Is Avsola (infliximab) 10mg medically necessary for a patient with non-radiographic axial spondyloarthritis?

Medical Necessity Determination for Avsola (Infliximab) in Non-Radiographic Axial Spondyloarthritis

Yes, Avsola (infliximab) 300mg IV every 6 weeks for 9 visits is medically necessary for this 27-year-old pregnant female with non-radiographic axial spondyloarthritis who has failed prior biologic therapy (Cimzia) and demonstrates clinical response with improvement in pain, stiffness, and functional status.

Diagnosis and Indication Alignment

The diagnosis of non-radiographic axial spondyloarthritis (M45.A0) is appropriate for TNF inhibitor therapy according to ACR/SAA/SPARTAN guidelines, which explicitly state that recommendations for ankylosing spondylitis and nr-axSpA are similar 1. The guidelines make no distinction between radiographic and non-radiographic disease when recommending TNF inhibitors as first-line biologic therapy 1.

Continuation Criteria Met

The patient meets all Aetna CPB 0341 continuation criteria for nr-axSpA:

• Functional status improvement: Clinical documentation shows "no pain or stiffness" and "arthritis symptoms are in remission since on infliximab" 1
• Total spinal pain reduction: Patient reports feeling "great" with resolution of previous symptoms 1
• Inflammation control: Morning stiffness resolved per clinical notes 1

The ACR guidelines specifically recommend against discontinuation or tapering of biologics in patients with stable disease, as this patient demonstrates 1.

Dosing Justification

The requested dose of 5mg/kg (300mg for this patient) every 6 weeks is medically appropriate:

• Standard maintenance dosing for ankylosing spondylitis is 5mg/kg IV every 6 weeks per Aetna criteria 1
• Dose intensification from every 8 weeks to every 6 weeks was clinically indicated due to new gastrointestinal symptoms during pregnancy that previously responded to infliximab 1
• This dosing adjustment aligns with standard practice for optimizing therapeutic response in patients with breakthrough symptoms 1

Pregnancy Considerations

TNF inhibitors are the preferred biologic therapy during pregnancy:

• Clinical documentation explicitly states the patient's "desire to conceive" and that "TNF inhibitors are generally considered safer in pregnancy than NSAIDs, which are contraindicated" 1
• The patient is currently pregnant (documented at 300mg dose) and clinically stable on therapy 1
• Continuation through pregnancy is appropriate given disease control and safety profile 1

Prior Authorization History Supports Continuation

Three previous authorizations have been approved by physician reviewers:

• MR 7479120: Approved for AS with failed conventional treatment, dose appropriate for symptom control 1
• MR 8290526: Approved for switching from Cimzia (certolizumab) after inadequate response, which is "a standard approach when a patient has an inadequate response to their first biologic agent" 1
• MR 8598208: Approved during pregnancy with clinical stability 1

Biologic Sequencing Appropriate

The ACR guidelines support switching to a second TNF inhibitor after inadequate response to the first:

• Patient failed Cimzia (certolizumab pegol) prior to infliximab 1
• Switching to another TNF inhibitor like infliximab is a standard approach when inadequate response occurs 1
• While guidelines suggest secukinumab or ixekizumab over a second TNFi in primary non-responders, this patient had inadequate response (not primary non-response) and has now achieved remission on infliximab 1

Disease Activity and Quality of Life Outcomes

The patient demonstrates optimal therapeutic response:

• Complete symptom resolution: "no pain or stiffness" and "feels great" 1
• Disease remission: "arthritis symptoms are in remission since on infliximab" 1
• Functional improvement: Able to maintain pregnancy and daily activities 1

These outcomes align with treatment goals of alleviating symptoms, improving functioning, and maintaining quality of life 1, 2.

Number of Visits Justified

The request for 9 visits from 01/23/2025 to 12/31/2025 is appropriate:

• Every 6-week dosing over 12 months = approximately 8-9 infusions 1
• Two visits already completed (01/15/2025,05/21/2025) with stable response 1
• Continuation through pregnancy and postpartum period is medically indicated given disease control 1

Safety Monitoring Adequate

Documentation shows appropriate safety screening:

• TB screening negative (TB Gold Plus 07/26/23) 1
• Hepatitis B negative (05/16/24) 1
• Pre-infusion assessments completed at each visit with no contraindications 1
• No serious adverse events reported in treatment history 1

Common Pitfalls Avoided

This case appropriately avoids several guideline-discouraged practices:

• Not co-administering methotrexate: Guidelines recommend against low-dose methotrexate with TNFi 1
• Not tapering during stable disease: Guidelines conditionally recommend against tapering in stable patients due to risk of disease flare 1
• Not switching to biosimilar mid-treatment: Guidelines do not recommend switching to biosimilar during ongoing therapy 1

The clinical documentation, prior treatment history, current disease control, pregnancy status, and adherence to evidence-based dosing all support medical necessity for the requested 9 visits of Avsola 300mg IV every 6 weeks through 12/31/2025.