Is continuation of Infliximab (Remicade) 5mg/kg IV every 8 weeks for Crohn's disease medically necessary?

Medical Necessity Determination for Continued Infliximab (Remicade) Therapy

Yes, continuation of infliximab (Remicade) 5 mg/kg IV every 8 weeks is medically necessary for this patient with Crohn's disease who has achieved and maintained long-term clinical and endoscopic remission on this therapy.

Clinical Justification for Continuation

This patient meets all criteria for maintenance infliximab therapy based on current evidence-based guidelines:

• Documented clinical remission: The patient is in sustained clinical remission since starting infliximab in the documented timeframe, with no GI symptoms or concerns 1
• Endoscopic remission confirmed: Colonoscopy showed no evidence of inflammation with normal neoterminal ileum and colonic mucosa, representing complete mucosal healing 1
• Objective biomarker normalization: Fecal calprotectin levels documented as normal, confirming absence of intestinal inflammation 1
• Complex disease phenotype: History of both stricturing and penetrating disease with prior ileocolonic resection, representing high-risk disease that requires ongoing maintenance therapy 1, 2

Guideline-Based Support for Maintenance Therapy

The 2024 ECCO guidelines provide a strong recommendation with moderate-quality evidence that patients with Crohn's disease who achieved remission with anti-TNF agents should continue maintenance treatment using the same therapy 1. The evidence demonstrates:

• Infliximab 5 mg/kg every 8 weeks maintains clinical remission in 39-45% of patients at week 30 compared to 21% with placebo (p<0.003) 1
• Median time to loss of response exceeds 38-54 weeks with maintenance therapy versus only 19 weeks with placebo (p=0.002) 1, 3
• Maintenance therapy achieves mucosal healing with a relative risk of 7.00 (95% CI: 1.02-48.10) compared to placebo 1

Risk of Therapy Withdrawal

Routine withdrawal of infliximab is not recommended even after achieving stable remission 1. The 2025 BSG guidelines explicitly state that withdrawal carries substantial relapse risk:

• Approximately one in three patients relapse within 1-2 years after stopping anti-TNF therapy, even with documented clinical, biochemical, and endoscopic remission 1
• This patient's complex disease history (stricturing, penetrating, prior resection) places him at higher risk for severe consequences if relapse occurs 1
• Re-treatment after withdrawal may be associated with higher failure rates and potential immunogenicity issues 1

Addressing the Biosimilar Question

Regarding the insurer's preference for biosimilar alternatives (Avsola, Inflectra, Renflexis):

The patient's established response to originator infliximab since the documented start date represents a valid clinical reason to continue the current formulation 1, 4. However, if cost considerations necessitate a switch:

• The 2019 BSG guidelines support switching from originator to biosimilar infliximab in patients with stable disease, but emphasize this must be a clinical decision made by the physician and patient, not an automatic substitution 1
• The NOR-SWITCH trial demonstrated non-inferiority of biosimilar CT-P13 over 52 weeks, though the confidence interval approached inferiority specifically in Crohn's disease patients 1
• Any switch should maintain the same dosing schedule (5 mg/kg every 8 weeks) with close monitoring for loss of response, including drug levels and anti-drug antibodies 1, 4

Dosing Appropriateness

The prescribed regimen of 5 mg/kg every 8 weeks for 7 visits per year is the FDA-approved standard maintenance dose for Crohn's disease 2. This dosing is supported by:

• FDA labeling specifies 5 mg/kg every 8 weeks as the recommended maintenance regimen after induction 2
• The ACCENT I trial established this as the evidence-based maintenance schedule 1, 3
• The patient tolerates this regimen without adverse events and maintains remission, indicating optimal dosing 1

Safety Monitoring Compliance

The patient meets all safety requirements for continued therapy:

• Tuberculosis screening: Documented negative QuantiFERON-TB Gold Plus test within the required timeframe 2
• No concurrent biologic therapy: Medication list confirms infliximab monotherapy without other biologics 2
• Regular monitoring: Patient has scheduled colonoscopy for disease surveillance and recent laboratory monitoring 1
• No active infections: Documentation confirms no recurrent illnesses or infections 1

Common Pitfalls to Avoid

Do not discontinue effective maintenance therapy based solely on achieving remission. The evidence clearly demonstrates that stopping anti-TNF therapy, even in complete remission, leads to high relapse rates 1.

Do not force an automatic switch to biosimilar without clinical assessment and shared decision-making. While biosimilars are appropriate alternatives, switching decisions require physician oversight and patient agreement, particularly in patients with stable disease on originator products 1.

Do not delay approval based on lack of documented biosimilar trial. The patient's disease history (fistulas on Humira requiring switch to Remicade prior to surgery) represents a documented therapeutic progression with valid clinical reasoning for the current regimen 1.

Medical Necessity Conclusion

This patient requires continued infliximab maintenance therapy to prevent disease relapse and maintain the achieved clinical and endoscopic remission 1. Discontinuation would expose the patient to substantial risk of disease recurrence with potential for serious complications given his history of penetrating and stricturing disease 1, 5. The prescribed dose, frequency, and duration align with FDA-approved labeling and evidence-based guidelines 1, 2.