ModifiedDelaware First HealthPolicy CP.PHAR.314

Clinical Policy: Romidepsin (Istodax) — Coverage Criteria

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Defines medical necessity criteria, dosing limits, and authorization requirements for romidepsin (Istodax) for T‑cell lymphomas across Delaware First Health lines of business; affects prescribers, pharmacists, and prior authorization reviewers.

Policy Summary

PayerDelaware First Health

PolicyRomidepsin (Istodax) coverage criteria

Policy CodePolicy CP.PHAR.314

Change TypeCriteria, dosing, coding, and approval duration updates

Effective DateJan 1, 2017

Last ReviewJul 10, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior systemic therapy history (or rationale if palliative peripheral T‑cell lymphoma), prescriber specialty, age, dosing, and appropriate HCPCS/J-code (J9318/J9319).

SourceLink

POLICY UPDATE CHANGES

Added an option that failure of prior systemic therapy is not required when peripheral T-cell lymphoma request is for palliative therapy.

Clarified dosing schedule to specify administration on days 1, 8, and 15 of a 28-day cycle and maximum dose of 14 mg/m2 per dose.

Added HCPCS code J9318 (non-lyophilized romidepsin) and updated J9319 description.

Extended initial approval duration to 12 months (from prior 6 months).

4Q 2025 annual review: extended initial approval duration from 6 to 12 months.

4Q 2024 annual review: for initial therapy, added criteria option 'unless peripheral T-cell lymphoma and request is for palliative therapy' under 'Failure of at least one prior systemic therapy' to align with NCCN.

Updated J-code listings including addition of J9318 and updates to J9319 description.

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ModifiedDelaware First HealthPolicy CP.PHAR.314

Clinical Policy: Romidepsin (Istodax) — Coverage Criteria

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Policy Summary

PayerDelaware First Health

PolicyRomidepsin (Istodax) coverage criteria

Policy CodePolicy CP.PHAR.314

Change TypeCriteria, dosing, coding, and approval duration updates

Effective DateJan 1, 2017

Last ReviewJul 10, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Added an option that failure of prior systemic therapy is not required when peripheral T-cell lymphoma request is for palliative therapy.

Clarified dosing schedule to specify administration on days 1, 8, and 15 of a 28-day cycle and maximum dose of 14 mg/m2 per dose.

Added HCPCS code J9318 (non-lyophilized romidepsin) and updated J9319 description.

Extended initial approval duration to 12 months (from prior 6 months).

4Q 2025 annual review: extended initial approval duration from 6 to 12 months.

Updated J-code listings including addition of J9318 and updates to J9319 description.

14 mg/m2Maximum per-dose

Days 1,8,15Dosing days

12 moApproval duration

J9318,J9319HCPCS codes

≥18Minimum age

4Q 2024Recent substantive review

Coverage Criteria

inv-03: Initial Therapy (with palliative exception) — Covered when ALL of the following are met (with palliative exception)

Covered when ALL of the following are met (with palliative exception):

Initial Therapy: Member has an indicated diagnosis for romidepsin per policy appendices (CTCL and Peripheral T‑Cell lymphoma subtypes); AND Failure of at least one prior systemic therapy OR the request is for palliative therapy for peripheral T‑cell lymphoma (this is the exception to the prior systemic therapy requirement).

Initial approval duration extended to 12 months as of 07.10.25.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

There are no other explicit exclusions listed in this policy beyond the standard prior therapy requirements and the need for coding alignment; template and coding updates were applied across reviews and Appendix subtype lists were updated as noted in the coding implications.

Uses for non‑FDA approved indications that lack sufficient supporting evidence are considered not medically necessary per the referenced off‑label use policies. Providers should follow the procedures and documentation requirements in CP.CPA.09, HIM.PA.154, or CP.PMN.53 when requesting coverage for off‑label indications.

Requests that do not document required prior systemic therapy failure (when the criterion applies) or that are submitted with incorrect or outdated coding (for example, missing the updated J‑code entries) may be at risk for denial or considered not medically necessary. The policy was updated to add and revise HCPCS codes and to align initial therapy criteria with guideline exceptions; ensure requests match the current coding and criteria.

Initial Therapy Criteria for Romidepsin

Initial Romidepsin

Covered when ALL of the following are met:

Initial Romidepsin: 1) Diagnosis of one of the following T-cell lymphomas: a) CTCL (see Appendix D for subtypes); b) Hepatosplenic T-cell lymphoma; c) Extranodal NK/T-cell lymphoma; d) Peripheral T-cell lymphoma (see Appendix E for subtypes); e) Breast implant-associated anaplastic large cell lymphoma; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Failure of at least one prior systemic therapy unless the member has Mycosis fungoides, Sezary syndrome, or the request is for palliative therapy for peripheral T-cell lymphoma (exception); 5) For Istodax requests, member must use romidepsin if available unless contraindicated or clinically significant adverse effects are experienced; 6) Request meets one of the following: a) Dose does not exceed 14 mg/m2 administered IV over 4 hours on days 1, 8, and 15 of a 28-day cycle; OR b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).14 mg/m2

Prescribed regimen must be FDA‑approved or recommended by NCCN; see Appendices D/E for subtype lists and dosing details.

Initial Therapy Criteria (summary)

Initial authorization criteria (summary):

Continuation Therapy Criteria

inv-25: Continuation Therapy — Continuation/renewal authorization implications based on approval duration change

Continuation/renewal authorization implications based on approval duration change:

Continuation approvals should align with the updated initial approval duration (12 months) and require documentation of ongoing clinical benefit per policy; reviewers should ensure coding and criteria alignment when processing renewals.

4Q 2025 extended initial approval duration from 6 to 12 months (effective 07.10.25).

Coding and Dose Limits

Referenced HCPCS CodesHCPCS

J9319	Injection, romidepsin, lyophilized, 0.1 mg
J9318	Injection, romidepsin, non-lyophilized, 0.1 mg

Updated HCPCS/J-CodesHCPCS

J9318	HCPCS code added/updated (romidepsin)
J9319	HCPCS code description updated

Per-dose maximum — romidepsin

Per-dose maximum14 mg/m2 per dose

Dosing scheduleAdminister IV on days 1, 8, and 15 of a 28-day cycle

Maximum per-cycle implicationRepeat cycles every 28 days provided patient continues to benefit and tolerates therapy

Provider Actions and Documentation

Prior Authorization

Prior authorization required — include diagnosis, prior therapy, prescriber specialty, and age

Submit a prior authorization request that includes the diagnosis, documentation of prior therapy or applicable exception, the prescriber's specialty, and the patient's age; include dosing and evidence for off‑label dosing when applicable.

Diagnosis must match one of the specified T‑cell lymphoma indications (see policy appendices).
Prescribed by or in consultation with an oncologist or hematologist.
Age ≥ 18 years must be documented.

Prior Authorization

Prior authorization required — initial approval duration 12 months

Prior authorization is required for romidepsin; initial approvals have been extended to 12 months as of the 4Q 2025 review.

Approval duration: initial and continuation approvals are 12 months.

Step Therapy Requirements

Step	Requirement
1	Prescriber must document failure of at least one prior systemic therapy, unless the member has mycosis fungoides, Sezary syndrome, or the request is for palliative therapy for peripheral T‑cell lymphoma; prescriber must also be an oncologist or hematologist or consult with one, member age ≥18, and romidepsin must be used if available unless contraindicated or adverse effects occur.

Step	Requirement
1	Failure of at least one prior systemic therapy is required before initiating romidepsin for initial therapy, except when the request is for palliative therapy for peripheral T‑cell lymphoma (palliative exception added to align with NCCN compendium/guideline).

Site of Care and Administration

Note

Infusion center administration — IV infusion over 4 hours

Administer romidepsin IV over approximately 4 hours per dose as specified in the dosing instructions.

Dosing schedule: 14 mg/m2 IV over a 4‑hour period on days 1, 8, and 15 of a 28‑day cycle.

Definitions and Exceptions

CTCL — Definition and included subtypes per WHO‑EORTC

Definition (CTCL)Cutaneous T-cell lymphoma (CTCL): primary cutaneous T-cell lymphomas including mycosis fungoides and Sezary syndrome and other primary cutaneous T-cell lymphoma subtypes per WHO‑EORTC classification.

Included subtypes (examples)Mycosis fungoides (including variants such as folliculotropic MF, pagetoid reticulosis, granulomatous slack skin); Sezary syndrome; primary cutaneous CD30+ lymphoproliferative disorders (cutaneous ALCL, lymphomatoid papulosis); subcutaneous panniculitis‑like T‑cell lymphoma; primary cutaneous peripheral T‑cell lymphoma rare subtypes (gamma‑delta, aggressive epidermotropic CD8+, CD4 small/medium proliferative disorder, acral CD8+, others).

Classification referenceWHO‑EORTC classification for primary cutaneous lymphomas (see Appendix D for full list and 2018 update note).

Palliative exception — Peripheral T‑cell lymphoma

Palliative exception summaryFor initial authorization, failure of at least one prior systemic therapy is required unless the member has peripheral T‑cell lymphoma and the request is for palliative therapy.

Background

Romidepsin is a histone deacetylase inhibitor used in T‑cell lymphomas. The policy documentation records coding and template updates across reviews and notes that HCPCS coding for romidepsin was updated (including addition of J9318 and revisions to J9319). The 4Q 2024 review aligned initial therapy criteria with NCCN guidance (adding a palliative exception for peripheral T‑cell lymphoma), and subsequent reviews updated appendices for CTCL and peripheral T‑cell lymphoma subtypes and code descriptions.

Policy Summary

PayerDelaware First Health

PolicyRomidepsin (Istodax) coverage criteria

Policy CodePolicy CP.PHAR.314

Change TypeCriteria, dosing, coding, and approval duration updates

Effective DateJan 1, 2017

Last ReviewJul 10, 2025

Next Review Date

SourceLink

On This Page

Initial Therapy: Member has an indicated diagnosis per policy appendices; AND Documented failure of at least one prior systemic therapy OR the request is for palliative therapy for peripheral T‑cell lymphoma (exception).

Prior authorization required; initial approval duration extended to 12 months as of 07.10.25. Requests must include appropriate HCPCS/J‑code (J9318/J9319 where applicable) and required documentation (diagnosis, prior systemic therapy history or rationale for palliative request, prescriber specialty, age, dosing).

Denial Risk

Ensure coding and criteria alignment to avoid denial

Requests that do not align with updated coding (e.g., missing or incorrect J‑code) or that fail to meet the updated initial therapy criteria (including the PTCL palliative exception) may be at risk for denial.

Verify use of J9318 (non‑lyophilized romidepsin) or J9319 (lyophilized romidepsin) and that the code matches the submitted clinical request.
Ensure the request documents prior systemic therapy failure or the applicable exception; missing elements increase denial risk.

Note

Use romidepsin (generic) when available unless contraindicated

When romidepsin (Istodax) is available in generic romidepsin form, the member must use romidepsin unless it is contraindicated or clinically significant adverse effects occur.

Prescriber should document contraindication or adverse effects if requesting Istodax instead of generic romidepsin.

Documentation Required

Documentation must be submitted to support that approval criteria are met

Providers must submit documentation (such as office chart notes, lab results, or other clinical information) showing the member has met all approval criteria.

Documentation should demonstrate diagnosis, prior systemic therapy failure or applicable exception, prescriber specialty, age, and dosing information.

Documentation Required

Include diagnosis, prior systemic therapy history or palliative rationale, and correct J‑code

Authorization requests should include documentation of the diagnosis, the member's prior systemic therapy history (or rationale if the request is for palliative peripheral T‑cell lymphoma), and the appropriate HCPCS/J‑code for romidepsin.

Include supporting evidence for off‑label dosing when applicable.
Ensure J9318/J9319 are used where applicable per coding updates.

Denial Risk

Non‑FDA indications require sufficient off‑label documentation to avoid denial

Requests for non‑FDA approved indications that are not addressed in this policy may be denied unless sufficient off‑label documentation of efficacy and safety is provided in accordance with the referenced off‑label use policies.

Refer to CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) for off‑label documentation requirements.

Denial Risk

Ensure coding and criteria alignment to avoid denial (J9318/J9319)

Requests that do not use updated coding (e.g., missing or incorrect J‑code such as J9318/J9319) or that do not meet the updated initial therapy criteria (including the palliative PTCL exception) may be at risk for denial.

Confirm submission of the correct HCPCS code (J9318 or J9319) and that the request meets initial therapy requirements.

Where appliedThis exception applies only to peripheral T‑cell lymphoma requests and was added to align initial therapy criteria with NCCN (4Q 2024).

Documentation implicationAuthorization requests should include documentation supporting the request is for palliative therapy when invoking this exception.