Last Review Date: 10/03/2023

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

1. Length of Authorization

Coverage will be provided for 12 months and may be renewed unless otherwise specified.

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

2. Dosing Limits

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

2. 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 TNF-inhibitor, IL-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitnib, 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 >5mg/kg are used]; AND

Crohn’s Disease † Ф ^{1-4,11,13,23,38,75-78}

• 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)

Pediatric Crohn’s Disease † Ф ^1-4,80

• 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.)

Ulcerative Colitis † ^{1-4,20,81-83, 91,93}

• 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

Pediatric Ulcerative Colitis † Ф ^1-4,84

• 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

Fistulizing Crohn’s Disease † ^38,76

• 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) for at least 3 months

Rheumatoid Arthritis (RA) † ^{1-4,74,85, 91}

• 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 oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; AND
• Used in combination with methotrexate (MTX) unless contraindicated

Psoriatic Arthritis (PsA) † ^1-4,39,41,71

• 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, a trial and failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated; OR
• For patients with peripheral arthritis, dactylitis OR active enthesitis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.

Ankylosing Spondylitis (AS) † ^1-4,19,73

• 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 agents (NSAIDs) over 4 weeks (in total), unless use is contraindicated

Plaque Psoriasis (PsO) † ^{1-4,67-69,79,88,89}

• 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 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)

Uveitis Associated with Behçet’s Syndrome ‡ ^{8-10,21,22,34,35, 93}

• 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)

Graft Versus Host Disease (GVHD) ‡ ^43,65,66

• Patient has received a 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 ‡ ^36,37,43,86

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, dostarlimab, tremelimumab, retifanlimab, 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; OR
              • Moderate (G 2) 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 >grade 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
    • Used as additional disease-modifying antirheumatic drug (DMARD) therapy; 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 (cs) DMARDs (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

• 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 compared to IBW, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].

Pediatric Crohn’s Disease ²³

• 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 compared to IBW, hematocrit, presence of extra-intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Crohn’s Disease Activity Index (PCDAI) score or the Harvey-Bradshaw Index score].

Ulcerative Colitis ^24-27

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].

Pediatric Ulcerative Colitis ^24-26

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Pediatric Ulcerative Colitis Activity Index (PUCAI) score or the Mayo Score].

Fistulizing Crohn’s Disease ²³

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as a reduction in number of enterocutaneous fistulas draining upon gentle compression, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].

Psoriatic Arthritis ^28,72

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts 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 ^{29-31, 91}

• 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].

Ankylosing Spondylitis ^19,87

• 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) ^{33,69,79,88,90}

• 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. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started].

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 ‡ ^65,66

• 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 ‡ ⁸⁶

• May not be renewed.

5. Dosage/Administration ^{1-4,36,37,42,66,86}

6. Billing Code/Availability Information

HCPCS Code:

• 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:

• 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

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2. Inflectra [package insert]. Yeonsu-gu, Incheon, Republic of Korea; CELLTRION, Inc; April 2023. Accessed September 2023.
3. Renflexis [package insert]. Yeonsu-gu, Incheon, Republic of Korea; Samsung Bioepis Co., Ltd; January 2022. Accessed September 2023.
4. Avsola [package insert]. Thousand Oaks, CA; Amgen, Inc; September 2021. Accessed September 2023.
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.
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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.
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Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):