ModifiedWellcare HawaiiPolicy CP.PHAR.139

Mogamulizumab-kpkc (Poteligeo)

Customize your policy alerts

Sign up for Wellcare Hawaii Policy CP.PHAR.139 alerts

Get alerted when Policy CP.PHAR.139 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy establishes medical-necessity and prior-authorization requirements for Poteligeo in Commercial, HIM, and Medicaid members with mycosis fungoides, Sézary syndrome, or specified adult T-cell leukemia/lymphoma indications.

Policy Summary

PayerWellcare Hawaii

PolicyMogamulizumab-kpkc (Poteligeo)

Policy CodePolicy N/A

Change TypeModified — HCPCS code J9204 added

Effective Date09.04.18

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

The policy added HCPCS code J9204 for mogamulizumab-kpkc injection.

3Lines of business

1 mg/kgMaximum dose

18+Minimum age

6 monthsInitial approval

12 months

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedWellcare HawaiiPolicy CP.PHAR.139

Mogamulizumab-kpkc (Poteligeo)

Customize your policy alerts

Sign up for Wellcare Hawaii Policy CP.PHAR.139 alerts

Get alerted when Policy CP.PHAR.139 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWellcare Hawaii

PolicyMogamulizumab-kpkc (Poteligeo)

Policy CodePolicy N/A

Change TypeModified — HCPCS code J9204 added

Effective Date09.04.18

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

The policy added HCPCS code J9204 for mogamulizumab-kpkc injection.

3Lines of business

1 mg/kgMaximum dose

18+Minimum age

6 monthsInitial approval

12 months

Coverage Criteria

Initial Therapy: Mycosis Fungoides or Sézary Syndrome

Covered when ALL of the following are met:

ALL of the following

Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS).
Prescribed by or in consultation with an oncologist or hematologist.
Member is age 18 years or older.≥ 18 years
ONE of the following dosing options
- 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 cycle.≤ 1 mg/kg
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence.

Initial Therapy: Adult T-Cell Leukemia/Lymphoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of adult T-cell leukemia/lymphoma (ATLL).
Prescribed by or in consultation with an oncologist or hematologist.
Member is age 18 years or older.≥ 18 years
Failure of first-line therapy (see Appendix B for examples).
Prior authorization may be required.
Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence.

Continued Therapy: All Indications

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving the medication through a Centene benefit, or documentation supports that the member is currently receiving Poteligeo for a covered indication and has received this medication for at least one 28-day cycle.
Member is responding positively to therapy.
If the request is for a dose increase, ONE of the following must apply
- New dose does not exceed 1 mg/kg on days 1 and 15 of each 28-day cycle.≤ 1 mg/kg
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence.

Non-FDA-approved indications that are not addressed in this policy are not authorized for coverage unless there is sufficient documentation of efficacy and safety according to the applicable off-label use policy—CP.CPA.09 for commercial, HIM.PHAR.21 for the health insurance marketplace, or CP.PMN.53 for Medicaid—or according to applicable evidence of coverage documents.

Initial Therapy Criteria

MF/SS Initial Therapy

Initial MF/SS therapy requires ALL of the following, with ONE of the dosing-support options.

MF/SS initial therapy

Diagnosis of mycosis fungoides or Sézary syndrome; member is age 18 years or older; and the medication is prescribed by or in consultation with an oncologist or hematologist.
ONE of the following dosing-support options
- 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 cycle.1 mg/kg
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, with supporting evidence submitted by the prescriber.

Continuation Therapy Criteria

Poteligeo Continuation Therapy

Continued Poteligeo therapy requires ALL of the following.

Continuation criteria

Treatment history
- Member is currently receiving medication through the Centene benefit.
- Documentation supports current treatment for a covered indication and at least one completed 28-day cycle.
Member is responding positively to therapy.
Dose-increase criteria, when applicable

Coding and Dosing

Referenced HCPCS CodeHCPCS

J9204

Injection, mogamulizumab-kpkc, 1 mg

MF/SS standard dosing

Dose1 mg/kg IV

Infusion durationOver at least 60 minutes

First 28-day cycleAdminister on days 1, 8, 15, and 22

Subsequent cyclesAdminister on days 1 and 15 of each cycle

Continuation dose increase

Maximum new dose1 mg/kg

Administration daysDays 1 and 15

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Criteria

Submit documentation, such as office chart notes, laboratory results, or other clinical information, supporting that the member has met all applicable initial or continuation approval criteria for Poteligeo.

Documentation must support all applicable diagnosis, age, specialist, treatment-history, response, dosing, and indication requirements.

Step Therapy

ATLL First-Line Therapy Failure

For off-label ATLL treatment, document failure of first-line therapy before requesting Poteligeo. Qualifying examples include the regimens listed in Appendix B.

Brentuximab vedotin plus CHP.
CHOP.
CHOEP.
Dose-adjusted EPOCH.
HyperCVAD alternating with high-dose methotrexate.

Clinical Background

Mogamulizumab-kpkc (Poteligeo) is a CCR4-directed monoclonal antibody. It is FDA-indicated for adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. The policy also provides conditional coverage for adult T-cell leukemia/lymphoma as an off-label indication, subject to the applicable treatment-history, dosing, and supporting-evidence requirements.

Definitions and Abbreviations

CCR4

AbbreviationCCR4

Expanded termCC chemokine receptor type 4

ATLL

AbbreviationATLL

Expanded termadult T-cell leukemia/lymphoma

AbbreviationMF

Step Therapy Requirements

Step	Requirement	Qualifying first-line regimen examples
1	For adult T-cell leukemia/lymphoma, the member must have failed first-line therapy. Prior authorization may be required.	Brentuximab vedotin plus CHP; CHOP; CHOEP; dose-adjusted EPOCH; or HyperCVAD alternating with high-dose methotrexate.

Quantity and Dose Limits

Poteligeo quantity limit

DrugPoteligeo

Maximum dose1 mg/kg/dose

Quantity-limit basisPer dose

Policy Summary

PayerWellcare Hawaii

PolicyMogamulizumab-kpkc (Poteligeo)

Policy CodePolicy N/A

Change TypeModified — HCPCS code J9204 added

Effective Date09.04.18

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

On This Page

ATLL Initial Therapy

Initial ATLL therapy requires ALL of the following.

ATLL initial therapy

Diagnosis of adult T-cell leukemia/lymphoma.
Member is age 18 years or older.
The medication is prescribed by or in consultation with an oncologist or hematologist.
Member has failed first-line therapy.
Prior authorization may be required.
Dose meets ONE of the following
- Dose is within the FDA maximum limit for any FDA-approved indication.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, with supporting evidence submitted by the prescriber.

The request is not for a dose increase.

New dose does not exceed 1 mg/kg on days 1 and 15 of each 28-day cycle.1 mg/kg

New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, with supporting evidence submitted by the prescriber.

Cycle timingEach 28-day cycle

Documentation Required

Clinical Documentation Required

Provide clinical documentation supporting the request, including office notes, laboratory results, and other relevant clinical information.

Documentation must substantiate that the member meets all approval criteria.

Documentation Required

Required Clinical Elements

Requests must include the required clinical elements for the applicable indication and treatment phase.

Document the diagnosis: mycosis fungoides (MF), Sézary syndrome (SS), or adult T-cell leukemia/lymphoma (ATLL), as applicable.
Document age of at least 18 years.
Document that the drug is prescribed by or in consultation with an oncologist or hematologist.
For continuation therapy, document current receipt through the Centene benefit or receipt for at least one 28-day cycle for a covered indication.

Documentation Required

Off-Label Dosing Support

If the requested regimen is not within the specified FDA-approved dosing limits, the prescriber must submit practice guidelines or peer-reviewed literature supporting the relevant off-label use.

For MF/SS initial therapy, the regimen must either not exceed 1 mg/kg on days 1, 8, 15, and 22 of the first 28-day cycle and days 1 and 15 of each subsequent cycle, or have supporting evidence.
For ATLL, the dose must be within the FDA maximum limit for any FDA-approved indication or have supporting evidence.
For continuation dose increases, the new dose must either not exceed 1 mg/kg on days 1 and 15 of each 28-day cycle or have supporting evidence.
The prescribed regimen must be FDA-approved or recommended by NCCN.

Denial Risk

Unaddressed Non-FDA-Approved Indications

Non-FDA-approved indications not addressed by this policy are not authorized unless sufficient documentation of efficacy and safety is provided under the applicable off-label use policy or evidence of coverage document.

Commercial: CP.CPA.09.
Health Insurance Marketplace: HIM.PHAR.21.
Medicaid: CP.PMN.53.

Unsupported block type: denial_risk noted_tool_error?

Denial Risk

ATLL Failure or Dosing Support Absent

ATLL requests are deficient when first-line therapy failure is not documented or when the requested dose lacks the required FDA-limit, guideline, or peer-reviewed literature support.

Document failure of first-line therapy, such as an applicable regimen listed in Appendix B.
For a dose exceeding the FDA maximum limit for any FDA-approved indication, submit practice guidelines or peer-reviewed literature supporting the relevant off-label use.
The prescribed regimen must be FDA-approved or recommended by NCCN.

Denial Risk

Continuation Response or Treatment History Not Documented

Continuation requests require documentation that the member is receiving Poteligeo for a covered indication and has completed at least one 28-day cycle, is responding positively to therapy, and meets any applicable dose-increase criteria.

Document current receipt through the Centene benefit, or treatment for at least one 28-day cycle for a covered indication.
Document positive response to therapy.
For a dose increase, document that the new dose meets the specified FDA dosing limit or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
The prescribed regimen must be FDA-approved or recommended by NCCN.

AbbreviationSS

Expanded termSézary syndrome

CTCL

AbbreviationCTCL

Expanded termcutaneous T-cell lymphoma

NCCN

AbbreviationNCCN

Expanded organization nameNational Comprehensive Cancer Network

AbbreviationSS

Expanded termSézary syndrome