Nelarabine (Arranon®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
The requested drug will be covered with prior authorization when the following criteria are met:
· The patient has a diagnosis of T-cell acute lymphoblastic leukemia (T-ALL)
AND
o This is an initial request for therapy
AND
§ The patient is at least one year of age
AND
§ The patient has relapsed or refractory disease
AND
§ The patient failed at least two prior chemotherapy regimens
OR
o The patient is already receiving treatment with the requested medication
AND
§ The patient has experienced disease stabilization or improvement
AND
§ The patient has NOT experienced unacceptable toxicity from treatment with the requested medication
OR
· The patient has a diagnosis of T-cell lymphoblastic lymphoma (T-LBL)
AND
o This is an initial request for therapy
AND
§ The patient is at least one year of age
AND
§ The patient has relapsed or refractory disease
AND
§ The patient failed at least two prior chemotherapy regimens
OR
o The patient is already receiving treatment with the requested medication
AND
§ The patient has experienced disease stabilization or improvement
AND
§ The patient has NOT experienced unacceptable toxicity from treatment with the requested medication
LENGTH OF AUTHORIZATION
Approval may be provided for six (6) months and may be renewed
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Arranon [package insert]. East Hanover, NJ; Novartis Pharmaceuticals; July 2019. Accessed July 2023.
2. Nelarabine. In: Clinical Pharmacology. Tampa (FL): Elsevier. Revised May 2023. Accessed July 2023
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 1/1/2024
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.