UnitedHealthcare Orencia prior auth Policy Update

Coverage Criteria for Orencia (abatacept) Subcutaneous

Initial Authorization — Rheumatoid Arthritis (Adults)

Approved when ALL of the following are met:

RA initial: (1) Diagnosis of moderately to severely active rheumatoid arthritis

prior therapy path

2a: i. One of the following: a. History of failure to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated or intolerant (document drug, date, and duration) OR b. Prior treatment with a targeted immunomodulator FDA‑approved for rheumatoid arthritis (document drug, date, and duration) (e.g., Cimzia, adalimumab, Simponi, Olumiant, Rinvoq, Xeljanz)
2a-ii: ii. History of failure, contraindication, or intolerance to two of the following preferred products: one of the preferred adalimumab products; Cimzia (certolizumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/Xeljanz XR (tofacitinib) (document drug, date, and duration)
2b: i. Patient is currently on Orencia therapy as documented by claims history or medical records (document date and duration of therapy)
2b-ii: ii. Patient has not received a manufacturer supplied sample at no cost in the prescriber's office or assistance from the Bristol‑Myers Squibb Orencia Co‑Pay Program to establish current use
Patients established via sample/copay must meet initial criteria as if new to therapy

concomitant therapy: (3) Patient is not receiving Orencia in combination with another targeted immunomodulator (examples include Enbrel, Cimzia, Simponi, adalimumab, Xeljanz, Olumiant, Rinvoq)

Combination therapy precludes approval; examples are illustrative

prescriber: (4) Prescribed by or in consultation with a rheumatologist

Initial Authorization and Reauthorization — Polyarticular Juvenile Idiopathic Arthritis (JIA)

Approved when ALL of the following are met:

JIA initial: (1) Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis

JIA concomitant therapy: (2) Patient is not receiving Orencia in combination with another targeted immunomodulator (examples include Enbrel, Cimzia, Simponi, adalimumab, Xeljanz, Olumiant, Rinvoq)

Combination therapy precludes approval

JIA prescriber: (3) Prescribed by or in consultation with a rheumatologist

Authorization will be issued for 12 months

Initial Authorization — Psoriatic Arthritis (PsA)

Approved when ALL of the following are met:

PsA diagnosis: (1) Diagnosis of active psoriatic arthritis

prior therapy

2a: i. One of the following: a. History of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated (document date and duration) OR b. Prior treatment with a targeted immunomodulator FDA‑approved for psoriatic arthritis (document drug, date, and duration) (e.g., Cimzia, adalimumab, Simponi, ustekinumab, Tremfya, Xeljanz, Otezla, Skyrizi, Enbrel)
2a-ii: ii. History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration): one of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab); one of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib)

Reauthorization — All Indications

Approved when ALL of the following are met:

positive response: (1) Documentation of positive clinical response to Orencia therapy

no combination: (2) Patient is not receiving Orencia in combination with another targeted immunomodulator (examples include Enbrel, Cimzia, Simponi, adalimumab, Xeljanz, Olumiant, Rinvoq)

Authorization will be issued for 12 months

Initial Therapy — Initial authorization

Initial authorization — Covered when ONE of the following is met:

Initial criteria: (a) Patient is less than 18 years of age; OR (b) Patient is less than 18 years of age AND has history of failure/contraindication/intolerance to one of the preferred ustekinumab products or Enbrel (etanercept) (document date and duration of trial); OR (c) Patient is currently on Orencia therapy as documented by claims or medical records and has not received manufacturer sample/co‑pay assistance to establish therapy (document date and duration)

Must not be receiving Orencia in combination with another targeted immunomodulator; prescriber must be or consult with a rheumatologist or dermatologist as applicable

Reauthorization / Continuation Therapy — Reauthorization

Reauthorization — Approved when ALL of the following are met

Reauthorization criteria: (1) Documentation of positive clinical response to Orencia therapy; AND (2) Patient is not receiving Orencia in combination with another targeted immunomodulator (examples listed)

Authorization issued for 12 months; state-specific mandates (e.g., CT/KY/MS 30‑day trial) may apply

Concomitant use of Orencia (abatacept) with other immunosuppressive agents or targeted immunomodulators is not recommended and is an explicit exclusion for approval under these criteria. Requests may be denied when documentation shows the patient is receiving Orencia in combination with another targeted immunomodulator or when required documentation of prior trials or prescriber specialty is not provided. Examples of targeted immunomodulators that preclude coverage when used in combination with Orencia include Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), ustekinumab, Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekizumab), and Otezla (apremilast).

For initial authorization, providers must also document prior therapy and prescriber specialty as required by the indication-specific criteria; patients who were established on Orencia solely through manufacturer-supplied samples or Bristol-Myers Squibb co‑pay assistance are considered new to therapy and must meet initial authorization documentation requirements (including dates and duration of prior trials) rather than being treated as established users.

Patients receiving Orencia in combination with another targeted immunomodulator are excluded from coverage under these criteria. Coverage will be denied if records show concurrent use of Orencia with any of the listed targeted immunomodulators (examples include Enbrel, Cimzia, Simponi, adalimumab, ustekinumab, Skyrizi, Tremfya, Cosentyx, Taltz, Xeljanz, Olumiant, Rinvoq, Otezla).

Providers seeking authorization must ensure documentation demonstrates the patient is not on combination therapy; failure to provide this documentation may result in denial of the request.

Provider Actions, Documentation, and Step-Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Diagnosis and step‑therapy/previous‑therapy documentation must be submitted for initial authorization. Authorization (when approved) will be issued for 12 months.

Prior authorization is required for Orencia (abatacept).
Authorization will be issued for 12 months when criteria are met.

Documentation Required

Initial Authorization Requirements

Initial authorization will be approved only when all applicable criteria are documented and met for the relevant diagnosis (rheumatoid arthritis or psoriatic arthritis). Documentation must include drug names, dates, and duration of prior trials, and the clinical rationale for failure, contraindication, or intolerance.

Diagnosis consistent with the requested indication (e.g., moderately to severely active rheumatoid arthritis or active psoriatic arthritis).

Initial Therapy Criteria and Drug-Specific Conditions

Initial therapy — Initial authorization criteria vary by indication and require diagnosis plus prior therapy steps or current documented use

Initial authorization criteria vary by indication and require diagnosis plus prior therapy steps or current documented use.

RA initial: See 'Initial Authorization — Rheumatoid Arthritis (Adults)' for specific required diagnosis, prior therapy steps, and prescriber requirements

Document drug, date, and duration of prior trials; step therapy requirements apply where specified

JIA initial: See 'Initial Authorization and Reauthorization — Polyarticular Juvenile Idiopathic Arthritis (JIA)' for specific requirements; authorization issued for 12 months

Prescriber must be or consult with a rheumatologist

PsA initial: See 'Initial Authorization — Psoriatic Arthritis (PsA)' for required diagnosis, prior therapy options, pediatric pathway, and prescriber requirements

Step Therapy Requirements and Preferred Products

Required documentation	Examples / notes
Document drug name(s), dates, and duration of prior trials of non‑biologic DMARDs or targeted immunomodulators (claims history or medical records)
For RA and PsA: document 3‑month trial of non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated; include dates and duration
Document history of failure, contraindication, or intolerance to preferred step products (document drug, date, and duration)
Preferred product lists are maintained in drug coverage tools — see footnote for preferred adalimumab/ustekinumab product guidance

Step requirement	Coverage effect / status
Failure, contraindication, or intolerance to two preferred step products (document drug, date, and duration of trial) — e.g., one of the preferred adalimumab products; Cimzia; Enbrel; Rinvoq; Simponi; Xeljanz/Xeljanz XR
For PsA pediatric pathway: history of failure/contraindication/intolerance to one of the preferred ustekinumab products or Enbrel (document date and duration)
Alternatively, prior treatment with a targeted immunomodulator FDA‑approved for the indication (document drug, date, and duration) can satisfy step requirement
Current documented Orencia user (claims or medical records) may bypass step therapy if therapy was not established solely via manufacturer samples or co‑pay assistance

Continuation / Reauthorization Criteria

Continuation therapy — Reauthorization/continuation requires specified clinical response and documentation

Reauthorization/continuation requires:

continuation: Documentation of positive clinical response to Orencia therapy

Authorization for continuation issued for 12 months

no_combination: Patient is not receiving Orencia in combination with another targeted immunomodulator

Examples of targeted immunomodulators listed in policy

Reauthorization — Reauthorization requirements for continuation therapy

Reauthorization requirements for continuation therapy

Continuation:

Definitions and Terminology

inv-18: Current user established by sample/co-pay — Patients started via sample or co-pay assistance considered new unless documentation supports current use

DefinitionPatients who were started on Orencia via manufacturer-supplied sample or participation in the Bristol‑Myers Squibb Orencia Co‑Pay Program are considered new to therapy and must meet initial authorization criteria as if new users; documentation must include drug name(s), dates, and duration of prior therapy (claims or medical records).

ImplicationClaims history or medical records must document current Orencia use; patients established only by free samples or program assistance do not qualify as 'current users' for streamlined authorization.

Documentation requiredFor patients who received manufacturer samples or co‑pay assistance, submit full documentation of prior trials and dates to satisfy initial authorization criteria.

inv-19: Examples of targeted immunomodulators — Lists examples of agents considered targeted immunomodulators

ExamplesTargeted immunomodulators include Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib).

Quantity Limits and Supply

inv-26: Orencia (abatacept) — Supply limits may be in place

Quantity limitsSupply limits may be in place for Orencia (abatacept).

Site of care noteThe intravenous infusion formulation is typically billed under the medical benefit (infusion center or hospital outpatient) — see UnitedHealthcare Medical Benefit Drug Policy for details.

Operational impactQuantity and site-of-care rules may affect authorization processing and benefit determination.

Site of Care and Benefit Coverage

Billing Rule

IV infusion site-of-care and billing reference

The intravenous formulation of abatacept (Orencia) is typically covered under the medical benefit and administered in an infusion center or hospital outpatient setting; refer to the UnitedHealthcare Medical Benefit Drug Policy for Orencia for billing and site‑of‑care guidance.

IV infusion billing and site‑of‑care follow Medical Benefit Drug Policy guidance.

Background

Abatacept (Orencia) is a selective T‑cell costimulation modulator indicated for the treatment of moderately to severely active rheumatoid arthritis in adults, for polyarticular juvenile idiopathic arthritis in patients aged ≥ 2 years, and for active psoriatic arthritis in patients aged ≥ 2 years. Concomitant use with other immunosuppressive agents, including biologic disease‑modifying antirheumatic drugs and Janus kinase (JAK) inhibitors, is not recommended.

OpenPayer

Prior authorization and medical necessity criteria for Orencia (abatacept) subcutaneous

Coverage Criteria for Orencia (abatacept) Subcutaneous

Provider Actions, Documentation, and Step-Therapy Requirements

Initial Therapy Criteria and Drug-Specific Conditions

Step Therapy Requirements and Preferred Products

Continuation / Reauthorization Criteria

Definitions and Terminology

Quantity Limits and Supply

Site of Care and Benefit Coverage

Background