Resource impact statement

Cancer Drugs Fund technology

NICE has recommended osimertinib 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.

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.

Osimertinib will be available to the NHS in line with the managed access agreement with NHS England. This means that, if a person has fully resected, stage 1b to 3a EGFR mutation-positive NSCLC and the doctor responsible for their care thinks that osimertinib is the right treatment, it should be available for use, in line with NICE's recommendations and the Cancer Drugs Fund criteria in the managed access agreement. The company has a commercial arrangement. This makes osimertinib available to the NHS with a discount. The size of the discount is commercial in confidence.

It is estimated that around 600 people per year with fully resected stage 1b to 3a EGFR mutation-positive NSCLC are eligible for treatment with osimertinib.

The resource impact of osimertinib will be covered by the Cancer Drugs Fund budget. More evidence on osimertinib is being collected until the final results of the ADAURA trial are available. After this, NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then. Further information can be found in NHS England’s Appraisal and Funding of Cancer Drugs from July 2016 (including the new Cancer Drugs Fund) - A new deal for patients, taxpayers and industry.

This technology is commissioned by NHS England. Providers are NHS hospital trusts.

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