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.
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