Neighborhood Health Plan RI infliximab Coverage

Coverage Criteria for Infliximab and Biosimilars

inv-01: Covered indications and required conditions

Covered when ALL of the following are met for each indication as specified below

General Indications: Medication is prescribed for an FDA‑approved or listed compendial indication and all approval criteria are met.

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Crohn's disease (CD): Moderately to severely active Crohn's disease in adults or pediatric patients ≥6 years with inadequate response to conventional therapy; authorization of 12 months may be granted.

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Ulcerative colitis (UC): Moderately to severely active ulcerative colitis in patients ≥6 years with inadequate response to conventional therapy; authorization of 12 months may be granted.

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Rheumatoid arthritis (RA): Adult with moderately to severely active RA; medication to be used in combination with methotrexate unless clinical reason not to (or leflunomide as alternative); prior biologic or targeted synthetic therapy history referenced; biomarker testing and prior methotrexate trial or documented intolerance/contraindication required; authorization of 12 months may be granted.

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Ankylosing spondylitis (AS) / non‑radiographic axial spondyloarthritis (nr‑axSpA): Active AS or nr‑axSpA in adults; prior biologic/targeted synthetic therapy history referenced; authorization of 12 months may be granted when either prior inadequate response to ≥2 NSAIDs or intolerance/contraindication to ≥2 NSAIDs is documented.

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Zymfentra specific: Maintenance treatment of moderately to severely active UC or CD in adults following treatment with an IV infliximab product.

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inv-02: Rheumatoid arthritis — initial authorization (12 months)

Authorization of 12 months may be granted for adult members meeting ALL of the following

RA initial criteria: Member meets either: (a) positive test for rheumatoid factor (RF) or anti‑cyclic citrullinated peptide (anti‑CCP); OR (b) has been tested for RF, anti‑CCP and C‑reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR). Member is prescribed the requested medication in combination with methotrexate or leflunomide or has a clinical reason not to use them. Member either has had an inadequate response to ≥3 months of methotrexate titrated to ≥15 mg/week, OR has intolerance or contraindication to methotrexate.

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inv-03: Ankylosing spondylitis and non-radiographic axial spondyloarthritis — initial authorization (12 months)

Authorization of 12 months may be granted when EITHER of the following is met

AS/nr-axSpA initial: Member has had an inadequate response to at least two NSAIDs; OR member has an intolerance or contraindication to two or more NSAIDs. (Prior biologic/targeted synthetic use is also referenced for adults.)

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inv-04: Psoriatic arthritis — initial authorization (12 months)

Authorization of 12 months may be granted when EITHER of the following is met

PsA initial: Member with mild‑to‑moderate disease has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD administered at adequate dose/duration; OR member has an intolerance or contraindication to those agents; OR member has enthesitis or predominantly axial disease; OR member has severe disease. (Prior biologic/targeted synthetic use is referenced for adults.)

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inv-05: Plaque psoriasis — initial authorization (12 months)

Authorization of 12 months may be granted when ANY of the following criteria are met

Psoriasis initial: Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected; OR at least 10% body surface area (BSA) is affected; OR at least 3% BSA is affected AND the member has either: inadequate response or intolerance to phototherapy or to methotrexate, cyclosporine, or acitretin; OR a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, or acitretin.BSA thresholds as stated

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inv-06: Other indications (Behcet's, Hidradenitis suppurativa, Pyoderma gangrenosum, Sarcoidosis, Takayasu's arteritis, Uveitis, Reactive arthritis)

Authorization of 12 months may be granted when EITHER of the following is met per condition

Other conditions initial: For each listed condition (Behcet's disease, hidradenitis suppurativa, pyoderma gangrenosum, sarcoidosis, Takayasu's arteritis, uveitis, reactive arthritis): member has had an inadequate response to at least one relevant non‑biologic therapy (examples provided per condition) OR has an intolerance or contraindication to those therapies. Authorization of 12 months may be granted when these criteria are met; prior biologic use is referenced for several conditions.

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inv-08: Continuation/maintenance criteria across indications

Authorization of 12 months may be granted for members (including new) who achieve or maintain a positive clinical response

Continuation criteria: Member demonstrates improvement or maintenance by condition‑specific measures (examples include disease activity scores, symptom improvement, laboratory markers, imaging/endoscopy findings, reduced BSA, reduced abscess/nodule counts, decreased flare frequency, or improved functional status/quality of life) as detailed per indication.

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inv-09: Indication-specific continuation criteria

Authorization of 12 months may be granted when ALL of the following are met:

Universal continuation requirements

Psoriasis response measures: Reduction in BSA affected from baseline OR improvement in signs and symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain).
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Hidradenitis suppurativa response measures: Any of: reduction in abscess/inflammatory nodule count from baseline; reduced formation of new sinus tracts/scarring; decreased frequency of inflammatory lesions; reduction in pain; reduction in suppuration; improvement in relapse frequency; improvement in quality of life; improvement on a disease severity tool.
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Uveitis response measures: Reduced frequency of flare recurrence; zero or reduced anterior chamber inflammation; decreased reliance on topical corticosteroids.

inv-10: TB screening and medication concurrency

TB screening and concurrency: Member has a documented negative TB test (TST or IGRA) within 12 months of initiating therapy if biologic‑naïve. If screening is positive, further testing is required to exclude active TB (e.g., chest x‑ray); do not administer the requested medication to members with active TB infection. If latent TB is present, TB treatment must be started before initiation. Member must not use the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication.

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All other indications that are not specifically listed in this policy (i.e., uses outside the FDA-approved or listed compendial indications such as those enumerated in the policy) are considered experimental/investigational and not medically necessary.

There are no explicit exclusions called out in this segment of the policy beyond the general coverage criteria; decision-making should follow the stated indication-specific requirements and authorization rules.

For all indications, the member must have documentation of a negative tuberculosis (TB) test (TST or IGRA) within 12 months if naïve to biologic or targeted synthetic therapies. If TB screening is positive, further evaluation is required to exclude active disease (for example, chest x-ray). Do not administer the requested medication to members with active TB infection. If latent TB is identified, treatment for latent TB must be started prior to initiating therapy.

Therapeutic uses that fall outside the FDA-approved indications and the compendial uses listed in this policy are treated as not medically necessary.

Authorization decisions may be denied when required prior therapies, testing, or combination therapy requirements are not documented. Examples include failure to meet mandated biomarker testing or prior methotrexate trial requirements for rheumatoid arthritis, or lack of documented inadequate response/intolerance to required NSAIDs for ankylosing spondylitis/non-radiographic axial spondyloarthritis.

Coding and Measurement Details

Plaque psoriasis BSA — eligibility thresholds

BSA threshold — primaryAt least 10% of body surface area (BSA) affected

BSA threshold — alternativeAt least 3% BSA PLUS either (a) inadequate response or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) OR (b) clinical reason to avoid those agents

Crucial body areasAny involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) qualifies regardless of BSA

Prior Authorization, Documentation, and Provider Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required; authorization of 12 months may be granted when coverage criteria are met for the specified indications. Providers must ensure required documentation and prior therapy/biomarker information is submitted to avoid denial or delay.

Authorization duration: 12 months (when criteria met)
Do not administer with another biologic or targeted synthetic for same indication
TB screening: documented negative TST or IGRA within 12 months for biologic/ts-naïve members; positive screen requires further testing to exclude active TB and latent TB must be treated prior to initiation

Prior Authorization

RA: 12‑Month PA with Biomarker and Prior Therapy Requirements

For rheumatoid arthritis (RA), a 12‑month prior authorization may be granted only when the member meets the biomarker and prior therapy requirements. Missing biomarker testing or lack of required prior therapy may result in denial.

Member must have been tested positive for RF or anti‑CCP OR have testing for RF, anti‑CCP, and CRP and/or ESR documented

Definitions and Product Details

Background: Infliximab and its biosimilars (e.g., Remicade, Avsola, Inflectra, Renflexis and other listed infliximab products) are tumor necrosis factor-alpha (TNF-α) inhibitors used to treat multiple autoimmune and inflammatory disorders such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis/non-radiographic axial spondyloarthritis, psoriatic arthritis, and moderate to severe plaque psoriasis. Coverage under this policy is limited to the FDA-approved and listed compendial indications; safety measures include required TB screening prior to initiation for biologic‑naïve patients and avoidance of concomitant use with other biologic or targeted synthetic agents for the same indication.

Infliximab products — Remicade and biosimilars

Included products (brand and biosimilars)Remicade (infliximab), Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), Zymfentra (infliximab-dyyb), unbranded infliximab

Zymfentra noteZymfentra referenced specifically for maintenance treatment of UC and CD following IV infliximab induction

ScopeDocument lists both brand and generic forms and all dosage forms/strengths unless otherwise stated

OpenPayer

Infliximab and Biosimilars (Remicade, Avsola, Inflectra, Renflexis, Zymfentra) — Coverage Criteria

Coverage Criteria for Infliximab and Biosimilars

Coding and Measurement Details

Prior Authorization, Documentation, and Provider Steps

Definitions and Product Details