Pralatrexate
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.
An example of a preparation of pralatrexate is Folotyn®.
REFER TO DECISION SUPPORT TREE
POLICY
Pralatrexate for the treatment of peripheral T-cell lymphoma (PTCL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pralatrexate for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Pralatrexate for the treatment of peripheral T-cell lymphoma (PTCL) is considered medically appropriate if ANY ONE of the following criteria are met:
Disease is relapsed
Disease is refractory
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of pralatrexate for the treatment of other conditions/diseases.
Peripheral T-cell lymphomas are considered within this policy as classified per the World Health Organization Classification of the Tumors of the Hematopoietic and Lymphoid Tissues.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Pralatrexate. Retrieved June 15, 2011 from Lexi-Comp Online with AHFS.
Macon, W. R. (2009). Peripheral T-cell lymphomas. Hematology/Oncology Clinics of North America, 23(4). W. B. Saunders Company.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010, December). Pralatrexate. Retrieved June 15, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Pralatrexate. Retrieved June 15, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2011, January). Center for Drug Evaluation and Research. Folotyn® (pralatrexate injection). Retrieved June 15, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 8/2/2011
ID_BT
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.
Pharmaceutical Decision Support Tree
Pralatrexate (Folotyn®)
Does the individual have a diagnosis of peripheral T-cell lymphoma (PTCL) that is relapsed or refractory?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.