BlueCross BlueShield of Tennessee Medical Policy Manual

Pralatrexate (Folotyn®)

NDC CODE(S)

48818-0001-XX Folotyn 20 MG/ML SOLN (SPECTRUM PHARMACEUTICALS)

DESCRIPTION

Pralatrexate is folate analog metabolic inhibitor or antimetabolite with antineoplastic properties.  It competitively inhibits dihydrofolate reductase and other enzymes causing depletion of thymidine and inhibiting the synthesis of other biological molecules leading to cell death.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

Adult T-Cell Leukemia/Lymphoma

Mycosis Fungoides/Sezary Syndrome

Hepatosplenic Gamma-Delta T-Cell Lymphoma

Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)

Extranodal NK/T-Cell Lymphoma

Peripheral T-Cell Lymphoma (PTCL)

Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

Primary Cutaneous T-cell lymphoma

30 mg/m² intravenously once weekly x 6 doses in 7 week cycles until progressive disease or unacceptable toxicity.

All Other Indications

15 mg/m² intravenously once weekly x 3 doses in 4 week cycles until progressive disease or unacceptable toxicity.

-OR

30 mg/m² intravenously once weekly x 6 doses in 7 week cycles until progressive disease or unacceptable toxicity.

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed

DOSING LIMITS

Max Units (per dose and over time) [HCPC Unit]:

All indications

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.

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, the express terms of the health plan will govern.

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).

SOURCES

1.     Folotyn [package insert]. East Windsor, NJ; Acrotech Biopharma LLC, September 2020. Accessed December 2020.

2.     Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) pralatrexate. National Comprehensive Cancer Network, 2020. 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 December 2020.

3.     O'Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. doi:10.1200/JCO.2010.29.9024. Epub 2011 Jan 18.

4.     Foss F, Horwitz SM, Coiffier B, et al. Pralatrexate is an effective treatment for relapsed or refractory transformed mycosis fungoides: a subgroup efficacy analysis from the PROPEL study. Clin Lymphoma Myeloma Leuk. 2012 Aug;12(4):238-43. doi: 10.1016/j.clml.2012.01.010. Epub 2012 Apr 26.

5.     Horwitz SM, Kim YH, Foss F, et al. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. doi: 10.1182/blood-2011-11-390211. Epub 2012 Mar 6.

6.     Lunning MA, Gonsky J, Ruan J, et al. Pralatrexate in Relapsed/Refractory HTLV-1 Associated Adult T-Cell Lymphoma/Leukemia: A New York City Multi-Institutional Experience. Blood 120(21):2735-2735. November 2012.

7.     Talpur R, Thompson A, Gangar P et al. Pralatrexate alone or in combination with bexarotene: long-term tolerability in relapsed/refractory mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2014 Aug;14(4):297-304. doi: 10.1016/j.clml.2014.01.010. Epub 2014 Feb 4.

8.     Lexi-Comp Online. (2020, March). AHFS DI. Pralatrexate. Retrieved December 29, 2020 from Lexi-Comp Online with AHFS.

9.     MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, November). Pralatrexate. Retrieved December 29, 2020 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE:  6/12/2010

MOST RECENT REVIEW DATE:   6/2/2021

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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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