CurrentNeighborhood Health Plan of Rhode IslandPolicy 2182 A Sgm P2023C

Infliximab Remicade And Biosimilars 2182 A Sgm P2023C

Defines covered indications, prior authorization documentation, prescriber specialty requirements, duration of authorization, continuation criteria, dosing/administration note, TB screening and contraindications for infliximab and listed biosimilars (Avsola, Inflectra, Renflexis, Zymfentra) and related compendial uses. Covers initial and continuation authorization rules and clinical response measures across multiple autoimmune and inflammatory conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInfliximab Remicade And Biosimilars 2182 A Sgm P2023C

Policy CodePolicy 2182 A Sgm P2023C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmission of indication-specific documentation (chart notes, medical records, claims history, laboratory results, biomarker testing) is required to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

12Typical authorization length (months)

6TB screening window (months)

>=15 mg/weekMethotrexate dosing threshold

Coverage Summary & Scope

Notes: Zymfentra is limited to maintenance treatment following prior IV infliximab. For pediatric use (Crohn’s, UC) authorization may be granted per age‑specific criteria. Prescriber specialty requirement must be met for initial requests; consult documentation must be provided when prescribed by non‑specialists.

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Covered Indications (General)

Covered Indications (General): Authorization is granted when ALL of the following general preconditions are met:

ALL of the following

Request is for an FDA‑approved indication or a compendial use listed in the policy.
Member has no exclusions to the prescribed therapy; indication is not labeled experimental/investigational.
Required documentation provided: diagnosis, prior medication trials and responses, relevant labs/biomarkers, and indication‑specific clinical notes (see Documentation section).
TB screening (e.g., TB test or IGRA) documented within the prior 6 months before initiation.<= 6 months
No concomitant use of another systemic biologic agent (concurrent biologic therapy is not permitted).

Rheumatoid Arthritis (RA) Specific Initial Criteria

Rheumatoid Arthritis (RA) — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member is an adult with moderately to severely active RA.
Member has previously received a biologic or targeted synthetic DMARD indicated for RA (e.g., JAK inhibitors) OR meets biomarker criteria below as documented.
Biomarker requirement: Biomarker testing: either a positive test for rheumatoid factor (RF) or anti‑CCP, OR testing documented for RF, anti‑CCP, and CRP and/or ESR.
Requested medication is prescribed in combination with methotrexate or leflunomide, or there is documented clinical reason to avoid methotrexate/leflunomide (see Appendix).
Member has had an inadequate response to at least a 3‑month trial of methotrexate at adequate dosing (titrated to >= 15 mg/week), or has intolerance/contraindication to methotrexate.

Ankylosing spondylitis (AS) / nr‑axSpA Initial Criteria

Ankylosing spondylitis (AS) / non‑radiographic axial spondyloarthritis (nr‑axSpA) — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization of 12 months may be granted when ONE of the following is met:

ANY of the following

Member has had an inadequate response to at least two non‑steroidal anti‑inflammatory drugs (NSAIDs).
Member has an intolerance or contraindication to two or more NSAIDs.
Member has previously received a biologic or targeted synthetic drug indicated for active AS or nr‑axSpA (e.g., JAK inhibitors) as documented in history.

Psoriatic Arthritis (PsA) Initial Criteria

Psoriatic Arthritis (PsA) — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization of 12 months may be granted when ONE of the following is met:

ANY of the following

Member with mild to moderate disease who has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at adequate dose and duration.
Member has an intolerance or contraindication to methotrexate or leflunomide, or other conventional synthetic DMARDs.
Member has enthesitis or predominantly axial disease.
Member has severe disease.

Plaque Psoriasis (PsO) Initial Criteria

Plaque Psoriasis (PsO) — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization of 12 months may be granted when ANY of the following are met:

ANY of the following

Crucial body areas affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).
At least 10% body surface area (BSA) involved.>= 10% BSA
At least 3% BSA involved with prior failure of topical and/or systemic therapies (documentation of prior therapy failure required).>= 3% BSA
Member has previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis (e.g., Sotyktu, Otezla).

Behcet's disease Initial Criteria

Behcet's disease — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization may be granted for initial requests with documentation of prior medications tried and response when applicable.

ALL of the following

Member has a diagnosis of Behcet's disease documented in chart notes or medical record.
Chart notes, medical record documentation, or claims history support previous medications tried (if applicable) and response to therapy, or provide clinical rationale for avoiding prior standard therapies.

Hidradenitis Suppurativa Initial Criteria

Hidradenitis Suppurativa — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization may be granted for initial requests with documentation of prior therapies and inadequate response or contraindication to standard treatments.

ALL of the following

Member has a diagnosis of hidradenitis suppurativa documented in the medical record.
Chart notes or claims history document prior medications tried and response, or document contraindication/intolerance to standard therapies.

Pyoderma gangrenosum Initial Criteria

Pyoderma gangrenosum — Initial Criteria (Avsola/Inflectra/Remicade/Renflexis only): Authorization may be granted for initial requests with documentation of prior therapies and response or clinical rationale to proceed.

ALL of the following

Member has a diagnosis of pyoderma gangrenosum documented in the medical record.
Chart notes, medical record documentation, or claims history support previous medications tried and response (if applicable), or provide clinical rationale for use of infliximab.

Initial Therapy Criteria (by indication)

FDA-Approved Indications: Infliximab / Avsola / Inflectra / Remicade / Renflexis

Authorization may be granted when indication-specific criteria are met:

Indications

Moderately to severely active Crohn's disease (CD) and fistulizing CD in adults with inadequate response to conventional therapy
Includes adult patients
Pediatric patients 6 years or older with moderately to severely active Crohn's disease with inadequate response to conventional therapy
Pediatrics ≥6 years
Moderately to severely active ulcerative colitis (UC) in patients 6 years or older with inadequate response to conventional therapy
Includes patients ≥6 years
RA branch
- Biomarker evidence
  - Member tested positive for rheumatoid factor (RF)
  - Member tested positive for anti-cyclic citrullinated peptide (anti-CCP)
  - OR all biomarkers: Member tested for RF, anti-CCP, and CRP and/or ESR
- RA methotrexate trial
  - Methotrexate trial or intolerance: Inadequate response to at least a 3-month trial of methotrexate at adequate dosing (>= 15 mg/week)>= 15 mg/week
    Or intolerance/contraindication
  - Methotrexate trial or intolerance: Intolerance or contraindication to methotrexate
    See Appendix for clinical reasons
Active ankylosing spondylitis (AS)
Active psoriatic arthritis (PsA)
Chronic severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy when other systemic therapies are less appropriate

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FDA-Approved: Zymfentra specific

ANY of the following

Maintenance treatment of moderately to severely active ulcerative colitis in adults following treatment with an infliximab product administered intravenously
Zymfentra is for maintenance following IV infliximab
Maintenance treatment of moderately to severely active Crohn's disease in adults following treatment with an infliximab product administered intravenously
Zymfentra is for maintenance following IV infliximab

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b1_1

Compendial Uses (covered when criteria met)

Compendial Uses

Non-radiographic axial spondyloarthritis
Compendial use
Behcet's disease
Compendial use
Hidradenitis suppurativa
Compendial use
Pyoderma gangrenosum
Compendial use
Sarcoidosis
Compendial use

Sarcoidosis, Takayasu's arteritis, Uveitis, Reactive arthritis, Immune checkpoint inhibitor-related toxicity, Acute GVHD

Authorization when ONE of the following general criteria is met (per indication):

Sarcoidosis/Takayasu/Uveitis/Reactive arthritis/ICI-toxicity/Acute GVHD

Therapy failure: Inadequate response to corticosteroids or immunosuppressive therapy
Examples include methotrexate, azathioprine, mycophenolate mofetil, cyclosporine
Intolerance or contraindication to corticosteroids and immunosuppressive therapy
Prior biologic: Member previously received a biologic indicated for the condition (where specified)

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Continuation Therapy Criteria

Continuation Criteria (across indications)

Continuation authorization of 12 months may be granted when ALL initial criteria are met and member demonstrates positive clinical response:

Continuation Criteria

Documentation supports response
- Indication-specific improvement measures (examples): CD: abdominal pain, diarrhea, weight, hematocrit, mucosal appearance, CDAI; UC: stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic appearance, UCEIS/Mayo score; RA: >=20% improvement from baseline in tender/swollen joint count, pain, or disability; AS/nr-axSpA: improved functional status, total spinal pain, inflammation (morning stiffness), swollen/tender joints, CRP; PsA: reduced swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, CRP; PsO: reduction in BSA or symptom improvement; HS: reduced abscess/inflammatory nodule count, fewer sinus tracts, decreased lesion frequency/pain/suppuration, QoL improvement, disease severity tool improvement; Uveitis: reduced flare recurrence, reduction/zero anterior chamber inflammation, decreased reliance on topical corticosteroids
  Any one or more measures may demonstrate positive response

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b2_0

Documentation Required

Continuation documentation — positive clinical response required

Continuation requests must include chart notes or medical record documentation demonstrating positive clinical response or remission using indication‑specific metrics (for example: CD—abdominal pain/diarrhea/weight/hematocrit/mucosal appearance/CDAI; UC—stool frequency/rectal bleeding/urgency/CRP/fecal calprotectin/endoscopic appearance/UCEIS or Mayo score; RA—≥20% improvement in tender/swollen joint count, pain, or disability; AS/nr‑axSpA—functional status, spinal pain, morning stiffness, CRP; PsA—reduced swollen/tender joints, dactylitis, enthesitis, skin/nail disease, functional status, CRP; PsO—reduction in BSA or symptom improvement; HS—reduced abscess/nodule count, fewer sinus tracts, decreased lesion frequency/pain; Uveitis—reduced flare recurrence or anterior chamber inflammation).

Compendial / Non-standard Uses & Exclusions

Compendial uses listed in the policy (e.g., non‑radiographic axial spondyloarthritis, Behcet's disease, hidradenitis suppurativa, pyoderma gangrenosum, sarcoidosis, Takayasu's arteritis, uveitis, reactive arthritis, immune checkpoint inhibitor‑related toxicity, acute graft versus host disease, and moderate to severe plaque psoriasis) are considered covered when the policy's approval criteria for those conditions are met. The policy treats these compendial indications as eligible for authorization under the same requirement that all approval criteria and documentation be satisfied.

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required — submit documentation to initiate review

Prior authorization is required. Submit indication‑specific documentation (chart notes, medical records, claims history, laboratory results, biomarker testing) to initiate prior authorization review.

Documentation Required

TB screening documentation

Provide documentation of a negative tuberculosis test (TST or IGRA) within 6 months for members naïve to biologic or targeted synthetic therapies. If screening is positive, document further testing to exclude active TB (e.g., chest x‑ray); do not administer therapy with active TB and begin latent TB treatment prior to initiation.

Documentation Required

Evidence of prior therapies or contraindications

For many indications, include chart notes or claims history documenting prior medication trials and responses, or documentation of a clinical reason to avoid specified therapies (examples provided in Appendix).

Prior Authorization

Prescriber specialty requirement

The medication must be prescribed by or in consultation with specified specialists based on the indication (e.g., gastroenterologist for Crohn’s disease and ulcerative colitis; rheumatologist for RA, AS, nr‑axSpA, Behcet’s, Takayasu’s, reactive arthritis; dermatologist or rheumatologist for PsA and hidradenitis suppurativa; dermatologist for plaque psoriasis and pyoderma gangrenosum; ophthalmologist or rheumatologist for uveitis; oncologist/hematologist or rheumatologist for immune checkpoint inhibitor‑related inflammatory arthritis/toxicity and acute GVHD).

Billing Rule

Authorization duration — typical length and ICI‑toxicity exception

Authorizations are typically granted for 12 months when criteria and response documentation are met. For immune checkpoint inhibitor‑related toxicity, a 6‑month authorization may be granted in certain situations. (Typical authorization length: 12 months.)

Documentation Required

Continuation requirement — chart notes demonstrating response

Continuation requests must include chart notes or medical record documentation supporting positive clinical response or remission as evidenced by the indication‑specific measures noted in the policy (see examples per indication).

Background & Definitions

Background: this policy defines prior authorization criteria for infliximab and listed biosimilars across FDA‑approved and compendial indications. It specifies required documentation to initiate PA review (e.g., chart notes, claims history, lab results, biomarker testing), prescriber specialty requirements by indication, typical authorization durations (generally 12 months), and continuation criteria that require documentation of a positive clinical response using indication‑specific measures. The policy also requires TB screening documentation (negative TST or IGRA within 6 months for biologic‑naïve members), additional evaluation if screening is positive, and prohibits concomitant use with other biologic or targeted synthetic therapies for the same indication.

Definition

TermPositive clinical response

DefinitionImprovement or low disease activity evidenced by indication-specific metrics (e.g., symptom reduction, laboratory markers, imaging/endoscopy findings, validated disease activity scores). Examples: reduced stool frequency/rectal bleeding/CRP/fecal calprotectin or improved endoscopic scores for UC; reduced abdominal pain/diarrhea/weight gain or improved CDAI for CD; >=20% improvement in tender/swollen joint count, pain, or disability for RA; reduction in BSA or symptom improvement for PsO).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInfliximab Remicade And Biosimilars 2182 A Sgm P2023C

Policy CodePolicy 2182 A Sgm P2023C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmission of indication-specific documentation (chart notes, medical records, claims history, laboratory results, biomarker testing) is required to initiate prior authorization review.

SourceLink

On This Page

Remicade / infliximab	Branded infliximab product referenced in policy
Avsola (infliximab-axxq)	Biosimilar infliximab
Inflectra (infliximab-dyyb)	Biosimilar infliximab
Renflexis (infliximab-abda)	Biosimilar infliximab
Zymfentra (infliximab-dyyb)	Subcutaneous infliximab formulation

OpenPayer

Infliximab Remicade And Biosimilars 2182 A Sgm P2023C

Coverage Summary & Scope

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria

Compendial / Non-standard Uses & Exclusions

Applicable Products / Codes

Provider Actions & Prior Authorization Requirements

Clinical Evidence & References

Background & Definitions

Revision History