NICE u-turn on osimertinib as first- and second-line treatment for NSCLC


  • Dawn O'Shea
  • Oncology drug update
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Patients with non-small cell lung cancer (NSCLC) will benefit from new draft NICE guidance which recommends osimertinib (Tagrisso, AstraZeneca) in the treatment of locally advanced or metastatic epidermal growth factor receptor (EGFR)-positive NSCLC.

The positive recommendation for untreated advanced EGFR-positive NSCLC follows a rapid review of NICE’s previous guidance, which did not recommend the treatment based on cost-effectiveness. Since the initial negative recommendation, AstraZeneca has offered an updated commercial arrangement which brings the cost-effectiveness to within the limits which NICE considers to be a good use of NHS resources.

The clinical evidence for osimertinib came from the FLAURA randomised controlled trial comparing the efficacy and safety of osimertinib with standard care (erlotinib or gefitinib) for patients with locally advanced or metastatic EGFR mutation-positive NSCLC. Patients in the trial had either the exon 19 deletion (del19) or exon 21 (L858R) EGFR mutation.

An interim analysis of FLAURA showed that progression-free survival (PFS) was significantly longer with osimertinib than with erlotinib or gefitinib. At the interim 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 ratio of 0.46 (95% CI 0.37-0.57; P

Overall survival (OS) data were very immature (25% of events) but the interim results suggest osimertinib extends OS compared with standard care (HR 0.63; 95% CI 0.45-0.88; P=0.007) which was not statistically significant.

Additionally, NICE has recommended osimertinib for routine use on the NHS as a second-line treatment for patients with locally advanced or metastatic EGFR-positive NSCLC with the T790M mutation.

The treatment was previously available through the Cancer Drugs Fund for this patient group but has now been approved for routine commissioning on the NHS.

The average cost of a course of the treatment is £5,770 at its list price, but the company has offered the NHS a confidential discount.