Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Mogamulizumab-kpkc (Poteligeo®)

Policy #:08.01.52

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Mogamulizumab-kpkc (Poteligeo®) injection is considered medically necessary and, therefore, covered as monotherapy for individuals 18 years of age or older with a diagnosis of relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS), when all of the following criteria are met:
  • The individual is receiving therapy for one of the following stages of disease:
    • Systemic therapy as primary treatment
      • Stage IA MF with blood B1 involvement, with or without skin-directed therapy
      • Stage IB-IIA MF with blood B1 involvement, with or without skin-directed therapy
      • Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation therapy for limited tumor lesions
      • Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without skin-directed therapy for generalized tumor lesions
      • 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 blood B1 involvement, with or without skin-directed therapy
      • Stage IV Sezary syndrome
    • Systemic therapy as subsequent treatment
      • Stage IA mycosis fungoides (MF) with blood B1 involvement refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies, with or without skin-directed therapy
      • Stage IA MF refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation for limited tumor lesions
      • Stage IA MF refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without skin-directed therapy for generalized tumor lesions
      • Stage IB-IIA MF refractory to multiple previous therapies or progression to > stage IB-IIA
      • Stage IIB MF with limited tumor lesions that is relapsed with T3 limited extent disease or has persistent T3 limited extent disease, with or without local radiation therapy
      • Stage IIB MF with limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapies
      • Stage IIB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapy
      • Stage III MF with blood B1 involvement that is relapsed or persistent, with or without skin-directed therapy
      • Stage IV Sezary syndrome that is relapsed or persistent
  • Prior documented failure, contraindication, or intolerance to at least one systemic therapy including retinoids (bexarotene, all-trans retinoic acid, isotretinoin), interferons (IFN-alpha, IFN-gamma), histone deacetylase inhibitors (vorinostat, romidepsin), methotrexate, brentuximab vedotin. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy.
  • The individuals does not have any of the following:
    • Prior allogeneic hematopoietic stem cell transplant (HSCT) or autologous HSCT within the last 90 days
    • Large cell transformation prior to initiation of the therapy

Mogamulizumab-kpkc (Poteligeo®) injection is considered medically necessary and, therefore, covered for individuals with diagnosis of adult T-Cell Leukemia/Lymphoma, when the following criteria are met:
  • As a second-line therapy (with intention to proceed to high-dose therapy/allogeneic stem cell rescue [HDT/ASCR]) or subsequent therapy to HDT/ASCR as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes.

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.

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/BTNMB Classification and Staging of Mycosis Fungoides and Sezary Syndrome
SkinT1
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
NodeN0
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
VisceralM0
M1

MX
No visceral organ involvement
Visceral involvement (must have pathology confirmation and organ involved should be specified)
Abnormal visceral site; no histologic confirmation
BloodB0


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 ≥30%CD4+/CD26- cells of total lymphocytes

Clinical Staging of MF and SS
TNMB
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] 2018. Available at: https://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/6684461 [via subscription only]. Accessed October 23, 2018.

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 October 23, 2018.

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

Lexi-Drugs Compendium. Mogamulizumab-kpkc. [Lexicomp Online Web site] 10/18/18. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 23, 2018.

Mogamulizumab-kpkc (Poteligeo)® [prescribing information]. Bedminster, NJ: Kyowa Kirin, Inc.; 8/2018. Available online at: https://www.poteligeohcp.com/Content/files/prescribing-information.pdf. Accessed October 23, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Drug & Biologics Compendium. Mogamulizumab-kpkc. [NCCN Web site]. Available at: https://www.nccn.org/professionals/drug_compendium/content/. [via subscription only]. Accessed October 23, 2018.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Mogamulizumab-kpkc. Greenwood Village, CO: [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed October 23, 2018.

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 October 23, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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)



C9038 Injection, mogamulizumab-kpkc, 1 mg

THE FOLLOWING CODE IS USED TO REPRESENT MOGAMULIZUMAB-KPKC (POTELIGEO®)

J3590 Not-otherwise-classified biologics


Revenue Code Number(s)

N/A

Coding and Billing Requirements

If there is no specific HCPCS code available for the drug administered, then the drug must be reported with the most appropriate unlisted code along with the corresponding National Drug Code (NDC).
Cross References

Related Documents


Policy History

Revisions from 08.01.52
01/01/2019This new policy has been issued to communicate the Company’s coverage position for Mogamulizumab-kpkc (Poteligeo®).

Version Effective Date: 01/01/2019
Version Issued Date: 12/31/2018
Version Reissued Date: N/A

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