CurrentCignaPolicy N/A

Inflammatory Conditions - Orencia Intravenous Prior Authorization Policy

Prior authorization policy for Orencia (abatacept) intravenous infusion covering FDA‑approved indications (GVHD prevention, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis), required prescriber specialties, trial/response requirements, approval durations, and excluded/unproven uses. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Orencia Intravenous Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified (age requirements added)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Orencia intravenous; initial approval requires prescription by or consultation with a specialist appropriate to the indication.

SourceLink

POLICY UPDATE CHANGES

History notes: Annual revisions with 'No criteria changes' and selected prior revisions adding age requirements for JIA (≥2 years), PsA (≥18 years), and RA (≥18 years).

4FDA-approved indications covered (GVHD, JIA, PsA, RA)

>=2Min age for JIA and GVHD (years)

>=18Min age for adult indications (years)

3Examples of not covered conditions

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Coverage summary

Orencia (abatacept) intravenous infusion is covered with criteria for its FDA‑approved indications: prevention of acute graft‑versus‑host disease (GVHD), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), and rheumatoid arthritis (RA). Coverage requires meeting indication‑specific prior authorization criteria (e.g., age requirements, concomitant therapy or prior treatment trials, objective or symptomatic improvement for continuation) and prescriber specialty requirements. Applicable prescriber specialties include oncologists/hematologists or physicians affiliated with transplant centers for GVHD prevention, and rheumatologists (and dermatologists for PsA) for the rheumatologic indications. The IV formulation is dosed by body weight; a subcutaneous formulation is also available and some adults initiating the SC formulation may receive a single IV loading dose.

Graft-versus-host disease — Prevention (FDA‑approved)

Graft-Versus-Host Disease - Prevention (FDA-approved)

Approve for 4 doses if the patient meets ALL of the following (A, B, C, D, E, and F):

ALL of the following

Patient is ≥ 2 years of age
Orencia is being used for prevention of acute graft-versus-host disease
Patient will also receive a calcineurin inhibitor for prevention of acute graft-versus-host disease
Examples of calcineurin inhibitors include cyclosporine and tacrolimus.
Patient will also receive methotrexate for prevention of acute graft-versus-host disease
Donor type
- Hematopoietic stem cell transplantation from a matched unrelated donor
- Hematopoietic stem cell transplantation from a 1-allele-mismatched unrelated donor
Medication is prescribed by or in consultation with an oncologist, hematologist, or a physician affiliated with a transplant center

Prior Authorization

Prior authorization and approval duration — GVHD prevention

Prior authorization is recommended for Orencia (abatacept) intravenous for prevention of acute graft‑versus‑host disease. Initial approval requires the medication to be prescribed by or in consultation with an appropriate specialist (oncologist, hematologist, or physician affiliated with a transplant center). Approval duration for GVHD prevention is 30 days (sufficient to receive four doses).

Juvenile idiopathic arthritis (JIA) — FDA‑approved

Juvenile Idiopathic Arthritis (JIA) - FDA-approved

Approve if patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is > 2 years of age
- ALL of the following
  - One of: Patient has tried one other agent for this condition
    Examples: methotrexate, sulfasalazine, leflunomide, NSAID. A biologic other than the requested drug counts; a biosimilar of the requested biologic does not count.
  - One of:

Psoriatic arthritis (PsA) — FDA‑approved

Psoriatic Arthritis (PsA) - FDA-approved

Approve if patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is > 18 years of age
- Medication is prescribed by or in consultation with a rheumatologist or a dermatologist
B) Patient is Currently Receiving Orencia (Intravenous or Subcutaneous)
- Patient has been established on therapy for at least 6 months
  Patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

Rheumatoid arthritis (RA) — FDA‑approved

Rheumatoid Arthritis (RA) - FDA-approved

Approve if patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is > 18 years of age
  Examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine. Exception: if patient already had a 3-month trial of at least one biologic other than the requested drug. Biosimilar of requested biologic does not count. A patient who already tried a biologic is not required to 'step back' to a conventional DMARD.
- Patient has tried ONE conventional synthetic DMARD for at least 3 months
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving Orencia (Intravenous or Subcutaneous)

Prescriber specialty and prior authorization rules

Prescriber specialty and general PA rules

General requirements applicable to approvals:

ALL of the following

Prior Authorization is recommended for prescription benefit coverage of Orencia intravenous
Initial approval requires Orencia intravenous to be prescribed by or in consultation with a physician who specializes in the condition being treated
Examples given across indications: oncologist/hematologist/transplant center physician for GVHD; rheumatologist for JIA/RA; rheumatologist or dermatologist for PsA.
Approval durations are as noted per indication; when in months, 1 month = 30 days. For prevention of GVHD, approval duration is 30 days (adequate to receive four doses).

Applicable codes

Drug Name / ProductmixedCovered

Orencia (abatacept) intravenous infusion

Covered product (intravenous formulation) per policy

Background and sources

Orencia is a selective T‑cell costimulation modulator available as an intravenous infusion and as a subcutaneous injection. The IV formulation is dosed on body weight. The subcutaneous formulation is also available and is approved for use in patients > 2 years of age for JIA and PsA and for adults with RA; some adults starting the SC product may receive a single IV loading dose. The policy references the FDA prescribing information and specialty society guidelines, including the American College of Rheumatology (ACR) and the National Comprehensive Cancer Network (NCCN).

Key evidence and guideline sources include: Prescribing information — Orencia intravenous infusion, Bristol‑Myers Squibb; May 2024, and specialty society guidance such as ACR guidelines for JIA, PsA, and RA and NCCN guidance for hematopoietic cell transplantation/GVHD.

Unproven / Not covered indications

Orencia IV is considered experimental, investigational, or unproven for any other uses. Examples of not‑covered or unsupported uses listed in the policy include ankylosing spondylitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), and psoriasis. The policy states other non‑FDA indications may be denied as experimental/investigational absent supporting evidence.

Policy revision history

09/11/2024selected_revision

Selected revision added age requirements for initial approvals: JIA ≥ 2 years, Psoriatic Arthritis ≥ 18 years, and Rheumatoid Arthritis ≥ 18 years.

03/19/2025annual_reviewLatest

Annual revision — No criteria changes.

03/13/2023annual_review

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Orencia Intravenous Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified (age requirements added)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Orencia intravenous; initial approval requires prescription by or consultation with a specialist appropriate to the indication.

SourceLink

On This Page

Patient will be starting on therapy concurrently with methotrexate, sulfasalazine, or leflunomide

One of: Patient has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide

Examples of absolute contraindications to methotrexate include pregnancy, breastfeeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias.

One of: Patient has aggressive disease, as determined by the prescriber

Medication is prescribed by or in consultation with a rheumatologist

B) Patient is Currently Receiving Orencia (Intravenous or Subcutaneous)

Patient has been established on therapy for at least 6 months
Patient who has received <6 months or restarting is reviewed under Initial Therapy
ANY of the following
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, CRP, ESR, reduced corticosteroid dose)
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved range of motion, less joint pain/tenderness, decreased morning stiffness/fatigue, improved function/ADLs)

Billing Rule

Approval durations (initial and continuation)

Initial approvals: when applicable, approve for 6 months. Continuation/renewal approvals: when criteria for ongoing benefit are met, approve for 1 year.

ANY of the following

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, MDA, PsAID-12, CRP, ESR)
Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling)

Patient has been established on therapy for at least 6 months
Patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy
ANY of the following
- Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI)
- Patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling)

Prior authorization required

Prior authorization is recommended for Orencia intravenous; initial approval requires the medication to be prescribed by or in consultation with a specialist appropriate to the indication (e.g., rheumatologist, oncologist/hematologist, transplant center physician). The policy also notes that prior authorization is recommended for prescription benefit coverage of Orencia IV and that initial approval requires specialist prescribing or consultation. The policy recommends PA for Orencia IV.

Documentation Required

Document prior treatments and response

Providers must document prior trials of therapies (or document reasons such as contraindication or need for concurrent therapy that preclude those trials) and must document objective measures and/or symptomatic improvement from baseline to support continuation of Orencia. Examples of required documentation include prior DMARDs/other agents and objective disease activity measures or symptom improvement.

Billing Rule

Approval durations

Approval durations by indication: GVHD prevention — approve for 30 days (adequate for four doses). JIA, PsA, and RA initial approvals — approve for 6 months. For patients currently receiving therapy who meet continuation criteria — approve for 1 year. (Note: when the policy lists months, 1 month = 30 days.)

Denial Risk

Not covered uses (denial risk)

Orencia intravenous is considered experimental, investigational, or unproven for any other uses and may be denied for those indications. Examples of not‑covered uses include ankylosing spondylitis, inflammatory bowel disease (Crohn’s disease, ulcerative colitis), and psoriasis.

Annual revision — No criteria changes.

02/22/2023annual_review

Annual revision — No criteria changes.