Orencia (abatacept) — Clinical Medical Policy (coverage criteria)
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Clinical medical policy governing prior authorization, step therapy, quantity limits, and coverage criteria for Orencia (abatacept) for Anthem members, including indications such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, GVHD prophylaxis, chronic GVHD, and immune checkpoint inhibitor–related toxicities.
Updated 'may not approve' section; removed infection and tuberculosis testing requirements.
Added indication language for immune checkpoint inhibitor–related toxicities per NCCN.
Added prophylaxis of acute graft-versus-host disease indication and corresponding quantity limit per label.
Update may not approve section; remove infection and tuberculosis testing requirements.
Coding Reviewed: Updated description for HCPCS J0129 and added multiple ICD-10-CM codes including D89.810 and T45.AX5A-T45.AX5S.
Select Review: Update may not approve section; remove infection and tuberculosis testing requirements.
Coverage Criteria for Orencia (abatacept)
Initial Therapy
Initial requests may be approved when ALL indication-specific requirements are met as outlined below.
Continuation Therapy
Continuation requests may be approved when ALL of the following are met:
May Not Approve
Requests may not be approved when ANY of the following are present:
Benefit-specific coverage stance
Coverage and step therapy stance by benefit
See step therapy table and preferred agent listings for indication‑specific requirements.
State‑specific effective dates are provided in the benefit table.
Requests for Orencia (abatacept) in combination with certain agents are excluded from approval. Specifically, use in combination 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 not approvable.
The policy’s combination-exclusion language has been updated historically. Recent document history notes an operational revision (02/20/2026) that modified the may not approve section; additional agents were considered in prior coding and step-therapy updates (see document history for dates and details).
Use of Orencia (abatacept) for any indication not explicitly listed in the coverage criteria, or when the indication-specific criteria in this policy are not met, may not be approved.
The policy’s may not approve/denial language was updated during a select review on 02/20/2026. That revision adjusted the non-approval section and removed prior infection and tuberculosis testing requirements; specific non-medically necessary conditions are described in the criteria but additional operational details were updated in the document history.
Coding, Quantity Limits, and Formulary Status
| 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] |
| 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) |
| J0129 | HCPCS J0129 (description updated) |
| D89.810 | ICD-10-CM D89.810 (added) |
| D89.811 | ICD-10-CM D89.811 (added) |
| D89.812 | ICD-10-CM D89.812 (added) |
| D89.813 | ICD-10-CM D89.813 (added) |
| I40.8 | ICD-10-CM I40.8 (added) |
| I40.9 | ICD-10-CM I40.9 (added) |
| M60.80 | ICD-10-CM M60.80 (added) |
| M60.9 | ICD-10-CM M60.9 (added) |
| M05.A | ICD-10-CM M05.A (added effective 10/1/25) |
| Preferred Agents | Preferred agents listings vary by benefit and state (e.g., Preferred infliximab product, Simponi Aria, Avsola). |
| Non-Preferred Agents | Orencia listed as Non-Preferred in Commercial and Medicaid listings. |
Provider Actions, Prior Authorization and Step Therapy
Indication-specific prior authorization
Prior authorization is required and is indication-specific. Requests must demonstrate the member meets the clinical criteria for the requested indication (age, diagnosis severity, indication-specific requirements, and prior trial history or contraindications to conventional therapy) as described in the Clinical Criteria. Benefits may also impose additional plan-level requirements (for example, use of preferred agents or step therapy) even when clinical criteria are met.
- Applies to initial and continuation requests across indicated diagnoses.
- Prior authorization decisions reference the Clinical Criteria section for indication-specific thresholds (age, prior DMARD trials, intolerance, contraindication).
Combination and criteria failure
Requests may be denied when Orencia is requested in combination with certain agents or when combination/continuation criteria are not met. Specifically, Orencia will not be approved in combination with oral or topical JAK inhibitors, ozanimod, etrasimod, apremilast, deucravacitinib, or listed biologic immunomodulators (including TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, IL-1 inhibitors, IL-6 inhibitors, rituximab, or natalizumab).
- Combination exclusions apply regardless of indication unless otherwise specified.
- Combination use with the listed agents is a basis for denial of the request.
May Not Approve Risk
May-not-approve (denial) decisions will be issued when the request does not meet the clinical criteria or when excluded combinations are present. Reviewers may also deny requests when required supporting information is not provided or when plan-level step therapy requirements are not satisfied.
- Failure to meet indication-specific clinical criteria = denial.
- Presence of excluded combinations (see Combination and criteria failure) = denial.
- Noncompliance with step therapy or lack of documentation of preferred-agent trials may result in denial.
Required clinical documentation
Providers must submit documentation demonstrating the indication-specific criteria are met. Documentation should include: diagnosis and severity, patient age, prior treatment history including trials and outcomes (dose, duration, reason for discontinuation or intolerance), contraindications to conventional therapies, and for continuation requests, evidence of clinical benefit or stability on current therapy.
- Document prior trials of methotrexate or other conventional DMARDs (or reason for intolerance/contraindication).
- For step therapy, document trials of preferred agents (agent name, dose, duration, and reason for failure/intolerance).
- For continuation, document stable dose and clinical improvement or stabilization.
Documentation Updates
Administrative documentation requirements have been updated periodically. Recent updates removed certain prior infection and tuberculosis testing requirements and clarified documentation expectations for rheumatoid arthritis and other indications. Providers should follow the latest documentation guidance and include historical trial and intolerance information.
- 02/20/2026: Updated may-not-approve language; removed infection and TB testing requirements.
- 07/01/2025 and 03/01/2024: Administrative updates to documentation requirements; see Document History for specifics.
Step therapy requirements
Step therapy requirements apply by benefit type and indication. Commercial and some Medicaid benefits require trials of preferred targeted immune modulators prior to approval of Orencia unless the member is already receiving Orencia, has had inadequate response or intolerance to the required number of preferred agents, or has contraindications to all preferred agents. Medicare currently does not apply step therapy.
- Commercial RA and PsA: approval if currently on Orencia, OR trialed and failed TWO preferred agents, OR documented inability to use all preferred agents.
- Commercial PJIA: approval if currently on Orencia, OR trialed and failed ONE preferred agent, OR documented inability to use all preferred agents (special-case for infliximab noted).
- Medicaid (CA,NJ,OH and other states as listed): typically requires trial of ONE preferred agent prior to Orencia unless other criteria met.
- Medicare Medical Benefit: step therapy does not currently apply.
Background on Abatacept and Indications
Abatacept (Orencia) is a selective costimulation modulator that inhibits T‑lymphocyte activation. It is FDA‑approved for rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis in IV and subcutaneous formulations. Additionally, abatacept is FDA‑approved for prophylaxis of acute graft‑versus‑host disease when given IV starting Day -1 with infusions on days 5, 14, and 28 in combination with a calcineurin inhibitor and methotrexate for hematopoietic stem cell transplant from matched or 1 allele‑mismatched unrelated donors. The agent is also used off‑label per NCCN guidance (2A) for certain steroid‑refractory chronic GVHD and for select immune checkpoint inhibitor–related toxicities such as myocarditis and concomitant myositis with myocarditis.
Key Definitions and Specific Indication Notes
Document Revision History
Updated 'May Not Approve' section to remove infection and tuberculosis testing requirements; coding reviewed with no changes.
Step therapy updated; coding description for HCPCS J0129 updated and multiple ICD-10-CM codes (D89.810, T45.AX5A-T45.AX5S) added.
Added ICD-10-CM M05.A effective 2025-10-01.
Removed documentation requirement for Rheumatoid Arthritis.
Updated step therapy tables.
Updated step therapy tables.
Step therapy and step therapy table updates implemented.
Updated use in immunotherapy-related toxicities per NCCN and updated step therapy effective 2025-01-01; added ICD-10-CM codes D89.811-D89.813, I40.8-I40.9, M60.80-M60.9.
Step therapy table updates.
Added administrative documentation.
Added immunotherapy-related toxicities and chronic GVHD per NCCN, added pediatric psoriatic arthritis indication, clarified contraindication language, clarified repeat TB testing requirements, included etrasimod in combination exclusion, and added continuation of use language.
Updated combination exclusion to include additional agents and specified biologic immunomodulators; added DMARD examples and formatting updates.
Step therapy table updates.
Added new indication for prophylaxis of acute graft-versus-host disease to clinical criteria and added quantity limit per label.
Clarified tuberculosis testing requirements, aligned RA criteria with guidelines, removed option of prior TNF trial, updated references, and updated exclusion list for combination use.
Updated step therapy table and made administrative step therapy updates.
Added continuation of use section and updated tuberculosis testing language.
Added drug-specific quantity limits.
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