Is Avsola (Infliximab-abda) 7mg/kg Every 6 Weeks Medically Necessary for This Patient?
Yes, the requested regimen of infliximab 7mg/kg every 6 weeks is medically necessary and represents standard of care for this patient with severe psoriatic arthritis and psoriasis who has demonstrated clinical response to this specific dosing schedule.
Medical Necessity Justification
Current Clinical Response Supports Continuation
This patient meets all continuation criteria established by the insurance policy:
- Improvement in swollen/tender joints: Documentation states "minimal joint symptoms" and "doing quite well" 1
- Improvement in skin involvement: Notes confirm "skin is quiet" and "skin has remained fairly quiet" 1
- Functional status improvement: Patient is "overall doing fairly well" 1
The patient has achieved low disease activity on the current regimen, which is the treatment target recommended by EULAR guidelines 1.
Dose Intensification is Evidence-Based Standard of Care
The AAD-NPF guidelines explicitly recommend that infliximab may be administered at more frequent intervals (less than every 8 weeks and as frequently as every 4 weeks) and/or at higher doses up to 10mg/kg for better disease control in adult patients (Strength of recommendation B). 1, 2
The FDA label for infliximab biosimilars states: "For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks" 3. The requested 7mg/kg every 6 weeks falls well within these approved parameters.
Clinical Indicators Supporting Intensified Dosing
Several factors in this case justify the intensified regimen:
- Pre-infusion symptom breakthrough: Patient experiences shortness of breath and joint aches "right before her next infusion," indicating waning drug levels 1, 2
- Severe disease with multiple treatment failures: Failed Humira (side effects), Stelara (inadequate response after 5 years), and Cimzia (allergic reaction) 1
- Young age with long disease duration: 25 years old with disease onset at age 16, representing aggressive disease requiring optimal control 4
- Recent shingles infection: Required infusion delay, demonstrating the consequences of treatment interruption 2
Standard Dosing Would Be Inadequate
The FDA-approved standard dosing of 5mg/kg every 8 weeks is the starting dose, not the maximum therapeutic dose 3. Guidelines from the American Academy of Dermatology state that "dose and interval of infusions may be adjusted as needed" 1.
Interrupted therapy or inadequate dosing should be avoided due to increased risk of infusion reactions and poorer disease control 2. Reducing this patient to standard dosing would constitute treatment interruption given her current stable regimen.
This is Standard of Care, Not Experimental
Guideline Support for Dose Escalation
Multiple authoritative guidelines support dose intensification:
- AAD-NPF 2019 Guidelines: Strength of recommendation B for more frequent dosing intervals and higher doses up to 10mg/kg 1
- AAD 2008 Guidelines: "Dose and interval of infusions may be adjusted as needed" 1
- FDA Label: Explicitly permits dosing "as often as every 4 weeks" and "up to 10 mg/kg" 3
Clinical Practice Standards
The 2009 treatment recommendations for psoriatic arthritis note that TNF inhibitors (including infliximab) are recommended with Level A evidence for moderate to severe peripheral arthritis and skin disease 1. The guidelines recognize that standard dosing may be insufficient for some patients.
Research demonstrates that approximately 39% of patients lose efficacy with standard maintenance dosing, supporting the need for individualized dose optimization 1, 5.
Safety Considerations
The patient is appropriately monitored with:
- Intensive laboratory monitoring every 12 weeks as documented in the treatment plan 1
- Consideration of Zostavax vaccination following recent shingles episode 2
- Regular clinical assessments every 6 months 1
The FDA label notes that while risk of serious infections increases at higher doses, the requested 7mg/kg every 6 weeks represents moderate intensification with acceptable risk-benefit ratio given the patient's excellent response 3.
Common Pitfalls to Avoid
Do not reduce to standard dosing in a patient with documented clinical response to intensified regimen. This constitutes treatment interruption and risks:
- Loss of disease control 2
- Development of anti-drug antibodies 1, 2
- Increased infusion reactions 2
- Irreversible joint damage 1, 6
Do not require failure on standard dosing before approving intensified regimens. The patient has already demonstrated need for this regimen through pre-infusion symptom breakthrough 1, 2.
Conclusion Regarding Medical Necessity
The treatment is medically necessary: Patient has severe psoriatic arthritis with documented response to current regimen and clinical indicators of inadequate drug levels at standard intervals 1, 2
The treatment is standard of care: Dose intensification up to 10mg/kg and intervals as frequent as every 4 weeks are explicitly recommended in AAD-NPF guidelines (Strength B) and FDA labeling 1, 2, 3
The treatment is not experimental: This represents established practice supported by Level A evidence for TNF inhibitors in psoriatic arthritis and specific guideline recommendations for dose optimization 1, 3