CurrentColorado Rocky Mountain Health PlansPolicy 2025 1463-2

Livdelzi (seladelpar) prior authorization for primary biliary cholangitis

Prior authorization criteria for coverage of Livdelzi (seladelpar) for treatment of primary biliary cholangitis (PBC) in adults, including initial and reauthorization requirements; applies to members whose benefits are governed by this payer/program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLivdelzi (seladelpar) prior authorization for primary biliary cholangitis

Policy CodePolicy 2025 1463-2

Change TypeNew prior authorization programreference update

Effective DateMar 1, 2026

Next Review Date2026-12

Key ActionObtain prior authorization documenting PBC diagnosis, absence of decompensated cirrhosis, and UDCA response or intolerance.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Livdelzi (seladelpar).

Updated reference (package insert dated October 2025).

3/1/2026Effective date

PBCIndication

12 moInitial auth duration

12 moReauth duration

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Coverage Criteria for Livdelzi (seladelpar)

Continuation Therapy

Reauthorization covered when the following is met:

Reauthorization: Documentation of positive clinical response to Livdelzi therapy.

Reauthorization will be issued for 12 months

Patients with decompensated cirrhosis are excluded from coverage under the initial authorization criteria. Documentation must demonstrate the absence of clinical features of hepatic decompensation before initial approval is granted.

Use of Livdelzi (seladelpar) for indications other than primary biliary cholangitis (PBC), or when the patient does not meet the specified UDCA response/intolerance and cirrhosis criteria, does not meet the documented coverage requirements and is not covered. The policy limits coverage to adults with PBC who either have an inadequate response to UDCA after at least 12 consecutive months of appropriate-dose therapy when used in combination with UDCA, or have a documented contraindication or intolerance to UDCA.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Livdelzi requires prior authorization. Initial approval is granted when ALL criteria below are met: diagnosis of primary biliary cholangitis, absence of decompensated cirrhosis, and either inadequate response to ursodeoxycholic acid (UDCA) after ≥12 consecutive months at an appropriate dose while used in combination with UDCA, or documented contraindication/intolerance to UDCA. Initial authorization will be issued for 12 months.

Diagnosis: primary biliary cholangitis (PBC)
No decompensated cirrhosis
Either:
• In combination with UDCA (e.g., ursodiol) AND inadequate response after ≥12 consecutive months at an appropriate dose
• OR documented contraindication or intolerance to UDCA

Documentation Required

Required documentation must include evidence supporting the PBC diagnosis, documentation that the patient does not have decompensated cirrhosis, and UDCA treatment history (or documented contraindication/intolerance). For reauthorization, provide documentation of positive clinical response to Livdelzi therapy.

Documentation of PBC diagnosis (relevant clinical notes, labs, imaging as applicable)
Documentation excluding decompensated cirrhosis
For patients using UDCA: record of ≥12 consecutive months of appropriate-dose UDCA and documentation of inadequate response
If UDCA not used: documentation of contraindication or intolerance to UDCA
For reauthorization: documentation of positive clinical response to therapy

Note

Reauthorization Requirements

Reauthorization Criteria: Livdelzi reauthorization is approved when there is documentation of a positive clinical response to therapy. Reauthorization will be issued for 12 months.

Documentation of positive clinical response to Livdelzi

Step Therapy

Step Therapy Note

Step Therapy / Program Rules: Step therapy and other utilization management rules (supply limits, medical necessity checks) may apply. Some approvals may be processed using automated claim/medication history or diagnosis-based logic depending on program.

Step therapy may be in place
Supply limits and medical necessity rules may apply
Automated approval/reauthorization based on claims or diagnosis codes may be used

Denial Risk

Denial Triggers

Triggers for Denial: Requests are likely to be denied if the patient does not have a diagnosis of primary biliary cholangitis, has decompensated cirrhosis, lacks required UDCA history (and no documented contraindication/intolerance), or if required documentation of clinical response for reauthorization is not provided.

No diagnosis of primary biliary cholangitis
Evidence of decompensated cirrhosis
No record of ≥12 consecutive months of UDCA when required and no documented contraindication/intolerance
Missing documentation of positive clinical response at reauthorization

Definitions

Inadequate response to UDCA

DefinitionFailure to achieve an adequate response after at least 12 consecutive months of appropriate‑dose ursodeoxycholic acid (UDCA) therapy.

ContextApplies when seladelpar (Livdelzi) is being considered as combination therapy with UDCA for patients with primary biliary cholangitis (PBC) who have inadequate response to UDCA.

ThresholdAt least 12 consecutive months of UDCA at an appropriate dosage without achieving an adequate response.

Evidence basisAccelerated approval of Livdelzi for PBC is based on reduction in alkaline phosphatase (ALP); clinical benefit on survival or prevention of decompensation not demonstrated.

Decompensated cirrhosis

DefinitionPresence of clinical features of hepatic decompensation (decompensated cirrhosis).

Coverage impactPatients with decompensated cirrhosis are excluded from approval under the initial authorization criteria for Livdelzi.

Authorization noteInitial authorization requires that the patient does not have decompensated cirrhosis; this is an explicit 'AND' criterion for approval.

OpenPayer

Livdelzi (seladelpar) prior authorization for primary biliary cholangitis

Coverage Criteria for Livdelzi (seladelpar)

Initial Therapy

Reauthorization / Continuation Criteria

Provider Actions and Requirements

Definitions

Step Therapy / Site Rules

Site of Care / Supply Limits

Background

Step	Requirement
1
Step therapy may be in place per program rules; approvals may also be based on prior claim/medication history, diagnosis codes, and/or automated claim logic as allowed by the program.