NICE rejects new type 2 diabetes drug Forxiga

Forxiga, the new first-in-class diabetes medication from Bristol-Myers Squibb and AstraZenecan, has been tuned down by the National Institute for Health and Clinical Excellence (NICE).
NICE, which decides if drugs should be available on the NHS in England and Wales based on their cost-effectiveness, said it was not able to recommend Forxiga (dapagliflozin) as an add-on therapy for use with other medicines, including insulin, as it needed more information from the manufacturers to adequately assess the oral type 2 diabetes drug.
The group has issued a “Minded Not to Recommend” to request further information on the cost-effectiveness model submitted by Bristol-Myers Squibb and AstraZeneca as part of the product’s appraisal.
One of the concerns raised during the Appraisal Committee meeting was the use of network meta-analyses to determine the clinical effectiveness of Forxiga, which according to the Committee meant there was a “significant uncertainty about the validity of the results”.
In a statement, Amadou Diarra, VP and general manager UK and Ireland at BMS, said the companies were disappointed with the outcomen, but added they were “committed to working with NICE to provide additional information and analysis on the cost-effectiveness model and will do everything we can to drive national access for this alternative treatment for type 2 diabetes”.
Dapagliflozin received Marketing Authorisation by the European Medicines Agency (EMA) on 14 November 2012 and last month was accepted for restricted use by the Scottish Medicines Consortium (SMC) and made available on the Scottish NHS.
The once-daily treatment is the first in a new class of type 2 diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which help improve blood sugar regulation and promote weight loss.