When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
American Hospital Formulary Service (AHFS). Pralatrexate. [LexiComp Web site]. 12/01/2010. Available at: http://online.lexi.com/lco/action/eula/show# [via subscription only]. Accessed March 27, 2019.
Elsevier's Clinical Pharmacology Compendium. Pralatrexate. [ClinicalKey Web site. 03/30/2017. Available at: https://www.clinicalkey.com/#!/content/drug_monograph/6-s2.0-3684 [via subscription only]. Accessed March 27, 2019.
Folotyn® (pralatrexate). [prescribing information] Westminster, CO: Spectrum Pharmaceuticals, Inc. November 2016. Available at: http://folotyn.com/HCP/Default.aspx. Accessed March 27, 2019.
Horwitz SM, Olsen EA, Duvic M, et al. Review of the treatment of mycosis fungoides and Sezary syndrome: a stage-based approach. JNCCN.2008;6(4):436-442.
Leukemia and Lymphoma Society. Peripheral T-Cell Lymphoma Facts. July 2014. Available at: https://www.lls.org/sites/default/files/file_assets/peripheraltcelllymphomafacts.pdf . Accessed March 28, 2019.
Lexi-Drugs Compendium. Pralatrexate. [Lexicomp Online Web site]. 01/24/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 27, 2019.
Lymphoma research foundation. T-Cell Lymphoma. 2019. Available at: https://www.lymphoma.org/aboutlymphoma/nhl/tcell/ . Accessed March 27, 2019.
National Institutes of Health. National Caner Institute. The Revised European American Lymphoma Classification (REAL). Available at: https://training.seer.cancer.gov/lymphoma/abstract-code-stage/morphology/real.html . Accessed March 27, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Primary Cutaneous Lymphomas. V2.2019. 12/17/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf . Accessed March 27, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. T-Cell Lymphomas. V2.2019. 12/17/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed March 27, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Drug and Biologics Compendium. Pralatrexate. [National Comprehensive Cancer Network Web site]. Subscription required. Available at: https://www.nccn.org/professionals/drug_compendium/content/. Accessed March 27, 2019.
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;29(9):1182-1189.
Olsen E, Vonderheid E, Pimpinelli N. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ICSL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood.2007;110(6):1713-1722.
Rodriguez J, Gutierrez A, Maritnez-Delgado B. Current and future aggressive peripheral T-cell lymphoma treatment paradigms, biological features and therapeutic molecular targets. Crit Rev Oncol/Hematol. 2009;71:181-198.
Truven Health Analytics Inc. Micromedex® 2.0 Healthcare Series. DrugDex®. Pralatrexate. [Micromedex Web site]. 02/28/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 27, 2019.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA.Drug Details: pralatrexate (Folotyn®) [FDA Web site]. 05/2016. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed March 27, 2019.
Policy: 08.00.15e:Off-label Coverage for Prescription Drugs and/or Biologics