CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Simponi Aria 2015 A Sgm P2023A

Defines prior authorization, clinical criteria, documentation requirements, prescriber specialties, duration of approval, continuation criteria, contraindications (e.g., active TB, concomitant biologics), and dosing limitation principles for Simponi Aria across RA, PsA, AS, nr-axSpA, JIA/pJIA, and immune checkpoint inhibitor-related inflammatory arthritis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi Aria 2015 A Sgm P2023A

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart notes, medical records, or claims history with biomarker/lab results for initial prior authorization and documentation of positive clinical response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

6Covered indications (FDA + compendial)

12 moTypical authorization

6 moTB test window (biologic‑naïve)

Coverage Summary

Simponi Aria (golimumab) is covered with criteria aligned to FDA-labeled indications and compendial uses for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), articular juvenile idiopathic arthritis (JIA/pJIA), and immune checkpoint inhibitor-related inflammatory arthritis. Prior authorization is required with documentation of prior therapies, applicable biomarkers, and clinical response. Approvals are generally for 12 months. Concomitant use of Simponi Aria with any other biologic or targeted synthetic drug for the same indication is prohibited. Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based practice guidelines.

Initial Therapy Criteria (by Indication)

Covered Indications (General)

The following FDA-approved indications and compendial uses are covered when all specified approval criteria are met and member has no exclusions to the prescribed therapy.

ALL of the following

Indication is one of the listed FDA-approved or compendial uses
See specific indication nodes for individual criteria
Member has no exclusions to the prescribed therapy

FDA-Approved Indications - Adult Rheumatoid Arthritis (RA)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member is an adult with moderately to severely active rheumatoid arthritis
Either biomarker criteria
- ONE of
  - Member has been tested and is positive for Rheumatoid factor (RF)
  - Member has been tested and is positive for anti-cyclic citrullinated peptide (anti-CCP)
- OR ALL of
  - Member has been tested for RF
  - Member has been tested for anti-CCP
  - Member has been tested for CRP and/or ESR
ALL of the following
- Member experienced inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (i.e., titrated to at least 15 mg/week)
- Member has intolerance or contraindication to methotrexate
  See Appendix A

FDA-Approved Indications - Psoriatic Arthritis (PsA)

Authorization of 12 months may be granted for members >=2 years when ONE of the following is met:

ANY of the following

Prior biologic requirement pathway
- Member is >=2 years of age
- Member has previously received a biologic or targeted synthetic drug indicated for active PsA (e.g., Rinvoq, Otezla)
Conventional therapy failure / severity criteria
- Mild to moderate disease - ONE of
  - Inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at adequate dose and duration

FDA-Approved Indications - Ankylosing Spondylitis (AS) and Non-radiographic Axial Spondyloarthritis (nr-axSpA)

Authorization of 12 months may be granted for adult members when ANY of the following is met:

ANY of the following

Member is an adult with active AS or active nr-axSpA
NSAID failure/intolerance
- Member experienced inadequate response to at least two NSAIDs
- Member has intolerance or contraindication to two or more NSAIDs

FDA-Approved Indication - Immune Checkpoint Inhibitor-Related Toxicity (Inflammatory Arthritis)

Authorization of 12 months may be granted when ANY of the following is met:

ANY of the following

Member has severe immunotherapy-related inflammatory arthritis and experienced inadequate response to corticosteroids
Member has severe immunotherapy-related inflammatory arthritis and has intolerance or contraindication to corticosteroids

Other Required Conditions (Pre-initiation and Concomitant Therapy)

For all indications, the following are required before initiating therapy:

ALL of the following

Documented negative tuberculosis (TB) test (TST or IGRA) within 6 months of initiating therapy for persons naïve to biologic or targeted synthetic drugs associated with increased TB risk
If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
Member cannot use Simponi Aria concomitantly with any other biologic or targeted synthetic drug for the same indication

Continuation / Renewal Criteria

Continuation/Renewal Criteria (All Indications)

Authorization of 12 months may be granted for members (including new members) who achieve or maintain a positive clinical response as evidenced below:

ANY of the following

RA continuation evidence
- Member achieves or maintains 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability
PsA continuation evidence
- Improvement in any of: number of swollen joints; number of tender joints; dactylitis; enthesitis; axial disease; skin and/or nail involvement; functional status; CRP
AS / nr-axSpA continuation evidence
- Improvement in any of: functional status; total spinal pain; inflammation (e.g., morning stiffness); swollen joints; tender joints; CRP
JIA continuation evidence
- Improvement in any of: number of joints with active arthritis; number of joints with limitation of movement; functional ability
Immune checkpoint inhibitor-related toxicity continuation evidence
- Achievement or maintenance of low disease activity or improvement in signs and symptoms of immunotherapy-related inflammatory arthritis

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization submission required

Submit chart notes, medical record documentation, or claims history supporting prior medications tried and the member’s response. For initial prior authorization requests include applicable biomarker and laboratory results (e.g., RF, anti-CCP, CRP/ESR) as indicated by the disease-specific criteria. For continuation/renewal requests, provide chart notes or medical record documentation demonstrating a positive clinical response to therapy.

Documentation Required

TB screening documentation required

Document a negative tuberculosis (TB) screening test (TST or IGRA) within 6 months prior to initiating therapy for persons naïve to biologic or targeted synthetic drugs associated with increased TB risk. If the TB screening test is positive, provide further testing to exclude active TB disease (e.g., chest x‑ray) and documentation that latent TB treatment was started prior to initiating the medication; do not administer therapy if active TB is present.

Prior Authorization

Prescriber specialty requirement

The medication must be prescribed by or in consultation with an appropriate specialist based on the indication: rheumatologist for RA, AS, nr‑axSpA, and articular JIA; rheumatologist or dermatologist for PsA; oncologist, hematologist, or rheumatologist for immune checkpoint inhibitor‑related inflammatory arthritis.

Documentation Required

Methotrexate combination requirement or documented clinical reason

For many adult indications, Simponi Aria should be prescribed in combination with methotrexate or leflunomide. If methotrexate or leflunomide is not used, document a clinical reason for avoidance as described in Appendix A (examples include chronic liver disease, drug interactions, pregnancy/planning pregnancy, breastfeeding, significant comorbidity, hypersensitivity, history of intolerance/adverse event).

Billing Rule

Dosing limits

Approvals may be subject to dosing limits that align with FDA‑approved labeling, accepted compendia, and evidence‑based practice guidelines.

Providers must submit relevant biomarker and laboratory results where applicable (e.g., RF, anti-CCP, CRP and/or ESR) and document prior drug trials including dose and duration — for example, methotrexate titrated to at least 15 mg/week when used prior to approval consideration.

OpenPayer

Simponi Aria 2015 A Sgm P2023A

Coverage Summary

Initial Therapy Criteria (by Indication)

Continuation / Renewal Criteria

Unproven Uses, Exclusions, and Contraindications

Provider Actions / Prior Authorization Requirements

Applicable Codes

Background & Clinical Evidence

Definitions / Appendices

Revision History