Commercial

Medical Policy

Notification

Mogamulizumab-kpkc (Poteligeo®)

Notification Issue Date:

This version of the policy will become effective 12/16/2019.

The policy has been updated to communicate changes based on National Comprehensive Cancer Network (NCCN).

Title:

Mogamulizumab-kpkc (Poteligeo®)

Policy #:

08.01.52e

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

ADULT T-CELL LEUKEMIA/LYMPHOMA

Mogamulizumab-kpkc (Poteligeo®) injection is considered medically necessary and, therefore, covered for individuals with a 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 (National Comprehensive Cancer Network [NCCN]-preferred treatment)

MYCOSIS FUNGOIDES OR SEZARY SYNDROME
Mogamulizumab-kpkc (Poteligeo®) injection is considered medically necessary and, therefore, covered as monotherapy for individuals 18 years of age or older with diagnosis of relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy, when any of the following criteria are met:

The individual is receiving primary systemic therapy for one of the following stages of the disease:
- Stage IB-IIA MF, with a higher disease burden (e.g., predominantly plaque disease), in combination with skin-directed therapy in select cases** ([NCCN]-preferred treatment)
- Stage IIB MF with limited tumor lesions, with or without local radiation therapy ([NCCN]-preferred treatment)
- Stage IIB MF with generalized tumor lesions, in combination with skin-directed therapy ([NCCN]-preferred treatment)
- Stage III MF in combination with skin-directed therapy ([NCCN]-preferred treatment)
- Stage IVA1 or IVA2 Sezary syndrome, in combination with skin-directed therapy ([NCCN]-preferred treatment)
- Stage IVA2 non-Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control
The individual is receiving subsequent systemic therapy for one of the following stages of the disease:

Stage IA mycosis fungoides (MF) that is refractory to multiple previous therapies, in combination with skin-directed therapy** ([NCCN]-preferred treatment)
Stage IB-IIA MF that is relapsed with a lower skin disease burden (eg, predominantly patch disease), in combination with skin-directed therapy in selected cases** ([NCCN]-preferred treatment)
Stage IB-IIA MF with a higher skin disease burden (eg, predominantly plaque disease) that is relapsed or persistent with T1-T2 disease, in combination with skin-directed therapy in selected cases** ([NCCN]-preferred treatment)
Stage IB-IIA MF that is refractory to multiple previous therapies, in combination with skin-directed therapy ([NCCN]-preferred treatment)
Stage IIB MF that is relapsed with T1-2 limited tumor lesions, in combination with skin-directed therapy in selected cases** ([NCCN]-preferred treatment)
Stage IIB MF with T3 limited tumor lesions that is relapsed with or without local radiation therapy ([NCCN]-preferred treatment)
Stage IIB MF, that is persistent with T1-3 limited tumor lesions with or without local radiation therapy ([NCCN]-preferred treatment)
Stage IIB MF with limited tumor lesions that is refractory to multiple previous therapies, in combination with skin-directed therapy ([NCCN]-preferred treatment)
Stage IIB MF that is relapsed with T1-2 generalized tumor lesions, in combination with skin-directed therapy in selected cases** ([NCCN]-preferred treatment)
Stage IIB MF that is persistent with T1-3 generalized tumor lesions, in combination with skin-directed therapy ([NCCN]-preferred treatment)
Stage IIB MF with generalized tumor lesions refractory to multiple previous therapies
Stage IIB MF with T3 generalized tumor lesions that is relapsed in combination with or without skin-directed therapy ([NCCN]-preferred treatment)
Stage III MF, that is relapsed or persistent, in combination with skin-directed therapy ([NCCN]-preferred treatment)
Stage III MF, that is refractory to multiple previous therapies, in combination with skin-directed therapies
Stage IVA1or IVA2 Sezary syndrome that is relapsed or persistent in combination with skin-directed therapy ([NCCN]-preferred treatment)
Stage IVA2 that is relapsed or persistent non Sezary or stage IVB visceral disease (solid organ), with or without radiation therapy for local control

NCCN note: *The Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG) have classified ATLL into four subtypes (smoldering, chronic, acute, or lymphoma based on laboratory evaluations (e.g., serum LDH, calcemia, lymphocytosis) and clinical features (e.g., lymphadenopathy, hepatosplenomegaly, skin involvement).

NCCN note:**Systemic therapies should be considered for individuals with extensive skin involvement, higher skin disease burden, predominantly plaque disease, blood involvement, and/or inadequate response to skin-directed therapy

CONTINUATION THERAPY
Mogamulizumab-kpkc (Poteligeo®) is considered medically necessary and, therefore, covered for continuation therapy until disease progression, drug intolerance, unacceptable toxicity, or any other criteria for discontinuation of the therapy.

EXPERIMENTAL/INVESTIGATIONAL

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

MANDATES

PENNSYLVANIA MEMBERS

In accordance with the Commonwealth of Pennsylvania's >Act 6 of 2020< or >Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive agents (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

DRUG INFORMATION

In accordance with US Food and Drug Administration (FDA) prescribing information, mogamulizumab-kpkc (Poteligeo®) is administered as 1 mg/kg as an intravenous infusion 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.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, mogamulizumab-kpkc (Poteligeo®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Mogamulizumab-kpkc (Poteligeo®) was approved by the FDA on August 8, 2018 for for the treatment of the Mycosis Fungoides; Sézary Syndrome. The safety and effectiveness have not been established in pediatric individuals.

National Comprehensive Cancer Network (NCCN) T-Cell Lymphomas Tumor-Node-Metastasis-Blood (TNMB) Classification

	T/N/M/B	TNMB Classification and Staging of Mycosis Fungoides and Sezary Syndrome
Skin	T1 T2 T2a T2b T3 T4	Limited patches, pupules, and/or plaques covering <10% of the skin surface Patches, papules, and/or plaques covering ≥ 10% of the skin surface Patch only Plaque psoriasis patch One or more tumors (≥1cm in diameter) Confluence of erythema ≥80% body surface area
Node	N0 N1 N2 N3 NX	No abnormal lymph nodes; biopsy not required Abnormal lymph nodes; histopathology Dutch Gr 1 or NCI LN 0-2 Abnormal lymph nodes; histopathology Dutch Gr 2 or NCI LN 3 Abnormal lymph nodes; histopathology Dutch Gr 3-4 or NCI LN 4 Abnormal lymph nodes; no histologic confirmation
Visceral	M0 M1 MX	No visceral organ involvement Visceral involvement (must have pathology confirmation and organ involved should be specified) Abnormal visceral site; no histologic confirmation
Blood	B0 B1 B2	Absence of significant blood involvement ≤5% of peripheral blood lymphocytes or <250mcL are atypical (Sezary) cells or <15% CD4+/CD26- or CD4+/CD7 cells of total lymphocytes Low blood tumor burden: >5% of peripheral blood lymphocytes are atypical (Sezary) cells or ≥15% CD4+CD26- or CD4+CD7- of total lymphocytes but do not meet the criteria of B0 or B2 High blood tumor burden: ≥1000/mcL Sezary cells (CD4+/CD26- or CD4+/CD7- cells by flow cytometry) or CD4/CD8≥10 or ≥40% CD4+/CD7- or ≥30Í4+/CD26- cells of total lymphocytes

Clinical Staging of MF and SS

	T	N	M	B
IA IB	1 2	0 0	0 0	0,1 0,1
IIA IIB	1-3 3	1.2 0-2	0 0	0,1 0,1
IIIA IIIB	4 4	0-2 0-2	0 0	0 1
IVA₁ IVA₂ IVB	1-4 1-4 1-4	0-2 3 0-3	0 0 1	2 0-2 0-2

Description

Mogamulizumab-kpkc (Poteligeo®) is a defucosylated humanized antibody directed against the chemokine receptor CCR4, which is over expressed on malignant T cells. Mogamulizumab was approved by the FDA for treatment of adult individuals with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy.

Mycosis fungoides and Sézary syndrome are neoplasias of malignant T lymphocytes that usually possess the helper/inducer cell surface phenotype. These kinds of neoplasms initially present as skin involvement and have been classified as cutaneous T-cell lymphomas. Cutaneous T-cell lymphomas differ from other T-cell lymphomas that involve the skin, such as anaplastic large cell lymphoma (CD30 positive), peripheral T-cell lymphoma (CD30 negative, with no epidermal involvement), adult T-cell leukemia/lymphoma (usually with systemic involvement), or subcutaneous panniculitic T-cell lymphoma.

Adult T-cell leukemia/lymphoma (ATLL) is a mature T-cell neoplasm, and its causative agent has been confirmed to be long-term infection by human T-lymphotropic (HTLV-1) virus type. A recent study demonstrated frequent expression of a chemokine receptor, CC chemokine receptor (CCR)4. Various HTLV-1-associated inflammatory diseases are also commonly characterized by the infiltration of HTLV-1 T cells into target organs.

Mogamulizumab-kpkc (Poteligeo®) 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. Prior to its approval, treatment options consisted of retinoids (bexarotene, all-trans retinoic acid isotretinoin), interferons (IFN-alpha, IFN-gamma), HDAC-inhibitors (vorinostat, romidepsin), methotrexate, brentuximab vedotin, doxorubicin, gemcitabine, etoposide, chlorambucil, pentosatin, cyclophosphamide, temozolomide, bortezomib, pembrolizumab or low dose pralatrexate.

PEER-REVIEWED LITERATURE
SUMMARY

MAVORIC was an open-label, international, phase 3, randomized controlled trial. Between Dec 12, 2012, and Jan 29, 2016, 372 eligible individuals with relapsed or refractory mycosis fungoides or Sézary syndrome were randomly assigned at 61 medical centers. Eligible individuals were aged at least 18 years (in Japan, ≥20 years), had failed (for progression or toxicity as assessed by the principal investigator) at least one previous systemic therapy, and had an Eastern Cooperative Oncology Group performance score of 1 or less and adequate haematological, hepatic, and renal function. Individuals were randomly assigned (1:1) using an interactive voice web response system to mogamulizumab-kpkc (1 mg/kg intravenously on a weekly basis for the first 28-day cycle, then on days 1 and 15 of subsequent cycles) or vorinostat (400 mg daily). Stratification was by cutaneous T-cell lymphoma subtype (mycosis fungoides vs Sézary syndrome) and disease stage (IB–II vs III–IV). The primary endpoint was progression-free survival by investigator assessment in the intention-to-treat population. Individuals who received one or more doses of study drug were included in the safety analyses. Mogamulizumab-kpkc therapy resulted in superior progression-free survival compared with vorinostat therapy (median 7.7 months [95% CI 5.7–10.3] in the mogamulizumab-kpkc group vs 3.1 months [2.9–4.1] in the vorinostat group; hazard ratio 0·53, 95% CI 0·41–0·69; stratified log-rank p<0·0001).

OFF-LABEL INDICATION

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Service (AHFS). Drug Information. Mogamulizumab-kpkc. [Lexicomp Web site] 04/21/23. Available at: https://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/6684461 [via subscription only]. Accessed September 13, 2023.

Elsevier’s Clinical Pharmacology Compendium. Mogamulizumab-kpkc. [Clinical Key Web site]. 08/27/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed September 13, 2023.

Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomized, controlled phase 3 trial. The Lancet Oncology. 2018;19(9):1180-1191.

Lexi-Drugs Compendium. Mogamulizumab-kpkc. [Lexicomp Online Web site] 08/23/23. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed September 13, 2023.

Mogamulizumab-kpkc (Poteligeo)® [prescribing information]. Bedminster, NJ: Kyowa Kirin, Inc.; 3/2022. Available online at: https://www.poteligeohcp.com/Content/files/prescribing-information.pdf. Accessed September 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Drug & Biologics Compendium. Mogamulizumab-kpkc. [NCCN Web site]. 2023. Available at: https://www.nccn.org/professionals/drug_compendium/content/. [via subscription only]. Accessed September 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Adult T-cell Lymphomas V1.2023. [NCCN Web site] subscription required. 01/05/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed September 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Adult Primary Cutaneous Lymphomas V1.2023. [NCCN Web site] subscription required. 01/05/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed September 13, 2023.

Micromedex Healthcare Series. DrugDex®. Mogamulizumab-kpkc (Poteligeo). 08/15/22. Greenwood Village, CO: [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 13, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mogamulizumab-kpkc (Poteligeo)® prescribing information and approval letter [FDA Web site]. 08/08/2018. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed September 13, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mogamulizumab-kpkc (Poteligeo) drug label & approval letter [FDA Web site]. updated 03/30/2022. Available at https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed September 13, 2023.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

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

C84.10 Sezary disease, unspecified site

C84.11 Sezary disease, lymph nodes of head, face, and neck

C84.12 Sezary disease, intrathoracic lymph nodes

C84.13 Sezary disease, intra-abdominal lymph nodes

C84.14 Sezary disease, lymph nodes of axilla and upper limb

C84.15 Sezary disease, lymph nodes of inguinal region and lower limb

C84.16 Sezary disease, intrapelvic lymph nodes

C84.17 Sezary disease, spleen

C84.18 Sezary disease, lymph nodes of multiple sites

C84.19 Sezary disease, extranodal and solid organ sites

C91.50 Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission

C91.52 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in relapse

HCPCS Level II Code Number(s)

J9204 Injection, mogamulizumab-kpkc, 1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 08.01.52e:

10/23/2023

This version of the policy will become effective 10/23/2023.

The policy has been updated to communicate changes based on National Comprehensive Cancer Network (NCCN) for mycosis fungoides (MF) or Sezary syndrome (SS).

Revisions From 08.01.52d:

07/18/2022

This version of the policy will become effective 07/18/2022.

The policy has been updated to communicate changes based on National Comprehensive Cancer Network (NCCN) for mycosis fungoides (MF) or Sezary syndrome (SS).

Revisions From 08.01.52c:

01/18/2021

This version of the policy will become effective on 01/18/2021.

The policy has been updated to communicate changes based on National Comprehensive Cancer Network (NCCN).

Revisions From 08.01.52b:

12/16/2019

This version of the policy will become effective 12/16/2019.

The policy has been updated to communicate changes based on National Comprehensive Cancer Network (NCCN).

Revisions From 08.01.52a:

10/01/2019

This policy has been identified for the HCPCS code update, effective 10/01/2019.

The following HCPCS codes have been termed from this policy:
J3590 Unclassified biologics
C9038 Injection, mogamulizumab-kpkc, 1 mg

The following HCPCS code has been added to this policy:
J9204 Injection, mogamulizumab-kpkc, 1 mg

Revisions From 08.01.52:

01/01/2019

This new policy has been issued to communicate the Company’s coverage position for Mogamulizumab-kpkc (Poteligeo®).

Version Effective Date:

10/23/2023

Version Issued Date:

10/23/2023

Version Reissued Date: