BlueCross BlueShield of Tennessee Medical Policy Manual

Mogamulizumab-kpkc

NDC CODE(S)

42747-0761-XX Poteligeo 20 MG/5ML SOLN (KYOWA KIRIN)

DESCRIPTION

Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells.  It is an IgG1 kappa immunoglobulin that binds to CCR4, a G protein-coupled receptor for CC chemokines involved in the trafficking of lymphocytes to various organs.  Binding targets the 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 expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications 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

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 months and may be renewed

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexicomp Online. (2018, September). AHFS DI. Mogamulizumab-kpkc. Retrieved October 1, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, August). Mogamulizumab-kpkc. Retrieved October 1, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Mogamulizumab-kpkc. Retrieved October 1, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, August). Center for Drug Evaluation and Research. POTELIGEO® (mogamulizumab-kpkc) injection, for intravenous use. Retrieved October 1, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  1/31/2019

MOST RECENT REVIEW DATE:  1/31/2019

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

All indications 1 billable unit = 4 mg

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