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| Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars | |
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| Description: |
Infliximab (e.g., Remicade and Unbranded Infliximab) is a chimeric monoclonal antibody that binds specifically to tumor necrosis factor alpha. It is administered via an intravenous infusion in the physician's office, outpatient setting or an infusion center.
Since tumor necrosis factor-alpha (TNF-alpha) mediates inflammation and modulates cellular immune response, infliximab (and other anti-TNF-alpha therapies) may affect normal immune response. It is not known whether long-term use of tumor necrosis inhibitors such as infliximab increases the incidence of infection or malignancy.
Regulatory Status
The initial labeled indications for infliximab by the U.S. Food and Drug Administration (FDA) included treatment of rheumatoid arthritis, fistulizing Crohn's disease, and inducing remission in individuals with moderately to severely active Crohn's disease that has had an inadequate response to conventional therapy. In 2002, the FDA approved an additional indication for
maintaining clinical remission in Crohn’s disease. Maintenance therapy is designed to prevent disease flares in individuals with quiescent disease; the drugs most commonly used are azathioprine and 6-mercaptopurine. This new, labeled indication markedly broadens the clinical indications for individuals with Crohn's disease. In December 2004, the FDA approved infliximab for the treatment of ankylosing spondylitis, and in early 2005, the FDA approved infliximab for the treatment of psoriatic arthritis. In September 2005, the FDA approved infliximab for the treatment of “reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in individuals with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.” In May 2006, the FDA approved infliximab for use in pediatric individuals with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. In September 2006, FDA approved infliximab for individuals 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. The need for close monitoring and regular follow-up visits with a physician is noted in the FDA approval. Most recently, on Sept. 23, 2011, FDA approval was granted for the use of infliximab to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy.
On September 4, 2008, the FDA released an FDA Alert notifying healthcare professionals that histoplasmosis and other invasive fungal infections are not consistently recognized in individuals taking tumor necrosis factor-α alpha blockers (TNF blockers) certolizumab pegol (e.g., Cimzia), etanercept (e.g., Enbrel), adalimumab (e.g., Humira), and infliximab (e.g., Remicade). This situation has resulted in delays in appropriate treatment, sometimes resulting in death. The FDA will require the makers of the tumor necrosis factor-α blockers (TNF blockers) to further highlight the information about the risk of invasive fungal infections, such as histoplasmosis, in the
Boxed Warning and Warnings sections of the drugs’ prescribing information and the Medication Guide for individuals. The FDA will also require that the makers of the TNF blockers educate prescribers about this risk.
In March 2013, the FDA issued further warnings and precautions regarding malignancies and concurrent administration of infliximab with other biological agents (FDA, 2013). For Malignancies, under section 5.2, the FDA stated that “the incidence of malignancies including lymphoma was greater in infliximab treated individuals than in controls. Due to the risk of HSTCL [hepatosplenic T-cell lymphoma] carefully assess the risk/benefit especially if the individual has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment.” For Concurrent Administration with other Biological Therapeutics, under section 5.11, the FDA stated that “there is insufficient information regarding the concomitant use of Remicade with other biological therapeutics used to treat the same conditions as Remicade. The concomitant use of Remicade with these biologics is not recommended because of the possibility of an increased risk of infection” (FDA, 2013).
On April 5, 2016, the U.S. FDA approved Inflectra, a biosimilar to Infliximab for multiple indications (FDA, 2016).
On April 21, 2017, the U.S. FDA approved infliximab-abda (e.g., Renflexis), a biosimilar to infliximab (e.g., Remicade). (FDA, 2017)
On December 13, 2017, the U.S. FDA approved infliximab-qbtx (e.g., Ixifi), a biosimilar to Infliximab (e.g., Remicade). (FDA, 2017)
On December 6, 2019, the US FDA approved infliximab-axxq (e.g., Avsola), the 4th biosimilar to U.S.-licensed Infliximab (e.g., Remicade). (FDA, 2019)
This policy applies to all drugs with Infliximab as the reference medication and have been designated by the FDA as a biosimilar.
Biosimilar modifiers
In 2016, CMS developed required modifiers to be used with specific biosimilar products. These modifiers provide CMS with the ability to track claims payment and to develop a better understanding of the use of specific biosimilar products in Medicare Part B, claims for separately paid biosimilar biological products will be required to include a modifier that identifies the manufacturer of the specific product.
Modifiers will be used to distinguish between biosimilar products that appear in the same HCPCS code but are made by different manufacturers. CMS will issue HCPCS codes for biosimilar biological products and will issue and assign modifiers to specific biosimilar products in each HCPCS code. The assignments will be published on this webpage. The use of the modifiers on claims for biosimilar products that appear on this webpage is mandatory. However, if a HCPCS code and corresponding biosimilar modifier(s) do not appear on the quarterly update, then a modifier is not required to appear on claims for the code. New biosimilar products that are not adequately described by an existing unique HCPCS code may be billed under a miscellaneous code or “not otherwise classified” code such as J3590. Similarly, a “not otherwise classified” code may also be used in situations where an existing biosimilar HCPCS code is associated with a corresponding modifier that is not yet in effect in the claims processing system. The manufacturer modifier is not required on claims that use a miscellaneous HCPCS code.
Effective April 1, 2018, there are specific CPT for the biosimilar products inflectra and renflexis:
Coding
HCPCS Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg
HCPCS Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg
HCPCS Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg
HCPCS Q5121 Injection, infliximab-axxq, biosimilar (avsola) 10 mg
Prior to April 1, 2018 the following biosimilar modifiers were required to be used when filing claims.
ZB-Pfizer/Hospira Q5102 Injection, infliximab, biosimilar, 10 mg Inflectra
ZC –Merck/Samsung Bioepis Q5102 Injection, infliximab, biosimilar, 10 mg Renflexis
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Policy/ Coverage: |
For members of plans that utilize a prescription drug program vendor (i.e., Arkansas State Employees and Public School Employees, Arkansas State Police and Arkansas State University) for preferred products under the medical benefit, the preferred products contained in this policy are NOT applicable. Please contact the member’s prescription drug program vendor.
Effective April 01, 2022 Prior Approval is required for Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars.
Infliximab-dyyb subcutaneous formulation (e.g., Zymfentra) is not covered under the medical benefit. Please check the member’s pharmacy benefit for coverage.
INITIAL AND CONTINUATION APPROVAL will be for duration of the treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.
Effective October 28, 2026
Select products [Infliximab (e.g., Remicade and Unbranded Infliximab) and Infliximab (e.g., Inflectra, Avsola)] are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5121 Avsola Infliximab-axxq
Q5103 Inflectra Infliximab-dyyb
J1745 Remicade and Unbranded Infliximab Infliximab
Non-preferred Products:
HCPCS Brand Name Generic Name
Q5109 Ixifi Infliximab-qbtx
Q5104 Renflexis Infliximab-abda
Initial request must be for a preferred product. If initial request is not a preferred product, an administrative denial will be issued.
If an exception request is submitted for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars meet member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes or for members with contracts without Primary Coverage Criteria, is considered
Medically Necessary and are covered when member receives a “recommended” determination from criteria review in InterQual® for Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars based on diagnosis and requested product.
Click the following link to view the specific criteria in InterQual®:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
See Criteria below.
FDA Labeled Indications
CROHN’S DISEASE
INITIAL APPROVAL
AUTHORIZATION RENEWAL
ULCERATIVE COLITIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
RHEUMATOID ARTHRITIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
ANKYLOSING SPONDYLITIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
PSORIATIC ARTHRITIS (PsA)
INITIAL APPROVAL
AUTHORIZATION RENEWAL
PLAQUE PSORIASIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
Off-label Indications
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
SARCOIDOSIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
BEHCET’S SYNDROME AND BEHCET’S UVEITIS
INITIAL APPROVAL
AUTHORIZATION RENEWAL
IMMUNE-MEDIATED TOXICITIES (COLITIS, PNEUMONITIS, ENTEROCOLITIS, OTHERS)
INITIAL APPROVAL
AUTHORIZATION RENEWAL
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars do not meet member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and are not covered for any indication or circumstance not described above including, but not limited to:
For contracts without Primary Coverage Criteria,
Infliximab (e.g., Remicade and Unbranded Infliximab) and Biosimilars are considered
not Medically Necessary and are not covered or are investigational
for any indication or circumstance not described above including but not limited:
Not Medically Necessary or
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Click the following link to view the specific criteria in InterQual®:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
POLICY GUIDELINES
Prescriber is responsible for verification that Individual does not have latent tuberculosis or serious active infection before starting the treatment.
Examples of Contraindications to Methotrexate:
High-risk features of adult Crohn’s disease when objective active inflammation is present:
The American College of Gastroenterology (ACG) recognizes cigarette smoking as a modifiable risk factor associated with more aggressive manifestations of Crohn’s disease and poorer clinical outcomes. This risk factor should be considered by the medical provider when selecting the most appropriate therapeutic agent for the patient.
Moderate to severe ulcerative colitis is characterized by the following:
Ulcerative Colitis activity index according to American College of Gastroenterology:
Psoriatic Arthritis
Diagnosis of psoriatic arthritis is based on the Classification Criteria for Psoriatic Arthritis (CASPAR), which require presence of inflammatory articular disease (joint, spine or entheseal)
AND at least two of the following:
Plaque psoriasis disease activity according to Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics:
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Please refer to a separate policy on Maximum Dosage and Frequency (policy #2025031) for pharmacologic/biologic medications.
Effective May 15, 2026 to October 27, 2026
Select products [Infliximab (e.g., Remicade and Unbranded Infliximab) and Infliximab (e.g., Inflectra, Avsola)] are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5121 Avsola Infliximab-axxq
Q5103 Inflectra Infliximab-dyyb
J1745 Remicade and Unbranded Infliximab Infliximab
Non-preferred Products:
HCPCS Brand Name Generic Name
Q5109 Ixifi Infliximab-qbtx
Q5104 Renflexis Infliximab-abda
Initial request must be for a preferred product. If initial request is not a preferred product, an administrative denial will be issued.
If an exception request is submitted for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
INITIAL AND CONTINUATION APPROVAL will be for duration of the treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Infliximab meets member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health or for members with contracts
without Primary Coverage Criteria, is considered Medically Necessary and is covered, when the following criteria are met based on diagnosis:
FDA Labeled Indications
CROHN’S DISEASE
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
ULCERATIVE COLITIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
RHEUMATOID ARTHRITIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
ANKYLOSING SPONDYLITIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
PSORIATIC ARTHRITIS (PsA)
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
PLAQUE PSORIASIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
Off-label Indications
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
SARCOIDOSIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
BEHCET’S SYNDROME AND BEHCET’S UVEITIS
INITIAL APPROVAL:
CONTINUATION OF THERAPY:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Infliximab does not meet member benefit certificate
Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered including, but not limited to:
For members with contracts without Primary Coverage Criteria, Infliximab is considered
not Medically Necessary and is not covered or is
investigational for any indication or circumstance not described above, including, but not limited:
Not Medically Necessary or Investigational services are contract exclusions in the member benefit certificate of coverage.
POLICY GUIDELINES
Prescriber is responsible for verification that Individual does not have latent tuberculosis or serious active infection before starting the treatment.
Examples of Contraindications to Methotrexate:
DOSAGE AND ADMINISTRATION
For FDA labeled indications, Infliximab (e.g., Remicade and Unbranded Infliximab) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.
For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication below.
The recommended dose of Infliximab and biosimilars are based on indication:
Infliximab and biosimilars are administered by intravenous infusion by a healthcare provider.
Infliximab-axxq (e.g., Avsola) is available as 100 mg lyophilized powder in a single-dose vial for reconstitution and dilution.
Infliximab-dyyb (e.g., Inflectra) is available as 100 mg lyophilized powder in a single-dose vial for reconstitution and dilution.
Infliximab-qbtx (e.g., Ixifi) is available as 100 mg lyophilized powder in a single-dose vial for reconstitution and dilution.
Infliximab (e.g., Remicade) is available as 100 mg lyophilized powder in a single-dose vial for reconstitution and dilution.
Infliximab-abda (e.g., Renflexis) is available as 100 mg lyophilized powder in a single-dose vial for reconstitution and dilution.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to May 15, 2026 is not online. If you would like a hardcopy print, please email:
codespecificinquiry@arkbluecross.com
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| Rationale: |
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email:
codespecificinquiry@arkbluecross.com”
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Tumor Necrosis Factor Blocker Safety
To inform the 2013 update of rheumatoid arthritis (RA) guidelines by the European League Against Rheumatism (EULAR), Ramiro et al conducted a systematic review of safety outcomes with conventional (eg, methotrexate, azathioprine) and biological (eg, tumor necrosis factor [TNF]-inhibitors) treatments of RA (Ramiro, 2014). Literature was searched through March 2013, and 49 comparative cohort and registry studies of biological disease-modifying antirheumatic drugs (DMARDs) were included. Meta-analysis was not possible due to substantial heterogeneity in study designs, eg, varying confounders adjusted for in analysis. In comparison with conventional DMARDs, patients on TNF-inhibitors had an increased risk of serious infections (7 studies with low to moderate risk of bias [total N=84,578]; range of adjusted hazard ratios [HRs]=1.1-1.8 [range of 95% confidence intervals (CIs), 0.8 to 2.7]) and an increased risk of skin infections, including herpes zoster (4 studies with low to moderate risk of bias [total N=77,163]; range of adjusted HRs=1.0-1.7 [range of 95% CIs, 0.8 to 2.7]). One included study with moderate risk of bias (N=81) reported an increased risk of tuberculosis reactivation in comparison with the general population (adjusted HR=34.9 [95% CI, 8.9 to 137.2]), but the risk estimate is unstable as evidenced by the very wide confidence interval. For malignancy, overall cancer risk was not increased in comparison with patients taking conventional DMARDs or with the general population. Lymphoma risk was not increased in comparison with patients taking conventional DMARDs but was increased in comparison with the general population (3 studies with low to moderate risk of bias [total N=10,100]; range of adjusted HRs=2.7-6.0 [range of 95% CIs, 1.6 to 15.4]). One study with low risk of bias (N=10,878) reported an increased risk of melanoma in comparison with patients taking conventional DMARDs (adjusted HR=1.5 [95% CI, 1.1 to 2.5]). Non-melanoma skin cancer risk was not increased in comparison with patients taking conventional DMARDs but was increased in comparison with the general population (1 study with low risk of bias [N=11,881]; adjusted HR=1.72 [95% CI, 1.43 to 2.04]). No new safety signals were identified.
These results align with a 2014 systematic review with meta-analysis of double-blind RCTs of TNFinhibitor treatment of RA conducted by the National Institutes of Health (Michaud, 2014). Literature was searched through May 2013; 44 RCTs were included (total N=11,700 receiving TNF-inhibitor, 5008 receiving conventional DMARDs, 893 receiving placebo). TNF-inhibitor treatment was associated with an increased risk of serious infection (odds ratio [OR]=1.42 [95% CI, 1.13 to 1.78]; I2=0%) and treatment discontinuation due to adverse events (OR=1.23 [95% CI, 1.06 to 1.43]; I2=31%) compared with placebo and/or conventional DMARD controls. For malignancy, no odds ratios reached statistical significance.
Subsequent systematic reviews published in 2013 and 2014 confirmed that TNF-inhibitors improve disease activity and functional capacity compared with placebo in patients with either ankylosing spondylitis or non-radiographic axial spondyloarthritis (Shu, 2013; Callhoff, 2014).
A 2014 systematic review with network meta-analysis concluded that TNF-inhibitors are effective for induction and maintenance of response and remission in the treatment of CD and found of clinical superiority among TNF-inhibitors (Stidham, 2014).
In 2010, the randomized, double-blind SONIC trial was published. In post-hoc subgroup analyses, researchers examined the prognostic ability of alternative outcome measures, eg, 50% mucosal healing, CRP, and CDAI; none were shown to accurately predict complete mucosal healing (Ferrante, 2013; Peyrin, 2014).
Additional, reviews of TNF-inhibitors for the treatment of UC were published in 2009 (Hyde, 2009), 2010 (Bryan, 2010), and 2014 (Lv, 2014; Danese, 2014; Thorlund, 2014; Stidham, 2014). The reviews found infliximab treatment appropriate for acute exacerbations of severely active UC when cyclosporine is not appropriate or contraindicated and confirmed that TNF-inhibitors are effective for the induction and maintenance of remission in UC.
Juvenile Idiopathic Arthritis
Two 2013 retrospective studies examined biologic treatments (etanercept, infliximab, adalimumab, and anakinra) for juvenile idiopathic arthritis (JIA) in children (Tambralli, 2013) and adults (McErlane, 2013). Study authors observed that evidence-based guidance for use of biologic agents in JIA was lacking and prospective controlled studies are needed.
Systematic reviews published in 2012, 2013, and 2014 assessed the effectiveness and safety of TNFinhibitors for psoriasis and psoriatic arthritis (Thorlund, 2012; Fenix, 2013; Lemos, 2014; Gupta, 2014; Sandoval, 2014; Schmitt, 2014). These reviews reported no significant differences in effectiveness and overall adverse reactions between available anti-TNF agents in patients with psoriasis or psoriatic arthritis.
Meta-analyses published in 2014 supported the efficacy of TNF-inhibitors for patients with RA, particularly as add-on therapy in the second-line setting (Jansen, 2014; Barra, 2014; Nam, 2014a). A 2014 double-blind RCT in 112 new-onset (3-12 months duration), DMARD-naïve patients with RA compared the efficacy of MTX and infliximab with MTX and high-dose intravenous corticosteroid for remission induction (Nam, 2014b). At 50 weeks of follow-up, there was no statistical between-group difference in mean modified total Sharp score, proportion of patients with radiographic nonprogression, improvement in quality of life.
In 2012, van Vollenhoven et al reported on 2-year results of the randomized, open-label SweFot (Swedish Pharmacotherapy) trial, which compared conventional combination treatment for RA with infliximab therapy in 258 patients refractory to MTX (van Vollenhoven, 2012). Clinical treatment response was not significantly different between groups at 18 and 24 months, and radiographic response was not significantly different between groups at 18 months. However, the infliximab treatment group had less radiologic disease progression at 24 months (mean [SD], 4.00 [10.0] vs 7.23 [12.7]; p=0.009). Karlsson et al (2013) examined quality-of-life outcomes at 21 months and found no statistical between-group difference (Karlsson, 2013).
Uveitis
In 2014, Simonini et al published 2 systematic reviews with meta-analyses of anti-TNF agents for treatment of autoimmune chronic uveitis in refractory pediatric (≤16 years-old) patients. In both studies, primary outcome was the change in intraocular inflammation using standardized criteria that have been validated in adults but not in children (Jabs, 2005). One study included only patients previously untreated with biological agents (Simonini, 2014a). Literature was searched through September 2012; 23 studies (1 RCT of etanercept and 22 retrospective studies; total N=229) were included. Most patients (63%) received infliximab; 24% received etanercept; and 13% received adalimumab. Meta-analysis of observational studies showed high response rates with infliximab (72% [95% CI, 64 to 79]) and adalimumab (87% [95% CI, 75-98]; chisquare vs infliximab, p=0.08) but not with etanercept (33% [95% CI, 19 to 47]; chi-square vs either group, p<0.001). The other study examined changing anti-TNF after failure of a first anti-TNF course (Simonini, 2014b). Literature was searched through April 2013; 10 observational studies were included (total N=40). Ninety-eight percent of patients had JIA, the leading cause of autoimmune chronic uveitis in children. Most children (58%) were switched from infliximab to adalimumab; 27% were switched from etanercept to adalimumab; and 15% were switched from etanercept to infliximab. Thirty patients (75% [95% CI, 51 to 100]) responded to treatment, 6 (100%) of 6 children on infliximab and 24 (32%) of 34 children on adalimumab. Adverse events occurred in 6 (23%) of 26 children for whom events were reported; 5 who were taking adalimumab reported local pain or discomfort, and 1 who was taking infliximab reported transient bronchospastic cough. Adverse event severity was not reported. Although results suggested that switching between anti-TNF drugs may be appropriate in some patients when response to a first anti-TNF drug is insufficient, RCTs are recommended.
Vasculitides
Preliminary studies have investigated infliximab for treatment of Wegener granulomatosis and other vasculitides. A 2007 placebo-controlled trial of 44 patients with giant cell arteritis was terminated early due to lack of treatment effect for clinical outcomes at interim analysis.108 In subsequent analysis, serum inflammatory biomarkers and markers of vascular remodeling on temporal artery biopsy also did not differ between groups (Visvanathan, 2011).
Silva-Fernandez et al (2013) conducted a systematic review of biological therapies for systemic vasculitides (Silva-Fernandez, 2014). Literature was searched through April 2013; of 80 included studies, 29 primarily uncontrolled, observational studies assessed TNF-inhibitors (infliximab, etanercept, adalimumab, golimumab). Evidence was contradictory for infliximab efficacy in anti-neutrophil cytoplasmic antibody associated vasculitides (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis [EGPA]) and in large vessel vasculitides (giant cell arteritis and Takayasu arteritis).
Kawasaki Disease
Preliminary studies have investigated infliximab for treatment of refractory Kawasaki disease. Tremoulet et al (2014) conducted a Phase 3, double-blind RCT in 196 children (age 4 weeks to 17 years) with active (fever
≥38ºC) Kawasaki disease (Tremoulet, 2014). Patients were randomized 1:1 to a single dose of infliximab or placebo administered before intravenous immunoglobulin therapy. There was no statistical between-group difference in the primary outcome, immunoglobulin resistance, defined as return or persistence of fever (11% both groups, Fisher’s exact test, p=0.81). Observed reductions at 2 weeks in fever duration, serum inflammatory markers, and left anterior descending coronary artery dimension did not persist to week 5. An accompanying editorial observed that larger studies with longer follow-up are required to establish efficacy and safety of infliximab for Kawasaki disease.
Pain Syndromes
Infliximab and other TNF-inhibitors have been investigated for the treatment of various pain syndromes. Two systematic reviews of low back pain with radiculopathy (sciatica) found insufficient evidence to conclude that TNF-inhibitors were safe and effective for treatment of these conditions (Pimentel, 2014; Williams, 2013). A placebo controlled RCT of 13 patients with complex regional pain syndrome found statistically significant reductions in quality of life in patients who received infliximab.
Ongoing and Unpublished Clinical Trials
A search of online site, ClinicalTrials.gov, identified 54 active studies of infliximab. These included 28 studies in inflammatory bowel disease, 20 studies in RA and spondyloarthropathies, 4 studies in psoriasis, 1 study in Behçet arthritis, and 1 study in steroid-refractory, acute graft-versus-host disease.
Additionally, early-phase studies are investigating conditions not reviewed in this policy
In 2012, ACR issued an evidence-based, consensus update to their 2008 recommendations for the use of DMARDs and biologic agents in the treatment of RA (Singh, 2012). In patients with early RA (disease duration, <6 months), anti-tumor necrosis factor (TNF) biologics with or without methotrexate are recommended for patients who have high disease activity with poor prognostic features (functional limitation, extra-articular disease, positive rheumatoid factor (RF), positive anti-cyclic citrullinated peptide (CCP) antibodies, bony erosions by radiograph). (Level of evidence, A-B [data derived from multiple RCTs, a single randomized trial, or nonrandomized studies]) Infliximab is the only exception and is recommended for use in combination with methotrexate but not as monotherapy. For patients with established RA (disease duration,
≥65 months), biologic agents, including anti-TNF drugs, are recommended if disease activity is moderate or high after 3 months of methotrexate therapy alone or in combination with other conventional DMARDs. (Level of evidence, A-C data derived from multiple RCTs, a single randomized trial, nonrandomized studies, consensus opinion, case studies, or standards of care)
American Uveitis Society
In 2014, AUS published evidence-based consensus recommendations for the use of anti-TNF agents in patients with ocular inflammatory disorders (Levy-Clarke, 2014). Literature was searched through April 2013, and approximately 400 publications were reviewed. The panel made the following recommendations:
European League Against Rheumatism
In 2013, EULAR updated its evidence-based consensus recommendations for the management of RA with conventional and biological DMARDs (Smolen, 2014). Biological DMARDs are recommended as second-line, add-on treatment for patients with poor prognostic factors (positive RF, positive anti-CCP antibodies, very high disease activity, early joint damage) (Grade of recommendation D [based on expert opinion without explicit critical appraisal]), and for patients responding inadequately to conventional DMARDs (Grade of recommendation A [based on individual RCT with narrow confidence interval]). Biological DMARDs, including TNF-inhibitors and others, were considered to have similar efficacy and safety. If a first biological DMARD fails, patients should be treated with another biological DMARD; if a first TNF-inhibitor fails, patients may receive another TNF-inhibitor or a biological agent with another mode of action (eg, abatacept, tocilizumab, or, under certain circumstances [history of lymphoma or demyelinating disease], rituximab) (Grade of recommendation A [based on systematic review of RCTs with homogeneity]).
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Crohn Disease
Two network meta-analyses on the comparative efficacy of biologics and immunosuppressants in Crohn disease have been published (Singh, 2014; Hazlewood, 2015).
2019 Update
A literature search conducted through November 2019 did not reveal any new information that would prompt a change in the coverage statement.
2020 Update
A randomized, double-blind comparative clinical study evaluated the efficacy and safety of Avsola compared to Remicade in patients with moderate-to-severe RA. There were 558 patients enrolled and randomized (1:1) to receive either Avsola or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also incorporated the evaluation of a single transition in 119 subjects from Remicade to Avsola at week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade.
2021 Update
A randomized, double-blind comparative clinical study evaluated the efficacy and safety of Avsola compared to Remicade in patients with moderate-to-severe RA. There were 558 patients enrolled and randomized (1:1) to receive either Avsola or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also incorporated the evaluation of a single transition in 119 subjects from Remicade to Avsola at week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement.
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2025. No new literature was identified that would prompt a change in the coverage statement.
2026 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2026. No new literature was identified that would prompt a change in the coverage statement.
August 2026 Update
Immune checkpoint inhibitor-induced enterocolitis is among the most common severe immune-related adverse events associated with CTLA-4 and PD-1/PD-L1 inhibitors. While most cases initially respond to systemic corticosteroids, approximately 30% to 50% of patients experience inadequate response, steroid dependence, or recurrence during steroid tapering. These patients are generally classified as having steroid-refractory immune-mediated colitis and often require selective immunosuppressive therapy.
Infliximab, a tumor necrosis factor-alpha (TNF-α) inhibitor, is recommended by NCCN, ASCO, SITC, and ESMO clinical practice guidelines as the preferred biologic therapy for steroid-refractory immune checkpoint inhibitor-associated colitis. The rationale for its use is based on the central role of TNF-α in intestinal inflammation and the growing body of evidence demonstrating rapid symptom control and reduced corticosteroid exposure.
The infliximab and infliximab biosimilar Crohn’s disease coverage criteria are being updated to align with the most recent American College of Gastroenterology (ACG) Clinical Guideline for the Management of Crohn’s Disease in Adults (2025). The updated guideline emphasizes a risk-based treatment strategy that recognizes the importance of early intervention with advanced therapies in patients at increased risk for disease progression, bowel damage, hospitalization, and surgery. Consistent with these recommendations, the revised criteria incorporate contemporary high-risk disease features, including penetrating, fistulizing, stricturing, or stenosing disease; perianal involvement; extensive ileal or ileocolonic disease; deep ulcerations; extraintestinal manifestations; prior intestinal resection; and other predictors of aggressive disease behavior. These updates ensure that coverage requirements reflect current standards of care and facilitate timely access to infliximab therapy for appropriately selected patients with moderate-to-severe Crohn’s disease.
The ulcerative colitis criteria are likewise being updated to maintain consistency with contemporary ACG recommendations and evolving treatment goals focused on achieving clinical remission, endoscopic improvement, and long-term disease control. The revised criteria continue to support use of infliximab in patients with moderate-to-severe ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to conventional therapies, while recognizing the role of biologic therapy as an effective treatment option for patients with more significant disease burden. Aligning the policy with the newest ACG guideline promotes evidence-based utilization management, improves consistency with current gastroenterology practice, and strengthens the clinical rationale underlying medical necessity determinations by ensuring coverage decisions are based on the most current expert consensus and available clinical evidence.
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ACIP(2025) Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention www.cdc.gov/acip/index.html
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