CurrentUnitedHealthcarePolicy 1 = 2024 P 2091-12

Ocaliva (obeticholic acid) prior authorization

Prior authorization and medical necessity criteria for coverage of Ocaliva (obeticholic acid) for treatment of primary biliary cholangitis (PBC) in adults, including initial and reauthorization rules and prescriber requirements.

Policy Summary

PayerUnitedHealthcare

PolicyOcaliva (obeticholic acid) prior authorization

Policy CodePolicy 1 = 2024 P 2091-12

Change TypeMaterial updates

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis of primary biliary cholangitis, cirrhosis status, UDCA trial results or intolerance, prescriber specialty, and labs showing ALP response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated initial authorization duration to 12 months.

Added requirement that patient not be receiving Ocaliva in combination with Iqirvo (elafibranor) or Livdelzi (seladelpar).

12 monthsinitial authorization duration

12 monthsreauthorization duration

ALP < 1.67 x ULNtreatment response target on UDCA prior to Ocaliva

Hepatologist/GIprescriber requirement

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inv-01: Initial Therapy

Ocaliva will be approved based on ALL of the following:

Initial Authorization: Initial authorization requires all listed nodes to be true

Diagnosis of primary biliary cholangitis

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

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UDCA response or intolerance: Either used in combination with ursodeoxycholic acid (UDCA) and patient failed to achieve ALP < 1.67 x ULN after >= 12 consecutive months of UDCA therapy OR history of contraindication or intolerance to UDCAALP < 1.67 x ULN after >=12 months

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

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Prescriber requirement: Prescribed by a hepatologist or gastroenterologist

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inv-02: Continuation/Reauthorization

Ocaliva will be reauthorized based on ALL of the following:

Reauthorization requires all listed nodes to be true

Laboratory documentation: Submission of medical records (laboratory values) documenting a reduction in ALP level from pre-treatment baseline on Ocaliva therapy

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

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

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Coverage excludes patients with decompensated cirrhosis or evidence of portal hypertension; initial and reauthorization criteria require either no cirrhosis or compensated cirrhosis without evidence of portal hypertension (see initial and continuation criteria).

Concomitant use of Ocaliva with Iqirvo (elafibranor) or Livdelzi (seladelpar) is not permitted; patients receiving either of these agents with Ocaliva do not meet the coverage criteria.

Prescriptions must be written by a hepatologist or gastroenterologist; failure to meet the cirrhosis/cirrhosis-compensation requirements or to avoid prohibited concomitant therapies are triggers for denial of authorization.

Initial Therapy Specifics

inv-12: Initial therapy

Initial Authorization - detailed: Initial authorization requires all nested conditions to be met

1. Diagnosis: Diagnosis of primary biliary cholangitis

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

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3. UDCA use and response

3a: Used in combination with ursodeoxycholic acid (e.g., Urso, ursodiol)
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3b: Patient has failed to achieve an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of normal after at least 12 consecutive months of treatment with ursodeoxycholic acidALP < 1.67 x ULN after >=12 months
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4. UDCA intolerance alternative: History of contraindication or intolerance to ursodeoxycholic acid

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

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6. Prescriber requirement: Prescribed by one of the following: Hepatologist OR Gastroenterologist

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Reauthorization / Continuation Criteria

inv-13: Reauthorization

Reauthorization - detailed: Reauthorization requires all nested conditions to be met

1. Laboratory documentation: Submission of medical records (laboratory values) documenting a reduction in ALP level from pre-treatment baseline on Ocaliva therapy

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

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

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4. Prescriber requirement: Prescribed by one of the following: Hepatologist OR Gastroenterologist

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Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit documentation showing diagnosis of primary biliary cholangitis (PBC) and cirrhosis status. Initial approvals are granted for 12 months.

Diagnosis: primary biliary cholangitis (PBC)
Cirrhosis status: no cirrhosis OR compensated cirrhosis without portal hypertension
Prescriber specialty: hepatologist or gastroenterologist
Initial authorization duration: 12 months

Documentation Required

UDCA Trial Requirement

Patient must have attempted a minimum 12 consecutive months of ursodeoxycholic acid (UDCA; e.g., ursodiol) unless UDCA is contraindicated or the patient is intolerant. Document UDCA use and duration in the medical record.

UDCA trial: ≥ 12 consecutive months unless contraindicated/intolerant
Documented failure to achieve ALP < 1.67 × ULN after UDCA trial

Documentation Required

Reauthorization — Laboratory Documentation

For reauthorization, submit medical records and laboratory values demonstrating a reduction in alkaline phosphatase (ALP) from pre-treatment baseline following initiation of therapy with Ocaliva.

Lab documentation: ALP compared to pre-Ocaliva baseline
Include dates of labs and relevant clinical notes

Denial Risk

Triggers for Denial

Denial risks include missing or incorrect diagnosis, decompensated cirrhosis or evidence of portal hypertension, concurrent use of prohibited agents (Iqirvo/elafibranor or Livdelzi/seladelpar), or inadequate documentation of prior UDCA therapy or required labs.

Prohibited concomitant therapy: Iqirvo (elafibranor), Livdelzi (seladelpar)
Decompensated cirrhosis or portal hypertension — not eligible
Insufficient documentation of UDCA trial or ALP response
Incorrect or absent PBC diagnosis

Step	Requirement
1	Trial of ursodeoxycholic acid (UDCA) for at least 12 consecutive months; patient must have failed to achieve an alkaline phosphatase (ALP) level < 1.67 x ULN while on UDCA unless UDCA is contraindicated or not tolerated.

Background on Ocaliva and PBC

Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy for those unable to tolerate UDCA. Approval is based on surrogate endpoint data (reduction in alkaline phosphatase).

For authorization purposes this policy requires a documented diagnosis of PBC and consideration of prior UDCA therapy and cirrhosis status when assessing candidacy for Ocaliva.

Definitions and Clinical Terms

Primary biliary cholangitis (PBC) — definition

DefinitionPrimary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease for which Ocaliva is indicated

Indication specificsIndicated for adults without cirrhosis or with compensated cirrhosis without evidence of portal hypertension

Therapy contextUsed in combination with ursodeoxycholic acid (UDCA) for patients with inadequate response to UDCA, or as monotherapy if UDCA intolerant

Alkaline phosphatase (ALP) response — definition

ALP response definitionReduction in alkaline phosphatase (ALP) used as a surrogate marker for accelerated approval

Accelerated approval basisApproval is based on ALP reduction; improvement in survival or disease-related symptoms has not been established

Timing for assessmentALP response assessed after at least 12 consecutive months of UDCA when Ocaliva is added for inadequate UDCA response

Policy Summary

PayerUnitedHealthcare

PolicyOcaliva (obeticholic acid) prior authorization

Policy CodePolicy 1 = 2024 P 2091-12

Change TypeMaterial updates

Effective DateMar 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Ocaliva (obeticholic acid) prior authorization

Coverage Criteria for Ocaliva (obeticholic acid)

Initial Therapy Specifics

Reauthorization / Continuation Criteria

Provider Requirements and Documentation

Key Clinical Thresholds and Codes

Step Therapy Requirement

Supply and Quantity Limits

Background on Ocaliva and PBC

Definitions and Clinical Terms