Clinical Policy: Golimumab (Simponi, Simponi Aria)
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Defines medical necessity, prior authorization, and coverage criteria for golimumab (Simponi and Simponi Aria) for Ambetter Georgia Medicaid members across labeled indications and continuation therapy.
For RA, added specific diagnostic criteria for definite RA, baseline CDAI score requirement, and decrease in CDAI score as positive response to therapy.
For UC, added requirement for Mayo score of at least 6 and revised redirection from AZA/6-MP/ASA to systemic corticosteroids.
Added dose rounding guidelines for Simponi and Simponi Aria.
PsA, AS, UC: clarified that the request must be for Simponi (and Simponi Aria where applicable); UC requests are limited.
Coverage Criteria
Initial Therapy
Covered when ALL of the following for the specific indication are met (each indication is its own criteria group):
Approval duration: 6 months
Approval duration: 6 months
Approval duration: 6 months
Approval duration: 6 months
Approval duration: 6 months
Continuation Therapy
Covered when ALL of the following for continuation requests are met:
Approval duration: 12 months
Other Indications / Off-label
Approval duration for other indications: 6 months or as specified
Extracted coverage criteria elements (partial)
Coverage elements and clinical thresholds referenced in appendices (partial extract)
Appendix E indicates Mayo Score 6-12 supports medical justification
Appendix H; requirement added in 2Q 2020 review
Appendix J dosing table
Appendix J and Appendix F
Coverage criteria (summary)
Covered when ALL of the following are met (policy-level summary):
See indication-specific criteria
2Q 2020 revision added baseline CDAI and CDAI decrease as response
2Q 2020 revision
Refer to indication nodes for details
Prescribing and redirection rules apply
Non–FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request includes sufficient clinical documentation to meet the Ambetter Georgia off‑label use requirements. Providers seeking coverage for an off‑label diagnosis must follow the referenced off‑label use policy CP.PMN.53 (Medicaid) or submit evidence of coverage documents that demonstrate safety and efficacy for the requested indication.
There are no listed contraindications in the appendix; however, golimumab carries boxed warnings for serious infections and malignancy. These boxed warnings should be considered when evaluating medical necessity and prior authorization requests.
Administrative updates to the policy removed the HIM line of business. This is a non‑clinical, administrative change and does not alter clinical coverage criteria or disease‑specific requirements.
Coding listed in this policy is for informational use only. Inclusion or exclusion of codes does not guarantee coverage; providers must ensure that claims and requests meet the clinical criteria described in the policy and follow current professional coding guidance prior to submission.
Use of prior redirections that were removed from the policy, or failure to meet indication‑specific diagnostic thresholds (for example, documented disease scores required by the indication), may render a request not medically necessary. Requests that do not document required prior trials, specialty verification, or the applicable diagnostic/score thresholds may be denied as not medically necessary.
Initial Therapy Criteria
Initial Therapy
Initial therapy requires meeting indication-specific criteria including diagnosis, prescriber specialty, age limits, prior therapy trials, baseline disease activity scores where specified, and dose limits.
See Sections I and Appendices G-J
Specialty requirements noted in Section I
See Section I for indication-specific prior therapy requirements
Appendices H, J, and E
Appendix J and Section I
Initial therapy dosing
Appendix J; Section I.D
Appendix J; Section I A-C
Section I; Appendix J
Appendix J; Section I.E
Initial therapy
Initial therapy authorization depends on indication-specific prior therapies and baseline scores.
Section I.D; Appendix E
Section I.A; Appendix H
Continuation Therapy Criteria
Continuation Therapy
Continuation approvals require evidence of positive response and adherence to maximum dosing limits.
Approval duration typically 12 months
Continuation / response documentation
Continuation therapy expectations referenced via disease activity improvement
Appendix D, H, J
Continuation therapy
Continuation requires documented improvement and adherence to response criteria where specified.
2Q 2020 revision
Step Therapy and Redirection
| Indication | Required prior trials/failures before golimumab | Notes / duration |
|---|---|---|
| Rheumatoid arthritis (RA) | Failure of a ≥3 month trial of methotrexate (MTX) at maximally indicated doses OR if MTX intolerant/contraindicated, failure of a ≥3 month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine), AND failure of at least TWO of the following each used ≥3 months unless contraindicated: Enbrel, Kevzara, Xeljanz/Xeljanz XR. | Approval duration: 6 months; concomitant use with MTX or another DMARD required if tolerated; baseline CDAI or RAPID3 required. |
| Ankylosing spondylitis (AS) | Failure of at least TWO NSAIDs each used ≥4 weeks unless contraindicated, AND failure of at least TWO of the following each used ≥3 months unless contraindicated: Cimzia, Enbrel, Taltz. | Approval duration: 6 months; dosing limits per product (Simponi 50 mg SC monthly or Simponi Aria 2 mg/kg IV induction then q8w). |
| Polyarticular juvenile idiopathic arthritis (pJIA) | Failure of a ≥3 month trial of MTX at maximally indicated doses OR if MTX intolerant/contraindicated, failure of a ≥3 month trial of sulfasalazine or leflunomide, OR for sacroiliitis/axial disease failure of a ≥4 week NSAID trial; AND failure of both Enbrel and Xeljanz each used ≥3 months unless contraindicated. | Request must be for Simponi Aria; age ≥2 years; documented baseline cJADAS-10 required; approval duration: 6 months. |
| Psoriatic arthritis (PsA) | Step/failure requirements vary by indication history; preferred redirections updated (some redirections to etanercept and adalimumab were removed); see full policy for exact current comparator trial requirements. | Approval duration: 6 months; prescribing specialist requirement (dermatologist or rheumatologist) applies. |
| Ulcerative colitis (UC) | Documentation of Mayo Score ≥6 and failure of an 8-week trial of systemic corticosteroids (aminosalicylate added as an option for trial/failure); prior redirections/required trials revised—refer to policy for specifics. | Request must be for Simponi (SC); induction/maintenance dosing specified in policy; approval duration: 6 months. |
| Summary | Policy guidance / action |
|---|---|
| Step therapy specifics vary by indication and have been revised across historical reviews. | Refer to the full policy CP.PHAR.253 for the current, indication-specific step therapy requirements and exact comparator/redirection lists before approving golimumab. |
| Preferred redirections and comparator trials have been updated (examples include redirection to Enbrel, Kevzara, Xeljanz/Xeljanz XR or 2-of-3 lists for certain indications). | Confirm which redirections are required for the member's indication in the complete policy; coding and product-specific requirements (e.g., Simponi vs Simponi Aria) must also be verified. |
| Indication | Redirection / required alternatives before golimumab | Policy note |
|---|---|---|
| Rheumatoid arthritis (RA) | Policy specifies redirection to 2 of 3 agents: Enbrel, Kevzara, Xeljanz/Xeljanz XR (member must have failed two of these alternatives each used ≥3 months unless contraindicated). | RA redirection updated in policy history; additional RA diagnostic and baseline CDAI requirements apply. |
| Ankylosing spondylitis (AS) | Redirection updated to 2 of 3 alternatives: Enbrel, Cimzia, Taltz (failure of two alternatives each used ≥3 months unless contraindicated). | NSAID trial requirements also apply (failure of ≥2 NSAIDs each used ≥4 weeks) per indication specifics. |
| Psoriatic arthritis (PsA) | Policy removed some prior redirections to etanercept and adalimumab; consult full policy for the current required alternatives and whether redirection is required for the member's scenario. | PsA redirection rules were modified across reviews; verify pediatric age rules where applicable. |
Coding and Reference Codes
| J1602 | Injection, golimumab, 1 mg, for intravenous use |
| Enbrel | Preferred redirection biologic listed in policy (etanercept) |
| Kevzara | Preferred redirection biologic listed in policy (sarilumab) |
| Xeljanz/Xeljanz XR | Preferred redirection oral JAK inhibitor listed in policy (tofacitinib) |
| Cimzia | Preferred redirection biologic listed in policy (certolizumab) |
| Taltz | Preferred redirection biologic listed in policy (ixekizumab) |
| adalimumab | Previously used redirection for several indications; removed in some redirections per revisions |
| AZA, 6-MP, ASA | Agents referenced for UC redirection revised to systemic corticosteroids |
Provider Actions and Documentation Requirements
Prior authorization required
Prior authorization is required. Providers must demonstrate the member meets the indication-specific approval criteria and submit supporting documentation with the request.
- See indication-specific initial criteria (e.g., RA, PsA, AS, UC, pJIA) for required prior trials, specialty prescriber, age limits, baseline scores, and dose limits.
Include product and indication on PA
Specify the exact product formulation in the request (Simponi or Simponi Aria) and the clinical indication being treated; include relevant supporting clinical information.
- UC requests must be for Simponi (SC) per policy clarifications.
- Requests for IV Simponi Aria should note IV dosing and weight/BSA-based regimen where applicable.
Verify prior therapies and baseline scores
PA requests may be audited for prior therapies and baseline disease scores; include verification of prior regimen trials and baseline scores such as CDAI for RA or Mayo Score for UC.
- Document prior therapy trials/redirections per indication (e.g., MTX, specified biologics).
- Provide baseline CDAI or RAPID3 for RA and baseline Mayo Score for UC when required.
Required trials before approval
Many indications require documented trials and failures of specified agents before golimumab will be authorized; ensure trial durations and agents match policy requirements.
- RA: ≥3 months of MTX (or ≥3 months of one conventional DMARD if MTX intolerant) plus failure of at least two agents (Enbrel, Kevzara, Xeljanz) each used ≥3 months.
- pJIA: ≥3 months of MTX (or alternatives) or cJADAS-10 >8.5 as alternate pathway.
Historical step therapy notes — confirm current requirements
Policy history documents specific prior trial/redirection expectations (e.g., trials of Enbrel, Humira, other biologics) that have informed current step edits; confirm current required alternatives before submitting.
- Preferred redirections have changed over time (examples include redirection to 2 of 3: Enbrel, Kevzara, Xeljanz for RA).
- Refer to current policy sections for exact, up-to-date step requirements.
Step therapy and redirection preferences
Policy contains redirection/step preferences; document attempts of preferred alternatives or provide justification for why redirection was not appropriate.
- Examples of redirection: RA — redirection to 2 of 3 (Enbrel, Kevzara, Xeljanz/Xeljanz XR); AS — Enbrel, Cimzia, Taltz options.
- UC redirection updated from AZA/6‑MP/ASA to systemic corticosteroids or aminosalicylate options per revisions.
Submit supporting clinical documentation
Submit office chart notes, relevant lab results, and other clinical documentation demonstrating the member met all approval criteria with the prior authorization request.
- Include documentation of prior trial durations, intolerance/contraindication notes, and objective response measures (e.g., ESR/CRP changes).
Document required clinical scores and response
Document disease activity scores where required: Mayo Score for UC, CDAI (or RAPID3) for RA, and cJADAS-10 for pJIA; include examples of clinical response where applicable.
- UC: include Mayo Score (see Appendix E) and note if score is 6–12 (moderate to severe).
- RA: include baseline CDAI and subsequent decrease (CDAI ranges in Appendix H).
- pJIA: include baseline cJADAS-10; high disease activity defined as cJADAS-10 > 8.5.
Include baseline disease activity assessments
When baseline assessments are required, include those baseline scores in the PA (e.g., baseline CDAI for RA; baseline Mayo Score for UC) and reference prior trials per the indication.
- RA: baseline CDAI required per 2Q2020 revisions.
- UC: baseline Mayo Score must be documented (Mayo ≥6 supports moderate–severe disease).
- pJIA: baseline cJADAS-10 required for pediatric requests.
Risk of denial for missing documentation
Failure to submit the required clinical documentation (office notes, labs, disease scores, prior therapy details) supporting that the member met all approval criteria may result in denial of the request.
- Ensure all objective scores, trial durations, intolerance explanations, and prescriber specialty documentation are included with the PA.
Avoid coding/product mismatches
Requests may be denied for coding or product-specific mismatches; ensure the requested product matches the indication and that IV requests align with HCPCS J1602 for golimumab IV.
- Verify that UC requests are for Simponi (SC) as required by the policy.
- Use correct HCPCS (J1602) and indicate IV formulation when requesting Simponi Aria.
UC severity must be documented (Mayo ≥6)
For ulcerative colitis, include a documented Mayo Score ≥ 6; lack of a Mayo Score ≥6 may lead to denial.
- Appendix E defines Mayo Score and notes that a score of 6–12 indicates moderate to severe UC suitable for medical justification.
Noncompliance with redirection may cause denial
Noncompliance with policy redirection preferences or failure to document prior trials of required redirected agents may trigger coverage denial or step edits; document attempts or provide clinical justification.
- If redirection to preferred biologics was not attempted, include clinical rationale (contraindication, intolerance, or inappropriateness).
- Policy revisions updated preferred redirections; confirm and document compliance with current redirection list.
Quantity Limits and Dosing
Site of Care and Product Presentation
Order by or consult appropriate specialty
Prescriptions must be by or in consultation with the appropriate specialty provider per indication (rheumatologist, dermatologist, gastroenterologist) as specified in the initial approval criteria.
- RA, AS, pJIA: prescribed by or in consultation with a rheumatologist.
- PsA: consultation with dermatologist or rheumatologist.
- UC: prescribed by or in consultation with a gastroenterologist/gastrointestinal specialist.
Document product presentation and administration setting
Be prepared to document product presentation and administration setting: Simponi is available as SC prefilled syringes/SmartJect autoinjector; Simponi Aria is supplied as single-use IV vials and administered in an appropriate infusion setting.
- Simponi: single-dose prefilled SmartJect autoinjector and prefilled syringes (50 mg, 100 mg).
- Simponi Aria: single-use 50 mg/4 mL vial for IV administration.
No explicit site-of-care restriction stated
The policy does not impose an explicit site-of-care restriction in the provided sections; follow indication-specific guidance and standard administration site practices.
Background
Golimumab (Simponi, Simponi Aria) is a TNF blocker indicated for inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), and certain juvenile arthritis indications such as polyarticular juvenile idiopathic arthritis (pJIA). The policy aligns product‑specific presentations (SC and IV) with indication‑appropriate dosing, prescriber specialty, and baseline/response assessments (e.g., CDAI, cJADAS‑10, Mayo Score) when determining medical necessity.
Definitions and Scoring Systems
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