UK NICE asks for more data on Tarceva, and Botox for migraine

UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) today issued new draft guidance requesting that Swiss drug major Roche (ROG: SIX), the manufacturer of Tarceva (erlotinib), provides further information on the use of this drug for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC). The draft guidance has been issued for consultation.

Commenting on the draft guidance, Sir Andrew Dillon, chief executive of the NICE, said: “NICE has already recommended a drug called gefitinib for the first-line treatment of EGFR mutation-positive NSCLC, which is now the treatment that most patients receive. When it was asked to consider Tarceva, our independent advisory committee concluded that it did not have enough information to be able to make the decision to recommend or not recommend it for routine use in the [National Health Service] as an alternative to gefitinib. It has therefore asked the manufacturer provide further analyses. We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic.”

Erlotinib is given orally at a recommended dosage of 150mg/day. The cost of a pack of 30 (150mg) tablets is £1631.53. Roche has agreed a patient access scheme for Tarceva with the Department of Health in which a confidential discount from the list price is applied to original invoices, the NICE noted.