Colorado Rocky Mountain Health Plans infliximab Coverage Update

Coverage and Medical Necessity Criteria

Preferred Product Criteria (use of non-preferred infliximab)

Treatment with Remicade or other non-preferred infliximab is medically necessary when BOTH one of the trial/attestation pathways AND the additional condition are met:

Preferred-product exception: One of the following pathways must be met:

Pathways: Pathway A: Documentation of a trial of at least 14 weeks of Avsola, Inflectra, or Renflexis resulting in minimal clinical response AND physician attests that clinical response would be expected to be superior with Remicade or other non-preferred infliximab; Pathway B: Documentation of intolerance, contraindication, or clinically significant adverse event to Avsola, Inflectra, or Renflexis AND physician attests that the same issue would not be expected with Remicade or other non-preferred infliximab.14 weeks for Pathway A

Additional condition: Patient has not had loss of a favorable response after established maintenance therapy with Avsola, Inflectra, Renflexis, or another infliximab biosimilar product.

Ankylosing Spondylitis — Initial Therapy

Covered when ALL of the following are met for initial therapy:

AS initial: Diagnosis of ankylosing spondylitis; AND one of: history of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for ankylosing spondylitis, OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for ankylosing spondylitis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist; AND initial authorization is for no more than 12 months.NSAID trials: ≥4 weeks each; authorization: ≤12 months

Ankylosing Spondylitis — Continuation Therapy

Covered when ALL of the following are met for continuation:

AS continuation: Documentation of positive clinical response to infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for ankylosing spondylitis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization is for no more than 12 months.reauthorization: ≤12 months

Crohn's Disease — Initial Therapy

Covered when ALL of the following are met for initial therapy:

Crohn's initial: Diagnosis of moderately to severely active Crohn's disease; AND one of: disease is high risk (e.g., fistulizing, stricturing, luminal, perianal, extensive disease, growth delay), OR history of failure to one conventional therapy at up to maximally indicated doses within the last 3 months (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for Crohn's disease, OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for Crohn's disease; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a gastroenterologist; AND initial authorization is for no more than 12 months.conventional therapy timeframe: within last 3 months; authorization: ≤12 months

Crohn's Disease — Continuation Therapy

Covered when ALL of the following are met for continuation:

Crohn's continuation: Documentation of positive clinical response to infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for Crohn's disease; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization is for no more than 12 months.reauthorization: ≤12 months

Noninfectious Uveitis — Initial Therapy

Covered when ALL of the following are met for initial therapy:

Uveitis initial: Diagnosis of refractory noninfectious uveitis causing or threatening vision loss; AND history of failure, contraindication, or intolerance to topical corticosteroids, systemic corticosteroids, AND immunosuppressive drugs (e.g., azathioprine, cyclosporine, methotrexate); AND infliximab dosed no higher than 5 mg/kg, administered at week 0, 2, 6 and every 8 weeks thereafter; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition; AND prescribed by or in consultation with a rheumatologist or ophthalmologist; AND initial authorization is for no more than 12 months.dose ≤5 mg/kg; dosing schedule: 0,2,6 then q8w; authorization: ≤12 months

Noninfectious Uveitis — Continuation Therapy

Covered when ALL of the following are met for continuation:

Uveitis continuation: Documentation of positive clinical response to infliximab; AND infliximab dosed no higher than 5 mg/kg administered every 8 weeks; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition; AND reauthorization is for no more than 12 months.dose ≤5 mg/kg; q8w dosing; reauthorization: ≤12 months

Plaque Psoriasis — Initial Therapy

Covered when ALL of the following are met for initial therapy:

Psoriasis initial: Diagnosis of chronic severe plaque psoriasis (extensive and/or disabling); AND one of: (A) ≥3% body surface area involvement or palmoplantar/facial/genital/severe scalp involvement AND history of failure to one topical therapy AND history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; OR (B) prior treatment with a systemic targeted immunomodulator for plaque psoriasis documented by claims/records; OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for plaque psoriasis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a dermatologist; AND initial authorization is for no more than 12 months.methotrexate trial: 3 months; authorization: ≤12 months

Plaque Psoriasis — Continuation Therapy

Covered when ALL of the following are met for continuation:

Psoriasis continuation: Documentation of positive clinical response to infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for plaque psoriasis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization is for no more than 12 months.reauthorization: ≤12 months

Psoriatic Arthritis — Initial Therapy

Covered when ALL of the following are met for initial therapy:

PsA initial: Diagnosis of psoriatic arthritis; AND one of: history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for PsA, OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for psoriatic arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist or dermatologist; AND initial authorization is for no more than 12 months.methotrexate trial: 3 months; authorization: ≤12 months

Plaque psoriasis (initial and continuation)

Plaque psoriasis — covered when ALL of the following are met

Plaque psoriasis initial therapy: Diagnosis of plaque psoriasis; infliximab dosed according to U.S. FDA‑labeled dosing for plaque psoriasis; patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a dermatologist; initial authorization no more than 12 months

Psoriatic arthritis (initial and continuation)

Psoriatic arthritis — covered when ALL of the following are met

PsA initial therapy: Diagnosis of psoriatic arthritis; AND one of: history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for PsA, OR patient is currently on infliximab; infliximab dosed per U.S. FDA‑labeled dosing for PsA; patient not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a rheumatologist or dermatologist; initial authorization up to 12 months

Continuation requires documentation of positive clinical response and reauthorization up to 12 months.

Rheumatoid arthritis (initial and continuation)

Rheumatoid arthritis — covered when ALL of the following are met

RA initial therapy: Diagnosis of moderately to severely active rheumatoid arthritis; AND one of: history of failure or intolerance to a 3‑month trial of one non‑biologic DMARD at maximally indicated doses within the last 6 months unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for RA, OR patient is currently on infliximab; infliximab dosed according to U.S. FDA‑labeled dosing for RA; patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a rheumatologist; initial authorization up to 12 months

Continuation requires documentation of positive clinical response and reauthorization up to 12 months.

Sarcoidosis (initial and continuation)

Sarcoidosis — covered when ALL of the following are met

Sarcoidosis initial therapy: Diagnosis of sarcoidosis; AND history of failure, contraindication, or intolerance to corticosteroids; AND history of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine); AND infliximab dosed no higher than 10 mg/kg administered at week 0, 2 then once every 4–6 weeks; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND initial authorization is for no more than 12 months.max dose 10 mg/kg

Continuation requires documentation of positive clinical response and dosing every 4–6 weeks; reauthorization up to 12 months.

Ulcerative colitis (initial and continuation)

Ulcerative colitis — covered when ALL of the following are met

UC initial therapy: Diagnosis of moderately to severely active ulcerative colitis; AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6‑mercaptopurine, aminosalicylate, azathioprine, corticosteroids), OR prior treatment with an FDA‑approved systemic targeted immunomodulator for UC documented by claims/medical records (document drug, date, duration), OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA‑labeled dosing for UC; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a gastroenterologist; AND initial authorization up to 12 months.

Continuation requires documentation of positive clinical response and reauthorization up to 12 months.

Acute GVHD (initial and continuation)

Acute graft‑versus‑host disease (GVHD) — covered when ALL of the following are met

GVHD initial therapy: Diagnosis of steroid‑refractory acute GVHD; AND one of: patient is receiving infliximab in combination with systemic corticosteroids, OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization is for no more than 4 doses.4 doses

Continuation requires documentation of positive clinical response, ongoing acute GVHD, and same steroid combination/intolerance criteria; reauthorization for no more than 4 doses.

Immune checkpoint inhibitor-related toxicities (initial and continuation)

Immune checkpoint inhibitor‑related toxicities — covered when ALL of the following are met

Checkpoint toxicity initial therapy: Recent receipt of checkpoint inhibitor therapy; AND diagnosis of an immune checkpoint inhibitor‑related toxicity; AND inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the diagnosis; AND one of: patient is receiving infliximab in combination with systemic corticosteroids, OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization is for no more than 4 doses.4 doses

Continuation requires documentation of positive clinical response and ongoing toxicities; reauthorization up to 4 doses.

Proven and FDA-indicated uses

Covered when consistent with proven indications and FDA‑labeled uses

Labeled/proven indications: Infliximab is indicated and proven for Crohn's disease (adult and pediatric ≥6 years), ulcerative colitis (adult and pediatric ≥6 years), rheumatoid arthritis in combination with methotrexate, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis; several indications reference prior inadequate response to conventional therapy.

See FDA labeling for full prescribing information.

NCCN recommended uses

NCCN‑recommended off‑label/compassionate uses (2A) where applicable:

NCCN 2A recommendations: NCCN recommends infliximab (2A) as adjunct/additional therapy for select conditions including steroid‑refractory acute GVHD and various checkpoint inhibitor‑related toxicities (e.g., myocarditis, severe colitis, uveitis refractory to steroids) with timing and steroid‑failure criteria per NCCN guidance.

See NCCN Drugs & Biologics Compendium for condition‑specific guidance.

Other clinical evidence

Evidence summaries and specialty uses (select examples):

Other studied indications: Randomized and observational studies summarized for sarcoidosis, noninfectious uveitis, juvenile idiopathic arthritis (JIA), and multiple small open‑label studies/case reports for other autoimmune conditions; evidence strength varies and some uses remain investigational pending larger trials.

See cited literature summaries for study specifics.

This policy applies to intravenous (IV) infliximab products. Subcutaneous infliximab formulations (for example, Zymfentra/infliximab-dyyb) are dispensed under the pharmacy benefit and are not covered by this medical-benefit policy.

Infliximab is considered unproven and not medically necessary for the following conditions as listed in the policy: hidradenitis suppurativa; juvenile idiopathic arthritis; myelodysplastic syndromes; Reiter's syndrome; Sjögren's syndrome; Still's disease; undifferentiated spondyloarthropathy; and Wegener's granulomatosis.

The literature includes a number of small open-label studies and case reports describing infliximab use for several rare or atypical autoimmune conditions. These small-study reports are noted in the policy but do not establish effectiveness because they lack large, controlled-trial evidence.

Statements of FDA approval in this document are provided for informational purposes only. FDA approval alone is not a basis for coverage; coverage decisions must follow applicable federal, state, or contractual benefit plan requirements.

Requests for non-preferred infliximab products (for example, Remicade) must meet the policy's Preferred Product Criteria to be considered medically necessary. Without documentation of the required trial(s) of preferred products or the physician attestation pathways described in the Preferred Product Criteria, coverage for non-preferred products is not supported.

The policy explicitly lists conditions for which infliximab is unproven and not medically necessary. Use of infliximab for these listed conditions is therefore not supported by this policy in the absence of robust trial evidence.

For conditions described only in small open-label series or case reports, the policy indicates that a standard of care has not been established. These uses remain investigational pending larger randomized controlled trials and are not considered standard indications for infliximab under this policy.

Initial Therapy — Requirements by Indication

Initial therapy general rules

Initial therapy criteria are diagnosis‑specific; generally require documented diagnosis plus prior therapy failure/contraindication/intolerance or high‑risk disease features, dosing per FDA labeling, specialist prescribing/consultation, and initial authorization limits up to 12 months.

Initial therapy general: Diagnosis confirmed; meet indication‑specific prior therapy or high‑risk criteria; dosing per U.S. FDA‑labeled dosing (or specified dosing limits); patient not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; prescribed by or in consultation with the appropriate specialist; initial authorization ≤ 12 months.initial authorization ≤12 months

See each indication for exact prior therapy requirements (e.g., NSAIDs for AS; conventional therapies for Crohn's/UC; topical/systemic corticosteroids and immunosuppressants for uveitis; topical plus methotrexate for plaque psoriasis; methotrexate or prior systemic therapy for PsA/RA).

Initial therapy requirements

Indication‑specific initial therapy requirements (summary):

Continuation and Reauthorization Criteria

Continuation therapy general rules

Continuation/reauthorization requirements for covered indications generally require documentation of positive clinical response, dosing per FDA labeling (or specified dosing), avoidance of combination with another systemic targeted immunomodulator for the same indication, and reauthorization periods up to 12 months.

General continuation: Documentation of positive clinical response; dosing per U.S. FDA‑labeled dosing (or specified dosing limits); patient not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication (except where combined with systemic corticosteroids for GVHD/checkpoint toxicity); reauthorization durations mirror initial limits (typically up to 12 months for chronic indications; up to 4 doses for GVHD/checkpoint toxicity).reauthorization ≤12 months (chronic indications); ≤4 doses (GVHD/checkpoint toxicity)

Continuation therapy requirements

Common continuation requirements across chronic and acute indications:

Continuation common requirements:

Applicable Billing and Diagnosis Codes

Prior Authorization, Documentation and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred infliximab products (e.g., Remicade) and for coverage of infliximab consistent with the Diagnosis-Specific Criteria. Submit the member's primary diagnosis code(s) on the prior authorization request; a valid ICD-10 code supporting the requested indication is required.

Include ICD-10 diagnosis code(s) for the specific condition being treated (e.g., K50.x for Crohn's disease, K51.x for ulcerative colitis, M05.x/M06.x for rheumatoid arthritis, M07.x for psoriatic arthritis, M45.x for ankylosing spondylitis).
Prior authorization is expected for FDA‑labeled and otherwise proven/medically necessary indications listed in the policy.
Provide member identifiers, prescriber information, and requested drug (product name, dose, schedule).

Step Therapy

Non-Preferred Product and Step Requirements

Coverage for non-preferred infliximab products (including Remicade) will only be granted when the policy criteria are met. For members currently receiving a non-preferred product, continued coverage may require switching to a preferred biosimilar (Avsola, Inflectra, or Renflexis) unless exceptions in this section are documented and justified.

Step Therapy Requirements and Tables

Requirement	Notes
Members must try preferred infliximab products (Avsola, Inflectra, Renflexis) before coverage of non-preferred infliximab (e.g., Remicade) is provided.
Coverage for Remicade or other non-preferred infliximab is contingent on meeting the Preferred Product Criteria (see next row for pathways and attestation).

Documentation Required	Examples / Context
Document a trial failure or intolerance to preferred infliximab products OR prior treatment with an FDA‑approved systemic targeted immunomodulator OR that the patient is currently on infliximab.
Indication-specific examples include: Psoriatic arthritis — prior 3‑month methotrexate trial failure or prior systemic targeted immunomodulator; Rheumatoid arthritis — failure/intolerance to a 3‑month non‑biologic DMARD in last 6 months or prior targeted immunomodulator; Ulcerative colitis — failure/intolerance to at least one conventional therapy or prior targeted immunomodulator (document drug, date, duration).

Documentation Required

Examples / Context

Document a trial failure or intolerance to preferred infliximab products OR prior treatment with an FDA‑approved systemic targeted immunomodulator OR that the patient is currently on infliximab.

Indication-specific examples include: Psoriatic arthritis — prior 3‑month methotrexate trial failure or prior systemic targeted immunomodulator; Rheumatoid arthritis — failure/intolerance to a 3‑month non‑biologic DMARD in last 6 months or prior targeted immunomodulator; Ulcerative colitis — failure/intolerance to at least one conventional therapy or prior targeted immunomodulator (document drug, date, duration).

Indication	Prior Conventional Therapy Context
Crohn's disease
Crohn's disease is indicated for patients with an inadequate response to conventional therapy; infliximab is proven to reduce signs/symptoms and maintain remission after inadequate response to conventional therapy.
Ulcerative colitis
Ulcerative colitis is indicated for patients with an inadequate response to conventional therapy; infliximab is proven to induce and maintain remission and mucosal healing after inadequate response to conventional therapy.
Other FDA‑indicated uses (e.g., RA, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis)
Several proven/FDA‑indicated uses reference prior inadequate response to conventional therapy or specified prior‑therapy trials as part of the coverage context (see respective indication criteria).

Step Therapy Sequence Specified?	Administration / Operational Note
No — the document does not specify a detailed sequential step therapy algorithm beyond preferring biosimilars first and requiring documentation when exceptions apply.
UnitedHealthcare may use third‑party tools (e.g., InterQual) to assist in administering benefits; check plan‑specific requirements and the Preferred Product Criteria for operational guidance.

Quantity Limits and Dosing Constraints

inv-80: Infliximab — Up to 4 doses for acute GVHD and immune checkpoint inhibitor-related toxicities; sarcoidosis dosing limited

GVHD and checkpoint-toxicity limitInitial authorization limited to no more than 4 doses for acute GVHD and for immune checkpoint inhibitor–related toxicities

Sarcoidosis dosing capSarcoidosis dosing is limited to no higher than 10 mg/kg with specified induction and maintenance intervals

Continuation conditionsContinuation requires documentation of positive clinical response and adherent dosing/combination criteria (reauthorization mirrors initial limits)

Infusion Site and Setting Considerations

Note

No site‑of‑care specification in excerpt

Site‑of‑care guidance is not specified in this excerpt; clinical context implies IV administration in an infusion setting and no explicit site‑of‑care restrictions are provided here.

The policy refers to IV administration under the medical benefit but does not impose site‑of‑care limits in this extract (chunks 31, 84).

Note

Infusion center: dosing strategies and trial/research considerations

Infusion dosing strategies such as dose escalation or interval shortening are reported in trial and series literature for managing relapses; clinicians may consider these strategies in infusion center settings consistent with clinical evidence.

Uveitis studies report relapse control by increasing topical steroid doses and shortening infliximab infusion intervals (chunk 65).
Higher starting doses (≥5 mg/kg) were associated with higher remission rates in a retrospective uveitis cohort (chunk 67).

Biosimilar Preference and Reference Products

Billing Rule

Preferred infliximab products (Avsola, Inflectra, Renflexis)

Avsola (infliximab‑axxq), Inflectra (infliximab‑dyyb), and Renflexis (infliximab‑abda) are identified as preferred infliximab products; these preferred biosimilars should be used in accordance with the policy criteria.

Preferred products named: Avsola, Inflectra, Renflexis; coverage for these is contingent on diagnosis‑specific criteria (chunk 4).

Billing Rule

Infliximab and biosimilar HCPCS/CPT codes

Procedure codes for infliximab and listed biosimilars are provided for billing/reference: J1745 (infliximab, non‑biosimilar) and Q5103/Q5104/Q5121 for biosimilars (Inflectra, Renflexis, Avsola respectively).

J1745 — Injection, infliximab, excludes biosimilar, 10 mg; Q5103 — infliximab‑dyyb (Inflectra), 10 mg; Q5104 — infliximab‑abda (Renflexis), 10 mg; Q5121 — infliximab‑axxq (Avsola), 10 mg (chunk 31).

Clinical Background

Infliximab is a chimeric anti–TNF-alpha monoclonal antibody administered intravenously; the policy distinguishes IV infliximab products (including Remicade and listed biosimilars) covered under the medical benefit from subcutaneous formulations managed under the pharmacy benefit. Preferred biosimilars (Avsola, Inflectra, Renflexis) are identified and coverage for non-preferred products (e.g., Remicade) is contingent on meeting the Preferred Product Criteria and diagnosis-specific requirements.

Definitions and Key Terms

inv-64: Infliximab definition (IV products under medical benefit)

Definition of infliximab in policy'Infliximab' refers to all infliximab products administered intravenously under the medical benefit, including Remicade and listed biosimilars

Benefit distinctionSubcutaneous infliximab (e.g., Zymfentra/infliximab-dyyb) is obtained under the pharmacy benefit and is not covered under this medical benefit policy

HCPCS referenceMedical-benefit infliximab and biosimilars are referenced by HCPCS codes (e.g., J1745, Q5103, Q5104, Q5121) elsewhere in the policy

inv-65: Systemic targeted immunomodulator — examples

Examples of systemic targeted immunomodulatorsExamples include adalimumab, bimekizumab (Bimzelx), certolizumab (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), tildrakizumab (Ilumya), apremilast (Otezla), risankizumab (Skyrizi), brodalumab (Siliq), deucravacitinib (Sotyktu), ixekizumab (Taltz), guselkumab (Tremfya), ustekinumab

Policy Revision History

2026-04-01operationalLatest

Archived previous policy version CS2026D0004AY (template update removed Louisiana‑specific content); current policy effective date set.

policy_note

Policy guidance: Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans and may be used with third‑party tools (e.g., InterQual) to assist administration; check plan‑specific federal, state, or contractual requirements for coverage determinations.

OpenPayer

Intravenous infliximab (Remicade and biosimilars) — Medical Benefit Drug Policy

Coverage and Medical Necessity Criteria

Initial Therapy — Requirements by Indication

Continuation and Reauthorization Criteria

Applicable Billing and Diagnosis Codes

Prior Authorization, Documentation and Billing Guidance

Step Therapy Requirements and Tables

Quantity Limits and Dosing Constraints

Infusion Site and Setting Considerations

Biosimilar Preference and Reference Products

Clinical Background

Definitions and Key Terms

Policy Revision History