CurrentunitedhealthcarePolicy 2025 P 3074-13

Clinical Pharmacy Programs

UnitedHealthcare step therapy program governing coverage authorization for Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC), requiring prior trial or intolerance to ursodeoxycholic acid and rules for continuation, authorization duration, and use of automated approval based on claims history. Effective 2026-03-01.

Policy Summary

Payerunitedhealthcare

PolicyClinical Pharmacy Programs

Policy CodePolicy 2025 P 3074-13

Change TypeRevised (background updated; criteria unchanged)

Effective DateMar 1, 2026

Next Review Date

Key ActionRequire documentation that member failed to achieve an adequate response to an appropriate dosage of ursodeoxycholic acid after at least 12 consecutive months, or has documented contraindication/intolerance, before approving Ocaliva.

SourceLink

POLICY UPDATE CHANGES

Updated background and references to reflect voluntary withdrawal of Ocaliva from US market (Intercept announcement 9/11/2025).

Revised outline of coverage criteria without change to clinical intent.

1Primary covered indication (PBC)

12Authorization duration

>=12Required ursodeoxycholic acid trial (months)

2026-03-01Policy effective date

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Coverage Summary

UnitedHealthcare step therapy program governing coverage authorization for Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC). Coverage is covered_with_criteria and requires trial and failure of a lower-cost alternative ursodeoxycholic acid (e.g., Urso, ursodiol) or documented contraindication/intolerance, includes rules for continuation and a 12-month authorization duration, and allows automated approval based on claims/medication history. Effective date: 2026-03-01. Background notes a voluntary withdrawal announcement affecting product availability.

Key policy facts

Policy effective date2026-03-01

Authorization duration12 months

Required ursodeoxycholic acid trial duration>= 12 consecutive months

Primary covered indicationPrimary biliary cholangitis (PBC)

Initial and Continuation Therapy Criteria

Initial and Continuation Approval Criteria for Ocaliva (obeticholic acid)

Ocaliva will be approved when ALL of the following are met:

ALL of the following

ONE of
- Diagnosis of primary biliary cholangitis
- Patient has not achieved an adequate response to an appropriate dosage of ursodeoxycholic acid (e.g., Urso, ursodiol) after at least 12 consecutive months of therapy
- History of contraindication or intolerance to ursodeoxycholic acid (e.g., Urso, ursodiol)
- Continuation users
  - As continuation of therapy

Other Indications & Authorization Duration

Other Indications

Ocaliva will be approved for other indications per program rules when criteria are met.

ALL of the following

Authorization will be issued for 12 months
State mandates, federal regulatory requirements, and member-specific benefit plan coverage may impact coverage criteria; other policies and utilization management programs may apply

Prior Authorization

Authorization duration

Authorization will be issued for 12 months.

Provider Actions & Documentation Requirements

Step Therapy

Step therapy requirement - try ursodeoxycholic acid

Require documentation that the member failed to achieve an adequate response to an appropriate dosage of ursodeoxycholic acid after at least 12 consecutive months of therapy, or has a documented contraindication or intolerance to ursodeoxycholic acid.

Documentation Required

Continuation therapy documentation

For continuation approvals, document ongoing therapy and confirm the patient has not been established as a current user of Ocaliva via manufacturer-supplied samples or assistance from the Intercept Ocaliva Interconnect® support program (e.g., sample card redeemed at a pharmacy).

Clinical Evidence & References

Ocaliva [package insert], Intercept Pharmaceuticals, May 2022.

Intercept Pharmaceuticals announced voluntary withdrawal of Ocaliva from the US market; published September 11, 2025. This voluntary withdrawal removes Ocaliva from US market availability per the manufacturer's announcement.

Definitions & Background

UnitedHealthcare Step Therapy program requires a trial and failure of a lower-cost alternative ursodeoxycholic acid (examples: Urso, ursodiol) — typically after at least 12 consecutive months of therapy — before approving Ocaliva (obeticholic acid) for primary biliary cholangitis. A documented history of contraindication or intolerance to ursodeoxycholic acid also meets the step requirement. For continuation approvals, documentation must show ongoing therapy and that the patient was not established as a current user via manufacturer samples or the Intercept Ocaliva Interconnect® support program. Authorization when approved will be issued for 12 months and UnitedHealthcare may use prior claim/medication history or diagnosis codes for automated approval when applicable.

Intercept Pharmaceuticals voluntarily withdrew Ocaliva from the US market on September 11, 2025; this withdrawal affects the product's availability in the US and is reflected in the program background and references.

Definitions: ursodeoxycholic acid — examples include Urso, ursodiol; this is the required step therapy agent prior to Ocaliva unless contraindicated or intolerant.

Applicable Codes

Policy Revision History

12/2025annual reviewLatest

Annual review; no changes to coverage criteria. Updated background and references to reflect voluntary withdrawal of Ocaliva from US market (Intercept announcement 9/11/2025).

12/2024administrative revision

Administrative revision to criteria presentation; revised outline of coverage criteria without change to clinical intent.