CurrentNeighborhood Health Plan of Rhode IslandPolicy 2014-A

Simponi (golimumab) — coverage criteria

Defines medical necessity and authorization criteria for golimumab (Simponi) across rheumatologic and inflammatory bowel disease indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi (golimumab) — coverage criteria

Policy CodePolicy 2014-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain and document a baseline and follow-up clinical response (e.g., joint counts, CRP, stool frequency, endoscopic findings) to support authorization of up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for covered indications

TB test within 12 monthsTB screening required for biologic-naïve

≥20% improvementRA response threshold

multiple outcomesOther indications monitoring

Coverage Criteria for Golimumab (Simponi)

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Rheumatoid Arthritis - Initial/Continuation

Rheumatoid Arthritis (RA): Covered when ALL of the following are met

RA authorization criteria: Member is an adult using the requested medication for moderately to severely active rheumatoid arthritis and achieves or maintains a positive clinical response>=20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

Includes new members

Psoriatic Arthritis - Initial/Continuation

Psoriatic Arthritis (PsA): Covered when ALL of the following are met

PsA authorization criteria: Member is an adult using the requested medication for psoriatic arthritis and achieves or maintains a positive clinical responseImprovement in any of: Number of swollen joints; Number of tender joints; Dactylitis; Enthesitis; Axial disease; Skin and/or nail involvement; Functional status; C-reactive protein (CRP)

Includes new members

AS / nr-axSpA - Initial/Continuation

Ankylosing Spondylitis (AS) and Non-Radiographic Axial SpA: Covered when ALL of the following are met

AS/nr-axSpA authorization criteria: Member is an adult using the requested medication for ankylosing spondylitis or non-radiographic axial spondyloarthritis and achieves or maintains a positive clinical responseImprovement in any of: Functional status; Total spinal pain; Inflammation (e.g., morning stiffness); Swollen joints; Tender joints; C-reactive protein (CRP)

Includes new members

Ulcerative Colitis - Initial/Continuation

Ulcerative Colitis (UC): Covered when ALL of the following are met

UC authorization criteria: Member is using the requested medication for moderately to severely active ulcerative colitis and achieves or maintains remission or a positive clinical responseImprovement in any of: Stool frequency; Rectal bleeding; Urgency of defecation; C-reactive protein (CRP); Fecal calprotectin (FC); Appearance of the mucosa on endoscopy, CTE, MRE, or intestinal ultrasound; Improvement on a disease activity scoring tool (e.g., UCEIS, Mayo)

Includes new members

Immune Checkpoint Inhibitor-Related Toxicity

Immune Checkpoint Inhibitor-Related (ICI) Inflammatory Arthritis: Covered when ANY of the following prior-failure/intolerance conditions are met plus response

ICI-related arthritis prior requirement: Member has had an inadequate response to corticosteroids or a conventional synthetic DMARD (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine), OR has an intolerance or contraindication to corticosteroids and a conventional synthetic DMARDN/A

Authorization of 12 months may be granted when combined with evidence of positive clinical response (low disease activity or symptom improvement)

Use of the requested medication without required TB screening or without documentation that latent TB has been treated where indicated, or use concurrently with another biologic/targeted synthetic agent for the same indication, is a basis for restriction or denial. Specifically, a documented negative TST or IGRA within 12 months is required for biologic/targeted synthetic–naïve members; positive screening requires confirmatory testing and TB treatment before initiation.

Coding and Response Definitions

Rheumatoid arthritis response threshold — inv-09

Threshold>= 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

Applies toAdult members (including new members) using the requested medication for moderately to severely active rheumatoid arthritis

Use for authorizationEvidence of this improvement supports prior authorization of up to 12 months

TB test recency — inv-10

Required testNegative tuberculosis test (TST or IGRA)

RecencyWithin 12 months of initiating therapy for biologic- or targeted synthetic–naïve members

If positiveFurther testing (e.g., chest x-ray) to exclude active TB and initiation of TB treatment if latent before starting therapy

Provider Action Requirements and Authorization Rules

Documentation Required

Rheumatoid Arthritis (RA) — Clinical response documentation

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active rheumatoid arthritis and who achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

Authorization of 12 months may be granted when responder criteria are met.

Documentation Required

Psoriatic Arthritis (PsA) — Clinical response documentation

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for psoriatic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin and/or nail involvement, functional status, or C-reactive protein (CRP).

Authorization of 12 months may be granted when responder criteria are met.

Documentation Required

Ankylosing Spondylitis (AS) / nr-axSpA — Clinical response documentation

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for ankylosing spondylitis or non-radiographic axial spondyloarthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline: functional status, total spinal pain, inflammation (e.g., morning stiffness), swollen joints, tender joints, or C-reactive protein (CRP).

Authorization of 12 months may be granted when responder criteria are met.

Documentation Required

Ulcerative Colitis (UC) — Clinical response documentation

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission or a positive clinical response as evidenced by improvement from baseline in stool frequency, rectal bleeding, urgency, C-reactive protein (CRP), fecal calprotectin (FC), endoscopic appearance (e.g., UCEIS, Mayo score), or imaging findings.

Authorization of 12 months may be granted when responder criteria are met.

Documentation Required

Immune Checkpoint Inhibitor-Related Toxicity — Clinical response documentation

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immunotherapy-related inflammatory arthritis and who achieve or maintain a positive clinical response with the requested medication as evidenced by low disease activity or improvement in signs and symptoms of the condition.

Authorization of 12 months may be granted when responder criteria are met for ICI-related toxicity.

Denial Risk

TB infection contraindication and screening documentation

Do not administer the requested medication to members with active tuberculosis (TB) infection. For members naïve to biologic or targeted synthetic drugs associated with increased TB risk, document a negative TB test (TST or IGRA) within 12 months prior to initiating therapy. If screening is positive, obtain further testing to exclude active TB (e.g., chest x‑ray). If latent TB is identified, start appropriate TB treatment before initiating the requested medication.

Acceptable TB screening: tuberculosis skin test (TST) or interferon-gamma release assay (IGRA) within 12 months for biologic/targeted-synthetic–naïve members.
If TB screening is positive: perform chest x‑ray or other evaluation to exclude active disease; do not start therapy until active TB is excluded.
If latent TB: initiate recommended latent TB treatment prior to therapy start.

Denial Risk

Concomitant biologic / targeted synthetic prohibition

Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication. Concomitant use is a contraindication and may result in denial of the request.

Prohibition applies to any other biologic or targeted synthetic DMARD used for the same indication.
Verify prior/current biologic or targeted synthetic DMARDs on the medication list and prior authorizations before approving continuation or new therapy.

Background

Golimumab (Simponi) is a tumor necrosis factor (TNF) inhibitor indicated for multiple immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis/axial spondyloarthritis, ulcerative colitis, and inflammatory arthritis related to immune checkpoint inhibitor therapy. Authorization criteria emphasize objective or clinician-assessed improvement or maintenance of low disease activity and adherence to standard safety screening, notably tuberculosis testing and management prior to initiation.

Definitions of Clinical Response

Positive clinical response (RA) — inv-19

DefinitionDisease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability

PopulationApplies to adults with moderately to severely active rheumatoid arthritis (including new members)

Authorization impactDocumented positive clinical response supports 12-month prior authorization

Positive clinical response (other indications) — inv-20

DefinitionAchieving or maintaining low disease activity or improvement in signs and symptoms as evidenced by indication‑specific measures

Examples of measuresJoint counts (swollen/tender), dactylitis, enthesitis, axial disease, functional status, C‑reactive protein (CRP); for UC: stool frequency, rectal bleeding, urgency, fecal calprotectin, endoscopic mucosal appearance, validated scores (e.g., UCEIS, Mayo)

Authorization impactDocumented improvement or low disease activity supports prior authorization of up to 12 months for the specific indication

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi (golimumab) — coverage criteria

Policy CodePolicy 2014-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain and document a baseline and follow-up clinical response (e.g., joint counts, CRP, stool frequency, endoscopic findings) to support authorization of up to 12 months.

SourceLink

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