GVS advice liraglutide (Saxenda®), extension of further conditions for certain people with an extremely increased weight-related health risk

Indication for which reimbursement is requested

Saxenda® is a glucagon-like peptide (GLP-1) analogue. It is available as a solution for injection with 6 mg of liraglutide/ml in a 3 ml pre-filled pen (= 18 mg liraglutide). The therapeutic indication is:

• In addition to a reduced-calorie diet and increased physical activity for weight management in adults with an initial BMI of:
  • ≥ 30 kg/m² (obesity), or
  • ≥ 27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity, such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.

The marketing authorisation holder has now requested reimbursement for a subset within the registered indication:

• In combination with a combined lifestyle intervention (CLI), for the treatment of adults with an extremely increased weight-related health risk (BMI ≥35 kg/m2 in combination with a co-morbidity or BMI ≥40 kg/m2) without type 2 diabetes, and who are not (yet) eligible for metabolic surgery.

National Health Care Institute's advice

The National Health Care Institute concludes that Saxenda® for the group of patients as stated in the marketing authorization holder's application complies with the established medical science and medical practice. For this group, Saxenda® in addition to CLI has a therapeutic added value compared to CLI alone. In this subset of patients, a clinically relevant difference was observed in the percentage of patients reaching ≥10% weight reduction with liraglutide compared to placebo.

The National Health Care Institute recommends the Minister to extend the reimbursement conditions of Saxenda® on the basis of the considerations mentioned in the report. 

List 2 conditions for liraglutide (Saxenda®)

1. Only for insured persons with type 2 diabetes mellitus and a BMI ≥ 30 kg/m² whose blood glucose values cannot be adequately regulated with the combination of metformin and a sulphonylurea derivative at the maximum tolerable dosages, and who do not use insulin, unless the insured person is already being treated with this medicinal product in combination with insulin on 1 May 2011.
2. As an addition to metformin and basal insulin (NPH insulin/long-acting analogue insulin) in an insured person with diabetes mellitus type 2 and a BMI ≥ 30 kg/m2 whose blood glucose values are insufficiently regulated after ≥ 3 months of treatment with optimal titrated basal insulin in combination with metformin (whether or not with a sulphonylurea derivative) in a maximum tolerable dosage.
3. In combination with a combined lifestyle intervention (CLI) recognized by the RIVM, for the treatment of adults with an extremely increased weight-related health risk, without diabetes mellitus type 2 and who are not (yet) eligible for metabolic surgery:
   1. BMI ≥35 kg/m2 in combination with a co-morbidity (cardiovascular disease, sleep apnoea and/or osteoarthritis) or
   2. A BMI ≥40 kg/m2.
      Treatment should be discontinued if after 3 months of using the maintenance dosage the initial weight has not decreased by at least 5%.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.