1 Recommendations

1 Recommendations

1.1 Osimertinib is recommended for use within the Cancer Drugs Fund as adjuvant treatment after complete tumour resection in adults with stage 1b to 3a non‑small‑cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. It is recommended only if:

  • osimertinib is stopped at 3 years, or earlier if there is disease recurrence or unacceptable toxicity and

  • the company provides osimertinib according to the managed access agreement.

1.2 This recommendation is not intended to affect treatment with osimertinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There are currently no targeted adjuvant treatments (including those specific to EGFR mutations) available in England for NSCLC after complete tumour resection.

Current clinical trial evidence shows that compared with active monitoring, treatment with osimertinib reduces the risk of the disease coming back. It may also lower the risk of death. However, this evidence is uncertain because information from the trial was released early and the data is still immature.

Because of this, the cost‑effectiveness estimates for osimertinib are also uncertain. It has the potential to be cost effective, but more evidence is needed to address these uncertainties before it can be recommended for routine use.

Because more data is being collected that addresses these uncertainties, osimertinib is recommended for use in the Cancer Drugs Fund.

  • National Institute for Health and Care Excellence (NICE)