Published

February 27, 2025

Osimertinib [OSI3]

Osimertinib for adjuvant treatment in adults after complete tumour resection in patients with UICC/AJCC 8th edition stage IB or stage IIA or stage IIB or stage IIIA or N2 only stage IIIB non-small cell lung cancer whose tumours have either an EGFR exon 19 deletion or an exon 21 (L858R) substitution mutation where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with adjuvant osimertinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a histologically documented non-small cell lung cancer (NSCLC).
  3. The patient has undergone a complete resection of the NSCLC with all surgical margins negative for tumour.
  4. The pathological stage determined on this patient’s surgical NSCLC specimen was a stage IB or IIA or IIB or IIIA or N2 only IIIB tumour according to the UICC/AJCC TNM 8th edition. Please mark below which stage applies to this patient:
  • stage IB disease (T2a N0)
  • stage IIA disease (T2b N0)
  • stage IIB disease (T1a N1 or T1b N1 or T1c N1 or T2a N1 or T2b N1 or T3 N0)
  • stage IIIA disease (T1a N2 or T1b N2 or T1c N2 or T2a N2 or T2b N2 or T3 N1 or T4 N0 or T4 N1)
  • N2 only stage IIIB disease (T3 N2 or T4 N2) Note: the trial included patients using the UICC/AJCC 7th edition and hence the corresponding 7th edition stages have been translated into those of the 8th edition.
  1. The patient’s NSCLC has been documented on the tumour specimen (biopsy or surgical specimen) as exhibiting either an epidermal growth factor (EGFR) exon 19 deletion (Ex19del) or an exon 21 (L858R) substitution mutation, whether alone or in combination with other EGFR mutations Please mark below which type of mutation applies to this patient:
  • exon 19 deletion (EX19del) or
  • exon 21 (L858R) substitution mutation
  1. The patient did not receive any pre-operative systemic therapy (cytotoxic chemotherapy, immunotherapy, EGFR-targeted tyrosine kinase inhibitors) for the NSCLC.
  2. The patient did not receive any pre-operative or post-operative radiation therapy for the NSCLC.
  3. No more than 10 weeks have elapsed since surgery if the patient did not receive adjuvant chemotherapy or no more than 26 weeks have elapsed since surgery if the patient was treated with adjuvant cytotoxic chemotherapy after surgery for the NSCLC. Please mark below which scenario applies to this patient:
  • the patient has not received adjuvant chemotherapy after surgery and this application for adjuvant osimertinib is occurring at a time when no more than 10 weeks have elapsed since surgery or
  • the patient has received and completed adjuvant chemotherapy after surgery and this application for adjuvant osimertinib is occurring at a time when no more than 26 weeks have elapsed since surgery
  1. The patient has had no prior treatment with an EGFR inhibitor.
  2. The patient has an ECOG performance status (PS) of 0 or 1.
  3. The patient does not have brain metastases on CT or MR imaging of the brain done either before surgery or prior to this application.
  4. The patient will be treated with osimertinib for whichever is the sooner of: disease progression or unacceptable toxicity or withdrawal of patient consent or for a total treatment duration of 3 calendar years.
  5. 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 the second 4-weekly cycle of treatment.
  6. When 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.
  7. Osimertinib will be used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 30 November 2021 - anticipated to move to NHS funding: 27 May 2025

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.351 of the CDF list, downloaded from an archive of NHS England’s website on 27 February 2025 at 18:00.

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.