Description
Golimumab (Simponi^®Aria^™) is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, psoriatic arthritis and ankylosing spondylitis.

Tumor necrosis factor (TNF) is a cytokine produced by macrophages and T cells. Its name is based on the original observations 25 years ago that TNF killed tumor cells in vitro. Further research has revealed that TNF has a broad spectrum of biologic activities; in particular, it is a key mediator of inflammation and is produced in response to infection and immunologic injury.

There are a number of TNF alpha blocking agents: etanercept (ENBREL^®, Amgen); adalimumab (HUMIRA^®, Abbott); certolizumab (CIMZIA^®, UCB) administered via subcutaneous injection; infliximab (REMICADE^® Centocor); and Golimumab (Simponi), administered via self-injection or intravenous (IV) infusion in the physician's office, outpatient setting or infusion center. 

Policy 
Simponi Aria is considered MEDICALLY NECESSARY for adult members who have tried and failed two self injectable therapies in addition to the following:

Moderately to severely active rheumatoid arthritis (RA) after trial and failure, contraindication or intolerance to one or more DMARDs (disease-modifying antirheumatic drugs ( i.e., methotrexate, sulfasalazine, leflunamide, or azathioprine)

Psoriatic arthritis (children > 2 and adolescents) 

Ankylosing spondylitis after trial and failure of two NSAIDS

Polyarticular juvenile idiopathic arthritis (PJIA) (children > 2 and adolescents) after trial and failure, contraindication, or intolerance to one of the following non-biologic disease-modifying antirheumatic drugs (DMARDs): Arava (leflunomide) or methotrexate (Rheumatrex/Trexall)

Simponi Aria must be prescribed in combination with methotrexate (MTX), unless the member has a contraindication or intolerance to MTX.

Contraindications to MTX — Examples:

• History of intolerance or adverse event
• Alcoholic liver disease or other chronic liver disease
• Elevated liver transaminases
• Interstitial pneumonitis or clinically significant pulmonary fibrosis
• Renal impairment
• Pregnancy or planning pregnancy (male or female)
• Breastfeeding
• Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia)
• Myelodysplasia
• Hypersensitivity
• Significant drug interaction

Golimumab (Simponi^®Aria^™) is considered NOT MEDICALLY NECESSARY when the criteria stated above are not met.

Golimumab (Simponi^®Aria^™) is considered NOT MEDICALLY NECESSARY for patients with an active infection, invasive fungal infections, Hepatitis B, malignancies, heart failure, demyelinating disease.

Golimumab (Simponi^®Aria^™) is considered NOT MEDICALLY NECESSARY when used in combination with Abatacept, Anakinra and live vaccines. 

Policy Guidelines
According to the Food and Drug Administration (FDA)-approved labeling for Golimumab (Simponi Aria), the dose for the intravenous infusion route is 2mg/kg over 30 minutes at weeks 0 and 4, then every 8 weeks.

Serious and sometimes fatal infections due to tuberculosis (TB), bacterial sepsis, invasive fungal and other opportunistic infections and pathogens have been reported in patients. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment. 

References 

1. Simponi Aria. Horsham, PA: Janssen Biotech, Inc.; December 2014
2. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014; 73:492-509.
3. Singh JA, Furst De, Bharat A, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639
4. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008; 59(6):762-784.
5. Simponi (golimumab). Product Information. Centocor Ortho Biotech, Inc. 2010.
6. Barclay L. Guidelines Issued for Management of Psoriatic Arthritis. (From guidelines in the October 24, 2008 Online First issue of the Annals of the Rheumatic Disease.) http://cme.medscape.com/viewarticle/582664; accessed May 1, 2009.
7. U.S. Food and Drug Administration. Prescribing information. Retrieved 8/9/13 from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf
8. Medical director- 8/2013
9. Specialty Matched Consultant Review Panel- 2/2014
10. Specialty Matched Consultant Review Panel- 2/2015
11. Specialty Matched Consultant Review Panel- 2/2016 

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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