Is Renflexis (infliximab) medically necessary for a patient with ankylosing spondylitis presenting with increased joint achiness, joint pain, swelling, morning stiffness, myalgia, and fatigue, who may have had an inadequate response or intolerance to at least two non-steroidal anti-inflammatory drugs (NSAIDs)?

Medical Necessity Determination for Renflexis in Ankylosing Spondylitis

Renflexis (infliximab-abda) cannot be approved as medically necessary for this patient because documentation of inadequate response or intolerance to at least two NSAIDs at appropriate doses and duration has not been established, which is a mandatory prerequisite according to both FDA labeling and clinical practice guidelines. 1, 2

Critical Missing Documentation

The case explicitly states "UNSURE IF HAS INADEQUATE RESPONSE OR INTOLERANCE TO AT LEAST TWO NSAIDS" and notes "NO RESPONSE TO ADDITIONAL INFORMATION REQUEST." This represents a fundamental gap in meeting approval criteria. 2

Required NSAID Trial Criteria Before TNF Inhibitor Approval

According to the American College of Rheumatology/Spondylitis Association of America 2019 guidelines, patients must demonstrate:

• Lack of response to at least two different NSAIDs at maximal doses over one month, OR 2
• Incomplete responses to at least two different NSAIDs over two months, OR 2
• Documented intolerance or contraindication to two or more NSAIDs 2

The ASAS/EULAR recommendations similarly specify that NSAIDs are the first-line drug treatment, and continuous NSAID therapy is preferred for patients with persistently active symptomatic disease before escalating to biologics. 2

Clinical Presentation Analysis

While this patient demonstrates several features consistent with active ankylosing spondylitis requiring treatment escalation, the absence of documented NSAID trials prevents approval:

Supporting Features Present:

• Active disease symptoms: Joint pain (5/10), joint swelling, morning stiffness, myalgia, and fatigue 3
• Confirmed diagnosis: Ankylosing spondylitis of unspecified sites in spine 1
• Ongoing treatment: Patient is presenting for "followup of AS and for Renflexis infusion," suggesting prior authorization may have existed 1

Confounding Factors:

• Anemia requiring transfusion: Recent blood transfusion for dropped hemoglobin, with history of anemia secondary to uterine cancer 1
• Fatigue attribution: Current fatigue and myalgia may be partially related to anemia rather than solely AS activity 4

FDA-Approved Indication Confirmation

Renflexis is FDA-approved for "reducing signs and symptoms in patients with active ankylosing spondylitis" at 5 mg/kg intravenously at weeks 0,2, and 6, then every 6 weeks for maintenance. 1 However, FDA approval does not supersede the requirement for documented conventional therapy failure.

Recommendation for Approval Pathway

To obtain approval, the following documentation must be provided:

1. NSAID trial documentation showing specific agents used, doses, duration, and reason for discontinuation or inadequacy 2
2. If NSAID trials were adequate: Confirmation that at least two NSAIDs were tried at therapeutic doses for appropriate duration 2
3. If NSAIDs contraindicated: Documentation of specific contraindications (e.g., cardiovascular, gastrointestinal, or renal risks that preclude NSAID use) 2
4. Disease activity measurement: Ideally a BASDAI score >4 to objectively demonstrate persistently high disease activity 2, 3

Common Pitfall to Avoid

Do not approve TNF inhibitors without documented NSAID failure, even when patients have clear active disease symptoms. This represents a deviation from evidence-based treatment algorithms and established guidelines. 2 The stepwise approach exists because NSAIDs provide adequate symptom control in many AS patients at substantially lower cost and risk compared to biologics. 2

Alternative Consideration

If this patient has been receiving Renflexis previously (suggested by "followup...for Renflexis infusion"), this may represent a continuation rather than new initiation. In that case, request documentation of the original approval criteria and assess whether continuation is appropriate based on treatment response and ongoing disease activity. 2