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New HTA Decisions in England
December 2020
Drug name
SAXENDA® (liraglutide)
Novo Nordisk
Decision date
Therapeutic area
Diabetes and other endocrinal, nutritional and metabolic conditions
Therapeutic sub area
Recommended with restrictions
Liraglutide is recommended as an option for managing overweight and obesity alongside a reduced-calorie diet and increased physical activity in adults.
Decision Detail
It is recommended only if: • they have a body mass index (BMI) of at least 35 kg/m2 (or at least 32.5 kg/m2 for members of minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population) and; • they have non-diabetic hyperglycaemia (defined as a haemoglobin A1c level of 42 mmol/mol to 47 mmol/mol [6.0% to 6.4%] or a fasting plasma glucose level of 5.5 mmol/litre to 6.9 mmol/litre) and; • they have a high risk of cardiovascular disease based on risk factors such as hypertension and dyslipidaemia and; • it is prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service and; • the company provides it according to the commercial arrangement. The commercial arrangement makes the Saxenda brand of liraglutide available to the NHS with a discount only if it is purchased through a secondary-care tier 3 weight management service. The size of the discount is commercial in confidence.
A post-hoc subgroup analysis of trial 1839 (a randomised double-blind trial of liraglutide or placebo, alongside diet and exercise) provided the clinical evidence for liraglutide. The post-hoc subgroup came from a pre-defined pre-diabetes subgroup. The clinical evidence shows that people lose more weight with liraglutide plus lifestyle measures than with lifestyle measures alone. Statistically significantly fewer people developed type 2 diabetes with liraglutide than with placebo, and more patients reverted to normal glucose tolerance on liraglutide than on placebo. The committee noted that the company's and the ERG's base case and scenario analyses resulted in ICERs for liraglutide of less than £20,000 per QALY gained. For people with a high BMI, non-diabetic hyperglycaemia and a high risk of cardiovascular disease the cost-effectiveness estimates are within what is normally considered a cost-effective use of NHS resources. For these people, liraglutide is recommended.