Pharmacy Prior Authorization Criteria

Infliximab – PA, NF

Indications for Prior Authorization

Remicade (infliximab), Infliximab, Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), Renflexis (Infliximab-abda)

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of Ankylosing Spondylitis (AS)
  Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of Sarcoidosis
  Has been used for the treatment of refractory sarcoidosis. [5-7]

Zymfentra (infliximab-dyyb) SC injection

• For diagnosis of Crohn’s Disease (CD)
  Indicated in adults for maintenance treatment of moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously.

• For diagnosis of Ulcerative Colitis (UC)
  Indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

Criteria

Avsola, Inflectra

Prior Authorization (Initial Authorization)

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

• 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 [2, 3]:
• methotrexate
• leflunomide
• sulfasalazine
AND
• Used in combination with methotrexate

Avsola, Inflectra

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 [1-3]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Avsola, Inflectra

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 [4]:
• 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

Avsola, Inflectra

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, 4]:
• 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

Avsola, Inflectra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Diagnosis of chronic severe (i.e., extensive and/or disabling) plaque psoriasis
AND
• One of the following [5]:
• 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 [6]:
• corticosteroids (e.g., betamethasone, clobetasol)
• vitamin D analogs (e.g., calcitriol, calcipotriene)
• tazarotene
• calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
AND
• Prescribed by or in consultation with a dermatologist

Avsola, Inflectra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Patient demonstrates positive clinical response to infliximab therapy as evidenced by ONE of the following [1, 5]
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Avsola, Inflectra

Prior Authorization (Initial Authorization)

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

• Diagnosis of active ankylosing spondylitis
AND
• Prescribed by or in consultation with a rheumatologist
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]

Avsola, Inflectra

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, 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

Avsola, Inflectra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Crohn's Disease (CD) or Fistulizing Crohn's Disease

• One of the following diagnoses:
• Moderately to severely active Crohn's disease
• Fistulizing Crohn's disease
AND
• One of the following [8, 9]:
• 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
• Prescribed by or in consultation with a gastroenterologist
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [8, 9]:
• 6-mercaptopurine
• Azathioprine
• Corticosteroids (e.g., prednisone)
• Methotrexate

Zymfentra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Crohn's Disease (CD)

• Diagnosis of moderately to severely active Crohn's disease
AND
• Patient has achieved a clinical response following a minimum of 10 weeks of IV infliximab
AND
• One of the following:
• Trial of BOTH of the following:
• Avsola
• Inflectra
OR
• Provider attests that continued IV administration is not appropriate for the patient (e.g., problems with IV access)
AND
• Prescribed by or in consultation with a gastroenterologist

Avsola, Inflectra, Zymfentra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Crohn's Disease (CD) or Fistulizing Crohn's Disease

• 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

Zymfentra

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Crohn's Disease (CD)

• Diagnosis of moderately to severely active Crohn's disease
AND
• Patient has achieved a clinical response following a minimum of 10 weeks of IV infliximab
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial of BOTH of the following:
• Avsola
• Inflectra
OR
• Submission of medical records (e.g., chart notes) confirming the provider attests that continued IV administration is not appropriate for the patient (e.g., problems with IV access)
AND
• Prescribed by or in consultation with a gastroenterologist

Avsola, Inflectra

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 [10, 11]:
• 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
• Prescribed by or in consultation with a gastroenterologist
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [10, 11]:
• 6-mercaptopurine
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
• Azathioprine
• Corticosteroids (e.g., prednisone)

Zymfentra

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
• Patient has achieved a clinical response following a minimum of 10 weeks of IV infliximab
AND
• One of the following:
• Trial of BOTH of the following:
• Avsola
• Inflectra
OR
• Provider attests that continued IV administration is not appropriate for the patient (e.g., problems with IV access)
AND
• Prescribed by or in consultation with a gastroenterologist

Avsola, Inflectra, Zymfentra

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, 10, 11]:
• 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

Zymfentra

Non Formulary

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

• Diagnosis of moderately to severely active ulcerative colitis
AND
• Patient has achieved a clinical response following a minimum of 10 weeks of IV infliximab
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial of BOTH of the following:
• Avsola
• Inflectra
OR
• Submission of medical records (e.g., chart notes) confirming the provider attests that continued IV administration is not appropriate for the patient (e.g., problems with IV access)
AND
• Prescribed by or in consultation with a gastroenterologist

Avsola, Inflectra

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Sarcoidosis [Off-label] [12-15]

• Diagnosis of sarcoidosis
AND
• Prescribed by or in consultation with one of the following:
• Pulmonologist
• Dermatologist
• Ophthalmologist
AND
• Trial and failure, contraindication, or intolerance to one corticosteroid (e.g., prednisone)
AND
• Trial and failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, or azathioprine)

Avsola, Inflectra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Sarcoidosis [Off-label] [12-15]

• Patient demonstrates positive clinical response to infliximab therapy

Remicade, Infliximab, Renflexis

Prior Authorization, Non Formulary

Length of Approval: 12 Month(s)

• Patient has one of the following diagnoses:
• Rheumatoid arthritis (RA)
• Psoriatic Arthritis (PsA)
• Plaque Psoriasis (PsO)
• Ankylosing Spondylitis (AS)
• Crohn's Disease (CD) or Fistulizing Crohn's Disease
• Ulcerative Colitis (UC)
• Sarcoidosis (off-label)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of BOTH of the following:
• Avsola
• Inflectra
AND
• Submission of medical records documenting why the covered products have not been effective

P & T Revisions

2024-09-15, 2024-08-02, 2024-07-08, 2024-04-16, 2023-11-07, 2023-10-09, 2023-10-09, 2022-10-23, 2022-08-23, 2022-01-22, 2021-08-04, 2021-06-15, 2021-05-19, 2020-12-09, 2020-12-09, 2020-08-16, 2020-07-18

References

1. Remicade Prescribing Information. Janssen Biotech, Inc. Horsham, PA. October 2021.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
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. 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.
9. 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.
10. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
11. 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.
12. DRUGDEX System [Internet database]. Greenwood Village, Colo: Truven Health Analytics. Updated periodically. Accessed July 7, 2020.
13. 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.
14. 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.
15. Per clinical consult with dermatologist. June 26, 2019.
16. Avsola Prescribing Information. Amgen Inc. Thousand Oaks, CA. September 2021.
17. Inflectra prescribing information. Hospira. Lake Forest, IL. March 2022.
18. Renflexis Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. December 2023.
19. Infliximab Prescribing Information. Janssen Biotech, Inc. Horsham, PA. October 2021.
20. Zymfentra Prescribing Information. Celltrion USA, Inc. Jersey City, NJ. February 2024.

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Revision History

• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
• 2024-08-02: August P&T - Addition of non-formulary criteria for Zymfentra. July P&T - Annual review - Created a separate PA, NF section for the nonpreferred infliximab products to require a diagnosis check, claims or records confirming a minimum duration of a 6-month trial of both of the preferred infliximab products (Avsola and Inflectra), plus documentation why the covered products have not been effective. Attestation stating a trial of one of the preferred products may not be appropriate has been removed.
• 2024-07-08: Annual review - Created a separate PA, NF section for the nonpreferred infliximab products to require a diagnosis check, claims or records confirming a minimum duration of a 6-month trial of both of the preferred infliximab products (Avsola and Inflectra), plus documentation why the covered products have not been effective. Attestation stating a trial of one of the preferred products may not be appropriate has been removed.
• 2024-04-16: Addition of Zymfentra criteria
• 2023-11-07: Updated effective date.
• 2023-10-09: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-09: Program update to standard reauthorization language. No changes to clinical intent.
• 2022-10-23: Further clinical detail and criteria added
• 2022-08-23: Annual review - Updated the rheumatoid arthritis methotrexate criterion to say, "Used in combination with methotrexate" to more closely align with the labeled indication; background updates
• 2022-01-22: Addition of unbranded infliximab
• 2021-08-04: Added separate NF criteria with additional claims/medical records requirements for steps; annual review
• 2021-06-15: Updated formulary strategy
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-09: Updated guideline name and type to say prior authorization, non-formulary (PA, NF).
• 2020-12-09: Addition of Avsola as a preferred step option for Remicade.
• 2020-08-16: Annual review - Sarcoidosis section: added biosimilars; added dermatologist and opthamologist as prescriber options; added step through preferred products for Avsola and Remicade
• 2020-07-18: Addition of new biosimilar Avsola

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