Blue Cross Blue Shield - Iowa Orencia Coverage

Coverage and Medical Necessity Criteria

inv-01: Initial Therapy and Authorization Criteria

Covered when ANY one of the listed pathways for initial approval is met for each indication

RA initial approval (subcutaneous preferred pathway): Member meets at least ONE of: A) inadequate response or intolerable adverse event to at least TWO of the preferred products (Adalimumab-aacf, Enbrel, Rinvoq, Simponi, Xeljanz/Xeljanz XR); B) clinical reason to avoid TNF-inhibitors (Enbrel, Adalimumab-aacf, Simponi) AND inadequate response or intolerable adverse event with Rinvoq AND Xeljanz/Xeljanz XR; C) currently receiving requested product through insurance with positive therapeutic outcome.at least TWO preferred products where specified

Applies to rheumatoid arthritis; see Appendix A for clinical reasons to avoid TNF-inhibitors

pJIA initial approval (subcutaneous preferred pathway): Member meets at least ONE of: A) inadequate response or intolerable adverse event to at least TWO of the preferred products (Adalimumab-aacf, Enbrel, Xeljanz/Xeljanz Oral Solution); B) clinical reason to avoid Enbrel and Adalimumab-aacf AND inadequate response or intolerable adverse event with Xeljanz or Xeljanz Oral Solution; C) currently receiving requested product through insurance with positive therapeutic outcome.at least TWO preferred products where specified

Applies to polyarticular juvenile idiopathic arthritis

PsA initial approval (subcutaneous preferred pathway): Member meets at least ONE of: A) inadequate response or intolerable adverse event to at least TWO of the preferred products (Cosentyx, Enbrel, Adalimumab-aacf, Otezla, Rinvoq, Simponi, Skyrizi, Otulfi, Tremfya, Xeljanz/Xeljanz XR); B) clinical reason to avoid TNF-inhibitors (Enbrel, Adalimumab-aacf, Simponi) AND inadequate response or intolerable adverse event with at least TWO of the specified non-TNF preferred products (Cosentyx, Otezla, Skyrizi, Otulfi, Tremfya, Rinvoq, Xeljanz/Xeljanz XR); C) currently receiving requested product through insurance with positive therapeutic outcome.at least TWO preferred products where specified

Applies to psoriatic arthritis

Pediatric PsA initial approval: Member meets at least ONE of: A) inadequate response or intolerable adverse event with both preferred products (Cosentyx and Enbrel); B) clinical reason to avoid Enbrel AND inadequate response to Cosentyx; C) currently receiving requested product through insurance with positive therapeutic outcome.both preferred products where specified

Applies to pediatric psoriatic arthritis

IV formulation preferred-product exception pathway (RA): For IV Orencia, initial approval for RA when at least ONE of: A) documented inadequate response or intolerable adverse event with Avsola, Inflectra, and Simponi Aria; B) documented clinical reason to avoid TNF inhibitors; C) currently receiving requested product through insurance with positive therapeutic outcome.

IV formulation preferred-product exception pathway (pJIA): For IV Orencia, initial approval for pJIA when at least ONE of: A) documented inadequate response or intolerable adverse event to Simponi Aria; B) documented clinical reason to avoid TNF inhibitors; C) currently receiving requested product through insurance with positive therapeutic outcome.

IV formulation preferred-product exception pathway (PsA): For IV Orencia, initial approval for PsA when at least ONE of: A) inadequate response or intolerable adverse event with Avsola, Inflectra, Simponi Aria, and Skyrizi; B) documented clinical reason to avoid TNF inhibitors; C) currently receiving requested product through insurance with positive therapeutic outcome.

RA authorization biomarker and methotrexate requirements: For 12-month authorization for RA when initiating or previously received biologic/targeted synthetic: A) member meets either: positive/elevated RF or anti-CCP OR has been tested for RF, anti-CCP, and CRP and/or ESR; AND B) member meets either: inadequate response to >=3 months of methotrexate titrated to >=15 mg/week OR intolerance/contraindication to methotrexate.

inv-02: Initial authorization — Moderately to severely active rheumatoid arthritis (adults)

Authorization of 12 months may be granted when ALL of the following are met:

RA initial criteria: Member meets BOTH criteria A and B as specified below

A: Biomarker requirement: Member meets either: (1) tested positive/elevated for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP); OR (2) has been tested for ALL of RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).

B: Methotrexate trial or intolerance: Member meets either: (1) inadequate response to at least a 3-month trial of methotrexate titrated to at least 15 mg/week; OR (2) intolerance or contraindication to methotrexate (see Appendix B).

inv-03: Initial authorization — Moderately to severely active articular juvenile idiopathic arthritis (members >=2 years)

Authorization of 12 months may be granted when ANY of the following criteria are met:

JIA initial criteria list: A) Inadequate response to methotrexate or another conventional synthetic DMARD (e.g., leflunomide, sulfasalazine, hydroxychloroquine) administered at adequate dose and duration; B) Inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids plus one risk factor for poor outcome (involvement of ankle/wrist/hip/sacroiliac/TMJ; erosive disease or enthesitis; delay in diagnosis; elevated inflammation marker; symmetric disease); C) Presence of risk factors for more severe/refractory disease (see Appendix C) AND one of: high-risk joint involvement, high disease activity, or judged at high risk for disabling joint disease.

See Appendix C for risk factors

inv-04: Initial authorization — Psoriatic arthritis (members >=2 years)

Authorization of 12 months may be granted when EITHER of the following are met:

PsA initial criteria A: Member has mild to moderate disease and meets one of: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD administered at adequate dose/duration; OR intolerance/contraindication to these agents; OR presence of enthesitis or predominantly axial disease.

PsA initial criteria B: Member has severe disease.

inv-05: Initial authorization — Prophylaxis of acute graft versus host disease (aGVHD)

Authorization of 1 month may be granted when BOTH of the following are met:

aGVHD prophylaxis: Member is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor AND the requested medication will be used in combination with a calcineurin inhibitor (e.g., cyclosporine, tacrolimus) and methotrexate.

inv-06: Initial authorization — Chronic graft versus host disease (cGVHD)

Authorization of 12 months may be granted when EITHER of the following are met:

cGVHD initial: Member has experienced an inadequate response to systemic corticosteroids OR member has an intolerance or contraindication to corticosteroids.

inv-07: Initial authorization — Immune checkpoint inhibitor-related toxicity (IV Orencia only)

Authorization of 1 month (intravenous Orencia only) may be granted when ALL of the following are met:

ICI-toxicity initial: A) Member diagnosed with a severe (G3) or life-threatening (G4) immune checkpoint-related cardiac toxicity (myocarditis, pericarditis, arrhythmias, impaired ventricular function, or conduction abnormalities); B) Member has had an inadequate response to corticosteroids; C) Member has recently received immune checkpoint inhibitor therapy; D) Treatment will not exceed 5 doses (500 mg IV every 2 weeks, total of 5 doses).

inv-08: Continuation/renewal criteria

Authorization of 12 months for ongoing therapy may be granted when members achieve or maintain a positive clinical response:

RA continuation: Improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.>=20% improvement

Applicable to all members including new members

JIA continuation: Low disease activity or improvement in number of active joints, number of joints with limitation of movement, or functional ability.

PsA continuation: Low disease activity or improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, or skin/nail involvement.

GVHD and ICI continuation:

This medical policy may not apply to the Federal Employee Program (FEP); benefits for FEP members are determined by the Federal Employee Program and are subject to applicable contract language.

Do not administer abatacept (Orencia) to members with active tuberculosis (TB) infection. For biologic/targeted synthetic DMARD–naïve persons, document a negative TB test within the prior 12 months. If TB screening is positive, confirm no active disease (e.g., chest x-ray) and treat latent TB before initiating abatacept.

No additional explicit exclusions are stated in the cited reference material.

Orencia (abatacept) is considered not medically necessary for members who do not meet the coverage criteria and requirements described in this policy.

No further conditions explicitly labeled as “not medically necessary” are stated in the provided reference excerpts.

Billing, Codes, and Dose Limits

Procedures and billing codesHCPCS

J0129

Injection, abatacept, 10 mg

Maximum doses for immune checkpoint inhibitor-related toxicity — IV Orencia

Maximum dosing regimenUp to 5 doses: 500 mg IV every 2 weeks (total of 5 doses)

RouteIntravenous (IV) formulation only for ICI-related toxicity pathway

Authorization duration1 month when criteria met

Indication limitationFor treatment of immune checkpoint inhibitor-related toxicity only (perpolicy criteria)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required and will evaluate prior trials of the plan's preferred products within the therapeutic class. Initial approval generally requires documented inadequate response or intolerable adverse events to required numbers of preferred products (see criteria for RA, pJIA, PsA and others). Authorization durations vary by indication (e.g., typically 12 months for RA, JIA, PsA, chronic GVHD; 1 month for prophylaxis of acute GVHD and immune checkpoint inhibitor-related toxicity where specified). Coverage decisions may allow exceptions when clinical circumstances preclude use of preferred products or the member is already receiving and benefiting from the non-preferred therapy.

Prior authorization required for subcutaneous and intravenous Orencia when applicable to indication and benefit.
Initial approval criteria include trials of preferred products or documented clinical reason to avoid them, or current receipt of requested product with positive clinical response.
Authorization durations specified by indication (e.g., 12 months for many chronic indications; 1 month for certain peri-transplant or acute uses).

Indications, Compendial Uses, and Drug Naming

FDA-Approved Indications for Orencia

Rheumatoid arthritis (RA)Moderately to severely active RA in adults

Polyarticular juvenile idiopathic arthritis (pJIA)Moderately to severely active pJIA in patients 2 years of age and older

Psoriatic arthritis (PsA)Active PsA in patients 2 years of age and older

Prophylaxis of acute GVHD (aGVHD)Prophylaxis of aGVHD in combination with a calcineurin inhibitor and methotrexate in HSCT recipients (adults and pediatric patients ≥2 years)

Compendial Uses

Oligoarticular juvenile idiopathic arthritisSupported use per compendia

Background and Scope

Orencia (abatacept) is approved for several inflammatory conditions. FDA-labeled indications include moderately to severely active rheumatoid arthritis (RA) in adults, polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older, psoriatic arthritis (PsA) in patients 2 years and older, and prophylaxis of acute graft-versus-host disease (aGVHD) in hematopoietic stem cell transplant recipients. Compendial (off‑label) uses referenced in the policy include oligoarticular JIA, chronic graft-versus-host disease (cGVHD), and intravenous use for immune checkpoint inhibitor–related toxicity. The policy references the Orencia package insert (Bristol‑Myers Squibb, January 2024) and current specialty society guidelines as the clinical context for these indications.

OpenPayer

Orencia (abatacept) — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing, Codes, and Dose Limits

Prior Authorization, Documentation, and Step Therapy

Indications, Compendial Uses, and Drug Naming

Background and Scope