Is golimumab (Simponi Aria) infusion medically indicated for a patient with rheumatoid arthritis?

Medical Necessity Assessment for Golimumab (Simponi Aria) in Rheumatoid Arthritis

Golimumab infusion is NOT medically necessary for this patient based on the current documentation, as critical criteria required by evidence-based guidelines are not met.

Critical Missing Requirements

The FDA label explicitly states that SIMPONI ARIA must be given in combination with methotrexate for rheumatoid arthritis 1. The current documentation shows:

• No concurrent methotrexate use (Current Prednisone dose is 0 mg per day noted, but MTX status unclear/not documented as active) 1
• Patient has documented failure of methotrexate in the past, but this represents a contraindication that has not been properly addressed 2

The 2014 EULAR guidelines require ALL of the following before initiating biologic DMARDs 3:

• Inadequate response to conventional synthetic DMARDs (csDMARDs) for at least 3 months at optimal doses
• Documented moderate to severe disease activity using validated measures
• For RA specifically, combination with methotrexate unless contraindicated 3

Documentation Deficiencies Preventing Approval

Disease Activity Assessment

The case lacks validated disease activity scores required by guidelines 3:

• No Clinical Disease Activity Index (CDAI) score documented (threshold >10 required) 3
• No Disease Activity Score (DAS28) documented (threshold ≥3.2 required) 3
• No Simplified Disease Activity Index (SDAI) score documented (threshold >11 required) 3
• Tender joint count of 22/28 and swollen joint count of 0/28 are documented, but without formal scoring 3

Prior DMARD Trials

Documentation shows failure of sulfasalazine and methotrexate, but critical details are missing 3, 2:

• No documentation of duration of prior DMARD trials (3-month minimum at optimal doses required) 3
• No documentation of dosing used for failed DMARDs 3
• No documentation of reason for methotrexate failure (toxicity vs. inefficacy) 2

Tuberculosis Screening

While QFT is documented as negative, the date of last TB test needs verification that it meets the requirement for testing "prior to initiating SIMPONI ARIA and periodically during therapy" 1.

Hepatitis B Screening

No hepatitis B screening documented, which is explicitly required by FDA labeling before initiating golimumab 1.

The Methotrexate Requirement Issue

This is the most critical barrier to approval:

FDA-approved indication: Golimumab IV "should be given in combination with methotrexate" for RA 1. The 2014 EULAR guidelines state that biologic DMARDs should be combined with methotrexate or another csDMARD 3.

Current situation: Patient is on azathioprine 100 mg daily and Plaquenil (hydroxychloroquine), but these do not substitute for the methotrexate requirement in the FDA indication 1. The 2012 ACR guidelines note that when methotrexate is contraindicated, alternative csDMARDs can be used, but this must be explicitly documented 3.

Required documentation:

• Clear statement of methotrexate contraindication (neurotoxicity mentioned in history but not formally documented as ongoing contraindication) 2
• Justification for why current csDMARD combination (azathioprine + hydroxychloroquine) is insufficient 3
• Consideration of leflunomide as alternative anchor csDMARD if MTX truly contraindicated 3

Dosing Verification

The documented dose of 2 mg/kg every 8 weeks is FDA-approved for RA 1. At week 0 and 4, then every 8 weeks thereafter is the correct regimen 1.

What Would Make This Medically Necessary

To approve golimumab for this patient, documentation must include:

1. Formal disease activity score showing moderate to severe disease (CDAI >10, DAS28 ≥3.2, or SDAI >11) 3

2. Documented methotrexate contraindication with specific reason (e.g., neurotoxicity) and why it cannot be reintroduced 2, 1

3. Adequate trial documentation for failed DMARDs:

   • Sulfasalazine: dose, duration (≥3 months), reason for failure 3
   • Methotrexate: dose achieved, duration, specific toxicity 3
   • Current combination therapy inadequacy: duration on azathioprine + hydroxychloroquine at optimal doses 3

4. Hepatitis B surface antigen testing (HBsAg) results 1

5. Plan for concurrent csDMARD: Either restart methotrexate if contraindication can be managed, or document why current azathioprine/hydroxychloroquine combination serves as the anchor DMARD 3, 1

6. Poor prognostic features are present (RF positive, multiple joint involvement) which support biologic use, but must be combined with above requirements 3, 2

Clinical Context

The patient reports "doing well on Simponi Aria infusions" with pain reduced from 8/10 to 3-5/10, suggesting clinical response to ongoing therapy 3. However, this is infusion #21, indicating long-term use that should have been properly authorized initially. The 2012 ACR guidelines support continuation of therapy when patients demonstrate favorable response 3.

For continuation/subsequent course approval, the requirements are less stringent 2:

• Age ≥18 years (met) 3
• Favorable response to prior golimumab (appears met based on clinical notes) 2
• No active infection (appears met) 1
• No concurrent use of other TNF inhibitors (met) 1

Recommendation for Case Resolution

Request the following from the provider before approval:

1. Validated disease activity score (CDAI, DAS28, or SDAI) from recent visit
2. Formal documentation of methotrexate contraindication and why it cannot be used
3. Hepatitis B surface antigen test results
4. Detailed history of prior DMARD trials with doses and durations
5. Justification for golimumab without concurrent methotrexate, or plan to add methotrexate if contraindication can be managed
6. If this is continuation therapy (infusion #21 suggests ongoing treatment), document baseline disease activity and improvement achieved with golimumab 3, 2

The ancillary codes (96413, J2919, 96375) are appropriate if the primary golimumab administration is approved, as they represent standard infusion administration and premedication 1.