BlueCross BlueShield of Tennessee Medical Policy Manual

Romidepsin

NDC CODE(S)

00069-0983-XX Romidepsin 10 MG SOLR (PFIZER U.S.)

00703-3125-XX Romidepsin 10 MG SOLR (TEVA PARENTERAL MEDICINES)

59572-0984-XX Istodax (Overfill) 10 MG SOLR (CELGENE CORP)

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.

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

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

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).

SOURCES

Lexi-Comp Online. (2019, February). AHFS DI. Romidepsin. Retrieved March 4, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, December). Romidepsin. Retrieved March 4, 2019 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Romidepsin. Retrieved March 4, 2019 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 March 4, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf.

ORIGINAL EFFECTIVE DATE: 6/12/2010

MOST RECENT REVIEW DATE:  6/30/2019

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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; 1 billable unit = 1mg

DIAGNOSIS

MAXIMUM UNITS

All indications

40 billable units on days 1, 8, and 15 of a 28-day cycle