Pharmacy Prior Authorization Criteria

Lynavoy (linerixibat) - PA, NF

Indications for Prior Authorization

Lynavoy (linerixibat)

• For diagnosis of Cholestatic Pruritus
  Indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use: Avoid use of Lynavoy in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy)

Criteria

Lynavoy

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of cholestatic pruritus associated with primary biliary cholangitis (PBC)
AND
• PBC is confirmed by both of the following: [3]
• Antimitochondrial antibodies (AMA) or other PBC‐specific autoantibodies (e.g., sp100 or gp210) as detected by serologic blood test
• Biochemical evidence of cholestasis (e.g., elevated alkaline phosphatase (ALP), elevated gamma-glutamyl transferase (GGT), mildly elevated alanine aminotransferase (ALT), mildly elevated aspartate aminotransferase (AST))
AND
• Presence of moderate to severe itch
AND
• Patient is receiving concurrent therapy for PBC (e.g., Ursodiol, Iqirvo, Livdelzi), unless there is a contraindication or intolerance to these medications
AND
• Trial and failure, contraindication or intolerance to at least two of the following treatments from different mechanisms of action used for the relief of pruritus: [3,4,6,7]
• Antihistamines (e.g., diphenhydramine, hydroxyzine)
• Rifampin
• Bile acid sequestrants (i.e., cholestyramine, colestipol)
• Opioid antagonists (e.g., naltrexone)
AND
• Prescribed by or in consultation with one of the following [5]:
• Hepatologist
• Gastroenterologist

Lynavoy

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by a reduction in itch severity
AND
• Patient is receiving therapy for PBC (e.g., Ursodiol, Iqirvo, Livdelzi), unless there is a contraindication or intolerance to these medications
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist

Lynavoy

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of cholestatic pruritus associated with primary biliary cholangitis (PBC)
AND
• Submission of medical records (e.g., chart notes) confirming PBC by both of the following: [3]
• Antimitochondrial antibodies (AMA) or other PBC‐specific autoantibodies (e.g., sp100 or gp210) as detected by serologic blood test
• Biochemical evidence of cholestasis (e.g., elevated alkaline phosphatase (ALP), elevated gamma-glutamyl transferase (GGT), mildly elevated alanine aminotransferase (ALT), mildly elevated aspartate aminotransferase (AST))
AND
• Submission of medical records (e.g., chart notes) confirming presence of moderate to severe itch
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient is receiving concurrent therapy for PBC (e.g., Ursodiol, Iqirvo, Livdelzi), unless there is a contraindication or intolerance to these medications
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure, contraindication or intolerance to at least two of the following treatments from different mechanisms of action used for the relief of pruritus: [3,4,6,7]
• Antihistamines (e.g., diphenhydramine, hydroxyzine)
• Rifampin
• Bile acid sequestrants (i.e., cholestyramine, colestipol)
• Opioid antagonists (e.g., naltrexone)
AND
• Prescribed by or in consultation with one of the following [5]:
• Hepatologist
• Gastroenterologist

P & T Revisions

2026-08-21

References

1. Lynavoy Prescribing information. GlaxoSmithKline GSK, Durham. Accessed July 2026
2. Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN. NCT04950127. Accessed July 2026.
3. 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. Accessed July 2026
4. Scratching The Itch: Management Of Pruritus In Cholestatic Liver Disease, Liver Fellow Network, AASLD.org. Accessed July 2026.
5. Hirschfield GM, Dyson JK, Alexander GJM, et al. The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines.Gut 2018;67:1568-1594
6. Micromedex - cholestyramine; cholestatic pruritus available at www.micromedexsolutions.com
7. Pruritus Associated with cholestasis, UpToDate, Raoul Poupon, MD, Sanjiv Chopra, MD, MACP, FRCP (London), Steven Flamm, MD. Accessed July 2026.

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Revision History

• 2026-08-21: New Program for Lynavoy

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