CurrentColorado Rocky Mountain Health PlansPolicy Program Number, 1 = 2025 P 3041-20

Step therapy for Orencia (abatacept) subcutaneous

Defines step therapy requirements for coverage of subcutaneous Orencia (abatacept) for rheumatoid arthritis and psoriatic arthritis, including prior trial requirements and exceptions; applies to pharmacy benefit and new-to-therapy members. Affects prescribers and members covered by the payer's pharmacy programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Orencia (abatacept) subcutaneous

Policy CodePolicy Program Number, 1 = 2025 P 3041-20

Change TypeAdministrative and clinical clarifications (material: step requirement reinforced)

Effective Date6/1/2025

Next Review Date

Key ActionObtain prior authorization and document trials of two preferred products (drug name, dates, duration) before requesting coverage for subcutaneous Orencia.

SourceLink

POLICY UPDATE CHANGES

Removed examples for adalimumab in step therapy and changed Stelara step therapy language to 'One of the preferred ustekinumab products'; added footnote referencing drug coverage tools for list of preferred products.

Updated step therapy requirement from Humira or Amjevita to one of the preferred adalimumab products and added reference to drug coverage tools.

Added Cosentyx as a step therapy agent for psoriatic arthritis.

Program requires a member to try two preferred products before providing coverage for Orencia; infused medications approved for RA are not part of the criteria.

2preferred-product trials required before Orencia coverage

12 moauthorization period length

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Coverage Criteria

inv-01: Rheumatoid Arthritis (Initial)

Covered when ALL of the following are met:

Rheumatoid Arthritis (Initial)

Diagnosis of moderately to severely active rheumatoid arthritis.
One of
- History of failure, contraindication, or intolerance to two of the following preferred products (document drug name, dates, and duration of each trial): one of the preferred adalimumab products; Cimzia (certolizumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/Xeljanz XR (tofacitinib).
- Patient is currently on Orencia therapy AND patient has not been established solely by a manufacturer‑supplied sample or any Bristol‑Myers Squibb Orencia Co‑Pay Program assistance (patients established only via manufacturer sample or co‑pay assistance must meet initial authorization criteria as new‑to‑therapy).
  Document that current use is reflected in claims history.

inv-02: Psoriatic Arthritis (Initial)

Covered when ALL of the following are met:

Psoriatic Arthritis (Initial)

Diagnosis of active psoriatic arthritis.
One of
- History of failure, contraindication, or intolerance to two of the following preferred products (document drug name, dates, and duration of each trial): one of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab‑rzaa); one of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib).
- History of failure, contraindication, or intolerance to one of the preferred ustekinumab products or Enbrel (etanercept) (document date and duration of trial).
- Patient is currently on Orencia therapy AND patient has not been established solely by a manufacturer‑supplied sample or any Bristol‑Myers Squibb Orencia Co‑Pay Program assistance (patients established only via manufacturer sample or co‑pay assistance must meet initial authorization criteria as new‑to‑therapy).

inv-03: Other Diagnoses

Other Diagnoses: Orencia will be approved for other diagnoses as indicated.

Intravenous abatacept (Orencia) administered via infusion is governed by the medical benefit and is not included in the pharmacy step therapy requirements for the subcutaneous formulation. Providers should refer to the UnitedHealthcare Drug Policy for Orencia (IV) for clinical and coverage guidance related to infusion administration and billing.

Patients who have not attempted or documented trials of the required preferred agents, or who were only established on Orencia through manufacturer-supplied samples or promotional co-pay assistance, must meet initial authorization criteria as new-to-therapy. Documentation must include the drug name, dates, and duration of each trial; failure to provide this information may result in denial under the step therapy rules.

Members currently receiving Orencia documented in claims history may be permitted to continue therapy, but patients established solely via manufacturer samples or Orencia co-pay program assistance are not considered established users and must satisfy the step therapy requirements.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for subcutaneous Orencia (abatacept). Approvals are limited to 12 months. Grandfathering: members currently on Orencia may qualify under continuation criteria but must meet the program's documentation rules (see documentation callout).

Prior authorization required for subcutaneous Orencia
Approval duration: up to 12 months
Grandfathering/continuation allowed for current users with documentation

Step Therapy

Step Therapy (Two Preferred Products Required)

A trial (failure, contraindication, or intolerance) of two preferred products is required prior to approval of Orencia. Requirements vary by diagnosis (Rheumatoid Arthritis vs Psoriatic Arthritis).

RA: Failure/contraindication/intolerance to two preferred products from the RA list (e.g., preferred adalimumab product, Cimzia, Enbrel, Rinvoq, Simponi, Xeljanz)

Initial Therapy Criteria

inv-12: Initial Therapy

Initial authorization - approvals limited to 12 months; members new to therapy must meet step requirements.

Initial Therapy

Diagnosis of rheumatoid arthritis or active psoriatic arthritis as specified in the applicable diagnosis‑specific criteria.
One of
- History of failure, contraindication, or intolerance to two preferred products (document drug name, dates, and duration of each trial).
  Preferred product lists differ by diagnosis and are enumerated in the diagnosis‑specific criteria.
- Patient is currently on Orencia therapy AND patient has not been established solely by a manufacturer‑supplied sample or by Bristol‑Myers Squibb Orencia Co‑Pay Program assistance (patients established only via manufacturer sample or co‑pay assistance must meet initial authorization criteria as new‑to‑therapy).

Continuation Therapy

inv-13: Continuation Therapy

Continuation/maintenance therapy rules

Continuation Therapy

Members currently on Orencia therapy as documented in claims history will be allowed to continue on their current therapy.
Patients established only via manufacturer‑supplied samples or co‑pay assistance are not considered established users and must meet initial authorization criteria as new‑to‑therapy.

Step Therapy Requirements

Diagnosis	Required prior trials (must document drug, date, duration)	Coverage label
Rheumatoid arthritis (moderately to severely active)	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 of trial.	Coverage requires 2 preferred-product trials prior to Orencia (subcutaneous)
Psoriatic arthritis (active)	History of failure, contraindication, or intolerance to two of the following preferred products: one of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab-rzaa); one of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib). Document drug, date, and duration of trial.	Coverage requires 2 preferred-product trials prior to Orencia (subcutaneous)

Site of Care / Benefit Distinction

Note

IV infusions handled under medical benefit; step therapy applies to subcutaneous (pharmacy)

Intravenous (IV) abatacept infusions are typically covered under the medical benefit (infusion center). The step therapy and two-preferred-product requirement described in this policy apply to the subcutaneous formulation under the pharmacy benefit, not IV infusions.

Definitions

Step therapy — key-value summary of the step therapy program

RequirementMember must try two preferred products (trial, failure, contraindication, or intolerance) prior to coverage of Orencia (abatacept) subcutaneous.

FormulationStep therapy applies to the subcutaneous formulation of abatacept (Orencia).

Exceptions - Infused MedicationsIntravenous abatacept infusions (medical benefit) are not part of this pharmacy step therapy program; refer to the Orencia drug policy for IV dosing and coverage.

Prior authorizationPrior authorization is required for subcutaneous Orencia; approvals may be issued for up to 12 months and members currently on Orencia per claims history may be continued.

DocumentationDocument drug name, dates, and duration of prior preferred-product trials to support claims of failure, intolerance, or contraindication.

Review/Effective Date

Background

Orencia (abatacept) subcutaneous is a T‑cell co‑stimulation modulator indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis and for treatment of patients 2 years of age and older with active psoriatic arthritis. This policy addresses coverage of the subcutaneous formulation under the pharmacy benefit and requires prior authorization with step therapy for new-to-therapy members.