Roche Holding AG will have to provide more information about the expense of the Zelboraf skin-cancer treatment before the U.K.’s drug-cost agency will decide whether to recommend use in the National Health Service.
The National Institute for Health and Clinical Excellence said it asked Roche for further clarification about the cost-effectiveness of the melanoma drug, also known as vemurafenib, after the drugmaker submitted information about pricing to NICE last month.
“We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay,” Carole Longson, director of NICE’s Health Technology Evaluation Centre, said in a statement today.
NICE, which advises the state-run National Health Service on the treatments that represent value for money, refused to back Zelboraf for approval after the first consultation in June. Roche offered to cut the price of the drug, which costs about 1,750 pounds ($2,734) a week in the U.K. The average duration of treatment is seven months, which would cost 52,500 pounds, NICE said. The amount of the offered discount is confidential, the authority said.
A melanoma pill for patients whose tumors can’t be removed surgically, fewer than 1,000 people a year would be eligible for treatment with Zelboraf in England and Wales, according to the London-based authority.
"Roche is confident that vemurafenib should be recommended by NICE and will provide further information to help NICE make its decision," the company said in an e-mailed statement.
Zelboraf won European approval in February and is among the new medicines the Basel, Switzerland-based company is counting on to boost growth as sales for its tumor drug Avastin decline. Zelboraf was backed by the U.S. Food and Drug Administration in August 2011 and competes with New York-based Bristol-Myers Squibb Co.’s Yervoy treatment.
NICE’s final guidance on Zelboraf will replace local NHS recommendations across country.
“Vemurafenib is an expensive drug and its long-term benefits are difficult to quantify,” NICE’s Longson said.