CareSource infliximab IV Coverage Prior Auth

Coverage Criteria and Indication-Specific Authorization Rules

Psoriatic arthritis / initial vs continuation (example of structure used across indications)

Covered when ONE of the following (Initial Therapy or Currently Receiving) applies per indication.

Initial Therapy (general pattern): Initial therapy approvals are time-limited (commonly 3–6 months) and require all listed items such as age criteria, prior trial(s) of specified conventional therapies, and that the medication be prescribed by or in consultation with a relevant specialist.see indication-specific nodes

Examples of objective measures are provided per indication (e.g., DAPSA, CDAI, fecal calprotectin).

Continuation Therapy (general pattern): For patients currently receiving an infliximab product, approve for longer durations (commonly 1 year) if patient has been established on therapy for a specified minimum time (commonly 1–6 months) AND meets at least one of: objective beneficial clinical response from baseline OR symptomatic improvement compared with baseline.established on therapy time varies by indication

Maximum dosing for continued therapy may be up to 10 mg/kg no more frequently than every 4 weeks.

Rheumatoid arthritis criteria

Approve for initial therapy up to 6 months if ALL criteria met; continuation approvals differ.

Initial RA therapy: (i) Age > 18 years; AND (ii) tried one conventional synthetic DMARD for >=3 months (exceptions if prior biologic tried); AND (iii) medication prescribed by or in consultation with a rheumatologist.3 months DMARD trial

A biosimilar does not count as prior biologic for stepping rules.

Continuation RA therapy: (i) Established on therapy >=6 months; AND (ii) meets at least one of: objective beneficial response or symptomatic improvement.established >=6 months

Continuation approved up to 1 year.

Ulcerative colitis criteria

Initial therapy approvals for pediatric and adult UC and dosing specified.

Initial UC therapy: (i) Patient >=6 years; AND (ii) trial of one systemic agent or intolerance; OR pouchitis-specific criteria; AND (iii) prescribed by or in consultation with a gastroenterologist.age >=6 years

Mesalamine does not count as systemic therapy.

Continuation UC therapy: (i) Established on therapy >=6 months; AND (ii) meets at least one of: objective beneficial response (e.g., fecal calprotectin, endoscopy, reduced steroid dose) OR symptomatic improvement compared with baseline.established >=6 months

Continuation approval up to 1 year; dosing: initial up to 5 mg/kg then maintenance, continuation up to 10 mg/kg no more frequently than every 4 weeks.

Behcet's disease, Graft-versus-host disease, Hidradenitis Suppurativa (examples of other evidence-supported uses)

Other uses with supportive evidence have indication-specific prior therapy, specialist, and response requirements.

Behcet's initial therapy: (i) Age >6 years; AND (ii) tried >=1 conventional therapy OR has ophthalmic manifestations; AND (iii) prescribed by or in consultation with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist.age >6 years

Initial approval commonly 3 months; continuation approvals up to 1 year with documented response.

GVHD initial therapy: (i) Age >6 years; AND (ii) tried >=1 conventional systemic treatment; AND (iii) prescribed by or in consultation with an oncologist/hematologist or transplant-affiliated physician.age >6 years

Initial approval commonly 1 month; continuation possible with response; dosing up to 10 mg/kg no more frequently than once weekly for some regimens.

Hidradenitis Suppurativa initial therapy:

JIA and Indeterminate colitis criteria

Pediatric-specific conditions include age thresholds and prior therapy requirements.

JIA initial therapy: (i) Age >6 years; AND (ii) tried one other systemic medication OR has aggressive disease per prescriber; AND (iii) prescribed by or in consultation with a rheumatologist.age >6 years

Initial approval commonly 6 months; continuation requires documented benefit.

Indeterminate colitis initial therapy: (i) Age >=6 years; AND (ii) tried one systemic corticosteroid; AND (iii) tried mesalamine; AND (iv) tried azathioprine or 6-mercaptopurine; AND (v) prescribed by or in consultation with a gastroenterologist.age >=6 years

Initial approval commonly 6 months; continuation up to 1 year with response evidence.

Dermatologic/ocular/pulmonary indications (pyoderma gangrenosum, sarcoidosis, scleritis, etc.)

Approvals require prior therapy trials, specialist involvement, and demonstration of benefit.

Pyoderma gangrenosum initial therapy: (i) Age >18 years; AND (ii) tried one systemic corticosteroid OR tried another immunosuppressant ≥2 months; AND (iii) prescribed by or in consultation with a dermatologist.age >18 years

Initial approval commonly 4 months; continuation requires lesion size/depth/number improvement and symptom improvement.

Sarcoidosis initial therapy: (i) Age >18 years; AND (ii) tried ≥1 corticosteroid; AND (iii) tried ≥1 immunosuppressant; AND (iv) prescribed by or in consultation with a pulmonologist, ophthalmologist, cardiologist, neurologist, or dermatologist.age >18 years

Initial approval commonly 3 months; objective measures like lung function or imaging may be used to show response.

Scleritis or sterile corneal ulceration initial therapy:

Dosing general regimens

Approve ONE of the following regimens (A or B) depending on whether initial or continuation therapy:

Regimen A - Initial Therapy (general): Approve up to 5 mg/kg IV with additional doses at 2 and 6 weeks after first infusion, then no more frequently than once every 6 weeks thereafter.dose up to 5 mg/kg; schedule: baseline, 2 and 6 weeks, then q6w

applies as a general initial regimen

Regimen B - Currently Receiving an Infliximab Product (general): Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks.dose up to 10 mg/kg; frequency >= 4 weeks

applies for patients currently on infliximab

Scleritis or Sterile Corneal Ulceration — Initial and Continuation

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy: Approve for 6 months if ALL: i. Patient > 18 years; ii. Tried one other therapy for this condition (e.g., NSAID, corticosteroid, methotrexate, cyclosporine, other immunosuppressant); iii. Prescribed by or in consultation with an ophthalmologist.age > 18; prior trial of one therapy; ophthalmologist involvement

examples of prior therapies provided

B) Currently receiving infliximab: Approve for 1 year if BOTH: i. Established on therapy >=6 months; ii. Patient meets at least ONE: a) objective beneficial response from baseline (e.g., CRP, ESR) OR b) improvement in at least one symptom (decreased eye pain, redness, light sensitivity, tearing, improved visual acuity).established >=6 months + objective or symptomatic improvement

restarting or <6 months reviewed under Initial Therapy

Spondyloarthritis, Other Subtypes — Initial and Continuation

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy: Approve for 6 months if ALL: i. Patient > 18 years; ii. Either (a) peripheral arthritis in specified joints and tried at least ONE conventional synthetic DMARD OR (b) axial spondyloarthritis with objective signs of inflammation (CRP elevated or sacroiliitis on MRI); iii. Prescribed by or in consultation with a rheumatologist.age > 18; prior DMARD or objective inflammation; rheumatologist involvement

examples and definitions provided

B) Currently receiving infliximab: Approve for 1 year if BOTH: i. Established on therapy >=6 months; ii. Patient has objective or symptomatic improvement compared to baseline (e.g., ASDAS, CRP, improved pain/stiffness/function).established >=6 months + objective or symptomatic improvement

restarting or <6 months reviewed under Initial Therapy

Still's Disease — Initial and Continuation

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy: Approve for 6 months if ALL: i. Patient > 18 years; ii. Tried one corticosteroid; iii. Tried one conventional synthetic DMARD for ≥2 months or was intolerant (a prior trial of one other biologic counts toward requirement but biosimilar does not); iv. Prescribed by or in consultation with a rheumatologist.age > 18; prior steroid; prior DMARD >=2 months or prior biologic (non-biosimilar); rheumatology involvement

examples of agents and allowed substitutions specified

B) Currently receiving infliximab: Approve for 1 year if BOTH: i. Established on therapy >=6 months; ii. Patient has at least ONE of: a) objective beneficial response from baseline (e.g., resolution of fever, rash improvement, normalization/improvement of CRP/ESR, reduced corticosteroid dose) OR b) improvement in at least one symptom (less joint pain/tenderness, decreased fatigue, improved function/ADLs).established >=6 months + objective or symptomatic improvement

restarting or <6 months reviewed under Initial Therapy

Uveitis — Initial and Continuation

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy: Approve for 6 months if ALL: i. Patient > 6 years; ii. Tried one of periocular, intraocular, or systemic corticosteroids, or immunosuppressives (examples: prednisolone, triamcinolone, methotrexate, mycophenolate, cyclosporine); exception: prior trial of etanercept or adalimumab or another biologic counts instead; iii. Prescribed by or in consultation with an ophthalmologist.age > 6; prior trial of steroid/immunosuppressive or prior biologic; ophthalmologist involvement

biosimilar of requested biologic does not count as prior biologic

B) Currently receiving infliximab: Approve for 1 year if BOTH: i. Established on therapy >=6 months; ii. Patient meets at least ONE: a) objective beneficial response from baseline (examples: best-corrected visual acuity, chorioretinal/inflammatory retinal vascular lesion assessment, anterior chamber cell grade, vitreous haze) OR b) improvement in at least one symptom (decreased eye pain, redness, light sensitivity, blurred vision, or improved visual acuity).established >=6 months + objective or symptomatic improvement

restarting or <6 months reviewed under Initial Therapy

Avsola, Inflectra, and Renflexis are approved as biosimilars to Remicade and have no clinically meaningful differences in safety or effectiveness compared with Remicade; they share the same mechanism, route, dosage form, and strength. However, biosimilarity has been demonstrated but interchangeability has not, and this policy does not treat biosimilars as interchangeable with the reference product.

For ulcerative colitis, a prior trial of a mesalamine product does not count as a systemic therapy when assessing required prior therapy for initial infliximab approval; acceptable systemic therapies include agents such as azathioprine, 6-mercaptopurine, cyclosporine, tacrolimus, or systemic corticosteroids.

Concurrent administration of infliximab with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not recommended. Because of safety concerns and limited evidence of additive benefit, combination therapy with these agents is discouraged and requests for such combinations may be denied. Initial approval also requires the medication to be prescribed by or in consultation with a specialist for the treated condition.

The Appendix lists example agents, mechanisms, and indications but is not an all-inclusive list of FDA-approved indications. Providers must consult the prescribing information for each product to confirm the agent’s FDA‑approved indications.

Prior authorization is recommended for medical benefit coverage of infliximab products and approval is contingent on meeting the policy’s listed indication-specific criteria, dosing, and prescriber specialty requirements. Requests that do not meet the applicable criteria, dosing regimens, or specialist-prescribing conditions may be considered not medically necessary and may be denied through the prior authorization process.

Situations that may be considered not medically necessary include failure to document required prior therapy trials or age thresholds, absence of the required specialty prescriber or consultation, or lack of objective documentation of clinical benefit or symptom improvement where continuation criteria require it.

Use of infliximab in combination with another biologic or with targeted synthetic oral small molecule drugs for inflammatory conditions is discouraged and coverage is not recommended for such concurrent use due to increased risk of adverse events and insufficient controlled data supporting additive efficacy.

Coding, Dosing Limits, and Product Lists

Neutral — codes not specified in this segmentmixed

NDC or HCPCS not listed in this part

No explicit CPT/HCPCS/NDC codes present in this document segment

Relevant product and comparator biologicsmixed

Remicade / infliximab IV	Infliximab IV Products (Remicade®, biosimilars) - Inhibition of TNF; examples of indications: AS, CD, PsO, PsA, RA, UC.
Zymfentra (infliximab-dyyb) SC	Zymfentra® (infliximab-dyyb SC injection) - SC formulation of infliximab; examples of indications: CD, UC.
Various biologics and targeted oral agents	Appendix lists comparator biologics and targeted synthetic oral small molecule drugs (e.g., adalimumab, certolizumab, etanercept, golimumab, tocilizumab, ustekinumab, secukinumab, guselkumab, vedolizumab, apremilast, upadacitinib, etc.)

inv-22: Maximum dose for patients currently receiving infliximab

Maximum dose10 mg/kg (maximum for patients currently receiving an infliximab product)

Route and frequency limitAdministered intravenously no more frequently than once every 4 weeks

Applies toPatients currently receiving any infliximab product (brand or biosimilar)

inv-23: Established therapy duration

Established therapy duration (general continuation)>= 6 months (patient must have been receiving infliximab for at least 6 months)

Initial therapy reviewPatients with < 6 months of therapy or restarting are reviewed under Initial Therapy criteria

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization requires that requests meet indication-specific criteria or the patient is already on an established infliximab therapy per the policy's Recommended Authorization Criteria. Initial approvals generally require prescription by or consultation with a specialist who manages the condition (for example, rheumatologist, gastroenterologist, dermatologist, ophthalmologist, or other relevant specialist).

Prior authorization required for medical benefit coverage of infliximab products.
Initial therapy typically requires specialist prescriber or documented specialist consultation.
Continuation approvals require documentation of prior benefit or meeting the continuation criteria (established on therapy for the required duration and evidence of objective or symptomatic improvement).

Denial Risk

Nonstandard Dosing Risk

Background and Scope

Infliximab and its biosimilars are tumor necrosis factor (TNF) inhibitors indicated for multiple inflammatory conditions including ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Dosing is weight‑based (commonly initial regimens up to 5 mg/kg with maintenance adjustments) and patients established on therapy may receive higher doses per the policy (up to 10 mg/kg in specified situations). Biosimilars share the same mechanism of action as Remicade but are not designated interchangeable in this policy.

Definitions and Abbreviations

inv-42: Biosimilar (to Remicade)

DefinitionProducts approved as biosimilar to Remicade (e.g., Avsola, Inflectra, Renflexis) have no clinically meaningful differences in safety and effectiveness and share the same mechanism, route, dosage form, and strength as Remicade; minor differences in inactive components are allowed

Interchangeability statusBiosimilarity demonstrated but these products are NOT designated interchangeable at this time

Implication for prior biologic trialsA biosimilar of the requested biologic does not count as a prior trial of a different biologic for step-therapy exceptions

inv-43: Indeterminate colitis

DefinitionIndeterminate colitis: colitis that cannot be classified with certainty as either ulcerative colitis or Crohn's disease

Initial therapy requirements

OpenPayer

Inflammatory Conditions - Infliximab Intravenous Products Utilization Management Medical Policy

Coverage Criteria and Indication-Specific Authorization Rules

Coding, Dosing Limits, and Product Lists

Prior Authorization, Documentation, and Prescriber Requirements

Background and Scope

Definitions and Abbreviations