20220614_Saxenda SMC card digital update_v1

Information intended for UK healthcare professionals only. The production of this Guidelines  card has been commissioned by Novo Nordisk Limited. Please see below for full disclaimer. 

View Saxenda® (liraglutide 3 mg) Great Britain and Northern Ireland prescribing information and adverse event reporting information

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Liraglutide (Saxenda®) SMC24551

The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows:

Advice: following a resubmission

Liraglutide (Saxenda®) is accepted for restricted use within NHSScotland.

Indication under review: 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:

  • ≥30kg/m2 (obese), or
  • ≥27kg/m2 to <30kg/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.

SMC restriction: BMI ≥35kg/m2* (obesity class II and above) with:

  • Non-diabetic hyperglycaemia (prediabetes) at high risk of type 2 diabetes which is defined as having either:
    • Fasting plasma glucose level of 5.5 to 6.9mmol/L or 
    • HbA1c of 6.0 to 6.4% (42 to 47mmol/mol), and
  • High risk of cardiovascular disease (CVD):
    • Total cholesterol >5mmol/L, or
    • High-density lipoprotein (HDL) <1.0mmol/L for men and <1.3mmol/L for women, or
    • Systolic blood pressure (SBP) >140mmHg.

Patients should be treated in a specialist weight management service.

In a phase III study, liraglutide, as an adjunct to diet and exercise, was associated with significant reduction in body weight compared with placebo in patients with BMI ≥30kg/m2 or ≥27kg/m2 if they had dyslipidaemia or hypertension.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. 

*a lower BMI cut-off may be more appropriate 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.

About the SMC

The Scottish Medicines Consortium (SMC) is part of Healthcare Improvement Scotland, the national healthcare improvement organisation for Scotland. SMC reviews new medicines that have received a licence from the Medicines and Healthcare products Regulatory Agency (MHRA – the licensing body for the UK). SMC also reviews new formulations of, and new ways to use, established medicines. Before a medicine can be prescribed routinely in Scotland, it has to be accepted for use by SMC. SMC advice helps the health service plan for the quick, uniform introduction of beneficial treatments across NHSScotland.

Reference

  1. Scottish Medicines Consortium. Liraglutide 6mg/mL solution for injection in pre-filled pen (Saxenda®) SMC2455. SMC, May 2022. www.scottishmedicines.org.uk/medicines-advice/liraglutide-saxenda-resub-smc2455/ 

The production of this Guidelines summary card has been commissioned by Novo Nordisk Ltd. Novo Nordisk Ltd has reviewed the card for technical accuracy and regulatory compliance and supplied the prescribing information. This summary card only displays the concise guidance; readers are strongly advised to refer to the full guidance at: www.scottishmedicines.org.uk/medicines-advice/liraglutide-saxenda-resub-smc2455/ 

The guidance is reproduced with permission of the Scottish Medicines Consortium (SMC). Copyright of the guidance rests with the SMC, and it may be freely reproduced for educational and not-for-profit purposes. No reproduction by, or for, commercial organisations, or for commercial purposes, is allowed without the express written permission of the SMC.

MGP Ltd owns copyright of the Guidelines brand, logo, and the design and format of this summary card.

The views and opinions expressed are not necessarily those of Guidelines, its publisher, advisers, or advertisers.

 

Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or App Store. Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0800 023 2573). Calls may be monitored for training purposes.

 

UK22SX00245

Date of preparation: June 2022