CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Orencia (abatacept) (Intravenous) — Clinical coverage criteria

Clinical coverage and medical necessity criteria for intravenous abatacept (Orencia) across Medicaid, Commercial, and Medicare-Medicaid members; defines indications, authorization lengths, dosing, renewal and monitoring requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOrencia (abatacept) (Intravenous) — Clinical coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review (no material change)

Effective DateJan 1, 2020

Next Review DateJan 22, 2025

Key ActionSubmit prior authorization with documentation of universal and indication-specific criteria (age, vaccinations, HBV and latent TB screening, no concurrent disallowed biologics, and listed ICD-10 diagnosis code).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsstandard length of authorization

1000 mgmaximum dose

5ICI toxicity doses

J0129HCPCS code

00003-2187NDC (vial)

multiplecovered diagnosis codes

Coverage and Medical Necessity Criteria

Universal Criteria

Covered when ALL of the following universal criteria are met

Universal criteria: Patient meets age requirement (at least 18 years of age unless otherwise specified); AND patient is up to date with age-appropriate vaccinations prior to initiating therapy; AND patient has been screened for hepatitis B virus (HBV) prior to initiating treatment; AND patient has been evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing TB monitoring during therapy; AND patient does not have an active infection (including clinically important localized infections); AND patient will not receive live vaccines during therapy; AND patient is not on concurrent treatment with another injectable biologic response modifier (including TNF inhibitors and specified IL-inhibitors) or specified oral non-biologic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib).

Documentation of screening and vaccination status must be provided with prior authorization request.

Step therapy exemption: MMP members who have received this medication within the past 365 days are exempt from step therapy requirements.

Initial Therapy — Rheumatoid Arthritis

Rheumatoid Arthritis — Covered when ALL of the following are met

RA initial criteria: Physician has assessed baseline disease severity using an objective measure/tool; AND documented moderate to severe active disease; AND patient has had at least a 3-month trial and failed one oral DMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide); AND may be used as monotherapy or in combination with other non-biologic DMARDs; AND patient has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Providers should document prior DMARD trials and objective disease severity in the prior authorization submission.

Initial Therapy — Polyarticular Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis — Covered when ALL of the following are met

pJIA initial criteria: Physician has assessed baseline disease severity using an objective measure/tool; AND patient is 2 years of age or older; AND documented moderate to severe active polyarticular disease; AND patient has had at least a 1-month trial and failure of either an NSAID OR an oral DMARD (unless contraindicated or intolerant); AND may be used alone or in combination with methotrexate; AND patient has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

For IV dosing, pediatric dosing schedules and age restrictions (patients aged ≥6 years for certain IV regimens) apply per dosing guidance.

Initial Therapy — Psoriatic Arthritis

Psoriatic Arthritis — Covered when ALL of the following are met

PsA initial criteria: Physician has assessed baseline disease severity using an objective measure/tool; AND documented moderate to severe active disease; AND for predominantly axial disease or active enthesitis, adequate trial and failure of at least one NSAID unless contraindicated; OR for peripheral arthritis, trial and failure of at least a 3-month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine); AND may be used as monotherapy or in combination with other non-biologic DMARDs; AND patient has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab at maximum tolerated doses.

Document prior therapies and reason for treatment selection in the prior authorization request.

Initial Therapy — Graft Versus Host Disease (cGVHD treatment and aGVHD prophylaxis)

Graft Versus Host Disease — Covered when ALL of the following are met

cGVHD treatment or aGVHD prophylaxis: Either: Used as additional therapy in combination with corticosteroids for chronic GVHD in a patient who received hematopoietic stem cell transplant (HSCT) and who has had no response to first-line therapy (steroid-refractory), OR used for prophylaxis of acute GVHD in a patient undergoing HSCT from a matched or 1 allele-mismatched unrelated donor (IV formulation only) in combination with a calcineurin inhibitor and methotrexate; AND patient is at least 2 years of age for prophylaxis; AND patient will receive antiviral prophylaxis for EBV for 6 months post-transplant and will be monitored for EBV and CMV reactivation.

Prior authorization must include HSCT details, planned concomitant immunosuppression, and EBV/CMV monitoring plan.

Initial Therapy — Immune Checkpoint Inhibitor Related Toxicity

Management of Immune Checkpoint Inhibitor Related Toxicity — Covered when ALL of the following are met

ICI toxicity criteria: Patient has been receiving therapy with an immune checkpoint inhibitor; AND patient has had no improvement within 24-48 hours of starting pulse-dose methylprednisolone; AND abatacept is used as additional therapy for management of myocarditis; AND dosing is 500 mg every 2 weeks for a total of 5 doses; AND this indication may not be renewed.

Indication is compendia-recommended and prior authorization should state that renewal is not permitted for this indication.

Indication-specific dosing and coverage

Covered when dosing matches an approved indication and schedule as listed

Rheumatoid and Psoriatic Arthritis Adults: Intravenous dosing by weight bands: weight <60 kg = 500 mg at weeks 0, 2, and 4, then every 4 weeks; weight 60–100 kg = 750 mg at weeks 0, 2, and 4, then every 4 weeks; weight >100 kg = 1,000 mg at weeks 0, 2, and 4, then every 4 weeks.weight bands

Maximum single dose listed up to 1,000 mg.

Polyarticular Juvenile Idiopathic Arthritis (>=6 years): Patients aged ≥6 years: weight <75 kg = 10 mg/kg at weeks 0, 2, and 4, then every 4 weeks; weight 75–100 kg = 750 mg at weeks 0, 2, and 4, then every 4 weeks; weight >100 kg = dosing per guidance (see dosing appendix).age ≥6 years; weight bands

Use pediatric dosing schedule when applicable; maximum dose considerations apply.

Chronic Graft-Versus-Host Disease: Up to 10 mg/kg (maximum 1,000 mg) at weeks 0, 2, and 4, then every 4 weeks until progression or unacceptable toxicity.<=1000 mg max

Document rationale for continued therapy and toxicity monitoring.

Prophylaxis for Acute GVHD: Patients ≥6 years: 10 mg/kg (max 1,000 mg) on Day -1, then Days 5, 14, and 28; Patients 2 to <6 years: 15 mg/kg on Day -1, then 12 mg/kg on Days 5, 14, and 28.age-specific dosing

Prior authorization must include transplant timing to align dosing schedule.

Management of Immune Checkpoint Inhibitor Related Toxicity: 500 mg every 2 weeks for a total of 5 doses.total 5 doses

This indication is not renewable.

General coverage criteria

Coverage is governed by Neighborhood's clinical criteria as adopted by the P&T committee and aligned with FDA labeling and relevant literature.

P&T-based coverage requirements: Member use of Orencia must align with FDA-approved labeling and/or relevant clinical literature; criteria were developed by Neighborhood's Pharmacy & Therapeutics (P&T) Committee; Neighborhood may require use of more cost-effective options first where appropriate and will give individual consideration to requests based on prescriber-submitted information; for INTEGRITY (Medicare-Medicaid Plan) members, these criteria apply only in the absence of applicable NCD or LCD criteria.

Providers should reference Appendix 1 diagnosis codes and include clinical justification when requesting coverage for indications outside standard labeling.

Concurrent administration of abatacept with other injectable biologic response modifiers or certain oral non-biologic immunomodulatory agents is prohibited. Specifically, patients receiving Orencia must not be on concurrent treatment with another injectable biologic response modifier (for example TNF inhibitors such as adalimumab, etanercept, certolizumab, infliximab, or IL‑inhibitors such as secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab) or specified oral non-biologic agents (for example apremilast, tofacitinib, baricitinib, upadacitinib).

Treatment with abatacept when used for management of immune checkpoint inhibitor related toxicity is considered a fixed, short-course intervention and may not be renewed beyond the prescribed regimen.

For members enrolled in the INTEGRITY Medicare‑Medicaid Plan, these Orencia coverage criteria apply only when there is no applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). Neighborhood will still consider prescriber‑submitted clinical information on a case‑by‑case basis when reviewing requests.

Certain indications for which abatacept may be initially authorized are explicitly excluded from renewal. In particular, prophylaxis for acute graft‑versus‑host disease (aGVHD) and management of immune checkpoint inhibitor related toxicity are not eligible for renewal of authorization.

Use of abatacept that is not consistent with FDA‑approved labeling, relevant clinical literature, or Neighborhood's adopted clinical coverage criteria may be considered not medically necessary and subject to denial unless adequate supporting clinical information is provided for individual consideration.

Billing, Quantity, and Diagnosis Codes

Quantity/HCPCS units and vial NDC referencesmixed

Orencia 250 mg vial	Quantity limits and vial NDC referenced in policy (see NDC group for exact NDC).
J0129	HCPCS: Injection, Abatacept, 10 mg; 1 billable unit = 10 mg (used for physician-administered billing)

Covered HCPCS CodesHCPCS

J0129

Injection, Abatacept, 10 mg; 1 billable unit = 10 mg (physician-administered)

NDCNDC

00003-2187-xx

Orencia 250 mg single-use vial - manufacturer NDC (last two digits variable packaging)

Covered ICD-10 Diagnosis Codes (partial list - block 1)ICD-10Covered

D89.811	Chronic graft-versus-host disease
D89.812	Acute on chronic graft-versus-host disease
D89.813	Graft-versus-host disease, unspecified
I30.8	Other forms of acute pericarditis
I30.9	Acute pericarditis, unspecified
I40.8	Other acute myocarditis
I40.9	Acute myocarditis, unspecified
I44.0	Atrioventricular block, first degree
I44.1	Atrioventricular block, second degree
I44.2	Atrioventricular block, complete

1–10 of 32

1/4

Covered ICD-10 Diagnosis Codes (Rheumatoid & Juvenile Arthritis)ICD-10Covered

M05.111	Rheumatoid lung disease with rheumatoid arthritis of right shoulder
M05.112	Rheumatoid lung disease with rheumatoid arthritis of left shoulder
M05.119	Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder
M05.121	Rheumatoid lung disease with rheumatoid arthritis of right elbow
M05.122	Rheumatoid lung disease with rheumatoid arthritis of left elbow
M05.129	Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow
M05.131	Rheumatoid lung disease with rheumatoid arthritis of right wrist
M05.132	Rheumatoid lung disease with rheumatoid arthritis of left wrist
M05.139	Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist
M05.141	Rheumatoid lung disease with rheumatoid arthritis of right hand

1–10 of 35

1/4

Additional Covered ICD-10 Diagnosis CodesICD-10Covered

M05.251	Rheumatoid vasculitis with rheumatoid arthritis of right hip
M05.252	Rheumatoid vasculitis with rheumatoid arthritis of left hip
M05.259	Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip
M05.261	Rheumatoid vasculitis with rheumatoid arthritis of right knee
M05.262	Rheumatoid vasculitis with rheumatoid arthritis of left knee
M05.269	Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee
M05.271	Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot
M05.272	Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot
M05.279	Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot
M05.29	Rheumatoid vasculitis with rheumatoid arthritis of multiple sites

1–10 of 28

1/3

Covered ICD-10 Diagnosis Codes (continued)ICD-10Covered

M05.369	Rheumatoid heart disease with rheumatoid arthritis of unspecified knee
M05.371	Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot
M05.372	Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot
M05.379	Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot
M05.39	Rheumatoid heart disease with rheumatoid arthritis of multiple sites
M05.40	Rheumatoid myopathy with rheumatoid arthritis of unspecified site
M05.411	Rheumatoid myopathy with rheumatoid arthritis of right shoulder
M05.412	Rheumatoid myopathy with rheumatoid arthritis of left shoulder
M05.419	Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder
M05.421	Rheumatoid myopathy with rheumatoid arthritis of right elbow

1–10 of 24

1/3

Covered ICD-10 Diagnosis Codes (Rheumatoid group - required list)ICD-10Covered

M05.641	Rheumatoid arthritis of right hand with involvement of other organs and systems
M05.642	Rheumatoid arthritis of left hand with involvement of other organs and systems
M05.649	Rheumatoid arthritis of unspecified hand with involvement of other organs and systems
M05.651	Rheumatoid arthritis of right hip with involvement of other organs and systems
M05.652	Rheumatoid arthritis of left hip with involvement of other organs and systems
M05.659	Rheumatoid arthritis of unspecified hip with involvement of other organs and systems
M05.661	Rheumatoid arthritis of right knee with involvement of other organs and systems
M05.662	Rheumatoid arthritis of left knee with involvement of other organs and systems
M05.669	Rheumatoid arthritis of unspecified knee with involvement of other organs and systems
M05.671	Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems

1–10 of 60

1/6

Covered ICD-10 Diagnosis Codes (M06, M08 groups)ICD-10Covered

M06.00	Rheumatoid arthritis without rheumatoid factor, unspecified site
M06.011	Rheumatoid arthritis without rheumatoid factor, right shoulder
M06.012	Rheumatoid arthritis without rheumatoid factor, left shoulder
M06.019	Rheumatoid arthritis without rheumatoid factor, unspecified shoulder
M06.021	Rheumatoid arthritis without rheumatoid factor, right elbow
M06.022	Rheumatoid arthritis without rheumatoid factor, left elbow
M06.029	Rheumatoid arthritis without rheumatoid factor, unspecified elbow
M06.031	Rheumatoid arthritis without rheumatoid factor, right wrist
M06.032	Rheumatoid arthritis without rheumatoid factor, left wrist
M06.039	Rheumatoid arthritis without rheumatoid factor, unspecified wrist

1–10 of 65

1/7

Appendix 1 - Remaining Covered ICD-10 Diagnosis Codes (juvenile & other)ICD-10Covered

M08.061	Unspecified juvenile rheumatoid arthritis, right knee
M08.062	Unspecified juvenile rheumatoid arthritis, left knee
M08.069	Unspecified juvenile rheumatoid arthritis, unspecified knee
M08.071	Unspecified juvenile rheumatoid arthritis, right ankle and foot
M08.072	Unspecified juvenile rheumatoid arthritis, left ankle and foot
M08.079	Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot
M08.08	Unspecified juvenile rheumatoid arthritis, vertebrae
M08.09	Unspecified juvenile rheumatoid arthritis, multiple sites
M08.20	Juvenile rheumatoid arthritis with systemic onset, unspecified site
M08.211	Juvenile rheumatoid arthritis with systemic onset, right shoulder

1–10 of 37

1/4

Medicare Part B Covered Diagnosis Codes / MAC jurisdictionsmixed

Medicare Part B applicability

N/A — see Appendix 2 for MAC jurisdictions; Policy references Medicare Benefit Policy Manual and potential NCD/LCD/LCA applicability

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be evaluated against the plan's clinical coverage criteria informed by FDA labeling and relevant literature; individual consideration will be given based on prescriber-submitted clinical information.

Use an Appendix 1 listed ICD-10 diagnosis code on the prior authorization request; requests using codes not in Appendix 1 may be at risk for denial.

Documentation Required

Providers must document the clinical indication and the dosing regimen consistent with the IV dosing schedules in the policy. Include objective baseline disease severity assessments where applicable (for example, RA disease activity measures) and evidence of prior trials/therapies as required by indication.

Document age and that the member is up to date with age‑appropriate vaccinations prior to initiating therapy.
Document hepatitis B (HBV) screening prior to initiation and latent tuberculosis (TB) screening with plans for ongoing TB monitoring during treatment.
If applicable, document a 3‑month trial and inadequate response/intolerance to prior DMARDs or other specified therapies per indication criteria.

Denial Risk

Concurrent Therapy Denial Risk

Do not bill when concurrent use of another injectable biologic response modifier or specified oral non‑biologic immunomodulator is being used unless otherwise allowed by the policy; concurrent therapy may lead to denial.

Concurrent injectable biologics include TNF inhibitors (e.g., adalimumab, etanercept, infliximab) and IL inhibitors (e.g., secukinumab, ustekinumab, guselkumab, risankizumab, bimekizumab).
Concurrent oral agents of concern include apremilast, tofacitinib, baricitinib, and upadacitinib.

Billing Rule

HCPCS Coding and Billing Guidance

Billing guidance: use HCPCS code J0129 for Abatacept (Orencia) when the drug is administered under the direct supervision of a physician for Medicare members. J0129 represents 10 mg; 1 billable unit = 10 mg. Do not use J0129 for self‑administered doses.

For Medicare billing when physician‑administered, report J0129 – Injection, Abatacept, 10 mg.
Do not use J0129 for doses that are self‑administered; follow payer-specific billing rules for other settings.

Step Therapy

Step Therapy and Exceptions

Step therapy exceptions and preference: Members of the Medicare‑Medicaid Plan (MMP) who received the medication within the prior 365 days are exempt from step therapy requirements. The policy favors cost‑effective alternatives first; trials of alternative agents may be required unless an exemption applies.

MMP members with documented receipt of the medication within the past 365 days are exempt from step therapy.
When step therapy is applied, document reason for exemption or failure/intolerance to preferred alternatives.

Denial Risk

Diagnosis Coding and Denial Risk

Providers must include a covered Appendix 1 ICD‑10 code on claims and prior authorization submissions when required. Requests for indications not supported by FDA labeling, the medical literature, or the plan's criteria may be denied.

Reference Appendix 1 for covered diagnosis codes when submitting prior authorization requests.
Claims or authorizations submitted with ICD‑10 codes not listed in Appendix 1 may be at risk for denial.

Clinical Background

Abatacept (Orencia) is a selective T‑cell costimulation modulator available for intravenous administration and indicated for several immune‑mediated conditions. Clinical trials support its efficacy in moderately to severely active rheumatoid arthritis in adults and in polyarticular juvenile idiopathic arthritis in pediatric patients, with common adverse events including headache, upper respiratory infection, and nausea. Neighborhood's P&T committee developed the coverage criteria to align use with FDA labeling and relevant literature and to promote safe and cost‑effective therapy.

Definitions and Terms

inv-42: Orencia (abatacept)

Generic name and brandAbatacept (Orencia) — a selective T‑cell costimulation modulator

Primary IV indicationsIndicated for moderately to severely active rheumatoid arthritis in adults and polyarticular JIA in pediatric patients ≥6 years

Clinical benefit summaryClinical studies show improved ACR response rates in adults and reduced flares with pediatric JIA

inv-43: Management of Immune Checkpoint Inhibitor Related Toxicity

IndicationManagement of immune checkpoint inhibitor (ICI) related myocarditis/toxicity as listed in dosing guidance

IV dosing summary500 mg IV every 2 weeks for a total of 5 doses

Renewal limitationThis indication may not be renewed (non‑renewable per policy)

inv-44: Medical necessity review

Individual reviewPrescriber-submitted clinical information will be reviewed and Neighborhood will give individual consideration to each request

Evaluation basisReviews are informed by FDA labeling, relevant clinical literature, and the plan's P&T‑adopted criteria

Documentation expectationProviders should submit indication, dosing regimen, and supporting clinical details to support medical necessity determinations

Policy Revision History

2025-01-22policy_reviewLatest

Policy next review date recorded (per document header review schedule).

2024-02-14revision

Document revision (listed in header) reflecting updates prior to 2025 review cycle.

2024-01-04revision

Document revision (listed in header) reflecting updates prior to 2025 review cycle.

2023-12-07revision

Document revision (listed in header) reflecting updates prior to 2024 revisions.

2023-08-10revision

Document revision (listed in header) reflecting updates during 2023.

2022-08-25revision

Document revision (listed in header) reflecting updates during 2022.

2022-01-20revision

Document revision (listed in header) reflecting updates during 2022.

2021-06-24revision

Document revision (listed in header) reflecting updates during 2021.

2020-11-16revision

Document revision (listed in header) reflecting updates during 2020.

2020-09-14revision

Document revision (listed in header) reflecting updates during 2020.

2020-01-29revision

Document revision (listed in header) reflecting updates during 2020 (post-effective updates).

2019-12-20revision

Document revision (listed in header) reflecting updates during 2019 prior to initial effective date.

2019-09-18revision

Document revision (listed in header) reflecting updates during 2019 prior to initial effective date.

2020-01-01effective_date

Policy effective date established.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOrencia (abatacept) (Intravenous) — Clinical coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review (no material change)

Effective DateJan 1, 2020

Next Review DateJan 22, 2025

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.