Primary Biliary Cholangitis | Treatment Algorithms: Claims Data Analysis | US | 2021

Primary biliary cholangitis (PBC) is a rare autoimmune liver disease characterized by inflammation, progressive damage, and, ultimately, destruction of the interlobular bile ducts; this process is followed by cholestasis, which drives debilitating fatigue and itch. Without adequate management, PBC culminates in liver fibrosis, cirrhosis, end-stage organ disease, and death. Currently, there is no cure for PBC. The goal of treatment is to halt or slow the progression of liver disease, reduce the need for liver transplantation, lower the risk of mortality, and alleviate symptoms (e.g., fatigue, itch). Ursodeoxycholic acid (UDCA) is the cornerstone of PBC treatment, and Intercept’s Ocaliva (obeticholic acid) is an option for patients who respond inadequately to or cannot tolerate UDCA. Although these drugs improve outcomes, they do not address the underlying autoimmune defect or meaningfully improve symptoms. Other alternative therapies in patients who are incomplete responders to UDCA include fenofibrates or other symptomatic treatments.


  • What patient shares do key therapies and brands garner by line of therapy in newly diagnosed PBC patients? What are the quarterly trends in prescribing among recently treated and newly diagnosed PBC patients?
  • How has UDCA been integrated into the treatment algorithm, and what is its source of business?
  • What percentage of PBC patients receive drug therapy within 365 days of diagnosis, and how quickly? What percentage of patients progress to later lines of therapy within 365 days of diagnosis?
  • What percentage of PBC patients are treated with monotherapy vs. combination therapy? What are the most commonly used combinations?
  • What are the product-level compliance and persistency rates among drug-treated patients?


Treatment Algorithms: Claims Data Analysis provides detailed, quantitative analysis of the treatment journey and brand usage across lines of therapy and overall using real-world, patient-level claims data so that marketers can accurately assess their source of business, benchmark usage against competitors, and quantify areas of opportunity for their marketed or emerging brand.

Geography: United States

Key companies: Allergan, Intercept Pharmaceuticals, others

Key drugs covered: Ursodeoxycholic acid (UDCA), obeticholic acid (Ocaliva), fibrates, oral corticosteroids, oral immunosuppressants, SSRIs, antihistamines, antiepileptics, serotonin receptor antagonists

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