Is intravenous golimumab (Simponi) infusion medically necessary for a patient with moderately to severely active rheumatoid arthritis (M06.9) who has not responded to previous treatments, has a history of arthritis, and is considering switching to golimumab 2mg/kg at weeks 0 and 4, then every 8 weeks thereafter?

Medical Necessity Determination: Intravenous Golimumab for Rheumatoid Arthritis

Based on the available documentation, intravenous golimumab (Simponi ARIA) on the date of service does NOT meet medical necessity criteria due to multiple critical documentation gaps, despite the patient having moderately to severely active RA with inadequate response to prior therapy.

Critical Missing Documentation Elements

The case fails to meet the insurer's clinical policy requirements on several mandatory criteria:

1. Tuberculosis Screening - NOT DOCUMENTED

• Prior to initiating golimumab, patients must have documented negative tuberculosis testing (tuberculin skin test or interferon-gamma release assay) within 12 months of therapy initiation 1
• This is a mandatory safety requirement that cannot be waived - the FDA label explicitly requires TB evaluation before starting therapy due to risk of reactivation of latent tuberculosis 1
• The case summary contains no evidence of TB screening being performed

2. Methotrexate Combination Therapy - UNCLEAR/NOT DOCUMENTED

• For rheumatoid arthritis, golimumab IV must be prescribed in combination with methotrexate unless the patient has a documented clinical contraindication or intolerance to methotrexate 1
• The EULAR guidelines specify that biologics should be commenced with MTX in patients responding insufficiently to conventional DMARDs 2
• While the provider's note mentions planning "PA for golimumab infusions 2mg/kg at week 0,4 and every 8 weeks thereafter," there is no documentation that methotrexate will be prescribed concurrently
• The medication list from the most recent visit does not clearly establish current methotrexate use

3. Prior Biologic Therapy Documentation - INCOMPLETE

• The insurer requires documentation that the patient "previously received a biologic or targeted synthetic drug indicated for moderately to severely active rheumatoid arthritis"
• While the case mentions the patient was "previously on [MEDICATION]" and that "RA seems to be worsening," the specific biologic agent is redacted and there is insufficient detail about:
  • Which specific biologic was used
  • Duration of therapy
  • Documented inadequate response or intolerance
• The EULAR guidelines support switching to golimumab after failure of a first TNF inhibitor 2, but this must be clearly documented

4. Baseline Disease Activity Measures - ABSENT

• For continuation of therapy approval, the insurer requires documentation of baseline disease activity to later assess "at least 20% improvement in tender joint count, swollen joint count, pain, or disability"
• No baseline quantitative disease activity measures are documented (no tender joint count, swollen joint count, DAS28, CDAI, or SDAI scores)
• The Mayo Clinic guidelines emphasize using validated disease activity measures like SDAI or CDAI to guide treatment decisions 2

Clinical Appropriateness Despite Documentation Gaps

Evidence Supporting Golimumab Use in This Clinical Scenario

If proper documentation were present, golimumab would be clinically appropriate:

• The patient has moderately to severely active RA with documented worsening despite 4.5 months of prior therapy, including "increase in stiffness/swelling in the wrists, left ankle/foot, shoulders" [@case summary@]
• Golimumab 2 mg/kg IV at weeks 0,4, and every 8 weeks is the FDA-approved dosing regimen for RA 1
• Clinical trials demonstrate that golimumab effectively reduces signs and symptoms of RA in patients with inadequate response to prior DMARDs 3, 4
• In the GO-AFTER study, 35-38% of patients with active RA who had previously received TNF inhibitors achieved ACR20 response with golimumab versus 18% with placebo 5
• Among patients receiving golimumab plus methotrexate who had prior TNF inhibitor exposure, 40.8% achieved ACR20 response at week 24 6

Disease Severity Justifies Biologic Therapy

• The patient's clinical presentation with persistent synovitis in multiple joints despite conventional therapy indicates moderate to severe disease activity requiring escalation to biologic therapy 2
• The EULAR guidelines recommend adding a biologic DMARD when poor prognostic factors are present and the treatment target is not achieved with conventional DMARDs 2

Required Actions for Approval

To establish medical necessity, the following documentation must be obtained and submitted:

1. TB Screening Results:

   • Tuberculin skin test (TST) or interferon-gamma release assay (IGRA) performed within 12 months
   • If positive, documentation of chest X-ray ruling out active TB and initiation of latent TB treatment if indicated 1

2. Methotrexate Co-Administration Plan:

   • Clear documentation that methotrexate will be prescribed concurrently with golimumab
   • If methotrexate cannot be used, documented contraindication or intolerance (e.g., hepatotoxicity, cytopenias, intolerable side effects) 1

3. Prior Biologic Therapy Details:

   • Specific name of prior biologic agent(s)
   • Duration of therapy (minimum adequate trial typically 3-6 months) 2
   • Documentation of inadequate response (persistent disease activity) or intolerance

4. Baseline Disease Activity Assessment:

   • Tender joint count (TJC) and swollen joint count (SJC)
   • Patient global assessment and/or pain score
   • Preferably a composite measure (DAS28, CDAI, or SDAI) 2
   • This establishes the baseline for measuring future treatment response

5. Hepatitis B Screening:

   • While not explicitly mentioned in the case summary, the FDA label requires testing for hepatitis B viral infection prior to initiating golimumab 1

Safety Monitoring Requirements

Once approved and initiated, the following monitoring is essential:

• Assess disease activity at 3 and 6 months using validated measures to ensure ≥20% improvement in TJC, SJC, pain, or disability for continuation approval [@insurer criteria@]
• Monitor for signs/symptoms of infection during and after treatment, including possible TB reactivation even in patients who tested negative initially 1
• Do not use golimumab concomitantly with other biologic DMARDs or targeted synthetic DMARDs [@insurer criteria@]

Common Pitfalls to Avoid

• Assuming prior authorization approval without complete documentation - insurers strictly enforce all criteria elements, particularly TB screening and methotrexate co-administration requirements
• Failing to obtain quantitative baseline disease activity measures - without these, continuation approval cannot be granted as improvement cannot be objectively assessed
• Not documenting specific reasons for prior therapy failure - vague statements like "RA worsening" are insufficient; need specific clinical parameters
• Overlooking mandatory safety screening - TB and hepatitis B testing are non-negotiable requirements before initiating any TNF inhibitor 1