Infliximab Agents (REMICADE [infliximab], infliximab, AVSOLA [infliximab-axxq], INFLECTRA [infliximab-dyyb], RENFLEXIS [infliximab-abda])

Office Administration – intravenous (IV) infusion 

 

Indication for Prior Authorization:

 

Rheumatoid Arthritis (RA): Indicated in combination with methotrexate, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. 

Psoriatic Arthritis (PsA): Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. 

Plaque Psoriasis (PsO): Indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Therapy should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. 

Ankylosing Spondylitis (AS): Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. 

Crohn’s Disease (CD): Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease. 

Pediatric Crohn’s Disease: Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. 

Ulcerative Colitis (UC): Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. 

Pediatric Ulcerative Colitis: Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. 

Sarcoidosis (off-label use): Has been used for the treatment of refractory sarcoidosis. 

 

Coverage Criteria:

 

Diagnosis of Moderate to Severe 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; AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

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; AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of chronic severe (i.e., extensive and/or disabling) PsO; AND
  • Prescribed by or in consultation with a dermatologist; AND
  • One of the following:
    • Greater than or equal to 3% body surface area involvement 
    • Severe scalp psoriasis 
    • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
  • Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: 
    • corticosteroids (e.g., betamethasone, clobetasol) 
    • vitamin D analogs (e.g., calcitriol, calcipotriene) 
    • tazarotene 
    • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
    • anthralin 
    • coal tar; AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

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; AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

For diagnosis of Crohn's Disease (CD) or Fistulizing Crohn's Disease:

  • Documented diagnosis of moderately to severely active Crohn's Disease (CD) or Fistulizing Crohn's Disease; AND 
  • Prescribed by or in consultation with a gastroenterologist; AND
  • One of the following:
    • Frequent diarrhea and abdominal pain 
    • At least 10% weight loss 
    • Complications such as obstruction, fever, abdominal mass 
    • Abnormal lab values (e.g., C-reactive protein [CRP]) 
    • CD Activity Index (CDAI) greater than 220; AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)
    • methotrexate; AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

For diagnosis of Ulcerative Colitis (UC):

  • Documented diagnosis of moderately to severely active UC; AND
  • Diagnosis confirmed by a gastroenterologist; AND
  • 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 
  • 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); AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

For diagnosis of Sarcoidosis [off-label]:

  • Documented diagnosis of sarcoidosis; AND
  • Prescribed by or in consultation with a pulmonologist, dermatologist or ophthalmologist; AND
  • Trial and failure, contraindication, or intolerance to a corticosteroid (e.g., prednisone); AND
  • Trial and failure, contraindication, or intolerance to an immunosuppressant (e.g., methotrexate, cyclophosphamide, or azathioprine); AND
  • For non-preferred infliximab agents: Trial and failure or intolerance to the preferred infliximab agent(s), or attestation demonstrating a trial may be inappropriate.
    • Consult with the medical group for product preference(s).

 

Reauthorization Criteria:

 

For diagnosis of RA:

  • 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 PsO:

  • Documentation of positive clinical response to therapy as evidenced by one of the following:
    • Reduction the body surface area (BSA) involvement from baseline 
    • Improvement in symptoms (e.g., pruritus, inflammation) 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 CD, 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 

 

For diagnosis of Sarcoidosis:

  • Documentation of positive clinical response to therapy. 

 

Dosing:

 

RA (adults): 

  • In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. 
    • Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks. 

 

PsA (adults), PsO (adults), UC (adults), Pediatric UC (age 6 years and older), Pediatric CD (age 6 years and older): 

  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. 

 

CD (adults): 

  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. 
    • Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response. 

 

AS (adults): 

  • 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. 

 

Coverage Duration:

 

PsO, RA, PsA, CD, UC, AS, sarcoidosis:

  • 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:
  • Infliximab agents increase the risk for developing serious infections. Contact a healthcare provider if any symptoms of an infection develop, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections.
  • Perform test for latent tuberculosis (TB); if positive, start treatment for TB prior to starting an infliximab agent. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

 

Policy Updates:
  • 12/2008 – Criteria reviewed.
  • 12/2013 – Criteria reviewed.
  • 11/2016 – Criteria reviewed.
  • 07/2011 – Criteria reviewed.
  • 07/2017 – Criteria reviewed.
  • 01/01/2023 – Updated prerequisite drugs for PsO, CD, UC; added duration of use for prerequisite drugd for RA, PsO, AS; added symptom requirements for PsA, PsO, CD, UC. added criteria for sarcoidosis; and added reauthorization criteria; updated coverage duration of initial authorization

 

References:
  1. 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. 
  2. 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. 
  3. 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. 
  4. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72. 
  5. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70. 
  6. 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. 
  7. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517. 
  8. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508. 
  9. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413. 
  10. 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. 
  11. Baughman RP, Drent M, Kavuru M, et al. Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement Am J Respir Crit Care Med. 2006 Oct 1;174(7):795-802. 
  12. Rossman M, Newman LS, Baughman RP, et al. A double-blinded, randomized, placebo-controlled trial of infliximab in subjects with active pulmonary sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2006;23(3):201-8. 
  13. Inflectra prescribing information. Hospira. Lake Forest, IL. March 2022. 
  14. Renflexis Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. January 2022. 
  15. Avsola Prescribing Information. Amgen Inc. Thousand Oaks, CA. September 2021. 
  16. Infliximab Prescribing Information. Janssen Biotech, Inc. Horsham, PA. October 2021. 
  17. Remicade Prescribing Information. Janssen Biotech, Inc. Horsham, PA. October 2021. 

Last review date: January 1, 2023