ModifiedCignaPolicy N/A

Orencia (abatacept) subcutaneous — coverage criteria (appendix)

Defines Cigna's prior authorization, medical necessity criteria, and coverage stance for Orencia (abatacept) subcutaneous injection for FDA‑approved indications (rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis) and specifies noncovered uses. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOrencia (abatacept) subcutaneous — coverage criteria (appendix)

Policy CodePolicy N/A

Change TypeAge minimums addedcombination therapy wording clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age, prior DMARD/biologic trials, prescriber specialty, and objective measures or symptomatic improvement to support approval.

SourceLink

POLICY UPDATE CHANGES

For initial approvals, a requirement that the patient is ≥ 18 years of age for rheumatoid arthritis and ≥ 2 years of age for juvenile idiopathic arthritis and psoriatic arthritis was added.

Conditions Not Covered: Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug wording was changed.

In the Overview, updated age of approval in psoriatic arthritis to patients ≥ 2 years of age.

3FDA‑approved indications listed

6 monthsTypical initial approval duration

1 yearTypical renewal duration for established therapy

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

~30agents listed or referenced

Coverage and Medical Necessity Criteria

Rheumatoid Arthritis

Covered when ONE of the following is met:

Rheumatoid Arthritis: A) Initial Therapy: Patient is ≥ 18 years of age AND has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). An exception to the DMARD trial may 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. The medication is prescribed by or in consultation with a rheumatologist.age >= 18; DMARD trial >= 3 months

Approve for 6 months for initial therapy.

Rheumatoid Arthritis: B) Currently Receiving Orencia (Intravenous or Subcutaneous): Patient has been established on therapy for at least 6 months AND meets at least ONE of: a) patient 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) patient experienced an improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).established >= 6 months

Approve for 1 year when continuing criteria are met.

Juvenile Idiopathic Arthritis (JIA)

Covered when ONE of the following is met:

JIA Initial Therapy: A) Initial Therapy: Patient is ≥ 2 years of age AND meets ONE of: a) has tried one other agent for this condition (examples include NSAIDs; a prior trial of one biologic other than the requested drug also counts; a biosimilar of the requested biologic does not count); OR b) will start therapy concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide (examples: pregnancy, breastfeeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias); OR d) has aggressive disease as determined by the prescriber. The medication is prescribed by or in consultation with a rheumatologist.age >= 2

Approve for 6 months for initial therapy.

JIA Continuing Therapy: 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: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers, or reduced corticosteroid dose); OR b) patient experienced improvement in at least one symptom or function from baseline.established >= 6 months

Psoriatic Arthritis

Covered when ONE of the following is met:

Psoriatic Arthritis Initial Therapy: A) Initial Therapy: Patient is ≥ 2 years of age AND the medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 2

Approve for 6 months for initial therapy.

Psoriatic Arthritis Continuing Therapy: 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: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, or serum markers); OR b) patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).established >= 6 months

Approve for 1 year when continuing criteria are met.

Use of Orencia (abatacept subcutaneous) for indications listed in this appendix is considered experimental, investigational or unproven when evidence does not support efficacy. Examples of such non‑covered uses include, but are not limited to: ankylosing spondylitis (no demonstrated major response in trial data), inflammatory bowel disease (Crohn’s disease and ulcerative colitis showed no consistent benefit over placebo in randomized trials), and plaque psoriasis (pivotal data did not show significant PASI benefit at Week 24). Requests for Orencia for these indications will be denied as not covered when submitted for these experimental/unproven uses.

The appendix provides examples of indications and is not an all‑inclusive list. Refer to the prescribing information for each agent for complete, FDA‑approved indications and consult the primary policy for formal prior authorization and coverage requirements.

Concurrent administration of Orencia with another biologic agent or with a targeted synthetic oral small molecule drug for inflammatory conditions is discouraged and is considered not medically necessary due to increased risk of adverse events and lack of controlled data demonstrating additive benefit. This does not preclude combination with conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

This appendix does not enumerate any additional specific conditions that are explicitly labeled as “not medically necessary.” Coverage determinations and any formal not‑medically‑necessary listings are handled in the primary policy and prescribing information.

Drug and Billing Codes

Drug list (no billing codes provided)mixed

Not applicable

Appendix lists drug names and mechanisms; no CPT/HCPCS/ICD-10/NDC or other billing codes are provided in this portion of the document.

Prescriber Requirements, Authorization & Documentation

Prior Authorization

Prior Authorization and Prescriber Specialty

Prior authorization and prescriber specialty — initial approvals require prescription by or consultation with an appropriate specialist. Because of the specialized skills required for evaluation and diagnosis and monitoring for adverse events and long-term efficacy, initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist for RA/JIA/PsA; dermatologist or rheumatologist for PsA where specified).

Initial approvals: prescriber must be specialist or documented consultation with specialist.

Note

Approval Durations

Approval durations — initial therapy approvals are typically for 6 months; renewals/continuation therapy for patients established on therapy are typically for 1 year (patients must generally have been on therapy ≥ 6 months to qualify for the 1-year continuation approval). When approval is authorized in months, 1 month = 30 days.

Initial therapy: approve for 6 months when initial criteria met.

Clinical Background

Abatacept (Orencia) is a selective T‑cell costimulation modulator indicated by labeling for moderately to severely active rheumatoid arthritis in adults, juvenile idiopathic arthritis in patients ≥ 2 years, and psoriatic arthritis in patients ≥ 2 years. Product guidance recommends against concomitant use with other potent immunosuppressants (for example, biologics or JAK inhibitors) because of increased risk of adverse events and limited evidence of added efficacy.

Definitions and Measures

inv-19: Orencia (abatacept) subcutaneous — drug definition and labeled indications

Generic nameAbatacept

Brand nameOrencia (subcutaneous)

Mechanism of actionSelective T‑cell costimulation modulator

FDA‑approved indications (labeling)Rheumatoid arthritis in adults with moderately to severely active disease; Juvenile idiopathic arthritis in patients ≥ 2 years with moderately to severely active polyarticular disease; Psoriatic arthritis in patients ≥ 2 years with active disease.

inv-20: Objective measures of disease activity — listed validated instruments

CDAIClinical Disease Activity Index — validated composite for rheumatoid arthritis

Policy Summary

PayerCigna

PolicyOrencia (abatacept) subcutaneous — coverage criteria (appendix)

Policy CodePolicy N/A

Change TypeAge minimums addedcombination therapy wording clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age, prior DMARD/biologic trials, prescriber specialty, and objective measures or symptomatic improvement to support approval.

SourceLink

On This Page

Approve for 1 year when continuing criteria are met.

Established/continuation therapy: approve for 1 year when continuation criteria met (established on therapy ≥ 6 months).

Time conversion: 1 month = 30 days.

Documentation Required

Prior Authorization and Appendix Scope

Prior authorization not defined in this appendix — the appendix is informational and catalogs agents, mechanisms, and example indications only. The primary policy contains the operational prior authorization requirements, documentation expectations, and step-therapy rules.

This appendix does not define prior authorization steps or documentation requirements; refer to the main policy for authorization rules.
The appendix catalogs agents, mechanisms, and example indications but does not define step therapy sequences.

Documentation Required

Documentation Expectations (Appendix)

None specified in this appendix — no additional documentation steps or prior authorization workflows are provided here. Providers should submit required clinical documentation (age, prior DMARD/biologic trials, prescriber specialty, disease activity measures, response to therapy) as specified in the main policy when requesting authorization or renewal.

This appendix: informational only — no documentation or prior authorization algorithms included.
Required clinical documentation (age, prior trials, prescriber specialty, disease activity measures) is described in the primary policy, not the appendix.

Step Therapy

Prior DMARD / Biologic Trial Requirement

Prior DMARD/biologic trial requirement — initial therapy for rheumatoid arthritis and juvenile idiopathic arthritis generally requires a trial of at least one conventional synthetic DMARD for ≥ 3 months, or prior trial of at least one biologic (a biosimilar of the requested biologic does not count). A patient who has already tried a biologic is not required to 'step back' to a conventional synthetic DMARD.

RA initial therapy: trial of one conventional synthetic DMARD ≥ 3 months required (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).
Exception: prior 3-month trial of at least one biologic other than the requested drug satisfies the requirement; biosimilars do NOT count.
JIA initial therapy: trial of one other agent (or concurrent start with methotrexate/leflunomide/sulfasalazine or absolute contraindication) or prior biologic counts.

Step Therapy

Step Therapy (Appendix Limitation)

This appendix does not define step therapy sequences — it catalogs agents, mechanisms, and example indications only. Step-therapy sequencing and any required prior agents or specific step rules are defined in the main policy and prior authorization criteria.

Appendix: agent catalog and example indications only — not a step-therapy algorithm.
Refer to main policy for step-therapy sequences and operational rules.

Documentation Required

No Documentation or Prior Authorization Steps in Appendix

No documentation or prior authorization steps provided in this appendix — providers must follow the main policy for required documentation to support initial and renewal requests (including objective measures of disease activity or symptom improvement, prescriber specialty, prior trial documentation, and duration on therapy).

Providers should include objective disease activity measures (e.g., CDAI, DAS28, PAS-II, RAPID-3, SDAI, DAPSA, CPDAI, PsA DAS, etc.) or documented symptom improvement when requesting continuation.
Include documentation of prior DMARD/biologic trials and prescriber specialty per main policy.

DAS28Disease Activity Score using 28 joints (ESR or CRP) — validated for rheumatoid arthritis

SDAISimplified Disease Activity Index — validated composite for rheumatoid arthritis

RAPID3Routine Assessment of Patient Index Data 3 — patient‑reported composite for rheumatoid arthritis

PAS-II / other RA indicesPatient Activity Scale II and similar instruments referenced in RA guidance

JDAS / cJDAS / JSpADAJuvenile disease activity scores referenced for JIA (JDAS, clinical JDAS, JSpADA) — used with MD/parent/patient global assessments and serum markers

inv-21: Abbreviations used in the appendix (SC, IV, AS, CD, PsO, etc.)

SCSubcutaneous

IVIntravenous

ASAnkylosing spondylitis

CDCrohn's disease

PsOPlaque psoriasis

PsAPsoriatic arthritis