A report published by The Lancet Oncology details the decision by the UK's National Institute for Health and Clinical Excellence (NICE) to uphold its original decision not to approve the drug erlotinib to treat locally advanced or metastatic non-small-cell lung cancer in patients who have stable disease following platinum-based chemotherapy.

The Special Report is by Fiona Rinaldi, Technical Advisor at NICE, Dr Elisabeth George, Associate Director at NICE and Professor Peter Clark, Chair of the Independent Appraisal Committee.

Work conducted by NICE's independent evidence review group (ERG) concluded, among other things:

• The cost per quality-adjusted life year (QALY) gained was well over NICE's usual upper-limit of £30,000; ERG's estimates were in the range £50,000 per QALY or higher. Even the manufacturer (Roche) placed the estimate per QALY gained at around £47,000.

• The main evidence for the efficacy of erlotinib came from the SATURN trial; yet a high proportion of patients in the trial had better prognostic factors than seen in UK clinical practice, which could thus overestimate the efficacy of erlotinib.

• Erlotinib did not qualify for consideration under supplementary advice issued by NICE for appraising treatments that might give patients with a short life-expectancy at least an additional 3 months of life, and which are licensed for indications that affect a small proportion of patients with incurable illnesses. NICE found that Roche had not provided sufficient evidence that erlotinib could extend life by at least 3 months.

• Furthermore, NICE concluded that the size of the cumulative population potentially eligible for treatment with erlotinib according to its UK marketing authorisations was not small. Therefore the Committee did not accept that erlotinib met the criteria for end-of-life treatments.

The authors conclude: "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."

The authors also note that Roche attempted to appeal against this guidance, but the appeal was dismissed on May 16, 2011.

Article: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70177-2/abstract

Source: Lancet Oncology