Pharmacy Prior Authorization Criteria

Livdelzi (seladelpar)

Indications for Prior Authorization

Livdelzi (seladelpar)

• For diagnosis of Primary biliary cholangitis (PBC)
  Indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had 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).Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)

Criteria

Livdelzi

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of primary biliary cholangitis (PBC) (also known as primary biliary cirrhosis)
AND
• One of the following:
• Both of the following:
• Patient has failed to achieve an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of normal (ULN) after at least 12 consecutive months of treatment with ursodeoxycholic acid (UDCA) (e.g., Urso, Urso Forte, ursodiol) [2, A]
AND
• Used in combination with ursodeoxycholic acid (UDCA)
OR
• History of contraindication or intolerance to ursodeoxycholic acid (UDCA)
AND
• Requested drug will not be used in combination with Ocaliva (obeticholic acid) or Iqirvo (elafibranor)
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist

Livdelzi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., ALP level less than 1.67 times ULN, total bilirubin less than or equal to ULN, ALP decrease greater than or equal to 15% from baseline )
AND
• Requested drug will not be used in combination with Ocaliva (obeticholic acid) or Iqirvo (elafibranor)

P & T Revisions

2024-10-02

References

1. Livdelzi Prescribing Information. Gilead Sciences, Inc Foster City, CA 94404. August 2024.
2. Lindor, Keith D.*,1; Bowlus, Christopher L.2; Boyer, James3; Levy, Cynthia4; Mayo, Marlyn5. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases. Hepatology 69(1):p 394-419, January 2019. | DOI: 10.1002/hep.30145

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End Notes

1. Biochemical response should be assessed after 1 year of treatment with UDCA [2]

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Revision History

• 2024-10-02: New program.

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