CurrentUnitedHealthcarePolicy 2025D0039V

Orenciac (Abatacept) Injection for Intravenous Infusion

UnitedHealthcare commercial medical benefit drug policy specifying clinical coverage criteria, continuation criteria, indications (RA, PsA, PJIA, chronic GVHD, aGVHD prophylaxis, immune checkpoint inhibitor toxicities), applicable HCPCS and ICD-10 codes, authorization durations, and benefit considerations for abatacept IV (Orencia).

Policy Summary

PayerUnitedHealthcare

PolicyOrenciac (Abatacept) Injection for Intravenous Infusion

Policy CodePolicy 2025D0039V

Change TypeClarified benefit assignment; ICD-10 updates; archived prior version

Effective DateOct 1, 2025

Next Review Date

Key ActionInitial and continuation authorizations must meet the listed clinical criteria and will be authorized for specified maximum durations (generally up to 12 months or up to 4 doses for certain indications).

POLICY UPDATE CHANGES

Added language to clarify Orencia (abatacept) for self-administered subcutaneous injection is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan documents; for certain UnitedHealthcare of California delegated provider groups the self-administered Orencia may be obtained under the medical benefit.

Updated list of applicable ICD-10 diagnosis codes to reflect annual edits.

Archived previous policy version 2025D0039U.

RA, PsA, PJIA, cGVHD, aGVHD, checkpoint toxicitiesCovered Indications

SLE, MS, Behcet uveitisUnproven Indications

J0129IV Drug HCPCS Listed

≤12 monthsTypical initial auth length

3FDA major indications referenced

Coverage Summary

Coverage: Medical benefit applies to intravenous (IV) Orencia (abatacept) injection (J0129). Self‑administered subcutaneous Orencia is obtained under the pharmacy benefit unless the member's benefit plan documents specify otherwise; an exception allows certain UnitedHealthcare of California delegated provider group arrangements to obtain self‑administered Orencia under the medical benefit. Covered major indications under the medical benefit include: rheumatoid arthritis (RA), psoriatic arthritis (PsA), polyarticular juvenile idiopathic arthritis (PJIA), steroid‑refractory chronic graft‑versus‑host disease (cGVHD), prophylaxis of acute GVHD (aGVHD) in specified transplant settings, and severe/life‑threatening immune checkpoint inhibitor‑related toxicities. The policy identifies the following as unproven / not medically necessary: systemic lupus erythematosus (SLE), multiple sclerosis (MS), and uveitis associated with Behcet's disease.

Authorization durations and quick facts

Initial authorization (most indications)No more than 12 months

aGVHD prophylaxis authorizationAuthorization is for no more than 4 doses

Immune checkpoint toxicity authorizationAuthorization is for no more than 4 doses

Required non-biologic DMARD trial before RA biologicFailure/intolerance to a 3-month trial of one non-biologic DMARD at maximally indicated doses (unless contraindicated)

Benefit routing note for subcutaneous OrenciaSelf-administered subcutaneous Orencia is obtained under the pharmacy benefit unless member plan specifies otherwise (certain UHC of CA delegated groups may obtain under medical benefit)

Initial Therapy Criteria (by indication)

Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Initial and Continuation Therapy

Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Initial Therapy

ALL of the following

Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA).
For initial therapy
- Orencia (abatacept) is initiated and titrated according to U.S. Food and Drug Administration (FDA) labeled dosing for polyarticular juvenile idiopathic arthritis.
- Prescribed by or in consultation with a rheumatologist.
- Initial authorization is for no more than 12 months.

Continuation Therapy Criteria (by indication)

Unproven or Not Medically Necessary Indications

Applicable Codes

Covered HCPCS (drug)HCPCSCovered

J0129

Injection, abatacept, excludes intramuscular and subcutaneous formulations

Relevant ICD-10 Diagnosis Codes (referenced indications)ICD-10

M08.041	Juvenile rheumatoid arthritis, right shoulder
M08.042	Juvenile rheumatoid arthritis, left shoulder
M08.049	Juvenile rheumatoid arthritis, shoulder, unspecified
M08.051	Juvenile rheumatoid arthritis, right elbow
M08.052	Juvenile rheumatoid arthritis, left elbow
M08.059	Juvenile rheumatoid arthritis, elbow, unspecified
M08.061	Juvenile rheumatoid arthritis, right wrist
M08.062	Juvenile rheumatoid arthritis, left wrist
M08.069	Juvenile rheumatoid arthritis, wrist, unspecified
M08.071	Juvenile rheumatoid arthritis, right hand

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Applicable ICD-10 diagnosis codes (listed in document)ICD-10

M08.041	Juvenile rheumatoid arthritis, right shoulder
M08.042	Juvenile rheumatoid arthritis, left shoulder
M08.049	Juvenile rheumatoid arthritis, shoulder, unspecified
M08.051	Juvenile rheumatoid arthritis, right elbow
M08.052	Juvenile rheumatoid arthritis, left elbow
M08.059	Juvenile rheumatoid arthritis, elbow, unspecified
M08.061	Juvenile rheumatoid arthritis, right wrist
M08.062	Juvenile rheumatoid arthritis, left wrist
M08.069	Juvenile rheumatoid arthritis, wrist, unspecified
M08.071	Juvenile rheumatoid arthritis, right hand

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Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with indication-specific criteria

Initial and continuation authorizations must meet the policy's indication‑specific clinical criteria (diagnosis, dosing per FDA label, prescriber specialty where specified) and are authorized for specified maximum durations (generally up to 12 months for most indications; up to 4 doses for aGVHD prophylaxis and certain checkpoint‑toxicity uses).

J0129

Documentation Required

Documentation of response for continuation

For continuation authorizations, providers must document a positive clinical response. Where specified by the indication, documentation must also show prior receipt of Orencia intravenous infusion before continuation.

Clinical Evidence Summary

39.4%PsA Phase 3 ACR20 at week 24 (abatacept) vs placebo 22.3% (p=0.001)

22.3%Placebo ACR20 at week 24 (PsA)

76.0%RA noninferiority ACR20 at month 6: SC abatacept

75.8%RA noninferiority ACR20 at month 6: IV abatacept (difference 0.3%, 95% CI ~ -4.2 to 4.8)

Cohort1 83.2%PJIA Phase 3 JIA-ACR30 at month 4 (cohort 1, ages 6–17)

Cohort2 89.1%PJIA Phase 3 JIA-ACR30 at month 4 (cohort 2, ages 2–5)

97%GVHD prophylaxis OS at 180 days (abatacept + CNI/MTX, 8/8 cohort)

84%GVHD prophylaxis OS at 180 days (placebo + CNI/MTX, 8/8 cohort)

Background

Background: Orencia (abatacept) is a soluble fusion protein that modulates T‑lymphocyte costimulation by binding CD80/CD86 and blocking interaction with CD28, thereby inhibiting full T cell activation. The policy distinguishes benefit routing by formulation: IV Orencia (administration coded as J0129) is addressed under the medical benefit, while self‑administered subcutaneous Orencia is obtained under the pharmacy benefit unless the member specific benefit plan or certain UnitedHealthcare of California delegated arrangements specify medical benefit routing. Providers should consult the member's plan document for final benefit assignment.

FDA Indications (informational for coverage decisions)

Targeted immunomodulatorExamples listed in the policy include Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), and others depending on indication.

OrenciaBrand name for abatacept, a CTLA4‑Ig fusion protein that modulates T‑cell co‑stimulation (binds CD80/CD86 to block CD28 interaction).

CNICalcineurin inhibitor (used in combination with Orencia for aGVHD prophylaxis in the policy).

Revision History

10/01/2025material_changeLatest

Added language clarifying that self‑administered subcutaneous Orencia (abatacept) is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise; exception for certain UnitedHealthcare of California delegated provider groups where self‑administered Orencia may be obtained under the medical benefit; archived previous policy version 2025D0039U.

10/01/2025codes_updated

Applicable ICD-10 diagnosis codes list updated to reflect annual edits (Applicable Codes section revised, MOS.A added).

10/01/2025administrative

Policy Summary

PayerUnitedHealthcare

PolicyOrenciac (Abatacept) Injection for Intravenous Infusion

Policy CodePolicy 2025D0039V

Change TypeClarified benefit assignment; ICD-10 updates; archived prior version

Effective DateOct 1, 2025

Next Review Date

On This Page

Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., Enbrel [etanercept], Cimzia [certolizumab], Simponi [golimumab], adalimumab, Xeljanz [tofacitinib], Olumiant [baricitinib], Rinvoq [upadacitinib]).

Chronic Graft‑Versus‑Host Disease (cGVHD) - Initial and Continuation Therapy

Chronic Graft‑Versus‑Host Disease (cGVHD) - Initial Therapy

ALL of the following

Diagnosis of steroid-refractory chronic graft-versus-host disease (cGVHD).
For initial therapy
- One of the following
  - Patient is intolerant to systemic corticosteroid therapy.
  - Patient is receiving Orencia in combination with systemic corticosteroids.
- Initial authorization is for no more than 12 months.

Prophylaxis of Acute Graft‑Versus‑Host Disease (aGVHD)

Prophylaxis of Acute Graft‑Versus‑Host Disease (aGVHD) - Initial Therapy style criteria

ALL of the following

One of the following age/donor options
- ALL of the following
  - Patient is at least 2 years old.
  - Patient is undergoing hematopoietic stem cell transplantation (HSCT) from a matched donor.
- Patient is undergoing HSCT from a 1 allele-mismatched unrelated donor.
Patient is receiving Orencia in combination with a calcineurin inhibitor (and mention methotrexate where present).
If specified, patient is receiving Orencia in combination with methotrexate.
Authorization is for no more than 4 doses.

Immune Checkpoint Inhibitor‑Related Toxicities

Immune Checkpoint Inhibitor‑Related Toxicities - Initial Therapy

ALL of the following

Diagnosis of severe (Grade 3) or life threatening (Grade 4) immunotherapy-related myocarditis, pericarditis, arrhythmias, impaired ventricular function, or conduction abnormalities.
Patient has recently received checkpoint inhibitor therapy (e.g., pembrolizumab, nivolumab).
No improvement of toxicity within 24 hours of starting pulse-dose methylprednisolone.
Prior therapy requirement
- History of failure, contraindication, or intolerance to infliximab (e.g., Inflectra, Remicade).
Authorization is for no more than 4 doses.

Note

Coverage Rationale / Benefit Considerations

Billing Rule

Do not combine with listed targeted immunomodulators

Claims reflecting concurrent use of Orencia with the targeted immunomodulators listed in the policy are excluded across multiple indications and may be denied.

etanercept (Enbrel)
certolizumab (Cimzia)
golimumab (Simponi)
adalimumab
tofacitinib (Xeljanz)
baricitinib (Olumiant)
upadacitinib (Rinvoq)
others listed in the policy (e.g., guselkumab, ustekinumab, secukinumab, ixekizumab, apremilast)

Documentation Required

Specialist prescribing requirement for certain indications

Prescriptions must be written by appropriate specialists as specified: for PJIA and RA, by or in consultation with a rheumatologist; for psoriatic arthritis, by or in consultation with a rheumatologist or dermatologist.

Prior Authorization

Prior authorization / benefit assignment

Self‑administered subcutaneous Orencia is generally obtained under the pharmacy benefit, while intravenous Orencia is routed under the medical benefit. Exception: for members enrolled in UnitedHealthcare of California plans where a delegated provider group conducts the prior authorization review, self‑administered subcutaneous Orencia may be obtained under the medical benefit. Providers should follow member‑specific benefit plan documents and delegated reviewer rules for prior authorization and benefit assignment.

Documentation Required

Member specific benefit plan governs

When there is any conflict between this policy and the member's plan, the member specific benefit plan document governs coverage decisions; always reference the member's plan documents and applicable mandates.

Note

CMS / Medicare note

For Medicare Advantage, in the absence of a Medicare NCD or LCD or other Medicare coverage guidance, a Medicare Advantage organization may create its own coverage determinations using objective evidence‑based rationale and authoritative evidence as described by CMS guidance.

Scope of evidence: The policy references randomized controlled trials and Phase 3 studies supporting efficacy of abatacept across multiple indications (e.g., PsA Phase 3 showing ACR20 benefit; RA SC vs IV noninferiority trials; PJIA trials with sustained responses; GVHD prophylaxis studies showing improved OS in some cohorts). In contrast, the ACCLAIM MS trial did not demonstrate efficacy — there was no statistically significant difference in the mean number of new gadolinium‑enhancing lesions versus placebo — and SLE and Behcet uveitis studies failed to meet primary endpoints or lack sufficient evidence, so these uses are considered unproven.

Applicable Codes section updated in policy history and prior policy version 2025D0039U archived.