Atezolizumab [ATE9]

Atezolizumab monotherapy for the first line treatment of locally advanced or metastatic non-small cell lung cancer which has PD-L1 expression in at least 50% of tumour cells or in at least 10% of tumour-infiltrating immune cells where the following criteria are met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with atezolizumab monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (squamous or non-squamous). Please mark below which histology applies to this patient:
  • squamous NSCLC
  • non-squamous NSCLC
  1. The patient has stage IIIB or IIIC or IV NSCLC or has disease that has recurred after previous potentially curative local management of NSCLC with surgery/chemoradiotherapy/surgery.
  2. An approved and validated test has demonstrated that there is PD-L1 expression in at least 50% of tumour cells or in at least 10% of tumour-infiltrating immune cells. Please document the tumour PD-L1 expression in this box:_____ or the PD-L1 expression in tumour-infiltrating immune cells:_____
  3. Either the patient has been documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion or the patient has a squamous cell carcinoma and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with atezolizumab has been discussed with the patient during the consenting process, i.e. the patient has consented to be treated with an unknown EGFR/ ALK status. Please mark below which option applies to this patient:
  • Documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion
  • Patient has squamous NSCLC and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with atezolizumab has been discussed with the patient during the consenting process.
  1. Either the patient has not received any previous systemic therapy for NSCLC or the patient completed the last treatment with chemotherapy or chemoradiotherapy or checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy at least 6 months prior to the first diagnosis of locally recurrent or metastatic disease. Please indicate below whether the patient has received any previous adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC:
  • the patient has not been previously treated with any adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC or
  • the patient has been previously treated with adjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease or
  • the patient has been previously treated with neoadjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease or
  • the patient has been previously treated with maintenance systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease
  1. The patient has not received prior treatment with an anti PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTL-4) antibody unless the patient discontinued or completed checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy without disease progression and at least 6 months elapsed between the date of the last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. all Please mark below if the patient received previous checkpoint inhibitor therapy and in which setting:
  • the patient has never received any immunotherapy for NSCLC. If so, please type ‘n/a’ in the ‘Time gap’ box below or
  • the patient has previously been treated with adjuvant immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse or
  • the patient has previously been treated with neoadjuvant immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse or
  • the patient has previously been treated with maintenance immunotherapy post chemoradiotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous maintenance immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant or maintenance checkpoint inhibitor immunotherapy and first diagnosis of disease relapse:_____ Note: the mandatory interval between the last date of administration of any prior adjuvant/neoadjuvant/maintenance immunotherapy and the date of first relapse is at least 6 months. For patients suffering a first relapse within 6- 12 months of previous immunotherapy, clinicians should bear in mind the long elimination half-lives of immunotherapies and make individual assessments of the overall benefit/risk ratio of re-treatment with immunotherapy.
  1. Atezolizumab will be administered as monotherapy either subcutaneously at a dose of 1875mg every 3 weeks or intravenously at a dose of 1200mg every 3 weeks or 1680 mg every 4 weeks.
  2. Atezolizumab will be stopped at disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. Note: there is NO stopping rule for atezolizumab in this indication and hence patients continuing to benefit from atezolizumab after 2 years of treatment can continue if the patient and clinician agree. Note: once atezolizumab is stopped for disease progression or unacceptable toxicity or withdrawal of patient consent, atezolizumab cannot be re-started.
  3. The patient has an ECOG performance status (PS) of 0 or 1.
  4. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  5. A formal medical review as to how atezolizumab is being tolerated and whether atezolizumab should continue or not will be scheduled to occur at least by the end of the second 3- or 4-weekly cycle of treatment.
  6. When a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  7. Atezolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 31 August 2021

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CDF Managed Access: NA

NICE Technology Appraisal: TA705 (02 June 2021)

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The data on this page was produced using version 1.343 of the CDF list, downloaded from an archive of NHS England’s website on 26 January 2025 at 22:41.

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