Pegaspargase (Oncaspar®)
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
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
Acute lymphoblastic leukemia (ALL):
1. Oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of pediatric and adult patients with ALL.
2. Oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
B. Compendial Uses
1. Extranodal natural killer/T-cell lymphoma (ENKL)
2. Aggressive NK-cell leukemia (ANKL)
3. Lymphoblastic lymphoma (managed in the same manner as ALL)
4. Acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapeutic regimen
5. Pediatric acute lymphoblastic leukemia (ALL) as a component of a multi-agent chemotherapeutic regimen
6. Hepatosplenic T-cell lymphoma
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Authorization of 12 months may be granted for the treatment of ALL or LL when the requested medication is used in conjunction with multi-agent chemotherapy
B. Extranodal Natural Killer/T-cell Lymphoma (ENKL) / Aggressive NK-cell Leukemia (ANKL)
Authorization of 12 months may be granted for the treatment of ENKL or ANKL when the requested medication is used in conjunction with multi-agent chemotherapy.
C. Hepatosplenic T-cell Lymphoma
Authorization of 12 months may be granted for the treatment of hepatosplenic T-cell lymphoma as subsequent therapy when the requested medication is used in conjunction with multi-agent chemotherapy.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
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. Oncaspar [package insert]. Boston, MA: Servier Pharmaceuticals LLC; December 2022.
2. The NCCN Drugs & Biologics Compendium® ©2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 31, 2023.
ORIGINAL EFFECTIVE DATE: 5/31/2019
MOST RECENT REVIEW DATE: 4/30/2024
ID_CHS
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.
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