BlueCross BlueShield of Tennessee Medical Policy Manual

Pralatrexate

NDC CODE(S)

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

 

48818-0001-XX Folotyn 40 MG/2ML 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

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

30 mg/m² 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.

Click here to view DOSAGE LIMITS

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).

No controlled studies were found in the published literature that validates the use of pralatrexate in the treatment/prevention of any other conditions/diseases.

SOURCES

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:  4/10/2018

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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.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit 

INDICATION(S)

BILLABLE UNIT

MAXIMUM UNITS

All indications

1 billable unit = 1 mg

80 billable units weekly x 6 doses in a 7-week cycle