Published

May 11, 2025

Osimertinib [OSI2]

For the first line treatment of locally advanced or metastatic epidermal growth factor receptor mutation-positive non- small cell lung cancer in adults where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with osimertinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has histological or cytological evidence of NSCLC that carries a sensitising EGFR mutation based on a validated test OR there is documented agreement by the lung MDT that the radiological appearances are in keeping with locally advanced or metastatic NSCLC AND there is an informative circulating free DNA test result confirming the presence of a sensitising EGFR mutation. Please mark below on which basis the diagnosis of EGFR mutation positive NSCLC has been made in this patient:
  • Histological or cytological evidence.
  • Documented agreement by the lung MDT that the radiological appearances are in keeping with locally advanced or metastatic NSCLC and there is an informative circulating free DNA test result confirming the presence of a sensitising EGFR mutation
  1. The patient has locally advanced or metastatic disease.
  2. The patient’s NSCLC has been documented as exhibiting an epidermal growth factor (EGFR) mutation.
  3. For the locally advanced/metastatic disease indication, the patient has not received any previous cytotoxic chemotherapy or immunotherapy.
  4. The patient has had no prior treatment with an EGFR inhibitor unless afatinib or dacomitinib or erlotinib or gefitinib has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or osimertinib has been received as adjuvant treatment for resected stages IB to N2 only IIIB NSCLC with either an EGFR exon 19 deletion or exon 21 substitution mutation and the patient did not progress whilst still receiving adjuvant osimertinib. Please mark below which scenario applies to this patient:
  • no prior treatment with an EGFR inhibitor
  • previous treatment with a 1st line EGFR inhibitor but treatment has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease
  • previously received adjuvant osimertinib for resected stages IB to N2 only IIIB NSCLC and did not progress whilst still receiving adjuvant osimertinib. Please state in box below how many months have elapsed since discontinuation of adjuvant osimertinib:
  1. The patient has an ECOG performance status (PS) of 0 or 1.
  2. Osimertinib will be given as monotherapy at the recommended maximum dose of 80 mg once a day. Note: the use of osimertinib doses higher than 80mg per day are not commissioned.
  3. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner. Note: treatment with osimertinib should be stopped if there is disease progression in the CNS and the CNS disease cannot be treated with surgery or stereotactic radiotherapy.
  4. A formal medical review as to how osimertinib is being tolerated and whether treatment with osimertinib should continue or not will be scheduled to occur at least by the end of the second 4-weekly cycle of treatment
  5. Where a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
  6. Osimertinib will be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 12 January 2021

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA654 (14 October 2020)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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