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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical 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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Draft guidance consultation

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1 Recommendations

1.1

Osimertinib should not be used for the maintenance treatment of locally advanced (stage 3) unresectable non-small cell lung cancer (NSCLC) in adults when the tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and the cancer has not progressed during or after platinum‑based chemoradiotherapy.

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 healthcare professional consider it appropriate to stop.

What this means in practice

Osimertinib is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that osimertinib provides value for money in this population.

Why the committee made these recommendations

Usual maintenance treatment for locally advanced unresectable NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations that has not progressed (not got worse) after platinum-based chemoradiotherapy is best supportive care including surveillance (regular outpatient appointments and scans).

Clinical trial evidence shows that osimertinib increases how long people have before their condition gets worse compared with best supportive care. It may also increase how long they live but this is uncertain.

There are also uncertainties in the economic model, including:

  • how long people live after their condition has got worse when having best supportive care or osimertinib

  • how long people having osimertinib have before their condition gets worse

  • the length of time people take osimertinib.

Regardless of the uncertainties, the cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, osimertinib should not be used.