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PEMBROLIZUM/ BERAHYALURONIDASE ALFA-PMPH INJ,SOLN NEW

Clinical Criteria Summary

This criteria document covers 2 drugs .
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  • PEMBROLIZUM/ BERAHYALURONIDASE ALFA-PMPH INJ,SOLN
  • PEMBROLIZUMAB INJ,SOLN

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
  • Pembrolizumab and berahyaluronidase does not have an indication in classical Hodgkin Lymphoma or Primary Mediastinal Large B-Cell Lymphoma

Additional Inclusion Criteria

  • 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
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • 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 4 months after the last dose.

Source Documents