ModifiedCentenePolicy CP PHAR.287

Clinical Policy: Obeticholic Acid (Ocaliva)

This policy defines medical necessity criteria, prescribing and continuation requirements, contraindications, dosing, and prior authorization expectations for obeticholic acid (Ocaliva) for members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyObeticholic Acid (Ocaliva)

Policy CodePolicy CP PHAR.287

Change TypeStep therapy bypass addedclarification

Effective DateNov 16, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that all initial approval criteria are met, including diagnosis, specialist involvement, UDCA trial or intolerance, cirrhosis status, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Clarified that UDCA refers to ursodiol in the policy.

12 monthsapproval duration for continued therapy

10 mg/daymaximum maintenance dose for PBC

5→10 mgtypical titration schedule

Decompensated cirrhosiscontraindicated in

Overrides when conflicting

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Coverage Criteria for Obeticholic Acid (Ocaliva)

Initial Therapy (PBC)

Covered when ALL of the following are met for initial approval:

Initial Approval for PBC: 1) Diagnosis of primary biliary cholangitis (PBC) established per policy (e.g., at least two of: positive AMA or other PBC-specific autoantibodies; elevated alkaline phosphatase (ALP) above the laboratory ULN; or histologic evidence of PBC on liver biopsy). 2) Prescribed by or in consultation with a hepatologist or gastroenterologist. 3) Age ≥ 18 years. 4) Member does not have decompensated cirrhosis (Child-Pugh B or C or prior decompensation event) and does not have compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). 5) Inadequate response to UDCA (ursodiol) as evidenced by sustained elevation in ALP ≥ 1.67 × ULN OR documented intolerance/contraindication to UDCA. 6) For combination therapy, Ocaliva is prescribed with ursodiol unless ursodiol is contraindicated or not tolerated. 7) Dose does not exceed 10 mg per day and 1 tablet per day.dose ≤ 10 mg/day

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy: 1) Member is currently receiving Ocaliva via the Centene benefit or previously met initial approval criteria (or is covered under state/product-specific continuity of care provisions). 2) Member is responding positively to therapy as evidenced by: a) initial reauthorization — a reduction in ALP from pretreatment level; or b) subsequent reauthorization — continued reduction or maintenance of the initial ALP reduction (response in trials defined as ALP < 1.67 × ULN, total bilirubin ≤ ULN, and ALP decrease ≥15%). 3) If a dose increase is requested, the new dose does not exceed 10 mg per day and 1 tablet per day. 4) Approval duration for continued therapy is 12 months.approval duration = 12 months

Use laboratory documentation (ALP and bilirubin) to support response assessments.

Non–FDA–approved indications for Ocaliva (obeticholic acid) are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Relevant off‑label policies include CP.CPA.09 for commercial members, HIM.PA.154 for the Health Insurance Marketplace, and CP.PMN.53 for Medicaid; providers should also consult the member's evidence of coverage for plan‑specific requirements.

Ocaliva is contraindicated in patients with decompensated cirrhosis (Child‑Pugh Class B or C) or a prior decompensation event, and in patients with compensated cirrhosis who have evidence of portal hypertension (for example, ascites, gastroesophageal varices, or persistent thrombocytopenia). Hepatic decompensation and liver failure, including fatal outcomes and need for liver transplant, have been reported in PBC patients with compensated or decompensated cirrhosis treated with Ocaliva; such patients are not eligible for authorization and therapy should be discontinued if clinical or laboratory evidence of hepatic decompensation develops.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should refer to the applicable state Medicaid manual for any coverage details or exceptions that supersede this policy.

Use of Ocaliva for indications that are not FDA‑approved and are not supported by required off‑label documentation is not authorized under this policy. Requests for such uses must include evidence of efficacy and safety per the referenced off‑label use policies and plan documentation to be considered.

Product Availability, Response Criteria, and Codes

Product availabilityNDC

NDC not listed

Product availability: tablets 5 mg, 10 mg

ALP response criteria — Composite response

Composite ALP response (trial)ALP < 1.67 × ULN, total bilirubin ≤ ULN, and ALP decrease ≥ 15%

ULN for ALP (females)118 U/L

ULN for ALP (males)124 U/L

ULN for total bilirubin (females)1.1 mg/dL

ULN for total bilirubin (males)1.5 mg/dL

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit documentation (such as office chart notes, laboratory results, or other clinical information) that supports the member meets all approval criteria for Ocaliva (e.g., diagnosis of primary biliary cholangitis, prescriber specialty, UDCA/ursodiol trial or documented contraindication). Requests may be denied if documentation does not support that the member meets all approval criteria or if the patient has decompensated cirrhosis or other contraindications listed in the policy.

Submit office chart notes, recent laboratory values (including ALP and bilirubin), and any relevant imaging or pathology reports.
Include documentation of prescriber specialty (hepatologist or gastroenterologist) or consultation notes.
If UDCA (ursodiol) was not tried, provide documentation of contraindication or intolerance.
Do not submit requests for members with decompensated cirrhosis or evidence of portal hypertension — these are contraindications.

Documentation Required

Clinical Background

Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease. Ocaliva (obeticholic acid) is a farnesoid X receptor agonist approved under accelerated approval for adults with PBC either without cirrhosis or with compensated cirrhosis without portal hypertension. It is indicated as add‑on therapy for patients with an inadequate response to ursodeoxycholic acid (UDCA) or as monotherapy for those intolerant to UDCA. Continued approval may depend on confirmatory trials, and clinical benefit on survival has not yet been established.

Key Definitions

PBC diagnostic criteria

Diagnostic ruleDiagnosis established when TWO of the following THREE are met: positive anti-mitochondrial antibodies (or other PBC-specific autoantibodies), elevated ALP above ULN, or histologic evidence of PBC on liver biopsy.

AutoantibodiesPositive anti-mitochondrial antibodies (AMA) or other PBC-specific autoantibodies (e.g., gp210 if AMA negative)

Biochemical criterionAlkaline phosphatase (ALP) elevated above the laboratory upper limit of normal (ULN)

HistologyHistologic evidence of PBC from liver biopsy

UDCA — Ursodeoxycholic acid (ursodiol)

DefinitionUrsodeoxycholic acid (UDCA) = ursodiol.