CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Simponi (golimumab) subcutaneous injection coverage policy

Defines clinical coverage criteria, prescriber requirements, documentation and continuation criteria for golimumab (Simponi) for FDA-approved indications (PsA, RA, AS, UC) and select compendial uses (immune checkpoint inhibitor-related inflammatory arthritis, non-radiographic axial spondyloarthritis) for adult members. Includes TB screening and concomitant therapy restrictions and dosing limit statement.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi (golimumab) subcutaneous injection coverage policy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart notes, medical records, or claims history documenting prior therapies and responses, biomarker testing (for RA initial requests), and for continuation requests documentation of positive clinical response.

POLICY UPDATE CHANGES

No material clinical/coverage changes to policy.

6Covered Indications (FDA + Compendial)

12 moTypical authorization duration

>=20%RA response threshold

Coverage Summary

Indications - Covered When All Approval Criteria are Met

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required with documentation

Submit chart notes, medical records, or claims history documenting prior therapies tried and responses. For initial RA requests include biomarker testing results (RF, anti-CCP, CRP and/or ESR) when applicable. For continuation requests provide chart notes or medical record documentation supporting positive clinical response. If a prior therapy is not advisable, include documentation of a clinical reason to avoid that therapy.

Chart notes, medical records, or claims history showing prior medications tried and response
RA initial: laboratory results or chart notes documenting RF, anti-CCP, CRP and/or ESR (if applicable)
Continuation: chart notes demonstrating positive clinical response
If therapy is not advisable, document clinical reason to avoid therapy

Documentation Required

TB screening documentation

Provide documentation of a negative TB screening test (PPD, IGRA, or chest X-ray) within 6 months prior to initiating golimumab for persons naive to biologic or targeted synthetic drugs. If TB screening is positive, submit further testing to exclude active TB; do not administer golimumab to members with active TB. If latent TB is identified, TB treatment must be started before initiating golimumab.

Negative TB test (PPD, IGRA, or chest X-ray) within 6 months for biologic/tsdm-naive members
If positive: additional testing to confirm no active TB
If latent TB: begin TB treatment before initiation
Do not administer golimumab for active TB

Prior Authorization

Prescriber specialty requirement

Golimumab must be prescribed by or in consultation with an appropriate specialist based on the treated indication: rheumatologist or dermatologist for psoriatic arthritis; rheumatologist for rheumatoid arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis; gastroenterologist for ulcerative colitis; and oncologist, hematologist, or rheumatologist for immune checkpoint inhibitor-related inflammatory arthritis.

Psoriatic arthritis: rheumatologist or dermatologist
Rheumatoid arthritis, ankylosing spondylitis, nr-axSpA: rheumatologist
Ulcerative colitis: gastroenterologist
Immune checkpoint inhibitor-related toxicity: oncologist, hematologist, or rheumatologist

Documentation Required

Continuation response documentation

For renewal requests, provide chart notes or medical record documentation demonstrating clinical improvement or low disease activity as specified for the indication (e.g., RA: ≥20% improvement from baseline in tender/swollen joint count, pain, or disability; PsA/AS/UC: improvement in the listed signs, symptoms, or disease activity measures).

RA continuation: ≥20% improvement from baseline in tender joint count, swollen joint count, pain, or disability
PsA continuation: improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, or skin/nail involvement
AS/nr-axSpA continuation: improvement in functional status, spinal pain, or inflammation (e.g., morning stiffness)
UC continuation: remission or improvement in rectal bleeding, stool frequency, fecal calprotectin, CRP, mucosal appearance, or disease activity scores
Immune checkpoint inhibitor-related toxicity: improvement or low disease activity in inflammatory arthritis signs/symptoms

Billing Rule

Concomitant therapy restriction

Do not administer golimumab concurrently with any other biologic drug or targeted synthetic drug for the same indication.

Concurrent use of golimumab with another biologic or targeted synthetic therapy for the same indication is prohibited

Continuation (Renewal) Criteria

Authorization of 12 months may be granted for members who achieve or maintain positive clinical response:

RA continuation: Member achieves or maintains positive clinical response evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.>= 20% improvement
PsA continuation: Member achieves or maintains low disease activity or improvement in signs and symptoms as evidenced by improvement from baseline in any of: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin and/or nail involvement.
AS / nr-axSpA continuation: Member achieves or maintains low disease activity or improvement in signs and symptoms as evidenced by improvement from baseline in any of: functional status, total spinal pain, inflammation (e.g., morning stiffness).
UC continuation: Member achieves or maintains remission or low disease activity as evidenced by improvement from baseline in any of: rectal bleeding, stool frequency, urgency of defecation, fecal calprotectin, C-reactive protein, appearance of mucosa on endoscopy/CTE/MRE/intestinal ultrasound, improvement on a disease activity scoring tool (e.g., UCEIS, Mayo score).
Immune checkpoint inhibitor-related toxicity continuation: Member achieves or maintains low disease activity or improvement in signs and symptoms of immunotherapy-related inflammatory arthritis.

Other Universal Requirements & Restrictions

Other Universal Requirements and Restrictions

Applies to all indications

TB testing: Member must have documented negative tuberculosis (TB) test (PPD, IGRA, or chest X-ray) within 6 months of initiating therapy for persons naive to biologic drugs or targeted synthetic drugs associated with increased TB risk. If TB screening is positive, further testing to confirm no active disease is required; do not administer golimumab to members with active TB. If latent TB, TB treatment must be started before initiation.Negative TB test within 6 months
Concomitant biologic/tsdm restriction: Member cannot use golimumab concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Dosing limits: Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Authorization of 12 months may be granted when criteria are met; approvals are typically limited to a 12-month duration. Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Background & Clinical Evidence

Simponi (golimumab) is a biologic therapy with FDA-approved indications for psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and ulcerative colitis (UC), and compendial uses including immune checkpoint inhibitor-related inflammatory arthritis and non-radiographic axial spondyloarthritis (nr-axSpA). Policy approvals are aligned with prior-therapy requirements and trials of prior biologic or targeted synthetic agents where applicable, require biomarker testing for RA (e.g., RF, anti-CCP, CRP/ESR) for some pathways, specify that medication be prescribed by or in consultation with appropriate specialists, and require TB screening (negative test within 6 months for biologic/tsdm-naive persons) with withholding of therapy for active TB and initiation of latent TB treatment prior to starting golimumab. Continuation criteria are based on documented positive clinical response or low disease activity per indication.

Primary product labeling: Simponi [package insert], Janssen Biotech, Inc; September 2019.

Guidelines cited include EULAR, ACR, ASAS and other rheumatology and dermatology guidance referenced in the policy.

Additional referenced guidance and compendia include AGA guidelines for ulcerative colitis and the NCCN Drugs & Biologics Compendium.

OpenPayer

Simponi (golimumab) subcutaneous injection coverage policy

Coverage Summary

Prior Authorization & Documentation Requirements

Initial Therapy Criteria (by indication)

Continuation (Renewal) Criteria

Other Universal Requirements & Restrictions

Applicable Codes

Background & Clinical Evidence

Definitions

Revision History