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.

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]