NICE has taken the decision not to approve osimertinib, within its marketing authorisation, 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. FLAURA which compares the efficacy and safety of osimertinib with standard care (erlotinib or gefitinib).
An interim analysis of FLAURA showed significantly improved progression-free survival (PFS) with osimertinib compared to erlotinib or gefitinib. At the latest data cut (12 June 2017) median PFS was 18.9 months for osimertinib (95% CI 15.2-21.4) and 10.2 months for standard care (95% CI 9.6-11.1), giving a hazard ration (HR) of 0.46 (95% CI 0.37-0.57; P<0.001).
However, overall survival (OS) data were very immature (25% of events). The interim results suggest osimertinib extends overall survival (HR 0.63; 95% CI 0.45-0.88; P=0.007) which was not statistically significant (P<0.0015 was needed for significance).
NICE concluded that osimertinib lengthens PFS and possibly OS compared with erlotinib or gefitinib but the OS benefit was difficult to establish.
There was no direct evidence comparing osimertinib with afatinib.
NICE determined that the most plausible cost-effectiveness estimates for osimertinib are above what is normally considered an acceptable use of NHS resources, and the treatment cannot be recommended. Furthermore, 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.
Patients currently receiving osimertinib outside this recommendation may continue without change to the funding arrangements in place.
