Precertification Required for IV Golimumab

Precertification of intravenous golimumab (Simponi Aria) is required for all Aetna participating providers and applicable plan designs. Failure to precertify may result in denial of coverage. For precertification call (866) 752-7021 or fax (888) 267-3277. See Specialty Pharmacy Precertification forms for Statement of Medical Necessity (SMN).

• Precertification phone: (866) 752-7021; fax: (888) 267-3277
• Simponi Aria (IV) requires precertification
• Site of Care UM policy may apply for infusions

TB Testing and Prior Therapy Documentation

Document a negative tuberculosis (TB) test (PPD, IGRA, or chest x-ray) within 6 months of initiating golimumab for biologic/targeted-synthetic–naive persons. Record prior therapies and dates when submitting authorization requests.

• Acceptable TB tests: PPD, IGRA, or chest x-ray within 6 months
• Document prior conventional and biologic/targeted-synthetic therapies and dates

Required Clinical Documentation for Prior Authorization

Prior authorization requests must include required clinical documentation: diagnosis, prior DMARD use (including methotrexate) with dosing and duration, biomarker/test results where applicable (RF, anti-CCP, CRP/ESR), and rationale if methotrexate or leflunomide are not used.

• Document diagnosis and relevant ICD-10 code
• Document biomarker results: RF, anti-CCP, CRP and/or ESR
• If bypassing MTX/leflunomide, provide clinical reason per Appendix A

Prior Authorization: Evidence of Prior Methotrexate and Dosing

Prior authorization must document prior methotrexate therapy and dosing where required by indication (examples: RA — at least a 3-month trial with MTX titrated to ≥15 mg/week; pJIA — at least 2 months of MTX). If member previously received biologic or targeted synthetic drugs, document specifics.

• RA: inadequate response to ≥3 months of MTX at adequate dose (≥15 mg/week) or intolerance/contraindication
• pJIA: documented MTX for at least 2 months in the trial (GO-VIVA context)
• Document prior biologic/targeted-synthetic exposure when relevant

Therapy Trial Requirements

Therapy trial requirements apply across multiple indications: members must have trialed and had an inadequate response to or intolerance of specified conventional therapies (e.g., MTX, leflunomide, sulfasalazine, NSAIDs) before approval, unless a clinical reason to omit is documented.

• Document trials of conventional synthetic DMARDs (MTX, leflunomide, sulfasalazine) with dose and duration
• NSAID trials required for AS/nr-axSpA (typically ≥2 NSAIDs unless contraindicated)

Therapy Sequencing for Ulcerative Colitis

For ulcerative colitis (UC), sequencing rules require prior failure, intolerance, or corticosteroid dependence after oral aminosalicylates, oral corticosteroids, azathioprine, or 6‑mercaptopurine as described in FDA indication language. Document prior UC therapies and steroid dependence or inadequate response.

• UC dosing/induction for subcutaneous golimumab: 200 mg at Week 0, 100 mg at Week 2, then 100 mg every 4 weeks
• Document prior use/failure of aminosalicylates, corticosteroids, azathioprine, or 6‑MP

Coding and Claim Documentation

Coding and claim submission must use appropriate HCPCS/J-codes and CPT codes. Use HCPCS J1602 for intravenous golimumab (Simponi Aria) — Injection, golimumab, 1 mg (IV). Include infusion administration CPT/HCPCS (e.g., 96365-96368) and relevant testing codes (e.g., TB test, CRP, RF) on claims as applicable. Subcutaneous Simponi has no specific HCPCS J‑code.

• HCPCS J1602 = Injection, golimumab, 1 mg (Simponi Aria IV)
• Include infusion administration codes: CPT 96365-96368 as applicable
• Include diagnostic/testing codes: 86580/86480/86140/86200 etc. when documented

Infusion Dosing Documentation

Infusion dosing and schedule for Simponi Aria must be documented: weight-based 2 mg/kg IV over 30 minutes at weeks 0 and 4, then every 8 weeks for adults (RA/PsA/AS). For pJIA, document BSA-based dosing of 80 mg/m2 IV at weeks 0 and 4, then every 8 weeks. Document concurrent methotrexate when required and any concomitant medications.

• Adult IV dosing: 2 mg/kg IV over 30 minutes at weeks 0, 4, then every 8 weeks
• pJIA IV dosing: 80 mg/m2 IV over 30 minutes at weeks 0, 4, then every 8 weeks
• Document concomitant methotrexate unless clinical reason to avoid

Trial Population Considerations

Trial population considerations: note key trial exclusions or contexts that affect interpretation of prior therapy — e.g., some PsA trials excluded prior TNF-blocker exposure; GO-FURTHER RA trial required background methotrexate for ≥3 months. Document how the member's prior therapy and trial context align with clinical evidence.

• PsA pivotal trial excluded prior biologic TNF-blocker exposure — document prior biologic history
• GO-FURTHER RA trial required background MTX for ≥3 months — relevant when assessing evidence

Coverage-Code Matching

Coverage-code mismatches may lead to denial. Ensure the ICD-10 diagnosis code submitted matches a covered indication for the specific formulation (IV vs SC). For example, some ICD-10 codes are covered for Simponi Aria but not for Simponi and vice versa; use the ICD-10 lists provided and verify selection criteria are met.

• Verify ICD-10 code matches covered indication and formulation (IV vs SC)
• ICD-10 codes not covered for CPB-listed indications may trigger denial (e.g., Crohn's disease is not covered)

Administrative / Prior Authorization Notes

No additional prior authorization details are specified in this excerpt beyond the above requirements; administrative metadata and policy history are available in the document footer. For plan‑specific variations, confirm with the member's benefit plan.

• Policy effective date: 2009-07-10; last review 02/20/2024
• Plan-specific rules may vary — verify member benefits