Prior authorization required; follow FDA dosing limits

Prior authorization is required for golimumab; approvals are subject to dosing limits consistent with FDA labeling and specialty medication quantity limits. Simponi Aria (IV) should be billed using HCPCS J1602 (injection, golimumab, 1 mg).

• Approvals subject to FDA-approved labeling, compendia, and Medical Specialty Medication Quantity Limits.
• Simponi Aria intravenous billing: J1602 (injection, golimumab, 1 mg).

PA must reflect FDA-approved and compendial indications

Submit PA requests that align with FDA-approved indications and recognized compendial uses (e.g., RA in combination with methotrexate; PsA; AS; UC in adults and pediatric patients ≥15 kg). Documentation may need to show prior therapy or inadequate response where applicable.

• Covered indications include RA (with MTX), PsA, AS, and UC (adult and pediatric ≥15 kg).
• Compendial/off-label uses (e.g., nr-axSpA) may be considered when supported by documentation of prior therapy failures.

Confirm indication and prior therapy in PA

PA must verify the specific indication matches FDA approvals or supported compendial uses and confirm prior treatment failures or contraindications per the trial/label context (for example, inadequate response to conventional therapy).

• Confirm indication (e.g., moderate-to-severe UC, RA, PsA, AS, pJIA) matches label or compendia.
• Verify prior treatments and documented inadequate response or contraindication when trials required prior therapy failures.

Document prior DMARD trials and rationale for biologic escalation

For RA, prior authorization should document attempted conventional DMARD therapy (including methotrexate) and the clinical rationale for escalation to a biologic when treatment targets were not met, consistent with guideline-recommended sequencing.

• Document trials of conventional DMARDs and reason for inadequate response or intolerance.
• Reference EULAR/ACR guidance supporting escalation from methotrexate to a TNF inhibitor when targets are unmet.

Follow plan-specific PA and administration guidance

Follow the Clinical Policy Bulletin and any plan-specific prior authorization processes listed; the bulletin is intended to assist in administering plan benefits and links to administrative notes and definitions.

• Use linked Clinical Policy Bulletin Notes and Definitions for plan-specific PA instructions.
• Policy history and review dates are provided for reference.

Document expected combination or sequence of therapies

Document combination therapy expectations per indication: for RA, golimumab is recommended in combination with methotrexate; for PsA or AS, golimumab may be given with or without methotrexate or other nonbiologic DMARDs.

• RA: Simponi/Simponi Aria should be given with methotrexate.
• PsA/AS: SC golimumab may be used with or without methotrexate or other nonbiologic DMARDs.

Require documentation of prior DMARD/NSAID therapy

PA should show trials of conventional DMARDs (including methotrexate) for RA and, where applicable, trials of two different NSAIDs for nr-axSpA before TNF inhibitor use, unless contraindicated.

• NICE guidance: trials of 2 DMARDs including methotrexate for RA unless contraindicated.
• nr-axSpA: compendia/UpToDate recommend inadequate response to two different NSAIDs used consecutively.

Document guideline-based sequencing with methotrexate first-line

Methotrexate is the preferred first-line DMARD for RA per guidelines; escalation to a TNF inhibitor such as golimumab should be documented when methotrexate monotherapy fails or is contraindicated.

• EULAR/ACR recommend methotrexate as preferred initial DMARD for RA.
• If targets not met within 3–6 months, escalation to a biologic DMARD is advised.

Document exceptions to step therapy and reference Appendix A

When bypassing step therapy (e.g., not using methotrexate first), providers must document clinical reasons or exceptions as listed in Appendix A (such as pregnancy, liver disease, allergy, or other contraindications).

• Appendix A lists acceptable clinical reasons to avoid methotrexate (e.g., pregnancy, liver disease, hypersensitivity).
• Documented rationale must accompany requests that do not follow standard step sequencing.

Refer to full policy for step therapy specifics when absent

If the policy text does not include specific step therapy algorithms for an indication, refer the reviewer to the full policy and linked Clinical Policy Bulletin Notes for plan-specific step therapy requirements and exceptions.

• Full policy and Clinical Policy Bulletin Notes contain administrative and step therapy specifics.
• Contact plan/PA reviewer for any insurer-specific step requirements not detailed in the excerpt.

Document dosing regimen and indication in the medical record

Provide documentation supporting the prescribed dosing regimen and indication: IV Simponi Aria dosing (2 mg/kg at weeks 0 and 4, then every 8 weeks) and SC Simponi dosing (50 mg monthly for RA/PsA/AS; UC induction/maintenance per label) must be clearly recorded.

• Simponi Aria IV: 2 mg/kg IV infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
• Simponi SC: 50 mg by subcutaneous injection once monthly for RA/PsA/AS; UC dosing per recommended table and weight tiers.

Perform and document TB screening and infection monitoring

Document latent tuberculosis testing before initiation and ongoing monitoring for active TB during treatment; TB testing within 12 months prior to starting a biologic should be in the record per CDC Quality ID #176.

• Perform and document TB screening within 12 months prior to initiating biologic therapy when indicated.
• If latent TB is positive, start TB treatment prior to initiating golimumab and monitor for active TB during therapy.

Document patient age, weight, and prior therapies

Include patient demographic and treatment history details in the PA: age, weight (especially for pediatric UC dosing thresholds ≥15 kg), prior therapies and whether the patient is TNF-alpha antagonist naive or experienced.

• Document patient age and weight; pediatric UC dosing applies to patients weighing at least 15 kg.
• Record prior therapies (e.g., MTX, corticosteroids, 6-MP, azathioprine) and prior TNF exposure status.

Include supportive references and prescribing information

Cite the prescribing information and guideline references included in the policy when submitting PA or medical record documentation to support dosing, prior therapy, and safety screening decisions.

• References and PI provide the basis for labeled dosing and safety monitoring expectations.
• Use cited guideline documents (ACR, EULAR, NICE) to justify sequencing and prior therapy requirements.

Reference policy history and review dates

Reference the policy history and review dates when needed; the document lists last review 07/31/2026 and next review 08/27/2026 for administrative context.

• Last review date: 07/31/2026; Next review: 08/27/2026.
• Use Clinical Policy Bulletin Notes and Definitions links for administrative details.

Denial risk: concomitant biologics or unproven IV uses

Requests for concomitant use of golimumab with another biologic or targeted synthetic agent for the same indication, or IV golimumab for indications listed as unproven, may be denied because these uses are considered experimental or investigational.

• Concomitant use with another biologic (e.g., adalimumab, etanercept) or targeted synthetic (e.g., tofacitinib) is considered experimental/investigational.
• IV golimumab is considered unproven for indications such as Crohn's disease, Behcet's disease, and non-infectious uveitis.

Denial risk if TB screening not documented before initiation

Initiating Simponi without documented latent TB testing within the prior 12 months or without TB screening documentation may increase the risk of coverage denial given the boxed warning and CDC Quality ID #176 recommendations.

• Policy and CDC guidance require TB screening documentation prior to starting biologic therapies with TB reactivation risk.
• Lack of TB testing documentation may trigger denial or request for additional information.

Denial risk for use outside FDA pediatric weight/indication

Use of subcutaneous Simponi in pediatric patients under 15 kg or other uses outside FDA-labeled pediatric weight/indication may be considered not medically necessary and risk denial if medical records do not support the off-label use.

• FDA pediatric UC approval applies to patients weighing at least 15 kg; PURSUIT data focused on ≥15 kg.
• Requests for dosing outside studied weight tiers should include robust supporting evidence.

Denial risk if safety-related documentation (serious infections/deaths) is absent

Failure to document safety screening and risk assessment (e.g., for serious infections reported in trials, including TB and reported deaths) may lead to denial or request for additional information before approval.

• IV golimumab trials reported increased infections, one TB case, and at least one death; safety screening documentation is expected.
• Documented infectious risk assessment and monitoring plans should be included in the record.

Clinical Policy Bulletins are administrative, not coverage guarantees

Clinical Policy Bulletins are administrative tools to assist in benefit management and do not constitute offers of coverage or clinical recommendations; providers remain responsible for treatment decisions and must follow plan provisions to avoid coverage issues.

• Bulletins contain only a partial description of plan benefits and are not a contract.
• Providers are solely responsible for medical advice and must adhere to plan prior authorization processes.