Prior authorization validity

Prior authorization is required. Initial approvals are provided for 6 months (180 days); renewals may be authorized every 12 months (365 days) thereafter when renewal criteria are met.

Prior authorization recommended per NQTL checklist

Per the NQTL Factor Checklist, prior authorization should be considered for golimumab products because indication, safety/efficacy, and drug cost were identified as factors to consider for PA.

Include a covered diagnosis with PA

Submit a covered ICD-10 diagnosis from Appendix 1 with prior authorization requests to support medical necessity for golimumab.

Prior authorization requires a listed Appendix 1 diagnosis

Prior authorization and coverage requests must reference a supported ICD-10 diagnosis listed in Appendix 1; only diagnoses enumerated in the appendix are accepted for coverage consideration.

Step therapy requirements by indication

Document required step therapy trials and failures per indication before requesting authorization; specific minimum trial durations and agents are specified by condition.

• Rheumatoid arthritis: ≥3-month trial and failure of ONE csDMARD (or already on biologic/targeted synthetic therapy).
• Psoriatic arthritis: ≥4-week trial of ONE NSAID for axial disease OR ≥3-month trial of ONE csDMARD for peripheral disease (or already on biologic/targeted synthetic therapy).
• Ankylosing spondylitis: failure of at least TWO NSAIDs over 4 weeks total (or already on biologic/targeted synthetic therapy).
• pJIA: ≥1-month trial and failure of NSAIDs OR csDMARDs (unless contraindicated) (or already on biologic/targeted synthetic therapy).

Perform and document required baseline screenings

Follow universal criteria screening prior to initiation and document results in the medical record.

• Confirm member age meets indication-specific minimums (e.g., ≥2 years for PsA and pJIA; otherwise ≥18 years unless specified).
• Document HBV and latent TB screening prior to initiating therapy.

Confirm absence of concurrent biologic therapy and vaccination plan

Ensure member is not on concurrent biologic or targeted synthetic therapy and confirm live vaccines will not be administered while on golimumab.

• Document absence of active infection and plan to avoid live vaccines during therapy.
• Document that no concurrent biologic or targeted synthetic therapy is prescribed.

Document ICI-related toxicity criteria

For management of immune checkpoint inhibitor–related toxicities, document inability to taper corticosteroids after one week and membership on immune checkpoint inhibitor therapy.

• Record that the member is receiving an immune checkpoint inhibitor and has moderate or severe immunotherapy-related inflammatory arthritis.
• Document attempts to taper corticosteroids and inability to do so after one week.

Documentation required for PA requests

Include member age, a baseline disease severity assessment using an objective measure/tool, and prior therapy trials and failures in the prior authorization or medical record documentation.

• Baseline objective disease assessment (e.g., DAS28, BASDAI, JADAS, etc.).
• Record of prior medications and documented trial durations and reasons for failure or intolerance.

Billing codes and NDC documentation

Use HCPCS codes J1602 (golimumab, 1 mg IV) and J3590 (unclassified biologics for Immgolis INTRI) as applicable on claims, and include the appropriate NDC for the product billed.

• J1602 — Injection, golimumab, 1 mg (1 billable unit = 1 mg).
• J3590 — Unclassified biologics (Immgolis INTRI only).
• Include NDC: Simponi ARIA 57894-0350-xx or Immgolis INTRI 69448-0029-xx as applicable.

Required diagnosis coding (use Appendix 1)

Record an appropriate ICD-10 diagnosis from Appendix 1 on the claim and in the medical record to support medical necessity for golimumab.

• Appendix 1 lists covered ICD-10 codes (M05.*, M06.*, M08.*, M45.*, L40.*, etc.) that must be used to justify coverage.

Support PA/claims with Appendix 1 diagnosis documentation

Ensure documentation supports one of the ICD-10 codes listed in Appendix 1 when requesting prior authorization or submitting claims for golimumab.

• Include specific code and description from Appendix 1 in the medical record and PA request.

Denial risks for missing screenings or age noncompliance

Prior authorization may be denied if the member does not meet age requirements, or if required HBV or latent TB screening was not performed prior to initiation, or if an active infection or concurrent biologic therapy is present.

• Denial risk if member is under the indicated age for the condition.
• Denial risk if HBV or latent TB screening results are absent from documentation.
• Denial risk if active infection exists or concurrent biologic/targeted synthetic therapy is being used.

PA consideration and potential denial if not obtained

Because the NQTL checklist identified indication, safety/efficacy, and cost as considerations, PA will be considered and lack of PA where required may result in denial.

• PA is applied due to indication, safety/efficacy concerns, and drug cost per the NQTL assessment.

Diagnosis code mismatch may trigger denial

Claims or PA requests that do not include one of the covered ICD-10 codes listed in Appendix 1 may be subject to denial for lack of an accepted diagnosis to support golimumab coverage.

Ensure compliance with Medicare NCDs/LCDs/LCAs where applicable

For Medicare beneficiaries, comply with applicable Medicare NCDs, LCDs, and Local Coverage Articles (LCAs); failure to follow applicable CMS coverage determinations may affect coverage decisions.

• Medicare Part B covered diagnosis codes in this policy segment: N/A — check applicable NCD/LCD/LCA for local requirements.