DESCRIPTION
Certolizumab pegol, a tumor necrosis factor (TNF) inhibitor, binds and selectively neutralizes TNF-alfa. TNF-alfa is a pro-inflammatory cytokine that plays a key role in the inflammatory process by stimulating the production of downstream inflammatory mediators, such as interleukin-1, prostaglandins, platelet activating factor, and nitric oxide.
An example of a preparation of certolizumab pegol is Cimzia®
REFER TO DECISION SUPPORT TREE
POLICY
Certolizumab pegol for the treatment of Crohn’s disease is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Certolizumab pegol for the treatment of rheumatoid arthritis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Certolizumab pegol for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Certolizumab pegol is considered medically appropriate for ANY ONE of the following conditions:
Crohn's disease with ALL of the following:
The individual is 18 years of age or older
Has moderately to severely active disease
Has had an inadequate response to conventional therapy (e.g., 5-aminosalicylates [e.g., Asacol, Pentasa, Salofalk, Dipentum], or immunosuppressive drugs [e.g., azathioprine and 6-mercaptopurine], or corticosteroids)
Rheumatoid arthritis with ALL of the following:
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
The agent is used as monotherapy or in combination with methotrexate
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., 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/diseases.
SOURCES
Drugs for rheumatoid arthritis. (2009, May). Treatment Guidelines from The Medical Letter, 7 (Issue 81), 1-15.
Lexi-Comp Online. (2009). AHFS DI. Certolizumab pegol. Retrieved June 18, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Certolizumab pegol. Retrieved June 18, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2009, May). Center for Drug Evaluation and Research. FDA Approval Letter. BL 125271/0. Retrieved June 18, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125271s000ltr.pdf.
U. S. Food and Drug Administration. (2009, May). Center for Drug Evaluation and Research. Cimzia (certolizumab pegol). Retrieved June 18, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125271s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/13/2008
MOST RECENT REVIEW DATE: 12/12/2009
ID_BT
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®)
Does the individual have a diagnosis of Crohn’s disease and ALL of the following?
The individual is 18 years of age or older
Has moderately to severely active Crohn's disease
Has had an inadequate response to conventional therapy (e.g., 5-aminosalicylates [e.g., Asacol, Pentasa, Salofalk, Dipentum], or immunosuppressive drugs [e.g., azathioprine and 6-mercaptopurine], or corticosteroids)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of rheumatoid arthritis and ALL of the following?
The individual is 18 years of age or older
Has moderately to severely active rheumatoid arthritis
The agent is used as monotherapy or in combination with methotrexate
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.