UK's NICE delays decision on Roche's Zelboraf, asking for more information

UK health care watchdog the National Institute for Health and Clinical Excellence (NICE) today (August 10) issued draft guidance requesting Swiss drug major Roche (ROG: SIX), the manufacturer of skin cancer drug Zelboraf (vemurafenib) provides further information on the use of its drug for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

The NICE published draft guidance not recommending vemurafenib for consultation in June (The Pharma Letter June 15). Publication of this new draft follows the submission of additional analysis on the cost effectiveness of the drug by Roche. The new draft guidance has been issued for consultation. Until final guidance is issued to the National Health Service, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Commenting on the new draft recommendations, Carole Longson, Health Technology Evaluation Centre Director at the NICE, said: “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. Vemurafenib is an expensive drug and its long term benefits are difficult to quantify.”