Last Review Date: 10/03/2024

Date of Origin: 07/20/2010

Dates Reviewed:  09/2010, 12/2012, 2/2011, 03/2011, 06/2011, 09/2011, 10/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 04/2019, 07/2019, 07/2020, 08/2021, 02/2022, 10/2022, 10/2023, 10/2024

1. Length of Authorization

Initial coverage will be provided for 12 months and may be renewed annually, unless otherwise specified.

• Therapy for the Management of Immune-Checkpoint Inhibitor Related Toxicity and Acute GVHD may not be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

B. Max Units (per dose and over time) [HCPCS Unit]:

• Rheumatoid Arthritis: 40 billing units at weeks 0, 2, 6, then 120 billing units every 28 days
• Ankylosing Spondylitis: 60 billing units at weeks 0, 2, 6, then 60 billing units every 42 days
• Crohn’s Disease & Ulcerative Colitis: 60 billing units at weeks 0, 2, 6 then 120 billing units every 56 days
• Psoriatic Arthritis, Plaque Psoriasis, Behcet’s Uveitis: 60 billing units at weeks 0, 2, 6 then 60 billing units every 56 days
• Management of Immune Checkpoint Inhibitor Related Toxicity: 60 billing units at weeks 0 & 2; no maintenance dosing
• Acute GVHD: 120 billing units at weeks 0, 1, 2, 3; no maintenance dosing

3. Initial Approval Criteria ^1-4

Coverage is provided in the following conditions:

• Patient has been evaluated and screened for the presence of hepatitis B (HBV) infection (i.e., HBsAg and anti-HBc) prior to initiating treatment; AND
• Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

• Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria ^1-4

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Must not be administered concurrently with live vaccines or therapeutic infectious agents (i.e., BCG bladder instillation for bladder cancer, etc.); AND
• Patient is not on concurrent treatment with another biologic therapy (e.g. IL-inhibitor, TNF-inhibitor, integrin receptor antagonist, T cell costimulation modulator, etc.) or targeted synthetic therapy (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND
• Will not be used in patients with moderate or severe heart failure (i.e., New York Heart Association [NYHA] Functional Class III/IV) [Note: Only applies when doses >5 mg/kg are used]; AND

Crohn’s Disease † Ф ^1-4,38,66,88

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate); OR
  • Patient has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of CD

Pediatric Crohn’s Disease † Ф ^1-4,70

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is at least 6 years of age; AND
• Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, etc.); OR
  • Patient has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of CD

Ulcerative Colitis † ^1-4,72,73,82

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe active disease; AND
  • Documented failure or ineffective response to a minimum (3) month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)] at maximum tolerated doses, unless there is a contraindication or intolerance to use; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of UC

Pediatric Ulcerative Colitis † Ф ^1-4,74

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is at least 6 years of age; AND
• Documented moderate to severe active disease; AND
  • Documented failure or ineffective response to a minimum (3) month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)] at maximum tolerated doses, unless there is a contraindication or intolerance to use; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of UC

Fistulizing Crohn’s Disease † ^38,66,88

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient has at least one draining fistula (i.e., enterovesical, enterocutaneous, enteroenteric, or enterovaginal fistulas)

Rheumatoid Arthritis (RA) † ^1-4,64,86

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe active disease; AND
  • Patient has had at least a 3-month trial and failed previous therapy with ONE conventional synthetic disease modifying anti-rheumatic drug (csDMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of RA; AND
• Used in combination with methotrexate (MTX) unless the patient has a contraindication or intolerance

Psoriatic Arthritis (PsA) † ^{1-4,39,41,,84}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe active disease; AND

• For patients with predominantly axial disease OR enthesitis, a failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory drug (NSAID), unless use is contraindicated; OR
• For patients with peripheral arthritis OR dactylitis, a failure of at least a 3-month trial of ONE conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.); OR
• Patient is already established on biologic or targeted synthetic therapy for the treatment of PsA

Ankylosing Spondylitis (AS) † ^1-4,63,87

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented active disease; AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory drugs (NSAIDs) over 4 weeks (in total), unless use is contraindicated; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of AS

Plaque Psoriasis (PsO) † ^{1-4,40,57-59,69,78,79,89}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe chronic disease for at least 6 months with at least one of the following:
  • Involvement of at least 3% of body surface area (BSA); OR
  • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
  • Incapacitation or serious emotional consequences due to plaque location (i.e., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND
• Patient meets ALL of the following ¥:
  • Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, tapinarof, roflumilast, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least one non-biologic systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • Patient did not respond adequately (or is not a candidate**) to a 3-month minimum trial of phototherapy (i.e., psoralens with UVA light [PUVA] or UVB with coal tar or dithranol)

¥ Note: For patients already established on biologic therapy, targeted synthetic therapy, or those with > 10%

 BSA involvement, trial and failure of topical agents, non-biologic systemic agents, and phototherapy is not

required.

Uveitis Associated with Behçet’s Syndrome ‡ ^{8-10,21,22,34,35,83}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient’s disease is refractory to immunosuppressive therapy (e.g., corticosteroids, cyclosporine, azathioprine, etc.); AND
• Patient had an inadequate response to a self-administered biologic therapy (e.g., adalimumab)

Acute Graft Versus Host Disease (aGVHD) ‡ ^43,55,56

• Patient has received an allogeneic hematopoietic stem cell transplant; AND
• Used for steroid-refractory acute GVHD; AND
• Used in combination with systemic corticosteroids as additional therapy following no response to first-line therapies

Management of Immune Checkpoint Inhibitor Related Toxicity ‡ ^36,37,43,76

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, dostarlimab, tremelimumab, retifanlimab, tislelizumab, toripalimab etc.); AND
• Patient has one of the following toxicities related to their immunotherapy:
  • • • • • •  
  • Myocarditis if no improvement within 24-48 hours of starting high-dose methylprednisolone; OR
  • Mild (G1) diarrhea or colitis if persistent or progressive symptoms and positive lactoferrin/calprotectin; OR
  • Moderate (G2) to severe (G3-4) diarrhea or colitis if no response or unable to transition to oral corticosteroids; OR
  • Moderate (G2) pneumonitis if no improvement after 48-72 hours of corticosteroids; OR
  • Severe (G3-4) pneumonitis if no improvement after 48 hours of methylprednisolone; OR
  • Stage 3 acute kidney injury/elevated serum creatinine if toxicity remains >stage 2 after 4-6 weeks of corticosteroids or if creatinine increases during or after steroid taper; OR
  • Uveitis (G1-4) that is refractory to high-dose systemic corticosteroids; OR
  • Moderate to severe inflammatory arthritis; AND
    • Patient’s symptoms have not improved after holding immunotherapy AND one of the following:
      • • Patient has not responded to oral corticosteroids; OR
        • Patient is unable to taper corticosteroids; OR
        • Patient has not had response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (i.e., methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-4

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, malignancy (e.g., lymphoma including hepatosplenic T-cell lymphoma, skin cancers, cervical cancer, etc.), significant hematologic abnormalities (e.g., leukopenia, neutropenia, thrombocytopenia, pancytopenia), serious infections (e.g., TB, serious fungal infections, HBV reactivation, etc.), cardiovascular and cerebrovascular accidents, heart failure, neurotoxicity/ demyelinating disorders, hepatotoxicity, lupus-like syndrome, etc.; AND

Crohn’s Disease ^23,82,92,93

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight regain, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, improvement in biomarker levels [i.e., fecal calprotectin or serum C-reactive protein (CRP)], and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Harvey-Bradshaw Index score].

Pediatric Crohn’s Disease ^23,82,92,93

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight regain, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, improvement in biomarker levels [i.e., fecal calprotectin or serum C-reactive protein (CRP)], and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Harvey-Bradshaw Index score].

Ulcerative Colitis ^24-27,94

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or an improvement on a disease activity scoring tool.

Pediatric Ulcerative Colitis ^24-26,94

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or an improvement on a disease activity scoring tool.

Fistulizing Crohn’s Disease ^23,91

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as a reduction in number of draining fistulas, reduced drainage from fistulas, improvement on imaging (e.g., pelvic CT, pelvic MRI or rectal endoscopic ultrasound) or endoscopy, reduction in rectal pain, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Harvey-Bradshaw Index score, etc.].

Psoriatic Arthritis ^28,62,85

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI), and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].

Rheumatoid Arthritis ^30,31,81

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria, an improvement of disease severity on RAPID3 assessment, etc.].

Ankylosing Spondylitis ^77,87

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)].

Plaque Psoriasis (PsO) ^59,89,90

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. Psoriasis Area and Severity Index (PASI) score ≤ 3, physician’s global assessment (PGA) score ≤ 1, etc.].

Uveitis Associated with Behçet’s Syndrome ^34-35

• Disease response as indicated by an improvement in signs and symptoms compared to baseline [e.g. reduction in inflammation and/or lesions, dose reduction of oral glucocorticoids and/or immunosuppressive agents, improvement in vitreous haze, improvement in best corrected visual acuity (BCVA), disease stability and/or reduced rate of decline].

Acute GVHD ‡ ^55,56

• May not be renewed (Note: Requests for continued therapy beyond four doses will be reviewed on a case-by-case basis.)

Management of Immune Checkpoint Inhibitor Related Toxicity ‡ ⁷⁶

• May not be renewed.

5. Dosage/Administration ^{1-4,36,37,42,56,76}

6. Billing Code/Availability Information

HCPCS Code(s):

• J1745 – Injection, infliximab, excludes biosimilar, 10 mg; 1 billable unit = 10 mg (Includes unbranded biologic)
• Q5103 – Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg: 1 billable unit = 10 mg
• Q5104 – Injection, infliximab-abda, biosimilar, (renflexis), 10 mg; 1 billable unit = 10 mg
• Q5121 – Injection, infliximab-axxq, biosimilar, (avsola), 10 mg: 1 billable unit=10 mg

NDC(s):

• Remicade 100 mg single-dose vial for injection: 57894-0030-xx
• Infliximab 100 mg single-dose vial for injection: 57894-0160-xx (Unbranded biologic*)
• Inflectra 100 mg single-dose vial: 00069-0809-xx
• Renflexis 100 mg single-dose vial: 78206-0162-xx
• Avsola 100 mg single-dose vial for injection: 55513-0670-xx

*An unbranded biologic is the same as the brand biologic, Remicade, using the same cell-line as the brand-name reference biologic.

7. References

1. Remicade/Infliximab [package insert]. Horsham, PA; Janssen Biotech, Inc; October 2021. Accessed September 2024.
2. Inflectra [package insert]. Yeonsu-gu, Incheon, Republic of Korea; CELLTRION, Inc; April 2023. Accessed September 2024.
3. Renflexis [package insert]. Yeonsu-gu, Incheon, Republic of Korea; Samsung Bioepis Co., Ltd; December 2023. Accessed September 2024.
4. Avsola [package insert]. Thousand Oaks, CA; Amgen, Inc; September 2021. Accessed September 2024.
5. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
6. Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. doi: 10.1002/art.39298.
7. Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007;56:31e1-15.
8. Niccoli L, Nannini C, Benucci M, et al. Long-term efficacy of infliximab in refractory posterior uveitis of Behcet’s disease: a 24-month follow-up study. Rheumatology (Oxford). 2007 Jul;46(7):1161-4. Epub 2007 May 3.
9. Giardina A, Ferrante A, Ciccia F, et al. One year study of efficacy and safety of infliximab in the treatment of patients with ocular and neurological Behcet’s disease refractory to standard immunosuppressive drugs. Rheumatol Int 2011;31:33–37.
10. Okada A, Goto H, Ohno S, et al. Multicenter study of infliximab for refractory uveoretinitis in Behcet disease. Arch Ophthalmol 2012;130(5):592-598.
11. Lichtenstein GR, Loftus EV, Isaacs KL, et al. American College of Gastroenterology. Clinical Guideline: Management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481-517.
12. Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
13. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
14. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
15. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
16. National Institute for Health and Clinical Excellence (NICE). Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 Aug. 73 p. (Technology appraisal guidance; no. 195)
17. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
18. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
19. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis.  Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770.
20. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
21. Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
22. Levy-Clarke G, Jabs DA, Read RW, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3. doi: 10.1016/j.ophtha.2013.09.048.
23. National Institute for Health and Care Excellence. NICE 2019. Crohn’s disease: management. Published 03 May 2019. NICE guideline [NG129]. https://www.nice.org.uk/guidance/ng129. Accessed September 2024.
24. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi:  10.1002/ibd.20520
25. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
26. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology  13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
27. Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
28. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed September 2024.
29. National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
30. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 10 October 2012. Clinical Guideline [TA195]. https://www.nice.org.uk/guidance/ta195/resources/adalimumab-etanercept-infliximab-rituximab-and-abatacept-for-the-treatment-of-rheumatoid-arthritis-after-the-failure-of-a-tnf-inhibitor-pdf-82598558287813.
31. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi:  10.1002/art.38705
32. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
33. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
34. Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513.
35. Levy-Clarke G, Jabs DA, Read RW, et al. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3. doi: 10.1016/j.ophtha.2013.09.048.
36. Minor DR, Chin K, Sashani-Sabet M, et al. Infliximab in the treatment of anti-CTLA4 antibody (Ipilimumab) induced immune-related colitis. Cancer Biotherapy & Radiopharmaceuticals. 2009 June; 24 (3). https://doi.org/10.1089/cbr.2008.0607
37. Villadolid J, Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Translational Lung Cancer Research. 2015;4(5):560-575. doi:10.3978/j.issn.2218-6751.2015.06.06.Appendix 1 – Covered Diagnosis Codes
38. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
39. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology. Vol. 0, No. 0, Month 2018, pp 1–28 DOI 10.1002/art.40726
40. 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 Feb 13. pii: S0190-9622(18)33001-9. https://doi.org/10.1016/j.jaad.2018.11.057.
41. American Academy of Dermatology Work Group, Menter A, Korman NJ, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.
42. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
43. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Infliximab. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2024.
44. Strik AS, van de Vrie W, Bloemsaat-Minekus JPJ, et al. Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):404-412.
45. Milassin A, Fabian A, Molnar T. Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective. Therap Adv Gastroenterol. 2019; 12: 1756284819842748.
46. Glintborg B, Sørensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017 Aug;76(8):1426-1431.
47. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017 Feb;76(2):355-363.
48. Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017 Feb;76(2):346-354.
49. Jorgensen KK, Olcen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017 Jun 10;389(10086):2304-2316.
50. Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019 Jun;285(6):653-669.
51. Celltrion. CT-P13 (infliximab biosimilar). Briefing document for the US FDA Arthritis Advisory Committee. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000MedR.pdf
52. Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017 Jan;76(1):58-64.
53. Smolen JS, Choe JY, Prodanovic N, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology (Oxford). 2017 Oct; 56(10): 1771–1779.
54. Chow V, Oh M, Gessner M, Fanjiang G. Pharmacokinetic similarity of ABP 710, a proposed biosimilar to infliximab: results from a randomized, single‐blind, single‐dose, parallel‐group study in healthy subjects. Clin Pharmacol Drug Dev. 2019. doi:10.1002/cpdd.738
55. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Cell Transplantation Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed September 2024.
56. Couriel D, Saliba R, Hicks K, et al. Tumor necrosis factor-alpha blockade for the treatment of acute GVHD. Blood 2004;104;649-65
57. Richard EG. (2022). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Last updated: December 1, 2022. Accessed on August 29, 2024. Available from https://www.uptodate.com/contents/psoralen-plus-ultraviolet-a-puva-photochemotherapy.
58. Elments, CA. (2024). UVB therapy (broadband and narrowband). In Callen J, Corona R (Eds.), UptoDate. Last updated: March 27,2024. Accessed on August 29, 2024. Available from https://www.uptodate.com/contents/uvb-therapy-broadband-and-narrowband .
59. Smith CH, Yiu ZZN, Bale T, et al; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020 Oct;183(4):628-637. doi: 10.1111/bjd.19039.
60. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020 Jan;82(1):161-201. doi: 10.1016/j.jaad.2019.08.049.
61. Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712. doi: 10.1136/annrheumdis-2020-217159.
62. Mease PJ. Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S64-85. doi: 10.1002/acr.20577.
63. 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 Oct;71(10):1599-1613. doi: 10.1002/art.41042.
64. Fraenkel L, Barthon, JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research Vol. 0, No. 0, Month 2021, pp 1–16 DOI 10.1002/acr.24596
65. Torres J, Bonovas S, Doherty G, et al. European Crohn’s and Colitis Organisation [ECCO] Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. Journal of Crohn's and Colitis, 2020, 4–22 doi:10.1093/ecco-jcc/jjz180.
66. Feurstein JD, Ho EY, Shmidt E, et al.  American Gastroenterological Association Institute – AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021;160:2496–2508.
67. Lamb CA, Kennedy NA, Raine T, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019;0:1–106. doi:10.1136/gutjnl-2019-318484.
68. Panaccione R, Steinhart AH, Bressler B, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Management of Luminal Crohn’s Disease. Journal of the Canadian Association of Gastroenterology, 2019, 2(3), e1–e34 doi: 10.1093/jcag/gwz019.
69. National Institute for Health and Care Excellence. NICE 2013. Psoriasis. Published 06 August 2013. Quality standard [QS40]. https://www.nice.org.uk/guidance/qs40. Accessed September 2024.
70. Van Rheenen PF, Aloi M, Assa A, et al. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2020 Oct 7:jjaa161. doi: 10.1093/ecco-jcc/jjaa161.
71. National Institute for Health and Care Excellence. NICE 2015. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. Published 25 February 2015. Technology appraisal guidance [TA329]. https://www.nice.org.uk/guidance/ta329. Accessed September 2024.
72. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol 2019;114:384–413. https://doi.org/10.14309/ajg.0000000000000152; published online February 22, 2019.
73. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006.
74. Turner D, Ruemmele FM, Orlanski-Meyer E, et al. Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care-An Evidence-based Guideline From European Crohn's and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Aug;67(2):257-291.
75. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases 2020;79:685-699.
76. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Management of Immunotherapy-Related Toxicities Version 1.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed September 2024.
77. National Institute for Health and Care Excellence (NICE). Spondyloarthritis. Quality standard [QS170]. Published: 28 June 2018 https://www.nice.org.uk/guidance/qs170/chapter/Quality-statements. Accessed September 2024.
78. National Institute for Health and Care Excellence. NICE 2017. Psoriasis: assessment and management. Published 24 October 2012. Clinical guideline [CG153]. https://www.nice.org.uk/guidance/CG153. Accessed September 2024.
79. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019 Sep;81(3):775-804. Doi:10.1016/j.jaad.2019.04.042.
80. Armstrong AW, Siegel MP, Bagel J, et al.  From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.  J Am Acad Dermatol. 2017 Feb; 76(2):290-298.  doi:  10.1016/j.jaad.2016.10.017.
81. National Institute for Health and Care Excellence. NICE 2018. Rheumatoid Arthritis in Adults: Management. Published 11 July 2018. Reference number [NG100]. Last updated 12 October 2020. https://www.nice.org.uk/guidance/ng100/resources/rheumatoid-arthritis-in-adults-management-pdf-66141531233989
82. Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022 Jan 28. 16 (1):2-17. Doi: 10.1093/ecco-jcc/jjab178
83. Hatemi G, Christensen R, Dongsik B, et al. 2018 update of the EULAR recommendations for the management of Behçet’s syndrome. Annals of the Rheumatic Diseases 2018;77:808-818.
84. Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024 May 15;83(6):706-719. doi: 10.1136/ard-2024-225531. PMID: 38499325
85. Tiwari V, Brent LH. Psoriatic Arthritis. [Updated 2024 Jan 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK547710/. Accessed July 19, 2024.
86. Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):3-18. doi: 10.1136/ard-2022-223356. Epub 2022 Nov 10. Erratum in: Ann Rheum Dis. 2023 Mar;82(3):e76. doi: 10.1136/ard-2022-223356corr1. PMID: 36357155.
87. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan; 82(1):19–34. doi:10.1136/ard-2022-223296
88. Gordon H, Minozzi S, Kopylov U, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment, Journal of Crohn's and Colitis, 2024;  https://doi.org/10.1093/ecco-jcc/jjae091
89. Elmets CA, Korman NL, Prater EF, 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 Feb; 84(2):432-470. Doi: 10.1016/j.jaad.2020.07.087
90. Foley P, Gebaur K, Sullivan J, et al. Australian consensus: Treatment goals for moderate to severe psoriasis in the era of targeted therapies – Adult patients. Australas J Dermatol. 2023 Nov;64(4):467-487. doi:10.1111/ajd.14138
91. Bitton A. (2024). Perianal Crohn Disease. In Kane SV, Robson KM (Eds.), UptoDate. Last updated: June 13, 2024. Accessed on September 13, 2024. Available from https://www.uptodate.com/contents/perianal-crohn-disease.
92. Ranasinghe IR, Tian C, Hsu R. Crohn Disease. [Updated 2024 Feb 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024.  https://www.ncbi.nlm.nih.gov/books/NBK436021/. Accessed August 22, 2024.
93. Ananthakrishnan AN, Alder J, Chachu KA, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Crohn’s Disease. Gastroenterology. 2023 Dec;165(6):1367-1399. doi: 10.1053/j.gastro.2023.09.029. PMID: 37981354.
94. Singh S, Ananthakrishnan AN, Nguyen NH, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007. PMID: 36822736.
95. National Government Services, Inc. Local Coverage Article:  Billing and Coding: INFLIXIMAB and biosimilars (A52423). Centers for Medicare & Medicaid Services, Inc. Updated on 06/05/2024 with effective date 08/01/2024. Accessed September 2024.
96. Palmetto GBA. Local Coverage Article:  Billing and Coding: INFLIXIMAB (A56432). Centers for Medicare & Medicaid Services, Inc. Updated on 09/06/2024 with effective date  10/01/2024. Accessed September 2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.