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New HTA Decisions in England
August 2020
Drug name
TAGRISSO® (osimertinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Not recommended
Osimertinib is not recommended, within its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.
Decision Detail
Clinical evidence was provided from the ongoing FLAURA randomised controlled trial, comparing efficacy and safety of osimertinib with standard care (erlotinib or gefitinib) for people with locally advanced or metastatic EGFR mutation-positive NSCLC. An interim analysis of FLAURA showed that progression-free survival (PFS) was statistically significantly longer with osimertinib than with erlotinib or gefitinib. At the latest data cut (12 June 2017) median PFS was 18.9 months for osimertinib (95% confidence interval [CI] 15.2 to 21.4) and 10.2 months for standard care (95% CI 9.6 to 11.1). The hazard ratio was 0.46 (95% CI 0.37 to 0.57; p0.0015). The committee acknowledged that the FLAURA data were very immature and that there was substantial uncertainty in OS because of the number of events still to be reported. It concluded that osimertinib lengthened progression-free survival, and possibly overall survival, compared with erlotinib or gefitinib but the OS benefit was difficult to establish because the data were very immature. However, there is no direct evidence comparing osimertinib with afatinib, which may be more effective than erlotinib and gefitinib. Using assumptions, all of the pairwise incremental cost-effectiveness ratios (ICERs; including all relevant confidential commercial arrangements) for osimertinib compared with erlotinib, gefitinib and afatinib were greater than £30,000 per quality-adjusted life year (QALY) gained. When a fully incremental analysis was done (that is, the calculation of incremental QALY gains and costs along a list of treatment options ranked by ascending cost) the ICER compared with erlotinib was also above £30,000 per QALY gained. The committee concluded that the most plausible ICER is above £30,000 per QALY gained. Also, osimertinib does not meet NICE's end-of-life criteria. Although some of the clinical uncertainty could be addressed through collecting further data from the clinical trial, osimertinib does not meet NICE's criteria to be included in the Cancer Drugs Fund because it does not have the potential to be cost-effective at the price offered.