NICE issue final appraisal determination for dapagliflozin
The type 2 drug dapagliflozin is set to become more widely available to people in the UK after the National Institute for Health and Care Excellence (NICE) issued a Final Appraisal Determination (FAD).
The organisation’s FAD recommends a sodium-glucose co-transporter 2 (SGLT2) inhibitor Forxiga® (dapagliflozin) as part of a triple oral therapy regimen in combination with metformin (MET) and sulfonylurea (SU) for people with type 2.
NICE had previously appraised dapagliflozin for monotherapy when metformin is contraindicated (recommended in NICE technology appraisal 390).
It was also recommended as part of combination therapy in specific dual therapy regimens (recommended in NICE technology appraisal 288).
Professor John Wilding, head of obesity and endocrinology at the University Hospital Liverpool, said: “For many patients whose blood sugar is no longer adequately controlled with metformin and sulphonylurea, adding another oral therapy such as dapagliflozin or a DPP-4 inhibitor is preferable to starting injectable treatment.
In my clinical experience, I have found that dapagliflozin offers a good alternative to DPP-4s, as it can help patients reach their blood glucose targets while also providing a significant secondary benefit of weight loss.
This is great news for patients and clinicians.
“Today’s announcement by NICE means that more patients will now have access to this treatment option.”
Dapagliflozin is not indicated for the management of weight loss. Weight change was a secondary endpoint in clinical trials.
The NICE recommendation was based on data from a randomised 24 week placebo controlled phase III trial (RCT) of dapagliflozin with MET + SU which included a 28-week blinded extension period.
The study, which enrolled a total of 219 patients, showed that:
- Dapagliflozin, compared to placebo, was superior in improving glycaemic control based on the reduction in HbA1c from baseline to week 24 of -0.86% vs. -0.17% for placebo (p-value <0.0001) at 24 weeks, and -0.8% (95% CI: −1.0, −0.6) vs. placebo: -0.1% (95% CI: −0.3, 0.1) at 52 weeks.
- Dapagliflozin showed a significant difference in body weight change from baseline versus placebo with weight loss of -2.7 kg vs -0.6 kg for placebo (p <0.0001) at 24 weeks, and -2.9 kg (95% CI: −3.6, −2.2) vs. -1.0 kg (95% CI: −1.8, −0.1) for placebo at 52 weeks.
According to the SmPC, the most frequently reported adverse reaction associated with dapagliflozin treatment was hypoglycaemia (when used with insulin or a sulphonylurea). Common adverse reactions are genital and urinary tract infections, dizziness, back pain, dysuria and polyuria. Further details can be found in the SmPC.
Lisa Anson, country president of AstraZeneca UK and Ireland, said: “Dapagliflozin is already used by thousands of patients every month in the UK, and it is welcome news that this NICE recommendation gives more NHS patients access to the treatment as part of a triple therapy regimen.
“Dapagliflozin has always had a license for use as part of triple therapy but, because it was the first SGLT2 inhibitor to launch, the data were not yet available for inclusion in our original NICE submission. This is great news for patients and clinicians.”
Approximately 2.9 million adults in England received a diagnosis of diabetes in 2015, of whom 90 per cent had type 2 diabetes.
However, it is estimated that approximately half a million people in the UK with diabetes remain undiagnosed.
The prevalence of type 2 diabetes in England is rising because of increased obesity, decreased physical activity and increased life expectancy after diagnosis because of better cardiovascular risk protection.