CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2025 P 2091-13

Ocaliva (obeticholic acid) prior authorization / medical necessity

Defines initial and reauthorization prior authorization and medical necessity criteria for Ocaliva (obeticholic acid) for treatment of primary biliary cholangitis (PBC), including prescriber requirements and restrictions on concurrent use with specific agents. Applies to the payer's pharmacy/medical program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOcaliva (obeticholic acid) prior authorization / medical necessity

Policy CodePolicy 1 = 2025 P 2091-13

Change TypeBackground updateconcurrent-use prohibition addedauthorization duration revised

Effective DateMar 1, 2026

Next Review Date

Key ActionFor initial authorization, document PBC diagnosis, cirrhosis status (none or compensated without portal hypertension), prior UDCA response or intolerance, and prescriber specialty (hepatologist or gastroenterologist).

SourceLink

POLICY UPDATE CHANGES

Background and references updated to reflect withdrawal of drug from market.

Added explicit prohibition on concurrent use with Iqirvo (elafibranor) or Livdelzi (seladelpar).

Initial authorization updated to 12 months.

12 monthsinitial and reauthorization approval duration

1diagnosis required (PBC)

2prescriber specialty options

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Authorization: Member has diagnosis of primary biliary cholangitis (PBC).

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

UDCA requirement: Either: (1) Ocaliva is used in combination with ursodeoxycholic acid AND patient has failed to achieve ALP < 1.67 x ULN after >= 12 consecutive months of UDCA; OR (2) history of contraindication or intolerance to ursodeoxycholic acid.

Concurrent therapy restriction: Patient is not receiving Ocaliva in combination with Iqirvo (elafibranor) or Livdelzi (seladelpar).

Prescriber requirement: Prescribed by a hepatologist or gastroenterologist.

Reauthorization

Covered for reauthorization when ALL of the following are met

ALP response documentation: Submission of medical records (e.g., laboratory values) documenting a reduction in ALP level from pre-treatment baseline.

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

Concurrent therapy restriction: Patient is not receiving Ocaliva in combination with Iqirvo (elafibranor) or Livdelzi (seladelpar).

Prescriber requirement: Prescribed by a hepatologist.

Use of Ocaliva is not covered for patients with decompensated cirrhosis or any clinical evidence of portal hypertension. The policy’s covered criteria explicitly require that the member either does not have cirrhosis or has compensated cirrhosis without evidence of portal hypertension, and exclusions apply when those conditions are not met. Providers should therefore document cirrhosis status and absence of portal hypertension when requesting authorization.

Concurrent prescribing of Ocaliva with the agents Iqirvo (elafibranor) or Livdelzi (seladelpar) is prohibited by this policy and will be excluded from coverage. Verify medication lists to ensure Ocaliva is not being used in combination with these products prior to submission.

Note on market status: the manufacturer announced a voluntary withdrawal of Ocaliva from the U.S. market on September 11, 2025. Coverage criteria remain documented here for clinical reference, but payers and providers should be aware of the product’s withdrawal when considering access and supply.

The accelerated approval for Ocaliva in primary biliary cholangitis (PBC) is based on the surrogate endpoint of a reduction in alkaline phosphatase (ALP). The indication was granted because ALP reduction is reasonably likely to predict clinical benefit, but improvement in survival or disease-related symptoms has not been established.

Because approval is contingent on a surrogate endpoint, continued or renewed coverage under this policy requires demonstration of clinical benefit in practice: for reauthorization the policy requires submission of medical records documenting a reduction in ALP from pre-treatment baseline. Continued approval by regulators is also contingent on confirmatory trials; the policy reflects that ongoing verification of clinical benefit may be required.

Laboratory Thresholds and Coding Notes

ALP threshold

ALP thresholdALP >= 1.67 x upper limit of normal (ULN) after ≥12 consecutive months of ursodeoxycholic acid (UDCA)

Context of useDefines inadequate response to UDCA for eligibility when Ocaliva is used in combination with UDCA

Requirement typeMeasured after at least 12 consecutive months of UDCA therapy

Prescriber Requirements, Documentation, and Operational Rules

Prior Authorization

Initial authorization requirements

Prior authorization required. Initial authorization for Ocaliva (obeticholic acid) will be approved only when all listed documentation and clinical criteria are met.

Diagnosis: primary biliary cholangitis (PBC) required
Cirrhosis status: patient must either NOT have cirrhosis OR have compensated cirrhosis without evidence of portal hypertension
UDCA use: patient must be on ursodeoxycholic acid (UDCA, e.g., ursodiol) in combination with Ocaliva and have failed to achieve ALP < 1.67x ULN after ≥12 consecutive months of UDCA, OR have documented contraindication/intolerance to UDCA

Documentation Required

Reauthorization requirements and required documentation

Reauthorization requires submission of objective documentation showing clinical benefit and continued eligibility.

Drug and Indication Background

Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in adults without cirrhosis or with compensated cirrhosis without evidence of portal hypertension. The labeled indication specifies use in combination with ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA, or as monotherapy for patients unable to tolerate UDCA.

Approval for Ocaliva was granted under the FDA’s accelerated approval pathway on the basis of a reduction in alkaline phosphatase (ALP); the label states that an improvement in survival or disease-related symptoms has not been established and that continued approval may be contingent on verification of clinical benefit in confirmatory studies.

Market status update: the manufacturer announced a voluntary withdrawal of Ocaliva from the U.S. market on September 11, 2025. This policy documents the clinical criteria and prior authorization requirements in effect, but providers should note the product withdrawal when evaluating access and therapy options.

Key Definitions

Primary biliary cholangitis (PBC)

DefinitionPrimary biliary cholangitis (PBC): chronic cholestatic liver disease for which Ocaliva (obeticholic acid) is indicated; applies to adults without cirrhosis or with compensated cirrhosis without evidence of portal hypertension.

Approval pathwayIndication granted under accelerated approval based on reduction in alkaline phosphatase (ALP)

Clinical benefit noteImprovement in survival or disease‑related symptoms has not been established; continued approval may be contingent on confirmatory trials

Inadequate response to UDCA

Inadequate response to UDCAFailure to achieve ALP < 1.67 x ULN after at least 12 consecutive months of UDCA therapy

Measurement timing