Is Simponi Aria (golimumab) 2mg/kg at weeks 0, 4, and then every 8 weeks medically necessary and appropriate for a patient with rheumatoid arthritis (RA) who has not responded to other therapies, including Enbrel (etanercept), Methotrexate (MTX), Actemra (tocilizumab), Orencia (abatacept), Olumiant (baricitinib), and Rinvoq (upadacitinib)?

Medical Necessity Assessment for Simponi Aria in Treatment-Refractory Rheumatoid Arthritis

The request for Simponi Aria (golimumab IV) 2mg/kg at weeks 0,4, and every 8 weeks is NOT medically necessary as currently presented, due to critical deficiencies in documentation and failure to meet standard-of-care requirements for biologic therapy in rheumatoid arthritis.

Critical Deficiencies That Preclude Approval

1. Inadequate Methotrexate Trial Documentation

The discontinuation of methotrexate for "toxicity issues" without documented trial of subcutaneous administration represents a fundamental gap in standard care. 1

• Methotrexate remains the anchor drug for RA and should be part of the first treatment strategy, with optimal dosing at 20-25 mg weekly (or approximately 0.3 mg/kg) 1
• If oral methotrexate causes intolerance, subcutaneous administration should be attempted before abandoning MTX altogether, as it has higher bioavailability and potentially fewer gastrointestinal side effects 2
• The FDA label for Simponi Aria explicitly states it should be given "in combination with methotrexate (MTX)" for rheumatoid arthritis 3
• No documentation indicates whether subcutaneous MTX was attempted or whether the patient reached optimal therapeutic dosing before discontinuation 2

2. Absence of Validated Disease Activity Measures

Documentation of disease activity using validated measures such as DAS28-CRP or CDAI is necessary to establish moderate-to-severe disease and meet medical necessity criteria. 2

• The appeal letter describes "active synovitis with evidence of joint damage" but provides no quantitative disease activity scores 2
• Without validated disease activity measures, it is impossible to determine if the patient meets criteria for moderate-to-severe active RA, which is required for biologic therapy 3

3. Questionable Rationale for TNF Inhibitor Switching

Switching from one TNF inhibitor (Enbrel/etanercept) to another TNF inhibitor (Simponi Aria/golimumab) without documented failure of the current agent contradicts standard practice. 2

• The letter states the patient "recently had resumed [Enbrel] but not having any significant improvement," but provides no documentation of adequate trial duration, dosing, or objective measures of treatment failure 2
• After failure of a first TNF inhibitor, switching to a biologic with a different mechanism of action (such as tocilizumab, abatacept, or rituximab) may be more appropriate than switching to another TNF inhibitor 4
• The patient has already failed Actemra (tocilizumab), Orencia (abatacept), Olumiant (baricitinib), and Rinvoq (upadacitinib), making the rationale for returning to TNF inhibitor therapy unclear 2

4. Structural Joint Damage Considerations

The presence of "evidence of joint damage" suggests end-stage structural damage that is unlikely to be reversed by switching biologics. 2

• Biologics prevent progression of structural damage but do not reverse established damage 2
• These findings may indicate the need for orthopedic surgical evaluation rather than biologic therapy escalation 2

Standard-of-Care Requirements Not Met

Methotrexate Combination Therapy Requirement

For rheumatoid arthritis, Simponi Aria must be used in combination with methotrexate according to FDA labeling and clinical guidelines. 3, 1

• The FDA indication specifically states: "SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis" 3
• Golimumab should be continued in combination with methotrexate according to ACR guidelines 1
• Population pharmacokinetic analysis shows that concomitant MTX use does not significantly influence golimumab clearance, but combination therapy is standard practice 3

Leflunomide as Alternative to Methotrexate

The plan to start leflunomide in conjunction with Simponi is mentioned but represents a deviation from standard practice without adequate justification. 1

• In cases of MTX contraindications or early intolerance, leflunomide or sulfasalazine should be considered as alternatives 1
• However, no documentation indicates that subcutaneous MTX was attempted before abandoning this anchor drug 2
• Leflunomide can be used in combination with biologics, but this represents a second-line approach when MTX cannot be used 1

Required Documentation for Medical Necessity

Complete DMARD Trial History

Complete documentation of prior DMARD trials, responses, and reasons for discontinuation is essential for medical necessity determination. 2

The following must be documented:

• Methotrexate trial details: 2

  • Maximum dose achieved (should be 20-25 mg weekly or 0.3 mg/kg) 1
  • Route of administration (oral vs. subcutaneous) 2
  • Duration of trial at maximum tolerated dose (minimum 3 months) 1
  • Specific toxicity that led to discontinuation 2
  • Whether subcutaneous administration was attempted if oral caused intolerance 2

• Enbrel (etanercept) trial details: 2

  • Duration of most recent trial 2
  • Dosing regimen (should be 50 mg weekly or 25 mg twice weekly) 2
  • Objective disease activity measures before and after treatment 2
  • Reason for inadequate response 2

• Prior biologic failures: 2

  • Documentation of adequate trials of Actemra, Orencia, Olumiant, and Rinvoq 2
  • Reasons for discontinuation of each agent 2
  • Disease activity measures during each trial 2

Validated Disease Activity Assessment

Current disease activity must be documented using validated instruments rather than relying solely on symptom descriptions. 2

Required measures include:

• DAS28-CRP or DAS28-ESR score 2
• Clinical Disease Activity Index (CDAI) or Simplified Disease Activity Index (SDAI) 2
• Swollen and tender joint counts 2
• Patient global assessment 2
• Physician global assessment 2

Alternative Treatment Considerations

Non-TNF Biologic Options

Given the patient's extensive treatment history including TNF inhibitor failure, switching to a biologic with a different mechanism of action may be more appropriate. 4

• After failure of a first TNF inhibitor, patients may switch to another TNF inhibitor or to a biologic with a different mechanism of action 4
• The patient has already failed tocilizumab (IL-6 inhibitor) and abatacept (T-cell costimulation modulator) 2
• Rituximab (B-cell depleting agent) demonstrated effectiveness in the REFLEX trial, with significantly more patients achieving ACR20 (RR 2.85) and ACR70 (RR 12.14) compared to placebo at 6 months 4

JAK Inhibitor Reconsideration

The patient has failed two JAK inhibitors (Olumiant/baricitinib and Rinvoq/upadacitinib), but the reasons for failure are not documented. 5

• Upadacitinib 15 mg demonstrated superiority to adalimumab in ACR50 response rate, DAS28-CRP ≤3.2, pain severity, and HAQ-DI in patients with inadequate response to MTX 6
• In patients refractory to biologic DMARDs, upadacitinib was superior to abatacept in achieving remission (30.0% vs. 13.3%) 7
• Documentation of why these agents failed would inform whether alternative dosing or rechallenge might be appropriate 5

Common Pitfalls to Avoid

Do Not Approve Without MTX Optimization

Do not approve switching between TNF inhibitors without documented failure of the current TNF inhibitor with adequate trial duration and dosing. 2

• The current appeal does not document adequate trial of Enbrel or optimization of methotrexate therapy 2
• Approving Simponi Aria without addressing these deficiencies perpetuates suboptimal care 2

Ensure Disease Activity Measurement

Ensure that disease activity is measured with validated instruments rather than relying solely on symptom descriptions. 2

• "Active synovitis" is insufficient documentation without quantitative measures 2
• Validated disease activity scores are required to establish moderate-to-severe disease 2

Address Structural Damage Appropriately

Recognize that established joint damage may require orthopedic intervention rather than biologic escalation. 2

• Biologics prevent progression but do not reverse structural damage 2
• Orthopedic consultation should be considered for established joint damage 2

Recommendation for Denial and Required Information

Deny the current request and require the following information before reconsideration:

1. Methotrexate optimization documentation: 2

   • Trial of subcutaneous methotrexate at optimal dosing (20-25 mg weekly) for minimum 3 months 1, 2
   • If truly contraindicated, detailed documentation of specific contraindication 2

2. Current disease activity assessment: 2

   • DAS28-CRP or CDAI score 2
   • Complete joint counts and patient/physician global assessments 2

3. Enbrel trial documentation: 2

   • Duration, dosing, and objective measures of treatment failure 2
   • Rationale for switching to another TNF inhibitor rather than different mechanism 2

4. Complete prior treatment history: 2

   • Documentation of adequate trials and reasons for failure of all prior biologics and JAK inhibitors 2

Only after these deficiencies are addressed can medical necessity for Simponi Aria be appropriately evaluated. 2, 3