Novo Nordisk’s Victoza is being recommended by the National Institute for Health and Clinical Excellence as a treatment for diabetes on the National Health Service, but only the 1.2mg forms and under certain conditions.

Draft guidance by the cost regulator says that, in the first instance, Victoza (liraglutide) 1.2 mg can be used as part of triple therapy regimens (together with metformin and sulfonylurea, or metformin and a thiazolidinedione) in patients with type 2 diabetes when control of blood glucose is inadequate, but only if the body mass index is greater than 35kg/m2 (for Europeans, adjusted for other ethnic groups) and the patient has specific psychological or medical problems associated with high body weight.

The Institute has also recommended the 1.2mg version, which costs around £954.84 per patient per year, for those with a smaller BMI when insulin therapy would significantly interfere with a patient’s job, or weight loss would benefit other significant obesity-related co-morbidities.

On the down side, NICE said it is currently minded not to recommend Victoza 1.2mg as a treatment option for type 2 diabetes in dual therapy, because of uncertainties in the clinical data provided by Novo “which need clarification”, and also rejected the 1.8 mg dose, which carries a price tag of around £1432.26 per year, for NHS use.

“The Committee concluded that there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual therapy regimens for this type of diabetes,” explained Carole Longson, Health Technology Evaluation Centre Director at NICE, and she said “the next step for the manufacturer is to consider the committee’s comments and respond to its concerns”.

Victoza is a stable analogue of the natural human hormone glucagon-like peptide-1 (GLP-1) and is in the same class as Eli Lilly/Amylin’s blockbuster Byetta (exenatide), although Novo has presented data showing that its drug provides statistically significantly better blood glucose control than Byetta, and offers the advantage of only requiring one injection per day instead of two.

Victoza benefits
There is considerable excitement over the drug, which was launched in the UK last July, not only because of its ability to by stimulate the body’s own insulin secretion when blood sugar levels get too high, but also because it is able to induce weight-loss by inhibiting gastric emptying and by reducing appetite and food intake.

In addition, evidence suggests that GLP-1 could also help to preserve or even boost the number of insulin-secreting cells in the pancreas, although this has only been shown in animal models and the duration of this effect is undetermined, the Institute noted.

The closing date for comments regarding NICE’s preliminary recommendations is March 5 in time for a second Appraisal Committee hearing scheduled for March 18.