Coverage Policies

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.

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

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.

Golimumab (Simponi) (Centocor Ortho Biotech Inc., Malvern, PA) was approved by the U.S. Food and Drug Administration (FDA) on April 24, 2009 for adults with moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.  It is intended for use in combination with methotrexate (MTX) in patients with rheumatoid arthritis.  It also may be used with or without MTX for active psoriatic arthritis and alone in patients with active ankylosing spondylitis, a chronic inflammatory arthritis of the spine.  For patients with rheumatoid arthritis, active psoriatic arthritis, or active ankylosing spondylitis, corticosteroids, non-biologic disease-modifying anti-rheumatic drugs (DMARDs), and/or non-steroidal anti-inflammatory drugs (NSAIDs) may be continued during treatment with Golimumab. 

In the clinical studies submitted to the FDA by the manufacturer, patients who received Golimumab showed improvements in the signs and symptoms common to their form of arthritis (i.e., rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis).

The safety and efficacy of Golimumab in rheumatoid arthritis were evaluated in 3 multicenter, randomized, double-blind, controlled trials (studies RA-1, RA-2, and RA-3).  Patients (n = 1,542) 18 years of age or older with moderately- to-severely active rheumatoid arthritis diagnosed according to the American College of Rheumatology (ACR) criteria at least 3 months prior to the study, with at least 4 swollen and 4 tender joints were included.  Golimumab was administered subcutaneously at doses of 50 mg or 100 mg every 4 weeks.  Double-blinded controlled efficacy data were collected and analyzed through week 24.  Patients were allowed to continue stable doses of concomitant low dose corticosteroids (equivalent to 10 mg or less of prednisone/day) and/or NSAIDs and patients may have received oral MTX during the trials.  The primary endpoint in study RA-1 and study RA-2 was the percentage of patients achieving an ACR response at week 14 and primary endpoint in study RA-3 was the percentage of patients achieving an ACR 50 response at week 24.  In studies RA-1, RA-2, and RA3, the median duration of rheumatoid arthritis disease was 9.4, 5.7, and 1.2 years; and 99%, 75%, and 54% of the patients used at least one DMARD in the past, respectively.  Approximately 77% and 57% of patients received concomitant NSAIDs and low dose corticosteroids, respectively, in the 3 pooled RA trials.  A greater percentage of patients treated with the combination of Golimumab and MTX achieved ACR responses at week 14 (studies RA-1 and RA-2) and week 24 (studies RA-1, RA-2, and RA-3) versus patients treated with MTX alone.  There was no clear evidence of improved ACR response with the higher Golimumab dose group (100 mg) compared to the lower dose group (50 mg).  In the subset of patients who received Golimumab in combination with MTX (n = 103) in study RA-1, the proportion of patients achieving ACR 20, 50 and 70 responses at week 14 were 40%, 18%, and 13%, respectively, compared with 17%, 6%, and 2%, respectively, in the placebo plus MTX group (n = 107).  ACR responses were observed in 38% of patients treated with the combination of 50-mg Golimumab and MTX at the first assessment (week 4) after the initial Golimumab administration.  In studies RA-1 and RA-2, the 50-mg Golimumab groups demonstrated a greater improvement compared to the control groups in the change in mean Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline to week 24: 0.25 versus 0.05 in RA-1, 0.47 versus 0.13 in RA-2, respectively.  Also, in studies RA-1 and RA-2, the 50-mg Golimumab groups had a greater proportion of HAQ responders (change from baseline > 0.22) compared to the control groups at week 24: 44% versus 28%, 65% versus 35%, respectively.

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.