The National Institute for Health and Care Excellence (NICE), Britain's drug-review agency, is no longer recommending that Roche's ($RHHBY) targeted lung cancer drug Tarceva (erlotinib) be used as a second-line treatment in patients with non-small cell lung cancer who have relapsed—sparking an angry response from the Swiss drugmaker.
"The decision will set lung cancer care in England and Wales backwards and over 1,000 patients a year will be left without an active treatment option after their first-line therapy has failed, while patients in Scotland and the rest of Europe continue to benefit from erlotinib," Roche said in a statement obtained by FiercePharma.
NICE issued its opinion in a draft guidance, and Roche has until February 24 to officially respond. But what the agency is effectively saying is that it no longer believes Tarceva is clinically effective—or cost-effective—as a second-line treatment. NICE is expected to make its final decision in June.
Tarceva is targeted to patients who test positive for the EGFR-TK mutation, and NICE does recommend the drug be used as a first-line treatment for those patients. But in a statement obtained by Pharmafile, the agency explained that it had consulted with clinicians, who indicated that once patients were treated with Tarceva and the other NICE-approved targeted therapy, AstraZeneca's Iressa (gefitinib), their tumors would become resistant to the drugs, so they would be unlikely to be re-treated EGFR-TK inhibitors.
The U.K.'s cost-effectiveness gatekeepers have long been a thorn in the side of Big Pharma. In addition to continuing pressure from NICE, drugmakers are facing a five-year pricing regulation agreement with the British government, which will cap price increases on patented drugs starting this year.
Roche, meanwhile, has good reason to worry about protecting Tarceva's market share. In its 2013 earnings release last week, Roche reported that sales of the drug grew 4% to 1.3 billion Swiss francs ($1.4 billion). Sales growth was particularly strong in the U.S., boosted by the FDA's decision last May to approve it as a first-line treatment in patients with the EGFR-TK mutation, along with a companion diagnostic. (It has previously been approved only for some lung cancer patients who had failed previous therapies.) But competitors are looming: In July, the FDA approved Boehringer Ingelheim's Gilotrif (afatinib) for patients with EGFR mutations.