CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Poteligeo (mogamulizumab) — Coverage Criteria

Coverage criteria for Poteligeo (mogamulizumab-PKPT) for adult patients with relapsed or refractory mycosis fungoides, Sézary syndrome, and select compendial uses (including ATLL) for BlueCross BlueShield of Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyPoteligeo (mogamulizumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (may be granted for up to 12 months) and document diagnosis plus that all approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

Relapsed/refractory MF or SSFDA-approved indication

ATLLListed compendial indication

Tennesseestate-specific mandate compliance

Coverage Criteria

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FDA-Approved Indication (MF/SS): Adult patient with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Authorization of 12 months may be granted.

Compendial Use: Adult T-cell leukemia/lymphoma (ATLL): Use in ATLL when either (1) in combination with CHOP if there is no intention to proceed to transplant, or (2) as a single agent when used as subsequent therapy for chronic high‑risk, acute, or lymphoma subtypes.

Authorization of 12 months may be granted.

Continuation Criteria: No evidence of unacceptable toxicity or disease progression while on the current regimen for members requesting reauthorization for a listed indication.

Authorization of 12 months may be granted for continued treatment.

Provider Actions and Authorization

Prior Authorization

Authorization Duration and Reauthorization

Prior authorization may be required and, when approved, may be granted for up to 12 months for covered indications. This includes initial authorization and continuation/reauthorization requests when the member is benefiting from therapy without unacceptable toxicity or disease progression.

Authorization duration: up to 12 months for covered indications (e.g., MF/SS, ATLL per criteria).
Reauthorization: 12-month approvals may be granted for continuation when no unacceptable toxicity or disease progression is documented.

Step Therapy

There is no explicit step therapy sequencing requirement stated for use of this therapy in the policy. Providers should follow any payer-specific step edits if present in the benefit plan.

Documentation Required

Required Documentation and References

Providers must document the diagnosis and that all approval criteria are met. Use standard reference compendia for regimen and dosing guidance.

Documented diagnosis supporting the requested indication.
Clinical documentation demonstrating member meets all policy approval criteria and has no exclusions to the prescribed therapy.
Regimen/dosing and supportive care per recognized compendia (NCCN, Drugdex, AHFS).

Denial Risk

Non-compendial Indications Not Covered

Use of the therapy for indications that are not FDA‑approved or supported by recognized compendia is considered experimental/investigational and is not medically necessary.

Non-compendial or other unlisted indications (other than FDA-approved and compendial uses) are not covered.

Background

Poteligeo (mogamulizumab) is addressed in this policy for its FDA-approved use in mycosis fungoides (MF) and Sézary syndrome (SS) and for selected compendial uses such as adult T-cell leukemia/lymphoma (ATLL). Use outside those approved or compendial indications is considered experimental/investigational and not medically necessary.

Definitions

Relapsed or refractory MF/SS — prior therapy requirement

DefinitionMycosis fungoides or Sézary syndrome in adult patients who have progression after or intolerance to at least one prior systemic therapy.

Required prior therapyAt least one prior systemic therapy (per FDA‑approved indication).

PopulationAdult patients with relapsed or refractory MF or SS.

ATLL use scenarios — compendial‑specified combinations and single‑agent uses

Combination scenarioPoteligeo in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) when there is no intention to proceed to transplant.

Single‑agent scenarioPoteligeo as a single agent when used as subsequent therapy for chronic high‑risk, acute, or lymphoma subtypes of ATLL.

Authorization durationAuthorization of up to 12 months may be granted for ATLL when used in the specified compendial scenarios.

Line of Therapy Specifications

second-line

Relapsed/Refractory MF/SS after prior therapy: Patient has relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

This corresponds to the FDA‑approved indication.

subsequent

ATLL specific scenarios: (1) In combination with CHOP if there is no intention to proceed to transplant; OR (2) as a single agent when used as subsequent therapy for chronic high‑risk, acute, or lymphoma subtypes.

These are compendial recognized uses for ATLL.

Covered Regimens and Regimen Tables

Indication	Regimen	Notes / Authorization Duration
Adult T‑cell leukemia/lymphoma (ATLL)	Poteligeo in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) as specified by compendia	Use when there is no intention to proceed to transplant. Authorization of 12 months may be granted.

Indication	Regimen	Notes / Authorization Duration
Adult T‑cell leukemia/lymphoma (ATLL) — subsequent therapy	Poteligeo as a single agent for subsequent therapy in chronic high‑risk, acute, or lymphoma subtypes	Authorization of 12 months may be granted.