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Sierra Health and Life Orencia Coverage Update | OpenPayer

Modifiedsierra health and lifePolicy 2025D0039V

Orencia (Abatacept) Injection for Intravenous Infusion - Medical Benefit Drug Policy

Medical benefit coverage criteria and authorization requirements for Orencia (abatacept) administered by intravenous infusion across multiple indications (RA, PsA, PJIA, GVHD, aGVHD prophylaxis, and immune checkpoint inhibitor toxicities) for Sierra Health and Life members governed by this policy.

Policy Summary

Payersierra health and life

PolicyOrencia (Abatacept) Injection for Intravenous Infusion - Medical Benefit Drug Policy

Policy CodePolicy 2025D0039V

Change TypeBenefit-channel clarificationICD‑10 code update

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, prior therapy per guideline sequencing, and confirm benefit channel per member plan (SC self‑administered usually pharmacy benefit).

SourceLink

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 members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, the self-administered Orencia may be obtained under the medical benefit.

Updated list of applicable ICD-10 diagnosis codes to reflect annual edits; added M05.A.

Archived previous policy version 2025D0039U.

12 monthsTypical auth length

4 dosesaGVHD limit

J0129

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Coverage Criteria and Indications

Polyarticular juvenile idiopathic arthritis (PJIA) - Initial and Continuation

Covered when ALL of the following are met

Initial therapy - PJIA: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); and Orencia is initiated and titrated according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., etanercept, certolizumab, golimumab, adalimumab, tofacitinib, baricitinib, upadacitinib); and Initial authorization is for no more than 12 months

Continuation therapy - PJIA: Patient has previously received Orencia IV infusion; and Documentation of positive clinical response; and Orencia is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., etanercept, certolizumab, golimumab, adalimumab, tofacitinib, baricitinib, upadacitinib); and Authorization is for no more than 12 months

Rheumatoid arthritis (RA) - Initial and Continuation

Covered when ALL of the following are met

Initial therapy - RA: Diagnosis of moderately to severely active rheumatoid arthritis (RA); and One of the following: history of failure or intolerance to a 3-month trial of one non-biologic DMARD at maximally indicated doses (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) unless contraindicated, OR prior treatment with a targeted immunomodulator FDA-approved for RA (e.g., certolizumab, adalimumab, golimumab, baricitinib, upadacitinib, tofacitinib, etanercept), OR patient is currently on Orencia; and Orencia is initiated and titrated according to FDA labeled dosing for rheumatoid arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., etanercept, certolizumab, golimumab, adalimumab, tofacitinib, baricitinib, upadacitinib); and Prescribed by or in consultation with a rheumatologist; and Initial authorization is for no more than 12 months

Includes embedded OR logic for prior therapy

Continuation therapy - RA: Patient has previously received Orencia IV infusion; and Documentation of positive clinical response; and Orencia is dosed according to FDA labeled dosing for rheumatoid arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., etanercept, certolizumab, golimumab, adalimumab, tofacitinib, baricitinib, upadacitinib); and Authorization is for no more than 12 months

Psoriatic arthritis (PsA) - Initial and Continuation

Covered when ALL of the following are met

Initial therapy - PsA: Diagnosis of active psoriatic arthritis (PsA); and One of the following: history of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated, OR prior treatment with a targeted immunomodulator FDA-approved for PsA (e.g., certolizumab, adalimumab, golimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, tofacitinib, apremilast, etanercept), OR patient is currently on Orencia; and Orencia is initiated and titrated according to FDA labeled dosing for psoriatic arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (examples include TNF inhibitors and other listed agents); and Prescribed by or in consultation with a rheumatologist or dermatologist; and Initial authorization is for no more than 12 months

Includes embedded OR logic for prior therapy

Continuation therapy - PsA: Patient has previously received Orencia IV infusion; and Documentation of a positive clinical response; and Orencia is dosed according to FDA labeled dosing for psoriatic arthritis; and Patient is not receiving Orencia in combination with a targeted immunomodulator (e.g., TNF inhibitors, IL-17/IL-23 inhibitors, JAK inhibitors, apremilast); and Authorization is for no more than 12 months

Chronic graft-versus-host disease (chronic GVHD) - Initial and Continuation

Covered when ALL of the following are met

Initial therapy - chronic GVHD: Diagnosis of steroid-refractory chronic graft-versus-host disease (chronic GVHD); and One of the following: patient is receiving Orencia in combination with systemic corticosteroids, OR patient is intolerant to systemic corticosteroid therapy; and Initial authorization is for no more than 12 months

Continuation therapy - chronic GVHD: Documentation of positive clinical response; and Patient continues to experience chronic GVHD; and One of the following: patient is receiving Orencia in combination with systemic corticosteroids, OR patient is intolerant to systemic corticosteroid therapy, OR patient has been successfully tapered off corticosteroid therapy; and Authorization is for no more than 12 months

Prophylaxis of acute graft-versus-host disease (aGVHD)

Covered when ALL of the following are met

aGVHD prophylaxis: Patient is at least 2 years old; and Patient is undergoing hematopoietic stem cell transplantation (HSCT) from a matched donor or a 1 allele-mismatched unrelated donor; and Patient is receiving Orencia in combination with a calcineurin inhibitor and methotrexate; and Authorization is for no more than 4 dosesno more than 4 doses

Dosing schedule per trials: Days -1, 5, 14, 28 (IV abatacept 10 mg/kg, 1,000 mg max)

Immune checkpoint inhibitor-related toxicities

Covered when ALL of the following are met

ICI-related severe cardiotoxicity: Recent receipt of checkpoint inhibitor therapy; and Diagnosis of severe (Grade 3) or life-threatening (Grade 4) immunotherapy-related myocarditis, pericarditis, arrhythmia, or impaired ventricular function or conduction abnormality; and No improvement within 24 hours of starting pulse-dose methylprednisolone; and History of failure, contraindication, or intolerance to infliximab; and Authorization is for no more than 4 dosesauthorization <= 4 doses

NCCN supports abatacept as additional immunosuppression when high-dose steroids fail to rapidly improve myocarditis

Evidence-supported indications and trial findings

Clinical uses and evidence summaries present the contexts in which abatacept has demonstrated efficacy or been studied:

Rheumatoid arthritis: Phase 3 trials demonstrate abatacept (SC and IV) noninferior efficacy vs IV and effectiveness with methotrexate in RA populations with inadequate response to MTX/DMARDs

ACR20 and related outcomes reported in trial publications

Psoriatic arthritis: Phase 3 randomized placebo-controlled trial showed higher ACR20 at week 24 with abatacept versus placebo (39.4% vs 22.3%); modest impact on psoriasis lesions; benefits maintained to week 52

Primary endpoint ACR20

Polyarticular juvenile idiopathic arthritis: Phase 3 and long-term extension data support SC abatacept with weight-tiered dosing in PJIA with JIA-ACR responses maintained to month 24 and steady-state trough concentrations above target exposure (>= 10 µg/ml)>= 10 µg/ml

JIA-ACR response rates and Cminss reported

Coverage criteria (integrated FDA and guideline-aligned)

Covered when consistent with FDA labeling and specialty society guidance; use criteria reflect trial evidence and guideline sequencing:

FDA-approved indications: Patient has an indication consistent with FDA labeling (adult rheumatoid arthritis; polyarticular juvenile idiopathic arthritis age >= 2 years; adult psoriatic arthritis)

Based on Orencia prescribing information

Guideline-supported uses: Use aligns with professional society recommendations (e.g., ACR, AAD, NCCN) such as switching to abatacept when TNF inhibitors or other preferred biologics are contraindicated or ineffective; treat-to-target and prior csDMARD optimization considered per ACR guidance

See ACR and NCCN guidance citations

Prior therapy/step therapy: For RA and PsA, documentation of previous trial and inadequate response or intolerance to recommended conventional synthetic DMARD(s) (e.g., methotrexate) or documented contraindication to preferred agents, or prior biologic therapy per guideline recommendations

Reflects ACR treatment sequencing and step therapy requirements

Benefit-channel coverage rule

Coverage/benefit determination instructions

Benefit channel determination: Self-administered subcutaneous Orencia (abatacept) is obtained under the pharmacy benefit unless member-specific benefit plan documents specify otherwise; for members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, self-administered Orencia may be obtained under the medical benefit.N/A

Follow member-specific plan in event of conflict.

Use of Orencia (abatacept) for multiple sclerosis, systemic lupus erythematosus (SLE), and uveitis associated with Behçet's disease is considered unproven and not medically necessary based on the evidence reviewed in this policy.

Orencia is explicitly listed in this policy as not medically necessary for the treatment of multiple sclerosis, systemic lupus erythematosus, and Behçet's-associated uveitis because available data do not support its effectiveness for these conditions.

The ACCLAIM Phase II trial in relapsing‑remitting multiple sclerosis did not show efficacy: there was no statistically significant difference between abatacept and placebo in the mean number of new gadolinium‑enhancing MRI lesions or in other MRI and clinical measures, and the study authors concluded abatacept did not demonstrate benefit in RRMS.

Clinical trial evidence does not support abatacept for the listed neurologic and autoimmune indications. The ACCLAIM Phase II study in RRMS failed to show a reduction in new Gd+ MRI lesions or clinical benefit. A separate randomized Phase II MS study was terminated early for safety concerns in one treatment arm and did not establish efficacy. A Phase II randomized trial in SLE did not meet its primary endpoint for reduction in adjudicated SLE flares. For uveitis associated with Behçet's disease, published peer‑reviewed evidence is insufficient to establish safety and efficacy.

When this policy does not explicitly exclude or approve a use for a particular member, coverage determinations must follow the member‑specific benefit plan document and any applicable federal or state mandates; in the event of conflict the member plan governs.

In summary, Orencia is designated in this policy as unproven and not medically necessary for multiple sclerosis, systemic lupus erythematosus, and uveitis associated with Behçet's disease and requests for these indications may be denied.

The policy explicitly lists three conditions—MS, SLE, and Behçet's‑associated uveitis—for which Orencia is considered not medically necessary due to lack of supportive clinical evidence.

Specific trial results underpin the not‑medically‑necessary stance: the ACCLAIM study in RRMS failed to demonstrate benefit, the SLE Phase II randomized trial did not meet its primary efficacy endpoint, and there is insufficient published evidence to support abatacept for Behçet's‑associated uveitis.

Note that although the policy identifies these indications as unproven and not medically necessary, coverage decisions should still reference the member's benefit plan and any applicable mandates because plan‑specific language or legal requirements may supersede the standard policy.

Coding, Diagnosis, and Authorization Limits

Applicable HCPCS CodesHCPCSCovered

J0129

Injection, abatacept, 10 mg

Applicable ICD-10 Codes (selected)ICD-10

D89.811	Chronic graft-versus-host disease
D89.812	Acute on chronic graft versus host disease
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy
M05.A	Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis

Related ICD-10 Codes (selection)ICD-10

M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.012	Felty's syndrome, left shoulder
M05.019	Felty's syndrome, unspecified shoulder
M05.021	Felty's syndrome, right elbow
M05.022	Felty's syndrome, left elbow
M05.029	Felty's syndrome, unspecified elbow
M05.031	Felty's syndrome, right wrist
M05.032	Felty's syndrome, left wrist
M05.039	Felty's syndrome, unspecified wrist

HCPCS Codes (neutral listing)HCPCS

J0129

Injection, abatacept, 10 mg

Example ICD-10 CodesICD-10

D89.811	Chronic graft-versus-host disease
L40.50	Arthropathic psoriasis, unspecified
M05.A	Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis

ICD-10 Diagnosis Codes - Extended ListICD-10

M05.611	Rheumatoid arthritis of right shoulder with involvement of other organs and systems
M05.612	Rheumatoid arthritis of left shoulder with involvement of other organs and systems
M05.619	Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems
M05.621	Rheumatoid arthritis of right elbow with involvement of other organs and systems
M05.622	Rheumatoid arthritis of left elbow with involvement of other organs and systems
M05.629	Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems
M05.631	Rheumatoid arthritis of right wrist with involvement of other organs and systems
M05.632	Rheumatoid arthritis of left wrist with involvement of other organs and systems
M05.639	Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems
M05.641	Rheumatoid arthritis of right hand with involvement of other organs and systems

1–10 of 126

1/13

Additional ICD-10 Code GroupsICD-10

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
M08.212	Juvenile rheumatoid arthritis with systemic onset, left shoulder
M08.219	Juvenile rheumatoid arthritis with systemic onset, unspecified shoulder
M08.221	Juvenile rheumatoid arthritis with systemic onset, right elbow
M08.222	Juvenile rheumatoid arthritis with systemic onset, left elbow
M08.229	Juvenile rheumatoid arthritis with systemic onset, unspecified elbow
M08.231	Juvenile rheumatoid arthritis with systemic onset, right wrist

No explicit codes in this sectionmixed

No codes listed

Updated ICD-10 Diagnosis CodesICD-10

M05.A

Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Orencia (abatacept) administered via intravenous infusion. Self-administered subcutaneous Orencia is typically obtained under the pharmacy benefit unless the member-specific plan or delegated review for certain UnitedHealthcare of California plans specifies the medical benefit. Always consult the member-specific benefit plan document to confirm benefit channel and prior authorization requirements.

Prior authorization required for Orencia IV (medical benefit) unless member plan specifies otherwise
Self-administered SC Orencia is typically pharmacy benefit; may be medical for certain delegated plans (UnitedHealthcare of California)

Billing Rule

Abatacept (Orencia) Billing and Coding

Background and Clinical Context

Abatacept (Orencia) is a fully human, soluble fusion protein that acts as a selective co‑stimulation modulator, inhibiting T‑lymphocyte activation via binding to CD80/CD86. Intravenous abatacept is used across rheumatologic and certain transplant‑related indications addressed in this policy and is administered per FDA‑labeled dosing for approved indications.

Definitions and Key Terms

inv-51: aGVHD prophylaxis

UseAbatacept used for prophylaxis of acute GVHD in HSCT recipients in combination with a calcineurin inhibitor and methotrexate

PopulationEvaluated in patients age ≥6 years in GVHD studies; policy aGVHD prophylaxis criterion includes patients ≥2 years old

Dosing regimen in trialsIV abatacept 10 mg/kg (1,000 mg max) infused Days -1, 5, 14, and 28 with CNI + MTX

inv-52: chronic GVHD

DefinitionChronic GVHD: graft-versus-host disease that is steroid-refractory or when abatacept is used with or as an alternative to systemic corticosteroids

Policy criteriaInitial therapy requires diagnosis of steroid-refractory chronic GVHD and either concurrent systemic corticosteroids or intolerance to corticosteroids

Policy Revision History

2025-10-01policy_revisionLatest

Added benefit-channel clarification that self-administered subcutaneous Orencia is obtained under the pharmacy benefit unless member plan specifies otherwise, with exception for certain UnitedHealthcare of California delegated reviews handled under the medical benefit; updated applicable ICD-10 diagnosis codes to add M05.A; archived prior policy version 2025D0039U.