CurrentCentenePolicy CP.PHAR.139

Mogamulizumab-kpkc (Poteligeo) coverage policy

Defines medical necessity, prior authorization, dosing, and coverage criteria for mogamulizumab-kpkc (Poteligeo) for Centene lines of business (Commercial, HIM, Medicaid) for adult patients with MF, SS, and select off‑label ATLL uses.

Policy Summary

PayerCentene

PolicyMogamulizumab-kpkc (Poteligeo) coverage policy

Policy CodePolicy CP.PHAR.139

Change TypeNo material changes

Effective DateSep 4, 2018

Next Review DateN/A

Key ActionPrior authorization required; provider must document that member meets all approval criteria and request coverage for HCPCS J9204.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 mg/kgstandard dose per administration

6 moinitial approval (Commercial)

12 moinitial approval (Medicaid/HIM)

J9204billing code

Coverage Criteria

Initial Therapy Criteria

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Initial Therapy — Initial approval criteria per indication

Initial approval criteria per indication

Initial Therapy Overview: See indication‑specific initial approval criteria: MF/SS and ATLL. Each set requires diagnosis, prescriber specialty, age ≥ 18 years, dosing limits or guideline‑supported dosing, and that the prescribed regimen is FDA‑approved or NCCN recommended.

Approval durations differ by line of business.

Initial therapy criteria updates — Documented annual review changes

Documented annual review changes affecting initial criteria

ATLL initial agent requirement: For ATLL initial criteria, added requirement 'prescribed as a single‑agent' to align with the NCCN compendium.

Change applied in 4Q 2024 annual review.

Continuation (Renewal) Criteria

Continuation Therapy — Renewal requirements and durations

Renewal requirements and durations

Renewal Conditions: Member must be currently receiving medication via the Centene benefit or have documentation of at least one 28‑day cycle, be responding to therapy, and any requested dose increase must meet dosing limits or be supported by guidelines or literature.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date.

Approval duration update — Approval duration updates noted in annual reviews

Approval duration updates noted in annual reviews

Approval duration: Initial approval duration extended from 6 months to 12 months for HIM and Medicaid as of the 4Q 2025 annual review.

Commercial initial approval remains 6 months or to the member's renewal date as specified.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required — Billing Code

Prior authorization is required. Provider must document clinical rationale and submit a prior authorization request for HCPCS J9204 (Injection, mogamulizumab-kpkc, 1 mg).

Prior authorization required for J9204
Requests should include supporting clinical documentation (see below)

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. This documentation should include diagnosis, prior therapies, treatment dates, dosing, response to therapy, and any guideline or literature citations for off-label dosing when applicable.

Office chart notes
Relevant laboratory and imaging results
Oncology/hematology consultation notes
Documentation of prior therapies and response (for ATLL, evidence of failure of first-line therapy)
Supporting literature or guideline references for non‑FDA dosing or off‑label use

Step Therapy

Step Therapy for ATLL

For ATLL (Adult T‑cell leukemia/lymphoma) requests, documentation must show failure of first‑line therapy prior to approval of mogamulizumab-kpkc as a single agent. See Appendix B for examples of first‑line regimens; prescriber should include treatment details and rationale for using Poteligeo.

ATLL requests must document prior first-line therapy and reason for failure
Examples of first-line regimens are listed in Appendix B

Step Therapy

Step Therapy Guidance

Step therapy and sequencing expectations align with NCCN guidance and the policy's updates. For ATLL the policy added the requirement that Poteligeo be prescribed as a single-agent to align with the NCCN compendium; prescribers must follow guideline-recommended sequencing and provide supporting evidence when deviating.

Follow NCCN recommendations for sequencing and regimen selection
If regimen deviates from guidelines, submit supporting peer‑reviewed literature or rationale

Note

Supporting References

Consult Poteligeo Prescribing Information and NCCN compendia to support medical necessity and to verify dosing, indications, and safety information. References included in the policy should be used when preparing documentation for prior authorization.

Poteligeo Prescribing Information — dosing and safety
NCCN compendia and guideline references for indications and sequencing
Policy references and Appendix B for therapeutic alternatives

Billing Rule

Coding / Billing Note

Inclusion or exclusion of any codes in this policy is informational only and does not guarantee coverage. Providers should reference the most up‑to‑date professional coding guidance prior to claim submission.

HCPCS: J9204 — Injection, mogamulizumab-kpkc, 1 mg
Verify current coding and billing guidance before claims submission

Step Therapy and Prior Treatments

Requirement	Details
Documentation of prior first-line therapy failure is required	For ATLL initial approval, provider must document failure of first-line therapy (see Appendix B for examples such as Brentuximab vedotin + CHP, CHOP, CHOEP, dose-adjusted EPOCH, HyperCVAD, and zidovudine plus interferon).
Prior authorization may be required	Policy notes that prior authorization may be required for ATLL off-label use when documenting prior therapy failure.

Policy update	Implication for step sequencing
ATLL initial criteria modified to specify 'prescribed as a single-agent' to align with NCCN compendium	Initial criteria were updated in the 4Q 2024 annual review to add the single‑agent requirement for ATLL to align with NCCN guidance.
Step sequencing should follow NCCN recommendations referenced in the policy	Policy directs that step or sequencing expectations for ATLL follow the referenced NCCN guidance and compendia; providers should sequence therapies per NCCN recommendations.

Site of Care Guidance

Note

Administer IV infusion over at least 60 minutes

Mogamulizumab-kpkc for MF/SS is administered intravenously over at least 60 minutes per the dosing regimen; ensure infusion administration adheres to this infusion time.

Dosing regimen: 1 mg/kg IV over at least 60 minutes on days 1, 8, 15, and 22 of the first 28‑day cycle and on days 1 and 15 of subsequent cycles.
Maximum dose stated as 1 mg/kg per dose.

Note

Provider may use clinical judgment for site of care

The policy does not mandate site of care; providers are expected to exercise professional judgment regarding infusion setting and follow standard coverage administration rules.

Clinical policy statement: providers should exercise professional medical judgment; policy is not intended to dictate site of care.
Standard coverage administration rules apply when selecting infusion site.

Definitions

inv-18: ATLL — Adult T-cell leukemia/lymphoma

TermAdult T-cell leukemia/lymphoma (ATLL)

ContextListed in Appendix A: abbreviation/acronym key

Policy relevanceIncluded as an off-label indication with specific initial approval criteria in the policy

inv-19: CCR4 — CC chemokine receptor type 4

TermCCR4 — CC chemokine receptor type 4

Mechanism relevanceMogamulizumab-kpkc is a CCR4-directed monoclonal antibody (see background/prescribing info)

SourceDefined in Appendix A abbreviation/acronym key and supported by Poteligeo prescribing information

inv-20: CTCL — Cutaneous T-cell lymphoma

TermCTCL — Cutaneous T-cell lymphoma

IncludesMycosis fungoides (MF) and Sézary syndrome (SS) as CTCL subtypes referenced in policy

ReferenceDefined in Appendix A and supported by NCCN references in the policy

inv-21: Notes that ATLL initial criteria were modified to specify 'prescribed as a single-agent' to align with NCCN compendium

Policy update summaryATLL initial criteria modified to require 'prescribed as a single-agent' to align with NCCN compendium

Timing of changeRecorded in 4Q 2024 annual review (Date = 07.15.24; P&T Approval Date = 11.24)

Related adjustmentsAppendix B updated with additional first-line therapeutic option (zidovudine and interferon)

OpenPayer

Mogamulizumab-kpkc (Poteligeo) coverage policy

Coverage Criteria

Initial Therapy Criteria

Continuation (Renewal) Criteria

Provider Actions and Requirements

Coding and Billing

Step Therapy and Prior Treatments

Quantity and Dosing Limits

Site of Care Guidance

Definitions

Background