Intravenous infliximab (medical benefit)
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Defines medical necessity criteria, dosing, continuation, and prior-authorization limits for intravenous infliximab under Blue Cross of Idaho medical benefit plans; affects providers requesting IV infliximab for covered indications.
Remicade added as a preferred product.
Policy added to prescription drug section and adopted by Blue Cross of Idaho.
Coverage Criteria for Intravenous Infliximab
Initial therapy criteria
Initial Treatment — Intravenous infliximab may be considered medically necessary when ALL of the following are met:
Documentation of prior therapies should be provided as specified in indication-specific sections
See pre-treatment screening requirements
See Appendices for lists of biologic and targeted synthetic DMARDs
See Dose Escalation section for permitted increases
See chunks 6–10 for indication-specific lines of therapy and age criteria
Continuation therapy criteria
Continuation of Treatment — requests may be considered medically necessary when ALL of the following are met:
See Appendices
Dose escalation criteria (RA, CD, UC)
Dose escalation for IV infliximab — additional dosing may be authorized when ALL of the following are met (criteria differ by disease):
Initial approval duration for increased dosing for CD/UC is 16 weeks; continued approval duration is 6 months
Initial approval for increased dosing (CD/UC) = 16 weeks; continued approval = 6 months
Indications (FDA-approved and Off-label)
Policy references FDA-approved indications and lists commonly considered off-label uses
See regulatory status list in chunk 21 for full details
See chunk 22 for off-label list and safety warnings
General coverage context and indication list
Coverage and use of infliximab and biosimilars are context-dependent and typically considered after conventional therapies or as indicated by disease-specific guidance.
See Appendices 1 and 2 for conventional therapy options and the list of biologic/targeted therapies
Subcutaneous formulations of infliximab are managed under the pharmacy benefit and are outside the scope of this medical policy. Intravenous infliximab is covered under the Blue Cross of Idaho medical benefit when the medical necessity criteria in this policy are met. Infliximab must not be used concomitantly with other biologic disease-modifying antirheumatic drugs (DMARDs), targeted synthetic DMARDs, or other immunomodulators; see the policy appendices for details on concurrent therapy exclusions and preferred product guidance.
Infliximab should not be administered to individuals with any clinically important active infection, including active tuberculosis, until the infection is adequately treated and resolved. Individuals should be screened for hepatitis B virus (HBV) prior to initiation because HBV reactivation has been reported with TNFα blocker therapy. Live vaccines are not recommended concurrently with infliximab; for infants exposed in utero, live vaccines should be delayed for at least 6 months after birth. Use in individuals with moderate to severe heart failure is cautioned and should follow consideration of alternative treatments.
The codes listed in this policy are provided for reference only. Inclusion of a code does not guarantee member coverage or provider reimbursement. All coverage and reimbursement decisions are subject to the member’s specific benefit plan documentation, the terms of this medical policy, and applicable legal and contractual requirements; providers should verify member benefits and prior authorization requirements before billing.
For Crohn’s disease and ulcerative colitis, requests for increased infliximab dosing will not be approved when the individual had no response to standard maintenance dosing (every 8 weeks). Dose escalation should only be considered for those who initially achieved an adequate response and subsequently lost response, and must not be requested based solely on therapeutic drug level or anti-drug antibody testing in the absence of clinical signs or symptoms. Adults’ escalation is limited to a maximum of 10 mg/kg every 8 weeks or 5 mg/kg every 4 weeks; pediatric patients with severe disease may be approved for up to 10 mg/kg every 4 weeks. Initial approval duration for increased dosing is 16 weeks with continued approval up to 6 months as specified in the policy.
This medical policy may not apply to all lines of business. Benefit exceptions can include, but are not limited to, the Federal Employee Program, Medicare Supplement, Medicare Advantage, Medicaid, and certain self-insured groups. Providers should consult member-specific benefit plan documentation to confirm applicability, coverage rules, and any alternate processes that may apply for those lines of business.
The policy text excerpt does not enumerate additional blanket ‘not medically necessary’ statements beyond the criteria already described; however, requests may be considered not medically necessary when the coverage criteria are not met (for example, active or untreated latent tuberculosis, hepatitis B, other active serious infections, or failure to meet prior‑therapy requirements). Final coverage determinations are made based on the member’s specific benefit plan documentation and the clinical criteria set forth in this policy.
Coding and Dosing
| J1745 | Injection, infliximab, excludes biosimilar, 10 mg (Remicade) |
| J1748 | Injection, infliximab-hyphendyyb (zymfentra), 10 mg |
| Q5103 | Injection, infliximab-hyphendyyb, biosimilar, (inflectra), 10 mg |
| Q5104 | Injection, infliximab-hyphenabda, biosimilar, (renflexis), 10 mg |
| Q5121 | Injection, infliximab-hyphenaxxq, biosimilar, (AVSOLA), 10 mg |
| D86.0 - D86.9 | Sarcoidosis |
| D89.810 | Acute graft-versus-host disease |
| D89.812 | Acute on chronic graft-versus-host disease |
| K52.82 | Eosinophilic colitis |
| K52.89 | Other specified noninfective gastroenteritis and colitis |
| K52.9 | Noninfective gastroenteritis and colitis, unspecified |
| K60.3 - K60.5 | Anal fistula |
| K63.2 | Fistula of intestine, excluding rectum and anus |
| L40.0 - L40.9 | Psoriasis |
| L73.2 | Hidradenitis suppurativa |
Provider Requirements and Authorization Steps
Prior-approval limits: vial size, usual dosing, and non-preferred product rules
Prior authorization requests are subject to prior-approval limits: dosing is referenced to a 100 mg vial with typical initiation at 5 mg/kg as frequently as every 8 weeks for up to 1 year; requests for non-preferred products must meet medical policy exceptions and preferred-product requirements in the policy.
- Prior-approval limits: 100 mg vial; 5 mg/kg as frequently as every 8 weeks, for up to 1 year (See Additional Dosing Information).
- Non-preferred product requests must meet coverage per medical policy and preferred-product listing.
Prior authorization required before initiation
Prior authorization is required for infliximab to ensure safe, clinically appropriate, and cost-effective use and must be obtained before treatment per the medical policy.
- Prior authorization is required to maintain optimal therapeutic outcomes.
Prior authorization applies to infliximab (J- and Q-codes) and biosimilars
Prior authorization applies to infliximab and its biosimilars (HCPCS/HCPCS Q-codes and J-codes listed in the policy); providers must follow member-specific prior authorization processes and billing guidance.
Step therapy — document prior-line failure/intolerance/contraindication
Providers must document inadequate response, intolerance, or contraindication to preferred infliximab products or to conventional (nonbiologic) therapies as specified for each indication before IV infliximab will be authorized.
- Initial therapy requires use of a preferred product or documentation of contraindication/intolerance or inadequate response to preferred products.
- Indication-specific criteria list required prior conventional therapy failures (see indication sections and Appendices).
Document prior inadequate response to conventional therapy for FDA‑approved indications
For many FDA-approved indications (e.g., pediatric CD/UC, adult CD/UC), infliximab use is contingent on documentation of prior inadequate response to conventional therapy; expect documentation of those prior therapies when requesting coverage.
- Pediatrics ≥6 years: moderate-to-severe CD or UC with inadequate response to conventional therapy.
- Adults: CD/UC use after inadequate response to conventional therapy is an FDA-approved indication and referenced in the policy.
Document conventional therapy alternatives and prior use
Providers should document use of conventional therapy alternatives (as appropriate per disease) prior to biologic initiation or to support step therapy exceptions; listed options include corticosteroids, azathioprine, methotrexate, antibiotics for fistulizing disease, and mesalamine for UC.
- Crohn's disease conventional options: mesalamine/budesonide for mild disease, azathioprine/mercaptopurine or methotrexate for maintenance; antibiotics for perianal/fistulizing disease.
- Ulcerative colitis conventional options: oral/rectal mesalamine, corticosteroids for induction, azathioprine/mercaptopurine for maintenance, and other listed alternatives per severity.
Documentation required: TB screening and prior-therapy evidence
Documentation must include tuberculosis screening within 6 months prior to initiating infliximab confirming no active TB, or documentation that latent TB treatment was started prior to infliximab; clinical rationale for intolerance/contraindication or inadequate response to prior therapies must also be provided.
- TB screening within 6 months confirming no active tuberculosis, or evidence latent TB treatment was begun before infliximab.
- If switching from another targeted immune modulator with prior TB screening and no new risk factors, repeat TB screening is not necessary.
- Documentation of prior therapy failure, intolerance, or contraindication as specified per indication.
Pre-treatment screening: HBV and immunizations
Screen for hepatitis B virus (HBV) prior to starting infliximab and ensure members are up-to-date on immunizations; live vaccines are not recommended concurrently with infliximab and infants exposed in utero should not receive live vaccines for at least 6 months.
- Individuals should be screened for HBV prior to initiation due to risk of HBV reactivation.
- Ensure vaccination status per current guidelines; do not give live vaccines concurrently with infliximab.
Verify member benefits and cite policy when billing
When submitting claims, providers must verify member-specific benefit plan coverage and reference this medical policy; the policy's code list is for reference and does not guarantee coverage or payment.
- Reference member-specific benefits and this medical policy when submitting claims.
- The inclusion of a code in the policy does not guarantee coverage or reimbursement.
Denial risks: active infections, HBV, untreated latent TB, and non-preferred products
Requests may be denied as not medically necessary for individuals with active or untreated latent tuberculosis, hepatitis B, other active serious infections, a history of recurrent infections, or when criteria (including preferred-product requirements) are not met.
- Active or untreated latent TB, active HBV, or other active serious infections are contraindications to approval.
- Requests for non-preferred medications will be considered not medically necessary unless policy exceptions are met.
Risk of denial if prior authorization is not obtained
Failure to obtain required prior authorization may result in non-coverage or denial of infliximab claims; obtain authorization per member-specific process before administration.
- Prior authorization is explicitly required by the policy to ensure appropriate use.
- Obtain authorization before treatment to avoid potential non-coverage.
Coverage is contingent on member-specific benefits and plan terms
Coverage determination for an individual is contingent on that member's specific benefit plan; inclusion of HCPCS or ICD-10 codes in this policy does not guarantee coverage under a given plan.
- All benefit coverage determinations are subject to member-specific benefit plan documentation and other terms and conditions.
- Verify plan-level coverage even when policy criteria are met.
Background on Infliximab
Infliximab is an intravenous tumor necrosis factor alpha (TNFα) inhibitor indicated for multiple immune-mediated inflammatory conditions, including rheumatoid arthritis (in combination with methotrexate), Crohn’s disease (including fistulizing disease), ulcerative colitis, ankylosing spondylitis/axial spondyloarthritis, psoriatic arthritis, and chronic severe plaque psoriasis; pediatric approvals include certain indications for Crohn’s disease and ulcerative colitis for patients aged 6 years and older. The policy requires tuberculosis screening prior to initiation and prohibits concurrent use with other biologic or targeted synthetic DMARDs. Safety concerns noted with TNFα blockers include serious infections, potential hepatitis B reactivation, and rare malignancies; vaccination and HBV screening recommendations should be followed per the policy.
Definitions and Safety Notes
Policy Revision History
Policy adopted by Blue Cross of Idaho with Remicade added as a preferred product; policy effective date recorded.
Policy last reviewed; New policy added to prescription drug section and Blue Cross of Idaho adoption documented; adoption effective 08/01/2025 noted in history.
Policy created and replaced prior policy content; initial drafting/replace action recorded in policy history.
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