 35 kg/m², and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Treatment with exenatide prolonged release suspension for injection in a triple therapy regimen should only be continued if a beneficial metabolic response has been shownⁱⁱⁱ.

Exenatide prolonged release suspension for injection in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended as a treatment option in people with type 2 diabetes, only if:

• either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated or not tolerated, and
• thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4^iv inhibitors are contraindicated or not tolerated.

Treatment with exenatide prolonged-release suspension for injection in a dual therapy regimen should only be continued if a beneficial metabolic response has been shown.

Exenatide improves glycaemic control in patients with type 2 diabetes in a number of ways, including: enhanced glucose-dependent insulin secretion, the result is the release of a higher, more appropriate amount of insulin that helps lower the rise in blood sugar from eating; and reduced glucose-dependent glucagon^v secretion in response to eating, which helps stop the liver from overproducing sugar when it is not needed, which prevents hyperglycemia (high blood sugar levels).

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Type 2 diabetes is becoming increasingly more common in adults, so we are pleased to recommend exenatide as a treatment option for some people with the condition. These draft recommendations are now available for public consultation, and the manufacturer and other consultees have the opportunity to respond to concerns and comments made by the Appraisal Committee.”

NICE has not yet issued final guidance to the NHS; these decisions may change after consultation.

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 likely to be published in February 2012.

Notes to Editors

References

i. Metformin, sulphonylurea and thiazolidinedione are other classes of drugs that are used in the management of type 2 diabetes mellitus. They lower glucose levels in the blood.

ii. The HbA_1c test indicates blood glucose levels for the previous two to three months. HbA_1c measures the amount of glucose that is being carried by the red blood cells in the body.

iii. This is defined as a reduction of at least 1 percentage point in HbA_1c and a weight loss of at least 3% of initial body weight at 6 months.

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 slow gastric emptying time after a meal.

v. Glucagon is a hormone secreted by the pancreas which raises blood glucose levels. Its effect is opposite that of insulin, which lowers blood glucose levels.

About the guidance

1. The appraisal consultation document can be found from Tuesday 18 October on the NICE website at: http://guidance.nice.org.uk/TA/Wave22/0

Please contact the press office for an embargoed copy.

Closing date for comments is Tuesday 8 November at 5.00pm.

2. After consultation the Appraisal Committee will meet again to consider the evidence, this appraisal consultation document and comments from the consultees. At that meeting, the Committee will also consider comments made by people who are not consultees.

3. After considering these comments, the Committee will prepare the final appraisal determination (FAD). Subject to any appeal of the FAD by consultees, NICE will produce final guidance on the use of exenatide in the NHS in England and Wales. For further details, see the NICE website at: http://www.nice.org.uk/aboutnice/howwework/devnicetech/developing_nice_technology_appraisals.jsp

4. Exenatide once weekly (Bydureon, Eli Lilly) has a UK marketing authorisation for the treatment of type 2 diabetes mellitus in adults to achieve glycaemic control in combination with:

• metformin
• a sulphonylurea
• a thiazolidinedione
• metformin and a sulphonylurea
• metformin and a thiazolidinedione,

in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. The recommended dose is 2 mg exenatide once weekly by subcutaneous injection.

5. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Incretin hormones like GLP-1 enhance glucose-dependent insulin secretion and exhibit other antihyperglycaemic actions. Exenatide improves glycaemic control in patients with type 2 diabetes in several ways, including through enhanced glucose-dependent insulin secretion, and reduced glucose-dependent glucagon secretion.

6. Exenatide once weekly costs £73.36 for a pack of four single-dose kits containing one vial of exenatide 2 mg powder and a pre-filled syringe of solvent (costs from manufacturer's submission). Costs may vary in different settings because of negotiated procurement discounts.

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.

4. NICE provides advice and support on putting NICE guidance and standards into practice throughits implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.