Blue Cross Blue Shield - Iowa Orencia Prior Auth

Coverage and Medical Necessity Criteria

Initial approval — subcutaneous Orencia by indication

Covered when ONE of the following indication-specific conditions is met for initial approval (subcutaneous Orencia):

Polyarticular Juvenile Idiopathic Arthritis (pJIA) - initial: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Adalimumab-aacf, Enbrel, and Xeljanz/Xeljanz Oral Solution) OR member has a clinical reason to avoid Enbrel and Adalimumab-aacf AND has had an inadequate response to or intolerable adverse event with Xeljanz/Xeljanz Oral Solution OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Psoriatic Arthritis (PsA) - initial: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Cosentyx, Enbrel, Adalimumab-aacf, Otezla, Rinvoq, Simponi, Skyrizi, Otulfi, Tremfya, and Xeljanz/Xeljanz XR) OR member has a clinical reason to avoid TNF-inhibitors (Enbrel, Adalimumab-aacf, Simponi) AND has had an inadequate response to or intolerable adverse event with at least TWO of the preferred non‑TNF products (Cosentyx, Otezla, Skyrizi, Otulfi, Tremfya, Rinvoq, Xeljanz/Xeljanz XR) OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Pediatric Psoriatic Arthritis - initial: Member has had an inadequate response to treatment or intolerable adverse event with both preferred products (Cosentyx and Enbrel) OR member has a clinical reason to avoid Enbrel AND has had an inadequate response to Cosentyx OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Rheumatoid Arthritis (RA) - initial: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Adalimumab-aacf, Enbrel, Rinvoq, Simponi, Xeljanz/Xeljanz XR) OR member has a clinical reason to avoid TNF-inhibitors (Enbrel, Adalimumab-aacf, Simponi) AND has had an inadequate response to or intolerable adverse event with Rinvoq AND Xeljanz/Xeljanz XR OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Initial approval — intravenous Orencia by indication

Covered when ONE of the following indication-specific conditions is met for initial approval (intravenous Orencia):

Polyarticular Juvenile Idiopathic Arthritis (pJIA) - IV initial: Member has a documented inadequate response or intolerable adverse event to Simponi Aria OR member has a documented clinical reason to avoid TNF inhibitors OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Psoriatic Arthritis (PsA) - IV initial: Member has a documented inadequate response or intolerable adverse event with each of Avsola, Inflectra, Simponi Aria, and Skyrizi OR member has a documented clinical reason to avoid TNF inhibitors OR member is currently receiving the requested product through insurance (excluding samples or manufacturer's patient assistance programs) and is experiencing a positive therapeutic outcome.at least one of the three bullets a-c

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Initial Therapy — Rheumatoid Arthritis

Initial approval for rheumatoid arthritis requires at least ONE of the following:

RA initial options: a) Documented inadequate response or intolerable adverse event with each of Avsola, Inflectra, and Simponi Aria; b) Documented clinical reason to avoid TNF inhibitors (See Appendix A); c) Currently receiving the requested product via insurance with positive therapeutic outcome

Chart notes required where applicable

Initial Therapy — RA (biologic/biomarker/methotrexate pathways)

Authorization for moderately to severely active RA (alternative pathway):

RA alternative pathway: Authorization of 12 months may be granted when: member previously received a biologic or targeted synthetic drug indicated for RA; OR member meets biomarker testing and methotrexate trial/intolerance criteria as specified (either positive RF or anti-CCP, or testing showing RF + anti-CCP + CRP and/or ESR) AND member has had an inadequate response to at least a 3-month trial of methotrexate titrated to at least 15 mg/week or has intolerance/contraindication to methotrexate.

Biomarker positive or combination testing options, and methotrexate trial of >=3 months at >=15 mg/week or documented intolerance

Initial Therapy — Articular JIA

Initial approval for moderately to severely active articular juvenile idiopathic arthritis (members >=2 years):

JIA initial options: a) Prior biologic or targeted synthetic for JIA; b) Inadequate response to methotrexate or another conventional synthetic DMARD at adequate dose and duration; c) Inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids plus one of listed risk factors (ankle, wrist, hip, sacroiliac joint, TMJ involvement; erosive disease; enthesitis; delay in diagnosis; elevated inflammation markers; symmetric disease); d) Presence of risk factors for severe/refractory disease (See Appendix C) and one of high-risk joint involvement, high disease activity, or judged high risk for disabling joint disease.

Risk factors listed in Appendix C

Initial Therapy — Psoriatic Arthritis

Initial approval for active psoriatic arthritis (members >=2 years):

PsA initial options: a) Mild to moderate disease: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD administered at adequate dose/duration OR intolerance/contraindication to those agents OR presence of enthesitis or predominantly axial disease; b) Severe disease.

Prior biologic or targeted synthetic history also qualifies for 12-month authorization

Initial Therapy — aGVHD Prophylaxis

Authorization for prophylaxis of acute GVHD (1 month) when BOTH are met:

aGVHD prophylaxis: a) Member is undergoing HSCT from a matched or 1 allele-mismatched unrelated donor; b) The requested medication will be used in combination with a calcineurin inhibitor and methotrexate.

Authorization duration: 1 month

Initial Therapy — Chronic GVHD

Authorization for chronic GVHD (12 months) when EITHER is met:

Chronic GVHD: a) Inadequate response to systemic corticosteroids; b) Intolerance or contraindication to corticosteroids.

Initial Therapy — Immune Checkpoint Inhibitor–Related Toxicity

Authorization for immune checkpoint inhibitor–related severe (G3) or life-threatening (G4) cardiac toxicities (IV abatacept) requires ALL of the following:

ICI-related toxicity: 1) Diagnosis of severe or life-threatening immune checkpoint-related cardiac toxicity (myocarditis, pericarditis, arrhythmias, impaired ventricular function, conduction abnormalities); 2) Inadequate response to corticosteroids; 3) Recent receipt of immune checkpoint inhibitor therapy; 4) Treatment will not exceed 5 doses (500 mg IV every 2 weeks, total of 5 doses).max 5 doses

Authorization of 1 month (intravenous Orencia only)

Continuation Therapy Criteria

Continuation authorization of 12 months may be granted when members achieve or maintain a positive clinical response as defined per indication:

RA continuation: For RA: ≥20% improvement from baseline in tender joint count, swollen joint count, pain, or disability.>=20% improvement

Includes new members using medication

JIA continuation: For JIA: improvement in number of active joints, limitation of movement, or functional ability; or low disease activity.

Includes new members

PsA continuation: For PsA: improvement or low disease activity evidenced by reduced swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement.

Includes new members

General and Safety Criteria

General requirements applicable to all indications:

TB screening: Negative TB test within 12 months for biologic/targeted synthetic-naïve persons; if screening is positive, further testing to exclude active disease (e.g., chest x-ray) is required; do not administer abatacept to members with active TB infection; latent TB must be treated prior to initiation.TB test within 12 months

Concomitant therapy restriction: Orencia cannot be used concomitantly with any other biologic DMARD or targeted synthetic DMARD.

Dosing and quantity limits: Approvals may be subject to dosing limits per FDA labeling and evidence-based guidelines; quantity limit = 4 vials or syringes/auto-injectors per 28 days.4 units/28 days

Coverage for Orencia (abatacept) is limited to the indications listed in this policy (FDA‑approved and compendial uses) and is provided only when the applicable approval criteria are met and the member has no plan exclusions to the prescribed therapy. Preferred agents and step‑therapy requirements differ by route (subcutaneous vs intravenous) and indication; the policy requires use of the plan's designated preferred products prior to non‑preferred Orencia unless a documented clinical exception applies, the member is currently receiving the non‑preferred medication with a positive therapeutic outcome, or only one preferred product exists for that indication.

Prior to initiating abatacept, members who are naïve to biologic DMARDs or targeted synthetic DMARDs must have a documented negative TB test within 12 months (TST or IGRA). If screening is positive, additional evaluation to exclude active disease (for example, chest x‑ray) is required. Do not administer abatacept to members with active tuberculosis. If latent TB is identified, treatment for latent infection must be started before abatacept initiation. Additionally, Orencia is considered not medically necessary for members who do not meet the criteria set forth in this policy.

No additional exclusions or statements are provided in this section of the policy.

If the approval criteria in this policy are not met — for example, required documentation of prior preferred product trials is absent, there is no documented clinical reason to avoid preferred agents, or the member is not currently receiving the non‑preferred product with documented benefit — the request for Orencia will not be covered.

Consistent with the policy's general statements, Orencia is considered not medically necessary for members who do not meet the criteria set forth above and therefore will not be approved for coverage.

No additional not‑medically‑necessary statements are provided in this section of the policy.

Billing and Procedure Codes

Procedures/BillingHCPCSCovered

J0129

Injection, abatacept, 10 mg

Reported HCPCSHCPCSCovered

J0129

Injection, abatacept, 10 mg

inv-20: TB testing window

TB testing windowDocumented negative TB test (TST or IGRA) within 12 months prior to initiating abatacept for persons naïve to biologic DMARDs or targeted synthetic DMARDs

Positive screening stepsIf TB screening is positive, perform further testing (e.g., chest x-ray) to exclude active disease before starting abatacept

Active TB restrictionDo not administer abatacept to members with active TB infection

Latent TB managementIf latent TB is identified, begin TB treatment before initiation of abatacept

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Orencia (abatacept). Initial approvals generally require documentation of inadequate response or intolerable adverse event to specified preferred products or biologics/targeted synthetics per indication. Typical authorizations are for 12 months when criteria are met; shorter authorizations (e.g., 1 month) apply for select indications (see policy).

Initial approval: document inadequate response or intolerable adverse event to required number of preferred products per indication (see Step Therapy/Preferred products).
Continuation: submit chart notes demonstrating positive clinical response.
Authorization length: typically 12 months when criteria met; some indications have shorter durations (e.g., 1 month for certain prophylaxis or ICI-related toxicity).

Documentation Required

Required Supporting Documentation

The payer requires supporting clinical documentation with all prior authorization submissions. Failure to provide complete documentation may result in denial.

Clinical Background and Rationale

Orencia (abatacept) is indicated in this policy for select autoimmune and immune‑mediated conditions, including moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis; the policy also addresses compendial uses such as oligoarticular JIA, chronic graft‑versus‑host disease, and immune checkpoint inhibitor–related toxicity. Coverage aligns with product labeling and cited clinical guidelines and includes route‑specific step‑therapy preferences (subcutaneous vs intravenous) to promote clinically appropriate and cost‑effective use.

Definitions and Key Terms

inv-34: Preferred product

DefinitionMedications designated by the plan that must generally be tried and failed before non‑preferred products are approved

Preferred agents (subcutaneous contexts)Adalimumab-aacf, Enbrel, Entyvio, Cosentyx, Otezla, Otulfi (ustekinumab-aauz), Rinvoq, Simponi, Skyrizi, Tremfya, Velsipity, and Xeljanz/Xeljanz XR/Oral Solution

Preferred agents (intravenous contexts)Avsola, Inflectra, Entyvio, Ilumya, Otulfi (ustekinumab-aauz), Skyrizi, and Simponi Aria

Step therapy requirementPolicy generally requires failure or intolerance to two preferred products prior to coverage of non‑preferred Orencia unless clinical exception applies

inv-35: Biomarkers referenced for RA

Required biomarkersRheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP)

OpenPayer

Orencia (abatacept) — Prior Authorization and Coverage Criteria

Coverage and Medical Necessity Criteria

Billing and Procedure Codes

Prior Authorization, Documentation, and Billing Actions

Clinical Background and Rationale

Definitions and Key Terms