Is Infliximab (infliximab) medically indicated for a 17-year-old female with a clinical diagnosis of colitis (ulcerative colitis) who has failed or is intolerant to conventional therapies?

Is Infliximab Medically Indicated for This 17-Year-Old Female with Ulcerative Colitis?

Yes, infliximab is medically indicated for this 17-year-old female with ulcerative colitis who has been hospitalized for abdominal pain and bloody stools, provided she meets the specific criteria outlined below and has demonstrated intolerance or inadequate response to conventional therapy. 1

Age Requirement - SATISFIED

• The patient is 17 years old, which meets the FDA-approved age requirement of ≥6 years for infliximab in ulcerative colitis 2
• Infliximab has established safety and effectiveness in pediatric patients aged 6-17 years with moderately to severely active ulcerative colitis 2

Clinical Diagnosis - SATISFIED

• The patient has a confirmed clinical diagnosis of ulcerative colitis (colitis) with objective evidence: hospitalization for abdominal pain and bloody stools, plus endoscopic evaluation (EGD and colonoscopy) with biopsies 1
• The severity appears moderate-to-severe based on hospitalization for bloody stools, which aligns with guideline indications 1

Conventional Therapy Failure - CRITICAL REQUIREMENT

This is the key criterion that must be documented:

• The American Gastroenterological Association strongly recommends infliximab over no treatment for moderate-to-severe ulcerative colitis 1
• However, infliximab should only be used after documented intolerance or inadequate response to conventional therapy, which includes: 1
  • 5-aminosalicylates (5-ASA/mesalamine)
  • Oral corticosteroids
  • Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate)

The authorization request must document which conventional therapies have failed or caused intolerance. Without this documentation, the request does not meet medical necessity criteria. 1

Safety Screening Requirements - MUST BE COMPLETED

Hepatitis B Status

• HBsAg must be negative OR patient must be on concurrent antiviral therapy 1, 2
• This is non-negotiable due to risk of hepatitis B reactivation with TNF inhibitors 1

Tuberculosis Screening

• Must exclude untreated latent or active tuberculosis before initiating therapy 1, 2
• Screening should include clinical risk stratification, chest X-ray, and interferon-gamma release assay 1
• If latent TB is detected, antitubercular therapy must be initiated before infliximab 2

Active Infection Exclusion

• No active infection should be present 1
• Given hospitalization with bloody stools, Clostridioides difficile and cytomegalovirus colitis must be excluded 1
• Stool culture and C. difficile testing should be documented as negative 1

Concurrent Medication Restrictions

• No concurrent treatment with other biologic drugs (e.g., another TNF inhibitor, anakinra, abatacept) 1
• No concurrent use of live vaccines - critically important in a 17-year-old who may be due for routine vaccinations 1, 2
• Infliximab crosses the placenta; infants exposed in utero should not receive live vaccines for at least 6 months after birth 2

Dosing for Pediatric Ulcerative Colitis

• Induction regimen: 5 mg/kg IV at weeks 0,2, and 6 2
• Maintenance regimen: 5 mg/kg IV every 8 weeks 2
• The 10 mg/kg dose showed similar efficacy to 5 mg/kg in adult trials but is not standard for pediatric patients 2

Evidence Supporting Use in This Population

Efficacy Data

• In the ACT1 and ACT2 trials, clinical response at week 8 was 67% for infliximab 5 mg/kg versus 33% for placebo 1, 2
• Clinical remission rates were 30% for infliximab versus 13% for placebo, sustained through week 54 1, 2
• Corticosteroid-free remission at week 30 was 22% versus placebo, demonstrating steroid-sparing effect 1

Pediatric-Specific Evidence

• In an open-label pediatric UC trial of 60 patients aged 6-17 years, 73% (44/60) achieved clinical response at week 8 2
• At week 8,40% (24/60) achieved clinical remission by Mayo score 2
• Approximately half of pediatric patients were on concomitant immunomodulators at baseline 2

Combination Therapy Consideration

• The AGA suggests combining TNF antagonists with immunomodulators rather than TNF antagonist monotherapy (conditional recommendation, low-to-moderate certainty) 1
• In the UC SUCCESS study, infliximab plus azathioprine achieved 40% remission at week 16 versus 22% for infliximab alone 1
• However, combination therapy increases risk of hepatosplenic T-cell lymphoma (HSTCL), requiring careful risk-benefit assessment in adolescents 2

Critical Safety Considerations for Adolescents

Infection Risk

• Serious infections occurred in 5.3% of infliximab-treated patients in clinical trials 2
• Opportunistic infections including tuberculosis, histoplasmosis, and listeriosis have been reported 2
• Infliximab should be discontinued if serious infection develops 2

Malignancy Risk

• Lymphoma and other malignancies have been reported in children and adolescent patients treated with TNF blockers 2
• Hepatosplenic T-cell lymphoma, a rare but often fatal malignancy, has occurred primarily in adolescent and young adult males with IBD treated with combination therapy (infliximab plus azathioprine or 6-mercaptopurine) 2

Vaccination Timing

• Complete all age-appropriate vaccinations before initiating infliximab 2
• Live vaccines are contraindicated during therapy and for at least 6 months after discontinuation 2

Common Pitfalls to Avoid

1. Do not approve without documented conventional therapy failure - The most common error is approving infliximab without clear documentation that 5-ASA, corticosteroids, or immunomodulators have been tried and failed 1

2. Do not skip tuberculosis screening - Reactivation of latent TB can be fatal; screening is mandatory before first dose 1, 2

3. Do not overlook infectious colitis mimics - In a hospitalized patient with bloody stools, C. difficile and CMV colitis must be excluded before attributing symptoms to UC alone 1

4. Do not initiate during active infection - Infliximab is contraindicated with active infections; any concurrent infection must be treated first 1, 2

5. Do not combine with live vaccines - Verify vaccination status and ensure no live vaccines are administered during therapy 1, 2

Final Determination Algorithm

APPROVE if ALL of the following are documented:

• Age ≥6 years ✓ (patient is 17)
• Confirmed UC diagnosis with endoscopic/histologic evidence ✓ (colonoscopy with biopsies performed)
• Documented failure/intolerance to ≥1 conventional therapy (5-ASA, corticosteroids, or immunomodulator) - MUST BE VERIFIED
• HBsAg negative or on antiviral therapy - MUST BE VERIFIED
• TB screening negative or latent TB being treated - MUST BE VERIFIED
• No active infection - MUST BE VERIFIED
• No concurrent biologic therapy - MUST BE VERIFIED
• No concurrent live vaccines planned - MUST BE VERIFIED

DENY or REQUEST ADDITIONAL INFORMATION if:

• No documentation of conventional therapy failure
• Missing required safety screening (HBV, TB)
• Active infection present
• Concurrent biologic therapy planned

1, 2