CIMZIA (certolizumab pegol) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O552.15.docx Page 1 of 7
CIMZIA (certolizumab pegol) Description: Cimzia is a tumor necrosis factor (TNF) inhibitor. TNF inhibitors are naturally occurring proteins involved in the body s normal immune responses. Overproduction of TNF can cause inflammation and tissue damage. TNF inhibition may ease certain inflammatory disease symptoms and prevent disease progression. Definitions: Adult: Age 18 years and older Preferred TNF Inhibitor Medications: Enbrel Humira Remicade Conventional systemic therapy for Crohn s disease include, but are not limited to: Azathioprine Corticosteroids Mesalamine Sulfasalazine O552.15.docx Page 2 of 7
CIMZIA (certolizumab pegol) Criteria: See Resources section for FDA-approved dosage. Cimzia is considered medically necessary for adults with documentation of ALL of the following: 1. ONE of the following: Moderately to severely active Crohn s disease in individuals who have had an inadequate response to conventional therapy Moderately to severely active rheumatoid arthritis Active psoriatic arthritis Active ankylosing spondylitis 2. Failure of, contraindication to or intolerance to TWO of the preferred TNF medications Enbrel, Humira, Remicade (refer to, Small Molecules and Biologics Chart #AP94 Administrative Procedure Guideline) 1 3. No evidence of active serious infections including clinically important localized infections or sepsis when initiating or continuing therapy 4. Evidence of testing for latent tuberculosis before Cimzia use and during therapy and any treatment for latent infection has been initiated prior to Cimzia therapy 5. Evidence of testing for hepatitis B infection before Cimzia use and ongoing monitoring in individuals who are known hepatitis B carriers for reactivation of this viral infection during Cimzia therapy 6. No evidence of lupus-like syndrome while on Cimzia therapy 7. Evidence of close monitoring in individuals who have a history of or develop heart failure while on Cimzia therapy 8. Cimzia is not being used concurrently with anakinra (e.g., Kineret ), abatacept (e.g., Orencia ), rituximab (e.g., Rituxan ), natalizumab (e.g., Tysabri ), other biologic DMARDs, TNF antagonists, live vaccines or live attenuated vaccines O552.15.docx Page 3 of 7
Criteria: (cont.) Cimzia for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These indications include, but are not limited to: Inflammatory bowel diseases other than Crohn s disease Ulcerative colitis Treatment with dosing or frequency outside the FDA-approved dosing and frequency 1 Not applicable for current members on Cimzia prior to 07/09/14 or new members who are actively being treated with Cimzia prior to their effective date with BCBSAZ. (Excludes any changes in route of administration, such as changing intravenous delivery to subcutaneous delivery.) Resources: Literature reviewed 01/10/18. We do not include marketing materials, poster boards and nonpublished literature in our review. 1. Biologics & Non-TNF Agents Potentially Winners in the New ACR Guidelines for Early & Experienced Rheumatoid Arthritis (RA) Patients. Specialty Pharma Journal. Received 06/11/2012. O552.15.docx Page 4 of 7
Resources: (cont.) Cimzia Package Insert: - FDA-approved indication and dosage: Indication Adult moderately to severely active Crohn s Disease Recommended Dose Cimzia is administered by subcutaneous injection. 400 mg (given as two injections of 200 mg) initially and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks. Adult moderately to severely active rheumatoid arthritis Adult psoriatic arthritis Adult ankylosing spondylitis 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every other week or alternatively 400 mg every four weeks. 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every other week or alternatively 400 mg every four weeks. 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every two weeks or alternatively 400 mg every four weeks. CIMZA is not recommended for use in pediatric patients. O552.15.docx Page 5 of 7
Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O552.15.docx Page 6 of 7
Multi-Language Interpreter Services: (cont.) O552.15.docx Page 7 of 7