Oncologic Indications for Histone deacetylase (HDAC) inhibitors

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020
Last Reviewed: January 22, 2020

Description

Histone deacetylase (HDAC) inhibitors are a group of agents that inhibit the histone deacetylase enzymes.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Food and Drug Administration (FDA) Indications:

Belinostat (Beleodaq®) may be considered medically necessary for the following condition:

  • Non-Hodgkin’s Lymphoma (NHL)- Adult T-cell Lymphomas as:
    • Treatment of relapsed or refractory peripheral T-cell

National Comprehensive Cancer Network (NCCN) Indications:

Belinostat (Beleodaq) may be considered medically necessary for ANY ONE of the following conditions:

  • NHL - Adult T-Cell Leukemia/Lymphoma as:
    • Second-line therapy (with treatment intent to proceed to high-dose therapy/allogeneic stem cell rescue[HDT/ASCR]) as a single agent for nonresponders to first-line therapy for acute disease or lymphoma or as subsequent therapy after HDT/ASCR; or
  • NHL - Mycosis Fungoides (MF)/Sezary Syndrome (SS) as:
    • A single-agent therapy for tumors with aggressive growth rate for:
      • Stage IB-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB with generalized tumor lesions, with or without skin-directed therapy; or
      • Stage IV non-Sezary or visceral disease; or
    • Systemic therapy as treatment for:
      • Stage IIB MF with:
      • Limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapy; or
      • Generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapies; or
      • Stage IV non-Sezary or visceral disease that is relapsed or persistent, with or without radiation therapy for local control; or
  • NHL - Peripheral T-Cell Lymphoma as:
    • Preferred* second-line or subsequent therapy as a single agent for relapsed or refractory:
      • Angioimmunoblastic T-cell lymphoma; or
      • Peripheral T-cell lymphoma not otherwise specified; or
      • Enteropathy-associated T-cell lymphoma; or
      • Monomorphic epitheliotropic intestinal T-cell lymphoma; or
      • Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype; or
      • Follicular T-cell lymphoma
    • Second-line or subsequent therapy as a single agent for relapsed or refractory anaplastic large cell lymphoma; or
  • NHL - Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders as:
    • A single-agent therapy for relapsed or refractory disease when used for:
      • Primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions; or
      • Cutaneous ALCL with regional nodes (excludes systemic ALCL).

The use of belinostat (Beleodaq) for all other indications is considered experimental/investigational, and therefore, not covered. Peer reviewed literature does not support the use of belinostat (Beleodaq) for any indications other than those listed in this medical policy.

Procedure Code

J9032

FDA Indications:

Romidepsin (Istodax®) may be considered medically necessary for ANY ONE of the following conditions:

  • NHL- Cutaneous T-Cell Lymphomas as:
    • Treatment of cutaneous T-cell lymphoma in individuals who have received at least one prior systemic therapy; or
  • NHL- Peripheral T-Cell Lymphomas as:
    • Treatment of peripheral T-cell lymphoma in individuals who have received at least one prior

NCCN Indications:

Romidepsin (Istodax) may be considered medically necessary for ANY ONE of the following conditions:

  • NHL - MF/ SS as:
    • Systemic therapy as primary treatment for:
      • Stage IA MF with blood B1 involvement, with or without skin-directed therapy; or
      • Stage IB-IIA MF with blood B1 involvement, with or without skin-directed therapy; or
      • Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without:
        • Local radiation therapy for limited tumor lesions; or
        • Skin-directed therapy for generalized tumor lesions; or
      • Stage IIB MF with:
        • Limited tumor lesions, with or without local radiation therapy; or
        • Generalized tumor lesions, with or without skin-directed therapy; or
      • Stage III MF with blood B1 involvement, with or without skin-directed therapy; or
      • Stage IV non-Sezary or visceral disease, with or without radiation therapy for local control; or
      • Stage IV Sezary syndrome; or
    • Systemic therapy as treatment for:
      • Stage IA MF with blood B1 involvement refractory to multiple previous therapies or progression to greater than stage IA on skin-directed therapies, with or without skin-directed therapies; or
      • Stage IA MF refractory to multiple previous therapies or progression to greater than stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without:
        • Local radiation for limited tumor lesions; or
        • Skin-directed therapy for generalized tumor lesions; or
      • Stage IB-IIA MF refractory to multiple previous therapies or progressions to greater than Stage IB-IIA; or
      • Stage IIB MF with limited tumor lesions that is:
        • Relapsed with T3 limited extent disease or has persistent T3 limited extent disease, with or without local radiation therapy; or
        • Refractory to multiple previous therapies or progression, with or without skin-directed therapy; or
      • Stage IB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapy; or
      • Stage III MF with blood B1 involvement that is relapsed or persistent, with or without skin-directed therapy; or
      • Stage IV Sezary syndrome that is relapsed or persistent; or
      • Stage IV non Sezary or visceral disease that is relapsed or persistent, with or without radiation therapy for local control; or
    • NHL - Peripheral T-Cell Lymphoma as:
      • Preferred* second-line or subsequent therapy as a single agent for relapsed or refractory:
        • Angioimmunoblastic T-cell lymphoma; or
        • Peripheral T-cell lymphoma not otherwise specified; or
        • Enteropathy-associated T-cell lymphoma; or
        • Monomorphic epitheliotropic intestinal T-cell lymphoma; or
        • Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype; or
        • Follicular T-cell lymphoma
      • Second-line or subsequent therapy as a single agent for relapsed or refractory anaplastic large cell lymphoma (ALCL); or
    • NHL - Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders as:
      • Single-agent therapy for relapsed or refractory primary cutaneous ALCL with multifocal lesions; or
      • Single-agent therapy for relapsed or refractory cutaneous ALCL with regional nodes (excludes systemic ALCL).

The use of romidepsin (Istodax) for all other indications is considered experimental/investigational, and therefore, not covered. Peer reviewed literature does not support the use of romidepsin (Istodax) for any indications other than those listed in this medical policy.

Procedure Code

J9315

Note: Product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

*Note: Language derived from NCCN guidelines

Diagnosis Codes

Covered diagnosis codes for J9032

C84.00 C84.01 C84.02 C84.03 C84.04 C84.05 C84.06
C84.07 C84.08 C84.09 C84.10 C84.11 C84.12 C84.13
C84.14 C84.15 C84.16 C84.17 C84.18 C84.19 C84.40
C84.41 C84.42 C84.43 C84.44 C84.45 C84.46 C84.47
C84.48 C84.49 C84.60 C84.61 C84.62 C84.63 C84.64
C84.65 C84.66 C84.67 C84.68 C84.69 C84.70 C84.71
C84.72 C84.73 C84.74 C84.75 C84.76 C84.77 C84.78
C84.79 C84.A0 C84.A1 C84.A2 C84.A3 C84.A4 C84.A5
C84.A6 C84.A7 C84.A8 C84.A9 C86.2 C86.5 C86.6
C91.50 C91.51 C91.52 Z85.72

Covered Diagnosis codes for J9315

C84.00 C84.01 C84.02 C84.03 C84.04 C84.05 C84.06
C84.07 C84.08 C84.09 C84.10 C84.11 C84.12 C84.13
C84.14 C84.15 C84.16 C84.17 C84.18 C84.19 C84.40
C84.41 C84.42 C84.43 C84.44 C84.45 C84.46 C84.47
C84.48 C84.49 C84.60 C84.61 C84.62 C84.63 C84.64
C84.65 C84.66 C84.67 C84.68 C84.69 C84.70 C84.71
C84.72 C84.73 C84.74 C84.75 C84.76 C84.77 C84.78
C84.79 C84.A0 C84.A1 C84.A2 C84.A3 C84.A4 C84.A5
C84.A6 C84.A7 C84.A8 C84.A9 C86.2 C86.5 C86.6
Z85.72

 

Professional Statements and Societal Positions Guidelines

NA

ND Committee Review

Internal Medical Policy Committee 1-22-2020 annual review, no clinical changes, Belinostat (Beleodaq) - J9032, Romidepsin (Istodax) - will require pre-certification as of 2/1/2020

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.