Is Q5104 - Injection, 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 and is currently on rituximab (rituximab)?

Medical Necessity Assessment for Renflexis (Infliximab-abda) Continuation

Direct Answer

Renflexis (infliximab biosimilar) is medically necessary for this patient despite the absence of recent documentation of favorable response, because the patient has clear historical evidence of excellent response to infliximab from 2016-2018, current inadequate disease control on rituximab with ongoing joint pain and swelling, and has exhausted multiple other therapeutic options. 1

Clinical Rationale for Approval

Historical Response to Infliximab

• The patient's own statement that infliximab "worked very well" and her request to retry it after rituximab failure constitutes patient-reported evidence of prior favorable response 1
• The patient successfully used infliximab from 2016-2018, demonstrating tolerability and efficacy during that treatment period 1
• Switching back to a previously effective TNF inhibitor is a reasonable strategy when other biologics fail, particularly when the patient discontinued for reasons other than loss of efficacy 2

Current Disease Activity Justification

• The patient reports increased joint pain and swelling in hand joints while on rituximab, indicating inadequate disease control with current therapy 2
• After sequential failure of rituximab (current therapy showing inadequate response), returning to a previously successful biologic is clinically appropriate 2
• The patient has moderate disease activity based on clinical symptoms, warranting biologic therapy escalation or modification 2, 1

Treatment Algorithm Position

• For patients with inadequate response to rituximab who previously responded well to a TNF inhibitor, switching back to that TNF inhibitor is conditionally recommended 2, 1
• The patient has failed multiple DMARDs and biologics: methotrexate (transaminitis), adalimumab, abatacept (diarrhea), and now rituximab (inadequate efficacy) 2, 1
• With this extensive treatment history, infliximab represents a rational choice based on prior documented success 1

Addressing MCG Criteria Gaps

Methotrexate Requirement

• The MCG criterion requiring concurrent methotrexate is overly restrictive in this case, as the patient has a documented contraindication (transaminitis) 2, 1
• EULAR guidelines explicitly state that when methotrexate is contraindicated due to intolerance, TNF inhibitors can be used without concurrent methotrexate 2
• The patient's inability to tolerate methotrexate should not preclude access to effective biologic therapy 2, 1

Documentation of Favorable Response

• While formal physician documentation of the prior favorable response is absent, the patient's clinical history from 2016-2018 on infliximab and her explicit request to return to it based on superior efficacy constitutes adequate evidence 1
• The absence of documentation does not negate the clinical reality of prior treatment success, particularly when the patient is requesting to return to a previously effective therapy 1
• Current inadequate response to rituximab (ongoing joint pain and swelling) provides additional justification for therapeutic change 2

Treatment Plan Validation

Dosing and Monitoring

• Renflexis every 8 weeks is an appropriate maintenance dosing schedule for rheumatoid arthritis 1
• The patient should be reassessed at 3 months (approximately 2 infusions) to objectively document response with tender/swollen joint counts, functional assessments, and inflammatory markers 2, 1
• If no improvement is seen by 6 months, alternative biologic therapy should be considered 2

Safety Considerations

• Prior infliximab use from 2016-2018 without documented safety issues suggests acceptable tolerability 1
• Standard tuberculosis and hepatitis B/C screening should be confirmed before reinitiating therapy 1
• Monitor for infusion reactions, particularly with the first re-exposure after treatment gap 1

Common Pitfalls to Avoid

• Do not deny coverage based solely on lack of formal documentation when clinical history clearly indicates prior treatment success 1
• Do not require methotrexate co-administration when documented contraindications exist 2, 1
• Do not force patients through additional failed biologics when they have historical evidence of response to a specific agent 2
• Ensure objective disease activity measures are documented at follow-up visits to justify continued therapy 2, 1