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    Livdelzi®

    Drug - Livdelzi® (seladelpar) [Gilead Sciences, Inc.]

    March 2025

    Therapeutic Area - Primary biliary cholangitis (PBC)

    Initial approval criteria

    • Age ≥ 18 years; AND 
    • Diagnosis of primary biliary cholangitis (PBC) confirmed by ≥ 2 of the following: 
      • Biochemical evidence of cholestasis with an alkaline phosphatase (ALP) elevation 
      • Presence of antimitochondrial antibody (AMA) tier > 1:80; OR 
      • If AMA is negative or present only in low titer (≤ 1:80), presence of other PBC-specific autoantibodies, including sp100 or gp210
      • Histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts; AND 
    • Prescriber has measured the patient’s baseline ALP level and total bilirubin level prior to treatment; AND 
    • ONE of the following:
      • Patient has had an inadequate response to treatment with ursodeoxycholic acid (UDCA) after 1 year of therapy (e.g., ALP greater than normal and/or total bilirubin greater than the upper limit of normal [ULN] but < 2 times ULN) and Lizdelzi will be used in combination with UDCA; OR
      • Patient has an intolerance or hypersensitivity to UDCA; OR
      • Patient has an FDA-labeled contraindication to UDCA; AND
    • Patient does NOT have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy); AND
    • Patient does NOT have complete biliary obstruction; AND
    • Prescriber attestation that patient will be appropriately monitored according to the product label and monitored for adverse reactions or changes in efficacy with certain concurrently administered drugs as detailed in the prescribing information; AND
    • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist) or has consulted with a specialist in the area of the patient’s diagnosis.

    Renewal criteria

    • Patient must continue to meet the initial approval criteria; AND
    • Patient must demonstrate a biochemical response (e.g., ALP level < 1.67 x ULN, with a reduction of ≥ 15% from baseline; total bilirubin levels ≤ ULN); AND
    • Patient has not experienced any treatment-restricting adverse effects (e.g., fracture; worsening of liver tests [e.g., alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and/or ALP], or signs and symptoms of clinical hepatitis [e.g., jaundice, upper right quadrant pain, eosinophilia]; biliary obstruction).

    Quantity limits

    • 34 capsules per 34 days. Max dose 10 mg daily.

    Background

    Livdelzi is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). 

    Questions

    Provider Call Center (844) 575-7887

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