NICE has taken the decision not to recommend osimertinib for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).
The clinical evidence for osimertinib came from the ongoing FLAURA randomised controlled trial comparing the efficacy and safety of osimertinib with standard care (erlotinib or gefitinib) for advanced EGFR-positive NSCLC. Afatinib was not a comparator in the standard care arm.
At the latest data cut (12 June 2017), median progression-free survival (PFS) was 18.9 months for osimertinib and 10.2 months for standard care (hazard ratio [HR] 0.46; 95% CI 0.37-0.57; P
The NICE appraisal committee raised a number of issues concerning the trial. In addition to the absence of afatinib in the comparator arm, many subsequent treatments used in the trial are not routinely used in the NHS.
The most plausible cost-effectiveness estimates for osimertinib are above what NICE normally considers an acceptable use of NHS resources. Furthermore, the committee concluded that osimertinib does not meet NICE's criteria for consideration as a life-extending end-of-life option.
The committee acknowledged that some of the clinical uncertainty could be addressed through collecting data from patients having osimertinib through the Cancer Drugs Fund (CDF) and that final data from FLAURA will be available soon. But at the current price, the committee conclude that osimertinib “does not have plausible potential for cost-effectiveness.” The ICER is above £30,000 per QALY gained when the commercial arrangement is taken into account and is not available within the CDF.
The draft guidance is now open for public consultation. Closing date for receipt of comments is 9 May 2019. The final guidance is expected to be published in August.