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Drug - Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn injection) [Jazz Pharmaceuticals Inc.]

April 2022

Therapeutic area - Oncology, Injectable

Initial approval criteria

  • Patient is at least 1 month of age AND

Universal Criteria 

  • Patient must not have a history of serious pancreatitis, thrombosis, or hemorrhagic events with prior L-asparaginase therapy AND

Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) 

  • Used as a component of multi-agent chemotherapy AND
  • Used as a substitute for E. coli-derived asparaginase (e.g., pegaspargase) in cases of hypersensitivity

Renewal criteria

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in the initial approval criteria AND
  • Disease stabilization or improvement as evidenced by a complete response [CR] (i.e., morphologic, cytogenetic or molecular complete response CR), complete hematologic response or a partial response by CBC, bone marrow cytogenic analysis, QPCR, or FISH AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe hypersensitivity reactions including anaphylaxis, pancreatitis, thrombosis, hemorrhage, hepatotoxicity, etc.

Quantity limits

  • 25 mg/m2 every 48 hours
  • Patient’s body surface area (in m2) must be submitted at time of request

Billing for Rylaze

  • Rylaze must be billed as a medical claim


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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