Romidepsin
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.
An example of a preparation of romidepsin is Istodax®.
REFER TO DECISION SUPPORT TREE
POLICY
Romidepsin for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Cutaneous T-cell lymphoma (CTCL)
Peripheral T-cell lymphoma (PTCL)
Romidepsin for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Romidepsin for the treatment of ANY ONE of the following is considered medically appropriate if the individual has received at least one prior systemic therapy:
Cutaneous T-cell lymphoma (CTCL)
Peripheral T-cell lymphoma (PTCL)
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of romidepsin for the treatment of other conditions/diseases.
Within this policy cutaneous T-cell lymphomas are considered as classified per the World Health Organization Classification of the Tumors of the Hematopoietic and Lymphoid Tissues. The classification is under peripheral T-cell and NK-cell lymphomas and includes such conditions as mycosis fungoides, Sezary syndrome, primary cutaneous anaplastic large-cell lymphoma, primary cutaneous aggressive epidermotropic CD8 positive cytotoxic T-cell lymphoma, primary cutaneous gamma-delta T-cell lymphoma and primary cutaneous small/medium CD4 positive T-cell lymphoma.
SOURCES
Lexi-Comp Online. (2011, May). AHFS DI. Romidepsin. Retrieved June 15, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2010, December). Romidepsin. Retrieved June 15, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Romidepsin. Retrieved June 15, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2011, May). Center for Drug Evaluation and Research. Istodax® (romidepsin for injection). Retrieved June 20, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 7/9/2011
ID_BT
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®)
Does the individual have a diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) and has received at least one prior systemic therapy?
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.