The UK's National Institute for Health and Clinical Excellence (NICE) has continued its decision of not approving erlotinib for treating locally advanced or metastatic non-small-cell lung cancer in patients who have stable disease following platinum-based chemotherapy. This special report was recently published in the Online First edition by The Lancet Oncology. The authors of the report are Fiona Rinaldi, Technical Advisor at NICE, Dr Elisabeth George, Associate Director at NICE and Professor Peter Clark, Chair of the Independent Appraisal Committee.

The independent review group (ERG) which conducted NICE's work came to the following conclusions: In line with the manufacturer's (Roche) estimated cost per quality-adjusted life year (QALY) of £47,000, ERG estimated that the cost was £50,000 per QALY or higher. This was much higher than NICE's usual upper limit of £30,000. The SATURN trial that formed the basis of the evidence for the efficacy of ertolinib differed from UK clinical practice since a high percentage of trial participants had better prognostic factors compared to clinical practice. This could have led to an exaggeration of erlotinib's efficacy. It is questionable whether erlotinib extends life by 3 months, a mandatory requirement that needs to be fulfilled for being considered under supplementary advice issued by NICE for assessing treatment options that might provide terminal patients with an additional 3 months of life. Roche did not provide enough evidence to prove that erlotinib extended life by an additional 3 months or more. In addition, NICE clarified that the population that could be potentially treated with erlotinib was quite large as per its UK marketing authorizations. This led the committee to conclude that erlotinib did not meet the criteria for end-of-life treatment. The researchers also wrote:

"The Committee noted that even if the end-of-life criteria were taken into account, the most plausible incremental cost-effectiveness ratios [per QALY] were higher than those normally considered to be associated with cost-effective treatments. Consequently, the Committee did not recommend erlotinib maintenance treatment for patients with locally advanced or metastatic non-small-cell lung cancer who have stable disease following platinum-based chemotherapy."

It was also noted by the authors that Roche tried to appeal against this decision, but it was dismissed on May 16, 2011.

Link to Abstract

Anne Hudsmith