Is retroactive administration of Tremfya (guselkumab) for 6 visits medically necessary for a 36-year-old female with moderate to severe ulcerative colitis, previously treated with steroids and other medications, who showed initial improvement but has persistent symptoms?

Retroactive Authorization Decision for Tremfya in Ulcerative Colitis

The retroactive administration of Tremfya for 6 visits should NOT be approved beyond the initial evaluation visit, as the patient failed to meet continuation criteria due to inadequate physician follow-up and documentation of clinical response. 1

Critical Documentation Deficiencies

The case presents fundamental gaps that preclude authorization for continuation therapy:

• No physician follow-up after initial visit: The patient was last seen by the gastroenterologist in the initial visit, with subsequent "response" documented only by RN during infusion visits [@case documentation]
• Continuation criteria require physician assessment: The insurance policy explicitly requires documented clinical response with improvement in stool frequency or rectal bleeding from baseline, which necessitates physician evaluation, not nursing notes [@8@, 1]
• State-specific requirement: The adverse determination letter must include the name of a state-licensed provider who reviewed the case, indicating physician oversight is mandatory [@case documentation]

Why Initial Visit Should Be Approved

The initial evaluation visit (first dose) meets all criteria for authorization:

• Appropriate prescriber: Board-certified gastroenterologist and IBD specialist 1
• Moderate to severe disease: Patient had 5-6 bloody bowel movements daily, nocturnal symptoms, weight loss, and CT evidence of active colitis [@case documentation]
• Failed conventional therapy: Previous treatment with steroids and other medications with inadequate response [@2@, 2]
• Correct indication: Tremfya is FDA-approved for moderately to severely active ulcerative colitis 1

Why Continuation Visits Cannot Be Approved

Physician documentation is essential for continuation therapy because:

• The FDA label for Tremfya in UC requires assessment of clinical response defined by decrease in modified Mayo score with improvement in rectal bleeding subscore [@8@]
• AGA guidelines emphasize that continuation of biologic therapy requires documented positive clinical response with improvement in signs and symptoms [@2@, @5@]
• Nursing documentation during infusion visits cannot substitute for comprehensive physician assessment of disease activity, which includes physical examination, review of symptoms, and clinical decision-making [@2@, @5@]

Clinical Response Assessment Requirements

For continuation therapy to be justified, the following must be documented by a physician:

• Objective improvement in stool frequency: Baseline was 10-15/day, current 5-6/day, but this requires physician verification and correlation with other disease markers [@2@, @8@]
• Reduction in rectal bleeding: Patient reports blood "only during flareup now" but this vague statement needs physician clarification of bleeding score 2, 1
• Assessment of disease activity: Physician must evaluate whether improvements represent true disease control versus partial response requiring dose adjustment [2, @5@]

Regulatory and Standard of Care Concerns

This case represents substandard care delivery that should not be retroactively endorsed:

• Biologic therapy for moderate to severe UC requires ongoing physician monitoring to assess efficacy, adjust therapy, and monitor for adverse events [2, @5@, 1]
• The patient missed appointments and was not seen again by the gastroenterologist, indicating breakdown in care coordination [@case documentation]
• Approving continuation without physician oversight sets dangerous precedent for inadequate monitoring of high-risk immunosuppressive therapy 2

Appropriate Next Steps

The authorization decision should be:

• APPROVE: Initial evaluation visit and first Tremfya dose (Week 0)
• DENY: Continuation visits (Weeks 4,8,12, and subsequent doses) due to lack of physician documentation of clinical response
• REQUIRE: Patient must be re-evaluated by the gastroenterologist with proper documentation of clinical response before any additional doses can be authorized 2, 1

Common Pitfalls to Avoid

• Do not accept nursing notes as adequate documentation for continuation of biologic therapy in UC, as this does not meet standard of care 2
• Do not approve retroactive authorization when fundamental care standards were not met, as this incentivizes poor practice patterns [@case documentation]
• Do not confuse initial authorization criteria with continuation criteria: Initial therapy requires demonstration of moderate-severe disease and failed conventional therapy, while continuation requires documented clinical response [@2@, @8@, 1]

Evidence-Based Treatment Standards

For context, current guidelines establish that:

• Biologic therapy including IL-23 antagonists like guselkumab (Tremfya) is appropriate for moderate to severe UC after conventional therapy failure [@2@, @12@, @14@]
• Continuation of biologic therapy requires documented positive clinical response with improvement in stool frequency, rectal bleeding, or endoscopic findings [2, @8@]
• Maintenance therapy should continue with the agent successful in achieving induction response, but only when response is properly documented [@6@, @7