Medical Policy
Effective Date:01/01/2010 Title:Simponi Aria
Revision Date:01/01/2022 Document:BI261:00
CPT Code(s):J1602
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Simponi Aria requires pre-authorization.

2)    Simponi requires pre-authorization through the contracted PBM (MagellanRx). Simponi is a self-injectable medication used to treat active psoriatic arthritis, moderate-to-severe rheumatoid arthritis when other treatments have failed, ankylosing spondylitis and ulcerative colitis. Simponi must be obtained through the contracted specialty pharmacy

3)    Simponi Aria is an intravenous drug used to treat moderate-to-severe rheumatoid arthritis when other treatments have failed, psoriatic arthritis, and ankylosing spondylitis. Simponi Aria is a specialty drug that is billed through the medical benefit.
Medical Statement

Simponi Aria is considered medically necessary for the treatment of adult members 18 years of age or older with any of the following conditions 1-3; and for condition 4 for members 2 years of age and older.

  1. Moderately-to-severely active rheumatoid arthritis (at least 6 swollen and tender joints, 45 minutes of morning stiffness and elevated ESR or CRP, unless patient is on corticosteroids):
    1. Used in combination with Methotrexate.
  2. Active psoriatic arthritis (at least 3 swollen and tender joints):
    1. When used alone or in combination with Methotrexate

3.    Active ankylosing spondylitis with evidence of inflammatory disease.

4.    Active polyarticular Juvenile Idiopathic Arthritis (pJIA)

 

Codes Used In This BI:

 

J1602   Golimumab Injection, 1 mg, IV use
Limits

1)    Simponi is considered experimental/investigational for all other uses.

2)    Because there are no studies supporting concomitant therapy with any two biologics, and because combinations have resulted in increases in serious infections, only one biologic will be covered at a time.
Reference

1.    Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to TNF-{alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate: The GO-FORWARD study. Ann Rheum Dis. 2008 Dec 11. [Epub ahead of print]

2.    Singh AJ, Furst DA, Bharat A, et al.  2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirehumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis.  Arthritis Care & research. 2012;64(5):625-639.

3.    Inman RD, Davis JC Jr, Heijde D, et al. Efficacy and safety of Golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402-3412.

4.    Kavanaugh A, McInnes I, Mease P, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976-986.

5.    U.S. Food and Drug Administration (FDA). FDA approves monthly injectable drug for treating three types of immune-related arthritis. Rockville, MD: FDA, April 24, 2009. Available at: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02000.html.

6.    Centocor Ortho Biotech, Inc. Simponi (Golimumab). Prescribing information. Horsham, PA: April 2009. Available at: http://www.simponi.com/simponi/Prescribing-Information/Prescribing-Information.pdf. 

7.    Simponi Aria Package Insert. Janssen Biotech, Inc. October 2017.

Addendum:

1.    Effective 01/01/2017: Removed prerequisite therapy with both Enbrel and Humira.

2.    Effective 01/01/2018: Added psoriatic arthritis and ankylosing spondylitis as approved indications for Simponi Aria.

3.    Effective 01/01/2020: Updated to include prerequisite therapy for ulcerative colitis.

4.    Effective 1/1/2022: Updated to indicate Simponi requires pre-authorization by the contracted PBM (MagellanRx) using their coverage criteria and is covered under the pharmacy benefit. Simponi Aria requires PA and is covered under the medical benefit.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.