Forxiga dapagliflozin regulatory update

The U.K.'s NICE said in draft guidance that it was "unable to recommend" the use of Forxiga dapagliflozin from Bristol-Myers Squibb and AstraZeneca as an add-on therapy to treat Type II diabetes. The committee said there was "significant uncertainty" about the validity of meta-analyses showing the clinical effectiveness of Forxiga compared to active comparators in combination therapies. The committee also said it could not "adequately replicate" the partners' economic model, which showed Forxiga had an incremental cost-effectiveness ratio (ICER) of less than £30,000 ($47,223) per quality-adjusted life year (QALY) gained compared with other anti-diabetic drug therapies. Comments are due Feb. 22. A second appraisal committee meeting is scheduled for April 5 and final guidance is expected in June. BMS said additional information will be submitted to NICE prior to the second appraisal committee meeting.

The committee said that the evidence of clinical effectiveness of dapagliflozin as add-on therapy to insulin came from 2 placebo-controlled trials, 1 of which was only 12 weeks in duration, and an additional network meta-analysis. NICE also noted the evidence for Forxiga as an add-on to metformin came from 3 trials and a network meta-analysis. Only 1 of the trials had an active comparator - sulfonylurea - and the clinical effectiveness of dapagliflozin compared to dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones and analogs of glucagon-like peptide-1 (GLP-1) were based on network meta-analyses. ...