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Folotyn® (pralatrexate)
Policy Number: VP-0216
Intravenous
Last Review Date: 01/05/2023
Date of Origin: 07/29/2014
Dates Reviewed: 07/2014, 07/2015, 07/2016, 01/2017, 01/2018, 01/2019, 01/2020, 01/2021, 01/2022, 01/2023
Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC unit]:
- Folotyn 20 mg/mL solution for injection, single-dose vial: 24 vials every 49 days
- Folotyn 40 mg/2 mL solution for injection, single-dose vial: 12 vials every 49 days
- Max Units (per dose and over time) [HCPCS Unit]:
All indications
- 80 billable units weekly x 6 doses in a 7-week cycle
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Adult T-Cell Leukemia/Lymphoma ‡ 2
- Used as subsequent therapy as a single agent in patients who did not respond to first-line therapy for acute or lymphoma subtypes
Mycosis Fungoides/Sezary Syndrome ‡ 2
- Patient does NOT have stage IA or IB-IIA mycosis fungoides
Hepatosplenic Gamma-Delta T-Cell Lymphoma ‡ 2
- Used as a single agent as subsequent therapy; AND
- Used for disease that is refractory to two previous first-line therapy regimens
Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL) ‡ 2
- Used as subsequent therapy; AND
- Used as single agent therapy for relapsed or refractory disease
Extranodal NK/T-Cell Lymphoma ‡ 2
- Used as single agent therapy for relapsed or refractory disease; AND
- Used as subsequent treatment following additional therapy with an alternate asparaginase-based combination chemotherapy regimen that was not previously used
Peripheral T-Cell Lymphoma (PTCL) † Ф 1,2
- Used as a single agent for relapsed or refractory disease; AND
- Patient has one of the following PTCL sub-types:
- 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
- Follicular T-Cell lymphoma
Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders ‡ 2
- Used as a single agent as primary treatment or for relapsed or refractory disease; AND
-
- Patient has primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions; OR
- Patient has cutaneous ALCL with regional node (N1) (NOTE: excludes systemic ALCL)
-
† FDA Approved Indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage can be renewed based upon the following criteria:
- Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; 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: myelosuppression suppression (e.g., neutropenia, anemia, and/or thrombocytopenia), mucositis, severe dermatologic reactions, tumor lysis syndrome (TLS), increased risk of toxicity (e.g., toxic epidermal necrolysis, mucositis, etc.) in patients with severe renal impairment, hepatic toxicity, etc.
- Dosage/Administration 1,4-7
Indication
Dose
Peripheral T-Cell Lymphoma (PTCL)
Administer 30 mg/m² intravenously once weekly x 6 doses in 7 week cycles until progressive disease or unacceptable toxicity.
All Other Indications
Administer 15 mg/m² intravenously once weekly x 3 doses in 4 week cycles until progressive disease or unacceptable toxicity.
-OR-
Administer 30 mg/m² intravenously once weekly x 6 doses in 7 week cycles until progressive disease or unacceptable toxicity.
- Billing Code/Availability Information
HCPCS Code:
- J9307: injection, pralatrexate, 1 mg; 1 billable unit = 1 mg
NDC:
- Folotyn 20 mg/mL solution for injection, single-dose vial: 72893-0003-xx
- Folotyn 40 mg/2 mL solution for injection, single-dose vial: 72893-0005-xx
- References
- Folotyn [package insert]. East Windsor, NJ; Acrotech Biopharma LLC, September 2020. Accessed December 2022.
- Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) pralatrexate. National Comprehensive Cancer Network, 2022. 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 2022.
- 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.
- 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.
- 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.
- 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.
- 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.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C84.00 |
Mycosis fungoides, unspecified site |
C84.01 |
Mycosis fungoides, lymph nodes of head, face, and neck |
C84.02 |
Mycosis fungoides, intrathoracic lymph nodes |
C84.03 |
Mycosis fungoides, intra-abdominal lymph nodes |
C84.04 |
Mycosis fungoides, lymph nodes of axilla and upper limb |
C84.05 |
Mycosis fungoides, lymph nodes of inguinal region and lower limb |
C84.06 |
Mycosis fungoides, intrapelvic lymph nodes |
C84.07 |
Mycosis fungoides, spleen |
C84.08 |
Mycosis fungoides, lymph nodes of multiple sites |
C84.09 |
Mycosis fungoides, extranodal and solid organ sites |
C84.10 |
Sézary disease, unspecified site |
C84.11 |
Sézary disease, lymph nodes of head, face, and neck |
C84.12 |
Sézary disease, intrathoracic lymph nodes |
C84.13 |
Sézary disease, intra-abdominal lymph nodes |
C84.14 |
Sézary disease, lymph nodes of axilla and upper limb |
C84.15 |
Sézary disease, lymph nodes of inguinal region and lower limb |
C84.16 |
Sézary disease, intrapelvic lymph nodes |
C84.17 |
Sézary disease, spleen |
C84.18 |
Sézary disease, lymph nodes of multiple sites |
C84.19 |
Sézary disease, extranodal and solid organ sites |
C84.40 |
Peripheral T-cell lymphoma, not classified, unspecified site |
C84.41 |
Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck |
C84.42 |
Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes |
C84.43 |
Peripheral T-cell lymphoma, not classified, intra-abdominal lymph nodes |
C84.44 |
Peripheral T-cell lymphoma, not classified, lymph nodes of axilla and upper limb |
C84.45 |
Peripheral T-cell lymphoma, not classified, lymph nodes of inguinal region and lower limb |
C84.46 |
Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes |
C84.47 |
Peripheral T-cell lymphoma, not classified, spleen |
C84.48 |
Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites |
C84.49 |
Peripheral T-cell lymphoma, not classified, extranodal and solid organ sites |
C84.60 |
Anaplastic large cell lymphoma, ALK-positive, unspecified site |
C84.61 |
Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck |
C84.62 |
Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes |
C84.63 |
Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes |
C84.64 |
Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb |
C84.65 |
Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb |
C84.66 |
Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes |
C84.67 |
Anaplastic large cell lymphoma, ALK-positive, spleen |
C84.68 |
Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites |
C84.69 |
Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites |
C84.7A |
Anaplastic large cell lymphoma, ALK-negative, breast |
C84.70 |
Anaplastic large cell lymphoma, ALK-negative, unspecified site |
C84.71 |
Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck |
C84.72 |
Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes |
C84.73 |
Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes |
C84.74 |
Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb |
C84.75 |
Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb |
C84.76 |
Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes |
C84.77 |
Anaplastic large cell lymphoma, ALK-negative, spleen |
C84.78 |
Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites |
C84.79 |
Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites |
C84.90 |
Mature T/NK-cell lymphomas, unspecified, unspecified site |
C84.91 |
Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face and neck |
C84.92 |
Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes |
C84.93 |
Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes |
C84.94 |
Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb |
C84.95 |
Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb |
C84.96 |
Mature, T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes |
C84.97 |
Mature T/NK-cell lymphomas, unspecified, spleen |
C84.98 |
Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites |
C84.99 |
Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites |
C84.Z0 |
Other mature T/NK-cell lymphomas, unspecified site |
C84.Z1 |
Other mature T/NK-cell lymphomas, lymph nodes of head, face and neck |
C84.Z2 |
Other mature T/NK-cell lymphomas, intrathoracic lymph nodes |
C84.Z3 |
Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes |
C84.Z4 |
Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb |
C84.Z5 |
Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb |
C84.Z6 |
Other mature T/NK-cell lymphomas, intrapelvic lymph nodes |
C84.Z7 |
Other mature T/NK-cell lymphomas, spleen |
C84.Z8 |
Other mature T/NK-cell lymphomas, lymph nodes of multiple sites |
C84.Z9 |
Other mature T/NK-cell lymphomas, extranodal and solid organ sites |
C86.0 |
Extranodal NK/T-cell lymphoma nasal type |
C86.1 |
Hepatosplenic T-cell lymphoma |
C86.2 |
Enteropathy-type (intestinal) T-cell lymphoma |
C86.5 |
Angioimmunoblastic T-cell lymphoma |
C86.6 |
Primary cutaneous CD30-positive T-cell proliferations |
C91.50 |
Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission |
C91.52 |
Adult T-cell lymphoma/leukemia (HTLV-1-associated) , in remission |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Article (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/Article): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto Government Benefit Administrators, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |