CurrentmhnPolicy CP.PHAR.253

Golimumab (Simponi, Simponi Aria)

Defines medical necessity criteria, initial and continuation approval rules, dosing limits, excluded combinations, and diagnostic requirements for golimumab (Simponi, Simponi Aria) across indications (AS, pJIA, PsA, RA, UC) for Medicaid lines of business affiliated with Centene.

Policy Summary

Payermhn

PolicyGolimumab (Simponi, Simponi Aria)

Policy CodePolicy CP.PHAR.253

Change TypeRevisions and SDC updates (material and non-material)

Effective Date07.16

Next Review DateN/A

Key ActionProvider must submit documentation (office notes, labs, scores) supporting that the member has met all approval criteria, including baseline CDAI or RAPID3 for RA and disease severity scores for UC.

SourceLink

POLICY UPDATE CHANGES

Multiple annual reviews updated criteria, added preferred adalimumab products, added agents to exclusion list, and updated therapeutic alternatives.

Removed redirection to preferred adalimumab products for UC based on 2024 AGA guidelines and added modified Mayo Score ≥ 5 option for initial UC criteria (2Q 2025).

Added preferred Stelara biosimilar requirement for PsA and UC (Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma) (04.23.25 SDC).

Added multiple adalimumab product examples as preferred (Yusimry, Hadlima, adalimumab-fkjp, adalimumab-adaz, adalimumab-adbm, Simlandi, adalimumab-aaty) across updates.

Removed HCPCS code J3490 and added HCPCS code J3590 (2Q 2025).

For pJIA, removed cJADAS-10 > 8.5 and baseline 10-joint documentation requirements and removed requirement to document response by decrease in cJADAS-10 for continued therapy.

Extended initial approval durations to 12 months for chronic conditions and allowed bypass to conventional therapies when member has failed a biologic for AS, pJIA, RA, and UC.

Reflected pediatric age extension for UC per product labeling and allowed Otezla XR in place of Otezla for PsA (RT4 updates 2026).

Updated appendices and section III.B with several newly available biologic products and biosimilar verbiage (Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, Velsipity, Spevigo).

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5Covered Indications (AS, pJIA, PsA, RA, UC)

12 monthsTypical approval duration

NoCombination with bDMARDs/JAKi allowed

J3590HCPCS new code added

>=5modified Mayo Score threshold

Coverage Summary

Overview: This policy (CP.PHAR.253) defines medical necessity criteria for golimumab (Simponi, Simponi Aria) and is effective 07.16 with last review 05.26. Coverage stance: covered_with_criteria. Covered indications include ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA), rheumatoid arthritis (RA), and ulcerative colitis (UC). Typical initial and continued approval duration for chronic indications is 12 months. The policy requires indication‑specific diagnostic and severity documentation, stepwise failure of conventional therapies and specified biologics/JAK inhibitors before approval in many settings, and prohibits combination use with other bDMARDs or JAK inhibitors.

Key thresholds and quick facts

Age for AS/RA>= 18 years

Age for pJIA>= 2 years

Pediatric weight threshold for UC>= 15 kg

Mayo Score (UC) threshold>= 6

Modified Mayo Score (UC) threshold>= 5

Mayo Endoscopic Score (UC) threshold>= 2

Initial approval duration12 months

Medical-Necessity Criteria

Continued Therapy / Renewal Criteria

ALL of the following

Eligibility: Member has active prescription or previous approval for Simponi or Simponi Aria for an FDA-approved or policy-covered indication;
Evidence of clinical response to therapy as documented in chart notes (e.g., improvement in disease activity scores, reduction in symptoms, or objective improvement on endoscopy/imaging where applicable);
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors (see Section III: Diagnoses/Indications for which coverage is NOT authorized);
Dose increases: Requests for dose escalation above policy-specified maximum dosing must include documentation of inadequate response to maximum approved doses and rationale for increase;

Policy Modifications & Selected Updates

Material changes and SDC updates summary: Revision history reflects iterative updates from 02.21.22 through 07.23.24 and ongoing SDC updates. Key modifications include clarifying bypass rules to allow members who have failed a biologic to bypass conventional therapies for AS, pJIA, RA, and UC, and an extension of initial approval durations to 12 months. UC initial criteria were updated in 2Q 2025 to add modified Mayo Score ≥ 5 as an acceptable severity metric and to revise redirection logic: redirection to Zeposia was modified to allow bypass when prior bDMARD or JAKi failure is documented, and later SDCs removed mandatory Zeposia redirection and added options to step through preferred adalimumab or preferred ustekinumab products. Preferred‑product list updates added multiple adalimumab examples (e.g., Yusimry, Hadlima, Simlandi, adalimumab‑fkjp/adaz/adbm/aaty) and, per 04.23.25 SDC, added a requirement in PsA and UC to use one preferred Stelara biosimilar (Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma). Administrative updates included coding changes replacing HCPCS J3490 with J3590 and other appendix/therapeutic alternative updates.

Ulcerative colitis (UC) initial criteria updates (selected extracts)

Policy-level statements and modifications reflected in the document:

Acceptable disease severity documentation (one of): Added option: Modified Mayo Score >= 5; OR Mayo Score >= 6; OR Mayo Endoscopic Score >= 2 (Mayo Endoscopic Score > 2 option added in later SDC)
See Appendix E for definitions and supplemental info

Coding

Billing Rule

HCPCS code change

Providers: report J3590 for unclassified SC golimumab instead of J3490 per recent coding updates. Also ensure disease activity documentation is submitted when requesting authorization for ulcerative colitis (Mayo Score ≥6, modified Mayo ≥5, or Mayo Endoscopic Score ≥2) and for polyarticular JIA (documentation of high disease activity and ≥5 joints with active arthritis).

Affected codes: J3590 (use for SC Simponi billing); J1602 (IV Simponi Aria infusion billing)
Documentation requirements: UC — include Mayo Score (total or modified) or Mayo Endoscopic Score per policy Appendix E; pJIA — document number of active joints (≥5) and evidence of high disease activity as required by criteria.

Provider Actions & Operational Guidance

Documentation Required

Support documentation required

Submit office chart notes, relevant laboratory results, and clinical scores to demonstrate the member meets approval criteria. For rheumatoid arthritis, provide baseline CDAI or RAPID3 assessment. For ulcerative colitis, supply disease severity documentation (Mayo Score, modified Mayo Score, or Mayo Endoscopic Score) as specified in the criteria.

Office notes supporting diagnosis and prior therapy failures
Relevant labs (e.g., CRP, ESR) and other clinical data
Baseline CDAI or RAPID3 for RA
Mayo, modified Mayo, or Mayo Endoscopic scores for UC

Prior Authorization

Prior authorization for referenced comparators

Prior authorization may be required for comparator products referenced in the indication-specific criteria. Examples called out in the policy include adalimumab products, Actemra (tocilizumab), Taltz (ixekizumab), Otezla/Otezla XR (apremilast), ustekinumab products, and Xeljanz/Xeljanz XR (tofacitinib) depending on the indication and redirection/step rules.

Background & References

Background: Golimumab (Simponi, Simponi Aria) is a TNF blocker with FDA approvals for RA, PsA, AS, pJIA, and UC as reflected in the policy indications. The coverage criteria align authorization to pivotal trials and specialty guidelines and require stepwise failure of conventional DMARDs (e.g., methotrexate) and specified biologics or JAK inhibitors prior to approval in many indications. The brief references the product prescribing information as evidence: Simponi Prescribing Information (October 2025) and Simponi Aria Prescribing Information (April 2025) as primary sources for dosing, indications, and safety.

Reference	Date
Simponi Prescribing Information	October 2025
Simponi Aria Prescribing Information	April 2025

Definitions: bDMARD = biological disease‑modifying antirheumatic drug; DMARD = disease‑modifying antirheumatic drug; CDAI = Clinical Disease Activity Index; RAPID3 = Routine Assessment of Patient Index Data 3; JAKi = Janus kinase inhibitor; modified Mayo Score = clinical scoring system for ulcerative colitis disease activity (policy accepts ≥ 5 as an initial‑criteria threshold).

Revision History

02.21.22revision

2Q 2022 annual review: iterative updates including added redirections (e.g., PJIA redirection to Actemra, RA redirection to Olumiant), added bypass language and clarified redirection application; template changes applied and combination-use prohibition reiterated. Part of the revision span 02.21.22 through 07.23.24.

07.23.24update

Per SDC updates through 07.23.24: added additional preferred adalimumab examples (Simlandi, unbranded adalimumab-aaty) to preferred product lists and updated Appendix B therapeutic alternatives. This entry reflects ongoing iterative updates within the 02.21.22 through 07.23.24 span.

01.23.25

Policy Summary

Payermhn

PolicyGolimumab (Simponi, Simponi Aria)

Policy CodePolicy CP.PHAR.253

Change TypeRevisions and SDC updates (material and non-material)

Effective Date07.16

Next Review DateN/A

SourceLink

On This Page

Dose increase limits: Do not exceed dosing schedules in Appendix F and indication-specific dose caps in the Initial Approval Criteria;

Approval duration: 12 months

Continued Therapy / Renewal Criteria (Additional Notes)

ALL of the following

Combination use: Coverage is NOT authorized for concomitant use of Simponi or Simponi Aria with other biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) such as tofacitinib, baricitinib, upadacitinib, or others;
Non‑authorized diagnoses/uses: Coverage is NOT authorized for indications or uses not listed as covered in this policy (including investigational or off‑label uses) unless otherwise approved by the pharmacy clinical policy team;
Adalimumab product redirection: Where policy criteria require trial or failure of an adalimumab product, members should try preferred adalimumab products first (examples include Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) unless there is documented intolerance, contraindication, or prior failure of two TNF blockers;
General coverage modifications and therapy bypass: Some formulary-level coverage modifications, quantity limits, or therapy bypass programs may apply. Prior authorization may be required for select comparator agents (e.g., adalimumab products, ustekinumab products, Actemra, Taltz, Otezla, Xeljanz/Xeljanz XR). Providers should consult plan-specific preferred product lists and formulary guidance;
Appendix and coding updates: Refer to Appendix D (clinical contraindications/intolerances), Appendix E (UC scoring), Appendix F (dose rounding guidelines), Appendix G (RA criteria), Appendix H (CDAI), and Appendix I (RAPID3) for operational definitions and required documentation. Ensure coding uses current ICD-10 and NDC/CPT/HCPCS codes per the latest coding bulletin;
See Section I notes for indication-specific prior authorization requirements and Appendix references.

Zeposia redirection/bypass rule (historical and revised): Originally: member must use Zeposia unless history of failure of a bDMARD or JAKi per 2024 AGA guideline; later SDC removed mandatory Zeposia redirection and allowed option to step through preferred adalimumab or preferred ustekinumab products; bypass allowed when prior bDMARD or JAKi failure documented

Per revision history: 2Q2025 and 04.23.25 SDC updates

Additional UC initial criteria options: Per later SDC updates: removed redirection to preferred adalimumab products due to 2024 AGA guidance; added option for Mayo Endoscopic Score > 2; added step options through preferred Stelara biosimilars for PsA and UC in 04.23.25 SDC

Adalimumab products (multiple preferred examples listed in policy appendices)
Actemra (tocilizumab)
Taltz (ixekizumab)
Otezla / Otezla XR (apremilast)
Ustekinumab products (Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek)
Xeljanz / Xeljanz XR (tofacitinib)

Denial Risk

Combination therapy denial risk

Combination use of golimumab with other biological DMARDs or JAK inhibitors is explicitly excluded by the policy and claims for concurrent use will not be authorized; such combinations present additive immunosuppression and increased infection/neutropenia risk and will result in denial.

Combination with other bDMARDs (e.g., other TNF antagonists, interleukin agents, anti‑CD20 agents, integrin antagonists, etc.) is not authorized
Combination with JAK inhibitors (e.g., Xeljanz, Rinvoq, Olumiant, etc.) is not authorized

Documentation Required

Response documentation for continued therapy

For continued therapy providers must document member response. For RA this means a decrease in CDAI or RAPID3 from baseline. If a CDAI re-assessment cannot be performed, submit medical justification and a RAPID3 score that is similar to or improved from the initial CDAI assessment. For other indications provide clinical justification of positive response per the continued therapy criteria.

For RA: decreased CDAI or RAPID3 from baseline
If CDAI cannot be reassessed: medical justification plus RAPID3 similar to or improved from baseline
For other indications: clinical documentation of positive response

Billing Rule

Dose rounding guidance

Follow Appendix F dose rounding guidelines and vial quantity recommendations for IV golimumab (Simponi Aria) when preparing doses; the policy provides rounding bands and vial recommendations to guide dosing and minimize waste.

See Appendix F for dose rounding bands and vial quantity recommendations for IV dosing
Apply rounding rules when determining number of 50 mg/4 mL vials for Simponi Aria IV doses

Prior Authorization

Use of Zeposia redirection and bypass rules for UC

The policy history includes redirection to Zeposia for UC with a bypass allowance: members were required to use Zeposia unless they had documented failure of a bDMARD or a JAK inhibitor per the 2024 AGA–based rationale. Later SDC updates removed mandatory Zeposia redirection and allowed stepping through preferred adalimumab or preferred ustekinumab products or use of preferred Stelara biosimilars for UC depending on the update.

2Q2025: Zeposia redirection required with bypass if prior bDMARD or JAKi failure (per 2024 AGA rationale)
04.23.25 SDC: removed mandatory Zeposia redirection; allowed step through preferred adalimumab or preferred ustekinumab products
UC initial criteria still accept Mayo / modified Mayo / Mayo Endoscopic scoring as disease severity documentation

Step Therapy

Step therapy / preferred agent requirements

Step therapy and preferred-agent requirements are specified in the policy. For PsA and UC, the policy added a requirement to use one preferred Stelara biosimilar (examples: Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma). The policy also lists preferred adalimumab product examples used in redirection/step rules and allows bypass of adalimumab when history of failure of two TNF blockers is documented.

Preferred Stelara biosimilars for PsA and UC: Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma
Preferred adalimumab examples listed in policy appendices (e.g., Yusimry, Hadlima, Simlandi, adalimumab-fkjp, adalimumab-adaz, adalimumab-adbm, adalimumab-aaty)
Bypass allowed if member has history of failure of two TNF blockers

Prior Authorization

Initial approval duration

Initial approval durations for chronic conditions were extended to 12 months in the policy revisions; providers should request initial authorizations reflecting a 12‑month approval where appropriate.

Initial approval duration for approved chronic indications: 12 months
Request initial authorization durations accordingly

2Q 2025 annual review: added option to accept modified Mayo Score ≥ 5 for UC disease severity documentation, removed redirection to preferred adalimumab products for UC per 2024 AGA guidance, revised Zeposia redirection to allow bypass when member has history of failure of a bDMARD or JAKi, removed HCPCS J3490 and added J3590, and removed prior pJIA cJADAS-10 > 8.5/baseline 10-joint requirements (pJIA alignment).

04.23.25material_addition

April SDC (04.23.25): added requirement to use one preferred Stelara biosimilar for PsA and UC (examples: Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma), removed mandatory Zeposia redirection, and added step-through option via preferred adalimumab or preferred ustekinumab products for UC.

08.05.25update

August 2025 SDC: added option for Mayo Endoscopic Score > 2 to define UC severity and applied pediatric step therapy adjustments for PsA (Otezla pediatric extension).

02.??.25 (2Q 2025 coding update)coding_change

Removed HCPCS code J3490 and added HCPCS code J3590 for reporting subcutaneous golimumab (coding implication recorded in the 2Q 2025 review).

04.23.25 (SDC)product_list_change

Across updates, multiple adalimumab product examples were added to preferred lists (examples include Yusimry, Hadlima, adalimumab-fkjp, adalimumab-adaz, adalimumab-adbm, Simlandi, adalimumab-aaty). These preferred-product additions affected redirection/step rules.

02.21.22 through 07.23.24iterative_revision_span

Multiple annual reviews and SDC updates occurred iteratively from 02.21.22 through 07.23.24, collectively updating redirections, preferred-product examples, step therapy rules, appendices, and template clarifications; no single isolated material clinical policy change is limited to one date within this span.

05.26.26administrative_updateLatest

2Q 2026 annual review: no significant clinical policy changes; allowed Otezla XR to be used in place of Otezla for PsA per RT4 updates and continued the policy state with prior SDC changes (this represents the latest documented update).