UHC: Livdelzi (seladelpar) Coverage Criteria for PBC — ALP‑Based Authorization

UnitedHealthcare updated coverage criteria for Livdelzi (seladelpar) for adults with primary biliary cholangitis (PBC), reflecting its FDA accelerated approval based on ALP reduction and noting that clinical benefit on survival or prevention of decompensation is unconfirmed. Initial authorization requires documented PBC, absence of decompensated cirrhosis, and either inadequate biochemical response to at least 12 months of ursodeoxycholic acid (UDCA) defined as ALP ≥1.67×ULN or documented UDCA intolerance/contraindication. Continued approval may depend on confirmatory trials demonstrating clinical benefit. The policy aligns coverage to the FDA-approved population and ties approval to a measurable ALP threshold and prior UDCA use or intolerance.

This revision outlines criteria for coverage of Livdelzi (seladelpar) under UnitedHealthcare's pharmacy clinical programs for hepatobiliary disorders. The document establishes initial authorization requirements that define when Livdelzi may be approved for adults with primary biliary cholangitis (PBC). The policy emphasizes that the indication is approved under accelerated approval based on a surrogate endpoint (reduction of alkaline phosphatase ALP) and notes that improvement in survival or prevention of liver decompensation events has not been demonstrated. It also states that continued approval may depend on confirmatory trials verifying clinical benefit.

The text formalizes specific, measurable criteria required for initial authorization including diagnostic confirmation of PBC, absence of decompensated cirrhosis, and either treatment failure on ursodeoxycholic acid (UDCA) or documented intolerance/contraindication to UDCA. These criteria operationalize the accelerated approval context by tying coverage to the clinical population reflected in the FDA-approved indication and to prior use or intolerance of UDCA.

The policy's initial authorization section requires all of the following: (1) a diagnosis of primary biliary cholangitis (PBC); (2) the patient does not have decompensated cirrhosis; and (3) one of two subcriteria related to status. The first subcriterion requires that be used in combination with and that the patient has failed to achieve an level of less than 1.67 times the upper limit of normal after at least 12 consecutive months of treatment with .

The policy explicitly excludes patients with decompensated cirrhosis from initial authorization for Livdelzi. "Decompensated cirrhosis" is listed as a disqualifying condition in the initial authorization criteria, indicating the drug's coverage under this policy is restricted to patients without evidence of clinical liver decompensation.

This exclusion aligns coverage with the safety and efficacy population described in the accelerated approval context, where demonstrated clinical benefit on hard outcomes such as prevention of decompensation has not been established. The policy therefore constrains use to compensated or non-decompensated PBC patients.

The policy operationalizes biochemical response criteria by specifying an ALP threshold: failure to achieve ALP < 1.67 x ULN after at least 12 consecutive months of UDCA therapy qualifies a patient for Livdelzi in combination with UDCA. This provides a quantifiable laboratory benchmark that must be met to satisfy the inadequate-response branch of the coverage criteria.

By anchoring approval to a specific ALP cutoff and treatment duration, the policy mirrors the surrogate endpoint on which the accelerated regulatory approval was based and delineates how biochemical nonresponse is assessed for coverage decisions.

OpenPayer

UHC Livdelzi Coverage Criteria and Accelerated Approval Context

Initial Authorization Requirements: Diagnosis, Cirrhosis Status, and UDCA Response

Exclusion of Decompensated Cirrhosis from Initial Approval

Biochemical Response Threshold: `ALP < 1.67 x ULN` After 12 Months of `UDCA`