The National Institute for Clinical Excellence (NICE), in a draft guidance has recommended Liraglutide (Victoza) 1.2mg injectable daily for some patients with diabetes mellitus type 2. NICE does not, however, recommend the 1.8mg daily dosage, saying there does not appear to be any significant additional benefit over the 1.2mg dose.

NICE recommends Liraglutide 1.2 mg daily in combination with metformin or a Sulphonylurea as an option for treatment of patients with diabetes type 2, only if:

  • the patient is intolerant of metformin or a sulphonylurea, or metformin or a sulphonylurea treatment is contraindicated, and
  • the individual is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or thiazolidinediones and DPP-4 inhibitor treatment is contraindicated

Liraglutide 1.2mg daily is recommended in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione (triple therapy regimes) only when blood glucose control becomes or remains inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual). The diabetes type 2 patient must also have either:

  • a BMI (body mass index) of 35kg/m2 (in those of European descent, and appropriate adjustments made for other ethnic groups), and specific psychological or medical problems associated with high body weight, or
  • a BMI ≤ 35 kg/m2, where insulin therapy would have significant occupational implications, or weight loss would benefit other significant obesity-related comorbidities

Liraglutide 1.2 mg daily treatment should only be continued if the patient’s diabetes has shown a beneficial metabolic response – a reduction of 1% or more in HbA1c at 6 months for dual therapy regimens, and for triple therapy regimens a reduction of 1% or more in HbA1c and a weight loss of 3% or more of initial body weight after six months.

As the benefit of increasing the dosage to liraglutide 1.8mg daily was only marginal compared to 1.2mg daily, NICE does not recommend that higher dosage for the treatment of type 2 diabetes.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said:

There are about 2.5 million people in the UK living with diabetes – 90% of whom have type 2 diabetes. It is a serious, progressive disease, and so we are pleased to be able to recommend liraglutide 1.2 mg daily as a clinically and cost effective treatment option for some patients with type 2 diabetes. We were unable to recommend use of the higher dose however, as the available evidence does not suggest any significant additional benefit.

In a press release, NICE added:

NICE has not yet issued final guidance to the NHS; these decisions may change after appeal. Final guidance is likely to be published in October 2010.

Liraglutide (brand name Victoza), is a long-acting glucagon-like peptide-1 (GLP-1) analog that has been developed by Novo Nordisk for the treatment of type 2 diabetes. The product was approved by the European Medicines Agency (EMEA) on July 3, 2009, and by the U.S. Food and Drug Administration (FDA) on January 25, 2010.

The National Institute for Health and Clinical Excellence (NICE) is the independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health in the United Kingdom. Put simply: as far as drugs are concerned, NICE decides whether a new drug becomes available on the National Health Service (UK’s universal healthcare coverage system).

Source: The National Institute for Health and Clinical Excellence (NICE)

Written by Christian Nordqvist