Cigna Orencia IV Prior Auth Policy Update

Medical Necessity and Coverage Criteria

Graft-Versus-Host Disease — Prevention

Covered when ALL of the following are met for GVHD prevention

GVHD prevention criteria: A) Patient is ≥ 2 years of age; AND B) Orencia (abatacept IV) is being used for prevention of acute graft-versus-host disease; AND C) Patient will also receive a calcineurin inhibitor for prevention of acute graft-versus-host disease (examples include cyclosporine or tacrolimus); AND D) Patient will also receive methotrexate for prevention of acute graft-versus-host disease; AND E) Patient will undergo hematopoietic stem cell transplantation from ONE of the following donors: (i) matched unrelated donor OR (ii) 1-allele-mismatched unrelated donor; AND F) Medication is prescribed by or in consultation with an oncologist, hematologist, or a physician affiliated with a transplant center.

GVHD dosing: Dose meets ONE: (i) patient ≥ 6 years of age: up to 10 mg/kg to a maximum of 1,000 mg per dose; OR (ii) patient ≥ 2 and < 6 years of age: up to 15 mg/kg. AND dosing schedule: one dose the day before transplantation, then doses on Days 5, 14, and 28 after transplantation.

Juvenile Idiopathic Arthritis

Covered when ONE of the following is met for Juvenile Idiopathic Arthritis (JIA)

JIA criteria (initial therapy OR currently receiving): A) Initial Therapy: patient > 2 years of age AND meets ONE of: (a) patient has tried one other agent for this condition (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID; a biologic other than the requested drug also counts as a trial but a biosimilar of the requested biologic does not count); OR (b) patient will be starting therapy concurrently with methotrexate, sulfasalazine, or leflunomide; OR (c) patient has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide (examples: pregnancy, breastfeeding, alcoholic liver disease, immunodeficiency, blood dyscrasias); OR (d) patient has aggressive disease as determined by the prescriber; AND medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Orencia (intravenous or subcutaneous): patient has been established on therapy for at least 6 months AND meets at least ONE of: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Physician Global Assessment, Parent/Patient Global Assessment, Juvenile Arthritis Disease Activity Score, serum markers such as CRP or ESR, or reduced corticosteroid dose); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., improved function, less joint pain/tenderness, decreased morning stiffness or fatigue).

JIA dosing: Weight-based dosing meets ONE: (i) 10 mg/kg if patient weighs < 75 kg; OR (ii) 750 mg if patient weighs 75–100 kg; OR (iii) 1,000 mg if patient weighs > 100 kg. AND schedule: administered at Weeks 0, 2, and 4, then every 4 weeks thereafter.

Psoriatic Arthritis

Covered when ONE of the following is met for PsA

PsA criteria (initial therapy OR currently receiving): A) Initial Therapy: patient > 18 years of age AND medication is prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Patient is Currently Receiving Orencia (intravenous or subcutaneous): patient has been established on therapy for at least 6 months AND meets at least ONE of: (a) when assessed by at least one objective measure (examples: DAPSA, CPDAI, PsA DAS, LEI, SPARCC, MDA, PsAID-12, or serum markers such as CRP/ESR), patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, decreased morning stiffness, improved function, decreased soft tissue swelling).

PsA dosing: Dose based on weight meets ONE: (i) 500 mg if patient weighs < 60 kg; OR (ii) 750 mg if patient weighs 60–100 kg; OR (iii) 1,000 mg if patient weighs > 100 kg. AND schedule: administered at Weeks 0, 2, and 4, then every 4 weeks thereafter.

Rheumatoid Arthritis

Covered when ONE of the following is met for Rheumatoid Arthritis (RA)

RA criteria (initial therapy OR currently receiving): A) Initial Therapy: patient > 18 years of age AND patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). An exception to the DMARD trial can be made if the patient has already had a 3-month trial of at least one biologic other than the requested drug (a biosimilar of the requested biologic does not count). AND medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Orencia (intravenous or subcutaneous): patient has been established on therapy for at least 6 months AND meets at least ONE of: (a) experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI); OR (b) experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, improved function, decreased soft tissue swelling).

RA dosing: Dose based on weight meets ONE: (i) 500 mg if patient weighs < 60 kg; OR (ii) 750 mg if patient weighs 60–100 kg; OR (iii) 1,000 mg if patient weighs > 100 kg. AND schedule: administered at Weeks 0, 2, and 4, then every 4 weeks thereafter.

Initial and continuation therapy

Considered medically necessary when ALL of the following are met:

Applicable policy criteria: Member meets the specific medical necessity criteria detailed in the applicable policy statements for abatacept IV (Orencia).

Use HCPCS code J0129 (Injection, abatacept, 10 mg). This code may be used for Medicare when drug is administered under the direct supervision of a physician and is not for self-administered use. Approval is contingent on meeting the applicable indication-specific criteria (see GVHD, JIA, PsA, RA sections).

Orencia (abatacept) intravenous for indications other than those specified in this policy is considered not medically necessary. Examples include treatment of ankylosing spondylitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, and primary psoriasis when the request does not meet the psoriatic arthritis criteria. Concurrent administration with another biologic or a targeted synthetic oral small molecule drug is not recommended and may be denied.

Use HCPCS code J0129 to bill for abatacept 10 mg IV. This code is not for use when the drug is self‑administered and may be used for Medicare when the drug is administered under the direct supervision of a physician.

Use of Orencia intravenous is considered not medically necessary for the following specific indications based on available evidence: Crohn's disease and ulcerative colitis (trial data showed no benefit over placebo), ankylosing spondylitis (insufficient clinical response in trials), and primary psoriasis when the request does not meet the psoriatic arthritis criteria.

Abatacept IV billed with HCPCS code J0129 is not considered medically necessary unless the member meets the applicable medical necessity criteria detailed elsewhere in this policy (indication-specific criteria, dosing, prior therapy requirements, and documentation of clinical response).

Billing Codes and Dosing Guidance

Considered medically necessary when policy criteria metHCPCSCovered

J0129

Injection, abatacept, 10 mg (Code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered)

Covered HCPCS CodesHCPCSCovered

J0129

Injection, abatacept, 10 mg

Weight-based dosing thresholds — multiple exact weight-based dose cutoffs per indication

JIA weight-based dosing10 mg/kg if patient <75 kg; 750 mg if 75–100 kg; 1,000 mg if >100 kg; administered Weeks 0, 2, 4, then every 4 weeks.

Psoriatic arthritis dosing500 mg if <60 kg; 750 mg if 60–100 kg; 1,000 mg if >100 kg; administered Weeks 0, 2, 4, then every 4 weeks.

Rheumatoid arthritis dosing500 mg if <60 kg; 750 mg if 60–100 kg; 1,000 mg if >100 kg; administered Weeks 0, 2, 4, then every 4 weeks.

GVHD pediatric dosingPatient ≥6 years: up to 10 mg/kg to a maximum of 1,000 mg per dose; Patient ≥2 and <6 years: up to 15 mg/kg; dosing schedule: day before transplant, then Days 5, 14, and 28 post-transplant.

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Orencia IV. Approval is recommended when the patient meets the policy Criteria and Dosing for the listed indications. Initial approval requires prescription by or consultation with a specialist (e.g., rheumatologist, oncologist/hematologist, or physician affiliated with a transplant center) as specified in the applicable indication criteria. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing.

Prior authorization required for Orencia IV (refer to full policy criteria for indication-specific specialist requirements)
Initial prescriber must be a specialist or in consultation with a specialist for the treated condition

Billing Rule

Billing Rule — J0129

Requests for abatacept IV billed with HCPCS code J0129 must include documentation that supports medical necessity. J0129 may be used for abatacept 10 mg IV when administered under direct physician supervision (not for self-administered use).

Drug and Clinical Background

Orencia (abatacept) is a selective T‑cell costimulation modulator available as an intravenous infusion dosed by weight and as a subcutaneous injection. The IV formulation is dosed by weight with indication‑specific weight cutoffs and schedules; for example, IV dosing regimens vary across graft‑versus‑host disease prevention, juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis. Prior authorization is required for IV abatacept, and the HCPCS code J0129 is used for the 10 mg unit when criteria are met.

Key Terms and Abbreviations

Calcineurin inhibitor — examples used with Orencia for GVHD prevention

ExamplesCyclosporine and tacrolimus are listed as examples of calcineurin inhibitors used in combination with Orencia for GVHD prophylaxis.

Role in regimenCalcineurin inhibitor is used concomitantly with methotrexate and Orencia for prevention of acute GVHD in patients ≥2 years undergoing hematopoietic stem cell transplantation.

ContextCombination with Orencia is specified in the GVHD prevention indication in the policy overview and dosing sections.

Orencia (abatacept) — T-cell costimulation modulator

DefinitionOrencia (abatacept) is defined as a selective T-cell costimulation modulator.

FormulationsAvailable as an intravenous infusion (weight‑based dosing) and as a subcutaneous injection (prefilled syringes).

Policy Changes and Revision Notes

Note

Appendix lists agents relevant to step therapy and preferred product rules

Appendix entries (biologics and oral therapies) are provided as examples and may inform step therapy or preferred product considerations; see Appendix for specific agents and indications.

Policy notes refer to preferred product requirements and directs providers to the referenced Preferred Specialty Management Policies (PSM006, PSM010) for additional preferred product criteria and exceptions.

Material change: the policy is new (effective 11/01/2024) with scheduled annual review; importantly, the role of HCPCS code J0129 for abatacept 10 mg IV is clarified — J0129 is considered medically necessary when the applicable policy criteria are met.

2024-11-01policy_created

New policy created with initial effective date of 11/01/2024.

OpenPayer

Orencia Intravenous Prior Authorization Policy