NICE says yes to prolonged-release exenatide for type 2 diabetes in final guidance
NICE, the healthcare guidance body, has today (Wednesday 22 February) confirmed its initial draft and final draft positive recommendation of prolonged release exenatide (Bydureon, Eli Lilly) 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 (HbA1cii 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 prolonged-release exenatide in a triple therapy regimen should only be continued if a beneficial metabolic response has been showniii.
Prolonged-release exenatide 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:
- the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated, and
- the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4iv) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicatedv.
Treatment with prolonged-release exenatide in a dual therapy regimen should only be continued if a beneficial metabolic response has been shownv.
Exenatide improves glycaemic control in patients with type 2 diabetes in a number of ways, including: enhanced glucose-dependent insulin secretion that helps lower the rise in blood sugar from eating; and reduced glucose-dependent glucagonvi secretion in response to eating, which helps stop the liver from overproducing sugar when it is not needed, which in turn prevents hyperglycemia (high blood sugar levels). The prolonged release suspension is injected once weekly, as opposed to twice a day for the conventional formulationvii.
Professor Carole Longson, Director, Centre for Health Technology Evaluation at NICE said: "Type 2 diabetes is increasingly more common in the UK, and now affects 2.25 million peopleviii. It is a serious, progressive disease, so we are very pleased to be able to recommend prolonged-release exenatide as both a clinically and cost effective treatment option."
The final guidance is available on the NICE website at http://www.nice.org.uk/guidance/TA248
NICE has now issued final guidance to the NHS. Once NICE issues its guidance on a technology it replaces any guidance by individual NHS trusts across England and Wales.
Notes to Editors
i. Metformin, sulphonylureas and thiazolidinediones are other drugs that are used in the management of type 2 diabetes mellitus. They lower glucose levels in the blood.
ii. The HbA1c test indicates blood glucose levels for the previous two to three months. HbA1c 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 HbA1c and a weight loss of at least 3% of initial body weight at 6 months, and as described in Type 2 diabetes - the management of type 2 diabetes (NICE clinical guideline 87).
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. And as described in Liraglutide for the treatment of type 2 diabetes mellitus, (NICE technology guidance 203).
vi. 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.
vii. NICE has only appraised prolonged-release exenatide in this guidance. The conventional formulation of exenatide is covered in Type 2 diabetes - the management of type 2 diabetes (NICE clinical guideline 87).
viii. Diabetes UK.
About the guidance
1. The final guidance is available from Wednesday 22 February at the NICE website at: http://www.nice.org.uk/guidance/TA248
2. For further details on developing technology appraisals, see the NICE website.
3. Exenatide prolonged release suspension for injection (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:
- 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.
4. 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.
5. Prolonged-release exenatide 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.
6. NICE has recommended liraglutide 1.2 mg daily in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) as a treatment option for people with type 2 diabetes.
7. NICE has issued a clinical guideline on type 2 diabetes: the management of type 2 diabetes.
8. Prolonged-release exenatide is accepted for restricted use within NHS Scotland for the treatment of type 2 diabetes:
1. The National Institute for Health and Care 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:
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This page was last updated: 21 February 2012