VA CFU Criteria Formulary Advisor Reference
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ATEZOLIZUMAB INJ,SOLN

Generic Name
ATEZOLIZUMAB INJ
Brand Names
TECENTRIQ
Drug Class
ANTINEOPLASTIC,OTHER
Formulary Status
PA-F
Copay Tier
3
Last Updated
2017-02-27

Clinical Criteria Summary

Document 18

Exclusion Criteria

  • Autoimmune disease
  • Immunosuppression including corticosteroid equivalent to >10 mg per day of prednisone
  • Primary immunodeficiency
  • History of allogeneic hematopoietic stem cell or solid organ transplant
  • Pregnancy (i.e., known pregnancy or positive pregnancy test)
  • Breastfeeding

Inclusion Criteria

  • Indication is FDA approved
  • Off-label use supported by high-level published data

Additional Inclusion & Practice Requirements

  • Care provided by a VA/VA Community Care oncology or hematology provider
  • Goals of care and role of Palliative Care consult discussed and documented
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Contraception counseling for female patients of child-bearing potential and male patients with female partners of child-bearing potential regarding risks vs. benefits; effective contraception required during therapy and for 5 months after the last dose

Document 810

Exclusion Criteria

  • Autoimmune disease
  • Immunosuppression including corticosteroid equivalent to >10 mg per day of prednisone
  • Primary immunodeficiency
  • History of allogeneic hematopoietic stem cell or solid organ transplant
  • Pregnancy (i.e. known pregnancy or positive pregnancy test)
  • Lactating

Inclusion Criteria

  • Indications & Administration
  • Indication is FDA approved
  • Off-label use supported by high-level published data
  • If administering with chemotherapy and/or bevacizumab, administer prior to chemotherapy and/or bevacizumab if given on the same day
  • Care Coordination & Documentation
  • Care is provided by a VA/VA Community Care oncology or hematology provider
  • Goals of care and role of Palliative Care consult have been discussed and documented
  • Performance Status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Reproductive Health & Contraception
  • Female patients of child-bearing potential and male patients with female partners of child-bearing potential: counseling provided on contraception and risks vs. benefits of treatment. Use effective contraception during therapy and for 5 months after the last dose.
  • Product Substitution/Transition
  • Do not substitute atezolizumab/hyaluronidase SubQ for atezolizumab IV on a mg per mg basis. Patients may transition products at the next dose.

Source Documents

Document 18 Document 810