Estimated impact for the NHS

Other pharmacological treatments

At the time of publication of this evidence summary, orlistat was the only other licensed pharmacological treatment for weight management available in the UK.

Costs of other pharmacological treatments

See table 3 for details.

Table 3 Costs of other treatment

Medicine/treatment

Usual dose

30‑day cost excluding VAT

Liraglutide (Saxenda)

3.0 mg dailya

£196.20b

Orlistat

120 mg 3 times a daya

£18.05c

a Doses shown do not represent the full range that can be used and do not imply therapeutic equivalence. Taken from the relevant SPC.

b Costs based on MIMS, May 2017; excluding VAT

c Costs based on Drug Tariff, May 2017; excluding VAT.

Current or estimated usage

The manufacturer has reported that they will only promote the use of liraglutide (Saxenda) on private prescription, so they anticipate that use on the NHS will be limited. Consequently the manufacturer expects the impact for the NHS to be small (Novo Nordisk: source March 2017). The manufacturers have indicated that they do not intend to promote the use of liraglutide (Saxenda) within the NHS. This evidence summary does not contain recommendations from NICE on whether the medicine should be prescribed within the NHS or by private prescription.

Likely place in therapy

Liraglutide (Saxenda) is licensed as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with an initial BMI of:

  • 30 kg/m² or more (obese), or

  • from 27 kg/m² to less than 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.

The summary of product characteristics (SPC) recommends that treatment should be discontinued after 12 weeks on the 3.0 mg daily dose (recommended maintenance dose) if people have not lost at least 5% of their initial body weight.

Liraglutide (Saxenda) has been compared to placebo in randomised controlled trials (RCTs) but there are currently no published double-blind RCTs comparing it with other medicines for weight management. Studies have shown statistically significant weight losses with liraglutide compared with placebo in people with and without type 2 diabetes. However, as reported in the European Public Assessment Report (EPAR) for liraglutide (Saxenda) it is unlikely that any potential weight loss would be sustained after treatment with liraglutide is stopped. There were high dropout rates in both the liraglutide and placebo groups in all of the studies so continuation with treatment may be a problem in practice.

The NICE guideline on identifying, assessing and managing obesity recommends considering pharmacological treatment only after dietary, exercise and behavioural approaches have been started and evaluated. The guideline recommends to consider pharmacological treatment for people who have not reached their target weight loss or have reached a plateau on dietary, activity and behavioural changes. At the time of publication of this evidence summary, orlistat was the only other licensed pharmacological treatment for weight management available in the UK. The guideline recommends orlistat only as part of a weight management plan in adults who are obese or have a BMI of 28 kg/m2 or more with associated risk factors, such as type 2 diabetes. Liraglutide (Saxenda) is not specifically mentioned in the NICE guideline, however it is another potential pharmacological treatment option for use in-line with its marketing authorisation, for adults for whom lifestyle and behavioural approaches have not been effective and for whom the potential benefits of treatment outweigh the risks. The cost, mode of delivery and adverse effect profiles of the 2 treatments should be considered when choosing treatment options. Liraglutide is given by subcutaneous injection. Orlistat is an oral treatment, which may be preferable to some people. Orlistat and liraglutide have different adverse effect profiles; the SPC for orlistat (Xenical), lists gastrointestinal disorders including fatty or oily stools, faecal urgency and oily spotting from the rectum as very common adverse events; the liraglutide (Saxenda) SPC lists nausea, vomiting, diarrhoea and constipation as very common adverse events.

Liraglutide (Saxenda) is a different licensed product to liraglutide (Victoza), which has been licensed in the UK for the treatment of type 2 diabetes in adults since 2009. Victoza is not licensed as a pharmacological treatment for weight management and it also has a different licensed dose range. In Davies et al. 2015, which was conducted in an overweight or obese population with type 2 diabetes, after 56 weeks' treatment, percentage body weight change from baseline was −6.0% in the liraglutide 3.0 mg group and −4.7% in the 1.8 mg group. However, this study was not designed to compare the 2 different doses of liraglutide. For people who are already using liraglutide (Victoza) for type 2 diabetes the EPAR for liraglutide (Saxenda) states that no data is available on switching from liraglutide 1.8 mg daily (Victoza) to liraglutide 3.0 mg daily (Saxenda) and therefore this cannot be recommended. Overall, the EPAR concluded that the higher liraglutide (Saxenda) dose did not appear to increase adverse event rates compared with the lower liraglutide (Victoza) dose, apart from gastrointestinal disorders, which were more frequent. The EPAR states however, that there is currently insufficient data to assess if uncommon events (pancreatitis/neoplasms) occur more frequently with liraglutide 3.0 mg daily compared with liraglutide 1.8 mg daily.

The SPC states that use of liraglutide for weight management in people with obesity secondary to endocrine or eating disorders, or obesity caused by another medicinal treatment is not recommended due to a lack of safety and efficacy data for use in these circumstances. The SPC also states that it is not recommended to use liraglutide (Saxenda) in conjunction with other pharmacological treatments for weight management.