48818-0001-XX Folotyn 20 MG/ML SOLN (SPECTRUM PHARMACEUTICALS)
48818-0001-XX Folotyn 40 MG/2ML SOLN (SPECTRUM PHARMACEUTICALS)
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.
Pralatrexate for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Adult T-cell leukemia/lymphoma
Extranodal NK/T-Cell Lymphoma
Hepatosplenic Gamma-Delta T-Cell Lymphoma
Mycosis fungoides (MF)/Sézary syndrome (SS)
Peripheral T-cell lymphoma (PTCL)
Primary cutaneous CD30-positive T-cell lymphoproliferative disorder (CD30+ CTCL)
Pralatrexate for the treatment of other conditions/diseases is considered investigational.
Pralatrexate is considered medically appropriate if ANY ONE of the following:
Individual is 18 years of age or older
Diagnosis of ANY ONE of the following:
Adult T-cell leukemia/lymphoma used as a single agent if individual has failed first line therapy
Extranodal NK/T-Cell Lymphoma if ALL of the following:
Used as single agent therapy for relapsed or refractory disease
Used as subsequent therapy following additional therapy with an alternate asparaginase based combination regimen that was not previously used
Individual has nasal type disease
Hepatosplenic Gamma-Delta T-Cell Lymphoma if ALL of the following:
Used as a single agent subsequent therapy
Used for disease that is refractory to at least two previous primary treatment regimens
Mycosis fungoides (MF)/Sézary syndrome (SS) and individual does NOT have stage IA-IIA disease with B1 blood involvement
Peripheral T-cell lymphoma (PTCL) for ALL of the following:
Used as a single agent if the disease is relapsed or refractory
Individual 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-positive T-cell lymphoproliferative disorder (CD30+ CTCL) used as a single agent therapy for relapsed or refractory disease and ANY ONE of the following:
Individual has primary cutaneous anaplastic large cell lymphoma (ALCL)s with multifocal lesions
Individual has cutaneous ALCL with regional nodes
Pralatrexate is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug such as hematological abnormalities (e.g., neutropenia, anemia, leukopenia, thrombocytopenia, etc.), mucositis, severe dermatologic reactions, tumor lysis syndrome, renal and hepatotoxicity, etc.
DOSAGE & ADMINISTRATION
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.
Refer to DOSAGE LIMITS below
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.
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.
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).
Lexi-Comp Online. (2017). AHFS DI. Pralatrexate. Retrieved January 29, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, October). Pralatrexate. Retrieved January 29, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Pralatrexate. Retrieved January 29, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2016, May). Center for Drug Evaluation and Research Folotyn® (pralatrexate injection). Retrieved January 29, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 5/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit