CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization, criteria, dosing, and approval durations for infliximab intravenous products (Remicade and biosimilars Inflectra, Avsola, Renflexis, Janssen infliximab) across FDA-approved indications and other supported uses; applies to medical-benefit infusions and requires specialist prescribing/consultation.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeRevisions, clarifications, and removals (2023-2024)

Effective Date

Next Review Date

Key ActionPrior authorization is required for medical-benefit infliximab products and approvals follow indication-specific criteria and durations; requests for non-standard dosing are reviewed case-by-case by a clinician.

SourceLink

POLICY UPDATE CHANGES

Timeframe for 'established on therapy' changed from 90 days to 3 months for several indications (plaque psoriasis, Behcet's disease, hidradenitis suppurativa, sarcoidosis).

For several initial approvals, age requirements were added (e.g., ≥ 18 years for multiple adult indications; ≥ 6 years for uveitis; ≥ 26 years for juvenile idiopathic arthritis in selected context).

Note added that mesalamine does not count as a systemic therapy for ulcerative colitis.

Conditions Not Recommended: concurrent use with a biologic or targeted synthetic oral small molecule updated wording.

Conditions Not Recommended for Approval: Inflammatory Myopathies and Vessel Vasculitis were removed from the list.

14+Indications covered (FDA & supportive)

Specialist required

Prescriber requirement

Prior authUtilization control

6+Explicit criteria count

4/6/8 wkDose interval variants

Coverage Summary

Scope: This policy defines prior authorization, indication-specific criteria, weight‑based dosing, and approval durations for infliximab intravenous products (Remicade and biosimilars Inflectra, Avsola, Renflexis, and the Janssen infliximab) applied to medical‑benefit infusions and other supported uses.

Coverage stance: covered_with_criteria — medical‑benefit infliximab products are covered when prior authorization criteria are met; initial approvals require prescription by or consultation with a relevant specialist and prior authorization, and requests for non‑standard dosing are reviewed case‑by‑case.

At-a-glance thresholds & dosing intervals

Established on therapy durations1 month; 3 months; 4 months; 6 months (varies by indication)

Age thresholds≥ 6 years or ≥ 18 years depending on indication

Common established-on-therapy (sarcoidosis)≥ 3 months

Common established-on-therapy (scleritis, spondyloarthritis, Still's disease, uveitis)≥ 6 months

Initial approval durationsTypically 3–6 months (example: 3 months for many other uses; 4 months for pyoderma gangrenosum; 6 months for many FDA indications)

Dosing interval variations (maintenance frequency)No more frequently than every 4, 6, or 8 weeks depending on regimen and indication

Initial Therapy Criteria

General Prior Authorization / Prescriber Requirement

Prior Authorization is recommended...

Prior Authorization required for medical benefit coverage of infliximab products
Initial approval requires infliximab to be prescribed by or in consultation with a physician who specializes in the condition treated (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist, pulmonologist, oncologist/hematologist/transplant-affiliated physician, neurologist)
Requests for doses outside of established documented dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist)

Other Uses with Supportive Evidence (non-FDA)

Approve when indication-specific supportive criteria are met (initial shorter approvals), with specialist prescribing requirement:

Continuation Therapy Criteria

Continuation / Patient is Currently Receiving an Infliximab Product

Render continuation/‘Patient is Currently Receiving’ branches with established-on-therapy durations and response assessment:

General continuation requirements: Patient has been established on therapy for the minimum duration specified per indication (commonly 1 month, 3 months, 4 months, or 6 months depending on indication); A patient who has received less than the established duration or is restarting is reviewed under Initial Therapy; When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline OR experienced improvement in at least one symptom; Approve for 1 year when continuation criteria met
Ankylosing spondylitis continuation: Patient has been established on therapy for at least 6 months; Response examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, CRP, ESR; Improvement in at least one symptom (eg decreased pain or stiffness, improved function/ADLs)
Approve for 1 year

Unproven / Exclusions

General Conditions Not Recommended for Approval

Coverage of infliximab IV products is not recommended in the following situations:

Concurrent therapy exclusion: Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not recommended; combination therapy generally not recommended due to higher adverse events and lack of controlled data; see Appendix for examples
Other circumstances not listed: Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as new published data are available
Exception note: This does NOT exclude use of conventional synthetic DMARDs (eg methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) in combination with infliximab

Applicable Codes

Not explicitly listed in part 1mixed

No codes listed

Examples of biologic agents and categories (Appendix list — informational)mixed

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for medical-benefit infliximab intravenous products. Approvals are provided according to indication-specific criteria and durations as listed in the policy. Requests for doses or regimens outside the established documented dosing will be reviewed case-by-case by a clinician.

Non-standard dosing reviewed case-by-case

Documentation Required

Specialist prescribing/consultation required for initial approval

Initial approval requires the infliximab product to be prescribed by or in consultation with a physician who specializes in the condition treated.

Rheumatologist
Gastroenterologist

Clinical Evidence

Evidence summary: Multiple specialty society guidelines support TNFi/infliximab use for specific indications (examples cited in policy include ACR, ACG, AGA, AAD/NPF, EULAR, NCCN, AAO, ERS).

Prescribing information: The policy cites infliximab and biosimilar prescribing information (Janssen Infliximab PI Oct 2021; Inflectra June 2021; Renflexis Dec 2023).

Guidelines referenced: Indication‑specific guideline sources noted in the policy include ACG, ACR, EULAR, ERS, AAD‑NPF, NCCN, and AGA supporting inclusion and use of infliximab for the listed conditions.

Background

Background: Infliximab and its biosimilars (Avsola, Inflectra, Renflexis) are tumor necrosis factor inhibitors approved for multiple inflammatory conditions; the biosimilars have demonstrated biosimilarity to Remicade but are not designated interchangeable.

Dosing: Recommended dosing is weight‑based and varies by indication; induction regimens commonly use doses at weeks 0, 2, and 6 followed by maintenance intervals that differ by disease (examples: no more frequently than every 4, 6, or 8 weeks depending on indication).

Loss of response: Dose escalation or shortening the dosing interval is an accepted strategy for patients who initially respond and then lose response; such requests for doses outside policy are considered case‑by‑case by a clinician.

Interchangeability note: Policy states biosimilars demonstrate no clinically meaningful differences in safety and effectiveness compared with Remicade but specifies that only biosimilarity has been demonstrated (not interchangeability).

Scope-specific quick stats

Indications covered (FDA-approved + supportive)14+

Prescriber requirementSpecialist required for initial approval (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist, pulmonologist, oncologist/transplant-affiliated, neurologist)

Definitions

Definitions:

Established on therapy: Patient has been receiving the infliximab product for the minimum duration specified per indication (commonly 1 month, 3 months, 4 months, or 6 months) prior to continuation review; policy notes common durations by indication (examples: 3 months for sarcoidosis; 6 months for many FDA indications).

Initial Therapy: New starts or patients restarting therapy who have not met the 'established on therapy' duration; initial approvals are shorter (generally 3–6 months, varying by indication).

Objective measure: Quantitative or semi‑quantitative clinical tests or imaging used to assess response (examples listed include CRP, ESR, ASDAS, PFTs, 6‑minute walk distance, imaging, visual acuity, ocular inflammation grading, fecal calprotectin, endoscopy).

Revision History

11/15/2023non-material_removed

Annual revision 11/15/2023: Conditions Not Recommended for Approval: Inflammatory Myopathies and Vessel Vasculitis were removed from the list.

03/27/2024material_revised

Selected Revision 03/27/2024: Timeframe for 'established on therapy' changed from 90 days to 3 months for several indications (plaque psoriasis, Behcet's disease, hidradenitis suppurativa, sarcoidosis); age requirements were added for multiple initial approvals (examples: ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Behcet's disease, GVHD, hidradenitis suppurativa, immunotherapy-related toxicities, juvenile idiopathic arthritis, pyoderma gangrenosum, sarcoidosis, scleritis).

09/11/2024material_revised

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeRevisions, clarifications, and removals (2023-2024)

Effective Date

Next Review Date

SourceLink

On This Page

Behcet's disease
- A) Initial Therapy (Approve for 3 months): Patient is ≥ 6 years of age; Patient has tried at least ONE conventional therapy (eg systemic corticosteroids, immunosuppressants); Medication prescribed by or in consultation with rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist
  Exceptions: prior biologic trial may waive conventional therapy requirement
- B) Patient is Currently Receiving an Infliximab Product (Approve for 1 year): Patient has been established on therapy for at least 3 months; When assessed by objective measures experienced beneficial response OR improved in at least one symptom
- Dosing: Initial: up to 5 mg/kg IV at weeks 0,2,6 then no more frequently than every 6 weeks; maintenance no more frequently than once every 4 weeks
Graft-Versus-Host Disease (GVHD)
- A) Initial Therapy: Patient is ≥ 6 years of age; Patient has tried at least one conventional systemic treatment for GVHD (eg corticosteroids, antithymocyte globulin, cyclosporine, tacrolimus, mycophenolate mofetil); Medication prescribed by or in consultation with an oncologist, hematologist, or transplant-affiliated physician
- B) Patient Currently Receiving (Approve for 3 months in some contexts / 1 year when established): Patient has been established on an infliximab product for at least 1 month in some contexts; Beneficial clinical response by objective measures (eg normalization of LFTs, RBC, platelets, resolution of fever/rash) OR improvement in at least one symptom; Approvals and durations vary
- Dosing: Doses administered no more frequently than once weekly; dose up to 10 mg/kg IV with repeats at weeks 2 and 6 for some regimens; maintenance frequency varies
Hidradenitis suppurativa
- A) Initial Therapy (Approve for 3 months): Patient is ≥ 18 years of age; Patient has tried one other therapy (eg intralesional/oral corticosteroids, systemic antibiotics, isotretinoin); Medication prescribed by or in consultation with a dermatologist
- B) Patient Currently Receiving (Approve for 1 year): Patient has been established on therapy for at least 3 months; Beneficial clinical response by objective measures (Hurley staging, Sartorius score, PGA, HS Severity Index) OR improvement in at least one symptom
- Dosing: Initial: up to 5 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 8 weeks; alternate regimens no more frequently than every 4 weeks
Immunotherapy-related toxicities from checkpoint inhibitor therapy
- A) Initial Therapy (Approve for 6 months): Patient is ≥ 18 years of age; Toxicity developed while receiving a checkpoint inhibitor (eg pembrolizumab, nivolumab, ipilimumab, atezolizumab, avelumab, durvalumab); Toxicity other than hepatitis; Medication prescribed by or in consultation with oncologist, gastroenterologist, rheumatologist, or ophthalmologist; Patient has tried one systemic corticosteroid
- B) Patient Currently Receiving (Approve for 1 year): Patient has been established on therapy for at least 6 months; Beneficial clinical response by objective measures OR improvement in at least one symptom
- Dosing: Initial: up to 10 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 4 weeks for some regimens
Indeterminate colitis
- A) Initial Therapy (Approve for 6 months): Patient is ≥ 6 years of age; Patient has tried mesalamine; tried one systemic corticosteroid; tried azathioprine or 6-mercaptopurine; Medication prescribed by or in consultation with a gastroenterologist
- B) Patient Currently Receiving (Approve for 1 year): Patient has been established on therapy for at least 6 months; Beneficial response from baseline by objective measures (fecal calprotectin, CRP, endoscopy, reduced corticosteroid dose) OR improvement in at least one symptom
- Dosing: Initial: up to 5 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 8 weeks; other regimens referenced no more frequently than every 4 weeks
Juvenile idiopathic arthritis (JIA)
- A) Initial Therapy (Approve for 6 months): Patient is ≥ 6 years of age; Patient has tried one other systemic medication for JIA (eg methotrexate, sulfasalazine, leflunomide, NSAIDs) OR patient has aggressive disease as determined by prescriber; Medication prescribed by or in consultation with a rheumatologist
- B) Patient Currently Receiving (Approve for 1 year): Patient has been established on therapy for at least 6 months; Beneficial clinical response by objective measures (Physician Global, PGA, JADAS, cJADAS, CRP, ESR) OR improvement in at least one symptom
- Dosing: Initial: up to 6 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 8 weeks; alternate regimens no more frequently than every 4 weeks referenced
Pyoderma gangrenosum
- A) Initial Therapy (Approve for 4 months): Patient is ≥ 18 years of age; Patient has tried one systemic corticosteroid; Patient has tried one other immunosuppressant for ≥ 2 months or was intolerant; Medication prescribed by or in consultation with a dermatologist
- B) Patient Currently Receiving: Patient has been established on therapy for at least 4 months; Beneficial clinical response (improvement in size, depth, number of lesions) OR improvement in at least one symptom; Approve for specified duration/1 year
- Dosing: Initial: up to 5 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 8 weeks; alternate regimens no more frequently than every 4 weeks
Sarcoidosis
- A) Initial Therapy (Approve for 3 months): Patient is ≥ 18 years of age; Patient has tried at least one corticosteroid and at least one immunosuppressive medication (eg methotrexate, azathioprine, leflunomide, mycophenolate mofetil, hydroxychloroquine); Medication prescribed by or in consultation with pulmonologist, ophthalmologist, cardiologist, neurologist, or dermatologist
- B) Patient Currently Receiving (Approve for 1 year): Patient has been established on therapy for at least 3 months; Beneficial response from baseline by objective measures dependent on organ involvement (eg predicted FVC, 6-minute walk, CRP, liver enzymes, NT-proBNP, imaging) OR improvement in at least one symptom
- Dosing: Initial: up to 5 mg/kg IV at weeks 0,2,6 then maintenance no more frequently than every 6 weeks; Maintenance no more frequently than once every 4 weeks
Still's disease: Supportive evidence: case series show efficacy; follows general 'Other Uses' pattern (specialist prescribing and prior therapy trials)

Crohn's disease continuation:

Patient has been established on therapy for at least 6 months; Response assessed by objective measures (fecal lactoferrin, fecal calprotectin, CRP, imaging, endoscopy) indicating benefit and/or reduced corticosteroid dose OR improvement in at least one symptom (decreased pain, fatigue, stool frequency, blood in stool)

Plaque psoriasis continuation: Patient has been established on therapy for at least 3 months; Beneficial clinical response assessed by objective measures (BSA, erythema, induration/thickness, scale) OR improvement in at least one symptom

Approve for 1 year

Psoriatic arthritis continuation: Patient has been established on therapy for at least 6 months; Beneficial response by objective measures (DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, PsAID-12, CRP, ESR) OR improvement in at least one symptom

Approve for 1 year

Rheumatoid arthritis continuation: Patient has been established on therapy for at least 6 months; Beneficial clinical response by objective measures (CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI) OR improvement in at least one symptom

Approve for 1 year

Ulcerative colitis continuation: Patient has been established on therapy for at least 6 months; Beneficial response from baseline by objective measures (fecal calprotectin, CRP, endoscopy, reduced corticosteroid dose) OR improvement in at least one symptom

Approve for 1 year

GVHD continuation: In some contexts patient is considered established after at least 1 month on therapy; Beneficial clinical response by objective measures (eg normalization of LFTs, RBC count, platelets, resolution of fever/rash) OR improvement in at least one symptom

Duration for continuation may be 3 months in some contexts or 1 year when established

Approval Durations and Established Therapy Definitions

Common initial approval durations: Initial approvals are generally 3–6 months depending on indication (3 months for many other uses; 4 months for pyoderma gangrenosum; 6 months for many FDA indications)
Established on therapy definitions: Patients 'currently receiving' an infliximab product are typically defined by being established on therapy for a specified minimum duration varying by indication: 1 month (GVHD in some contexts), 3 months (plaque psoriasis, sarcoidosis), 4 months (pyoderma gangrenosum), or 6 months (many FDA indications)
Month conversion note: When approval is authorized in months, 1 month = 30 dosing days

Oncologist/hematologist/transplant-affiliated physician

Documentation Required

Objective measures to document response

For continuation approvals, providers must document a beneficial clinical response from baseline by at least one objective measure or an improvement in at least one symptom compared with baseline. Objective measures and symptom examples vary by indication and should be used to support continuation requests.

Disease activity scores (eg ASDAS, BASDAI, DAPSA, CDAI, DAS28)
Laboratory markers (eg CRP, ESR)
Relevant imaging or endoscopy (eg MRE/CTE, endoscopic assessment)
Visual measures (eg best-corrected visual acuity/ocular inflammation grading)

Billing Rule

Approval duration and dosing constraints

Approvals vary by indication: initial (short) approvals are typically for a limited number of months and continuation approvals for patients established on therapy are commonly 1 year. Dosing is weight-based with induction and maintenance regimens specified per indication; maximum dosing frequencies are defined and doses outside those constraints are reviewed case-by-case.

Example induction/maintenance regimens: 3–10 mg/kg with infusions at Weeks 0, 2, and 6 for induction
Maintenance: dosing no more frequently than every 4, 6, or 8 weeks depending on indication
Deviations from listed dosing/frequency are reviewed on a case-by-case basis

Prior Authorization

Prior authorization required with indication-specific criteria

Prior authorization requires documentation of indication-specific initial or continuation criteria, including prior therapy trials, prescriber specialty or consultation, objective measures of response when applicable, and the duration the patient has been established on therapy.

Common prior therapies to document: corticosteroids, immunosuppressives, conventional synthetic DMARDs

Documentation Required

Document objective measures and baseline comparisons

For continuation approvals, providers must document objective measures demonstrating a beneficial clinical response from baseline or improvement in at least one symptom. Examples of acceptable objective measures depend on organ system and indication.

Examples: ASDAS and other disease activity scores, CRP/ESR, pulmonary function or 6-minute walk distance, imaging findings, endoscopic assessment, best-corrected visual acuity and ocular inflammation grading

Denial Risk

Concurrent biologic or targeted synthetic oral small molecule use prohibited

Claims may be denied if infliximab is used concurrently with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition. This restriction does not exclude use of conventional synthetic DMARDs in combination with infliximab.

Conventional synthetic DMARDs (eg methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are allowed in combination

Billing Rule

Dosing frequency constraints

Dosing must adhere to the policy-stated maximum frequencies for maintenance regimens (examples include no more frequently than once every 4, 6, or 8 weeks depending on the indication). Requests for dosing more frequently than these maximum intervals are considered on a case-by-case basis.

Out-of-policy or more frequent dosing is reviewed case-by-case

Prior authorization required

Indications with explicit criteria in policy6+ (indication-specific prior therapies, objective measures, and durations listed)

Common established-on-therapy thresholds (examples)Sarcoidosis: 3 months; Many FDA indications: 6 months; Some others: 3 or 4 months

Maximum dosing interval frequency variationsMaintenance dosing specified as no more frequently than every 4, 6, or 8 weeks; some indications allow up to 10 mg/kg and shorter intervals (eg every 4 weeks)

Selected Revision 09/11/2024: Additional age requirements added for initial approvals (examples: spondyloarthritis other subtypes and Still's disease ≥ 18 years; uveitis ≥ 6 years); language change in Conditions Not Recommended for Approval: 'Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule' wording updated (previously listed as 'oral small molecule as DMARD').

2024-12-11material_clarifiedLatest

Annual revision (last_review 2024-12-11): Clarified that a mesalamine product does not count as a systemic therapy for ulcerative colitis; note added that counting/definitions and established-on-therapy timeframes (commonly 1, 3, 4, or 6 months) apply across indications.