Is Renflexis (infliximab) medically necessary for a patient with rheumatoid arthritis who has no updated physician visit notes indicating a favorable response to prior infliximab administration?

Medical Necessity Assessment for Renflexis (Infliximab-abda) Continuation in Rheumatoid Arthritis

Renflexis continuation is NOT medically necessary at this time because the patient lacks documented evidence of favorable response to prior infliximab therapy, which is a fundamental requirement for subsequent treatment courses according to established treatment guidelines.

Critical Missing Documentation

The authorization request fails to meet standard medical necessity criteria due to:

• No updated physician visit notes documenting favorable response to infliximab - This is the primary deficiency that prevents approval 1, 2
• The patient received infliximab from [DATE] to [DATE], but there is no clinical documentation showing improvement in disease activity measures during that treatment period 1
• The progress note from [DATE] only states the patient is "wondering about retrying infliximab" because it "worked very well," but this is patient recollection rather than objective clinical documentation 1, 2

Evidence Requirements for Biologic Continuation

For subsequent courses of TNF inhibitor therapy, guidelines require documented favorable response to prior administration:

• The European League Against Rheumatism (EULAR) recommends monitoring every 1-3 months in active disease, with therapy adjustment if no improvement occurs by 3 months after treatment initiation 3, 1
• Clinical response should be documented using objective measures including tender/swollen joint counts, pain scales, functional assessments, and inflammatory markers (CRP, ESR) 1, 4
• The American College of Rheumatology emphasizes that treatment decisions should be based on documented disease activity and response to prior therapies 2, 4

Current Clinical Status Does Not Support Approval

The patient's current presentation suggests inadequate disease control on rituximab, but this alone does not justify infliximab restart without prior response documentation:

• The patient reports "increased joint pain and swelling on and off over hand joints" and believes "rituximab is not working as good" 1
• However, objective disease activity measures are missing - no documented tender/swollen joint counts, no disease activity scores (DAS28, CDAI, or SDAI) 1, 2
• Laboratory values show CRP 1.2 mg/dL (normal), normal ESR, and unremarkable CBC/CMP, which do not clearly indicate high inflammatory activity 1

Concurrent Methotrexate Requirement Not Met

The authorization criteria specifically require concurrent methotrexate treatment, which this patient cannot receive:

• MCG criteria state "concurrent treatment with methotrexate" is required but "NOT MET, STOPPED DUE TO TRANSAMINITIS" 3
• While EULAR guidelines acknowledge that methotrexate should be part of first treatment strategy, they also recognize contraindications exist 3
• The patient's methotrexate intolerance (transaminitis from [DATE]-[DATE]) is a legitimate contraindication, but this creates a coverage barrier under the stated authorization criteria 3

What Is Required for Approval

To establish medical necessity, the following documentation must be provided:

• Historical clinical records from [DATE]-[DATE] showing objective improvement during prior infliximab therapy, including:

  • Baseline and follow-up tender/swollen joint counts
  • Disease activity scores (DAS28, CDAI, or SDAI)
  • Patient-reported outcomes (HAQ-DI, pain scales)
  • Inflammatory markers (CRP, ESR) demonstrating improvement 1, 2

• Current disease activity assessment documenting active rheumatoid arthritis requiring escalation:

  • Current tender/swollen joint counts
  • Current disease activity score indicating moderate to high disease activity
  • Documentation that rituximab has been given adequate trial duration (typically 6 months minimum) 3, 1

• Justification for infliximab over other options given the patient's treatment history:

  • The patient has failed methotrexate, adalimumab, and abatacept
  • Rituximab appears inadequate based on patient report
  • However, other TNF inhibitors (certolizumab, golimumab) or alternative mechanisms (tocilizumab, JAK inhibitors) have not been documented as tried 3, 2

Alternative Pathways to Consider

If historical documentation of infliximab response cannot be obtained, alternative approaches include:

• Trial of a different TNF inhibitor not previously used (certolizumab pegol or golimumab), as these may be effective even after adalimumab failure 3
• Switch to non-TNF biologic with different mechanism such as tocilizumab (IL-6 inhibitor) or JAK inhibitors (tofacitinib, baricitinib, upadacitinib), which are appropriate after multiple DMARD failures 3, 2, 4
• Optimization of current rituximab therapy with objective disease activity assessment before declaring treatment failure, as rituximab dosing can be adjusted 3

Biosimilar Considerations

Renflexis (infliximab-abda) as a biosimilar is appropriate IF infliximab is indicated:

• Multiple guidelines support biosimilar infliximab use as equivalent to originator infliximab for both treatment-naïve patients and those switching from originator 3
• The NOR-SWITCH study demonstrated non-inferiority of biosimilar infliximab (CT-P13) versus originator across multiple conditions including rheumatoid arthritis 3
• However, biosimilar appropriateness does not override the requirement for documented prior response to the infliximab molecule itself 3

Common Pitfalls to Avoid

• Do not approve based solely on patient recollection of prior benefit without objective clinical documentation 1, 2
• Do not assume all TNF inhibitors are interchangeable - while class effect exists, individual patient responses vary and prior response to one TNF inhibitor should be documented before restarting that specific agent 3
• Do not overlook alternative treatment options that may be more appropriate given the patient's complex treatment history and inability to use methotrexate 3, 2, 4