Information intended for UK healthcare professionals only.
This formulary decision guide was developed from content provided by Novo Nordisk in a format developed by Guidelines in Practice. Novo Nordisk carried out full medical approval to ensure compliance with regulations.
Saxenda® (liraglutide injection 3 mg):
- contains liraglutide, a human glucagon-like peptide-1 receptor analogue (GLP1-RA)1
- induced greater weight loss vs placebo (a difference of -5.6kg, 95% CI: -6.0 to -5.1, p<0.001, n=Saxenda 2487, placebo=1244) at week 56 in the SCALE Obesity and Pre-diabetes Trial—over twice as many patients lost ≥5% of baseline body weight with Saxenda® vs placebo (odds ratio: 4.8, 95% CI: 4.1 to 5.6, p<0.001) and over three times as many patients lost >10% of baseline body weight with Saxenda® vs placebo (odds ratio: 4.3, 95% CI: 3.5 to 5.6, p<0.001)2,3
- has a NICE final technology appraisal decision due on 18 November 2020.4
Saxenda® (liraglutide injection 3 mg)
Saxenda® is licensed as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial body mass index (BMI) of:1
- ≥30 kg/m2 (obese) or
- ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related co-morbidity, such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.
Burden of disease
- Increasing numbers of reports have linked obesity to more severe COVID-19 illness and death5–7
- In England alone, in 2018/19 there were 876,000 hospital admissions where obesity was recorded as the primary or secondary diagnosis; this is an increase of 23% on 2017/188
- If people were at a healthy weight, 14% of premature deaths could be prevented in the UK9
- Obesity increases the risk of developing many co-morbid conditions including type 2 diabetes, fatty liver disease, cardiovascular, respiratory, joint diseases, and sleep disorders10,11
- Increased BMI is associated with increased risk of serious health conditions, increased mortality, and reduced life expectancy.12,13
Evidence for use
- Saxenda®, in addition to diet and exercise, may complement the multidisciplinary team in providing an additional pharmacotherapeutic option for weight manangement
- The Satiety and Clinical Adiposity—Liraglutide (SCALE) Obesity and Pre-diabetes trial was part of a substantial clinical trial programme for Saxenda®2
- The SCALE Obesity and Pre-diabetes trial was a 56-week double-blind trial to evaulate the efficacy and safety of Saxenda® versus placebo2
- The results from this trial showed, in patients with pre-diabetes who completed 56 weeks of treatment:2
- a significant greater mean weight loss in the liraglutide group vs the placebo group (-8.0±6.7% and -2.6±5.7%, respectively; estimated treatment difference -5.4%, 95% CI: -5.8 to -5.0, p<0.001, n=Saxenda 2487, placebo=1244)
- over twice as many patients lost ≥5% of baseline body weight in the liraglutide group vs the placebo group (63.2% vs 27.1%, respectively; odd ratio 4.8, 95% CI: 4.1 to 5.6, p<0.001)
- over three times as many patients lost >10% of baseline body weight in the liraglutide group vs the placebo group (33.1% vs 10.6%, respectively; odd ratio 4.3, 95% CI: 3.5 to 5.3, p<0.001)
- By week 160, 2% of individuals in the liraglutide group vs 6% of individuals in the placebo group were diagnosed with diabetes3
- An 80% risk reduction for development of type 2 diabetes relative to placebo at 160 weeks. Absolute risk reduction of 0.04. Hazard ratio of 0.2 (95% CI: 0.13 to 0.34, p<0.0001) for risk of developing type 2 diabetes vs placebo.3
- The NICE final techology appraisal recommendation decision for Saxenda® is due on 18 November 20204
- Novo Nordisk’s proposed patient population in the NICE technology appraisal:14
- specialist mutlidisciplinary weight management services as an adjunctive pharmacotherapy option
- the proposed position for Saxenda® is as a treatment option in addition to diet and exercise for adult patients with a BMI ≥35 kg/m2, pre-diabetes, high risk of developing cardiovascular disease, and referral to treatment in a specialist multidisciplinary weight management service.
Dosing and administration
- Saxenda® is supplied in a pre-filled pen containing 18 mg of liraglutide in 3 ml of solution, which is self-administered by patients as a sub-cutaneous injection each day1
- The starting dose is 0.6 mg once daily—the dose should be increased to 3.0 mg once daily, in increments of 0.6 mg for intervals of at least one week, to improve gastrointestinal tolerability; if escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment1
- Daily doses higher than 3.0 mg are not recommended1
- Saxenda® is administered once daily at any time, independent of meals, via subcutaneous injection in the abdomen, thigh, or upper arm—the injection site and timing can be changed without dose adjustment; however, it is preferable that Saxenda® is injected at around the same time of day1
- If a dose is missed:1
- within 12 hours of the usual administration time: the patient should take the dose as soon as possible
- if there are fewer than 12 hours to the next dose: the patient should not take the missed dose, but should resume the once‑daily regimen with the next scheduled dose
- an extra dose or increase in dose should not be taken to make up for the missed dose.
- Saxenda® is contraindicated in individuals hypersensitive to liraglutide or any of the excipients (see the summary of product characteristics for the full list of excipients)1
- Gastrointestinal events are the most frequently reported side‑effects of treatment with Saxenda® —most episodes of gastrointestinal events were mild to moderate, transient, and did not lead to discontinuation of therapy1
- The most common gastrointestinal adverse reactions reported with Saxenda® are nausea, vomiting, diarrhoea, and constipation1
- The use of Saxenda® is not recommended if a patient:1
- has NYHA class IV heart failure
- is 75 years or older
- has severe hepatic or renal impairment, or is on dialysis
- has pancreatitis.
- Do not use Saxenda® if the patient is pregnant, if she thinks she might be pregnant, or if she is planning to have a baby; patients should not breastfeed if using Saxenda®1
- For the full list of possible side-effects and precautions for use, please refer to the summary of product characteristics.1
- Novo Nordisk Limited. Saxenda® summary of Product Characteristics.
- Pi-Sunyer X, Astrup A, Fujioka K et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015; 373 (1): 11–22.
- Le Roux C, Astrup A, Fujioka K et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017; 389 (10077): 1399–1409.
- NICE. Liraglutide for managing overweight and obesity. In development ID740. Available at: www.nice.org.uk/guidance/indevelopment/gid-ta10388 (Accessed 29 October 2020)
- Petrilli C, Jones S, Yang J et al. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ 2020; 369: m1966.
- Simonnet A, Chetboun M, Poissy J et al. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus–2 (SARS–CoV–2) Requiring Invasive Mechanical Ventilation. Obesity. 2020; 28 (7): 1195–1199.
- Lighter J. Phillips M, Hochman S et al. Obesity in patients younger than 60 years is a risk factor for Covid-19 hospital admission. Clin Infect Dis. 2020; doi: 10.1093/cid/ciaa415. Online ahead of print.
- NHS Digital. Statistics on obesity, physical activity, and diet, England 2019. Part 1: Obesity-related hospital admissions. England, 2019. Available at: www.digital.nhs.uk/data-and-information/publications/statistical/statistics-on-obesity-physical-activity-and-diet/england-2020/part-1-obesity-related-hospital-admissions-copy (Accessed 29 October 2020)
- Royal College of Physicians. RCP Position Statement. What the RCP thinks about obesity. www.rcplondon.ac.uk/projects/outputs/what-rcp-thinks-about-obesity (Accessed 29 October 2020)
- NICE. Obesity: identification, assessment and management. Clinical Guideline 189. NICE, 2014. www.nice.org.uk/cg189 (Accesed 29 October 2020)
- Yumuk V, Tsigos C, Fried M et al. European Guidelines for Obesity Management in Adults. Obes Facts. 2015; 8 (6): 402–424.
- Haase CL et al. BMI and risk of obesity-related outcomes in a large UK population-representative cohort: a CPRD/HES study (Abstract PO1.244). Obesity Facts. 2019; 12 (178).
- Bhaskaran K, Dos-Santos-Silva I, Leon D et al. Association of BMI with overall and cause-specific mortality: a population-based cohort study of 3·6 million adults in the UK. Lancet Diabetes Endocrinol. 2018; 6 (12): 944–953.
- NICE. Appraisal consultation document. Liraglutide for managing overweight and obesity. England, 2020. Available at: www.nice.org.uk/guidance/GID-TA10388/documents/129 (Accessed 29 October 2020)
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845 6005055). Calls may be monitored for training purposes.
Job code: UK20SX00110
Date of preparation: October 2020