HCPCS J9261 SUBJECT: Arranon ® (Nelarabine)

Policy: 201944_MRx Initial Effective Date: 01/01/2020 HCPCS J9261 Code(s): Annual Review Date: 01/16/2020

SUBJECT: ® Arranon (nelarabine) Last Revised Date: 01/16/2020

Prior approval is required for some or all procedure codes listed in this Corporate Drug Policy.

OVERVIEW

POLICY STATEMENT This policy involves the use of Arranon. Prior authorization is recommended for medical benefit coverage of Arranon. Approval is recommended for those who meet the conditions of coverage in the Initial Approval and Renewal Criteria, Preferred Drug (when applicable), Dosing/Administration, Length of Authorization, and Site of Care (when applicable) for the diagnosis provided. The requirement that the patient meet the Criteria and Preferred Drug for coverage of the requested medication applies to the initial authorization only. All approvals for initial therapy are provided for the initial approval duration noted below; if reauthorization is allowed, a response to therapy is required for continuation of therapy. The site of care medical necessity criteria applies to initial therapy and reauthorizations under the medical benefit only.

RECOMMENDED AUTHORIZATION CRITERIA Coverage of Arranon is recommended in those who meet the following criteria:

I. Length of Authorization

Coverage is provided for six months and may be renewed.

II. Initial Approval Criteria Coverage is provided in the following conditions: Adult-Young Adult/Adult T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma †

• Patient is 18 years or older (unless otherwise specified); AND o Patient has not responded to or has relapsed following treatment with two or more chemotherapy regimens †; OR

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o Used as induction and/or consolidation therapy as a component of COG AALL0434 regimen (daunorubicin, vincristine, prednisone, and pegaspargase); AND ▪ Patient is 15 years or older; AND ▪ Patient is Philadelphia chromosome-negative; OR o Used for relapsed/refractory disease; AND ▪ Patient is Philadelphia chromosome-negative; AND • Used as a single agent; OR • Used in combination with etoposide and cyclophosphamide in young and fit patients; OR ▪ Patient is Philadelphia chromosome-positive; AND • Patient is refractory to tyrosine kinase inhibitor therapy (e.g., imatinib, dasatinib, ponatinib, nilotinib, bosutinib, etc.) Pediatric Acute Lymphoblastic Leukemia • Patient is 1 year or older; AND o Patient has not responded to or has relapsed following treatment with two or more chemotherapy regimens †; OR o Used as consolidation therapy as a component of COG AALL0434 regimen (daunorubicin, vincristine, prednisone, and pegaspargase); OR o Used for relapsed or refractory disease in combination with etoposide and cyclophosphamide

† FDA-labeled indication(s); ‡ Compendia approved indication(s)

III. Renewal Criteria

Authorization may be renewed based on the following criteria:

• Patient continues to meet criteria in Section II; AND • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: any severe neurologic (central and/or peripheral) adverse reactions, severe anemia/leukopenia/anemia/thrombocytopenia, tumor lysis syndrome, etc.

IV. Dosage/Administration

Indication Dose Adults All 1500 mg/m2 IV on Days 1, 3, & 5 repeated every 21 days indications Pediatrics 650 mg/m2 IV daily for 5 consecutive days repeated every 21 days

V. Billing Code/Availability Information

Jcode: • J9261 – Injection, nelarabine, 50 mg; 1 billable unit = 50 mg

NDC: • Arranon 250 mg/50 mL solution for injection; single-dose vial: 00078-0683-xx

VI. References

1. Arranon [package insert]. East Hanover, NJ; Novartis Pharmaceuticals; July 2019. Accessed November 2019. 2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) nelarabine. National Comprehensive Cancer Network, 2017. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2019. 3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Acute Lymphoblastic Leukemia. Version 2.2019. National Comprehensive Cancer Network, 2019. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2019. 4. Winter SS, Dunsmore KP, Devidas M, et al. Improved Survival for Children and Young Adults With T-Lineage Acute Lymphoblastic Leukemia: Results From the Children's Oncology Group AALL0434 Methotrexate Randomization. J Clin Oncol. 2018 Oct 10;36(29):2926- 2934. doi: 10.1200/JCO.2018.77.7250. Epub 2018 Aug 23. 5. Daniel J. DeAngelo, Daohai Yu, Jeffrey L. Johnson, et al. Nelarabine induces complete remissions in adults with relapsed or refractory T- lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. Blood. 2007 Jun 15; 109(12): 5136–5142.

Documentation Requirements:

The Company reserves the right to request additional documentation as part of its coverage determination process. The Company may deny reimbursement when it has determined that the drug provided or services performed were not medically necessary, investigational or experimental, not within the scope of benefits afforded to the member and/or a pattern of billing or other practice has been found to be either inappropriate or excessive. Additional documentation supporting medical necessity for the services provided must be made available upon request to the Company. Documentation requested may include patient records, test results and/or credentials of the provider ordering or performing a service. The Company also reserves the right to modify, revise, change, apply and interpret this policy at its sole discretion, and the exercise of this discretion shall be final and binding.

Prior approval is required for HCPCS Codes J9261