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Clinical Policy Bulletin:
Romidepsin (Istodax)
Number: 0865


Policy

Aetna considers romidepsin (Istodax) medically necessary for the following indications:

  1. Adult T-cell lymphoma; or
  2. Cutaneous T-cell lymphoma (CTCL) in persons who have received at least one prior systemic therapy; or
  3. Mycosis fungoides/ Sezary syndrome; or
  4. Relapsed or refractory peripheral T-cell lymphomas (PTCL) (includes angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma).

Aetna considers romidepsin experimental and investigational for all other indications.

Selection criteria are presented in the background section.



Background

Istodax was approved by the FDA for treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy.

Guidelines from the National Comprehensive Cancer Network (2013) recommend Istodax for the following indications:

  • Adult T-cell lymphoma - Therapy for nonresponders to first-line therapy for acute disease or lymphoma [2A]
  • Mycosis fungoides/ Sezary syndrome - Systemic biologic therapy as a

    • single agent or in combination with skin-directed therapy for stage I-IIA and stage III MF with blood involvement
    • single agent or in combination with skin-directed therapies for stage I-IIA MF with histologic evidence of folliculotropic or large cell transformed or stage IIB MF with limited extent tumor disease
    • single agent or in combination with systemic retinoids, interferons, or photopheresis for stage IA-IIB with histologic evidence of folliculotropic or large cell transformed MF, stage IIB MF with generalized extent tumor, transformed, and/or folliculotropic disease, or SS [2A; 2B for stage I-IIA with blood involvement]

  • Mycosis fungoides/ Sezary syndrome - May be used as adjuvant systemic biologic therapy after total skin electron beam therapy for stage IIB MF generalized extent tumor, transformed, and/or folliculotropic disease or after chemotherapy for stage IV non-Sezary or visceral disease [2A]
  • Mycosis fungoides/ Sezary syndrome - Systemic biologic therapy for refractory or progressive stage IA-IIA or stage IIB (patch or plaque) MF [2A]
  • Peripheral T-Cell Lymphoma - Second-line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma [2A]
 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96401 - 96549
HCPCS codes covered if selection criteria are met:
J9315 Injection, romidepsin, 1 mg
ICD-9 codes covered if selection criteria are met:
202.10 - 202.18 Mycosis fungoides
202.20 - 202.28 Sezary’s disease
202.70 - 202.78 Peripheral T-cell lymphoma
204.80 - 204.82 Other lymphoid leukemia [adult T-cell lymphoma]


The above policy is based on the following references:
  1. Istodax [package insert]. Cambridge, MA: Gloustester Pharmaceuticals; September 2011.
  2. Istodax, NCCN Drugs and Biologics Compendium, (http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=352), accessed 4/18/2012
  3. McEvoy GK,Romidepsin, AHFS: Drug Information. Bethesda, MD: American Society ofHealth-System Pharmacists; 2012.
  4. Istodax, Clinical Pharmacology Compendium (http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=3689&n=Istodax), accessed 4/18/2012.
  5. Istodax, DrugDex Compendium.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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