CurrentCignaPolicy N/A

Ocaliva (obeticholic acid) prior authorization for primary biliary cholangitis

Defines prior authorization and medical necessity criteria for coverage of Ocaliva (obeticholic acid) for adults with primary biliary cholangitis (PBC); applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOcaliva (obeticholic acid) prior authorization for primary biliary cholangitis

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective Date

Next Review DateJul 16, 2025

Key ActionObtain prior authorization with documentation of PBC meeting two of three diagnostic criteria, prior UDCA therapy and response or intolerance, cirrhosis/portal hypertension status, and specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Annual revisions noted with no criteria changes.

6initial approval duration

12renewal approval duration (months)

>=18minimum patient age (years)

2diagnostic criteria required (two of three)

Medical Necessity Criteria for Ocaliva (obeticholic acid)

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Medically Necessary — FDA-approved indication (Primary Biliary Cholangitis)

Approve Ocaliva when the patient meets ONE of the following (A or B):

A) Initial Therapy (approve for 6 months)

Patient is >= 18 years of age
At least 2 of the following
- Alkaline phosphatase (ALP) is elevated above the upper limit of normal per lab reference
- Positive anti-mitochondrial antibodies (AMA) OR other PBC-specific autoantibodies (e.g., sp100 or gp210) if AMA negative
- Histologic evidence of PBC on liver biopsy
ANY of the following
- Patient has been receiving ursodiol (UDCA) therapy for >= 1 year and has had an inadequate response (per prescriber)
- Patient is unable to tolerate ursodiol (per prescriber)
ANY of the following
- Patient does not have cirrhosis
- Patient has compensated cirrhosis without evidence of portal hypertension
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician

B) Patient Currently Receiving Therapy (approve for 1 year)

ANY of the following
- Patient does not have cirrhosis
- Patient has compensated cirrhosis without evidence of portal hypertension
Patient has responded to Ocaliva as determined by the prescriber
Examples of response include improved biochemical markers (e.g., ALP, bilirubin, GGT, AST, ALT).

Not Medically Necessary / Exclusions

Ocaliva is considered not medically necessary for ANY use(s) other than the FDA-approved indication for PBC described above, including (but not limited to):

ANY of the following

Alcoholic liver disease (including alcoholic hepatitis)
Nonalcoholic fatty liver disease (NAFLD), including NAFL and NASH

Key Thresholds

Age>= 18 years

Duration of prior UDCA therapy for inadequate response>= 1 year

What Providers Must Do / Watch For

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Ocaliva. All approvals are time-limited: initial approvals are for 6 months; renewal approvals for patients currently receiving therapy are provided for up to 1 year. Ocaliva must be prescribed by or in consultation with a specialist (gastroenterologist, hepatologist, or liver transplant physician).

Initial approval: 6 months
Renewal approval: up to 1 year
Specialist: gastroenterologist/hepatologist/liver transplant physician

Documentation Required

Documentation of diagnosis and prior therapy

Provider must document that the patient has primary biliary cholangitis meeting two of three diagnostic criteria, document prior ursodiol (UDCA) therapy duration and whether there was an inadequate response or intolerance, document cirrhosis/portal hypertension status, and confirm specialist prescribing or consultation.

Diagnostic elements (need two of three): elevated alkaline phosphatase (cholestasis), positive anti‑mitochondrial antibodies or other PBC‑specific autoantibodies (e.g., sp100 or gp210) if AMA negative, or histologic evidence of PBC on liver biopsy
Prior UDCA (ursodiol) therapy ≥ 1 year and assessment of inadequate response or documentation of UDCA intolerance
Cirrhosis status and evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)
Specialist involvement: prescribed by or in consultation with gastroenterologist, hepatologist, or liver transplant physician

Denial Risk

Contraindications and exclusion risk

Do not prescribe or request coverage for patients with contraindications or excluded indications; requests for patients with decompensated cirrhosis, evidence of portal hypertension, complete biliary obstruction, or for non‑FDA‑approved indications (e.g., alcoholic liver disease or NASH) will be considered not medically necessary.

Decompensated cirrhosis or prior/current liver decompensation
Evidence of portal hypertension (examples: ascites, gastroesophageal varices, persistent thrombocytopenia)
Complete biliary obstruction
Excluded indications: alcoholic liver disease (including alcoholic hepatitis) and NAFLD/NASH

Clinical 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 in adults with compensated cirrhosis without evidence of portal hypertension. It may be given as an add-on to ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA or as monotherapy for patients who are unable to tolerate UDCA. (See prescribing guidance for dosing and monitoring.)

Ocaliva carries a Boxed Warning for hepatic decompensation and failure in patients with PBC and cirrhosis. It is contraindicated in patients with PBC who have decompensated cirrhosis or a prior decompensation event, and it is also contraindicated in patients with compensated cirrhosis with evidence of portal hypertension (for example, ascites, gastroesophageal varices, or persistent thrombocytopenia). Requests for Ocaliva for patients with these features should be denied as not medically necessary.

Prior authorization is required for Ocaliva; approvals are time-limited per policy (initial approvals and renewals) and the medication should be prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician. Review dates for this policy are listed as 07/19/2023 and 07/24/2024, with the next review scheduled for 07/16/2025, and no coverage criteria changes were made in the most recent annual revisions.

Defined Terms

Policy Definitions

Primary biliary cholangitis (PBC)Chronic autoimmune cholestatic liver disease; diagnosis confirmed when two of the following are present: cholestasis (elevated ALP), positive anti-mitochondrial antibodies or other PBC-specific autoantibodies, or histologic evidence on liver biopsy.

Inadequate response to UDCAPer prescriber assessment after >= 1 year of ursodiol (UDCA) therapy, typically persistent abnormal biochemical markers (e.g., ALP).

Compensated cirrhosis without portal hypertensionCirrhosis without clinical or objective evidence of portal hypertension (e.g., no ascites, no gastroesophageal varices, no persistent thrombocytopenia).