National Institute for Health and Clinical Excellence (NICE)
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NICE appraisal of liraglutide for type 2 diabetes
The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of liraglutide for the treatment of type 2 diabetes.
Liraglutide works by stimulating the release of insulin; it also reduces the appetite and therefore food intake by slowing gastric emptying.
In preliminary recommendations published today (15 February 2010), NICE has recommended liraglutide 1.2 mg daily as part of triple therapy regimens (in combination with metformin and sulfonylurea, or metformin and a thiazolidinedione) as an option for the treatment of type 2 diabetes, when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual). The patient being treated must have a body mass index of ≥ 35kg/m2 (in those of European descent, and appropriate adjustments made for other ethnic groups), and specific psychological or medical problems associated with high body weight. Liraglutide is also recommended for patients with a BMI ≤ 35 kg/m2, where insulin therapy would have significant occupational implications, or weight loss would benefit other significant obesity-related comorbidities1. Treatment with liraglutide should only be continued if the person has a beneficial metabolic response. This is defined as a reduction of at least 1.0 percentage point in HbA1c (the level of glucose present in the blood) and a weight loss of at least 3% of initial body weight after six months2.
However, NICE is minded not to recommend liraglutide as a treatment option for type 2 diabetes, 1.2mg daily in dual therapy. The independent Appraisal Committee felt that there were uncertainties in the data which need clarification from the manufacturer – Novo Nordisk. The manufacturer now has opportunity to consider and respond to the comments made by the Committee.
Liraglutide, 1.8 mg daily, is also not recommended for the treatment of people with type 2 diabetes.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “We are pleased to recommend liraglutide 1.2 mg daily as a clinically and cost effective treatment option as part of triple therapy regimens for some patients under restrictions. However we felt that there was not sufficient evidence to recommend it in dual therapy regimens for type 2 diabetes mellitus. The Committee concluded that there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual therapy regimens for this type of diabetes. The next step for the manufacturer is to consider the committee’s comments and respond to its concerns.”
This draft guidance has been issued for consultation; NICE has not yet issued final guidance to the NHS.
1 Liraglutide (1.2mg daily) is recommended as part of a triple therapy regimen only if used as described for exenatide in Type 2 diabetes: the management of type 2 diabetes. (NICE clinical guideline 87)
2 Treatment with Liraglutide (1.2mg daily) as part of a triple therapy regimen should only be continued as described for exenatide in Type 2 diabetes: the management of type 2 diabetes. (NICE clinical guideline 87)