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