WHA

SIMPONI, SIMPONI ARIA (golimumab)

Self-Administration (Simponi) – subcutaneous (SC) injection

Office-Administration (Simponi Aria) – intravenous (IV) infusion

 

Indications for Prior Authorization:

 

Simponi (golimumab) for SC use: 

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

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

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

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 IV use:

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

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

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

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

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

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

 

For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA):

  • Documented diagnosis of active PJIA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Request is for Simponi Aria (IV formulation); AND
  • Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses: 
    • methotrexate 
    • leflunomide 
    • sulfasalazine

 

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • One of the following:
    • actively inflamed joints 
    • dactylitis 
    • enthesitis 
    • axial disease 
    • active skin and/or nail involvement; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist.

 

For diagnosis of ankylosing spondylitis (AS):

  • Documented diagnosis of active AS; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses.

 

For diagnosis of Ulcerative Colitis (UC):

  • Documented diagnosis of moderately to severely active UC; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • Request is for Simponi (self-administered SC formulation)
  • One of the following:
    • 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)
    • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
      • 6-mercaptopurine
      • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
      • azathioprine
      • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)

 

Reauthorization Criteria:

 

For diagnosis of RA, PJIA:

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

 

For diagnosis of PsA:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • 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 

 

For diagnosis of AS:

  • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
    • 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 

 

For diagnosis of UC:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • 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

 

Dosing:

 

RA, AS (adults):

  • Simponi Aria IV infusion:
    • Adults: 2 mg/kg intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.
  • Simponi SC injection:
    • Adults: 50 mg administered by subcutaneous injection once a month.

 

PJIA (pediatrics):

  • Simponi Aria IV infusion
    • Pediatrics (2 years of age and older): 80 mg/m^2 intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.

 

PsA (adults and pediatrics):

  • Simponi Aria IV infusion:
    • Pediatrics (2 years of age and older): 80 mg/m^2 intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.
    • Adults: 2 mg/kg intravenous infusion at weeks 0 and 4, and every 8 weeks thereafter.
  • Simponi SC injection:
    • Adults: 50 mg administered by subcutaneous injection once a month.

 

UC (adults):

  • Simponi SC injection:
    • Adults: 200 mg initially administered by subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks.

 

Coverage Duration:

 

RA, AS, PsA, pJIA:

  • Initial: 1 year
  • Reauthorization: 1 year

 

UC:

  • Initial: 6 months
  • Reauthorization: 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:

 

Review History:
  • 07/01/2020 – Annual review
  • 12/11/2020 – Criteria and format updated
  • 10/19/2021 – Added Simponi Aria (IV infusion) criteria to Simponi (SC injection) policy. Added indications specific to Simponi Aria including pJIA: added pJIA indication with criteria including age 2 or older, prescribing in consultation with a rheumatologist, FDA-approved dosing requirement, and trial of methotrexate and Humira; extended initial authorization duration of Simponi for UC from 10 weeks to 3 months.
  • 01/01/2023 – Update prerequisite drugs for RA, PJIA; add symptom requirements for PsA, UC. add reauthorization criteria for all indications; updated coverage duration of initial authorization

 

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. 

Last review date: January 1, 2023