Coverage Policies

Use the index below to search for coverage information on specific medical conditions.

QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.

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Medical Providers: Payment for care or services is based on eligibility, medical necessity and available benefits at time of service and is subject to all contractual exclusions and limitations, including pre-existing conditions if applicable.

Future eligibility cannot be guaranteed and should be rechecked at time of service. Verify benefits by signing into My Account or calling Customer Service at 800.235.7111 or 501.228.7111.

QualChoice follows care guidelines published by MCG Health.

INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 05/01/2012 Title: Erwinia Asparaginase (Erwinaze, Rylaze)
Revision Date: 01/01/2022 Document: BI359:00
CPT Code(s): J9019, J9021
Public Statement

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.


Medical Statement

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


Reference

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.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.