ModifiedAnthemPolicy CC-0078

Orencia (abatacept) — Clinical Medical Policy (coverage criteria)

Clinical medical policy defining coverage criteria, step therapy, quantity limits, coding, and use cases for Orencia (abatacept) across rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and graft-versus-host disease; applies to Anthem benefit review and prior authorization processes.

Policy Summary

PayerAnthem

PolicyOrencia (abatacept) — Clinical Medical Policy

Policy CodePolicy CC-0078

Change TypeMultiple material updates (step therapy, indications, coding)

Effective Date12/22/2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis, age, prior treatment history and evidence of inadequate response or intolerance to required therapies.

SourceLink

POLICY UPDATE CHANGES

Repeat testing for tuberculosis not required for ongoing authorization.

Step therapy requirements updated (commercial and Medicaid variations).

Step therapy table updates were made effective multiple dates in 2025 (including 05/01/2025, 04/01/2025, 02/03/2025, and 07/01/2025 administrative update).

Added indications/uses for immunotherapy-related toxicities and chronic graft-versus-host disease per NCCN and a pediatric indication for psoriatic arthritis.

Added ICD-10-CM codes D89.810 and T45.AX5A-T45.AX5S; updated HCPCS J0129 description.

4vials per 28 days

4syringes per 28 days

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Coverage Criteria for Orencia (abatacept)

Initial Therapy — Initial requests for Orencia may be approved if the following indication-specific criteria are met

Initial requests for Orencia may be approved if the following indication-specific criteria are met.

Rheumatoid arthritis (RA)

Prior therapy: Inadequate response to methotrexate titrated to maximally tolerated dose (ACR 2021) OR if methotrexate not tolerated inadequate response to or intolerance of other conventional therapy (sulfasalazine, leflunomide, or hydroxychloroquine) OR contraindication to methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine
per ACR guidance

Polyarticular juvenile idiopathic arthritis (PJIA): Moderate to severe PJIAage >= 6 for IV, age >= 2 for SC

AND inadequate response to or intolerance of conventional therapy (nonbiologic DMARDs such as methotrexate) OR contraindication to methotrexate

Psoriatic arthritis (PsA): Individual is 2 years of age or older with moderate to severe PsAage >= 2

AND inadequate response to or intolerance of conventional therapy (nonbiologic DMARDs such as methotrexate, sulfasalazine, cyclosporine or leflunomide) OR contraindication to listed agents

Acute graft-versus-host disease (GVHD) prophylaxis: Individual is 2 years of age or older and will be undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donorage >= 2

AND Orencia used in combination with a calcineurin inhibitor and methotrexate; administered Day -1, and days 5, 14, 28 per label

Chronic graft-versus-host disease (GVHD): Diagnosis of steroid-refractory chronic GVHD

Initiating abatacept in combination with systemic corticosteroids; NCCN 2A

Immune checkpoint inhibitor-related toxicities: Patient receiving immune checkpoint inhibitor therapy AND experiencing immunotherapy-related myocarditis unresponsive to high-dose systemic corticosteroids OR concomitant myositis and myocarditis

NCCN 2A

Continuation Therapy — Continuation requests for Orencia may be approved if the following are met

Continuation requests for Orencia may be approved if the following are met.

Continuation: Individual has been receiving and is maintained on a stable dose of Orenciastable dose

AND there is confirmation of clinically significant improvement or stabilization in clinical signs and symptoms of the disease

Indications and benefit-level coverage stance — Covered for specified rheumatologic indications when policy criteria are met; subject to step therapy and benefit-specific preferred agent rules

Covered for specified rheumatologic indications when policy criteria are met; subject to step therapy and benefit-specific preferred agent lists.

Indications: Rheumatoid arthritis, Psoriatic arthritis, Polyarticular Idiopathic Juvenile Arthritis (policy CC-0078).

Policy lists these indications and notes pediatric psoriatic arthritis added in reviews.

Benefit and formulary: Commercial, Medicaid, and Medicare medical benefits have differing step therapy and preferred/non-preferred designations; Medicaid lists Orencia as non-preferred in multiple states with effective dates, and Medicare notes step therapy does not apply.

See Document History and Medicaid Medical Benefit state effective dates for specifics.

Requests for Orencia (abatacept) will not be approved when it is used in combination with certain other immunomodulatory therapies. Specifically, combination use with topical or oral JAK inhibitors, ozanimod, etrasimod, apremilast, deucravacitinib, or any of the listed biologic immunomodulators (including TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, IL-1 inhibitors, IL-6 inhibitors, rituximab, or natalizumab) is excluded.

The policy’s combination-use exclusions have been revised over time. Notable updates documented in the history include the 11/18/2022 revision that expanded the combination exclusion to specify additional biologic immunomodulators and the 11/17/2023 update that explicitly added etrasimod to the exclusion list and added continuation-of-use language.

Requests for Orencia (abatacept) will be denied when the policy’s specified criteria are not met. Examples include failure to document required testing or prior therapy, lack of a required tuberculin skin test (TST) or CDC-recommended equivalent when initiating therapy (unless switching from another targeted immune modulator with no new risk factors), or when the request is for an indication not listed in the policy. The policy also specifies that treatment should not proceed in the presence of active tuberculosis, other active serious infections, or a history of recurrent infections.

Orencia (abatacept) is listed as a Non-Preferred Agent on certain formularies per the policy table (policy CC-0078 effective 01/01/2025). Prior authorization and step therapy requirements apply and coverage may be contingent on meeting plan-specific preferred-agent step therapy prior to approval.

Coding and Quantity Limits

HCPCSHCPCS

J0129

Injection, abatacept, 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) [Orencia]

HCPCSHCPCS

J0129

Injection, abatacept, 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) [Orencia]

ICD-10 DiagnosisICD-10

D89.810-D89.813	Graft-versus-host disease
I40.8-I40.9	Acute myocarditis
L40.50-L40.59	Arthropathic psoriasis
M05.00-M05.A	Rheumatoid arthritis with rheumatoid factor
M06.00-M06.09	Rheumatoid arthritis without rheumatoid factor
M06.4	Inflammatory polyarthropathy
M06.80-M06.9	Other specified and unspecified rheumatoid arthritis
M08.00-M08.09	Unspecified juvenile rheumatoid arthritis
M08.20-M08.29	Juvenile rheumatoid arthritis with systemic onset
M08.3	Juvenile rheumatoid polyarthritis (seronegative)

1–10 of 13

1/2

Reviewed HCPCSHCPCS

HCPCS J0129

description updated (HCPCS J0129) per coding review note

Added/Reviewed ICD-10-CM codesICD-10

ICD-10-CM D89.810
ICD-10-CM D89.811
ICD-10-CM D89.812
ICD-10-CM D89.813
ICD-10-CM I40.8
ICD-10-CM I40.9
ICD-10-CM M60.80
ICD-10-CM M60.9
ICD-10-CM T45.AX5A
ICD-10-CM T45.AX5S

1–10 of 11

1/2

IV vial limit per 28 days

IV vial limit4 vials per 28 days (250 mg/vial)

IV vial strength250 mg per vial

Initial therapy overrideMay approve 4 additional vials (250 mg/vial) in the first 28 days for initiation of IV therapy for RA, PJIA, or PsA

GVHD infusion allowanceFor GVHD prophylaxis, may approve up to 4 vials (250 mg/vial) per infusion for a total of 4 infusions (Day -1, days 5, 14, and 28)

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required — approval only with indication-specific criteria

Prior authorization is required for Orencia (abatacept) and may be approved only when the indication-specific clinical criteria in this policy are met (e.g., inadequate response or intolerance to specified conventional DMARDs, age thresholds, or approved GVHD/NCCN 2A uses).

Prior Authorization

Prior authorization and step therapy apply (CC-0078)

This clinical policy (CC-0078) applies prior authorization and step therapy requirements to Orencia (abatacept); Medicaid medical benefit listings identify Orencia as a non-preferred agent with specified state effective dates.

Step Therapy

Step therapy trials required — preferred-agent trials vary by plan

Commercial and Medicaid plans require trials of preferred agents before approving Orencia; the required number of failed preferred agents varies by indication and benefit (commercial RA/PsA often requires two, PJIA often requires one, Medicaid often requires one).

Background and Drug Information

Abatacept (Orencia) is a selective costimulation modulator that inhibits T‑cell activation and is available in both intravenous and subcutaneous formulations. It is FDA‑approved for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis; it is also FDA‑approved in combination with calcineurin inhibitor and methotrexate for prophylaxis of acute graft‑versus‑host disease in hematopoietic stem cell transplantation. Per guideline sources cited in the policy, abatacept has an NCCN 2A recommendation for steroid‑refractory chronic graft‑versus‑host disease and may be used for certain immune checkpoint inhibitor–related toxicities such as myocarditis when high‑dose corticosteroids are unsuccessful.

Definitions and Terms

Orencia — Abatacept (key identifiers)

Drug nameOrencia (abatacept)

MechanismSelective costimulation modulator that inhibits T‑cell activation

FormulationsIntravenous and subcutaneous injection formulations

Policy identifierClinical policy CC-0078 (Orencia) — listed as non-preferred on the 01/01/2025 preferred/non-preferred summary

Polyarticular juvenile idiopathic arthritis (PJIA) — definition

DefinitionPolyarticular juvenile idiopathic arthritis (PJIA): JIA with more than four affected joints in the first six months of illness

Revision History and Policy Changes

11/14/2025annual_reviewLatest

Annual review with step therapy update and coding review; updated HCPCS J0129 description and added ICD-10-CM D89.810 and T45.AX5A-T45.AX5S.

09/24/2025coding_update

Added ICD-10-CM M05.A effective 10/01/2025.

07/01/2025administrative_update

Administrative update to remove documentation for Rheumatoid Arthritis.

Policy Summary

PayerAnthem

PolicyOrencia (abatacept) — Clinical Medical Policy

Policy CodePolicy CC-0078

Change TypeMultiple material updates (step therapy, indications, coding)

Effective Date12/22/2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis, age, prior treatment history and evidence of inadequate response or intolerance to required therapies.

SourceLink

On This Page

Step Therapy

Step therapy requirements and table updates (2024–2025)

Step therapy tables and requirements were updated multiple times between 2024–2025; commercial, Medicaid, and medical-benefit listings identify preferred and non-preferred agents and state-specific Medicaid effective dates.

Step therapy table updates documented 02/03/2025, 04/01/2025, 05/01/2025 and other 2024–2025 updates.
Medicaid listings (multiple states) show Orencia as non-preferred and list preferred agents by effective date.

Documentation Required

Required clinical documentation for initial prior authorization

Initial prior authorization requests must include documentation of the diagnosis, patient age, and prior treatment history demonstrating trials and inadequate response or intolerance (or contraindication) to the specified conventional DMARDs per indication.

Document methotrexate dosing/tolerance or reason for intolerance if applicable.
For PJIA and PsA include age and prior nonbiologic DMARD history as specified.

Documentation Required

Documentation and testing expectations (including TB guidance)

Documentation expectations and testing references were updated in administrative reviews; the policy clarifies tuberculosis and infection screening expectations and references CDC/guideline resources for testing. Repeat TB testing is not required for ongoing authorization.

Follow CDC and guideline resources cited in the policy for TB and other infection screening.
Repeat tuberculosis testing not required for continuation authorizations per policy note.

Denial Risk

Contraindicated combinations and infection-related denial risk

Requests for Orencia will be denied if the medication is used in combination with listed agents (topical/oral JAK inhibitors, ozanimod, etrasimod, apremilast, deucravacitinib, or specified biologic immunomodulators) or if the patient has active serious infection or a history of recurrent infections.

Combination use with topical or oral JAK inhibitors, ozanimod, etrasimod, apremilast, deucravacitinib, TNF antagonists, IL‑23/IL‑17 inhibitors, vedolizumab, ustekinumab, IL‑1/IL‑6 inhibitors, rituximab, or natalizumab will result in non-approval.
Active tuberculosis, other active serious infections, or history of recurrent infections are exclusions.

Denial Risk

Non-preferred agent denial risk — Orencia listed as non-preferred on some formularies

Orencia is identified as a non-preferred agent on some formularies; use of a non-preferred agent may trigger step therapy requirements or medical-benefit designation and lead to denial if step therapy conditions are not met. Medicaid listings specifically mark Orencia as non-preferred in multiple states with effective dates.

Medicaid medical benefit entries list Orencia as Non‑Preferred (state-specific effective dates shown).
If step therapy or preferred-agent trials are not satisfied, requests for a non-preferred agent may be denied.

Orencia (abatacept) — summary

Indications (selected)Approved indications include rheumatoid arthritis, juvenile idiopathic arthritis (including PJIA), psoriatic arthritis, and FDA‑approved acute GVHD prophylaxis in HSCT patients age >=2

GVHD detailsFDA approved for prophylaxis of acute GVHD in combination with a calcineurin inhibitor and methotrexate; administered Day -1, and days 5, 14, and 28

Formulations and codingAvailable IV and SC formulations; HCPCS code J0129 for abatacept (10 mg) referenced in policy coding sections

Formulary stancePolicy CC-0078 lists Orencia as a non-preferred agent on the 01/01/2025 summary (subject to step therapy and benefit-specific rules)