Neighborhood Health Plan RI IV abatacept Coverage

Coverage Criteria

Universal Criteria

Covered when ALL of the following universal criteria are met

Universal Requirements: Patient is at least 18 years of age (unless otherwise specified); up-to-date with age-appropriate vaccinations prior to initiating therapy; screened for hepatitis B virus (HBV) prior to initiating treatment; evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment with ongoing TB monitoring during therapy; no active infection (including clinically important localized infections); will not receive live vaccines during therapy; and patient is not receiving concurrent treatment with another injectable biologic response modifier or specified oral non-biologic agents (for example TNF inhibitors or specified IL inhibitors, or oral agents such as apremilast, tofacitinib, baricitinib, upadacitinib).

MMP members who received this medication within the past 365 days are not subject to Step Therapy requirements.

Rheumatoid Arthritis (Initial)

Rheumatoid Arthritis — Covered when ALL of the following are met

RA Initial Criteria: Physician has assessed baseline disease severity using an objective measure/tool; documented moderate to severe active rheumatoid arthritis; patient has had at least a 3-month trial and failed one oral disease-modifying antirheumatic drug (DMARD) (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide); may be used as a single agent or in combination with non-biologic DMARDs; and patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Consistent with universal requirements (vaccination, HBV/TB screening, no concurrent biologics/oral agents).

Polyarticular Juvenile Idiopathic Arthritis (Initial)

Polyarticular Juvenile Idiopathic Arthritis — Covered when ALL of the following are met

pJIA Initial Criteria: Physician has assessed baseline disease severity using an objective measure/tool; patient is 2 years of age or older; documented moderate to severe active polyarticular disease; patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either an oral NSAID OR an oral DMARD (e.g., methotrexate, leflunomide, sulfasalazine); may be used alone or in combination with methotrexate; and patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

IV dosing for pJIA per dosing section applies to patients aged 6 years or older (see dosing table).

Psoriatic Arthritis (Initial)

Psoriatic Arthritis — Covered when ALL of the following are met

PsA Initial Criteria: Physician has assessed baseline disease severity using an objective measure/tool; documented moderate to severe active psoriatic arthritis; for predominantly axial disease or active enthesitis: trial and failure of at least one NSAID unless contraindicated; for peripheral arthritis: trial and failure of at least a 3-month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine); may be used as a single agent or in combination with non-biologic DMARDs; and patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab at maximum tolerated doses.

Consistent with universal requirements (vaccination, HBV/TB screening, no concurrent biologics/oral agents).

Graft Versus Host Disease (Initial)

Graft Versus Host Disease — Covered when ALL of the following are met

GVHD Indications: Either: Patient has received a hematopoietic stem cell transplant (HSCT) and abatacept is used as additional therapy in combination with corticosteroids for chronic GVHD in patients refractory to first-line therapy; OR: Patient is undergoing HSCT from a matched or one allele-mismatched unrelated donor and abatacept IV is to be used for prophylaxis of acute GVHD in combination with a calcineurin inhibitor and methotrexate (prophylaxis requires antiviral prophylaxis for EBV for 6 months and monitoring for EBV and CMV).

Prophylaxis dosing and age-specific dosing described in dosing section; prophylaxis may not be renewed beyond specified regimen.

Immune Checkpoint Inhibitor Related Toxicity (Initial)

Management of Immune Checkpoint Inhibitor Related Toxicity — Covered when ALL of the following are met

Checkpoint Toxicity: Patient is receiving an immune checkpoint inhibitor; patient has had no improvement within 24-48 hours of starting pulse-dose methylprednisolone; abatacept is being used as additional therapy for management of myocarditis related to checkpoint inhibitor therapy; dosing limited to 500 mg every 2 weeks for a total of 5 doses.

This indication may not be renewed; HCPCS/quantity limits apply per dosing guidance.

Covered when indication and dosing match listed regimens

Coverage is tied to indication-specific dosing and matching covered diagnosis codes listed in Appendix 1.

Indication and dosing match: Requested use must be for an indication listed in the policy (e.g., RA, PsA, pJIA [age/dosing constraints], chronic or acute-on-chronic GVHD, or management of immune checkpoint inhibitor-related toxicity) AND the requested dose must match the regimen provided for that indication (see dosing table: weight-based and fixed regimens, GVHD prophylaxis schedules, and ICI toxicity dosing).

Use the specific ICD-10 diagnosis codes from Appendix 1 when submitting claims; dosing details in dosing/administration section.

General Coverage Criteria

Covered when consistent with FDA labeling and the plan's P&T–adopted clinical coverage criteria

General coverage requirement: Use must align with FDA-approved labeling and/or relevant clinical literature as adopted by Neighborhood's Pharmacy & Therapeutics Committee; individual consideration will be given based on prescriber-submitted information; Medicare NCD/LCD criteria supersede for applicable members.

Requests will be assessed against FDA labeling and the plan's clinical coverage criteria.

Concurrent administration of abatacept with other injectable biologic response modifiers or certain oral targeted non‑biologic agents is not permitted. Specifically, patients must not receive abatacept at the same time as injectable TNF inhibitors or IL‑inhibitors (examples: adalimumab, etanercept, certolizumab, infliximab, secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab) or the oral agents listed (examples: apremilast, tofacitinib, baricitinib, upadacitinib).

Certain uses of abatacept may not be renewed. Prophylaxis of acute graft‑versus‑host disease (aGVHD) is explicitly stated as not renewable, and management of immune checkpoint inhibitor–related toxicity is also described as not renewable in the policy.

For Medicare billing, use of the abatacept HCPCS code may be restricted depending on the setting and supervision. The HCPCS code listed (J0129) may be used for Medicare when the drug is administered under the direct supervision of a physician; it is not for use when the drug is self‑administered.

Where a National Coverage Determination (NCD), Local Coverage Determination (LCD), or Local Coverage Article (LCA) exists, those Medicare policies take precedence over the plan’s clinical criteria for applicable members. The policy directs providers to the CMS Medicare Coverage Database for existing determinations, and notes that Neighborhood will apply its coverage criteria only for INTEGRITY members in the absence of an applicable NCD/LCD.

Concurrent administration exclusions: abatacept must not be given at the same time as another injectable biologic response modifier (including but not limited to TNF inhibitors and IL inhibitors) or specified oral non‑biologic targeted agents (examples provided in policy include apremilast, tofacitinib, baricitinib, and upadacitinib). Requests documenting concurrent use with these agents will be subject to denial.

Off‑label use or use that does not follow FDA‑approved labeling or the clinical coverage criteria adopted by Neighborhood’s Pharmacy & Therapeutics Committee may be considered not medically necessary. Neighborhood will review prescriber‑submitted information and give individual consideration, but requests that do not demonstrate concordance with FDA labeling or the plan’s criteria risk denial.

Coding and Diagnosis Codes

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

M05.761	Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement.
M05.762	Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement.
M05.769	Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement.
M05.771	Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement.
M05.772	Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement.
M05.779	Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement.
M05.79	Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement.
M05.80	Other rheumatoid arthritis with rheumatoid factor of unspecified site.
M05.811	Other rheumatoid arthritis with rheumatoid factor of right shoulder.
M05.812	Other rheumatoid arthritis with rheumatoid factor of left shoulder.

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Covered ICD-10 Diagnosis Codes (selection)ICD-10Covered

M05.761	Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement.
M05.762	Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement.
M05.769	Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement.
M05.771	Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement.
M05.772	Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement.
M05.779	Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement.
M05.79	Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement.
M05.80	Other rheumatoid arthritis with rheumatoid factor of unspecified site.
M05.811	Other rheumatoid arthritis with rheumatoid factor of right shoulder.
M05.812	Other rheumatoid arthritis with rheumatoid factor of left shoulder.

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HCPCS CodesHCPCS

J0129

Injection, Abatacept, 10 mg; 1 billable unit = 10 mg

NDCNDC

00003-2187-xx

Orencia 250 mg single-use vial

Covered ICD-10 Diagnosis CodesICD-10Covered

M06.00	Rheumatoid arthritis without rheumatoid factor, unspecified site.
M06.011	Rheumatoid arthritis without rheumatoid factor, right shoulder.
M06.012	Rheumatoid arthritis without rheumatoid factor, left shoulder.
M06.019	Rheumatoid arthritis without rheumatoid factor, unspecified shoulder.
M06.021	Rheumatoid arthritis without rheumatoid factor, right elbow.
M06.022	Rheumatoid arthritis without rheumatoid factor, left elbow.
M06.029	Rheumatoid arthritis without rheumatoid factor, unspecified elbow.
M06.031	Rheumatoid arthritis without rheumatoid factor, right wrist.
M06.032	Rheumatoid arthritis without rheumatoid factor, left wrist.
M06.039	Rheumatoid arthritis without rheumatoid factor, unspecified wrist.

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Covered ICD-10 Diagnosis CodesICD-10Covered

M06.80	Other specified rheumatoid arthritis, unspecified site.
M06.811	Other specified rheumatoid arthritis, right shoulder.
M06.812	Other specified rheumatoid arthritis, left shoulder.
M06.819	Other specified rheumatoid arthritis, unspecified shoulder.
M06.821	Other specified rheumatoid arthritis, right elbow.
M06.822	Other specified rheumatoid arthritis, left elbow.
M06.829	Other specified rheumatoid arthritis, unspecified elbow.
M06.831	Other specified rheumatoid arthritis, right wrist.
M06.832	Other specified rheumatoid arthritis, left wrist.
M06.839	Other specified rheumatoid arthritis, unspecified wrist.

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Covered ICD-10 Diagnosis Codes - JuvenileICD-10Covered

M08.00	Unspecified juvenile rheumatoid arthritis of unspecified site.
M08.011	Unspecified juvenile rheumatoid arthritis, right shoulder.
M08.012	Unspecified juvenile rheumatoid arthritis, left shoulder.
M08.019	Unspecified juvenile rheumatoid arthritis, unspecified shoulder.
M08.021	Unspecified juvenile rheumatoid arthritis, right elbow.
M08.022	Unspecified juvenile rheumatoid arthritis, left elbow.
M08.029	Unspecified juvenile rheumatoid arthritis, unspecified elbow.
M08.031	Unspecified juvenile rheumatoid arthritis, right wrist.
M08.032	Unspecified juvenile rheumatoid arthritis, left wrist.
M08.039	Unspecified juvenile rheumatoid arthritis, unspecified wrist.

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Provider Actions and Authorization

Prior Authorization

Authorization length and quantity limits

Initial authorization is for 6 months; renewals permitted where indicated. Quantity limits and HCPCS unit limits vary by indication as summarized below.

Initial authorization length: 6 months (therapy for management of immune‑checkpoint inhibitor related toxicity is not renewable)
Quantity limits (NDC units) and HCPCS unit limits are indication-specific — see dosage/limits groups below

Prior Authorization

Prior authorization required

Prior authorization is required. Requests will be reviewed against FDA‑approved labeling and the plan's clinical coverage criteria as developed by the P&T committee. Individual consideration will be given based on prescriber‑submitted information.

Prior authorization required and reviewed for concordance with FDA labeling and plan criteria
Neighborhood will give individual consideration to each request based on prescriber‑submitted information

Background

Abatacept (Orencia) is a selective T‑cell costimulation modulator indicated for moderately to severely active rheumatoid arthritis in adults and for polyarticular juvenile idiopathic arthritis in pediatric patients. Clinical trial evidence demonstrates improved ACR response rates and benefit in JIA; common adverse events reported include headache, upper respiratory infection, and nausea. Neighborhood’s P&T Committee reviewed the evidence and adopted the coverage criteria to align use with FDA‑approved labeling and relevant clinical literature.

Definitions

Orencia (abatacept) — definition and approved indications summary

Drug class/definitionOrencia (abatacept) is a selective T‑cell costimulation modulator

FDA‑approved indications (summary)Moderately to severely active rheumatoid arthritis in adults; moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients aged 6 years and older

Evidence summaryMultiple randomized controlled trials in adult RA and pediatric JIA demonstrated improved ACR response rates and reduced disease flares; generally well tolerated

Typical route/formulation referencedIntravenous formulation (250 mg vials referenced in policy dosing tables)

INTEGRITY members — Medicare‑Medicaid Plan members note re: NCD/LCD precedence

INTEGRITY (Medicare‑Medicaid Plan) members note

OpenPayer

Orencia (abatacept) (Intravenous) — Coverage Criteria

Coverage Criteria

Coding and Diagnosis Codes

Provider Actions and Authorization

Background

Definitions