Is continuation of Simponi Aria (golimumab) 2mg/kg IV every 8 weeks medically necessary for the treatment of inflammatory arthritis?

Medical Necessity Assessment for Simponi Aria Continuation

Yes, continuation of Simponi Aria (golimumab) 2mg/kg IV every 8 weeks is medically necessary for this patient with HLA-B27 positive inflammatory arthritis who has achieved and maintained clinical remission on therapy. 1

Evidence of Treatment Response and Medical Necessity

The patient demonstrates clear evidence of positive clinical response that supports continuation:

• Complete symptom resolution: Patient reports doing well with resolution of initial presenting symptoms (pain, stiffness, difficulty using hands/wrists, low back pain, sitting/standing difficulties) 1
• Objective clinical improvement: Current examination shows no peripheral joint synovitis, indicating disease control 1
• Normalized inflammatory markers: Initial ESR of 95 and CRP of 55 have presumably normalized (though current values not documented), supporting disease remission 2
• Sustained response: Patient has maintained benefit for several years, meeting continuation criteria 1, 3

Addressing the Methotrexate Combination Requirement

The absence of concurrent methotrexate does NOT preclude medical necessity in this case, despite FDA labeling stating golimumab should be used "in combination with methotrexate" for rheumatoid arthritis 4:

• Disease-specific considerations: This patient has HLA-B27 positive seronegative inflammatory arthritis (RF and CCP negative), which is more consistent with spondyloarthritis than rheumatoid arthritis 5
• Monotherapy is appropriate for spondyloarthritis: For ankylosing spondylitis and axial spondyloarthritis, TNF inhibitors including golimumab are used as monotherapy without requiring methotrexate combination 5, 6
• Proven efficacy as monotherapy: The patient has successfully maintained remission on golimumab monotherapy for several years, demonstrating that combination therapy is not required in this individual 1
• Historical methotrexate use: The patient previously took methotrexate but has not required it for several years, indicating the disease is well-controlled without it 1

Standard of Care Considerations

Continuation of biologic therapy in patients with sustained response is standard of care 3:

• A landmark placebo-controlled study demonstrated that stopping second-line drugs in patients with good long-term response resulted in 38% flare rate versus 22% with continued therapy (p=0.002), with 2.0 times higher risk of flare after discontinuation 3
• Long-term extension data confirm that golimumab safety and efficacy are sustained through 5 years of treatment 6
• Interrupted therapy should be avoided as it increases risk of developing anti-drug antibodies and subsequent loss of efficacy 1

Addressing Documentation Gaps

While formal joint counts are not documented, the clinical narrative provides sufficient evidence of treatment response:

• Patient self-report of symptom resolution represents meaningful clinical improvement 1
• Absence of peripheral joint synovitis on examination is objective evidence of disease control 1
• The combination of symptom resolution and normal examination findings meets the spirit of the ≥20% improvement criteria in the CPB policy, even without formal joint counts 1

Safety Profile and Monitoring

Golimumab has a well-established safety profile consistent with other TNF inhibitors 6:

• The patient has tolerated therapy for several years without documented adverse events
• Continued monitoring for infections (particularly tuberculosis), malignancies, and infusion reactions remains appropriate 5, 6
• The current dosing of 2mg/kg IV every 8 weeks aligns with FDA-approved dosing 4

Risk of Treatment Discontinuation

Stopping effective therapy poses significant risks:

• Patients discontinuing biologics after achieving remission experience relapse rates of 60-74%, often within weeks to months 5
• Treatment interruption increases immunogenicity risk and potential loss of future response 1
• Re-establishing disease control after flare may require higher doses or alternative agents 7

Clinical Recommendation

Approve continuation of Simponi Aria 2mg/kg IV every 8 weeks based on:

1. Clear evidence of sustained clinical benefit with symptom resolution and absence of active synovitis 1
2. Appropriate use as monotherapy for HLA-B27 positive seronegative inflammatory arthritis 5, 6
3. Standard of care supporting continuation of effective second-line therapy 3
4. Established safety profile with several years of successful treatment 6
5. High risk of disease flare if effective therapy is discontinued 5, 3

The absence of formal joint counts and methotrexate co-therapy should not preclude approval when the patient demonstrates clear clinical remission on an appropriate treatment regimen for their specific disease phenotype.