Pharmacy Prior Authorization Criteria

Simponi, Simponi Aria (golimumab)

Indications for Prior Authorization

Simponi (golimumab) - for subcutaneous use

• For diagnosis of Rheumatoid Arthritis (RA)
  In combination with methotrexate, indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

• For diagnosis of Psoriatic Arthritis (PsA)
  Alone or in combination with methotrexate, indicated for the treatment of adult patients with active psoriatic arthritis.

• For diagnosis of Ankylosing Spondylitis (AS)
  Indicated for the treatment of adult patients with active ankylosing spondylitis.

• For diagnosis of Ulcerative Colitis (UC)
  Indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine or 6-mercaptopurine for: (1) inducing and maintaining clinical response, (2) improving endoscopic appearance of the mucosa during induction, (3) inducing clinical remission, and (4) achieving and sustaining clinical remission in induction responders.

Simponi Aria (golimumab) - for intravenous use

• For diagnosis of Rheumatoid Arthritis (RA)
  In combination with methotrexate, indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

• For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
  Indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

• For diagnosis of Psoriatic Arthritis (PsA)
  Indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older.

• For diagnosis of Ankylosing Spondylitis (AS)
  Indicated for the treatment of adult patients with active ankylosing spondylitis.

Criteria

Simponi or Simponi Aria

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Diagnosis of moderately to severely active RA
AND
• Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [3, 4]:
• methotrexate
• leflunomide
• sulfasalazine
AND
• Used in combination with methotrexate
AND
• Prescribed by or in consultation with a rheumatologist

Simponi or Simponi Aria

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-4]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Simponi Aria

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Diagnosis of moderate to severely active PJIA
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [5]:
• leflunomide
• methotrexate

Simponi Aria

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [2, 5]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Simponi or Simponi Aria

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active PsA
AND
• One of the following [6]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Simponi or Simponi Aria

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 2, 6]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
• Reduction in the body surface area (BSA) involvement from baseline

Simponi or Simponi Aria

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Diagnosis of active ankylosing spondylitis
AND
• Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [7]
AND
• Prescribed by or in consultation with a rheumatologist

Simponi or Simponi Aria

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 2, 7]:
• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count

Simponi

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• One of the following [8, 9]:
• Greater than 6 stools per day
• Frequent blood in the stools
• Frequent urgency
• Presence of ulcers
• Abnormal lab values (e.g., hemoglobin, ESR, CRP)
• Dependent on, or refractory to, corticosteroids
AND
• One of the following:
• Patient is corticosteroid dependent (i.e., an inability to successfully taper corticosteroids without a return of the symptoms of UC)
OR
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [1, 8, 9]
• 6-mercaptopurine
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
• Azathioprine
• Corticosteroids (e.g., prednisone)
AND
• Prescribed by or in consultation with a gastroenterologist

Simponi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 8, 9]:
• Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
• Reversal of high fecal output state

P & T Revisions

2024-10-07, 2023-10-30, 2022-10-24, 2021-11-04, 2021-09-27, 2021-05-26, 2021-05-25, 2020-12-03, 2019-12-10

References

1. Simponi Prescribing Information. Janssen Biotech Inc. Horsham, PA. September 2019.
2. Simponi Aria Prescribing Information. Janssen Biotech, Inc. Horsham, PA. February 2021.
3. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
4. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
5. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
6. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
7. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
8. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
9. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.

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Revision History

• 2024-10-07: Annual review - no criteria changes; background updates
• 2023-10-30: Annual review - Updated standard reauth criteria verbiage to "Patient demonstrates..."
• 2022-10-24: Further clinical detail and criteria added; annual review - updated verbiage for the methotrexate requirement with RA to match the labeling, and updated UC initial approval duration to 6 months
• 2021-11-04: Annual review
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-03: Addition of criteria for new PJIA indication; updated PsA indication to include pediatric patients; Annual review - background and reference updates
• 2019-12-10: Added examples of NSAIDs in the ankylosing spondylitis section; removed criterion regarding use in combination with another biologic agent

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