CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Primary biliary cholangitis (PBC): Iqirvo, Livdelzi

Covers authorization criteria for Iqirvo and Livdelzi to treat primary biliary cholangitis (PBC) in adults, including initial 6-month approval and 6-month continuation criteria, prescribing specialist requirements, exclusions, and concomitant therapy restrictions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPrimary biliary cholangitis (PBC): Iqirvo, Livdelzi

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2025

Next Review Date

Key ActionSubmit prior authorization documenting PBC diagnosis (>=2 diagnostic criteria), baseline elevated ALP, prior UDCA trial or intolerance, specialist involvement, and absence of decompensated cirrhosis; for continuation provide ALP result within 6 months showing response.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy content.

2Drugs covered (Iqirvo, Livdelzi)

6 moInitial authorization length

6 moContinuation ALP timeframe

12 moRequired prior UDCA trial

Coverage Summary

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Coverage stance: covered with criteria. Scope: authorization criteria for Iqirvo (elafibranor) and Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults, including initial 6‑month approval and 6‑month continuation criteria, specialist prescribing/consultation requirements, exclusions, and concomitant therapy restrictions. Status: CURRENT (effective 02/01/2025; reviewed 11/2024). Subject: Iqirvo and Livdelzi for PBC. Background: Iqirvo and Livdelzi received accelerated approval based on reductions in alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation has not been demonstrated, continued approval may require confirmatory trials. Use is not recommended in patients with decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Surface thresholds summary

Age>= 18 years

Prior UDCA therapy duration>= 12 months at 13-15 mg/kg/day (or documented UDCA intolerance)

Baseline ALP requirementElevated serum ALP prior to initiation; biochemical cholestasis with elevated ALP for at least 6 months can confirm diagnosis

Continuation ALP responses>=15% reduction OR ALP < 1.67 x ULN OR normalization of ALP (documented within last 6 months)

Initial authorization length6 months

Continuation authorization length6 months