BlueCross BlueShield of Tennessee Medical Policy Manual

Pralatrexate

NDC CODE(S)

48818-0001-XX - Folotyn 20mg/ml solution for injection (Allos Therapeutics)

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

30 mg/m² weekly x 6 doses in 7 week cycles

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 validate the use of pralatrexate in the treatment/prevention of any other conditions/diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Pralatrexate. Retrieved November 16, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, November). Pralatrexate. Retrieved November 16, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Pralatrexate. Retrieved November 16, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, May). Center for Drug Evaluation and Research Folotyn® (pralatrexate injection). Retrieved November 16, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/12/2010

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Is the individual 18 years of age or older with a diagnosis of non-Hodgkin lymphoma?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a further diagnosis of adult T-cell leukemia/lymphoma and has failed first line therapy?

If yes, go to question #7

If no, go to question #4

  1. Does the individual have a further diagnosis of Mycosis fungoides (MF)/Sézary syndrome (SS)?

If yes, go to question #7

If no, go to question #5

  1. Does the individual have a further diagnosis of peripheral T-cell lymphoma (PTCL) as second line therapy or later if the disease is relapsed or refractory?

If yes, go to question #7

If no, go to question #6

  1. Does the individual have a further diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorder (CD30+ CTCL) further classified as cutaneous anaplastic large cell lymphoma (Cutaneous ALCL) if used as a single agent?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 80 billable units weekly x 6 doses in a 7-week cycle for dosage of 30 mg/m² weekly x 6 doses in 7 week cycles for an authorization period of 6 months with possible renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 3 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as hematological abnormalities (e.g., neutropenia, anemia, leucopenia, thrombocytopenia, etc.), mucositis, nausea and/or fatigue?

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.