Infliximab products (Avsola, Inflectra, Infliximab, Remicade, Renflexis) — FDA-Approved Indications
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This policy governs prior authorization and coverage criteria for FDA‑approved and approvable compendial uses of infliximab products for Mass General Brigham Health Plan members, primarily under the pharmacy benefit and specialty pharmacy processes.
Avsola and Inflectra are designated as the preferred infliximab products.
Coverage criteria include diagnosis‑specific step requirements and product‑specific intolerable adverse event or inadequate response requirements when requesting Remicade, infliximab, or Renflexis.
Reauthorization criteria updated to require submission of medical records (e.g., chart notes) documenting improvement and to require that biologic trial requirements for the treated diagnosis are met.
Policy updated to indicate that Avsola will be a preferred product effective 07/01/2026.
For certain diagnoses (Takayasu's arteritis and uveitis) documented intolerance to both Inflectra AND Avsola is required for Remicade, infliximab, and Renflexis.
Coverage Criteria for Infliximab Products
Moderately to severely active Crohn's disease (Initial therapy or switch)
Authorization may be granted when ALL of the following are met:
Moderately to severely active Ulcerative Colitis
Authorization may be granted when ALL of the following are met:
Moderately to severely active Rheumatoid Arthritis
Authorization may be granted when ALL of the following are met:
Active Ankylosing Spondylitis
Authorization may be granted when ALL of the following are met:
Active Psoriatic Arthritis
Authorization may be granted when ALL of the following are met:
Chronic Severe Plaque Psoriasis
Authorization may be granted when ALL of the following are met:
Behcet's syndrome (refractory)
Authorization may be granted when ALL of the following are met:
Granulomatosis with polyangiitis
Authorization may be granted when ALL of the following are met:
Hidradenitis suppurativa (severe, refractory)
Authorization may be granted when ALL of the following are met:
Juvenile Idiopathic Arthritis (JIA)
Authorization may be granted when ALL of the following are met:
Pyoderma gangrenosum
Authorization may be granted when ALL of the following are met:
Sarcoidosis
Authorization may be granted when ALL of the following are met:
Takayasu's arteritis
Authorization may be granted when ALL of the following are met:
Uveitis
Authorization may be granted when ALL of the following are met:
Takayasu's arteritis (initial)
Takayasu's arteritis — Covered when ALL of the following are met
Uveitis (initial)
Uveitis — Covered when ALL of the following are met
Continuation / Reauthorization
Continuation of Therapy — Covered when ALL of the following are met
This policy excludes approval when required documentation is not provided for members who are new to the plan. Specifically, if the member's coverage effective date is ≤ 90 days, submit medical records demonstrating that the member is currently receiving the requested infliximab product. Documentation obtained only as samples or via a manufacturer's patient assistance program does not satisfy this requirement and may result in denial.
The policy applies to prior authorization and coverage of infliximab products under the pharmacy benefit and specialty pharmacy processes; note that administrative updates in the review history state that the policy no longer applies to the medical benefit. Confirm benefit applicability and operational procedures with the full policy and plan-specific administration guidance when processing requests.
For the indications of Takayasu's arteritis and uveitis, requests for branded Remicade, unbranded infliximab, or Renflexis require documented intolerance to both listed biosimilars. Specifically, the member must have a documented intolerable adverse event with both Inflectra AND Avsola that is not an expected adverse event attributed to the active ingredient per the prescribing information. For uveitis, this requirement is in addition to meeting the diagnosis and immunosuppressive therapy trial requirements. Failure to document the required biosimilar intolerances may render the request not medically necessary.
Provider Actions and Documentation Requirements
Prior authorization required — route via specialty pharmacy/pharmacy benefit
Prior authorization is required for infliximab products under the pharmacy benefit. Use the specialty pharmacy contact channels listed in the policy for submission and benefit routing; specialty pharmacy phone and fax numbers are provided for pharmacy‑benefit processing.
- Pharmacy Benefit routing: Phone: 833-895-2611; Phone: 800-711-4555; Fax: 844-403-1029
- Specialty pharmacy contact: Phone: 833-895-2611; Fax: 888-656-6671
Prior authorization and limits — duration and quantity limits
Prior authorization must be obtained for infliximab products; initial approvals and reauthorizations are issued for up to 24 months. The policy also imposes quantity limits for 100 mg infliximab products.
- Initial approvals and reauthorizations: up to 24 months
- Quantity limit: 10 vials per 28 days for 100 mg infliximab products
Indication-specific therapy sequencing — trials vary by diagnosis
Therapy sequencing and step requirements differ by indication — some diagnoses require trials of specific agents or conventional therapies before infliximab products (or specific branded infliximab products) will be approved.
- Examples: Crohn's and ulcerative colitis require prior trials of Entyvio and another agent (Selarsdi/Steqeyma/Yesintek) for Remicade/infliximab/Renflexis.
- Rheumatologic and dermatologic indications list required conventional therapy trials (e.g., methotrexate, NSAIDs, topical therapies) or allow biologic first‑line when severity warrants.
Step requirements for uveitis and continuation — immunosuppressive trial then meet reauthorization criteria
For uveitis, the member must have had an inadequate response, intolerance, or contraindication to a trial of immunosuppressive therapy (e.g., methotrexate, azathioprine, or mycophenolate mofetil). Continuation (reauthorization) requires that the initial biologic trial requirements for the treated diagnosis are met.
- Initial requirement: documented inadequate response, intolerance, or contraindication to immunosuppressive therapy for uveitis (examples listed).
- Continuation: member must meet initial biologic trial requirements for the treated diagnosis and submit documentation of improvement.
New-member treatment documentation — 90‑day lookback and acceptable records
If a member is new to the plan (coverage effective date ≤ 90 days), submit medical records documenting that the member is currently receiving the requested drug; samples and manufacturer patient assistance program supplies do not count as acceptable documentation.
- Applies when coverage effective date is less than or equal to 90 days.
- Exclude samples or manufacturer patient assistance program supplies from acceptable documentation.
Diagnosis and prior therapy records — what to submit
Include medical documentation that shows the member's diagnoses and prior therapies tried, with outcomes (failure, intolerance, or contraindication); when seeking Remicade, infliximab, or Renflexis also include any documented intolerable adverse events with Inflectra AND Avsola.
- Diagnosis supporting the requested indication.
- Prior therapies tried, with dates and outcomes (failure/intolerance/contraindication).
- Documentation of intolerable adverse events to both Inflectra AND Avsola when applicable.
Reauthorization documentation — medical records showing improvement required
For reauthorization, submit medical records or chart notes documenting clinical improvement, demonstrated by low disease activity or improvement in signs and symptoms of the treated condition.
- Documentation must show improvement (e.g., low disease activity or symptom improvement).
- Reauthorization depends on meeting the initial biologic trial requirements for the diagnosis.
Denial risk — missing current‑treatment records for new‑to‑plan members
Failure to submit current‑treatment medical records for members new to the plan (coverage effective date ≤ 90 days) may result in denial of the request.
- Required records must document that the member is currently receiving the requested drug; samples and manufacturer patient assistance program supplies are not acceptable.
Denial risk — missing prior therapy or adverse event documentation when requesting branded infliximab products
Requests for Remicade, infliximab, or Renflexis without documented prior trials/inadequate response or without documented intolerable adverse events to required comparator agents may be denied.
- Examples: For IBD indications, lack of documented inadequate response to Entyvio and a second listed agent (Selarsdi/Steqeyma/Yesintek) risks denial.
- For other indications, absence of required conventional therapy trials (or documented contraindication/intolerance) may risk denial.
Biosimilar intolerance requirement — must document intolerance to Inflectra AND Avsola
For Takayasu's arteritis and uveitis, approval of Remicade, infliximab, or Renflexis requires documented intolerable adverse events to both Inflectra AND Avsola; absence of documentation of intolerance to both biosimilars may lead to denial.
- The intolerable adverse events must not be expected adverse events attributed to the active ingredient per prescribing information.
- This biosimilar cross‑intolerance requirement is specific to Takayasu's arteritis and uveitis.
Drug Coding, Limits, and Authorization Length
| Remicade | Remicade |
| Inflectra | Inflectra |
| Renflexis | Renflexis |
| Avsola | Avsola |
| Infliximab (unbranded) | inflximab (unbranded) |
Key Definitions and Criteria Thresholds
Background
Infliximab and its biosimilars are monoclonal antibody Tumor Necrosis Factor (TNF) inhibitors used to treat a range of immune‑mediated inflammatory diseases. The policy lists FDA‑approved and approvable compendial uses across gastrointestinal, rheumatologic, dermatologic, and ocular inflammatory conditions and sets indication‑specific prior therapy and intolerance requirements for initiating or switching between infliximab products. Recent administrative updates reflected in the review history include preference designations for biosimilars and operational clarifications for benefit applicability and reauthorization documentation.
Revision History and Policy Changes
Avsola designated as a preferred infliximab product (preferred product status effective 07/01/2026).
Policy updated to indicate Avsola will be a preferred product (noted in review history).
Reauthorization wording changed to require 'submission of medical records (e.g., chart notes)' documenting improvement and clarified documentation for members new to the plan.
Reauthorization criteria revised to require that biologic trial requirements for the treated diagnosis are met (replacing previous language that initial criteria are met).
Policy updated to indicate it no longer applies to the medical benefit and included minor verbiage updates; effective 01/01/2026 noted in review history.
Updated reauthorization criteria to replace 'initial criteria are met' with 'biologic trial requirements for the treated diagnosis are met.'
Criteria for Crohn's disease and ulcerative colitis revised to allow approval if disease severity warrants biologic as first-line therapy and removed some disease characteristic requirements.
Multiple updates including plaque psoriasis BSA threshold change to 3% and consolidation of conventional therapies; effective 02/01/2024 recorded in review history.
Policy review history entries recorded (earliest listed review date 03/21/05).
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