ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0039AE

Orencia (abatacept) Injection for Intravenous Infusion

Medical benefit drug policy describing coverage criteria, indications, and coding for Orencia (abatacept) administered by intravenous infusion for UnitedHealthcare Community Plan members; affects providers requesting medical benefit authorization for IV abatacept.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOrencia (abatacept) Injection for Intravenous Infusion

Policy CodePolicy CS2026D0039AE

Change TypeOperational — revised example drug lists and terminology

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation that the patient meets the indication-specific criteria, including diagnosis, prior therapy requirements or intolerance, dosing per FDA label, and prescriber specialty where specified.

SourceLink

POLICY UPDATE CHANGES

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and updated lists of examples of systemic targeted immunomodulators for multiple indications, including replacing 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)'.

12 monthstypical initial or continuation authorization duration for many indications

4 dosesauthorization limit for acute GVHD and certain indications

J0129listed HCPCS code for abatacept (10 mg)

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Multiple labeled indications

06/01/2026Policy revision date

Coverage Criteria for IV Abatacept (Orencia)

Applicable diagnosis codes

Applicable diagnosis codes (ICD-10) that may support medical necessity for indications listed in this policy. Presence of a listed code does not by itself guarantee coverage; coverage is determined by meeting the clinical criteria in the applicable indication-specific criteria groups.

M05.441 - Rheumatoid myopathy with rheumatoid arthritis of right hand

M05.442 - Rheumatoid myopathy with rheumatoid arthritis of left hand

M05.449 - Rheumatoid myopathy with rheumatoid arthritis of unspecified hand

M05.451 - Rheumatoid myopathy with rheumatoid arthritis of right hip

M05.452 - Rheumatoid myopathy with rheumatoid arthritis of left hip

M05.459 - Rheumatoid myopathy with rheumatoid arthritis of unspecified hip

M05.461 - Rheumatoid myopathy with rheumatoid arthritis of right knee

M05.462 - Rheumatoid myopathy with rheumatoid arthritis of left knee

M05.469 - Rheumatoid myopathy with rheumatoid arthritis of unspecified knee

M05.471 - Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot

M05.472 - Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot

M05.479 - Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot

M05.49 - Rheumatoid myopathy with rheumatoid arthritis of multiple sites

M05.50 - Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site

M05.511 - Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder

M05.512 - Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

M05.519 - Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder

M05.521 - Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow

Documentation requirement: Medical record documentation supporting the diagnosis (history, exam, relevant labs/imaging, prior treatment trials and responses) must be submitted with the authorization request and must correlate to the submitted ICD-10-CM code(s).

Coding — HCPCS and ICD-10 Codes

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for IV abatacept (J0129) and must include documentation that the patient meets the indication-specific criteria (diagnosis, prior therapy requirements or intolerance, dosing per FDA label, and prescriber specialty or consultation where specified).

Applicable HCPCS: J0129 must be used for billing of IV abatacept.

Billing Rule

Applicable ICD-10 codes for prior authorization

Use an applicable diagnosis code from the M05, M06, or M08 series listed in the policy when submitting authorization requests and claims for IV abatacept.

Examples include M05.* (rheumatoid arthritis with rheumatoid factor), M06.* (rheumatoid arthritis without rheumatoid factor), and M08.* (juvenile arthritis codes) as listed in the policy.

Background and Clinical Summary

Background: Abatacept (Orencia) is a selective co‑stimulation modulator that inhibits T‑lymphocyte activation by binding CD80 and CD86. This policy covers the intravenous formulation of abatacept under the medical benefit (subcutaneous formulations are managed under the pharmacy benefit). The document addresses labeled rheumatologic indications (adult rheumatoid arthritis, adult psoriatic arthritis, and pediatric polyarticular juvenile idiopathic arthritis ≥2 years) as well as transplant-related uses (acute and chronic graft‑versus‑host disease) and certain immune checkpoint inhibitor–related toxicities. Coverage requirements reference FDA dosing and specialty-society guidance (e.g., NCCN for GVHD and ACR/NPF and ACR/Arthritis Foundation guidelines for rheumatologic conditions).

Definitions and Key Terms

inv-40: Benefit split (medical vs pharmacy benefit)

Medical vs Pharmacy benefitIV abatacept (Orencia) is managed under the medical benefit; subcutaneous abatacept is managed under the pharmacy benefit.

Implication for orderingRequests for IV Orencia should be submitted through medical benefit authorization processes; SC products are channelled via pharmacy benefit.

Source statementPolicy specifically refers to Orencia injection for intravenous infusion and notes SC formulation is obtained under the pharmacy benefit.

inv-41: M05 series definition

M05 series descriptionRheumatoid arthritis with rheumatoid factor (various anatomic site specifications).

Examples includedNumerous site-specific M05 codes are listed (e.g., M05.441, M05.442, M05.449, M05.471).

Revision History and Policy Updates

2026-06-01policy_revisionLatest

Revised coverage rationale and prior authorization examples: replaced 'targeted immunomodulator' with 'systemic targeted immunomodulator' and updated lists of example agents (e.g., Xeljanz listed as Xeljanz/Xeljanz XR).

2026-06-01policy_revision_archived_prior_version

Updated indication-specific example drug lists (RA, PsA, polyarticular JIA) including addition of Bimzelx and removal of Olumiant; archived prior policy version CS2026D0039AD.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOrencia (abatacept) Injection for Intravenous Infusion

Policy CodePolicy CS2026D0039AE

Change TypeOperational — revised example drug lists and terminology

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Prior Authorization

Prior authorization — GVHD and NCCN-recommended uses

For chronic GVHD and certain NCCN-recommended uses (e.g., ICI-related toxicities), include documentation reflecting NCCN-recommended scenarios: chronic GVHD as additional therapy with systemic corticosteroids for steroid-refractory disease, and ICI-related myocarditis/pericarditis when steroid-refractory and infliximab is failed/contraindicated.

For aGVHD prophylaxis/trial dosing (when relevant), document the clinical regimen consistent with trials (e.g., 10 mg/kg IV on Day -1, 5, 14, 28) and concomitant CNI and methotrexate where applicable.

Note

Updated prior authorization examples and terminology

Policy language and example drug lists were updated to reference 'systemic targeted immunomodulator' and to revise the examples of agents that must not be used concurrently or that may satisfy prior exposure requirements.

Examples were revised (e.g., replaced 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)'; Bimzelx was added and Olumiant removed in PsA examples).

Step Therapy

Required prior DMARD or targeted therapy trial

For initial therapy in RA and for PsA in many cases, the policy requires prior trial and failure (or intolerance) of a 3-month course of a non-biologic DMARD (e.g., methotrexate) at maximally indicated doses unless contraindicated, or prior treatment with a systemic targeted immunomodulator.

A 3-month trial duration is specified for csDMARD/methotrexate prior therapy unless contraindicated.
Prior treatment with a systemic targeted immunomodulator FDA‑approved for the indication may satisfy the requirement.

Note

Not applicable

Not applicable.

Step Therapy

Step therapy considerations — Psoriatic arthritis

For psoriatic arthritis, guidelines cited in the policy recommend switching to a TNF inhibitor, IL-17 inhibitor, or IL-12/23 inhibitor over abatacept in many scenarios; document reasons for choosing abatacept (e.g., contraindication to preferred agents) when requesting authorization.

Consider abatacept only when guideline-preferred agents are contraindicated or not tolerated; include supporting clinical rationale in the request.

Step Therapy

Guideline-based preferred sequencing

Follow guideline-based sequencing: for PsA prefer TNFi, IL-17i, or IL-12/23i over abatacept in many cases; for RA follow treat-to-target with csDMARDs (e.g., methotrexate) before escalating to biologic/targeted therapies, and document prior therapies accordingly.

Document prior csDMARD therapy and treat-to-target rationale when applicable.

Documentation Required

Continuation documentation

For continuation authorizations, provide documentation of prior receipt of IV Orencia and a positive clinical response, and confirm dosing is per FDA labeling for the indication.

Continuation requests should include prior infusion records, clinical response notes, and current dosing schedule.

Documentation Required

Documentation of applicable ICD-10 code requirement

Authorization requests and claims must list the applicable ICD-10 diagnosis code from the M05, M06, or M08 series as specified in the policy.

Ensure the diagnosis code used matches the clinical indication and the codes listed in the policy's coding section.

Documentation Required

Diagnosis coding documentation for juvenile arthritis

When treating juvenile arthritis, include the specific ICD-10-CM juvenile arthritis code (M08 series) that corresponds to the affected site/subtype from the policy's extensive code list when submitting claims or authorizations.

Examples include M08.262 (juvenile rheumatoid arthritis with systemic onset, left knee) and other site-specific M08 codes listed in the policy.

Documentation Required

Required documentation on concurrent biologic use

Prescriber documentation must confirm that Orencia is not being administered concomitantly with TNF antagonists or other biologic RA therapies; include indication, prior therapies, and rationale for combination if claimed.

Clinical notes should document absence of concurrent TNF antagonist or other biologic RA therapy use, or provide clear justification if combination is being proposed.

Denial Risk

Concomitant therapy and prescriber requirement

Do not request concurrent administration of Orencia with TNF antagonists or other biologic RA therapies; the policy and FDA label state concomitant use was associated with higher rates of infections and lacked demonstrated benefit.

Requests proposing concurrent biologic therapy for the same indication risk denial unless clear, policy‑supported justification is provided.

Billing Rule

Provider action — ICD-10 list only (no triggers)

When submitting an authorization, include only the applicable ICD-10 diagnosis code(s) from the policy's listed M05/M06/M08 series; the coding section contains the full list to select the precise code.

The policy's code lists should be used to pick the most specific ICD-10 code for the clinical indication.

Note

Provider action — no explicit denial triggers in these chunks

These policy sections containing code lists do not include explicit additional authorization or denial triggers; they serve to list applicable diagnosis codes used for coverage and billing.

Ensure clinical documentation meets the coverage criteria; code lists alone do not establish medical necessity.

Denial Risk

Concurrent biologic therapy risk

Requests proposing concurrent biologic therapy (e.g., Orencia plus a TNF antagonist or anakinra) present a high risk of denial because trials showed increased infections and no added efficacy; prescribers must avoid or justify such combinations in documentation.

Controlled trials reported higher infection rates with concomitant Orencia and TNF antagonists (63% infections vs 43% and serious infections 4.4% vs 0.8%).
Policy states not to administer Orencia concomitantly with TNF antagonists or other biologic RA therapies.

Use in policyM05.* codes are applicable diagnosis codes for coverage and prior authorization submissions where relevant.

inv-42: M06 series definition

M06 series descriptionRheumatoid arthritis without rheumatoid factor and other specified rheumatoid arthritides (various anatomic site specifications).

Examples includedMultiple M06 site-specific codes are listed (e.g., M06.012, M06.019, M06.021).

Use in policyM06.* codes are among the diagnosis codes applicable for coverage and prior authorization submissions.

inv-43: M08 series definition

M08 series descriptionJuvenile rheumatoid arthritis / juvenile idiopathic arthritis subtypes with site-specific coding (e.g., M08.00, M08.3, M08.262).

Examples includedCodes for systemic onset, polyarthritis, unspecified juvenile arthritis, and many site-specific variants are listed (M08.011–M08.979, etc.).

Use in policyM08.* codes are the applicable pediatric JIA diagnosis codes to document on claims and authorization requests.

inv-44: abatacept mechanism

Mechanism of actionSelective co-stimulation modulator that inhibits T‑lymphocyte activation by binding to CD80 and CD86, blocking interaction with CD28.

Pharmacologic classFully human, soluble fusion protein (abatacept).

Clinical implicationInhibits T‑cell costimulation; informs contraindication against concurrent use with other biologic RA therapies due to increased infection risk noted in trials and labeling.

inv-45: JIA outcome measures

Common JIA outcome measuresJIA‑ACR response criteria (30/50/70/90/100) and JADAS‑71‑CRP are used to assess improvement and remission in trials.

Trial endpointsPrimary PK endpoint in PJIA study was abatacept steady‑state trough (Cminss) at month 4; clinical endpoints included JIA‑ACR responses and JADAS‑71‑CRP over time.

Long‑term assessmentLong-term extension reported maintenance of ACR pediatric responses and JADAS remission up to several years of follow-up.

inv-46: Orencia (abatacept) term

Proprietary nameOrencia (abatacept)

Formulation scopePolicy refers to Orencia injection for intravenous infusion; SC Orencia products are available under the pharmacy benefit.

Labeling noteOrencia may be used as monotherapy or with non‑TNF DMARDs; labeling advises against concomitant use with TNF antagonists or other biologic RA therapies.

inv-47: treat-to-target definition

DefinitionTreat‑to‑target: a management strategy recommending a predefined treatment goal (e.g., low disease activity or remission) with regular assessment and adjustment of therapy to reach that goal.

Guideline sourceRecommended by ACR 2021 RA guideline for DMARD‑naïve patients to guide initial therapy and adjustments.

Clinical implicationSupports methotrexate‑first and escalation to biologic/targeted therapies per guideline until treatment target is achieved.