Is Infliximab (Infliximab) treatment medically necessary for a 17-year-old female patient with Inflammatory Bowel Disease (IBD) and colitis, who has undergone endoscopy (Esophagogastroduodenoscopy) and colonoscopy with biopsies, and has a history of abdominal pain and bloody stools, given her intolerance or inadequate response to conventional therapy?

Medical Necessity Assessment for Infliximab in 17-Year-Old with Ulcerative Colitis

Infliximab is medically necessary for this 17-year-old female patient with moderate-to-severe ulcerative colitis who has been hospitalized for abdominal pain and bloody stools, provided she meets the specific safety criteria outlined below.

Rationale for Approval

Infliximab is FDA-approved and guideline-recommended for pediatric patients aged 6 years and older with moderate-to-severe ulcerative colitis who have had inadequate response to conventional therapy. 1

Age Appropriateness

• The patient at 17 years old meets the FDA-approved age requirement of ≥6 years for infliximab treatment in ulcerative colitis 1
• Pediatric dosing follows the same regimen as adults: 5 mg/kg IV at weeks 0,2, and 6, followed by maintenance every 8 weeks 1

Disease Severity and Indication

• Hospitalization for abdominal pain and bloody stools indicates moderate-to-severe disease activity, which is the specific FDA-approved indication for infliximab 1
• The 2020 AGA guidelines recommend infliximab as a first-line biologic agent for moderate-to-severe ulcerative colitis in biologic-naïve patients 2
• Infliximab demonstrated superior efficacy over adalimumab in network meta-analysis (OR 2.10; 95% CI 1.16-3.79) 2

Evidence of Conventional Therapy Failure

• The criteria state "intolerance or inadequate response to conventional therapy" has been documented 1
• This aligns with FDA labeling requiring inadequate response to conventional therapies before initiating infliximab 1

Critical Safety Requirements That Must Be Verified

Before approval, the following mandatory safety criteria must be documented:

Tuberculosis Screening

• Latent or active tuberculosis must be ruled out through tuberculin skin test or interferon-gamma release assay 1
• If latent TB is present, appropriate anti-tuberculosis treatment must be initiated before infliximab 1

Hepatitis B Status

• HBsAg must be negative, or if positive, concurrent antiviral therapy must be in place 1
• Reactivation of hepatitis B can occur with TNF-inhibitor therapy and can be fatal 1

Active Infection Exclusion

• No active infections can be present at the time of infliximab initiation 1
• This includes bacterial, viral, fungal, or opportunistic infections 1

Concurrent Medication Restrictions

• No concurrent use of other biologic drugs (e.g., other TNF inhibitors, vedolizumab, ustekinumab) 1
• No live vaccines should be administered during infliximab therapy 1
• Concomitant immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) are permitted and may enhance efficacy 1

Expected Clinical Outcomes

Efficacy Data in Pediatric Ulcerative Colitis

• In the pediatric UC trial, 73% (44/60) of patients aged 6-17 years achieved clinical response at Week 8 with 5 mg/kg infliximab 1
• Clinical remission (Mayo score ≤2) was achieved in 40% (24/60) of patients at Week 8 1
• Every 8-week maintenance dosing is superior to every 12-week dosing for sustained remission 1

Steroid-Sparing Effect

• Among patients on corticosteroids at baseline in adult trials, 22-23% in infliximab groups achieved clinical remission and discontinued corticosteroids by Week 30, compared to 3-10% in placebo groups 1
• This effect was maintained through Week 54 1

Mucosal Healing

• Mucosal healing (Mayo endoscopy subscore 0-1) was achieved in 60-62% of infliximab-treated patients at Week 8 versus 31-34% with placebo 1
• Mucosal healing is associated with reduced hospitalization and surgery rates 2

Dosing and Administration Schedule

The approved regimen for this patient should be:

• Induction: 5 mg/kg IV at weeks 0,2, and 6 1
• Maintenance: 5 mg/kg IV every 8 weeks thereafter 1
• Dose escalation to 10 mg/kg or shortening interval to every 4 weeks may be considered for loss of response 1

Common Pitfalls to Avoid

• Do not use every 12-week maintenance dosing as it is significantly less effective than every 8-week dosing in pediatric patients (24% vs 56% remission at Week 54) 1
• Do not delay treatment in hospitalized patients with severe disease, as infliximab can prevent colectomy 3
• Do not discontinue abruptly if patient achieves remission; scheduled maintenance is required to sustain response 4
• Ensure endoscopy with biopsies has been performed to confirm ulcerative colitis diagnosis and rule out infectious colitis 1

Conclusion on Medical Necessity

This request meets medical necessity criteria provided all safety screening requirements are documented as negative/appropriate. The patient's age, disease severity requiring hospitalization, documented inadequate response to conventional therapy, and diagnosis of ulcerative colitis all align with FDA-approved indications and current gastroenterology guidelines. 2, 1