Outpatient Medical Injectable Infliximab Authorization (including biosimilars) - Coverage Criteria
Customize your policy alerts
Sign up for all Highmark Delaware policy alerts
Know when Highmark Delaware releases new policies or updates existing guidance.
Monitor payer policy activity
Form and requirements for prior authorization of outpatient medical benefit infliximab (including biosimilars) for Highmark Delaware members; intended for prescribing clinicians, infusion providers, and billing offices requesting authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria
Authorization and product preference
Coverage consideration per form fields and product preference
Based on required form fields
Explicit step/preference rule
Form states exception for Medicare
Non-preferred infliximab products listed on the form are Remicade (J1745) and Renflexis (Q5104). These non-preferred agents will be considered only after documentation shows an adequate therapeutic trial resulting in drug therapy failure, or documented intolerance, or a documented contraindication to both preferred products. Note: the form explicitly allows a Medicare exception — Medicare members currently established on a non-preferred therapy are not required to try a preferred option.
Coding
Provider Actions & Submission Requirements
Authorization submission requirements — use the Outpatient Medical Injectable Infliximab Authorization Request Form
Submit the completed Outpatient Medical Injectable Infliximab Authorization Request Form with member and provider identifiers, place of administration, requested drug name/strength/dose/quantity, ICD-10 diagnosis code, member weight, site of care and drug dispensing method, and the physician/NPI and office contact information.
- Form must indicate Place of Administration Type (home infusion, office professional, ambulatory infusion suite professional, or outpatient hospital).
- Form must indicate Drug Dispensing Information (specialty pharmacy or buy & bill) and include dispensing provider name and NPI when applicable.
- Include requested drug name, strength/dose, directions, quantity (# of doses/visits), and ICD-10 diagnosis code.
Preference and step requirement for non-preferred products
Non-preferred infliximab products (Remicade J1745, Renflexis Q5104) will only be considered after documentation of drug therapy failure after an adequate therapeutic trial, or intolerance, or contraindication to BOTH preferred products (Avsola Q5121 and Inflectra Q5103).
- Medicare members already established on a non-preferred therapy are exempt from the preferred trial requirement.
Required documentation to attach with authorization
Attach all pertinent clinical information to the form, including whether this is a new start or continuation, date of last infusion, and whether the member has demonstrated disease stability or a beneficial response to therapy.
- List all previous therapies tried and failed.
- Indicate diagnosis (selected from form), member weight, and whether infliximab is being used in combination with methotrexate.
- Mark Attached: YES/NO and specify New Start or Continuation of Therapy.
Triggers for possible denial
Requests may be denied if required fields or supporting clinical information are missing or if prior therapy trials or failures to preferred products (when required) are not documented.
- Missing member/provider/place of administration details, dose, dates, or ICD-10 diagnosis may trigger denial.
- Failure to document prior therapies tried and failed, or failure/intolerance to both preferred agents when requesting a non-preferred product, may trigger denial.
- Not attaching pertinent clinical information or indicating date of last infusion and response to therapy may result in denial.
Background
Infliximab and its biosimilars are intravenous tumor necrosis factor (TNF)-alpha inhibitors used across multiple inflammatory conditions. The authorization form groups available products into preferred and non-preferred options and requires clinical details to support therapy (diagnosis, prior therapies, and response). For non-preferred agents, the policy requires documentation of failure, intolerance, or contraindication to both preferred infliximab biosimilars before consideration, although established Medicare beneficiaries on a non-preferred product are exempt from that trial requirement.
Definitions
Initial Therapy Criteria
Initial therapy
Initial therapy selection and documentation
Form fields
Continuation of Therapy Criteria
Continuation of therapy
Continuation requires documentation
Form field
Step Therapy Requirements
| Step | Requirement | Preferred products (must be tried) | Non-preferred products (considered only after requirement met) |
|---|---|---|---|
| 1 | Documented drug therapy failure after an adequate therapeutic trial, OR intolerance, OR contraindication to BOTH preferred products | Avsola (Q5121); Inflectra (Q5103) | Remicade (J1745); Renflexis (Q5104) |
Site of Care
Specify site of care and facility billing status on the form
Specify the site of care on the authorization form — select Home Infusion, Office - Professional, Ambulatory Infusion Suite - Professional, or Outpatient Hospital and indicate whether the site is hospital-affiliated or facility-billed.
- Also indicate the drug dispensing method (Specialty Pharmacy or Buy & Bill) on the form.
Biosimilar / Reference Product Information
Preferred infliximab: Avsola (Q5121)
Avsola (Q5121) is a preferred infliximab product for all indications and should be selected as the preferred agent when appropriate.
- Preferred product selection is documented on the form under 'PREFERRED for ALL indications'.
Preferred infliximab: Inflectra (Q5103)
Inflectra (Q5103) is a preferred infliximab product for all indications and should be selected as the preferred agent when appropriate.
- Preferred product selection is documented on the form under 'PREFERRED for ALL indications'.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.