sitagliptin (Januvia) monotherapy

following a full submission

sitagliptin (Januvia) is accepted for restricted use within NHS Scotland.

Licensed indication under review: as monotherapy, to improve glycaemic control in patients with type 2 diabetes mellitus who are inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

SMC restriction: to patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance.

Sitagliptin met the pre-defined efficacy criterion for non-inferiority versus metformin in a study of treatment naïve patients. It appears to have minimal effect on body weight.

The health economic case was demonstrated only for a sub-population of patients within the licensed indication.

The licensed indication for sitagliptin has also recently been extended to include use in triple combination therapy with metformin plus thiazolidinediones and use as add-on therapy toinsulin. The manufacturer’s submission related only to the use of sitagliptin as monotherapy Therefore SMC cannot recommend the use of sitagliptin in combination with metformin plus thiazolidinediones or as add-on therapy to insulin.