Is Simponi Aria (golimumab) every 6 weeks medically necessary for the treatment of arthropathic psoriasis, unspecified?

Medical Necessity Review: Simponi Aria Every 6 Weeks for Psoriatic Arthritis

Direct Answer

Based on the submitted documentation, the requested Simponi Aria (golimumab IV) every 6 weeks for psoriatic arthritis does NOT meet medical necessity criteria due to insufficient documentation of prior treatment failures and deviation from FDA-approved dosing intervals.

Critical Documentation Deficiencies

The case fails to meet Aetna's criteria on multiple fronts:

Missing Prior Treatment Documentation

• No evidence of inadequate response to conventional synthetic DMARDs: While methotrexate is listed as a current medication (prescribed 06/13/2025), there is no documentation of treatment duration, dosing adequacy, or therapeutic failure 1
• Insufficient biologic failure documentation: The allergy to ixekizumab (rash, swelling) documents intolerance but does not establish whether this was a biologic or targeted synthetic DMARD indicated for active PsA, nor does it document adequate trial duration 1
• No disease severity classification: Documentation lacks specification of whether disease is mild, moderate, or severe, which is required to determine appropriate treatment pathway 1

Dosing Interval Deviation

The requested every-6-week dosing contradicts FDA-approved labeling: The standard Simponi Aria regimen for psoriatic arthritis is 2 mg/kg at weeks 0,4, then every 8 weeks thereafter 2, 3, 4. The requested every-6-week interval represents off-label dosing without clinical justification provided in the documentation.

Required Documentation for Approval

To establish medical necessity, the following must be documented:

For Initial Biologic Approval (Age ≥2 years)

Option 1 - Prior Biologic/Targeted Synthetic Failure:

• Documentation that patient previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active PsA 1
• Evidence of adequate trial duration and dosing
• Documentation of treatment failure or intolerance

Option 2 - Conventional DMARD Failure (for mild-moderate disease):

• Clear documentation of disease severity classification
• Evidence of inadequate response to methotrexate, leflunomide, or sulfasalazine at adequate dose and duration 1
• For methotrexate specifically: trial of up to 25 mg weekly for at least 3 months 1
• OR documented contraindication/intolerance to these agents with specific clinical details

Option 3 - Severe Disease:

• Explicit documentation of severe disease classification
• Clinical justification for bypassing conventional DMARD trial 1

For Dosing Justification

• Clinical rationale for every-6-week dosing instead of FDA-approved every-8-week interval
• Documentation of inadequate disease control on standard dosing
• Evidence of disease flare pattern requiring shortened interval

Clinical Context and Evidence

Golimumab IV Efficacy in Psoriatic Arthritis

Golimumab IV demonstrates robust efficacy when dosed appropriately:

• PASI 75 response: Achieved in significantly more patients versus placebo through week 24 (P ≤ .0098) 2
• Nail psoriasis improvement: Mean mNAPSI improvement of -11.4 versus -3.7 with placebo (P < .0001) 2
• Quality of life: DLQI improvement of -9.8 versus -2.9 with placebo (P < .0001) 2
• Long-term maintenance: ACR20 responses maintained at 62.8-69.9% through 5 years with standard dosing 4

Treatment Sequencing Guidelines

Current guidelines establish clear treatment hierarchies:

• First-line for peripheral arthritis: NSAIDs and intra-articular corticosteroids 1
• Second-line: Conventional DMARDs (sulfasalazine, leflunomide, methotrexate) 1
• Third-line: TNF inhibitors for patients who fail at least one DMARD therapy 1
• Exception: Patients with poor prognosis or severe disease may proceed directly to TNF inhibitors 1

Recommendation for This Case

DENY the request as submitted with the following specific requirements for reconsideration:

1. Document methotrexate trial adequacy: Provide dates of initiation, dose escalation schedule, maximum dose achieved, duration at therapeutic dose (should be ≥3 months at 15-25 mg weekly), and specific reasons for inadequacy 1

2. Clarify ixekizumab use: Document whether this was prescribed for PsA (not just psoriasis), treatment duration, and whether intolerance occurred before adequate therapeutic trial

3. Establish disease severity: Provide objective measures (joint counts, PASI scores, functional assessments) to classify disease as mild, moderate, or severe

4. Justify dosing interval: Provide clinical rationale for every-6-week versus standard every-8-week dosing, including documentation of disease activity patterns

5. If approved, limit initial authorization to standard dosing: Approve 2 mg/kg every 8 weeks per FDA labeling 2, 3, with requirement for documented inadequate control before considering interval shortening

Alternative Consideration

If urgent treatment is warranted due to severe, rapidly progressive disease:

• Consider 3-month trial approval at standard every-8-week dosing with requirement for comprehensive documentation of prior treatments and disease severity within 30 days
• Require objective disease activity measures at baseline and 3 months to establish response
• This approach balances patient access with payer stewardship requirements 1