BlueCross BlueShield of Tennessee Medical Policy Manual

Certolizumab Pegol

NDC CODE(S)

50474-0700-XX - Cimzia 200 mg powder for recon (UCB, Inc)

 

50474-0710-XX - Cimzia 200 mg prefilled syringe (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.

REFER TO DECISION SUPPORT TREE

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

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 of other conditions and diseases

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Certolizumab pegol. Retrieved November 7, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, October). Certolizumab pegol.  Retrieved November 7, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, April). Center for Drug Evaluation and Research. Cimzia® (certolizumab pegol) lyophilized powder or solution for subcutaneous use. Retrieved November 7, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125160s241lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/13/2008

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Certolizumab Pegol (Cimzia®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Does the individual meet ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of ankylosing spondylitis that is active with documentation of adequate trial and failure of minimum trial and failure of two (2) non-steroidal anti-inflammatory agents (NSAIDS) unless contraindicated?

If yes, go to question #7

If no, go to question #4

  1. Does the individual have a diagnosis of moderately to severely active Crohn’s disease and response is inadequate to conventional therapy, including one oral immunosuppressive therapy (e.g., 5-aminosalicylates [Asacol®, Pentasa®, Salofalk®, Dipentum®]; corticosteroids, 6-mercaptopurine [Purinethol®], azathioprine [Imuran®]) for at least three months unless use is contraindicated?

If yes, go to question #7

If no, go to question #5

  1. Does the individual have a diagnosis of active psoriatic arthritis that is ANY ONE of the following?

If yes, go to question #7

If no, go to question #6

  1. Does the individual have a diagnosis of moderately to severely active rheumatoid arthritis and ALL of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 400 billable units for loading dose on days 1, 15 and 29 and 400 billable units every 4 weeks, for dosages of ANY ONE of the following for an authorization period of 6 months?

Ankylosing Spondylitis

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

Crohn’s Disease

400mg day 1, 15 & 29; then 400mg every 4 weeks

Psoriatic Arthritis

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

Rheumatoid Arthritis

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

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation of ongoing monitoring for TB and other infections along with absence of unacceptable toxicity from the agent?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response from treatment documented as determined by a diagnosis of ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.