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)
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.
Romidepsin for the treatment of T-cell lymphoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Romidepsin for the treatment of other conditions/diseases is considered investigational.
Romidepsin is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis is T-cell lymphoma further classified as ANY ONE of the following:
Cutaneous T-cell lymphoma (CTCL) as single agent therapy if failed prior systemic therapy
Mycosis Fungoides (MF)/ Sézary Syndrome if ALL of the following:
As systemic therapy with or without skin-directed or radiation therapy
Individual does NOT have refractory stage IA with blood B1 involvement
Peripheral T-cell lymphoma (PTCL) as a single agent if failed previous therapy, second-line and subsequent for relapsed/refractory disease
Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders if ALL of the following:
Used as a single agent
Individual has ANY ONE of the following:
Relapsed or refractory Cutaneous Anaplastic Large Cell Lymphoma (ALCL) with multifocal lesions
Cutaneous ALCL with regional nodes (excludes systemic ALCL)
Extranodal Natural Killer (NK)/T-Cell Lymphoma, nasal type if ALL of the following:
Used as a single agent for relapsed/refractory disease
Following additional therapy with alternate asparaginase-based chemotherapy regimen, not previously used
Hepatosplenic Gamma-Delta T-Cell Lymphoma if ALL of the following:
Refractory disease after two primary treatment regimens
Second-line and subsequent as a single agent
Romidepsin is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent such as hematological abnormalities (e.g., neutropenia, anemia, leucopenia, thrombocytopenia, etc.), severe infections, severe tumor lysis syndrome, and ECG T-wave changes
DOSAGE & ADMINISTRATION
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
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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1mg