CurrentCentenePolicy CP.PHAR.139

Mogamulizumab-kpkc (Poteligeo) (PDF)

Defines medical necessity, initial and continuation approval criteria, dosing limits, approved indications (MF/SS), an off-label ATLL pathway, approval durations by line of business, and coding implications for mogamulizumab-kpkc (Poteligeo) for Centene-affiliated plans.

Policy Summary

PayerCentene

PolicyMogamulizumab-kpkc (Poteligeo) (PDF)

Policy CodePolicy CP.PHAR.139

Change TypeAnnual reviews; material updates in 2024–2025

Effective Date09.04.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2024 annual review: for ATLL initial criteria, added 'prescribed as a single-agent' to align with NCCN compendium and guideline; added 'Zidovudine and interferon' to Appendix B as ATLL first-line therapy option.

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

Multiple annual reviews (2021-2023) noted no significant clinical changes; references and template updates applied.

2Covered Indications (MF/SS, ATLL conditional)

1J-code provided

18Policy years since effective

Coverage Summary

Coverage stance: covered_with_criteria. Scope: defines medical necessity, initial and continuation approval criteria, dosing limits, approved indications (MF/SS) and an off-label ATLL pathway, approval durations by line of business, and coding implications for mogamulizumab-kpkc (Poteligeo) for Centene-affiliated plans.

FDA-approved indication: Poteligeo is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy (per Poteligeo PI referenced Jan 2025).

Off-label ATLL pathway: the policy includes an off-label pathway for adult T-cell leukemia/lymphoma (ATLL) with specific criteria — diagnosis of ATLL, prescriber specialty requirement, age ≥ 18 years, prescribed as a single-agent, failure of first-line therapy (see Appendix B), dose within FDA maximum or supported by guidelines/literature, and requirement that prescribed regimen be FDA‑approved or recommended by NCCN.

Dates: policy effective 2018-09-04; last review/P&T approval reflected as 11.25 with last_review date expressed as 11.25 in the brief (annual review entries through 07.11.25 noted).

Key thresholds and quick facts

Age≥ 18 years

Dose maximum1 mg/kg per dose

Covered indications2 (MF/SS; ATLL conditional off-label)

HCPCS J-codeJ9204

Policy numberCP.PHAR.139

Policy statusCURRENT

Initial Therapy Criteria

I. Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Poteligeo is medically necessary when the following criteria are met:

Indication

A. Mycosis Fungoides/Sézary Syndrome (must meet all)
- Diagnosis of MF or SS
- Prescribed by or in consultation with an oncologist or hematologist
- Age ≥ 18 years
- Dose requirement (one of)
  - Dose does not exceed 1 mg/kg on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle1 mg/kg per dose
  - Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
- Prescribed regimen must be FDA-approved or recommended by NCCN
B. Adult T-Cell Leukemia/Lymphoma (off-label) (must meet all)
- Diagnosis of adult T-cell leukemia/lymphoma (ATLL)
- Prescribed by or in consultation with an oncologist or hematologist
- Age ≥ 18 years
- Prescribed as a single-agent
- Failure of first-line therapy (see Appendix B for examples); prior authorization may be required
- Dose requirement (one of)
  - Dose is within FDA maximum limit for any FDA-approved indication

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title

Provider Actions / Billing

Documentation Required

Supportive clinical documentation required

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

Prior Authorization

Prior authorization required

Prior authorization may be required for ATLL and for other off-label uses; prescriber must submit supporting evidence when dose or off-label use is asserted.

Billing Rule

Use J9204 for claims

HCPCS J9204 (Injection, mogamulizumab-kpkc, 1 mg) is the referenced billing code for the drug; inclusion is informational and does not guarantee coverage.

J9204

Documentation Required

Prescriber specialty requirement

Drug must be prescribed by or in consultation with an oncologist or hematologist for covered indications.

Denial Risk

Coverage denial for non-authorized indications

Claims for non-FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Clinical Evidence

Evidence summary — FDA approved indication: Poteligeo (mogamulizumab-kpkc) is FDA‑approved for relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy (Poteligeo Prescribing Information, Jan 2025).

Guideline support: the policy references NCCN recommendations and the NCCN Drugs & Biologics Compendium to support dosing and regimen conformity; the policy requires that prescribed regimens be FDA‑approved or recommended by NCCN for both labeled and off‑label uses.

Dosing/evidence notes: the policy cites the approved MF/SS dosing regimen of 1 mg/kg IV on days 1, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles (maximum 1 mg/kg/dose) and permits guideline‑supported alternative dosing for off‑label indications if prescriber provides supporting evidence.

Administrative/effective dates: prescribing information reference is Jan 2025 and the policy revision log documents material updates in 4Q2024 (added 'prescribed as a single-agent' for ATLL) and 4Q2025 (extended initial approval duration for HIM and Medicaid), supporting the brief's evidence entries.

Background

Background: Mogamulizumab-kpkc (Poteligeo) is a CCR4-directed monoclonal antibody indicated for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

The policy also includes an off-label pathway for adult T-cell leukemia/lymphoma (ATLL) aligned with guideline recommendations; ATLL initial criteria require diagnosis of ATLL, prescriber specialty, adult age, single‑agent use, prior failure of first‑line therapy (examples provided in Appendix B), and dosing supported by FDA limits or practice guidelines/peer‑reviewed literature.

Appendix B lists ATLL first‑line therapy examples (e.g., CHOP, CHOEP, dose‑adjusted EPOCH, hyperCVAD, brentuximab vedotin + CHP) and includes zidovudine plus interferon as an added option per the revision history.

Definitions

ATLLadult T-cell leukemia/lymphoma

MFmycosis fungoides

SSSézary syndrome

CCR4CC chemokine receptor type 4

Revision History

07.15.24material_change

4Q 2024 annual review (P&T 11.24): For ATLL initial criteria, added 'prescribed as a single-agent' to align with NCCN compendium and guideline; added 'Zidovudine and interferon' to Appendix B as an ATLL first-line therapy option.

07.11.25material_changeLatest

4Q 2025 annual review (P&T 11.25): Extended initial approval duration from 6 months to 12 months for HIM and Medicaid; references reviewed and updated.

08.11.21clarification

4Q 2021 annual review: No significant clinical changes; modified reference from HIM.PHAR.21 to HIM.PA.154; references reviewed and updated.

08.08.22clarification

4Q 2022 annual review: No significant clinical changes; references reviewed and updated; template changes applied to other diagnoses/indications.

08.10.23clarification

4Q 2023 annual review: No significant clinical changes; references reviewed and updated.