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    • Has all of the relevant evidence been taken into account?
  • Question on Consultation

    • Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?
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    • Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 The committee recognised that osimertinib is promising, but was not persuaded that there is sufficient evidence of clinical and cost effectiveness to recommend it for routine commissioning for the adjuvant treatment of stage 1b to 3a non-small-cell lung cancer (NSCLC) after complete tumour resection in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

1.2 The committee saw that osimertinib may be suitable for use in the Cancer Drugs Fund. Therefore, the company is invited to submit a proposal for including osimertinib in the Cancer Drugs Fund for this indication.

1.3 The Cancer Drugs Fund proposal should:

  • detail any commercial access arrangements

  • show plausible potential for cost effectiveness

  • explain how data collection will address the main clinical uncertainties described in section 3

  • state the likelihood that additional research will reduce uncertainty enough to support positive guidance in the future

  • state how data will be collected and what data is currently available

  • state when the results will be available.

    If appropriate data is already being collected, the proposal should summarise the study protocol.

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 suggests that, compared with active monitoring, treatment with osimertinib increases how long people live. It may also lower the risk of the disease coming back and the risk of death. However, this evidence is uncertain because information on what treatment patients were getting was revealed early.

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.

Osimertinib may be suitable for use in the Cancer Drugs Fund so that more data can be collected to address these uncertainties, So, the company is invited to submit a proposal for including osimertinib in the Cancer Drugs Fund for this indication.