CurrentUnitedHealthcarePolicy 2024 P 3074-12

Ocaliva (obeticholic acid) step therapy

UnitedHealthcare pharmacy step therapy program requiring trial and failure of ursodeoxycholic acid (ursodiol) before coverage of Ocaliva for primary biliary cholangitis; applies to UnitedHealthcare pharmacy benefit members.

Policy Summary

PayerUnitedHealthcare

PolicyOcaliva (obeticholic acid) step therapy

Policy CodePolicy 2024 P 3074-12

Change TypeAdded manufacturer sample/assistance languageoutline clarified

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting diagnosis of primary biliary cholangitis and ≥12 months of ursodeoxycholic acid use (or documented intolerance/contraindication) before requesting Ocaliva.

SourceLink

POLICY UPDATE CHANGES

Program includes manufacturer sample language and references to Ocaliva Interconnect support program as affecting eligibility for automated approvals.

Revised outline of coverage criteria without change to clinical intent.

2025-03-01policy effective date

12 monthsminimum ursodiol trial

6/2024,12/2024P&T approval dates

12 moauthorization duration

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Coverage Criteria

Initial and continuation coverage criteria

Covered when ONE of the following criteria groups is met:

Diagnosis of primary biliary cholangitis is documented

Step requirements: Either inadequate response to ursodeoxycholic acid after at least 12 consecutive months of therapy OR history of contraindication or intolerance to ursodeoxycholic acid>= 12 months

Inadequate response defined as failure to achieve adequate clinical response despite appropriate dosing

Continuation or other: Both of the following for continuation: (1) criteria for continuation of therapy (documented prior use) AND (2) patient has not received manufacturer sample or Intercept Ocaliva Interconnect assistance to establish current user status

Manufacturer sample/support program disqualifies establishing current use

Use of a manufacturer sample or assistance from the Intercept Ocaliva Interconnect support program to establish current user status may preclude approval. Documentation showing that a member’s Ocaliva history is based on samples or program assistance (for example, a redeemable sample card or free supply provided through the Intercept program) can disqualify the member from automated continuation determinations and may result in denial unless other continuation criteria are met.

Prior authorization for Ocaliva requires evidence that the member attempted and did not achieve an adequate response to ursodeoxycholic acid (Urso, ursodiol) unless there is a documented contraindication or intolerance. The step therapy requirement is defined as inadequate response after at least 12 consecutive months of ursodeoxycholic acid at an appropriate dosage.

Coding and Key Values

Minimum ursodeoxycholic acid trial

Minimum ursodeoxycholic acid trial>= 12 consecutive months

Required contextInadequate response to appropriate dosage of ursodeoxycholic acid after the trial period

Applies toPatients with primary biliary cholangitis seeking Ocaliva (obeticholic acid)

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization required for Ocaliva (obeticholic acid) for treatment of primary biliary cholangitis (PBC). Approval requires documentation of PBC diagnosis and meeting step-therapy criteria.

Affected drug: Ocaliva (obeticholic acid)
Required diagnosis: Primary biliary cholangitis

Step Therapy

Step therapy requirement

Step therapy — patient must have tried ursodeoxycholic acid (e.g., Urso, ursodiol) and failed therapy. "Failure" is defined as inadequate response after at least 12 consecutive months at an appropriate dose.

Step requirement: ≥12 consecutive months of ursodeoxycholic acid at appropriate dose
Failure = inadequate response after ≥12 months

Background

Ocaliva (obeticholic acid) is indicated for primary biliary cholangitis. UnitedHealthcare’s step therapy program requires that members try a lower-cost alternative—ursodeoxycholic acid (ursodiol)—and demonstrate inadequate response after at least 12 consecutive months of therapy, unless a contraindication or intolerance is documented. For continuation determinations, prior established use must be verifiable by claims or prior authorization records; use established solely through manufacturer samples or Intercept support program assistance may not qualify as verified prior use.

Definitions

Step therapy

Step therapy definitionRequires trial and failure of a lower‑cost alternative (ursodeoxycholic acid/ursodiol) before coverage of Ocaliva

Failure definitionInadequate response after at least 12 consecutive months at an appropriate dosage

ExceptionDocumented contraindication or intolerance to ursodeoxycholic acid may satisfy requirement

Policy purposeEncourages use of lower‑cost alternatives within the therapeutic class

Initial Therapy Criteria

Initial therapy — requires diagnosis and fulfillment of step therapy criteria

Initial coverage requires diagnosis and fulfillment of step therapy criteria.

Diagnosis: Primary biliary cholangitis diagnosis documented

Step requirements: Either: (A) inadequate response to an appropriate dosage of ursodeoxycholic acid (Urso, ursodiol) after at least 12 consecutive months of therapy OR (B) documented contraindication or intolerance to ursodeoxycholic acid>= 12 months

Document duration and dose of ursodeoxycholic acid or provide documentation of contraindication/intolerance

Continuation Therapy Criteria

Continuation therapy — continuation approvals require prior established use and absence of manufacturer sample/support program use to establish current user status

Continuation approvals require prior established use and absence of manufacturer sample/support program use to establish current user status.

Continuation - prior use: Patient is a current user with documented prior authorization or claim history for Ocaliva (documentation of prior use)

Automated approvals may be based on prior claim/medication history

Continuation - assistance: Patient has not received a manufacturer sample at no cost in the prescriber's office or any form of assistance from the Intercept Ocaliva Interconnect support program to establish current use

Use of samples or assistance to establish current user status may preclude approval

Step Therapy Details

Step	Requirement
1	Member must try and fail ursodeoxycholic acid (Urso, ursodiol) — defined as inadequate response to an appropriate dosage after at least 12 consecutive months of therapy — unless there is a documented contraindication or intolerance.