AstraZeneca, Bristol-Myers’s Forxiga Not Backed by NICE

AstraZeneca Plc and Bristol-Myers Squibb Co.’s drug Forxiga failed to win the backing of the U.K.’s health-cost adviser when used with other diabetes treatments after the companies didn’t offer a discount.

The National Institute for Health and Clinical Excellence is requesting further information from the companies before an appraisal committee meets in April, the agency, known as NICE, said today in an e-mailed statement. NICE advises the state-run health system on which treatments represent value for money.

“There was significant uncertainty about the validity of the results” of the companies’ analysis of the effectiveness of Forxiga compared with other therapies, NICE said.

Forxiga won European Union approval in November after the EU drug regulator said the medicine’s benefits outweighed the risks of infection and some types of cancer. The product is the first of a new class of diabetes medicines called SGLT2-inhibitors. AstraZeneca, based in London, needs new medicines to boost revenue as older products lose market exclusivity.

The medicine costs 36.59 pounds ($57.80) for 28 tablets, according to NICE. Final guidance on the drug will be published in June, the agency said.

Companies Disappointed

The companies said in a joint statement they will submit additional information to NICE before March 5.

“Bristol-Myers Squibb and AstraZeneca are disappointed with the outcome today,” Amadou Diarra, vice president and general manager of the U.K. and Ireland for Bristol-Myers Squibb, said in the statement. He said the companies responded to all the questions raised ahead of a meeting of the appraisal committee. “We submitted a robust dossier of information, which included an externally-validated cost-effectiveness model.”

Diabetes occurs when the body doesn’t produce enough insulin or use it effectively to regulate blood sugar. Over time the elevated levels of blood sugar can damage nerves and blood vessels and can increase the risk of heart disease, stroke and kidney damage. Diabetes affects almost 3 million people in the U.K., with 90 percent having the Type 2 form of the disease that develops later in life, according to NICE.

Forxiga helps the body flush out excess sugar through the urine. The medicine has been shown in studies to help patients lose weight and lower blood pressure. Older diabetes drugs either reduce blood-sugar levels or increase insulin production.

The companies expect to resubmit an application to market the drug in the U.S. in the middle of this year, AstraZeneca said yesterday.

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