BlueCross BlueShield of Tennessee Medical Policy Manual

Certolizumab Pegol

NDC CODE(S)

50474-0700-XX - Cimzia 400 mg Kit - powder for injection (UCB, Inc)

 

50474-0710-XX - Cimzia 200 mg prefilled syringe & Starter Kit (UCB, Inc)

DESCRIPTION

Certolizumab pegol is a biologic response modifier classified as a tumor necrosis factor (TNF) inhibitor.  It is composed of a fragment antigen-binding (Fab fragment) of a recombinant, humanized anti-TNF monoclonal antibody fused to a polyethylene glycol moiety (pegylation) to delay metabolism and elimination.  The particular Fab fragment of certolizumab pegol is specific for human TNF alpha, a key pro-inflammatory cytokine with a central role in the inflammatory process.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Ankylosing Spondylitis

400mg at day 1, 15 and 29; then 200mg every other week or 400mg every 4 weeks thereafter

Crohn’s Disease

400mg at day 1, 15 and 29; then 400mg every 4 weeks thereafter

Psoriatic Arthritis

400 mg at day 1, 15, and 29; then 200mg every other week or 400mg every 4 weeks thereafter

Rheumatoid Arthritis

400mg at day 1, 15 and 29; then 200mg every other week or 400mg every 4 weeks thereafter

LENGTH OF AUTHORIZATION

Coverage will be provided for six 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 certolizumab pegol for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2018). AHFS DI. Certolizumab pegol. Retrieved February 19, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Certolizumab pegol.  Retrieved February 19, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Cimzia® (certolizumab pegol) lyophilized powder or solution for subcutaneous use. Retrieved February 19, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/13/2008

MOST RECENT REVIEW DATE:  3/13/2018

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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; 1 billable unit = 1 mg

Diagnosis

Dosage

All indications

Loading dose - 400 billable units on days 1, 15 and 29

Maintenance Dose - 400 billable units every 4 weeks