BBlueCross BlueShield of Tennessee Medical Policy Manual

Tildrakizumab-asmn

NDC CODE(S)

47335-0177-XX Ilumya 100 MG/ML SOSY (SUN PHARMACEUTICALS)

DESCRIPTION

Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Plaque Psoriasis 100 mg subcutaneously at Weeks 0 and 4, then 100 mg every 12 weeks thereafter. Ilumya should be administered by a health care provider only.

LENGTH OF AUTHORIZATION

Coverage will be provided 6 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. Tildrakizumab-asmn. Retrieved November 19, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, August). Tildrakizumab-asmn. Retrieved November 19, 2018 from MICROMEDEX Healthcare Series

U. S. Food and Drug Administration. (2018, March). Center for Drug Evaluation and Research. Ilumya™ (Tildrakizumab-asmn) injection, for subcutaneous use. Retrieved November 19, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf.

ORIGINAL EFFECTIVE DATE: 4/30/2018

MOST RECENT REVIEW DATE:  4/2/2019

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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

MAXIMUM UNITS

Plaque Psoriasis

Loading: 100 mg at Week 0 & 4

 

Maintenance: 100 mg every 12 weeks