liraglutide (Saxenda)

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.