The UK’s National Institute for Health and Care Excellence (NICE) has decided to not recommend National Health Service (NHS) use of Novo Nordisk’s Saxenda (liraglutide).

Saxenda is approved in the European Union (EU) for managing obesity in adults alongside a reduced calorie diet and increased physical activity.

In an appraisal committee document (ACD), the pricing regulator concluded there was too much uncertainty about the clinical and cost-effectiveness of Saxenda for it to recommended at this time.

The document states that although clinical trial evidence indicates that Saxenda plus lifestyle changes is more effective in weight loss and delaying the development of type 2 diabetes than lifestyle changes alone, “long-term effectiveness, particularly on the risk of cardiovascular disease, is unknown.”

Evidence from Novo Nordisk trial 1839 did not show a significant reduction in CV outcomes in people given Saxenda, compared to those only engaging in lifestyle changes, according to NICE’s document. The ACD notes that this was probably linked to the low average age of the trial participants meaning their baseline CV risk would not be particularly high.

Due to this clinical uncertainty and the narrow population group – BMI over 35kg/mwith pre-diabetes and a high risk of CV disease – that Novo Nordisk’s cost estimate focused on, the committee deemed the cost-effectiveness of the drug to be “highly uncertain and potentially much higher than what NICE considers a cost-effective use of NHS resources”.

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Saxenda is indicated in the EU for adults with a BMI classified as overweight (27 to 30km/m2) or obese (over 30kmg/m2) with at least one weight-related comorbidity, for example pre-diabetes, hypertensive, dyslipidaemia or obstructive sleep apnoea.

The ACD is based upon expert submissions from Obesity UK, the Royal College, the British Dietetic Association and Novo Nordisk themselves, among others.

Stakeholders have until the 14February 2020 to submit comments on the ACD. The committee will meet for a second time on 25 February to discuss further comments; a final decision is expected to be made in May this year.