CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0039AE

Orencia® (Abatacept) Injection for Intravenous Infusion – Community Plan Medical Benefit Drug Policyopen_in_new

Medical benefit drug policy for Orencia (abatacept) injection for intravenous infusion detailing indications covered, initial and continuation criteria, dosing per FDA label, combination therapy exclusions, prescriber requirements, authorization durations, and applicable procedure/diagnosis codes. Does not apply to specified states where state policies govern.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOrencia® (Abatacept) Injection for Intravenous Infusion – Community Plan Medical Benefit Drug Policyopen_in_new

Policy CodePolicy CS2026D0039AE

Change TypeRevised coverage criteria (RA, PJIA, PsA); examples updated

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit prior authorization with indication-specific documentation (diagnosis, prior therapy or prior Orencia use, FDA dosing, prescriber specialty) per the policy criteria.

SourceLink

POLICY UPDATE CHANGES

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and revised coverage criteria for Polyarticular Juvenile Idiopathic Arthritis to update examples of systemic targeted immunomodulators not to be used in combination with Orencia, replacing 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)'.

Updated rheumatoid arthritis criteria to replace 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)' and updated list of examples of systemic targeted immunomodulators U.S. FDA-approved for treatment of rheumatoid arthritis previously treated for initial therapy.

Updated psoriatic arthritis criteria: added Bimzelx (bimekizumab-bkzx), removed Olumiant (baricitinib), replaced 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)', and expanded list of previously-treated FDA-approved systemic targeted immunomodulators to include Bimzelx, Cosentyx, Rinvoq, Skyrizi, and Taltz.

Updated References section to reflect current information and archived previous policy version CS2026D0039AD.

Coverage Summary & Rationale

General Coverage Rationale

Covered when ONE of the following groups of criteria is met:

Covered Indications (ONE of)

Polyarticular juvenile idiopathic arthritis (PJIA) - Initial
- Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA).
- Orencia is initiated and titrated according to FDA‑labeled dosing for PJIA.
- Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (e.g., adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, tofacitinib) for treatment of the same indication.
- Prescribed by or in consultation with a rheumatologist.
- Initial authorization is for no more than 12 months.
Polyarticular juvenile idiopathic arthritis (PJIA) - Continuation
- Patient has previously received Orencia IV for PJIA.
- Documentation of a positive clinical response.
- Orencia is dosed according to FDA‑labeled dosing for PJIA.
- Patient is not receiving Orencia in combination with a systemic targeted immunomodulator for treatment of the same indication.
- Authorization is for no more than 12 months.
Rheumatoid arthritis (RA) - Initial
- Diagnosis of moderately to severely active rheumatoid arthritis (RA).
- ANY of the following
  - History of failure or intolerance to a 3‑month trial of one non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.
  - Patient has been previously treated with a systemic targeted immunomodulator FDA‑approved for RA (e.g., adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, tofacitinib).
  - Patient is currently on Orencia.
- Orencia is initiated and titrated according to FDA‑labeled dosing for RA.
Rheumatoid arthritis (RA) - Continuation
- Patient has previously received Orencia IV for RA.
- Documentation of a positive clinical response.
- Orencia is dosed according to FDA‑labeled dosing for RA.
- Patient is not receiving Orencia in combination with a systemic targeted immunomodulator for treatment of the same indication.
- Authorization is for no more than 12 months.
Psoriatic arthritis (PsA) - Initial
- Diagnosis of active psoriatic arthritis (PsA).
- ANY of the following
  - History of failure to a 3‑month trial of methotrexate at the maximally indicated dose unless contraindicated or clinically significant adverse effects are experienced.
  - Patient has been previously treated with a systemic targeted immunomodulator FDA‑approved for PsA (e.g., adalimumab, bimekizumab, certolizumab, secukinumab, etanercept, apremilast, upadacitinib, golimumab, risankizumab, ixekizumab, guselkumab, tofacitinib, ustekinumab).
  - Patient is currently on Orencia.
- Orencia is initiated and titrated according to FDA‑labeled dosing for PsA.
Psoriatic arthritis (PsA) - Continuation
- Patient has previously received Orencia IV for PsA.
- Documentation of a positive clinical response.
- Orencia is dosed according to FDA‑labeled dosing for PsA.
- Patient is not receiving Orencia in combination with a systemic targeted immunomodulator for treatment of the same indication.
- Authorization is for no more than 12 months.
Chronic graft‑versus‑host disease (cGVHD) - Initial
- Diagnosis of steroid‑refractory chronic GVHD.
- ANY of the following
  - Patient is receiving Orencia in combination with systemic corticosteroids.
  - Patient is intolerant to systemic corticosteroid therapy.
- Initial authorization is for no more than 12 months.
Chronic graft‑versus‑host disease (cGVHD) - Continuation
- Documentation of positive clinical response.
- Patient continues to experience chronic GVHD.
- ANY of the following
  - Patient is receiving Orencia in combination with systemic corticosteroids.
  - Patient is intolerant to systemic corticosteroid therapy.
  - Patient has been successfully tapered off of corticosteroid therapy.
- Authorization is for no more than 12 months.
Acute graft‑versus‑host disease (aGVHD)
- Patient is at least 2 years old.
- ANY of the following
  - 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.
- Patient is receiving Orencia in combination with methotrexate.
- Authorization is for no more than 4 doses.
Immune checkpoint inhibitor‑related toxicities
- Patient has recently received checkpoint inhibitor therapy (e.g., pembrolizumab, nivolumab).
- Diagnosis of severe (G3) or life‑threatening (G4) immunotherapy‑related myocarditis, pericarditis, arrhythmias, impaired ventricular function, or conduction abnormalities.
- No improvement of toxicity within 24 hours of starting pulse‑dose methylprednisolone.
- History of failure, contraindication, or intolerance to infliximab (e.g., Inflectra, Remicade).
- Authorization is for no more than 4 doses.

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Initial Therapy Criteria (by Indication)

Initial-therapy criteria

Polyarticular juvenile idiopathic arthritis — Initial therapy

Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA).
Orencia is initiated and titrated according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Examples provided in policy text (e.g., adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, tofacitinib).
Prescribed by or in consultation with a rheumatologist.

Continuation Therapy Criteria (by Indication)

Continuation-therapy criteria

Polyarticular juvenile idiopathic arthritis — Continuation therapy

Patient has previously received Orencia injection for intravenous infusion.
Documentation of a positive clinical response.
Orencia is dosed according to FDA labeled dosing for polyarticular juvenile idiopathic arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Examples provided in policy text.

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required. Initial and continuation authorizations must document that indication-specific criteria are met (diagnosis, prior treatment trials or prior Orencia use, dosing per FDA label, prescriber specialty). Authorization durations are limited (typically up to 12 months; up to 4 doses for select acute indications).

Affected HCPCS / J-code: J0129
Maximum typical authorization duration: up to 12 months (most indications)
Maximum authorization for select acute indications (e.g., aGVHD, checkpoint inhibitor toxicities): up to 4 doses

Documentation Required

Documentation of prior therapy or intolerance

Document prior therapy or intolerance as specified for the indication. For initial RA and PsA therapy, document failure/intolerance to specified non-biologic DMARD(s) or prior treatment with a systemic targeted immunomodulator as listed. For PJIA/continuation, document prior Orencia use and a positive clinical response for continuation requests.

Applicable Codes

HCPCS / J-code for drugHCPCS

J0129

Injection, abatacept, 10 mg

Applicable Diagnosis Codes (ICD-10)ICD-10

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
M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.012	Felty's syndrome, left shoulder

1–10 of 212

1/22

Applicable ICD-10 Diagnosis Codes (juvenile arthritis / related)ICD-10

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
M08.232	Juvenile rheumatoid arthritis with systemic onset, left wrist
M08.239	Juvenile rheumatoid arthritis with systemic onset, unspecified wrist
M08.241	Juvenile rheumatoid arthritis with systemic onset, right hand
M08.242	Juvenile rheumatoid arthritis with systemic onset, left hand

1–10 of 74

1/8

Clinical Evidence & Indications Summary

39.4%Psoriatic arthritis ACR20 at week 24 vs placebo 22.3% (p<0.001)

76.0%RA SC ACR20 at month 6 vs IV 75.8% (difference 0.3%, 95% CI -4.2,4.8)

83.2%PJIA JIA‑ACR30 at month 4 (cohort 1) — cohort 2 (2–5 yrs) 89.1%

97%GVHD (8/8 cohort) OS Day 180 with abatacept+CNI+MTX vs placebo 84%

Evidence supports IV abatacept for its FDA- and guideline-indicated uses with variable strength by indication. For rheumatoid arthritis (RA), Phase 3/3b trials including the SC versus IV noninferiority study demonstrate clinically meaningful ACR responses (SC vs IV ACR20 ~ 76.0% vs 75.8% at month 6) and AVERT data support efficacy with acceptable safety when used per label; policy requires prior csDMARD failure or prior use of an FDA‑approved systemic targeted immunomodulator, dosing per FDA label, rheumatology prescriber involvement, and no concurrent systemic targeted immunomodulator for the same indication (avoid combination therapy). For psoriatic arthritis (PsA), a Phase 3 randomized trial showed higher ACR20 versus placebo (39.4% vs 22.3% at week 24) with modest effects on skin; policy requires methotrexate trial or prior treatment with an FDA‑approved systemic targeted immunomodulator and specialist prescriber (rheumatologist or dermatologist), and prohibits concurrent systemic targeted immunomodulators for the same indication. For polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥2 years, Phase 3 data with weight‑tiered dosing showed robust JIA-ACR responses at month 4 (e.g., JIA‑ACR30 83.2% cohort 1; 89.1% cohort 2) and sustained benefit through extensions; policy requires FDA dosing, specialist prescribing, and exclusion of combination systemic targeted immunomodulators. For prophylaxis of acute graft‑versus‑host disease (aGVHD) in HSCT, clinical cohorts (GVHD‑1/GVHD‑2) using IV abatacept 10 mg/kg (1,000 mg max) with calcineurin inhibitor and methotrexate demonstrated improved Day 180 overall survival in certain cohorts (e.g., OS 97% vs 84% in 8/8 cohort comparisons) and the policy allows a limited number of doses (up to 4 doses) with documented dosing schedule. For chronic GVHD, NCCN compendium supports abatacept as additional therapy for steroid‑refractory disease (2A) and the policy permits use with documentation of steroid‑refractory status and clinical response. Unproven indications—multiple sclerosis (ACCLAIM and other studies), systemic lupus erythematosus (Phase II trial), and uveitis associated with Behçet's disease—lack convincing efficacy and are designated not medically necessary/unproven in this policy.

Background & Definitions

Orencia (abatacept) is a biologic, selective T‑cell co‑stimulation modulator. This policy covers the intravenous (IV) infusion formulation under the medical benefit; the self‑administered subcutaneous (SC) formulation is addressed under the pharmacy benefit. The policy excludes certain states from its application and directs users to state‑specific guidance (see application/state list). The policy falls within the medical benefit scope and is intended to define when IV abatacept is medically necessary to provide the stated clinical benefits (e.g., reduction in signs and symptoms and prevention/prophylaxis in specified indications) while preventing unsafe or unsupported concurrent biologic combinations.

Term	Definition
Systemic targeted immunomodulator
Examples provided in policy include adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, tofacitinib, among others.
ACR20
American College of Rheumatology 20% improvement criteria.
JIA-ACR
Juvenile Idiopathic Arthritis - American College of Rheumatology response criteria.
GFS
GVHD-free survival.
systemic targeted immunomodulator
Term used to describe systemic immunomodulatory therapies (updated phrasing replacing 'targeted immunomodulator').

Revision History

2026-06-01revisedLatest

2026-06-01revised

2026-06-01

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOrencia® (Abatacept) Injection for Intravenous Infusion – Community Plan Medical Benefit Drug Policyopen_in_new

Policy CodePolicy CS2026D0039AE

Change TypeRevised coverage criteria (RA, PJIA, PsA); examples updated

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit prior authorization with indication-specific documentation (diagnosis, prior therapy or prior Orencia use, FDA dosing, prescriber specialty) per the policy criteria.

SourceLink

On This Page

Rheumatoid arthritis — Initial therapy

ONE of
- History of failure or intolerance to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced.
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for RA (examples provided).
  Examples provided in policy text (e.g., adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, tofacitinib).
- Patient is currently on Orencia.
Orencia is initiated and titrated according to FDA labeled dosing for rheumatoid arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Prescribed by or in consultation with a rheumatologist.
Initial authorization is for no more than 12 months.

Psoriatic arthritis — Initial therapy

Diagnosis of active psoriatic arthritis (PsA).
ONE of
- History of failure to a 3-month trial of methotrexate at the maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced.
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of psoriatic arthritis (examples provided).
  Examples provided in policy text (e.g., adalimumab, Bimzelx, certolizumab, secukinumab, etanercept, apremilast, upadacitinib, golimumab, risankizumab, ixekizumab, guselkumab, tofacitinib, ustekinumab).
- Patient is currently on Orencia.
Orencia is initiated and titrated according to FDA labeled dosing for psoriatic arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Prescribed by or in consultation with a rheumatologist or dermatologist.
Initial authorization is for no more than 12 months.

Rheumatoid arthritis — Continuation therapy

Patient has previously received Orencia injection for intravenous infusion.
Documentation of a positive clinical response.
Orencia is dosed according to FDA labeled dosing for rheumatoid arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Examples provided in policy text.
Authorization is for no more than 12 months.

Psoriatic arthritis — Continuation therapy

Patient has previously received Orencia injection for intravenous infusion.
Documentation of a positive clinical response.
Orencia is dosed according to FDA labeled dosing for psoriatic arthritis.
Patient is not receiving Orencia in combination with a systemic targeted immunomodulator (examples provided) for treatment of the same indication.
Examples provided in policy text.
Authorization is for no more than 12 months.

Chronic graft-versus-host disease (GVHD) — Continuation therapy

Documentation of positive clinical response.
Patient continues to experience chronic GVHD.
ONE of
- Patient is receiving Orencia in combination with systemic corticosteroids.
- Patient is intolerant to systemic corticosteroid therapy.
- Patient has been successfully tapered off of corticosteroid therapy.
Authorization is for no more than 12 months.

Required prior therapies for RA: failure or intolerance to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated; OR prior treatment with a systemic targeted immunomodulator (examples listed in policy).
Required prior therapies for PsA: failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated; OR prior treatment with a systemic targeted immunomodulator (examples listed in policy).
Required prior therapies for PJIA: initiation/titration per FDA label for PJIA; patient must not be receiving Orencia in combination with a systemic targeted immunomodulator for the same indication.
Continuation documentation: prior IV Orencia administration and documentation of a positive clinical response for continuation requests.

Billing Rule

Dose and dosing source

Dose and dosing source: Orencia IV must be initiated and titrated according to the FDA labeled dosing for each specific indication; IV billing uses J0129 (10 mg = unit of drug).

IV dosing per FDA label (use J0129 for billing: Injection, abatacept, 10 mg)
For aGVHD prophylaxis see specified IV schedule (10 mg/kg, 1,000 mg max; Day -1, Days 5, 14, 28) — see GVHD dosing block for full schedule

Denial Risk

Combination therapy exclusion

Combination therapy exclusion: claims may be denied if the patient is receiving Orencia in combination with a systemic targeted immunomodulator listed in the policy for treatment of the same indication.

Policy lists examples of systemic targeted immunomodulators that must not be used concurrently for the same indication (e.g., adalimumab, certolizumab, etanercept, baricitinib, upadacitinib, golimumab, Xeljanz/Xeljanz XR among others).

Documentation Required

Prescriber specialty requirement

Prescriber specialty requirement: prescriptions must be written by or in consultation with specified specialists depending on indication.

Rheumatologist required for RA and PJIA indications (prescribed by or in consultation with a rheumatologist).
Rheumatologist or dermatologist required for PsA (prescribed by or in consultation with a rheumatologist or dermatologist).

Documentation Required

Do not co-administer with TNF antagonists/other biologics

Do not co-administer Orencia with TNF antagonists or other biologic RA therapies. Chart documentation should confirm Orencia is not given concomitantly with TNF antagonists or other biologic RA therapies because clinical trials showed higher infection rates and no added benefit with concurrent administration.

Safety rationale: controlled trials in RA demonstrated increased overall infections (63% vs 43%) and serious infections (4.4% vs 0.8%) with concomitant Orencia plus TNF antagonist therapy versus TNF antagonist alone; trials did not show superiority for combination therapy.

Documentation Required

Reference clinical evidence and guideline updates

Providers should reference current clinical evidence and guideline sources when supporting medical necessity and documentation for coverage decisions.

Reference ACR guidelines (RA, JIA), NCCN Drugs & Biologics Compendium (GVHD, checkpoint inhibitor toxicities), and pivotal clinical trials (e.g., GVHD studies, RA/PSA/PJIA trials) when providing documentation.