BlueCross BlueShield of Tennessee Medical Policy Manual

Romidepsin

NDC CODE(S)

59572-0983-XX - Istodax single-use 10 mg vial (Celgene)

DESCRIPTION

Romidepsin is a histone deacetylase (HDAC) inhibitor.  HDACs function on a genetic level in histones by removing acetyl groups from acetylated lysine residues in histones, resulting in changes in gene expression and affecting genetic transcription.  Romidepsin causes the accumulation of acetylated histones and induces cell cycle arrest and apoptosis of some cancer cell lines, although the complete mechanism of the antineoplastic effect of romidepsin is not fully understood.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All Indications

14 mg/m² on days 1, 8, and 15 of a 28-day cycle

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 romidepsin for the treatment of any other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Romidepsin. Retrieved November 23, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, November). Romidepsin. Retrieved November 23, 2016 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Romidepsin. Retrieved November 23, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Istodax® (romidepsin for injection). Retrieved November 23, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/12/2010

MOST RECENT REVIEW DATE:  2/27/2018

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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.

Pharmaceutical Decision Support Tree

Romidepsin (Istodax®)

  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 adult T-cell leukemia/lymphoma having failed first-line therapy?

If yes, go to question #7

If no, go to question #3

  1. Does the individual have a diagnosis of Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders if ALL of the following?

If yes, go to question #7

If no, go to question #4

  1. Does the individual have a diagnosis of Cutaneous T-cell lymphoma (CTCL) and has failed prior systemic therapy?

If yes, go to question #7

If no, go to question #5

  1. Does the individual have a diagnosis of Mycosis Fungoides (MF)/ Sézary Syndrome?

If yes, go to question #7

If no, go to question #6

  1. Does the individual have a diagnosis of Peripheral T-cell lymphoma (PTCL) and the agent will be used as subsequent therapy?

If yes, go to question #7

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

  1. Is the request for 40 billable units on days 1, 8 and 15 of a 28 day cycle for dosage of 14 mg/m² on days 1, 8, and 15 of a 28-day cycle in an authorization period of six months which may be renewed?

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 initial approval criteria in numbers 2 through 7?

If yes, go to question #9

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

  1. Is there 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 agent such as hematological abnormalities (e.g., neutropenia, anemia, leucopenia, thrombocytopenia, etc.), infections, nausea, fatigue, vomiting, anorexia, and ECG T-wave changes?

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.