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AVELUMAB INJ,SOLN

Clinical Criteria Summary

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 Criteria

  • 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
  • Counseling on contraception and risks vs. benefits of treatment provided for female patients of child-bearing potential and male patients with female partners of child-bearing potential; effective contraception required during therapy and for 1 month after the last dose

Source Documents