UK regulator rejects Roche's Tarceva; Roche to appeal decision
The U.K.'s health-cost regulator Thursday dealt another blow to Swiss pharma giant Roche Holding AG (ROG.VX) as it said it won't recommend the company's cancer drug Tarceva as a maintenance treatment for certain lung cancer patients, a decision Roche said it will appeal.
- (1888PressRelease) November 27, 2010 - The National Institute for Health and Clinical Excellence, or NICE, said there is "uncertainty about [the] clinical effectiveness" of Roche's Tarceva as a maintenance treatment for people with non-small-cell lung cancer who have had first line treatment and their disease has remained stable.
"Maintenance treatment is a relatively new concept in lung cancer care," said NICE chief executive Andrew Dillon. "Its goals are to prolong the benefits of treatment and to maximize quality of life for as long as possible."
While NICE has "recommended pemetrexed, [a chemotherapy drug] as a treatment under some of these circumstances" it said "it is uncertain how much benefit [Tarceva] can offer as a maintenance treatment."
Roche said it is disappointed by the decision, saying that trial data submitted to the UK body have showed that Tarceva has a survival benefit to patients. Some 39,000 new cases of lung cancer are registered in the UK every year, with around 80% of patients dying within a year.
"We will challenge this decision," said John Melville, General Manager of Roche UK. "But in the interim period the Department of Health has recognized the need to address issues such as this with the launch of the Cancer Drugs Fund, which enables oncologists to make treatment decisions based on clinical judgment rather than on a medicine's NICE approval status," he added.
While NICE said that it was aware of Tarceva's drug trial data, which showed the drug can potentially extend life by approximately 3.3 months, "the independent Appraisal Committee didn't feel the evidence was sufficiently robust to demonstrate this extension to life."
Companies such as Roche are attempting to find new cancer therapies that can convert deadly cancers into chronic diseases. Recent data suggested that drugs such as Roche's Avastin can help achieve this.
NICE's reluctance to follow Roche's rationale in the case of Tarceva shows that regulators remain skeptical about the maintenance treatment approach and about the ability of pharmaceutical companies to turn cancer into chronic disease.
The negative decision on Tarceva follows NICE's negative stance on Avastin, which regulator didn't back for patients suffering from bowel cancer, saying that the cost of the medicine were too high compared to the drug's effectiveness.
Cancer treatments can be long and extremely costly. As governments around the world are trying to curb costs, regulators are increasingly weighing the cost and benefits of a drug before backing reimbursement.
The rejection of Avastin in the U.K. also risks to be followed by regulators in other countries. In the U.S., for example, regulators are mulling whether to drop the use of Avastin in treating breast cancer patients.
Such concerns have put increased pressure on Roche, which earlier this months launched a major restructuring, including 4,800 job cuts and several factory closures.
Although the company doesn't face imminent patent expirations--its key cancer drugs such as Avastin and MabThera will remain protected for several years--pressure from regulators is hurting sales and profits.
-By Goran Mijuk, Dow Jones Newswires, +41 43 443 80 47; goran.mijuk ( @ ) dowjones dot com
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