Published

May 7, 2025

Atezolizumab [ATE3]

Atezolizumab for locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy where all the following criteria are met:

  1. The application is made by and the first cycle of systemic anti-cancer therapy with atezolizumab 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 the immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
  3. The patient has histologically or cytologically documented transitional cell carcinoma of the urothelial tract
  4. The patient’s disease is either locally advanced (ie T4b any N or any T N2-3 disease) or metastatic (any T any N M1 disease).
  5. The patient has either not received previous adjuvant chemotherapy, neoadjuvant chemotherapy or chemo-radiotherapy, or if previously treated with platinum-based chemotherapy whether as adjuvant chemotherapy or as neoadjuvant chemotherapy or with chemo-radiotherapy, has relapsed =< 12 months since completing the platinum-based chemotherapy. Patients meeting this criterion are eligible to be considered as previously treated for locally advanced/ metastatic disease (see below for criterion 6) but must satisfy all other criteria. * Patients meeting this criterion are eligible to be considered as previously treated for locally advanced/ metastatic disease (and can answer “Yes” to criteria 6 below) but must satisfy all other criteria
  6. There has been disease progression during or following previous platinum-based combination chemotherapy for inoperable locally advanced or metastatic urothelial cancer.
  7. The patient has an ECOG performance status (PS) score of 0 or 1
  8. 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 completed or discontinued checkpoint inhibitor immunotherapy as part of adjuvant or neoadjuvant therapy without disease progression on treatment and at least 12 months elapsed between the date of last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission any re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. Please mark below if the patient has received previous checkpoint inhibitor therapy and in which setting:
  • the patient has never received any immunotherapy for urothelial cancer. If so, please type ‘n/a’ in the ‘Time gap’ box below
  • the patient has previously been treated with adjuvant immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse stable disease at the end of 1st line chemotherapy
  • the patient has previously been treated with neoadjuvant treatment containing immunotherapy for urothelial cancer and discontinued immunotherapy without disease progression and at least 12 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant checkpoint inhibitor immunotherapy and first diagnosis of disease relapse:______
  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. A formal medical review as to whether treatment with atezolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment.
  3. The patient is to be treated until disease progression and loss of clinical benefit or excessive toxicity or patient choice or for a maximum treatment duration of 2 years of uninterrupted treatment (ie a maximum of 35 administrations if given 3-weekly or a maximum of 26 administrations if given 4-weekly).
  4. When treatment break of more than 3 months beyond the expected 3- or 4-weekly cycle length, a treatment break approval form will be completed.
  5. The patient has no symptomatically active brain metastases or leptomeningeal metastases
  6. Atezolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC)

NHS funded From: 13 July 2018

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA525 (13 June 2018)

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 13 May 2025 at 19:45.

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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