CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Istodax (romidepsin) — Coverage Criteria for Cutaneous T‑Cell Lymphoma

Defines accepted indications, inclusion and exclusion criteria, and utilization management authority for coverage of Istodax (romidepsin) for members; applies to medication requests processed by the payer's UM vendor (Evolent).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIstodax (romidepsin) — Coverage Criteria for Cutaneous T‑Cell Lymphoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 26, 2024

Next Review DateN/A

Key ActionObtain prior authorization; ensure member received at least one prior systemic therapy for CTCL and verify no disease progression with continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1minimum prior therapy required for CTCL indication

14 mg/m2single dose maximum excluded if exceeded

FDA/CMS/NCCN/ASCOevidence sources required

≤30‑day lapsecontinuation timing window

UM Deptapproval authority

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Coverage Criteria

Coverage criteria

Covered when ALL of the following are met for CTCL

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

from B.1

Continuation exception

No disease progression: The member has not experienced disease progression on the requested medication.
II.A.1
Recent use without lapse: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.within 1 year; lapse ≤30 days
II.A.2
No new medications: Additional medication(s) are not being added to the continuation request.
II.A.3

Coverage is excluded when there is disease progression while taking Istodax (romidepsin) or another histone deacetylase (HDAC) inhibitor. Concurrent administration with other systemic chemotherapy is not permitted; however, Istodax may be used concomitantly with skin-directed therapy or radiation therapy. Requests will also be denied if dosing exceeds the single dose limit of 14 mg/m2. Finally, investigational or off‑label uses lacking sufficient evidence as defined by the policy are excluded (see investigational use criteria).

Use of Istodax (romidepsin) for off‑label indications is considered investigational and not approvable when the available evidence is insufficient or not generally accepted by the medical community. Insufficient evidence includes, but is not limited to: inadequate representation of patient or cancer characteristics in published reports; regimens not reflected in the literature; outcomes that are not clinically meaningful as described by ASCO benchmarks (for example, hazard ratio ≥ 0.80 or survival benefits below recommended thresholds); poorly designed studies for the question under investigation; reliance solely on case reports or meeting abstracts without full peer‑reviewed publication. Uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature will be denied.

Coding & Quantity Limits

Single dose limit — 14 mg/m2

Single dose maximum14 mg/m2

ApplicationDosing that exceeds 14 mg/m2 is listed as an exclusion criterion and will result in denial

Unitmg/m2 (body surface area)

Istodax (romidepsin) — single dose must not exceed 14 mg/m2 (quantity limits)

DrugIstodax (romidepsin)

Quantity limitSingle dose must not exceed 14 mg/m2

Policy effectDosing above this single‑dose limit is an explicit exclusion and may result in denial

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Requests for romidepsin (Istodax) require prior authorization; continuation requests may be approved if the member has not progressed on the medication, the medication was used within the last year without a lapse >30 days of active authorization, and no additional medications are being added to the continuation request.

Continuation approval triggers: member has not experienced disease progression on the requested medication; requested medication used within the last year without a lapse of more than 30 days of having an active authorization; no additional medications are being added to the continuation request.

Documentation Required

Documentation & Evidence Required for Off‑Label Use

Evidence required to support off‑label use. Off‑label indications must be supported by one or more of the following: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS standards.

Initial Therapy

Initial therapy — CTCL (labeled indication)

Initial therapy coverage for the labeled CTCL indication — covered when ALL of the following are met:

CTCL initial therapy: Member has a diagnosis of cutaneous T‑cell lymphoma (CTCL).

B. Cutaneous T‑Cell Lymphomas

Prior systemic therapy requirement: Member has received at least one prior systemic therapy for CTCL.At least 1 prior systemic therapy

B.1; step therapy requirement

Dose limits: Requested dosing does not exceed the single dose limit of 14 mg/m2.≤ 14 mg/m2 per single dose

Continuation Therapy

Continuation therapy

Continuation requests may be approved under specific conditions — all conditions below must be met:

Continuation approval criteria: Member has not experienced disease progression on the requested medication.

II.A.1

Authorized recent use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.Within 1 year; lapse ≤30 days

II.A.2

No additions: No additional medication(s) are being added to the continuation request.

II.A.3

Step Therapy Requirements

Step	Requirement	Notes
1	Patient must have received at least one prior systemic therapy before romidepsin (Istodax) will be covered for cutaneous T‑cell lymphoma (CTCL).	Applies to initial therapy requests for CTCL per policy section B.1; documentation of prior systemic therapy should be provided with the request.

Background & Definitions

Romidepsin (Istodax) is a histone deacetylase (HDAC) inhibitor referenced in this policy for treatment of cutaneous T‑cell lymphoma (CTCL) and related oncologic uses. This policy defines the scope of coverage, applicable inclusion and exclusion criteria, and utilization management requirements for Istodax requests processed by the payer's utilization management vendor. Key limits include exclusion for progression on an HDAC inhibitor, prohibition of concurrent systemic chemotherapy (except for skin‑directed therapy or radiation), and a single dose maximum of 14 mg/m2; investigational/off‑label uses must meet the policy's evidentiary standards to be considered for approval.

Investigational use insufficiently supported — definition/key value

Defined termInvestigational/off‑label use insufficiently supported

Evidence requirementsUse lacking adequate supporting evidence is considered investigational when not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature

Examples of inadequate evidenceCase reports and meeting abstracts without full peer‑reviewed articles are generally considered insufficient

Evidence considerationsAssess whether patient/cancer characteristics, regimen representation, clinically meaningful outcomes, and study design are adequate