CurrentViva HealthPolicy IC-0378

Poteligeo (mogamulizumab-kpkc) IV therapy — Prior authorization criteria

Prior authorization policy for intravenous mogamulizumab-kpkc (Poteligeo) for adults with cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome) and adult T-cell leukemia/lymphoma, describing eligibility, dosing, approval length, and renewal requirements for Viva Health members.

Policy Summary

PayerViva Health

PolicyPoteligeo (mogamulizumab-kpkc) IV therapy — Prior authorization criteria

Policy CodePolicy IC-0378

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateApr 1, 2026

Key ActionObtain prior authorization; initial approvals issued for 6 months and may be renewed every 6 months except certain ATLL CHOP-combination cases where renewal is not allowed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial PA validity

120Max units per dose

>=18Minimum age

J9204HCPCS

C84/C91Covered diagnoses

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Universal eligibility: Member is at least 18 years of age

Cutaneous lymphomas (Mycosis Fungoides/Sezary Syndrome): Used as single‑agent systemic therapy AND (used as subsequent therapy OR used as primary treatment excluding stage IA mycosis fungoides)

Compendia recommended; orphan drug indication noted

Adult T‑Cell Leukemia/Lymphoma (ATLL): Used as single‑agent systemic therapy AND (used as subsequent therapy in chronic high‑risk, acute, or lymphoma subtypes that did not respond to first‑line therapy) OR used in combination with CHOP followed by single‑agent therapy in members with no intention to proceed to transplant (including use as first‑line for certain subtypes, continued treatment in responders, or additional therapy for specified nonresponders)

FDA‑approved and compendia‑recommended indications indicated; CHOP‑combination has cycle limits

inv-02: Continuation / Renewal Therapy

Renewal is allowed when ALL of the following are met:

Continued eligibility: Member continues to meet the universal and indication‑specific relevant criteria identified in Section III (initial approval criteria)

Authorization duration: Duration of authorization has not been exceeded per Section I (see length of authorization and special limits for ATLL CHOP‑combination)

Refer to length of authorization limits; ATLL CHOP‑combination prior authorization may have a maximum of eight 14‑ or 21‑day cycles and is not renewable

Clinical response: Disease response demonstrated by stabilization of disease or decrease in tumor size or tumor spread

Toxicity: Absence of unacceptable toxicity from the drug (examples include Stevens‑Johnson syndrome/toxic epidermal necrolysis, severe infusion reactions, severe infections, autoimmune complications, complications of allogeneic HSCT)

The policy excludes use of mogamulizumab-kpkc as primary treatment for stage IA mycosis fungoides. Requests for first-line primary therapy in members with stage IA disease do not meet the coverage criteria and should not be authorized under this policy.

When mogamulizumab-kpkc is used in combination with CHOP for adult T-cell leukemia/lymphoma (ATLL) followed by single-agent therapy, prior authorization for the combination regimen may be issued for up to a maximum of eight 14‑day or 21‑day treatment cycles. Per the length-of-authorization rules, approvals for this CHOP-combination scenario may not be renewed after the allowed cycles.

Renewal requests must document clinical benefit and acceptable safety. Renewal is considered not medically necessary when there is no evidence of disease response (defined as stabilization of disease or decrease in tumor size or spread) or when the member is experiencing unacceptable toxicity from the drug (examples include Stevens-Johnson syndrome/toxic epidermal necrolysis, severe infusion reactions, severe infections, autoimmune complications, or HSCT-related complications).

Coding (HCPCS, NDC, ICD-10, Dose Units)

Covered HCPCS CodesHCPCSCovered

J9204

Injection, mogamulizumab-kpkc, 1 mg; 1 billable unit = 1 mg

NDCsNDC

42747-0761-xx

Poteligeo 20 mg/5 mL single-dose vial (format shown)

Covered ICD-10 Diagnosis CodesICD-10Covered

C84.00	Mycosis fungoides, unspecified site
C84.01	Mycosis fungoides, lymph nodes of head, face, and neck
C84.02	Mycosis fungoides, intrathoracic lymph nodes
C84.03	Mycosis fungoides, intra-abdominal lymph nodes
C84.04	Mycosis fungoides, lymph nodes of axilla and upper limb
C84.05	Mycosis fungoides, lymph nodes of inguinal region and lower limb
C84.06	Mycosis fungoides, intrapelvic lymph nodes
C84.07	Mycosis fungoides, spleen
C84.08	Mycosis fungoides, lymph nodes of multiple sites
C84.09	Mycosis fungoides, extranodal and solid organ sites

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Dose unit reporting — invoicing and maximums

Unit definition1 mg = 1 billable HCPCS unit (J9204)

Typical maximum per dosing event120 billable units per dose

Initial cycle schedule (per policy)120 units on days 1, 8, 15, and 22 of the first 28-day cycle

Maintenance schedule (per policy)120 units every 14 days after the first cycle

Covered Regimens and Dosing

Indication	Dose / Schedule	Coverage
Cutaneous lymphoma (Mycosis fungoides / Sézary syndrome)
1 mg/kg IV on days 1, 8, 15, and 22 of the first 28-day cycle; then 1 mg/kg IV on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Covered with criteria

Indication	Dose / Schedule	Coverage
Adult T-Cell Leukemia/Lymphoma (ATLL) — single-agent
1 mg/kg IV on days 1, 8, 15, and 22 of the first 28-day cycle; then 1 mg/kg IV on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Covered with criteria

Indication	Dose / Schedule	Coverage / Authorization Limits
Adult T-Cell Leukemia/Lymphoma (ATLL) — in combination with CHOP followed by single-agent therapy
1 mg/kg IV every 14 to 21 days in combination with CHOP for six (6) 14- or 21-day cycles, followed by two (2) 14- or 21-day cycles of monotherapy.
Covered with criteria; prior authorization may be provided for up to a maximum of eight 14- or 21-day treatment cycles (permitted 6 combination cycles plus up to 2 monotherapy cycles); prior authorization renewal is NOT permitted for this CHOP-combination scenario.

Provider Actions, Documentation & Authorization

Prior Authorization

Prior authorization length and renewal timing

Prior authorization is required. Initial approvals are issued for 6 months (180 days) unless otherwise specified; renewals may be granted every 6 months (180 days) thereafter except where noted for ATLL CHOP-combination therapy.

ATLL in combination with CHOP followed by single-agent therapy: prior authorization may be provided for up to eight 14- or 21-day treatment cycles and is not renewable.

Step Therapy

Position in therapy (primary vs subsequent; CHOP-combination rules)

Use as single-agent systemic therapy is covered as subsequent therapy for both cutaneous T‑cell lymphoma (CTCL) and adult T‑cell leukemia/lymphoma (ATLL). For CTCL it may also be used as primary treatment except for stage IA mycosis fungoides; for ATLL, selected patients may receive mogamulizumab in combination with CHOP followed by monotherapy when not proceeding to transplant.

CTCL: single-agent systemic therapy — subsequent therapy OR primary treatment (stage IA excluded).
ATLL: single-agent systemic therapy — subsequent therapy; or combination with CHOP followed by single-agent therapy in patients with no intention to proceed to transplant (first-line allowed for certain subtypes).

Documentation Required

Required documentation for initial and renewal requests

Include documentation showing the member is ≥18 years old, that the indication-specific initial criteria are met, and that the requested duration does not exceed authorization limits; renewal requests must additionally include evidence of disease response and absence of unacceptable toxicity.

Age: documentation that member is at least 18 years of age.
Initial criteria: clinical notes supporting the applicable indication-specific requirements (CTCL or ATLL).
Duration: dates showing authorization duration has not been exceeded per Section I.
Renewals: objective evidence of disease response (stabilization or decrease in tumor size or spread) and documentation of no unacceptable toxicity.

Denial Risk

Renewal denial triggers

Renewal requests may be denied if there is no demonstrated disease response (no stabilization or decrease in tumor burden) or if unacceptable drug-related toxicity is present.

Examples of unacceptable toxicity include Stevens‑Johnson syndrome/toxic epidermal necrolysis, severe infusion reactions, severe infections, autoimmune complications, and HSCT-related complications.
For ATLL patients treated with CHOP followed by single-agent therapy, prior authorization validity may not be renewed after the allowed cycles.

Line of Therapy Determination

inv-17: first-line | subsequent

First‑line: For ATLL: when used in combination with CHOP followed by single‑agent therapy in members with no intention to proceed to transplant (allowed as first‑line for certain chronic high‑risk, acute, or lymphoma subtypes)

CHOP‑combination limited to a maximum of eight 14‑ or 21‑day treatment cycles; not renewable

Subsequent: Used as single‑agent systemic therapy as subsequent therapy for Cutaneous T‑cell lymphoma (except stage IA primary treatment) and for ATLL in relapsed/refractory chronic high‑risk, acute, or lymphoma subtypes that did not respond to first‑line therapy

Compendia recommended indications

Definitions and Exclusions

Subsequent therapy — definition and context

DefinitionSubsequent therapy: use of mogamulizumab-kpkc as single-agent systemic therapy after prior systemic treatment (i.e., for relapsed or refractory disease)

Cutaneous lymphoma contextFor mycosis fungoides/Sezary syndrome, subsequent therapy allows single-agent systemic use; primary use is allowed except stage IA

ATLL contextFor adult T-cell leukemia/lymphoma, subsequent therapy applies to chronic high risk, acute, or lymphoma subtypes that failed first-line therapy

Stage IA exclusion — Cutaneous T-cell lymphoma

Exclusion statementStage IA mycosis fungoides is excluded from primary treatment use of mogamulizumab-kpkc

ImplicationFor CTCL, mogamulizumab-kpkc may be used as primary treatment except in members with stage IA disease

Reference contextThis exclusion applies specifically to primary (first-line) use in stage IA mycosis fungoides

Background

Mogamulizumab-kpkc (Poteligeo) is a monoclonal antibody targeting CCR4 indicated for certain T‑cell lymphomas, including cutaneous T‑cell lymphoma (mycosis fungoides and Sézary syndrome) and adult T‑cell leukemia/lymphoma (ATLL). It is administered intravenously with indication-specific dosing schedules: for cutaneous lymphomas and ATLL as a single agent the common regimen is 1 mg/kg IV on days 1, 8, 15, and 22 of the first 28‑day cycle, then days 1 and 15 of each subsequent 28‑day cycle until disease progression or unacceptable toxicity. The agent is also permitted in ATLL in combination with CHOP on 14‑ or 21‑day cycles for selected patients who are not proceeding to transplant, with specific cycle limits described in the authorization section.

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