Is infliximab (Avsola) injection medically necessary for the treatment of Crohn's disease?

Medical Necessity Assessment for Infliximab (Avsola) in Crohn's Disease

Infliximab (Avsola) is medically necessary for this patient with Crohn's disease, as the European Crohn's and Colitis Organisation (ECCO) strongly recommends infliximab as maintenance therapy for moderate-to-severe Crohn's disease (strong recommendation), and this patient has documented clinical response with disease control on current therapy. 1

Critical Documentation Gaps Requiring Immediate Attention

The case presents significant documentation deficiencies for the dates of service 05/29/25 and 06/16/25 that must be addressed:

• No clinical notes exist for DOS 05/29/25 and 06/16/25, which is the primary barrier to confirming medical necessity for these specific dates 2
• Clinical response documentation is absent - there is no documentation of improvement in abdominal pain, diarrhea, body weight, abdominal mass, hematocrit, or disease activity scoring tools for these visits 2
• The most recent clinical assessment is from an earlier date (page 22), which documents the patient "is now on seemingly successful infliximab therapy with appropriate TDM" but does not cover the specific DOS in question 2

Evidence Supporting Medical Necessity (When Documentation is Complete)

Guideline-Based Recommendations

• ECCO guidelines (2024) provide the strongest evidence: Infliximab is strongly recommended as maintenance therapy in moderate-to-severe Crohn's disease (strong recommendation, low-quality evidence) 1
• Infliximab is indicated for patients who achieve or maintain positive clinical response, demonstrated by improvement in signs and symptoms of the condition 1, 2
• The patient's diagnosis of K50.90 (Crohn's disease, unspecified, without complications) falls within the approved indication for moderate-to-severe Crohn's disease 1, 3

Dosing Appropriateness

• Standard maintenance dosing is 5 mg/kg IV every 8 weeks, which matches the patient's current regimen 1, 2, 3
• The patient received 200 mg infliximab (Avsola) on 05/29/25, which is appropriate for maintenance therapy 1
• FDA-approved dosing for pediatric patients (age 6-17 years) with Crohn's disease is 5 mg/kg at weeks 0,2, and 6, then every 8 weeks thereafter 3

Prescriber Specialty Requirement

• The prescriber specialty requirement is met - treatment must be prescribed by or in consultation with a gastroenterologist for Crohn's disease 2
• The case history indicates ongoing gastroenterology management 2

Safety Monitoring Requirements Met (With Caveats)

Tuberculosis Screening

• TB screening requirement has a critical timing issue: The most recent QuantiFERON TB Gold test was negative on 8/8/2022 2
• This test is now beyond the 6-month window required for patients continuing biologic therapy 1, 3
• Updated TB screening within 6 months of the DOS (05/29/25,06/16/25) is required to meet safety criteria 1, 3

Concomitant Therapy

• The patient meets the requirement for no concurrent biologic therapy - page 12 documents only Remicade (infliximab), with no other biologics 2
• Concomitant immunosuppressive therapy with azathioprine, 6-mercaptopurine, or methotrexate may improve outcomes by reducing antibody formation, though this is not mandatory 4, 5

Clinical Context Supporting Continuation

Disease History and Complexity

• The patient has a complex presentation: 19-year-old male with autism, restrictive eating patterns (ARFID-like feeding disorder), and Crohn's disease diagnosed in 2018 2
• Disease progression necessitated escalation: By fall 2024, the patient developed significant weight loss requiring initiation of infliximab after inadequate response to oral methotrexate 2
• Historical disease activity documented: Initial presentation showed aphthous gastritis, ileitis, and left-sided colitis; January 2020 restaging showed minimal aphthoid change in distal colon with granulomas and mild focal changes 2

Prior Authorization History

• Consistent treatment pattern established: Previous authorizations document ongoing infliximab therapy from at least 09/06/24 through 04/03/25 2
• Multiple prior certifications exist for the same medication and diagnosis (K50.10, K50.90) 2

Critical Deficiencies Preventing Full Approval

To establish medical necessity for DOS 05/29/25 and 06/16/25, the following must be provided:

1. Clinical notes from 05/29/25 and 06/16/25 documenting disease status and treatment response 2
2. Evidence of clinical response through at least one of the following:
   • Improvement in abdominal pain or tenderness 2
   • Reduction in diarrhea frequency 2
   • Stabilization or improvement in body weight (particularly relevant given the patient's ARFID and weight loss history) 2
   • Improvement in disease activity scoring (e.g., CDAI score) 2
   • Endoscopic, CTE, MRE, or intestinal ultrasound findings showing mucosal improvement 2
3. Updated TB screening within 6 months of the DOS (the 8/8/2022 test is insufficient) 1, 3

Recommendation for Payer Decision

Medical necessity CANNOT be fully confirmed for DOS 05/29/25 and 06/16/25 without the missing clinical documentation. However, the following supports approval pending documentation:

• Strong guideline support exists for infliximab maintenance therapy in Crohn's disease 1
• The patient has established disease requiring biologic therapy, with documented inadequate response to conventional therapy (methotrexate) 2
• Dosing and administration are appropriate per FDA labeling and guidelines 1, 3
• Prior treatment history demonstrates ongoing need for maintenance therapy 2

Request the following from the provider within 10 business days:

• Clinical notes for 05/29/25 and 06/16/25 documenting disease activity and response to therapy
• Updated TB screening results (QuantiFERON or TST) performed within 6 months of DOS
• Documentation of clinical response using objective measures (weight, symptom scores, or imaging)

Upon receipt of complete documentation showing clinical response and updated TB screening, approve the claims retroactively. The weight of evidence strongly supports infliximab maintenance therapy for this patient's moderate-to-severe Crohn's disease. 1, 2