CurrentunitedhealthcarePolicy 2025 P 2356-2

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Livdelzi (seladelpar)

Defines UnitedHealthcare's prior authorization and medical necessity criteria for Livdelzi (seladelpar) for treatment of primary biliary cholangitis (PBC) including initial authorization, reauthorization, prescribing provider requirements, and additional clinical/billing rules. Effective date 2026-03-01.

Policy Summary

Payerunitedhealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs - Livdelzi (seladelpar)

Policy CodePolicy 2025 P 2356-2

Change TypeProgram created; annual review

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit prior authorization with required documentation showing diagnosis of PBC, absence of decompensated cirrhosis, appropriate UDCA history or intolerance, exclusion of specified combinations, and prescriber specialty (hepatologist or gastroenterologist).

SourceLink

POLICY UPDATE CHANGES

Program created and effective 3/1/2026 with criteria for Livdelzi (seladelpar).

Annual review in 12/2025 with updated reference to package insert (October 2025).

1Indication covered

12Reauthorization duration

1.67xALP threshold referenced

Coverage Summary

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UnitedHealthcare covers Livdelzi (seladelpar) with specified prior authorization criteria for the treatment of primary biliary cholangitis (PBC). The policy is effective 2026-03-01. Reauthorization is granted for 12 months. Approval is based on the drug's accelerated approval pathway, which was granted on the basis of a reduction in alkaline phosphatase (ALP) and for which improvement in survival or prevention of liver decompensation has not been demonstrated.

Thresholds / Durations

ALP response threshold (prior UDCA therapy)Failure to achieve ALP < 1.67 times the upper limit of normal

Duration of prior UDCA therapyAt least 12 consecutive months

Reauthorization duration12 months

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization/medical necessity is required. Initial approval requires all initial criteria: diagnosis of primary biliary cholangitis; no decompensated cirrhosis; either used in combination with UDCA after at least 12 consecutive months without achieving ALP < 1.67x ULN or history of contraindication/intolerance to UDCA; not used in combination with elafibranor (Iqirvo) or obeticholic acid (Ocaliva); and prescribed by a hepatologist or gastroenterologist.

Documentation Required

Documentation for reauthorization

Submit medical records (for example, laboratory values) documenting a reduction in alkaline phosphatase (ALP) level from the pre-treatment baseline for reauthorization. Reauthorization will be issued for 12 months.

Billing Rule

Combination therapy exclusion

Do not combine Livdelzi with Iqirvo (elafibranor) or Ocaliva (obeticholic acid). Claims indicating combination therapy may be denied.

Documentation Required

Prescriber specialty requirement

The prescribing clinician must be a hepatologist or gastroenterologist for both initial approval and reauthorization.

Billing Rule

Supply limits

Supply limits may be in place per plan; check benefit-specific limits and any plan-level restrictions.

Prior Authorization

Automated approval allowed

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval processes.

Clinical Evidence & Rationale

The accelerated approval for Livdelzi was based on its ability to reduce alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation events has not been demonstrated. Reference: Livdelzi package insert, Gilead Sciences, Inc.; October 2025.

Evidence metrics

Basis of approvalApproved under accelerated approval based on reduction of alkaline phosphatase (ALP)

Confirmatory trials required?Continued approval may be contingent on verification of clinical benefit in confirmatory trial(s)

Background & Definitions

Livdelzi (seladelpar) is indicated for PBC in adults with an inadequate response to ursodeoxycholic acid (UDCA) when used in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA. The approval was granted under the accelerated approval pathway based on reduction in ALP, and continued approval may depend on verification of clinical benefit in confirmatory trials.

Term	Definition
Decompensated cirrhosis	Policy excludes patients with decompensated cirrhosis from approval; specific clinical definition not provided in policy.
UDCA	Ursodeoxycholic acid (e.g., Urso, ursodiol)

Revision History

2024-12program_established

Initial program established (P&T approval) in 12/2024; new prior authorization/medical necessity program for Livdelzi (seladelpar) created.

2025-12annual_review

Annual review in 12/2025 noted no changes to coverage criteria; updated reference to package insert (October 2025).

2026-03-01program_effectiveLatest

Program created and effective 3/1/2026 implementing prior authorization/medical necessity criteria for Livdelzi (seladelpar).