Roche Holding AG (ROG)’s Zelboraf skin- cancer treatment failed to win the backing of the U.K. health- cost agency, and German regulators said the drug’s side effects reduced its benefit to patients.
The National Institute for Health and Clinical Excellence, or NICE, didn’t back the Roche drug even after the Swiss company offered to cut Zelboraf’s price.
Zelboraf costs about 1,750 pounds ($2,720) a week in the U.K. Also known as vemurafenib, the melanoma drug is among the new medicines Roche is counting on to boost growth as sales slow for its tumor drug Avastin.
“Vemurafenib is an expensive drug, and its long-term benefits are difficult to quantify,” NICE Chief Executive Officer Sir Andrew Dillon said today in an e-mailed statement.
The Roche drug’s long-term impact on survival was uncertain because many patients taking dacarbazine, an older drug, in a study were shifted onto other therapies such as Zelboraf when their disease worsened, NICE said. That made a comparison difficult, the U.K. health-cost agency said.
Taking Zelboraf’s side effects as well as its benefits into account, the new drug showed an indication of a considerable benefit to patients versus the older therapy dacarbazine, Germany’s IQWiG drug-review panel said in a statement today. The agency said Zelboraf’s side effects prevented it from getting a higher rating of additional patient benefit.
NICE advises the U.K. state-run National Health Service on which treatments represent value for money. Zelboraf won European approval in February, and a diagnostic test is available to identify which patients are most likely to benefit from the drug. The drug was approved in the U.S. in August and competes with Bristol-Myers Squibb Co. (BMY:US)’s Yervoy.
Germany’s Federal Joint Committee will use IQWiG’s recommendation to make a final ruling on its benefit for patients, a key step in negotiating the price of new drugs in that country.
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