Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Erwinaze and Rylaze require prior authorization.

2)    Erwinaze is used to treat acute lymphoblastic leukemia.

3)    Rylaze is used to treat acute lymphoblastic leukemia and lymphoblastic lymphoma.

4)    Erwinaze and Rylaze are covered under the medical benefit as specialty drugs.

Acute Lymphoblastic Leukemia (Initial Approval)

1)    Diagnosis of acute lymphoblastic leukemia (C91.00, C91.02);   AND

2)    Prescribed by or in consultation with an oncologist or hematologist; AND

3)    Member meets (a or b):

a)    Member has developed hypersensitivity to an E. coli derived asparaginase product (Elspar – off market) or pegaspargase (Oncaspar);

b)    Age > 65 years and prescribed as combination induction therapy.

4)    Request meets one of the following (a, b, or c):*

a)    Erwinaze: dose does not exceed 25,000 International Units/m2 administered three times per week;

b)    Rylaze: dose does not exceed 25mg/m2 every 48 hours;

c)    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval Duration: 3 months

Lymphoblastic Lymphoma

1)    Diagnosis of lymphoblastic lymphoma; AND

2)    Request is for Rylaze; AND

3)    Prescribed by or in consultation with an oncologist or hematologist; AND

4)    Prescribed as a component of a multi-agent chemotherapeutic regimen;

5)    Member has developed hypersensitivity to an E. coli derived asparaginase product (Elspar – off-market) or pegaspargase (Oncaspar);

6)    Request meets one of the following (a or b):*

a.    Dose does not exceed 25mg/m2 every 48 hours;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Approval Duration – 3 months

Reauthorization (6 months)

1)    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving  Erwinaze or Rylaze for a covered indication and has received this medication for at least 30 days;

2)    Member is responding positively to therapy;

3)    If request is for a dose increase, request meets one of the following (a, b, or c):

a.    Erwinaze: new dose should not exceed 25,000 I.U./m2 administered three times per week;

b.    Rylaze: new dose does not exceed 25mg/m2 every 48 hours;

c.    New dose is supported by practice guidelines or peer-reviewed

1)    Erwinaze Product Information. Palo Alto, CA: Jazz Pharmacuticals, Inc.; December 2019.

2)    Rylaze Prescribing Information. Palo Alto, CA: Jass Pharmaceuticals, Inc.; June 2021.

3)    Oncaspar Prescribing Information. Gaithersburg, MD: Sigma-Tau Pharmaceuticals, Inc.; August 2019.

4)    NCCN Drugs and Biologics Compendium. Accessed online July 13, 2021.

5)    Acute Lymphoblastic Leukemia Version 1.2021. NCCN Guidelines.

6)    Pediatric Acute Lymphoblastic Leukemia Version 2.2021. NCCN Guidelines.

7)    B-Cell Lymphomas Version 4.2021. NCCN Guidelines

Addendum:

 Effective 07/01/2018: Added code J9019 (Injection, asparaginase, 1,000 IU) to policy.

Effective 01/01/2022: Updated to include Rylaze (J9021), updated criteria for ALL, and added coverage criteria for lymphoblastic lymphoma.