British cost watchdog backtracks again on Roche's Tarceva

Courtesy of Roche

The U.K.'s cost-effectiveness gatekeeper has once again flip-flopped on Roche's ($RHHBY) Tarceva. After initially recommending the targeted cancer drug for use by Britain's National Health Service, the National Institute for Health and Care Excellence (NICE) said in February it was reviewing the recommendation. Now, it looks likely to revert back to its original stance--a reversal of fortune the Swiss drugmaker is pleased with.

As PMLiVE reports, NICE has backtracked on its latest draft guidance, publishing a new recommendation after consulting with patients, doctors and Roche itself that backs the continued use of Tarceva as a second-line treatment for patients with non-small cell lung cancer.

"The voices of clinicians and patients have been heard," the Basel-based company said in a statement posted by FirstWord Pharma.

Roche certainly left no part of its position in doubt, proclaiming in February that NICE's U-turn would "set lung cancer care in England and Wales backward." But the agency needed some time to weigh the value of re-treating tumors with EGFR inhibitors like Tarceva and AstraZeneca's ($AZN) Iressa, which also came under review. Clinicians had raised concerns that once patients were treated with those drugs, their tumors would grow resistant, NICE explained at the time.

But now that the cost watchdog has come around, Roche can get back to ramping up Tarceva's global market share before competitors settle in. In July, the FDA approved Boehringer Ingelheim's Gilotrif, for one, to treat patients with EGFR mutations. But that didn't stop Roche's drug from growing 4% last year, racking up 1.3 billion Swiss francs ($1.4 billion); an FDA decision to approve Tarceva as a first-line treatment in EGFR patients, along with a companion diagnostic, helped pad that total.

- here's the statement
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