Infliximab (medical benefit) — Medicare Part B coverage and prior authorization criteria
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Medicare Part B coverage and prior authorization criteria for infliximab and its biosimilars for Aloha Care Medicare members, including indication-specific requirements and continuation/renewal conditions. Applies to medical benefit administration of infliximab products (J1745 and Q-codes).
No material clinical or coverage changes in this revision.
Coverage Criteria for Infliximab and Biosimilars
inv-01: Indication-specific Initial and Continuation Criteria
Covered when ALL of the following are met per indicated condition
Prior therapy requirements
- Rheumatoid Arthritis: Diagnosis of moderately to severely active RA; prescribed by or in consultation with a rheumatologist; minimum 3-month trial and failure, contraindication, or intolerance to one of the following at maximally tolerated doses: methotrexate, leflunomide, or sulfasalazine; infliximab to be used in combination with methotrexate.
- Psoriatic Arthritis: Diagnosis of active PsA with features such as actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement; prescribed by or in consultation with a dermatologist or rheumatologist.
- Plaque Psoriasis: Diagnosis of chronic severe plaque psoriasis (extensive and/or disabling) with >= 3% BSA involvement or special-site disease (palmoplantar, facial, genital) or severe scalp psoriasis; minimum 4-week trial and failure, contraindication, or intolerance to one topical therapy (e.g., high-potency corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar); prescribed by or in consultation with a dermatologist.>= 3% BSA
- Ankylosing Spondylitis: Diagnosis of active ankylosing spondylitis; prescribed by or in consultation with a rheumatologist; trial and failure, contraindication, or intolerance to two different NSAIDs for a minimum total duration of one month at maximally tolerated doses.
- Crohn's Disease (including fistulizing): Moderately to severely active Crohn's disease or fistulizing Crohn's; clinical features may include frequent diarrhea and abdominal pain, >=10% weight loss, complications (obstruction, fever, abdominal mass), abnormal labs (e.g., elevated CRP), and CDAI > 220; prescribed by or in consultation with a gastroenterologist; trial and failure, contraindication, or intolerance to conventional therapies such as 6-mercaptopurine, azathioprine, methotrexate, or corticosteroids.CDAI > 220
- Ulcerative Colitis: Diagnosis of moderately to severely active ulcerative colitis with features such as >6 stools per day, frequent urgency, frequent blood in stools, presence of ulcers, abnormal labs (e.g., hemoglobin, ESR, CRP), or steroid dependence/refractory disease; prescribed by or in consultation with a gastroenterologist; trial and failure, contraindication, or intolerance to conventional therapies such as 6-mercaptopurine, azathioprine, aminosalicylates, or corticosteroids.> 6 stools per day
Continuation criteria prohibit combination therapy with other listed agents
inv-02: Preferred agent and biosimilar sequencing
Product selection and sequencing rules
inv-03: Sarcoidosis (Off-label) — Initial Coverage Criteria
Covered for refractory sarcoidosis when ALL of the following are met:
From off-label sarcoidosis section
inv-04: Dosing Guidance (informational)
Dosing references for various FDA and guideline indications (informational):
FDA dosing references aggregated
Guideline dosing cited in FDA Indications & Dosing section
Use of infliximab in combination with another anti‑TNF agent is explicitly excluded. Requests for concurrent treatment with two anti‑TNF biologics will not meet coverage criteria and are subject to denial.
Infliximab must not be prescribed concurrently with another anti‑TNF therapy. Such combination therapy is listed as an exclusion and will not be approved under the policy.
The policy indicates that combination anti‑TNF therapy is not acceptable: administration of infliximab together with any other anti‑TNF agent is excluded from coverage and would be considered not medically necessary.
Billing and Coding
| J1745 | Injection, infliximab, excludes biosimilar, 10 mg (Remicade) |
| Q5103 | Injection, infliximab-dyyb, biosimilar, (Inflectra), 10 mg (preferred) |
| Q5104 | Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg |
| Q5109 | Injection, infliximab-qbtx, biosimilar, (Ixifi), 10 mg [Product not launched] |
| Q5121 | Injection, infliximab-axxq, biosimilar, (Avsola), 10 mg (preferred) |
| No explicit codes listed | Document references CodeSource/OptumRx but does not list specific CPT/HCPCS/ICD codes in this section. |
Prior Authorization, Documentation, and Denials
Prior authorization required; initial 3 months, renewal up to 12 months
Prior authorization is required under the medical benefit for infliximab products. Initial authorization is for 3 months; renewals may be approved for up to 12 months.
Sarcoidosis prior authorization: diagnosis and prior‑therapy documentation required
For off-label use in sarcoidosis, prior authorization must include documentation of the sarcoidosis diagnosis and evidence of trial and failure, contraindication, or intolerance to required prior therapies.
- Diagnosis of sarcoidosis required
- Evidence of trial and failure, contraindication, or intolerance to required prior therapies
Step therapy for Medicare Part B new starts (policy notes)
Medicare Part B new starts must meet step therapy criteria in addition to coverage criteria; the policy text also includes a statement 'No step therapy' in the step therapy section.
- For new Medicare Part B starts, step therapy criteria must be met before approval
- Policy includes a note: 'No step therapy' (policy nuance)
Required prior therapies for sarcoidosis before infliximab
Approval for sarcoidosis requires documented trial and failure, contraindication, or intolerance to one corticosteroid and one immunosuppressant prior to infliximab.
- Trial and failure, contraindication, or intolerance to one corticosteroid (e.g., prednisone)
- Trial and failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, or azathioprine)
Document diagnosis, specialist consultation, baseline measures, and objective response
Required clinical documentation for continuation and approval includes the diagnosis, prescriber specialty or consultation, and objective baseline and follow-up measures of disease activity.
- Clear diagnosis documentation (indication-specific)
- Prescriber specialty or documentation of specialist consultation
- Baseline disease activity and objective evidence of clinical response from baseline (e.g., joint counts, BSA for psoriasis, lab markers, mucosal healing)
Specialist prescribing/consult required for sarcoidosis
For sarcoidosis cases, infliximab must be prescribed by or in consultation with an appropriate specialist (pulmonologist, dermatologist, or ophthalmologist).
- Prescriber or documented consultation must be a pulmonologist, dermatologist, or ophthalmologist for sarcoidosis
Denial triggers: unmet continuation criteria or excluded combinations
Requests may be denied if infliximab is prescribed in combination with another anti‑TNF agent or if continuation criteria—such as documented positive clinical response and required prior trials—are not met.
- Denial risk if combination with another anti‑TNF agent is present
- Denial risk if continuation criteria (objective clinical response and required prior therapies) are not documented
Combination therapy exclusion — infliximab + other anti‑TNF agents
Use of infliximab in combination with another anti‑TNF agent is an exclusion and will trigger denial of the request.
- Exclusion: infliximab combined with any other anti‑TNF agent
Background and Clinical Context
Infliximab is an intravenous anti‑TNF biologic covered under the medical benefit for multiple inflammatory conditions. It is indicated for uses including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis, and the policy also lists off‑label use for refractory sarcoidosis when specific criteria are met. Continuation approvals require documentation of objective clinical response from baseline and appropriate specialist involvement.
Definitions and Products
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