Coverage Policy Manual
Policy #: 2021010
Category: Pharmacy
Initiated: June 2021
Last Review: March 2025
  Mogamulizumab- kpkc (e.g., Poteligeo)
Description:
Mogamulizumab- kpkc is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult individuals with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells. (Poteligeo, 2025)
 
Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some T-cell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells. (Poteligeo, 2025)
 
Mycosis fungoides (MF) and Sézary syndrome (SS) are subtypes of cutaneous T-cell lymphomas (CTCL), which are rare non-Hodgkin lymphomas characterized by skin involvement. MF is the most common form of CTCL and presents on the skin as lesions, plaques, and generalized erythroderma. MF progresses slowly and can have extracutaneous involvement of the lymph nodes, blood, and less commonly other organs in advanced disease. SS is rarer, yet more aggressive, and is characterized by erythroderma, lymphadenopathy, and blood involvement with cancerous T-cells. MFSS together represent two-thirds of all CTCL. The median overall survival of individuals with advanced stages of MFSS is roughly 5 years. There is no curative treatment for CTCL other than allogeneic hematopoietic stem cell transplantation. Treatment resistant or advanced disease requires systemic treatment, and individuals often experience disease progression or resistance to standard systemic therapies. (Poteligeo, 2025)
 
Regulatory Status
 
Mogamulizumab-kpkc (e.g., Poteligeo) was approved by the U.S. Food and Drug Administration (FDA) in August 2018.
 
Coding
 
See CPT/HCPCS Code section below.
Policy/
Coverage:
Prior Approval is required for Mogamulizumab- kpkc (e.g., Poteligeo).     
 
Effective August 1, 2021, for members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program.
 
Approval timeframes may differ for members/participants of Self-Insured plans.
 
Effective March 12, 2025
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Mogamulizumab-kpkc (e.g., Poteligeo) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
For FDA labeled indications, Mogamulizumab-kpkc (e.g., Poteligeo) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
 
For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication in the dosage and administration section.
 
FDA Labeled Indications
 
The use of this drug is covered if an FDA-approved oncologic indication exists [not listed as an indication below with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”)].
 
INITIAL APPROVAL STANDARD REVIEW for up to 12  months:
 
1. Individual is 18 years of age or older (Poteliegeo, 2025); AND
2. Individual is diagnosed with relapsed or refractory mycosis fungoides or Sezary syndrome after at least one prior systemic therapy (Poteligeo, 2025; NCCN 2A); AND
3. Individual does not have the following conditions:
a. No recent (less than 90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT (Kim, 2018); OR
b. No evidence of CNS metastases (Kim, 2018); OR
c. No evidence of active autoimmune disease (psoriasis, Grave’s disease, SLE, RA, etc.) (Poteligeo, 2025; Kim, 2018).
 
CONTINUED APPROVAL for up to 12 months:
 
1. Continuous use mogamulizumab-kpkc treatment previously; AND
2. A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease.
 
Off Label Indications
 
The use of this drug for off-label indications not listed below is subject to policy 2000030.
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):
 
1. Primary Cutaneous Lymphomas:
a. Mycosis Fungoides/Sezary Syndrome (NCCN 2A); OR
2. T-Cell Lymphomas:
a. Adult T-Cell Leukemia/Lymphoma (NCCN 2A); AND
3. Individual does not have the following conditions:
a. No recent (less than 90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT (Kim, 2018); OR
b. No evidence of CNS metastases (Kim, 2018); OR
c. No evidence of active autoimmune disease (psoriasis, Grave’s disease, SLE, RA, etc.) (Poteligeo, 2025; Kim, 2018).
 
CONTINUED APPROVAL for up to 12 months:
 
1. Continuous use mogamulizumab-kpkc treatment previously; AND
2. A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease.
 
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications.
 
Policy Guidelines
 
Prescribing physician responsible for confirming individual does not have an active viral infection (HIV, hepatitis A, hepatitis B, hepatitis C, herpes; etc.)
 
Dosage and Administration
Dosing per FDA Guidelines unless otherwise specified below.
 
The recommended dose for mogamulizumab-kpkc is 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle.
 
Do not administer subcutaneously or by rapid intravenous administration.
 
Mogamulizumab-kpkc is available as 20 mg/5 mL (4 mg/mL) solution in a single-dose vial.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Mogamulizumab-kpkc (e.g., Poteligeo) for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 20, 2024 to March 11, 2025
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Mogamulizumab-kpkc (e.g., Poteligeo) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
FDA Labeled Indications
 
For FDA labeled indications, all products must be dosed in accordance with the FDA label unless otherwise specified.
 
INITIAL APPROVAL STANDARD REVIEW for up to 12  months:
 
1. Indivdiual is 18 years of age or older (Poteliegeo, 2022); AND
2. Individual is diagnosed with one of the following stages of relapsed or refractory mycosis  fungoides or Sezary syndrome after at least one prior systemic therapy (Poteligeo, 2022):
a. Stage IA MF that is refractory to multiple previous therapies, with or without skin-directed therapy (NCCN 2A); OR
b. Relapsed stage IB-IIA MF with a lower skin disease burden (e.g., predominantly patch disease), in combination with skin-directed therapy in selected cases (NCCN 2A); OR
c. Stage IB-IIA MF with a higher disease burden (e.g., predominantly patch disease), that is relapsed or persistent with T1-T2 disease, with or without skin-directed therapy (NCCN 2A); OR
d. Stage IB-IIA MF that is refractory to multiple previous therapies, in combination with skin-directed therapy (NCCN 2A); OR
e. Relapsed stage IIB MF with T1-2 limited tumor lesions, in combination with skin-directed therapy in selected cases (NCCN 2A); OR
f. Relapsed stage IIB T3 MF with limited tumor lesions, with or without local radiation therapy and with or without skin-directed therapy (NCCN 2A); OR
g. Persistent stage IIB T1-3 MF with limited tumor lesions, with or without local radiation therapy and with or without skin-directed therapy (NCCN 2A); OR
h. Stage IIB MF with limited tumor lesions that is refractory to multiple previous therapies, in combination with skin-directed therapy (NCCN 2A); OR
i. Relapsed stage IIB T1-2 MF with generalized tumor lesions, in combination with skin-directed therapy in selected cases (NCCN 2A); OR
j. Relapsed stage IIB T3 MF with generalized tumor lesions, in combination with skin-directed therapy (NCCN 2A); OR
k. Persistent stage IIB T1-3 MF with generalized tumor lesions, in combination with skin-directed therapy (NCCN 2A); OR
l. Stage IIB MF with generalized tumor lesions refractory to multiple previous therapies; OR
m. Relapsed or persistent stage III MF, in combination with skin-directed therapy (NCCN 2A); OR
n. Stage III that is refractory to multiple previous therapies, in combination with skin-directed therapy (NCCN 2A); OR
o. Relapsed or persistent stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy (NCCN 2A); OR
p. Relapsed or persistent stage IVA2 non Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control (NCCN 2A); AND
3. Individual does not have the following conditions:
a. No recent (less than 90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT; AND
b. No evidence of CNS metastases; AND
c. No evidence of active viral infection (HIV, hepatitis A, B, or C, herpes, etc.); AND
d. No evidence of active autoimmune disease (psoriasis, Grave’s disease, SLE, RA, etc.).
 
CONTINUED APPROVAL for up to 12 months:
 
1. Continuous use mogamulizumab-kpkc treatment previously; AND
2. A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease.
 
Off Label Indications
 
For off-label indications, authorizations will not exceed 1 mg/kg administered as up to 4 doses over a 28-day cycle for induction or up to 2 maintenance doses over a 28 day cycle unless medical literature supports a higher dose.
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Primary Cutaneous Lymphomas
a. Mycosis Fungoides/Sezary Syndrome
i. Preferred systemic therapy as primary treatment of mycosis fungoides (MF) or Sezary syndrome (NCCN 2A) for:
1. Stage IB-IIA MF in combination with skin-directed therapy in selected cases.
2. Stage IIB MF with limited tumor lesions, with or without local radiation therapy.
3. Stage IIB MF with generalized tumor lesions, with or without in combination with skin-directed therapy.
4. Stage III MF, in combination with skin-directed therapy.
5. Stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy.
6. Stage IVA2 non-Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control; OR
2. T-Cell Lymphomas
a. Adult T-Cell Leukemia/Lymphoma
i. Preferred second-line  or subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes; AND
3. Individual does not have the following conditions:
a. No recent (less than 90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT; AND
b. No evidence of CNS metastases; AND
c. No evidence of active viral infection (HIV, hepatitis A, B, or C, herpes, etc.) ; AND
d. No evidence of active autoimmune disease (psoriasis, Grave’s disease, SLE, RA, etc.)
 
CONTINUED APPROVAL for up to 12 months:
 
1. Continuous use mogamulizumab-kpkc treatment previously; AND
2. A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease.
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria  (See policy #2000030).
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dose for mogamulizumab-kpkc is 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle.
 
Do not administer subcutaneously or by rapid intravenous administration.
 
Mogamulizumab-kpkc is available as 20 mg/5 mL (4 mg/mL) solution in a single-dose vial.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Mogamulizumab-kpkc (e.g., Poteligeo) for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 2023 to March 19, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIATION OF THERAPY
 
The use of Mogamulizumab-kpkc meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adult individuals (≥18 years old) (FDA Poteligeo, 2021) for the following indications:
 
    1. Preferred systemic therapy as primary treatment of mycosis fungoides (MF) or Sezary syndrome (NCCN 2A) for:
a.  stage IB-IIA MF in combination with skin-directed therapy in selected cases.
b.  stage IIB MF with limited tumor lesions, with or without local radiation therapy
c.  stage IIB MF with generalized tumor lesions, with or without skin-directed therapy
d.  stage III MF, in combination with skin-directed therapy
e.  stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy.
f.  stage IVA2 non-Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control
 
OR
 
2.  Preferred systemic therapy as subsequent treatment of mycosis fungoides (MF) or Sezary syndrome  (NCCN 2A) for:
a.  stage IA MF that is refractory to multiple previous therapies, with or without skin-directed therapy
b.  relapsed stage IB-IIA MF with a lower skin disease burden (e.g., presdominantly patch disease), in combination with skin-directed therapy in selected cases.
c.  stage IB-IIA MF with a higher disease burden (e.g., predominantly patch disease), that is relapsed or persistent with T1-T2 disease, with or without skin-directed therapy.  
d.  stage IB-IIA MF that is refractory to multiple previous therapies, in combination with skin-directed therapy
e.  relapsed stage IIB mF with T1-2 limited tumor lesions, in combination with skin-directed therapy in selected cases
f.  relapsed stage IIB MF with T3 limited extent, with or without local radiation therapy
g.  persistent stage IIB MF with T1-3 limited tumor lesions, with or without local radiation therapy
h.  stage IIB MF with limited tumor lesions that is refractory to multiple previous therapies, in combination with skin-directed therapy
i.  relapsed stage IIB MF with T1-2 generalized tumor lesions, in combination with skin-directed therapy in selected cases
j.  relapsed stage IIB MF with T3 generalized tumor lesions, with or without skin-directed therapy
k.  persistent stage IIB MF with T1-3 generalized tumor lesions, with or without skin-directed therapy
l.  stage IIB MF with generalized tumor lesions refractory to multiple previous therapies
m.  relapsed or persistent stage III MF, with or without skin-directed therapy
n.  stage III MF that is refractory to multiple previous therapies, with or without skin-directed therapy
o.  relapsed or persistent stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy
p.  relapsed or persistent stage IVA2 non Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control
OR
 
The use of Mogamulizumab-kpkc meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adult individuals (≥18 years old) with Adult T-Cell Leukemia/lymphoma for the following indications (NCCN 2A):
 
1.  Preferred second-line as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes; or
2.  Subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes.
 
AND
 
None of the below conditions exist:
 
1.  Individual has no recent (<90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT
2.  Individual has no evidence of CNS metastases
3.  Individual has no evidence of active viral infection [HIV, hepatitis A, B, or C, herpes, etc]
4.  Individual has no evidence of active autoimmune disease [psoriasis, Grave’s disease, SLE, RA, etc]
 
CONTINUATION OF THERAPY
 
Continuation of treatment with mogamulizumab-kpkc beyond 12 months after initiation of therapy for the treatment of mycosis fungoides or Sézary syndrome meets member benefit primary coverage criteria that be scientific evidence of effectiveness in improving health outcomes when the following criteria are met:
 
1.  Continuous use mogamulizumab-kpkc treatment previously; AND
2.  A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria  (See policy #2000030).
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dose for mogamulizumab-kpkc is 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle
 
Do not administer subcutaneously or by rapid intravenous administration.
 
Mogamulizumab-kpkc is available as 20 mg/5 mL (4 mg/mL) solution in a single-dose vial.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of mogamulizumab-kpkc does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any  indication or circumstance other than those outlined above.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 9, 2022 to February 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIATION OF THERAPY
 
The use of Mogamulizumab-kpkc meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of adult patients (≥18 years old) (FDA Poteligeo, 2021) for the following indications:
 
  • Preferred systemic therapy as primary treatment of mycosis fungoides (MF) or Sezary syndrome (NCCN 2A) for:
    • stage IB-IIA MF in comvination with skin-directed therapy in selected cases.
    • stage IIB MF with limited tumor lesions, with or without local radiation therapy
    • stage IIB MF with generalized tumor lesions, with or without skin-directed therapy
    • stage III MF, in combination with skin-directed therapy
    • stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy.
    • stage IVA2 non-Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control
 
OR
 
  • Preferred systemic therapy as subsequent treatment of mycosis fungoides (MF) or Sezary syndrome  (NCCN 2A) for:
    • stage IA MF that is refractory to multiple previous therapies, with or without skin-directed therapy
    • relapsed stage IB-IIA MF with a lower skin disease burden (e.g., presdominantly patch disease), in combination with skin-directed therapy in selected cases.
    • stage IB-IIA MF with a higher disease burden (e.g., predominantly patch disease), that is relapsed or persistent with T1-T2 disease, with or without skin-directed therapy.  
    • stage IB-IIA MF that is refractory to multiple previous therapies, in combination with skin-directed therapy
    • relapsed stage IIB mF with T1-2 limited tumor lesions, in combination with skin-directed therapy in selected cases
    • relapsed stage IIB MF with T3 limited extent, with or without local radiation therapy
    • persistent stage IIB MF with T1-3 limited tumor lesions, with or without local radiation therapy
    • stage IIB MF with limited tumor lesions that is refractory to multiple previous therapies, in combination with skin-directed therapy
    • relapsed stage IIB MF with T1-2 generalized tumor lesions, in combination with skin-directed therapy in selected cases
    • relapsed stage IIB MF with T3 generalized tumor lesions, with or without skin-directed therapy
    • persistent stage IIB MF with T1-3 generalized tumor lesions, with or without skin-directed therapy
    • stage IIB MF with generalized tumor lesions refractory to multiple previous therapies
    • relapsed or persistent stage III MF, with or without skin-directed therapy
    • stage III MF that is refractory to multiple previous therapies, with or without skin-directed therapy
    • relapsed or persistent stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy
    • relapsed or persistent stage IVA2 non Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control
 
OR
 
The use of Mogamulizumab-kpkc meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of adult patients (≥18 years old) with Adult T-Cell Leukemia/lymphoma for the following indications (NCCN 2A):
 
  • Preferred second-line as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes; or
  • Subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes.
 
AND
 
None of the below conditions exist:
  • Member has no recent (<90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT
  • Member has no evidence of CNS metastases
  • Member has no evidence of active viral infection [HIV, hepatitis A, B, or C, herpes, etc]
  • Member has no evidence of active autoimmune disease [psoriasis, Grave’s disease, SLE, RA, etc]
 
CONTINUATION OF THERAPY
 
Continuation of treatment with mogamulizumab-kpkc beyond 12 months after initiation of therapy for the treatment of mycosis fungoides or Sézary syndrome meets member benefit primary coverage criteria when the following criteria are met:
 
• Continuous use mogamulizumab-kpkc treatment previously; AND
• A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria  (See policy #2000030).
 
Dosage and Administration
 
  • 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle
  • Do not administer subcutaneously or by rapid intravenous administration.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of mogamulizumab-kpkc does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for any  indications other than those outlined above.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 2022 to March 8, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIATION OF THERAPY
 
The use of Mogamulizumab-kpkc (Poteligeo) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of adult patients (≥18 years old) (FDA Poteligeo, 2021) for the following indications:
 
    • Preferred systemic therapy as primary treatment of mycosis fungoides (MF) or Sezary syndrome (NCCN 2A) for:
        • stage IB-IIA MF with a higher skin disease burden (e.g., predominantly plaque disease), with or without skin-directed therapy
        • stage IIB MF with limited tumor lesions, with or without local radiation therapy
        • stage IIB MF with generalized tumor lesions, with or without skin-directed therapy
        • stage III MF, with or without skin-directed therapy
        • stage IVA1 or IVA2 Sezary syndrome
OR
 
    • Preferred systemic therapy as subsequent treatment of mycosis fungoides (MF) or Sezary syndrome  (NCCN 2A) for:
        • stage IA MF that is refractory to multiple previous therapies, with or without skin-directed therapy
        • stage IB-IIA MF with a higher skin disease burden (e.g., predominantly plaque disease) that is relapsed or persistent with T1-T2 disease, with or without skin-directed therapy
        • relapsed stage IIB MF with T3 limited extent, with or without local radiation therapy
        • persistent stage IIB MF with T1-3 limited tumor lesions, with or without local radiation therapy
        • relapsed stage IIB MF with T3 generalized tumor lesions, with or without skin-directed therapy
        • persistent stage IIB MF with T1-3 generalized tumor lesions, with or without skin-directed therapy
        • relapsed or persistent stage III MF, with or without skin-directed therapy
        • stage III MF that is refractory to multiple previous therapies, with or without skin-directed therapy
        • relapsed or persistent stage IVA1 or IVA2 Sezary syndrome
 
 OR
 
The use of Mogamulizumab-kpkc (Poteligeo) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of adult patients (≥18 years old) with Adult T-Cell Leukemia/lymphoma for the following indications (NCCN 2A):
 
    • Preferred second-line as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes; or
    • Subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes.
 
AND
 
None of the below conditions exist:
    • Member has no recent (<90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT
    • Member has no evidence of CNS metastases
    • Member has no evidence of active viral infection [HIV, hepatitis A, B, or C, herpes, etc]
    • Member has no evidence of active autoimmune disease [psoriasis, Grave’s disease, SLE, RA, etc]
 
CONTINUATION OF THERAPY
 
Continuation of treatment with mogamulizumab-kpkc (Poteligeo) beyond 12 months after initiation of therapy for the treatment of mycosis fungoides or Sézary syndrome meets member benefit primary coverage criteria when the following criteria are met:
 
• Continuous use mogamulizumab-kpkc treatment previously; AND
• A durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria  (See policy #2000030).
 
Dosage and Administration
 
    • 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle
    • Do not administer subcutaneously or by rapid intravenous administration.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of mogamulizumab-kpkc (Poteligeo) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for any  indications other than those outlined above.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc (Poteligeo) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective June 1, 2021 through December 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The use of Mogamulizumab-kpkc (Poteligeo) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of adult patients (≥18 years old) with relapsed or refractory mycosis fungoides or Sézary syndrome.
 
INITIATION OF THERAPY
 
A. None of the below conditions exist:
 
      • recent (<90 days) history of allogeneic or autologous hematopoietic stem cell transplant HSCT
      •  evidence of CNS metastases
      •  evidence of active viral infection [HIV, hepatitis A, B, or C, herpes, etc]
      •  evidence of active autoimmune disease [psoriasis, Grave’s disease, SLE, RA, etc]
 
 
B.  One of the below indications is documented:
 
      • relapsed or refractory mycosis fungoides or Sézary syndrome or after at least one prior systemic* therapy [FDA] (Kim 2018;) and as a single systemic agent, OR
      • diagnosis of adult T-cell leukemia/lymphoma (ATTL), as a second-line or subsequent therapy as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes ([NCCN]-preferred treatment) as a single agent [NCCN 2A]
 
* Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
 
CONTINUATION OF THERAPY
 
Continuation of treatment with mogamulizumab-kpkc (Poteligeo) beyond 12 months after initiation of therapy for the treatment of mycosis fungoides or Sézary syndrome meets member benefit primary coverage criteria when the following criteria are met:
 
• continuous use mogamulizumab-kpkc treatment previously; AND
• a durable clinical benefit has been demonstrated while receiving mogamulizumab-kpkc treatment, with partial or complete response or stable disease
 
The use of this drug is covered if a FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria  (See policy #2000030).
 
Dosage and Administration
 
      • 1 mg/kg as an intravenous infusion over at least 60 minutes of days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle
      • Do not administer subcutaneously or by rapid intravenous administration.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of mogamulizumab-kpkc (Poteligeo) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for any other indications than those outlined above.
 
For members with contracts without primary coverage criteria, mogamulizumab-kpkc (Poteligeo) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
A randomized, open-label, multicenter trial (Study 0761-010) evaluated the efficacy of in adult patients with MF or SS after at least one prior systemic  therapy. Trial randomized 372 patients 1:1 to either mogamulizumab (186 patients; 56% with MF, 44% with SS) or vorinostat (186 patients; 53% with MF, 47% with SS). The trial included patients regardless of tumor CCR4 expression status and excluded patients with histologic transformation, prior allogeneic HSCT, autologous HSCT within 90 days, active autoimmune disease, or active infection. The trial required patients to have ANC ≥1500/μL (≥1000/μL if bone marrow was involved), platelet count ≥100,000/μL (≥75,000/μL if bone marrow was involved), creatinine clearance >50 mL/min or serum creatinine ≤1.5 mg/dL and hepatic transaminases ≤2.5 times ULN (≤5 times ULN if lymphomatous liver infiltration). The dose of mogamulizumab was 1 mg/kg administered intravenously 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 each subsequent cycle. Vorinostat was dosed at 400 mg orally once daily, continuously for 28-day cycles. Treatment continued until disease progression or unacceptable toxicity. Vorinostat-treated patients with disease progression or unacceptable toxicities were permitted to cross over to mogamulizumab.
 
Efficacy was based on investigator-assessed progression-free survival (PFS), which was defined as the time from the date of randomization until documented progression of disease or death. Other efficacy measures included overall response rate (ORR) based on global composite response criteria that combine measures from each disease compartment (skin, blood, lymph nodes and viscera). Responses required confirmation at two successive disease assessments, which included the modified Severity Weighted Assessment Tool, skin photographs, central flow cytometry, and computed tomography .
 
Compared with vorinostat,  mogamulizumab had superior progression-free survival (PFS; 7 versus 4 months) by independent review, ORR (37 versus 2 percent, and 21 versus 7 percent for SS and MF, respectively), and quality of life (measured by Skindex-29 and FACT-G). Infusion-related eruptions and skin eruptions due to drug were reported in 33 and 24 percent of patients treated with mogamulizumab; other reported toxicities were diarrhea (62 percent), nausea (43 percent), thrombocytopenia (31 percent), dysgeusia (29 percent), and elevated serum creatinine (28 percent).
 
Mogamulizumab can deplete normal regulatory T cells (Treg) and may increase the risk of acute graft-versus-host disease in patients who undergo allogeneic hematopoietic cell transplantation soon after mogamulizumab treatment, if administered <50 days after transplant. (Kim, 2018)
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2024. No new literature was identified that would prompt a change in the coverage statement.
 
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2025.
CPT/HCPCS:
J9204Injection, mogamulizumab kpkc, 1 mg
References: 2021 National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf. Accessed on September 01, 2021. Primary Cutaneous Lymphomas v 2.2021. Revised March 4, 2021.

2021 National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™.( NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed September 01, 2021. T-Cell Lymphomas v.1.2021. Revised October 5, 2020.

Hiroshi Ureshino 1 , Kazuharu Kamachi 2 , Shinya Kimuran,(2019) Mogamulizumab for the Treatment of Adult T-cell Leukemia/Lymphoma ,Clin Lymphoma Myeloma Leuk . 2019 Jun;19(6):326-331. doi:10.1016/j.clml.2019.03.004. Epub 2019 Mar 23.

Kim YH, Bagot M, Pinter-Brown L, et al.(2018) Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol 2018; 19:1192.

Poteligeo (package insert). Kyowa Kirin, Inc. Bedminister, NJ.

Poteligeo(2025) package insert Kyowa Kirin, Inc. Bedminister, NJ. 2025.

Yonekura K, Kusumoto S, Choi I et al,(2020) Mogamulizumab for adult T-cell leukemia-lymphoma: a multicenter prospective observational study, Blood Adv. 2020 Oct 27;4(20):5133-5145. doi: 10.1182/bloodadvances.2020003053.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association.