CurrentCentenePolicy CP PHAR.698

Seladelpar (Livdelzi) for primary biliary cholangitis

Defines medical necessity and prior authorization criteria for Seladelpar (Livdelzi) to treat primary biliary cholangitis (PBC) for Centene-affiliated health plans and specifies requirements for initial and continued approval.

Policy Summary

PayerCentene

PolicySeladelpar (Livdelzi) for primary biliary cholangitis

Policy CodePolicy CP PHAR.698

Change TypeNo material change

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval duration

12 more-authorization duration

ALP ≥1.67× ULNUDCA failure definition

10 mgmaximum daily dose

Adults ≥18age of covered population

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy (PBC)

Covered when ALL of the following are met:

Initial Approval Criteria for PBC: Member has a diagnosis of primary biliary cholangitis (PBC); prescribed by or in consultation with a hepatologist or gastroenterologist; age ≥ 18 years; documented failure of ursodeoxycholic acid (UDCA) defined as sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 × upper limit of normal after a ≥ 12‑month trial of UDCA at a dose ≥ 13 mg/kg/day unless contraindicated or intolerant; seladelpar (Livdelzi) is prescribed in combination with UDCA unless UDCA is contraindicated or not tolerated; seladelpar dose does not exceed 10 mg (1 capsule) per day.ALP ≥ 1.67 × ULN; UDCA ≥ 12 months at ≥ 13 mg/kg/day

Approval duration: 6 months

Continuation Therapy

Continued therapy (re-authorization) requires:

Continued Therapy Requirements: Member is currently receiving seladelpar via the Centene benefit OR member previously met the initial approval criteria; member is demonstrating clinical response as evidenced by: (a) initial reauthorization — reduction in ALP from pretreatment baseline; or (b) subsequent reauthorization — continued reduction or maintenance of the initial ALP reduction. If the request is for a dose increase, the new dose must not exceed 10 mg (1 capsule) per day.ALP reduction or maintenance

Approval duration: 12 months

Use of Livdelzi (seladelpar) is not recommended for patients with decompensated cirrhosis (for example, ascites, variceal bleeding, or hepatic encephalopathy). Coverage is limited to the FDA‑approved indication for primary biliary cholangitis (PBC) in adults; requests for indications outside those addressed in this policy may be denied unless adequate documentation and evidence support off‑label use per applicable off‑label policies. Prior authorization requires documentation that the member has PBC and meets the specified clinical criteria (see initial and continuation therapy sections).

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed in this policy through their contracts; where no contract exists, providing services to members or submitting claims constitutes agreement to be bound.

Requests for non‑FDA approved indications that are not specifically addressed in this policy are considered not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents that support the requested use.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has a diagnosis of primary biliary cholangitis (PBC) and has met all approval criteria. Prescriptions should be by or in consultation with a hepatologist or gastroenterologist.

Approval duration: Initial 6 months; Continued: 12 months
Dose limit: does not exceed 10 mg (1 capsule) per day

Step Therapy

Therapeutic Alternatives / UDCA Trial Requirement

Provider must document a trial of ursodeoxycholic acid (UDCA/ursodiol) at a dose ≥13 mg/kg/day for at least 12 months with evidence of failure (sustained elevation in alkaline phosphatase ≥1.67× ULN) unless UDCA is contraindicated or not tolerated. Lack of documentation of an adequate UDCA trial or failure to show the required laboratory criteria may result in denial.

UDCA dosing per AASLD guidance: 13–15 mg/kg/day
Clinical trial eligibility required ≥12 months UDCA use

Denial Risk

Non‑FDA Indications

Requests for indications that are not FDA‑approved and are not addressed in this policy will not be authorized unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Non‑FDA indications require submission of supporting evidence per off‑label policies

Documentation Required

Continued Therapy Documentation

If the member is responding to therapy, continued approval requires documentation of clinical response such as reduction in ALP from pretreatment level (initial reauthorization) or maintenance of the initial reduction (subsequent reauthorizations). If a dose increase is requested, the new dose must not exceed 10 mg (1 capsule) per day.

Continued therapy approvals require laboratory documentation of ALP response
Dose increase requests: cap at 10 mg/day

Note

Step Therapy / Alternatives

This document does not specify additional step‑therapy sequences beyond the required UDCA trial and listed therapeutic alternatives; no other formal step therapy requirements are specified in this policy segment.

Preferred alternative: ursodiol (ursodiol/Urso Forte) — dosing referenced in Appendix B

Note

Unauthorized Copying, Use, or Distribution

Unauthorized copying, use, or distribution of this clinical policy or any information contained herein is strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions through their contracts; where no contract exists, providing services or submitting claims constitutes agreement to be bound.

Unauthorized use may lead to enforcement per Health Plan terms

Definitions and Clinical Response Criteria

Biochemical response / PBC diagnostic criteria (inv-18)

Biochemical response definitionALP < 1.67 × ULN, an ALP decrease ≥ 15% from baseline, and total bilirubin ≤ ULN

ALP threshold for diagnosis/supportElevated ALP above laboratory ULN can support diagnosis of PBC (one of two of diagnostic criteria)

Diagnostic criteria for PBCDiagnosis can be established with two of: elevated ALP, positive anti‑mitochondrial antibodies (AMA) or PBC‑specific autoantibodies, or compatible liver histology

Medicaid precedence (inv-19)

Medicaid precedence statementWhen state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence.

Action for providersRefer to the applicable state Medicaid manual for specific coverage provisions

ScopeApplies to Medicaid members; overrides clinical policy provisions when discrepant

OpenPayer

Seladelpar (Livdelzi) for primary biliary cholangitis

Coverage Criteria for Seladelpar (Livdelzi)

Coding and Key Clinical Thresholds

Provider Actions and Prior Authorization Requirements

Background and Drug Overview

Definitions and Clinical Response Criteria