Modifiedsierra health and lifePolicy 2026D0004AR

Infliximab (IV) products — coverage criteria

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.

Policy Summary

Payersierra health and life

PolicyInfliximab (IV) products — coverage criteria

Policy CodePolicy 2026D0004AR

Change TypeRemoved multiple indication-specific criteriaupdated terminology and prior/combination therapy lists

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with applicable ICD-10 diagnosis code and documentation of prior therapy or intolerance when requesting non-preferred infliximab.

SourceLink

POLICY UPDATE CHANGES

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.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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:

Non-preferred infliximab approval: 1) Either: (a) Documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response and residual disease activity AND physician attestation that the clinical response would be expected to be superior with the non-preferred infliximab product (e.g., Remicade, Renflexis), OR (b) 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 non-preferred infliximab product; AND 2) Patient has not had loss of a favorable response after established maintenance therapy with Inflectra, Avsola, or another infliximab biosimilar product.14 weeks trial

Used to approve non-preferred products

Ankylosing Spondylitis

Infliximab is medically necessary for ankylosing spondylitis when ALL of the following are met:

Initial therapy for AS: Diagnosis of ankylosing spondylitis; AND one of: (a) history of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated, OR (b) prior treatment with an FDA‑approved systemic targeted immunomodulator for ankylosing spondylitis, OR (c) patient is currently on infliximab; AND infliximab 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 for no more than 12 months.NSAIDs each ≥4 weeks

Continuation therapy for AS: Documentation of positive clinical response to infliximab; AND infliximab 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 for no more than 12 months.

Crohn's disease

Infliximab is medically necessary for Crohn's disease when ALL of the following are met:

Initial therapy for Crohn's disease: Diagnosis of moderately to severely active Crohn's disease; AND disease considered high risk (e.g., fistulizing, stricturing, luminal, perianal, extensive disease, growth delay); AND one of: history of failure to one conventional therapy at maximally indicated doses (e.g., 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 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 for no more than 12 months.

Continuation therapy for Crohn's disease: Documentation of positive clinical response to infliximab; AND infliximab 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 for no more than 12 months.

Noninfectious uveitis

Infliximab is medically necessary for refractory noninfectious uveitis causing or threatening vision loss when ALL are met:

Initial therapy for noninfectious uveitis: Diagnosis of refractory noninfectious uveitis that is causing or threatening vision loss; AND history of failure, contraindication, or intolerance to topical corticosteroids AND 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, then 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 for no more than 12 months.<= 5 mg/kg starting schedule

Continuation therapy for noninfectious uveitis: Documentation of positive clinical response to infliximab; AND infliximab dosed no higher than 5 mg/kg every 8 weeks; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition; AND reauthorization for no more than 12 months.

Plaque psoriasis

Infliximab is medically necessary for chronic severe plaque psoriasis when ALL are met:

Initial therapy for plaque psoriasis: Diagnosis of chronic severe plaque psoriasis (extensive and/or disabling); AND one of: (a) ≥3% body surface area involvement or palmoplantar/facial/genital/scalp involvement AND history of failure to one topical therapy unless contraindicated AND history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated, OR (b) prior treatment with an FDA‑approved systemic targeted immunomodulator for plaque psoriasis, OR (c) patient is currently on infliximab; AND infliximab 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 for no more than 12 months.

Continuation therapy for plaque psoriasis: Documentation of positive clinical response to infliximab; AND infliximab 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 for no more than 12 months.

Psoriatic arthritis

Infliximab is medically necessary for psoriatic arthritis when ALL are met:

Initial therapy for PsA: 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 psoriatic arthritis, OR patient is currently on infliximab; AND infliximab 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 for no more than 12 months.

Continuation therapy for PsA: Documentation of positive clinical response to infliximab; AND infliximab 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 reauthorization for no more than 12 months.

Rheumatoid arthritis

Infliximab is medically necessary for rheumatoid arthritis when ALL are met:

Initial therapy for RA: 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 rheumatoid arthritis, OR patient is currently on infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for rheumatoid 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; AND initial authorization for no more than 12 months.

Continuation therapy for RA: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization for no more than 12 months.

Sarcoidosis

Infliximab is medically necessary for sarcoidosis when ALL are met:

Initial therapy for sarcoidosis: 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 to 6 weeks thereafter; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND initial authorization for no more than 12 months.≤ 10 mg/kg

Continuation therapy for sarcoidosis: Documentation of positive clinical response to infliximab; AND infliximab dosed no higher than 10 mg/kg every 4 to 6 weeks; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization for no more than 12 months.≤ 10 mg/kg

Rheumatoid arthritis — initial and continuation

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

Continuation of therapy: Documentation of positive clinical response to infliximab; infliximab dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; patient not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; reauthorization for no more than 12 months.

Sarcoidosis — initial and continuation

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

Continuation of therapy: Documentation of positive clinical response to infliximab; infliximab dosed no higher than 10 mg/kg administered every 4 to 6 weeks; patient not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; reauthorization for no more than 12 months.≤10 mg/kg

Ulcerative colitis — initial and continuation

Ulcerative colitis — initial and continuation criteria

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 ulcerative colitis, OR patient is currently on infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for ulcerative colitis; 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 for no more than 12 months.

Continuation of therapy: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for ulcerative colitis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization for no more than 12 months.

Acute GVHD — initial and continuation

Acute GVHD — initial and continuation criteria

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

Continuation of therapy: Documentation of positive clinical response; patient continues to experience acute GVHD; AND one of: patient is receiving infliximab in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; AND reauthorization for no more than 4 doses.

ICI-related toxicities — initial and continuation

ICI-related toxicities — initial and continuation criteria

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 specific severity and diagnosis; AND one of: patient is receiving infliximab in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization for no more than 4 doses.

Continuation of therapy: Documentation of positive clinical response; patient continues to experience toxicities from checkpoint inhibitor therapy; AND one of: patient is receiving infliximab in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; AND reauthorization for no more than 4 doses.

Covered indications (FDA and NCCN-supported)

Infliximab is considered proven/covered for the following indications when clinical criteria are met:

FDA‑approved indications: Crohn's disease (adult and pediatric ≥6), ulcerative colitis (adult and pediatric ≥6), rheumatoid arthritis (in combination with methotrexate), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and fistulizing Crohn's disease.

NCCN recommended uses: Selected NCCN (2A) recommendations include steroid‑refractory acute GVHD and certain immune checkpoint inhibitor‑related toxicities (e.g., severe GI inflammation, steroid‑refractory uveitis, myocarditis) when criteria are met.

Limited evidence / off-label indications

Uses supported by smaller trials, trials with mixed results, or limited evidence:

Sarcoidosis: Randomized trial showed a small improvement in FVC at 24 weeks for infliximab versus placebo; additional small studies support use in treatment‑resistant sarcoidosis.

Juvenile idiopathic arthritis: Randomized trial data were mixed and did not demonstrate clear efficacy for the lower dose; safety concerns noted; larger studies are needed.

Miscellaneous off‑label uses: Small open‑label studies and case reports suggest benefit in conditions such as adult‑onset Still's disease, Sjögren's syndrome, hidradenitis suppurativa, and others but robust controlled trial evidence is lacking; coverage depends on member benefits and state mandates.

Immune Checkpoint Inhibitor-Related Toxicities

Updated criterion for immune checkpoint inhibitor-related toxicity

Immune checkpoint inhibitor‑related toxicity: Patient has a diagnosis of an 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

Terminology update: References to 'targeted immunomodulator' have been replaced with 'systemic targeted immunomodulator' across medical necessity criteria.

Combination therapy exclusions per indication: For each indication the patient must not be receiving specified systemic targeted immunomodulators in combination with infliximab for the same indication; the lists of disallowed combination agents and prior targeted therapies were updated (examples vary by indication).

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).

General initial therapy requirements: Initial authorization requires documentation of the indicated diagnosis, applicable prior therapy failure or prior targeted immunomodulator use as specified per indication, dosing consistent with U.S. FDA labeling (or indication‑specific maximum dosing where stated), prescriber specialty or consultation as specified (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist), and initial authorization limited to no more than 12 months for chronic indications (or up to 4 doses for acute GVHD and ICI‑related toxicities).

Initial therapy rules

Initial therapy rules — Operational rules and variation by indication.

Per‑indication initial rules: See indication‑specific criteria: prior therapy requirements (e.g., NSAID trials for AS; conventional therapy or prior targeted immunomodulator for IBD; corticosteroid and immunosuppressant failure for uveitis and sarcoidosis), specialist prescriber or consultation requirements, prohibition on concurrent systemic targeted immunomodulator for the same indication, and specified initial authorization durations (commonly ≤12 months; acute indications ≤4 doses).

Continuation / Reauthorization Requirements

Continuation Therapy

Continuation Therapy — Continuation (reauthorization) requirements are consistent across indications

General continuation requirements: Documentation of positive clinical response to infliximab; dosing consistent with U.S. FDA labeled dosing for the indication (or specified maximum dosing where stated); patient not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; reauthorization limited to no more than 12 months for chronic indications (commonly) or up to 4 doses for acute indications (e.g., acute GVHD, ICI‑related toxicities).

Continuation therapy requirements

Continuation therapy requirements — Operational continuation requirements across indications.

Operational continuation requirements: For reauthorization provide evidence of positive clinical response, continued dosing consistent with labeling or indication‑specific limits (e.g., ≤10 mg/kg for sarcoidosis; ≤5 mg/kg for uveitis), documentation that infliximab is not combined with a systemic targeted immunomodulator for the same indication, and requests should not exceed established duration limits (commonly 12 months for chronic indications; up to 4 doses for acute indications).

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

HCPCS / J-codesHCPCS

J1745	Injection, infliximab, excludes biosimilar, 10 mg.
Q5103	Injection, infliximab-dyyb, biosimilar, (Inflectra), 10 mg.
Q5104	Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg.
Q5121	Injection, infliximab-axxq, biosimilar, (Avsola), 10 mg.

ICD-10: Ophthalmologic, GI, Cardiac, Respiratory, Fistula and related (neutral)ICD-10

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.

1–10 of 24

1/3

ICD-10: Fistula, Psoriasis, and Select Rheumatologic Codes (neutral)ICD-10

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.

1–10 of 18

1/2

ICD-10: Rheumatologic (M05-M06 range) — REQUIRED LIST (neutral)ICD-10

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.

1–10 of 164

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ICD-10: Additional diagnosis codes (neutral)ICD-10

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

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.

Denial Risk

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.

Biosimilars and Product Preference

Billing Rule

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

Billing Rule

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

Site of Care and Administration

Note

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

Billing Rule

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.

Infliximab — definition

Definition'Infliximab' refers to all infliximab products (originator and biosimilars).

IncludesReference product (Remicade) and biosimilars such as Inflectra, Avsola, Renflexis, CT-P13, SB2.

Benefit routing noteIntravenous infliximab products are handled under the medical benefit unless self-administered subcutaneous formulations are obtained via pharmacy benefit per plan documents.

Systemic targeted immunomodulator — examples

Policy Overview and Key Metrics

multipleIndications with specific criteria listed

12 monthsTypical max initial/reauthorization period for chronic indications

J1745,Q5103,Q5104,Q5121Listed HCPCS codes (reference and biosimilars)

6Indications removed from coverage criteria (per revision)

Policy Changes and Revision History

2026-02-01policy_revisionLatest

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.

2026-02-01clinical_criteria_update

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).

Policy Summary

Payersierra health and life

PolicyInfliximab (IV) products — coverage criteria

Policy CodePolicy 2026D0004AR

Change TypeRemoved multiple indication-specific criteriaupdated terminology and prior/combination therapy lists

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with applicable ICD-10 diagnosis code and documentation of prior therapy or intolerance when requesting non-preferred infliximab.

SourceLink

On This Page

Continuation therapy evidence

Continuation therapy evidence — Long‑term/continuation therapy observations from uveitis studies:

Uveitis long‑term observations: Long‑term infliximab treatment reduced ocular attack frequency and improved best‑corrected visual acuity in many patients; relapse occurred in about 59% with ~80% of relapses within one year, most relapses managed by corticosteroid adjustments or infusion interval changes; treatment was continued in ~85% of patients with ~15% discontinuation due to adverse effects or insufficient efficacy.

Documentation Required

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.

Billing Rule

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.

DefinitionSystemic targeted immunomodulator — agents listed in policy that should not be combined with infliximab for same indication.

Examples (selected)adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), tofacitinib (Xeljanz), vedolizumab (Entyvio), mirikizumab (Omvoh), risankizumab (Skyrizi), guselkumab (Tremfya), ustekinumab.

Policy applicationLists updated across indications; combination therapy with these systemic targeted immunomodulators is prohibited for the same indication per policy.

Infliximab — mechanism

Mechanism of actionChimeric human/mouse monoclonal antibody against tumor necrosis factor alpha (TNF-alpha) that neutralizes TNF-alpha by binding soluble and transmembrane forms.

Biologic effectBlocks TNF-alpha binding to receptors, inhibiting interleukin induction, leukocyte migration, and adhesion molecule expression; can mediate lysis of cells expressing transmembrane TNF-alpha.

Clinical relevanceMechanism underpins efficacy in Crohn's disease, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, psoriatic conditions, and sarcoidosis.

Infliximab and biosimilars — comparability

Biosimilar comparabilityRandomized equivalence studies and prescribing information demonstrate that biosimilar infliximab products (e.g., CT-P13, SB2/Avsola/Inflectra) are comparable in efficacy and safety to the reference product.

Supporting evidenceKey references include PLANETRA and PLANETAS trials and multiple biosimilar prescribing information cited in policy references.

Policy implicationPolicy treats infliximab to include originator and biosimilars for coverage determinations; Inflectra and Avsola are listed as preferred products.