CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Orencia (abatacept) subcutaneous — Pharmacy step therapy coverage criteria

Defines step therapy requirements for coverage of subcutaneous Orencia (abatacept) for rheumatoid arthritis and psoriatic arthritis, specifying required prior trials of preferred alternatives and continuity rules; applies to pharmacy benefit management for members under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Orencia (abatacept) subcutaneous — Coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative edits to preferred product examples and footnotes

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionDocument drug name, date, and duration of trial for each required preferred product (or provide evidence of contraindication/intolerance) when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

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

2required prior preferred product trials for new RA and many PsA approvals

12authorization duration (months)

subcutaneousformulation covered by step therapy

JIA exempt

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polyarticular JIA patients exempt

Coverage Criteria

Infused (intravenous) formulations approved for treatment of rheumatoid arthritis are not part of the step therapy criteria for Orencia subcutaneous; intravenous infusion is typically billed under the medical benefit. The step therapy policy applies to the subcutaneous formulation of abatacept and requires adherence to the program's prior trial and documentation rules for pharmacy benefit coverage.

This policy requires members new to therapy to try preferred alternatives before Orencia subcutaneous will be covered, but infusion products administered in an infusion center are handled separately under medical benefit rules and are excluded from the pharmacy step therapy requirement.

Initial Therapy Requirements

inv-11: Initial therapy — Initial therapy requirements for new users

Initial therapy requirements for new users

Initial RA/Adult PsA: Diagnosis of the indicated condition AND history of failure, contraindication, or intolerance to required number of preferred products (document drug, date, and duration).2 products

Preferred product lists and specific pediatric exceptions are detailed in policy; infusion formulations are not part of this pharmacy step therapy.

Continuation Therapy Requirements

inv-12: Continuation therapy — Continuation approvals

Continuation approvals

Continuation approval: Patient is currently on Orencia and has not relied on manufacturer supplied samples or Orencia Co‑Pay Program assistance to establish current use; then Orencia may be approved without required prior trials.

Patients established via samples or co‑pay assistance must meet initial authorization criteria.

Step Therapy Rules

Step	Requirement	Notes
1	Try two preferred products prior to coverage of Orencia (abatacept) subcutaneous for most adult patients with rheumatoid arthritis or psoriatic arthritis (document drug name, date, and duration of each trial).	Preferred products include adalimumab products, certolizumab (Cimzia), etanercept (Enbrel), upadacitinib (Rinvoq), golimumab (Simponi), tofacitinib (Xeljanz/Xeljanz XR), and others listed in policy; see preferred products list in drug coverage tools.
2	Alternative continuation path: patient currently on Orencia may be approved without required prior trials if not established solely via manufacturer samples or Orencia Co‑Pay Program assistance (documented current user).	Patients established via manufacturer-supplied samples or co‑pay assistance must meet initial authorization criteria as new to therapy.
3	Pediatric PsA (<18 years): requirement may be only one trial of a specified preferred product (one of the preferred ustekinumab products or etanercept) documented by date and duration.	This pediatric alternative applies only to patients under 18 with active psoriatic arthritis per policy wording.

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization requires documentation that the member has a qualifying diagnosis and has failed, is intolerant to, or has a contraindication to required preferred alternatives, OR documentation that the member is an existing Orencia (abatacept) user who did not obtain therapy via a manufacturer free sample or co-pay assistance program.

Qualifying diagnosis: moderately to severely active rheumatoid arthritis (RA) or approved indication per policy.
If requesting under failure/intolerance route: Document drug name, trial dates, and duration for each required preferred product tried.
If requesting as current Orencia user: Document that patient is currently on Orencia therapy and has not received a manufacturer-supplied free sample in the prescriber's office or assistance from the Bristol-Myers Squibb Orencia Co-Pay Program to establish current use.

Step Therapy

Step Therapy Requirement

Step therapy requirement — Members new to Orencia subcutaneous must have trialed and failed (or have contraindication/intolerance to) two preferred products before Orencia will be approved. Infused RA medications are not included among the required step-therapy alternatives.

Definitions

Current user (definition and continuation rule)

DefinitionCurrent user = patient with documented current Orencia (abatacept) subcutaneous therapy in claims history.

Continuation allowanceMembers currently on Orencia therapy documented in claims history may continue without meeting step trials.

Exclusions to documented statusPatients established solely via manufacturer‑supplied free samples or Orencia co‑pay assistance are not considered current users for continuation and must meet initial criteria.

Required documentationClaims history or medical record evidence confirming active Orencia use (drug, date) is required to qualify as a current user for continuation approval.

Formulation scopeThis continuity rule applies to the subcutaneous formulation of abatacept (Orencia); infused formulations are addressed separately under medical benefit rules.

Background

Orencia (abatacept) subcutaneous is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of patients 2 years of age and older with active psoriatic arthritis. The step therapy program is intended to encourage use of lower‑cost preferred alternatives by requiring trials of preferred products prior to coverage of Orencia subcutaneous.

Site of Care / Billing Notes

Note

Infusion billed under medical benefit — not subject to pharmacy step therapy

Intravenous (infusion) formulations of Orencia are typically billed under the medical benefit and are not governed by this pharmacy step therapy program for the subcutaneous formulation.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Orencia (abatacept) subcutaneous — Coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative edits to preferred product examples and footnotes

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionDocument drug name, date, and duration of trial for each required preferred product (or provide evidence of contraindication/intolerance) when requesting prior authorization.

SourceLink

On This Page

Required trials: Two of the preferred alternatives listed in the policy (examples include preferred adalimumab product, Cimzia, Enbrel, Rinvoq, Simponi, Xeljanz/Xeljanz XR; for certain indications additional biologics such as Cosentyx, Skyrizi, preferred ustekinumab products, Tremfya may be applicable).
Infused RA medications approved for RA are excluded from the step-therapy count.

Documentation Required

Trial Documentation

Trial documentation — Provide specific documentation for each required preferred product trial: drug name, start and end dates, and duration. If a medication was not tried due to contraindication or intolerance, include clinical rationale or supporting documentation.

For each preferred product trial include: drug name, date(s) of trial, and duration.
If claiming contraindication/intolerance, include clinical notes explaining the contraindication or description of the adverse event.
Failure to supply these details may result in denial or delay of prior authorization.
Patients who received Orencia via manufacturer free samples or co-pay assistance must meet initial authorization criteria as new-to-therapy unless documentation shows ongoing commercial/covered therapy without such assistance.

Denial Risk

Documentation & Prior Trials

Documentation & prior trials — Failure to document trials (drug, date, duration) of the required preferred alternatives, or to document that the patient is an existing Orencia user who did not rely on manufacturer samples or Orencia Co‑Pay assistance to establish therapy, may result in denial of the authorization request.

Patients established on Orencia solely through manufacturer free samples or Orencia Co‑Pay Program assistance are considered new to therapy and must meet initial step-therapy requirements.
Ensure prior authorization submission includes all relevant chart notes, medication administration/dispensing records, and any supporting lab or clinical information that justifies exceptions.