CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Istodax (romidepsin) — Drug Policy / Coverage Criteria

Defines coverage, utilization management, and clinical criteria for Istodax (romidepsin) use for cancer treatment (including FDA-approved and certain off-label uses) for members whose medication requests are processed by Evolent/Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIstodax (romidepsin) — Drug Policy / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJuly 26, 2024

Next Review Date

Key ActionObtain prior authorization and document FDA labeling or recognized compendia/guideline support for romidepsin requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Jul 26, 2024Effective date

≥1 prior therapyCTCL step

14 mg/m2Dose limit

FDA/CompendiaEvidence required

Coverage Criteria for Istodax (romidepsin)

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Initial and Continuation Coverage Criteria

Covered when ALL of the following are met for continuation or initial CTCL use

Continuation therapy conditions: For continuation requests: (1) the member has not experienced disease progression on the requested medication AND (2) the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND (3) additional medication(s) are not being added to the continuation request.

From continuation criteria

CTCL initial therapy: Treatment of cutaneous T-cell lymphoma (CTCL) in members who have received at least one prior systemic therapy.

From indication section

Requests for Istodax (romidepsin) will be excluded when there is disease progression while the member is taking romidepsin or another histone deacetylase (HDAC) inhibitor (for example, vorinostat). Concurrent administration of romidepsin with other systemic chemotherapy is not permitted; skin-directed therapies or radiation therapy are allowed to be used concurrently. Dosing that exceeds a single dose of 14 mg/m2 is an exclusion. Additionally, use of romidepsin for off-label indications is excluded when the indication lacks sufficient supporting evidence — defined as inadequate representation of the patient or regimen in the published evidence, lack of clinically meaningful outcomes, inappropriate study design, reliance solely on uncontrolled case reports or abstracts, or absence from CMS-recognized compendia or acceptable peer-reviewed literature.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of romidepsin (Istodax). Continuation (re-authorization) requests may be approved if the member has not experienced disease progression while on the requested medication, the medication was used within the last year without a gap of more than 30 days in active authorization, and no additional medications are being added to the continuation request.

Continuation allowed if no disease progression on romidepsin or another HDAC inhibitor
Continuation allowed if used within last 12 months with ≤30-day authorization gap
Continuation allowed only when no additional medications are being added to the request

Step Therapy

Step Requirement for CTCL

For cutaneous T-cell lymphoma (CTCL), coverage is limited to members who have received at least one prior systemic therapy.

Step requirement: ≥1 prior systemic therapy for CTCL is required before approval

Documentation Required

Required Supporting Documentation

Use must be supported by one of the following types of documentation: FDA approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or acceptable peer-reviewed literature that meets CMS standards.

Acceptable evidence: FDA labeling; CMS compendia; NCCN or ASCO guidelines; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards

Denial Risk

Triggers for Denial / Exclusion

Requests will be denied for the following exclusion criteria: disease progression while taking romidepsin or another HDAC inhibitor; concurrent use with other chemotherapy (romidepsin may be used with skin-directed therapy or radiation therapy); dosing that exceeds single-dose limits; investigational or off-label uses that lack sufficient evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature.

Denial if disease progression occurred while on Istodax (romidepsin) or another HDAC inhibitor (e.g., vorinostat)
Denial if concurrent use with other systemic chemotherapy is requested (exception: may be used with skin-directed therapy or radiation)
Denial if requested dosing exceeds single-dose limit (e.g., single dose >14 mg/m2)
Denial for investigational/off-label indications lacking support from CMS compendia or acceptable peer-reviewed literature

Step	Requirement
1	Member must have received at least one prior systemic therapy for cutaneous T-cell lymphoma (CTCL) before romidepsin (Istodax) will be covered.

Definitions and Evidence Thresholds

inv-09: Investigational / insufficient evidence — Use lacking support from CMS-recognized compendia or acceptable peer-reviewed literature; inadequate clinical representation, poor study quality, etc.

DefinitionUse lacking support from CMS-recognized compendia or acceptable peer-reviewed literature; considered investigational or insufficient evidence

Evidence gaps considered inadequateInadequate clinical representation of patient/cancer characteristics in published evidence

Study quality concernsPoor experimental design or inappropriate study methods reduce acceptability of evidence

Insufficient data typesCase reports and meeting abstracts without full peer‑reviewed articles are generally considered inadequate

Clinical outcome standardsStudies should report clinically meaningful outcomes (ASCO examples: hazard ratio <0.80 or recommended OS/PFS benefit ≥3 months) to be considered sufficient

Background

Romidepsin (Istodax) is a histone deacetylase (HDAC) inhibitor indicated for certain T‑cell lymphomas. This policy defines coverage and utilization management for romidepsin, addressing FDA‑approved indications and select off‑label uses supported by recognized evidence sources. Coverage includes treatment of cutaneous T‑cell lymphoma (CTCL) for members who have received at least one prior systemic therapy, and continuation may be permitted when prior authorization criteria are met. For medication management details including administration and monitoring, refer to the FDA labeling; the policy does not impose an explicit site‑of‑care restriction.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIstodax (romidepsin) — Drug Policy / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJuly 26, 2024

Next Review Date

Key ActionObtain prior authorization and document FDA labeling or recognized compendia/guideline support for romidepsin requests.

SourceLink

On This Page

OpenPayer

Istodax (romidepsin) — Drug Policy / Coverage Criteria

Coverage Criteria for Istodax (romidepsin)

Initial Therapy

Continuation Therapy

Provider Actions and Authorization Requirements

Coding and Dose Limits

Step Therapy Requirements

Site of Care and Administration

Definitions and Evidence Thresholds

Background