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vp-0378

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Poteligeo® (mogamulizumab-kpkc)

Policy Number: VP-0378

Intravenous

 

Last Review Date: 10/03/2023

Date of Origin: 09/05/2018

Dates Reviewed: 09/2018, 10/2019, 10/2020, 10/2021, 10/2022, 10/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Poteligeo 20 mg single-dose vial: 24 vials per the first 28 days, then 12 vials each subsequent 28 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • All Indications: 120 billable units (120 mg) days 1,8,15 and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Used as single agent systemic therapy; AND

Mycosis Fungoides (MF)/Sezary Syndrome (SS) † ‡ Ф 1,2,4

  • Used as subsequent therapy; OR
  • Used as primary treatment (excluding use in patients with stage IA mycosis fungoides)

Adult T-Cell Leukemia/Lymphoma 2

  • Used as subsequent therapy in patients with acute or lymphoma subtypes which did not respond to first-line therapy

FDA Approved Indication(s); Compendia Recommended Indications(s); Ф Orphan Drug

  1. Renewal Criteria 1

Coverage can be renewed based on the following criteria:

  • Patient continues to meet the universal and indication-specific relevant criteria identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: dermatologic toxicity (e.g., Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN], etc.), severe infusion reactions, severe infections, autoimmune complications, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.
  1. Dosage/Administration 1,6

Indication

Dose

All Indications

Administer 1 mg/kg intravenously on days 1, 8, 15 and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.

  1. Billing Code/Availability Information

HCPCS Code:

  • J9204 – Injection, mogamulizumab-kpkc, 1 mg; 1 billable unit = 1 mg

NDC(s):

  • Poteligeo 20 mg/5 mL single-dose vial: 42747-0761-xx
  1. References
  1. Poteligeo [package insert]. Bedminster, NJ; Kyowa Kirin, Inc.; March 2023. Accessed September 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for mogamulizumab-kpkc. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.
  3. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) T-Cell Lymphomas Version 1.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.
  4. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) Primary Cutaneous Lymphomas Version 1.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.
  5. Kim YH, Bagot M, Eradat HA, et al. Phase 3 study of anti-CCR4 monoclonal antibody mogalizumab versus vorinostat in relapsed or refractory cutaneous T-cell lymphoma (CTCL). Journal of Clinical Oncology 2014 32:15_suppl, TPS8623-TPS8623.
  6. Phillips AA, Fields P, Hermine O, et al. A prospective, multicenter, randomized study of anti-CCR4 monoclonal antibody mogamulizumab (moga) vs investigator's choice (IC) in the treatment of patients (pts) with relapsed/refractory (R/R) adult T-cell leukemia-lymphoma (ATL). J Clin Oncol. 2016;34(15_suppl):7501-7501.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

Sézary disease, unspecified site

C84.11

Sézary disease, lymph nodes of head, face, and neck

C84.12

Sézary disease, intrathoracic lymph nodes

C84.13

Sézary disease, intra-abdominal lymph nodes

C84.14

Sézary disease, lymph nodes of axilla and upper limb

C84.15

Sézary disease, lymph nodes of inguinal region and lower limb

C84.16

Sézary disease, intrapelvic lymph nodes

C84.17

Sézary disease, spleen

C84.18

Sézary disease, lymph nodes of multiple sites

C84.19

Sézary 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

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

 

 

POTELIGEO® (mogamulizumab-kpkc) Prior Auth Criteria
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