CurrentUnitedHealthcarePolicy N/A

Ocaliva (obeticholic acid) prior authorization

Prior authorization and reauthorization requirements for Ocaliva (obeticholic acid) for treatment of primary biliary cholangitis (PBC) under UnitedHealthcare Pharmacy Clinical Pharmacy Programs, affecting covered adult members and prescribing providers.

Policy Summary

PayerUnitedHealthcare

PolicyOcaliva (obeticholic acid) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateJun 1, 2025

Key ActionSubmit prior authorization with documentation of PBC diagnosis, cirrhosis status, and either >=12 months of UDCA failure or UDCA intolerance, or for reauthorization document positive clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsreauthorization duration

12 monthsUDCA trial

Acceleratedregulatory

2025 P 1188-10program

Coverage Criteria

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Initial Therapy — Initial Authorization

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

Initial Authorization: Patient has a diagnosis of primary biliary cholangitis

Cirrhosis status: Either: (1) patient does not have cirrhosis OR (2) patient has compensated cirrhosis without evidence of portal hypertension

UDCA use: Either: (1) used in combination with ursodeoxycholic acid (e.g., ursodiol) AND patient has not achieved an adequate response to an appropriate dosage of ursodeoxycholic acid after at least 12 consecutive months of therapy, OR (2) history of contraindication or intolerance to ursodeoxycholic acid (e.g., ursodiol)UDCA >= 12 consecutive months for inadequate response option

Continuation Therapy / Reauthorization

Reauthorization — Ocaliva will be approved when the following is met:

Reauthorization: Documentation of positive clinical response to Ocaliva therapy

Reauthorization will be issued for 12 months

Initial Therapy Requirements

Initial Therapy — Initial authorization requirements for Ocaliva

Initial authorization requirements for Ocaliva

Initial therapy: Diagnosis of PBC; no cirrhosis OR compensated cirrhosis without evidence of portal hypertension; AND either combination use with UDCA after inadequate response to at least 12 consecutive months of appropriately dosed UDCA, OR history of contraindication or intolerance to UDCAUDCA inadequate response defined after >= 12 consecutive months

Examples of UDCA include ursodiol

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Initial authorization for Ocaliva (obeticholic acid) is approved only when ALL listed criteria are met.

Diagnosis: primary biliary cholangitis (PBC).
Cirrhosis status: patient either does not have cirrhosis OR has compensated cirrhosis without evidence of portal hypertension.
Therapy with ursodeoxycholic acid (UDCA, e.g., ursodiol): either used in combination with Ocaliva and patient has not achieved an adequate response to an appropriate dose of UDCA after at least 12 consecutive months, OR there is a documented history of contraindication or intolerance to UDCA.

Documentation Required

Documentation is required to support the diagnosis, cirrhosis status, prior UDCA use or contraindication, and clinical response for reauthorization.

Required documentation must include: diagnosis of primary biliary cholangitis; documentation that the patient either does not have cirrhosis or has compensated cirrhosis without portal hypertension.
If approval is requested based on inadequate response to UDCA: documentation of appropriate UDCA dosage and at least 12 consecutive months of therapy and evidence of inadequate response.
If approval is requested based on UDCA intolerance/contraindication: documentation of the contraindication or intolerance.
For reauthorization: documentation of positive clinical response to Ocaliva therapy.

Denial Risk

Denial Risk — Incomplete or Missing Documentation

Lack of required documentation may result in denial of the request.

Absence of documentation confirming PBC diagnosis or cirrhosis status (no cirrhosis or compensated without portal hypertension) may lead to denial.
Absence of documentation of prior UDCA trial of ≥12 months at an appropriate dose, or lack of documentation of UDCA intolerance/contraindication, may lead to denial.
Lack of documentation of positive clinical response for reauthorization may lead to denial.

Step Therapy

Step Therapy / Clinical Rules

Step therapy and automated clinical rules may affect approval pathways; check program-specific requirements and limits.

UnitedHealthcare may use prior claims/medication history, diagnosis codes (ICD-10) and claim logic to approve initial or reauthorization requests.
Step therapy, supply limits, and medical necessity rules may be applied per program.
Verify any program-specific step therapy requirements before submitting an authorization request.

Step	Requirement
1	Step therapy may be in place per clinical rules; check program-specific step therapy requirements.

Quantity Limits

inv-15: Ocaliva (obeticholic acid) — quantity limit details

Quantity limits presentSupply limits may be in place per program-specific rules

Program variabilityUnitedHealthcare may apply medical necessity and step therapy rules which can affect quantity limits

Approval sourcesApprovals may be granted based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic that can influence quantity allowances

Definitions

inv-10: Primary biliary cholangitis (PBC)

DefinitionA chronic autoimmune cholestatic liver disease; in this policy Ocaliva is indicated for adults with PBC without cirrhosis or with compensated cirrhosis without evidence of portal hypertension

Indication specificsOcaliva is indicated as an add-on to UDCA for adults with inadequate response to UDCA, or as monotherapy for adults intolerant of UDCA

Regulatory noteIndication approved under accelerated approval based on reduction in alkaline phosphatase; clinical benefit on survival or symptoms not established

inv-11: Inadequate response to UDCA

Definition of inadequate response to UDCAFailure to achieve an adequate biochemical response after at least 12 consecutive months of appropriately dosed ursodeoxycholic acid (UDCA)

When appliedUsed to determine eligibility for combination therapy with Ocaliva when patient has not met biochemical response after UDCA trial

Alternative pathwayPatients with a history of contraindication or intolerance to UDCA may be eligible for Ocaliva without meeting the UDCA trial requirement

Background

Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist indicated for treatment of primary biliary cholangitis (PBC) in adults without cirrhosis or with compensated cirrhosis without portal hypertension. It is approved as an add-on to ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA, or as monotherapy for adults who cannot tolerate UDCA. The indication was granted under accelerated approval based on reduction in alkaline phosphatase (ALP); improvement in survival or disease-related symptoms has not been established, and continued approval may depend on confirmatory trial results.