Osimertinib [OSI1]
The the second-line treatment of locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non small cell lung cancer in adults where all the following criteria are met:
- 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.
- The patient has histological or cytological evidence of NSCLC that carries an EGFR T790M 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 an EGFR T790M mutation. Please mark below on which basis the diagnosis of EGFR T790M 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 an EGFR T790M mutation
- The patient has locally advanced or metastatic disease.
- The patient’s NSCLC has been documented as exhibiting an epidermal growth factor (EGFR) mutation.
- The patient has been documented as exhibiting unequivocal evidence of a T790M mutation.
- There is at least evidence of radiological disease progression on 1st line EGFR-targeted tyrosine kinase (TKI) therapy and there has been no further systemic anti-cancer treatment. Please mark below on which TKI the patient has had progressive disease:
- erlotinib
- gefitinib
- afatinib
- dacomitinib
- Either the patient has had no prior treatment with osimertinib 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 osimertinib
- 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:
- The patient has not received any previous cytotoxic chemotherapy or immunotherapy for the locally advanced/metastatic disease indication.
- The patient has an ECOG performance status (PS) of 0 or 1.
- 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.
- 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.
- 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.
- Osimertinib will be used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 12 January 2021
Additional information
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.