U.K. gatekeepers shut out AZ and BMS' new diabetes drug

U.K. cost-effectiveness watchdogs have stiff-armed the new diabetes drug from Bristol-Myers Squibb and AstraZeneca. Forxiga, approved in November for sale in the EU, failed to impress the gatekeepers at the National Institute for Health and Clinical Excellence. Essentially, NICE isn't yet convinced that Forxiga works any better as an add-on therapy than other drugs already in use.

Bristol ($BMY) and AZ ($AZN) had asked NICE to usher Forxiga onto the National Health Service formulary as an add-on to insulin, and as an add-on to metformin. In both cases, significant chunks of the supportive data came from meta-analyses, rather than actual comparative studies, NICE said. "The Committee concluded there was significant uncertainty about the validity of the results," the agency said in a statement.

NICE also questioned the economic model that Bristol-Myers and AstraZeneca used to support the cost side of the equation. Forxiga costs £36.59, or about $58, for 28 tablets, the agency says. But the companies can submit revisions--to both sides of the cost-effectiveness balance--for review at the appraisal committee's March session.

Forxiga won the EU's blessing in spite of questions about Forxiga's side effects, which have held up its approval by the FDA. EU officials figured that the drug's novel action--it's the first in a new class of diabetes drugs--and efficacy outweighed those risks. The drugmakers are aiming to go back to the FDA in mid-2013 with new data.

Though a NICE recommendation would by no means make Forxiga's European launch a smooth sail, it would chart a course toward acceptance in other countries. A variety of governments keep tabs on NICE decisions, adopting those approvals as their own.

Meanwhile, Johnson & Johnson ($JNJ), Pfizer ($PFE), Eli Lilly ($LLY) and Boehringer Ingelheim have their own SGLT-2 drugs. The FDA's expert advisers backed J&J's canagliflozin last month but raised questions about potential effects on the heart and kidneys. If NICE ends up blessing Forxiga, it could be a harbinger of success for the rest of the class as well.

- read the NICE release
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