CAM 149

SIMPONI ARIA (golimumab injection for intravenous use)

Category:Prescription Drug   Last Reviewed:May 2019
Department(s):Medical Affairs   Next Review:May 2020
Original Date:May 2016    

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 with moderately to severely active rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis .

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 

Code Number Description
HCPCS J1602 Injection, golimumab, 1 mg, for intravenous use
ICD-10 Diagnosis

M05.9

Rheumatoid arthritis with rheumatoid factor, unspecified

 

M05.00 – M05.09

Felty's syndrome
 

M05.10 – M05.19

Rheumatoid lung disease with rheumatoid arthritis

  M05.20 – M05.29 Rheumatoid vasculitis with rheumatoid arthritis
  M05.30 – M05.39 Rheumatoid heart disease with rheumatoid arthritis
 

M05.40 – M05.49

Rheumatoid myopathy with rheumatoid arthritis
  M05.50 – M05.59 Rheumatoid polyneuropathy with rheumatoid arthritis
 

M05.60 – M05.69

Rheumatoid arthritis with involvement of other organs and systems
  M05.70 – M05.79 Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
  M05.80 – M05.89

Other rheumatoid arthritis with rheumatoid factor

  M06.00 – M06.09 Rheumatoid arthritis without rheumatoid factor
 

M06.20 – M06.29

Rheumatoid bursitis
 

M06.30 – M06.39

Rheumatoid nodule
  M06.4 Inflammatory polyarthropathy
  M06.80 – M06.89 Other specified rheumatoid arthritis
 

M06.9

Rheumatoid arthritis, unspecified
 

M06.9

Rheumatoid Arthritis

 

M12.00 – M12.09

Chronic postrheumatic arthropathy (Jaccoud)

 

M45.0

Ankylosing spondylitis of multiple sites in spine

 

M45.1 

Ankylosing spondylitis of occipito-atlanto-axial region 

 

M45.2

Ankylosing spondylitis of cervical region 

 

M45.3 

Ankylosing spondylitis of cervicothoracic region 

 

M45.4 

Ankylosing spondylitis of thoracic region 

 

M45.5 

Ankylosing spondylitis of thoracolumbar region 

 

M45.6 

Ankylosing spondylitis lumbar region 

 

M45.7 

Ankylosing spondylitis of lumbosacral region 

 

M45.8 

Ankylosing spondylitis sacral and sacrococcygeal region

 

M45.9 

Ankylosing spondylitis of unspecified sites in spine 

 

L40.50

Psoriasis unspecified

 

L40.51 

Distal interphalangeal psoriatic arthropathy

 

L40.52 

Psoriatic arthritis mutilans 

 

L40.53

Psoriatic spondylitis 

 

L40.54 

Psoriatic juvenile arthropathy 

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 and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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

History From 2016 Forward     

05/01/2019 

Annual review, no change to policy intent. 

07/9/2018 

Interim review, removing "who have failed treatment with or cannot tolerate treatment with Humira and Enbrel" related to RA, psoriatric arthritis and ankylosing spondylitis. No other changes made. 

06/04/2018

Interim review adding coverage for psoriatic arthritis and ankylosing spondylitis. Updating coding to include those issues. 

05/21/2018 

Typo correction in history.  Should read. Annual review, updating policy verbiage to include that this medication is for adults who have failed treatment or cannot tolerate treatment with Enbrel and Humira. No other changes made 

05/02/2018 

Annual review, updating policy verbiage to include that this medication is for adults who have failed treatment of cannot tolerate treatment with Enbrel and Humira. No other changes made. 

05/16/2017 

Annual review, no change to policy intent. 

05/02/2016

NEW POLICY


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