42747-0761-XX Poteligeo 20 MG/5ML SOLN (KYOWA KIRIN)
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.
Mogamulizumab-kpkc is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Adult T-Cell Leukemia/Lymphoma
Mogamulizumab-kpkc for the treatment of other conditions/diseases is considered investigational.
Mogamulizumab-kpkc is considered medically appropriate if ALL of the following:
Individual is/has ALL of the following:
18 years of age or older
Free of active autoimmune disease or active infections
Free from evidence of CNS metastases
Not had a prior allogeneic hematopoietic stem cell transplant (HSCT) or autologous HSCT within the last 90 days
Used as single agent therapy
Diagnosis of ANY ONE of the following:
Mycosis fungoides/Sézary syndrome for ANY ONE of the following:
Relapsed or refractory disease having treatment with at least one previous systemic therapy (Note: topical and/or photochemotherapy cannot be considered systemic therapies)
Primary treatment as systemic therapy
Adult T-Cell Leukemia/Lymphoma in acute disease or disease which did not respond to first-line treatment for ANY ONE of the following:
Second-line therapy prior to high-dose therapy/autologous stem cell rescue (HDT/ASCR
Subsequent therapy to HDT/ASCR
Mogamulizumab-kpkc is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., dermatologic toxicity, severe infusion reactions, fatal and life threatening infections, autoimmune complications, etc.
|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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit