Osimertinib for untreated EGFR-mutation-positive NSCLC – NICE decision


  • Dawn O'Shea
  • Oncology drug update
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Osimertinib will not be available on the NHS for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in adults, after a NICE appraisal found uncertainty around overall survival benefit and high costs.

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) in this patient population. Participants had either exon 19 deletion (del19) or exon 21 (L858R) EGFR mutation.

At the latest data cut, median progression-free survival was 18.9 months for osimertinib vs 10.2 months for standard care (HR 0.46; 95% CI 0.37-0.57; P

Furthermore, NICE concluded that although some of the clinical uncertainty could be addressed through further data collection, osimertinib does not meet NICE's criteria to be included in the Cancer Drugs Fund because the treatment does not have the potential to be cost-effective at the price offered.