Defines prior authorization requirements, coverage criteria, and limitations for Simponi subcutaneous (golimumab) for inflammatory conditions under Cigna-administered health plans.
Change TypeMaterial revisions to Ulcerative Colitis initial therapy criteria
Effective Date11/15/2025
Next Review Date
Key ActionObtain prior authorization; initial approvals require prescription by or in consultation with a specialist and documentation of age/weight and prior treatment or objective measures as specified per indication.
Ulcerative Colitis initial therapy criteria were changed: removed prior options requiring trial of one systemic therapy and certain pouchitis treatments.
Ulcerative Colitis initial therapy age requirement modified: removed ≥18 years requirement and added weight requirement of ≥15 kg.
New policy created.
4FDA-approved indications listed
6 moInitial approval duration
1 yrRenewal duration
IP0667
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Policy Number
Coverage Criteria for Simponi (golimumab) Subcutaneous
Ankylosing Spondylitis (FDA-approved)
Approve for the duration noted if the patient meets ONE of the following (A or B):
Ankylosing Spondylitis - A or B
A) Initial Therapy
Patient is ≥ 18 years of age;
The medication is prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving Simponi (Subcutaneous or Aria)
Patient has been established on therapy for at least 6 months;
ANY of the following
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers such as C-reactive protein or erythrocyte sedimentation rate).
Compared with baseline (prior to initiating Simponi), patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living).
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Psoriatic Arthritis (FDA-approved)
Approve for the duration noted if the patient meets ONE of the following (A or B):
Psoriatic Arthritis - A or B
A) Initial Therapy
Patient is ≥ 18 years of age;
The medication is prescribed by or in consultation with a rheumatologist or a dermatologist.
B) Patient is Currently Receiving Simponi (Subcutaneous or Aria)
Patient has been established on therapy for at least 6 months;
ANY of the following
Rheumatoid Arthritis (FDA-approved)
Approve for the duration noted if the patient meets ONE of the following (A or B):
Rheumatoid Arthritis - A or B
A) Initial Therapy
Patient is ≥ 18 years of age;
Patient has tried one conventional synthetic disease-modifying antirheumatic drug (DMARD) for at least 3 months (examples include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception: if the patient has already had a 3-month trial with at least one biologic other than the requested drug, the conventional synthetic DMARD trial may be waived; biosimilars do not count toward this exception.
The medication is prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving Simponi (Subcutaneous or Aria)
Ulcerative Colitis (FDA-approved)
Approve for the duration noted if the patient meets ONE of the following (A or B):
Ulcerative Colitis - A or B
A) Initial Therapy
Patient weighs ≥ 15 kilograms (kg);
The medication is prescribed by or in consultation with a gastroenterologist.
B) Patient is Currently Receiving Simponi (Subcutaneous or Aria)
Patient has been established on therapy for at least 6 months;
ANY of the following
Spondyloarthritis, Other Subtypes (Supportive evidence)
Approve for the duration noted if the patient meets ONE of the following (A or B):
Other Spondyloarthritis - A or B
A) Initial Therapy
Patient is ≥ 18 years of age;
ANY of the following
Patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet AND has tried at least one conventional synthetic DMARD (examples include methotrexate, leflunomide, sulfasalazine).
Patient has axial spondyloarthritis AND has objective signs of inflammation defined as either (1) elevated C-reactive protein beyond the laboratory upper limit of normal or (2) sacroiliitis reported on magnetic resonance imaging.
Simponi (golimumab) subcutaneous for any use not specifically listed in the FDA‑approved or supportive‑evidence indications is considered not medically necessary. The policy lists excluded uses explicitly, and this list may be updated as new evidence becomes available.
Concurrent administration of Simponi subcutaneous with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and should not be prescribed. The policy explains this prohibition is due to increased adverse‑event risk and lack of controlled data demonstrating additive benefit. (This exclusion does not apply to concomitant use of conventional synthetic DMARDs such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine.)
Ulcerative colitis pediatric weight threshold>= 15 kg
Provider Actions and Prior Authorization Requirements
Prior Authorization
Prior Authorization Required
Prior Authorization Required — Initial approvals require prescription/consult by a specialist and prior authorization for Simponi Subcutaneous. All approvals are provided for the duration listed in the policy. Because of the specialized skills required for evaluation and diagnosis of patients treated with Simponi Subcutaneous as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Simponi Subcutaneous to be prescribed by or in consultation with a physician who specializes in the condition being treated.
Preferred product requirement: use preferred products per the referenced Inflammatory Conditions Preferred Specialty Management Policies (PSM001, PSM002, PSM017) prior to approval; exceptions and additional criteria are detailed in those policies.
Note
Appendix Association
Associated with Policy IP0667 — appendix lists drugs, mechanisms, formulations, and example indications used for reference in prior authorization processes. The appendix does not contain authorization or denial criteria.
Background on Simponi (golimumab)
Simponi (golimumab) subcutaneous is a tumor necrosis factor inhibitor (TNFi) approved for several inflammatory conditions, including ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis (in combination with methotrexate), and ulcerative colitis. TNFis are commonly used in clinical practice as targeted biologic therapies for these disorders and are listed in the policy appendix alongside other agents grouped by mechanism of action.
Definitions and Mechanisms
inv-22: Simponi (golimumab) subcutaneous
DrugSimponi (golimumab) subcutaneous
ClassTumor necrosis factor inhibitor (TNFi)
FormulationSubcutaneous injection
FDA-approved indications (examples)Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis (with methotrexate), Ulcerative colitis (adults and pediatric ≥15 kg)
inv-23: Mechanism of Action entries
Inhibition of TNFMechanism applies to TNF inhibitor biologics such as Simponi (golimumab)
Change TypeMaterial revisions to Ulcerative Colitis initial therapy criteria
Effective Date11/15/2025
Next Review Date
Key ActionObtain prior authorization; initial approvals require prescription by or in consultation with a specialist and documentation of age/weight and prior treatment or objective measures as specified per indication.
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID12, and/or serum markers such as C-reactive protein or erythrocyte sedimentation rate).
Compared with baseline (prior to initiating Simponi), patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, or fatigue; improved function or activities of daily living).
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Patient has been established on therapy for at least 6 months;
ANY of the following
Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples include CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI).
Patient experienced an improvement in at least one symptom compared with baseline (e.g., decreased joint pain, morning stiffness, fatigue, improved function or activities of daily living, decreased soft tissue swelling).
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When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers such as fecal calprotectin, serum markers such as C-reactive protein, endoscopic assessment, and/or reduced corticosteroid dose).
Compared with baseline (prior to initiating Simponi), patient experienced symptomatic improvement.
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The medication is prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving Simponi (Subcutaneous or Aria)
Patient has been established on therapy for at least 6 months;
ANY of the following
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS and/or serum markers such as C-reactive protein or erythrocyte sedimentation rate).
Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness or improved function).
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Appendix includes examples of biologics, IV/SC formulations, mechanisms of action, and targeted oral small molecules.
Appendix is for reference and does not replace clinical criteria in the main policy.
Step Therapy
Preferred Product Requirement
Preferred product requirement — Use of preferred products is required prior to approval per the referenced Inflammatory Conditions Preferred Specialty Management Policies. Refer to PSM001 (Employer Plans Standard/Performance, Value/Advantage, Total Savings), PSM002 (Individual and Family Plans), or PSM017 (Legacy Prescription Drug Lists) for specific preferred product criteria and exceptions.
Preferred product lists: PSM001, PSM002, PSM017.
Exceptions and step therapy details are in the respective PSM documents.
Note
Provider Actions — Appendix Note
Provider actions — The appendix pages list drugs, mechanisms, formulations, and example indications for reference; they do not include authorization or denial criteria. Providers must follow the main policy criteria for authorization and documentation requirements.
Do not rely on appendix content as authorization/denial criteria.
Submit requests with documentation per the policy's Initial and Continuation Therapy criteria.
Documentation Required
Initial Therapy Documentation
Initial therapy documentation — For initial approvals, include documentation demonstrating age/weight criteria and prescriber specialty, and prior treatment where applicable (for example, trial of one conventional synthetic DMARD for rheumatoid arthritis when required).
Ankylosing Spondylitis: patient ≥ 18 years and prescribed by or in consultation with a rheumatologist (initial therapy).
Rheumatoid Arthritis: patient ≥ 18 years, trial of one conventional synthetic DMARD for ≥3 months unless exception applies, and prescribed by or in consultation with a rheumatologist.
Ulcerative Colitis: patient ≥ 15 kg and prescribed by or in consultation with a gastroenterologist (initial therapy).
Documentation Required
Continuation Therapy Documentation
Continuation therapy documentation — For continuation approvals, document established therapy ≥ 6 months and provide objective evidence of benefit (e.g., validated disease activity scores, laboratory markers, endoscopic assessment, or symptom improvement compared with baseline).
Examples of objective measures: ASDAS, BASDAI, BASFI, CDAI, DAS28 (ESR or CRP), RAPID-3, SDAI, fecal calprotectin, CRP, ESR, endoscopic findings.
Continuation approvals typically granted for 1 year when criteria are met.
Denial Risk
Claims Coding and Denial Risk
Claims coding mismatch — Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. When billing, use the most appropriate codes as of the date of service.
Claims lacking covered diagnosis or procedure codes per the policy will be denied.
Providers must reference the policy's Coding Information section when submitting claims.
Denial Risk
Prohibited Combination Therapy
Prohibited combination therapy — Use of Simponi Subcutaneous in combination with another biologic or a targeted synthetic oral small molecule for an inflammatory condition is considered not medically necessary. This does not exclude concurrent use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).
Combination with other biologics or targeted synthetic oral small molecules is not covered.
Concomitant use of conventional synthetic DMARDs is permitted.
Mechanism for tocilizumab products (Actemra) and sarilumab (Kevzara)
Inhibition of IL-12/23Mechanism for ustekinumab products (Stelara)
Inhibition of JAK pathwaysMechanism for targeted oral therapies like upadacitinib (Rinvoq), tofacitinib (Xeljanz), baricitinib (Olumiant)
Sphingosine 1 phosphate receptor modulatorMechanism for oral agents such as ozanimod (Zeposia) and etrasimod (Velsipity)