Pralatrexate (Folotyn®)
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
Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
B. Compendial Uses
1. Adult T-cell leukemia/lymphoma (ATLL)
2. Mycosis fungoides/Sezary syndrome (MF/SS)
3. Cutaneous anaplastic large cell lymphoma (ALCL)
4. Extranodal NK/T-cell lymphoma
5. Hepatosplenic T-cell lymphoma
6. Anaplastic large cell lymphoma
7. Peripheral T-cell lymphoma not otherwise specified
8. Angioimmunoblastic T-cell lymphoma
9. Enteropathy associated T-cell lymphoma
10. Monomorphic epitheliotropic intestinal T-cell lymphoma
11. Nodal peripheral T-cell lymphoma with TFH phenotype
12. Follicular T-cell lymphoma
13. Breast implant associated anaplastic large cell lymphoma (ALCL)
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Peripheral T-cell lymphoma (PTCL)
Authorization of 12 months may be granted for treatment of PTCL (including the following subtypes: anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, or follicular T-cell lymphoma) when both of the following criteria are met:
1. The requested medication will be used as a single agent.
2. The requested medication will be used to treat relapsed or refractory disease or for initial palliative therapy.
B. Adult T-cell leukemia/lymphoma (ATLL)
Authorization of 12 months may be granted for treatment of ATLL when both of the following criteria are met:
1. The requested medication is used as a single agent.
2. The requested medication is used as subsequent therapy.
C. Mycosis fungoides/Sezary syndrome (MF/SS)
Authorization of 12 months may be granted for treatment of MF or SS.
D. Cutaneous anaplastic large cell lymphoma
Authorization of 12 months may be granted for treatment of cutaneous anaplastic large cell lymphoma (ALCL) when the requested medication is used as a single agent.
E. Extranodal NK/T-cell lymphoma
Authorization of 12 months may be granted for treatment of extranodal NK/T-cell lymphoma when all of the following criteria are met:
1. The requested medication will be used as a single agent.
2. The member has relapsed or refractory disease.
3. The member has had an inadequate response or contraindication to asparaginase-based therapy (e.g., pegaspargase).
F. Hepatosplenic T-cell lymphoma
Authorization of 12 months may be granted for treatment of hepatosplenic T-cell lymphoma when both of the following criteria are met:
1. The requested medication will be used as a single agent.
2. The member has had two or more previous lines of chemotherapy.
G. Breast implant-associated anaplastic large cell lymphoma (ALCL)
Authorization of 12 months may be granted for treatment of breast implant associated ALCL when both of the following criteria are met:
1. The requested medication will be used as a single agent.
2. The requested medication will be used as subsequent therapy.
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).
REFERENCE
1. Folotyn [package insert]. East Windsor, NJ: Acrotech Biopharma LLC; September 2020.
2. Pralatrexate [package insert]. Lake Zurich, IL: Fresenius Kabi; September 2022.
3. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 5, 2023.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 5/14/2024
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.
This document has been classified as public information.