CurrentUnitedHealthcarePolicy N/A

Orencia® (Abatacept) Injection for Intravenous Infusion – Individual Exchange Medical Benefit Drug Policy

This part provides clinical evidence summaries, guideline recommendations, FDA-approved indications, references, and a policy history entry updating applicable ICD-10 diagnosis codes for Orencia (abatacept) under UnitedHealthcare's Medical Benefit Drug Policy. It is informational and supports coverage decision-making when combined with member-specific benefits.

Policy Summary

PayerUnitedHealthcare

PolicyOrencia® (Abatacept) Injection for Intravenous Infusion – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy N/A

Change TypeRevised ICD-10 diagnosis codes

Effective DateOctober 1, 2025

Next Review DateN/A

Key ActionWhen deciding coverage, reference the member specific benefit plan document as it may differ from the standard benefit plan; in the event of conflict, the member specific benefit plan governs.

SourceLink

POLICY UPDATE CHANGES

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

MultipleIndications summarized

1Policy history entry (10/01/2025)

May 2024Latest referenced FDA label date

Coverage summary & scope

This part is informational and is intended to support coverage decision-making when considered together with the member-specific benefit plan. It summarizes FDA-approved indications for Orencia (abatacept): treatment of rheumatoid arthritis (RA), treatment of psoriatic arthritis (PsA), treatment of polyarticular juvenile idiopathic arthritis (PJIA/JIA) in pediatric patients 2 years and older, and use for graft-versus-host disease (GVHD) prophylaxis and treatment-related GVHD indications described in the label and clinical studies. The document also notes areas where evidence is insufficient or trials were negative or failed to show efficacy, including multiple sclerosis (ACCLAIM), systemic lupus erythematosus (Phase II), and Behçet's-associated uveitis.

Provider guidance and operational notes

Documentation Required

Reference member-specific benefit plan

When deciding coverage, reference the member specific benefit plan document as it may differ from the standard benefit plan; in the event of conflict, the member specific benefit plan governs.

When deciding coverage, reference the member specific benefit plan document as it may differ from the standard benefit plan; in the event of conflict, the member specific benefit plan governs.

Documentation Required

Check federal/state mandates and third-party tools

Before using this policy, check the member specific benefit plan document and any applicable federal or state mandates; UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administering benefits.

Before using this policy, check the member specific benefit plan document and any applicable federal or state mandates.
UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administering benefits.

This document is provided for informational purposes only. Prior authorization decisions and actual coverage depend on the member-specific benefit plan and any applicable federal or state mandates or third-party tools (for example, InterQual). In the event of a conflict, the member-specific benefit plan governs.

Key trials, outcomes, and guideline summaries

60.9%DAS28(CRP) remission at 12 months (abatacept + MTX vs MTX 45.2%)

76.0%ACR20 at 6 months — SC abatacept (noninferior to IV 75.8%)

83.2%/89.1%JIA‑ACR30 at month 4 — cohort1 (6–17y) / cohort2 (2–5y)

87%/50%/97%GVHD Day 180 — grade III‑IV GFS / grade II‑IV GFS / OS (abatacept, 8/8 cohort)

Evidence summary: AVERT (early RA) — DAS28(CRP) remission at 12 months: abatacept + MTX 60.9% vs MTX 45.2% (p=0.010); sustained remission after withdrawal 14.8% vs 7.8% (p=0.045).

SC vs IV abatacept (Genovese et al, Phase 3b) — ACR20 at 6 months: SC 76.0% vs IV 75.8% (noninferiority demonstrated); comparable safety profiles.

PJIA phase 3 open-label (Brunner et al) — JIA-ACR30 at month 4: cohort 1 83.2%, cohort 2 89.1%; responses were maintained to month 24 and steady-state trough concentrations exceeded the target (Cminss > 10 µg/ml).

GVHD prophylaxis (GVHD-1, 8/8 cohort Day 180) — Grade III–IV GVHD-free survival 87% (HR 0.55); Grade II–IV GFS 50% (HR 0.54); Overall survival 97% (HR 0.33) versus placebo rates 75%, 32%, and 84%, respectively.

ACCLAIM (RRMS) — trial did not demonstrate efficacy; no statistically significant difference in mean number of new gadolinium-enhancing lesions.

SLE Phase II — failed to meet primary endpoint (no difference in proportion experiencing new SLE flare over 12 months).

Behçet's uveitis — insufficient published clinical evidence to support safety and efficacy.

Background, FDA label, and definitions

Background: This document part summarizes clinical trial evidence and guideline recommendations across multiple conditions (RA, PsA, JIA/PJIA, GVHD prophylaxis and treatment, MS, SLE, Behçet's uveitis), and provides FDA indications and safety information for Orencia (abatacept). The latest referenced FDA label date in this part is May 2024.

Definitions: ACR20/30/50/70/90/100 — American College of Rheumatology criteria indicating the percentage improvement in rheumatoid arthritis or juvenile idiopathic arthritis signs and symptoms (e.g., ACR20 = 20% improvement; ACR30 = 30% improvement, etc.).

DAS28(CRP) — Disease Activity Score using 28 joints with C-reactive protein; used to define remission and disease activity in rheumatoid arthritis (for example, DAS28(CRP) < 2.6 = remission in AVERT).

References

References: Orencia [package insert]. Bristol-Myers Squibb Company; May 2024.

Genovese MC et al. Subcutaneous abatacept versus intravenous abatacept. Arthritis Rheum. 2011.

Brunner HI et al. Subcutaneous Abatacept in PJIA. Arthritis Rheumatol. 2018.

Bristol-Myers Squibb Company. Primary Clinical Study Report for abatacept for GVHD prophylaxis (IM101311) and related trial reports.

Merrill JT et al. Abatacept in SLE. Arthritis Rheum. 2010.