Infliximab (IV) products — coverage criteria
Customize your policy alerts
Sign up for sierra health and life Policy 2026D0004AR alerts
Get alerted when Policy 2026D0004AR changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity and prior authorization criteria for intravenous infliximab products (including specified biosimilars) across multiple indications for Sierra Health and Life members. Applies to providers requesting coverage under the medical benefit unless the product is self-administered subcutaneous infliximab obtained under pharmacy benefit as noted.
Removed coverage criteria for proven treatment of ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' in medical necessity criteria.
Updated lists of systemic targeted immunomodulators that must not be used in combination with infliximab and lists of prior U.S. FDA–approved systemic targeted immunomodulators for initial therapy across multiple indications (adds and removes multiple specific agents).
Added criterion requiring diagnosis of an immune checkpoint inhibitor-related toxicity for that indication.
Removed HCPCS code Q5109.
Removed Documentation Requirements section from the policy.
Coverage Criteria and Medical Necessity
Preferred Product Criteria
Coverage for non-preferred infliximab products (e.g., Remicade, Renflexis) is medically necessary when BOTH of the following are met:
Used to approve non-preferred products
Ankylosing Spondylitis
Infliximab is medically necessary for ankylosing spondylitis when ALL of the following are met:
Crohn's disease
Infliximab is medically necessary for Crohn's disease when ALL of the following are met:
Noninfectious uveitis
Infliximab is medically necessary for refractory noninfectious uveitis causing or threatening vision loss when ALL are met:
Plaque psoriasis
Infliximab is medically necessary for chronic severe plaque psoriasis when ALL are met:
Psoriatic arthritis
Infliximab is medically necessary for psoriatic arthritis when ALL are met:
Rheumatoid arthritis
Infliximab is medically necessary for rheumatoid arthritis when ALL are met:
Sarcoidosis
Infliximab is medically necessary for sarcoidosis when ALL are met:
Rheumatoid arthritis — initial and continuation
Rheumatoid arthritis — initial and continuation
Sarcoidosis — initial and continuation
Sarcoidosis — initial and continuation
Ulcerative colitis — initial and continuation
Ulcerative colitis — initial and continuation criteria
Acute GVHD — initial and continuation
Acute GVHD — initial and continuation criteria
ICI-related toxicities — initial and continuation
ICI-related toxicities — initial and continuation criteria
Covered indications (FDA and NCCN-supported)
Infliximab is considered proven/covered for the following indications when clinical criteria are met:
Limited evidence / off-label indications
Uses supported by smaller trials, trials with mixed results, or limited evidence:
Immune Checkpoint Inhibitor-Related Toxicities
Updated criterion for immune checkpoint inhibitor-related toxicity
Replaced prior severity‑specific initial therapy requirements; steroid‑failure wording requires inadequate improvement despite corticosteroid therapy of adequate dose and duration for the specific severity and diagnosis.
Terminology and Prior/Combination Therapy Requirements
Revised medical necessity criterion language and prior therapy/combination restrictions across multiple indications
See per‑indication lists in the policy for the updated agent examples.
Self-administered subcutaneous infliximab (for example, Zymfentra/infliximab-dyyb) is dispensed under the pharmacy benefit unless the member's benefit plan documents specify otherwise. Exception: certain delegated UnitedHealthcare of California reviews may route the self-administered product under the medical benefit. Prior authorization is required for medical‑benefit intravenous infliximab products, and Inflectra and Avsola are identified as preferred infliximab products; non‑preferred products (e.g., Remicade, Renflexis) require additional documented justification per policy (see preferred product criteria and step therapy rules).
The policy designates certain uses of infliximab as unproven and not medically necessary. Listed examples include hidradenitis suppurativa, juvenile idiopathic arthritis (juvenile rheumatoid arthritis), myelodysplastic syndromes, and Reiter's syndrome. Small open‑label studies or case reports exist for a variety of other conditions, but the policy considers these indications unproven in the absence of large, randomized controlled trials.
When requesting coverage or submitting a prior authorization, providers must include an applicable ICD‑10 diagnosis code from the policy's listed codes that supports medical necessity for the requested infliximab service or administration.
Experimental, investigational, or unproven uses of infliximab may be excluded from coverage unless the member's specific Certificate of Coverage permits such treatments or a state mandate requires coverage. Always consult the member's benefit document and applicable federal/state mandates when making coverage determinations.
The policy was revised to remove coverage criteria that previously listed certain conditions as proven treatment indications. Requests for infliximab for the following removed indications — ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis — may be denied or require alternate review per the updated policy and the member's benefit terms.
Indications designated as unproven are labeled not medically necessary because available randomized controlled trial data are insufficiently robust to demonstrate clear superiority in clinical efficacy; therefore the policy does not consider routine use of infliximab for these conditions to be medically necessary in the absence of stronger evidence or specific benefit coverage allowances.
The policy cites specific examples where evidence is limited or conflicting. For example, a randomized controlled pediatric trial of infliximab for juvenile idiopathic arthritis failed to show statistically significant benefit for the 3 mg/kg dose and raised safety concerns; other indications are supported only by small open‑label studies or case series. These limitations underpin the policy's classification of those uses as unproven.
Operationally, indications that were removed from the coverage criteria table are no longer listed as proven treatment criteria in this policy version; providers should not assume continued coverage under the criteria and must follow the updated policy language and the member's specific plan for coverage determination.
Initial Authorization Requirements
Initial Therapy
Initial Therapy — General initial authorization requirements vary by indication (diagnosis, prior therapy failure/prior targeted therapy, dosing limits).
Initial therapy rules
Initial therapy rules — Operational rules and variation by indication.
Initial therapy indications
Initial therapy indications — FDA‑labeled initial uses
Initial therapy — Immune checkpoint inhibitor-related toxicity
Initial therapy — Immune checkpoint inhibitor-related toxicity requirement
Continuation / Reauthorization Requirements
Continuation Therapy
Continuation Therapy — Continuation (reauthorization) requirements are consistent across indications
Continuation therapy requirements
Continuation therapy requirements — Operational continuation requirements across indications.
Continuation therapy evidence
Continuation therapy evidence — Long‑term/continuation therapy observations from uveitis studies:
Step Therapy and Prior Authorization Conditions
| Requirement | Details |
|---|---|
| Preferred-product trial requirement | |
| Documentation of a trial of at least 14 weeks of Inflectra (infliximab-dyyb) or Avsola (infliximab-axxq) with minimal clinical response and residual disease activity; AND physician attestation that clinical response would be expected to be superior with the requested non-preferred infliximab (e.g., Remicade, Renflexis) | |
| Intolerance/contraindication alternative | |
| Documentation of intolerance, contraindication, or adverse event to Inflectra or Avsola; AND physician attestation that the same intolerance/contraindication/adverse event would not be expected with the requested non-preferred infliximab product | |
| Continuation condition | |
| Member already receiving non-preferred infliximab must change to Inflectra or Avsola unless criteria above are met to continue non-preferred product |
| Indication group | Prior therapy / step required |
|---|---|
| Sarcoidosis | |
| History of failure, contraindication, or intolerance to corticosteroids; AND history of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine) | |
| Ulcerative colitis | |
| History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6‑mercaptopurine, aminosalicylate, azathioprine, corticosteroids) OR prior treatment with a systemic targeted immunomodulator FDA‑approved for UC (document drug, date, duration) OR patient currently on infliximab | |
| Ankylosing spondylitis | |
| History of failure to two NSAIDs each used ≥4 weeks at maximally indicated doses unless contraindicated; OR prior treatment with an FDA‑approved systemic targeted immunomodulator for AS; OR current infliximab use |
| NCCN-recommended use | Required prior therapy before infliximab |
|---|---|
| Steroid-refractory acute GVHD | |
| Recommended after inadequate response to systemic corticosteroids (steroid‑refractory); often used in conjunction with original immunosuppressive agent per NCCN | |
| Immune checkpoint inhibitor-related toxicities (e.g., steroid‑refractory uveitis, severe GI inflammation, myocarditis, pneumonitis) | |
| Consider adding infliximab when there is inadequate improvement despite appropriate systemic corticosteroid therapy (NCCN guidance specifies timeframes such as 24–72 hours for select toxicities) — i.e., after failure/inadequate response to first‑line corticosteroids | |
| Stage 3 AKI related to checkpoint inhibitors | |
| Consider infliximab if toxicity remains > stage 2 after 4–6 weeks of corticosteroids or if creatinine worsens during steroid taper |
| Program | Requirement / Note |
|---|---|
| Medicare Part B Step Therapy Programs | |
| Preferred therapy criteria and Medicare Part B step therapy programs may apply for Medicare Advantage members; follow Medicare Part B Step Therapy Programs where specified (refer to applicable LCDs/LCAs and Medicare Benefit Policy Manual guidance) |
Billing and Diagnosis Codes
| D89.810 | Acute graft-versus-host disease. |
| H20.041 | Secondary noninfectious iridocyclitis, right eye. |
| H20.042 | Secondary noninfectious iridocyclitis, left eye. |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral. |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye. |
| H20.10 | Chronic iridocyclitis, unspecified eye. |
| H20.11 | Chronic iridocyclitis, right eye. |
| H20.12 | Chronic iridocyclitis, left eye. |
| H20.13 | Chronic iridocyclitis, bilateral. |
| H20.821 | Vogt-Koyanagi syndrome, right eye. |
| K50.011 | Crohn's disease of small intestine with rectal bleeding. |
| K50.013 | Crohn's disease of small intestine with fistula. |
| K50.113 | Crohn's disease of large intestine with fistula. |
| K50.813 | Crohn's disease of both small and large intestine with fistula. |
| K51.313 | Ulcerative (chronic) rectosigmoiditis with fistula. |
| K51.413 | Inflammatory polyps of colon with fistula. |
| K51.513 | Left sided colitis with fistula. |
| K51.813 | Other ulcerative colitis with fistula. |
| K51.913 | Ulcerative colitis, unspecified with fistula. |
| K60.311 | Anal fistula, simple, initial. |
| M05.631 | Rheumatoid arthritis of right wrist with involvement of other organs and systems. |
| M05.632 | Rheumatoid arthritis of left wrist with involvement of other organs and systems. |
| M05.639 | Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems. |
| M05.641 | Rheumatoid arthritis of right hand with involvement of other organs and systems. |
| M05.642 | Rheumatoid arthritis of left hand with involvement of other organs and systems. |
| M05.649 | Rheumatoid arthritis of unspecified hand with involvement of other organs and systems. |
| M05.651 | Rheumatoid arthritis of right hip with involvement of other organs and systems. |
| M05.652 | Rheumatoid arthritis of left hip with involvement of other organs and systems. |
| M05.659 | Rheumatoid arthritis of unspecified hip with involvement of other organs and systems. |
| M05.661 | Rheumatoid arthritis of right knee with involvement of other organs and systems. |
| M06.861 | Other specified rheumatoid arthritis, right knee. |
| M06.862 | Other specified rheumatoid arthritis, left knee. |
| M06.869 | Other specified rheumatoid arthritis, unspecified knee. |
| M06.871 | Other specified rheumatoid arthritis, right ankle and foot. |
| M06.872 | Other specified rheumatoid arthritis, left ankle and foot. |
| M06.879 | Other specified rheumatoid arthritis, unspecified ankle and foot. |
| M06.88 | Other specified rheumatoid arthritis, vertebrae. |
| M06.89 | Other specified rheumatoid arthritis, multiple sites. |
| M06.8A | Other specified rheumatoid arthritis, other specified site. |
| M06.9 | Rheumatoid arthritis, unspecified. |
Provider Actions, Prior Authorization & Documentation
Prior Authorization Required
Prior authorization is required for medical benefit infliximab products. Submit prior authorization requests with clinical documentation supporting the diagnosis and prior therapy history. Include dosing, treatment response, and rationale when requesting a non-preferred infliximab product (e.g., Remicade, Renflexis) such as documentation of a trial of at least 14 weeks of a preferred product (Inflectra or Avsola) with minimal response, or documentation of intolerance/contraindication to preferred products.
- Preferred products: Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq).
- Non-preferred examples: Remicade (infliximab), Renflexis (infliximab-abda), other infliximab biosimilars.
Diagnosis Coding Required — Missing or Mismatched Codes May Cause Denial
Requests must include an applicable ICD-10 diagnosis code from the policy's list of covered/acceptable diagnoses. Claims or authorizations submitted without a listed applicable ICD-10 code may be denied.
- Provider must document diagnosis using one of the applicable ICD-10 codes included in the policy.
- Diagnosis-code mismatch or omission may trigger denial of authorization or claim.
Required Clinical Documentation and Prior Therapy History
For many indications, prior authorization requires documentation of prior therapies: history of failure, contraindication, or intolerance to specified conventional therapies (for example, NSAIDs, corticosteroids, DMARDs, methotrexate, or other immunosuppressants) or trial/failure of preferred infliximab products. Typical approval durations are indication-specific (generally up to 12 months for chronic indications; up to 4 doses for certain acute indications).
- Document prior treatment history (failures, contraindications, or intolerances) and dates/duration of trials.
- Include prescriber specialty when required (e.g., rheumatologist, gastroenterologist) and dosing consistent with FDA labeling.
Medicare Advantage / Part B Note
Medicare Advantage members may be subject to Medicare Part B billing rules and Part B step therapy programs. Refer to applicable LCDs/LCAs and Medicare Part B Step Therapy guidance when processing requests for MA members; preferred therapy and Part B step therapy criteria may apply.
- Medicare may cover outpatient (Part B) infliximab furnished "incident to" a physician's service when not usually self-administered — check LCDs/LCAs.
- Preferred therapy criteria for Medicare Advantage members: follow Medicare Part B Step Therapy Programs where applicable.
Benefit Limitations and Plan-Specific Rules
Coverage decisions must also be consistent with the member-specific benefit plan. Coverage may be denied if the member's benefit plan excludes experimental/off-label uses or other plan limits apply.
- Consult the member-specific benefit plan document for exclusions or state mandates that may supersede policy language.
Biosimilars and Product Preference
Inflectra — preferred infliximab product
Inflectra (infliximab‑dyyb) is identified as a preferred infliximab product; preferred products (Inflectra and Avsola) are first‑line for coverage and should be used prior to requesting non‑preferred products unless the Preferred Product Criteria are met.
- Preferred infliximab products: Inflectra and Avsola
Avsola — preferred infliximab product
Avsola (infliximab‑axxq) is identified as a preferred infliximab product; preferred products (Inflectra and Avsola) are first‑line for coverage and should be trialed before non‑preferred infliximab products unless criteria for non‑preferred use are documented.
- Preferred infliximab products: Avsola and Inflectra
Infliximab HCPCS codes — billing reference
Infliximab biosimilars and the reference product are listed with HCPCS codes (J1745, Q5103, Q5104, Q5121); the policy lists biosimilar HCPCS codes alongside J1745 but does not state a separate biosimilar‑specific step beyond the preferred‑product requirements.
infliximab‑abda (Renflexis) — billing reference
Renflexis (infliximab‑abda) is listed among infliximab biosimilars in the policy’s HCPCS/code listings and as an example of a non‑preferred infliximab product requiring justification for use.
infliximab‑axxq (Avsola) — billing reference
Avsola (infliximab‑axxq) is listed as a biosimilar to Remicade and is identified as a preferred infliximab product in the policy.
Biosimilars similarity to Remicade — billing note
The policy notes that biosimilars are highly similar to Remicade and share the same FDA‑indicated uses; supporting randomized equivalence studies and prescribing information are cited in the references.
Site of Care and Administration
Infusion center — site of care
Infliximab is typically administered as an outpatient intravenous infusion. For Medicare members, outpatient infusions may be covered under Part B when furnished 'incident to' a physician’s service—check Part B rules and applicable LCDs/LCAs.
- Site of care: outpatient infusion center or physician office per Medicare rules
Infusion center | office — Medicare site‑of‑care billing
Medicare may cover outpatient (Part B) drugs furnished 'incident to' a physician service if the drug is not usually self‑administered; verify Medicare local coverage guidance and beneficiary plan specifics for site‑of‑care billing.
Background and Definitions
Infliximab is a chimeric monoclonal antibody that neutralizes tumor necrosis factor‑alpha (TNF‑alpha) and is used intravenously to treat a range of inflammatory and autoimmune conditions. The policy uses the term "infliximab" to refer to the reference product (Remicade) and FDA‑approved biosimilars (for example, Inflectra, Avsola, Renflexis, CT‑P13/SB2). Biosimilars have been evaluated in randomized trials demonstrating high similarity to the reference product and share the same FDA‑approved indications, and preferred biosimilar products (Inflectra, Avsola) are identified in the policy for first‑line coverage considerations.
Policy Overview and Key Metrics
Policy Changes and Revision History
Removed coverage criteria for ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis; replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and updated lists of systemic targeted immunomodulators across indications.
Updated lists of systemic targeted immunomodulators that must not be used in combination with infliximab and updated lists of prior FDA‑approved systemic targeted immunomodulators for initial therapy (adds include bimzelx, cosentyx, taltz, vedolizumab, mirikizumab, tremfya, zeposia, risankizumab, guselkumab, and others; multiple removals and replacements noted per indication).
Added a required diagnosis criterion for immune checkpoint inhibitor–related toxicities and clarified the steroid-failure language to require inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the specific severity and diagnosis.
Removed HCPCS code Q5109 from the policy's listed procedure codes.
Removed the Documentation Requirements section and archived the previous policy version 2025D0004AQ.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.