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NICE consultation

Liraglutide not recommended for adults with overweight and obesity

This recommendation is not intended to affect treatment with liraglutide that was started in the NHS before this guidance was published

In a consultation document, the UK’s National Institute for Health and Care Excellence has decided not to recommend liraglutide (Saxenda, Novo Nordisk), within its marketing authorisation, for managing adult who are overweight and with obesity alongside a reduced-calorie diet and increased physical activity.

The NICE guidance, ‘Liraglutide for managing overweight and obesity’, is currently open for comments until 14th February and is not NICE's final guidance on this technology. The recommendations may change after consultation. The appraisal committee will meet again to consider the responses received and prepare the final appraisal document, expected to be published in May 2020.

“This recommendation is not intended to affect treatment with liraglutide that was started in the NHS before this guidance was published,” the consultation document states. “Adults having treatment outside this recommendation may continue without changes to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.”

Clinical trial evidence shows that liraglutide with lifestyle measures is more effective for weight loss and delaying the development of type 2 diabetes than lifestyle measures alone. However, its long-term effectiveness, particularly on the risk of cardiovascular disease, is unknown.

In its submission, Novo Nordisk stated that liraglutide was cost-effective in people who were considered at high risk of the adverse consequences of obesity (adults BMI≥35 pre-diabetes and a high risk of cardiovascular disease). However, NICE noted that the company did not provide evidence for the whole population covered by the marketing authorisation. Due to the uncertainty in the clinical evidence, even in this high-risk subgroup, NICE stated “the cost-effectiveness estimate is highly uncertain and potentially much higher than what NICE considers a cost-effective use of NHS resources. Therefore, liraglutide cannot be recommended.”

The current marketing authorisation for liraglutide states that it is indicated 'as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of ≥30 kg/m² (obese), or ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea’.

The NICE committee noted that liraglutide with diet and exercise is an effective short-term treatment for weight loss and has temporary benefits on diabetic status. However, the incremental cost-effectiveness ratio (ICER) for liraglutide could as high as £105,000 if only the effects on BMI are included. The committee subsequently identified several uncertainties around the modelling assumptions, particularly about what happens after stopping liraglutide and the calculation of long-term benefits. These result in considerable uncertainty about the true ICER, the documents states.  Therefore, the committee was unable to recommend liraglutide as a cost-effective treatment for use in the NHS for adults with BMI>35 with pre-diabetes and a high risk of cardiovascular disease.

“NICE proposes that the guidance on this technology is considered for review by the guidance executive three years after publication of the guidance. NICE welcomes comment on this proposed date. The guidance executive will decide whether the technology should be reviewed based on information gathered by NICE, and in consultation with consultees and commentators.”

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