BlueCross BlueShield of Tennessee Medical Policy Manual

Golimumab for Intravenous Infusion

NDC CODE(S)

57894-0350-XX - Simponi Aria 50 MG/4ML SOLN (JANSSEN BIOTECH)

DESCRIPTION

Golimumab is a human IgG1K monoclonal antibody specific for tumor necrosis factor alpha (TNFα), a cytokine protein.  It is considered an immune modulator and TNF-blocker.  Golimumab binds to bioactive forms of human TNFα and inhibits their biological activity by preventing them from binding to their receptors.  Elevated TNFα levels are found in the blood, synovium, and joints in multiple chronic inflammatory conditions.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications 2 mg/kg intravenous infusion at weeks 0, and 4, then every 8 weeks thereafter

Length of Authorization

Coverage will be provided for 6 months and may be renewed

Click here to view DOSAGE LIMITS

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).

No controlled studies were found in the published literature that validate the use of golimumab for intravenous infusion for the treatment or prevention of other conditions or diseases.

SOURCES

Deodhar, A., Reveille, J. D., Harrison, D. D., Kim, L. Lo, K., Leu, J. H., Hsia, E. C. (2017). Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. The Journal of Rheumatology. Retrieved January 11, 2018 from http://www.jrheum.org/content/early/2017/12/18/jrheum.170487.

Kavanaugh, A., Husni, M. E., Harrison, D. D., Kim, L., Lo, K. H., Leu, J. H., Hsia, E., C. (2017, October). Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis and Rheumatology, 69 (11), 2151-2161.

Lexicomp Online. (2018). AHFS DI. Golimumab. Retrieved January 9, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, October). Golimumab. Retrieved January 9, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, October). Center for Drug Evaluation and Research. Simponi Aria® (golimumab) injection for intravenous use. Retrieved January 9, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s018lbl.pdf.

ORIGINAL EFFECTIVE DATE: 9/4/2013

MOST RECENT REVIEW DATE:  3/1/2018

ID_MRx

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/DOSE

All indications

1mg = 1 billable unit

Loading dose - 250 billable units weeks 0 & 4; Maintenance - 250 billable units every 56 days