The National Institute for Health and Clinical Excellence has agreed to reassess its proposed guidance rejecting the use of Tarceva (erlotinib) for the treatment of relapsed non-small cell lung cancer on the National Health Service, after a successful appeal by Roche.

Earlier this year, NICE proposed to close the door to Tarceva on grounds that “it is not an effective use of NHS resources when compared with either docetaxel or best supportive care.” But Roche argued that this decision was based on evidence that was assessed neither fairly nor appropriately, and slammed the proposed guidance as “perverse in the light of the evidence made available to the NICE Appraisal Committee.”

Furthermore, as a company spokesperson told PharmaTimes, Roche believes that the Institute has miscalculated its QALY (quality adjusted life year) by not taking into account the impact of febrile neutropenia, a serious side effect of docetexel, and the implicit costs that are associated with such a condition.

Roche estimates that, in the two years since the product received its green light in Europe, at least 4,000 patients died would have been eligible for treatment with Tarceva. Moreover, as NICE’s reassessment could take as long as six-12 months to complete, a further 2,500 patients may be denied the benefits of an alternative to chemotherapy, it said.

Therefore, to help boost the interim use of Tarceva, Roche has undertaken the unprecedented move of introducing an access programme to temporarily remove the barrier of cost when primary care trusts are making their prescribing decisions. The company has promised that, until final guidance is issued, it will subsidise the cost of Tarceva to the NHS so that the average cost per patient will be the same as docetaxel at its basic NHS price.

Removing cost issues

“We do not want to sit back and watch while blocks prevent patients gaining access to Tarceva, while NICE is re-evaluating its clinical and cost effectiveness,” explained John Melville, Roche General Manager in the UK. “We are confident that Tarceva is clinically and cost effective. Yet, by matching the price of current 2nd line lung cancer chemotherapy we have taken the issue of cost off the table, while NICE continues its deliberations,” he added.

The NHS price of Tarceva is £6,798 for 125 treatment days versus £4,931 for docetaxel for 1010 treatment days (the difference is the usual treatment cycle). Therefore, Roche is offering Tarceva at a 27.5% reduction in price, the spokesperson told PharmaTimes, and added that, should there ultimately be a negative outcome from NICE, Roche “would consider” continuing this programme.

Professor Nick Thatcher, Professor of Medical Oncology, Christie Hospital Manchester comments, has welcomed the move. “I have had patients whose lives have been transformed by this treatment, who have seen an improvement in their prognosis and a reduction in some of the devastating symptoms that come with the disease,” he stated. “I welcome Roche’s interim measure and the chance to be given the same freedom as clinicians in Scotland to prescribe this drug to patients whom I consider eligible for treatment.”