CurrentEmblemHealthPolicy N/A

Evolent Clinical Guideline 3217 for Poteligeo TM (mogamulizumab-kpkc)

Evolent Clinical Guideline defining accepted indications, continuation and exclusion criteria, and billing code for Poteligeo (mogamulizumab-kpkc) for cancer treatment requests processed by Evolent across specified lines of business.

Policy Summary

PayerEmblemHealth

PolicyEvolent Clinical Guideline 3217 for Poteligeo TM (mogamulizumab-kpkc)

Policy CodePolicy N/A

Change TypeAdministrative/template conversion; wording update

Effective Date

Next Review Date

Key ActionEvolent is responsible for processing all medication requests; medication use must be supported by FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS standards; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces prior UM ONC_1344 Poteligeo guideline (noted in history for November 2025).

Updated NCH verbiage to Evolent (November 2024).

1Covered Indications (listed)

4Exclusion criteria (listed)

1HCPCS code listed

Coverage Summary

Coverage stance: covered_with_criteria for Poteligeo (mogamulizumab-kpkc). Subject: Poteligeo (mogamulizumab-kpkc). Scope: Evolent Clinical Guideline 3217 defining accepted indications, continuation and exclusion criteria, and billing code for Poteligeo for cancer treatment requests processed by Evolent across specified lines of business (Commercial, Exchange/Marketplace, Medicaid). High-level note: Evolent is responsible for processing all medication requests and may exempt certain continuation requests from denial when specific continuation conditions are met; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Payer / policy metadata: EmblemHealth; Evolent Clinical Guideline 3217 Poteligeo. Key billing code: J9204 (Injection, mogamulizumab-kpkc, 1 mg).

Initial Therapy Criteria — Mycosis Fungoides / Sézary Syndrome

Initial Therapy - Mycosis Fungoides/Sezary Syndrome

Poteligeo may be used when ALL of the following are met:

Patient is an adult member
Diagnosis of relapsed or refractory mycosis fungoides or Sézary syndrome
After at least one prior systemic therapy

Supportive evidence requirements: Medication use must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Providers must document prior systemic therapy for relapsed/refractory mycosis fungoides or Sézary syndrome and submit evidence from these authoritative sources to support the requested use; lacking such support may result in non-approval and non-reimbursement.

Continuation Therapy Criteria

Continuation Therapy

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Prior Authorization

Prior authorization required

Evolent is responsible for processing all medication requests for Poteligeo (mogamulizumab-kpkc). Prior authorization is required; medication use must be supported by FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or peer-reviewed literature that meets CMS standards. Evolent may exempt continuation requests from prior authorization when all continuation criteria are met (no disease progression on the medication, used within the last year without a lapse >30 days of authorization, and no additional medications are being added). Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Affected code: J9204
Evolent processes all medication requests and may exempt certain continuation requests when continuation criteria are met (no progression, used within last year without >30 day lapse, no additional meds).

Exclusions / Not Medically Necessary

Exclusion / Not Medically Necessary

Use is excluded when ANY of the following apply:

Disease progression while receiving Poteligeo (mogamulizumab-kpkc)
Concurrent use with other systemic therapies (may be used with skin directed therapy or radiation therapy)
Dosing exceeds single dose limit of Poteligeo (mogamulizumab-kpkc)single dose > 1 mg/kg
Investigational use for an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community

Denial Risk

Denial for excluded uses

Claims may be denied for uses that meet any of the exclusion criteria listed by Evolent.

Affected code: J9204
Denial conditions: disease progression while receiving Poteligeo (mogamulizumab-kpkc)
Denial conditions: concurrent use with other systemic therapies (note: may be used with skin-directed therapy or radiation therapy)
Denial conditions: dosing exceeds single dose limit of Poteligeo 1 mg/kg (single dose limit <= 1 mg/kg)
Denial conditions: investigational/off-label use without sufficient evidence or not generally accepted by the medical community

Provider Actions / Documentation & Billing

Documentation Required

Supportive clinical evidence required

Provider must document prior systemic therapy for relapsed or refractory mycosis fungoides or Sézary syndrome and provide evidence that the requested use is supported by acceptable compendia or peer-reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

Required documentation of prior systemic therapy for relapsed/refractory mycosis fungoides or Sézary syndrome
Evidence sources: FDA prescribing information, CMS-recognized compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS standards

Prior Authorization

Prior authorization required

Evolent is responsible for processing all medication requests; prior authorization is required. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Affected code: J9204
Medications not authorized by Evolent may be deemed not approvable and not reimbursable

Clinical Evidence & References

MAVORICKey clinical trial: MAVORIC trial (Lancet Oncol. 2018) - mogamulizumab vs vorinostat in previously treated cutaneous T-cell lymphoma

PI 2025Poteligeo prescribing information, Kyowa Kirin, Inc. (2025)

Definition — Sufficient evidence: Evidence supported by CMS-recognized compendia or acceptable peer-reviewed literature considering representativeness of the patient population, regimen, clinically meaningful outcomes (per ASCO standards), and appropriate study design. Evidence details: Key trial cited is the MAVORIC phase 3 trial (mogamulizumab vs vorinostat) and prescribing information (Poteligeo prescribing information, Kyowa Kirin, Inc. 2025). Off-label indications require authoritative support from compendia or peer-reviewed literature meeting these standards; uncontrolled case reports or abstracts without full peer-reviewed articles are generally insufficient.

Background

Background: This guideline defines accepted indications for Poteligeo including the FDA-approved and off-label uses when supported by authoritative sources. Specifically, Poteligeo may be used as a single agent for adult members with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Evolent processes all medication requests and may exempt certain continuation requests from the policy when the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request. Exclusion criteria include disease progression while receiving Poteligeo, concurrent use with other systemic therapies, dosing that exceeds the single dose limit of 1 mg/kg, and investigational off-label use without sufficient evidence. Billing code: J9204.

Revision History

November 2025administrative

Converted to new Evolent guideline template and replaces prior UM ONC_1344 Poteligeo guideline; updated references.

November 2024administrative

Updated NCH verbiage to Evolent.