Is continuation of Simponi Aria (golimumab) medically necessary for a patient with rheumatoid arthritis when unable to determine if there is an improvement of at least 20% from baseline?

Medical Necessity Determination for Simponi Aria Continuation

Continuation of Simponi Aria is NOT medically necessary in this case because the patient's clinical response cannot be adequately assessed due to medication non-adherence, and the current presentation suggests confounding factors (possible DVT, medication discontinuation) rather than true treatment failure.

Critical Assessment Issues

Inability to Determine Treatment Response

• The patient discontinued methotrexate approximately 2.5 months ago and has not been adherent to his medication regimen, making it impossible to assess whether the combination therapy (Simponi Aria + methotrexate) was truly effective or whether current symptoms represent disease flare versus other pathology 1

• Aetna's continuation criteria explicitly require "disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability" - this cannot be determined when the patient has been off his anchor DMARD (methotrexate) for 2.5 months 2

• The bilateral lower extremity swelling may represent DVT recurrence (given history of left leg DVT and 2 months off Coumadin) rather than purely rheumatoid disease activity, as no ultrasound has been performed to rule this out 2

Baseline Disease Control Was Adequate

• Prior to medication discontinuation, the patient stated "this combination was working well for him", indicating the Simponi Aria + methotrexate regimen was achieving adequate disease control 3

• Laboratory trends show improvement: ESR decreased from 74 to 30-32, and CRP decreased from 15.9 to 2.1-4.4, suggesting the biologic therapy was effective when combined with methotrexate 3, 4

Recommended Management Strategy

Immediate Steps Required

• Restart methotrexate 8 tablets weekly (as ordered) and allow 12-16 weeks to reassess true disease activity on the combination regimen before determining if Simponi Aria continuation meets medical necessity criteria 1, 3

• Obtain stat lower extremity ultrasound to rule out DVT and re-establish Coumadin immediately, as bilateral lower extremity swelling in a patient with DVT history off anticoagulation requires urgent evaluation 2

• Optimize methotrexate dosing to 20-25 mg weekly (current dose appears to be 20 mg based on "8 tabs"), which aligns with ACR recommendations for adequate DMARD optimization before continuing biologic therapy 3, 4

Reassessment Timeline

• The American College of Rheumatology recommends assessing disease activity every 1-3 months during active disease, with therapy adjustment if no improvement by 3 months or target not reached by 6 months 1, 3

• After restarting methotrexate, the patient should be reassessed at 8-12 weeks with objective measures including tender joint count, swollen joint count, and inflammatory markers (ESR, CRP) to determine if ≥20% improvement from current baseline is achieved 1, 2

Critical Pitfalls in This Case

Confounding Medical Issues

• The patient's A1C was initially >17% after 6 months of prednisone, now improved to 8% on insulin - steroid-induced diabetes may have contributed to poor adherence and overall clinical deterioration 3

• Prednisone has been continued for 6 months, which after 1-2 years carries risks (cataracts, osteoporosis, cardiovascular disease) that outweigh benefits, necessitating the taper as ordered 3

Medication Non-Adherence Pattern

• The patient ran out of methotrexate 2.5 months ago and has not refilled it, also stopped Coumadin for 2 months despite DVT history - this pattern suggests adherence barriers that must be addressed before continuing expensive biologic therapy 2

• Biologic monotherapy (Simponi Aria without methotrexate) is less effective than combination therapy and increases risk of anti-drug antibody formation, potentially explaining the apparent loss of efficacy 1, 5

Evidence-Based Rationale

ACR/EULAR Treatment Principles

• The 2021 ACR guidelines emphasize that biologic DMARDs should be combined with conventional synthetic DMARDs (particularly methotrexate) for optimal efficacy in moderate-to-high disease activity RA 1, 3

• Treatment targets should be remission (SDAI ≤3.3 or CDAI ≤2.8) or low disease activity (SDAI ≤11 or CDAI ≤10), assessed with standardized measures rather than subjective symptoms alone 3, 4

Golimumab-Specific Evidence

• Clinical trials of golimumab (GO-FORWARD, GO-BEFORE) demonstrated efficacy when combined with methotrexate, with sustained ACR20 responses in 57-67% of patients through long-term follow-up 5, 6, 7

• The GO-AFTER study showed that even in patients who failed prior TNF inhibitors, golimumab maintained efficacy through 160 weeks when adherence was maintained 6

Final Determination

Medical necessity cannot be established at this time. The appropriate course is to:

1. Restart methotrexate and optimize adherence to the combination regimen 1, 3
2. Rule out alternative causes of lower extremity swelling (DVT) 2
3. Reassess in 8-12 weeks with objective disease activity measures to determine if ≥20% improvement is achieved, meeting Aetna's continuation criteria 1, 2
4. If disease activity remains moderate-to-high despite optimized methotrexate + Simponi Aria after 3-6 months, consider switching to a different mechanism of action rather than continuing ineffective therapy 1, 4