Cost regulators for the National Health Service in England and Wales have again rejected Roche's Tarceva as a maintenance therapy for non-small cell lung cancer, a decision which has disappointed the Swiss drugs major.

The National Institute for Health and Clinical Excellence has issued a second negative preliminary recommendation on Tarceva (erlotinib) as a maintenance therapy in patients with NSCLC whose disease is considered to be stable after first-line treatment with chemotherapy. This follows rejection in an earlier draft guidance in June.

Andrew Dillon, NICE chief executive, noted that maintenance treatment "is a relatively new concept in lung cancer care" and the agency has already recommended Eli Lilly’s rival drug Alimta (pemetrexed) for use under some circumstances. However, he added that "where pemetrexed was demonstrated to offer a potential additional 5.2 months of life to patients, it is uncertain how much benefit erlotinib can offer as a maintenance treatment".

Roche submitted data which it says shows that in this setting Tarceva can give patients with stable disease an average survival benefit of 3.3 months compared to placebo. However, NICE's independent appraisal committee "did not feel the evidence was sufficiently robust to demonstrate this extension to life".

Sir Andrew said "we are disappointed not to have been able to recommend a further treatment option for this cancer, however, there is considerable uncertainty about its clinically effectiveness in this setting". He added that "we need to be sure that new and existing treatments offer good value for the NHS".

Roche is also disappointed, saying that it hoped  NICE "would apply its ‘end of life’ criteria to this appraisal". They were "specifically set up to help patients with a short-life expectancy get access to life extending treatments" and the company believes Tarceva "meets the cost-effective threshold for these criteria".

Roche added that in this particular appraisal for lung cancer, "the population also fits the small patient numbers required. However, NICE has taken into account erlotinib’s licence in pancreatic cancer, despite the fact there is virtually no use on the NHS".
John Melville, general manager at Roche UK, said that other treatments have been approved by NICE "which we believe have a higher cost per quality adjusted life year (QALY) and this decision only helps to widen the gap between the UK and the rest of Europe in the management of lung cancer". He added that "we will challenge this decision, but in the interim period the Department of Health has recognised the need to address issues such as this with the launch of the Cancer Drugs Fund". This enables oncologists "to make treatment decisions based on clinical judgement rather than on a medicine’s NICE approval status,” he concluded.