59572-0984-XX ISTODAX 10MG Solution Reconstituted (CELGENE CORP)
00703-4004-XX ROMIDEPSIN 5MG/ML Solution (TEVA PARENTERAL MEDICINES)
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 of Lymphoma further classified as ANY ONE of the following:
Peripheral T-cell lymphoma (PTCL) (Non-Cutaneous) further diagnosed as ANY ONE of the following as a single agent for relapsed/refractory disease as second-line therapy OR used as initial and subsequent palliative intent therapy:
Anaplastic large cell lymphoma
Peripheral T-cell lymphoma not otherwise specified
Angioimmunoblastic T-cell lymphoma
Enteropathy-associated T-cell lymphoma
Monomorphic epitheliotropic intestinal T-cell lymphoma
Nodal peripheral T-cell lymphoma with TFH phenotype
Follicular T-cell lymphoma
Extranodal NK/T-Cell Lymphoma (nasal type)
Hepatosplenic Gamma-Delta T-Cell Lymphoma
Primary Cutaneous Lymphoma further diagnosed as ANY ONE of the following:
Mycosis Fungoides/Sézary Syndrome if not stage IA with B1 blood involvement, used as primary treatment OR for relapsed, refractory or persistent disease
Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorder further diagnosed as Primary Cutaneous Anaplastic Large Cell Lymphoma as a single agent for relapsed/refractory disease
Romidepsin is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria, not including prerequisite therapy
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, lymphopenia, anemia, leucopenia, thrombocytopenia, etc.), severe infections, severe tumor lysis syndrome, and ECG T-wave and/or ST-segment changes
DOSAGE & ADMINISTRATION
Recommended dose is 14 mg/m² on days 1, 8, and 15 of a 28-day cycle. Repeat cycles until disease progression or intolerable toxicity.
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. (2020). AHFS DI. Romidepsin. Retrieved September 11, 2020 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, September). Romidepsin. Retrieved September 11, 2020 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2020). NCCN Drugs & Biologics Compendium®. Romidepsin. Retrieved September 11, 2020 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Istodax® (romidepsin for injection). Retrieved September 11, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022393s015lbl.pdf.
U. S. Food and Drug Administration. (2020, March). Center for Drug Evaluation and Research. ROMIDEPSIN injection, for intravenous use. Retrieved September 11, 2020 from
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 12/31/2020
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1mg