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Primary Biliary Cholangitis: Medical and Specialty Pharmacy Management Update.

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    New treatments for primary biliary cholangitis (PBC) are needed as many patients inadequately respond to ursodiol (UDCA). Obeticholic acid shows promise, and specialty pharmacy will manage access to new orphan disease therapies for PBC.

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    Area of Science:

    • Hepatology and autoimmune liver diseases.
    • Pharmacology and therapeutic development.

    Background:

    • Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease leading to significant morbidity and mortality.
    • Ursodiol (UDCA) is the sole FDA-approved treatment, but 1 in 3 patients show an inadequate response.
    • Unmet clinical needs drive the development of new therapies for PBC.

    Purpose of the Study:

    • To summarize a symposium on PBC pathophysiology and emerging treatments.
    • To highlight medical and specialty pharmacy roles in managing orphan disease drug access.

    Main Methods:

    • A satellite symposium was presented at the 2015 AMCP Nexus meeting.
    • Expert panelists discussed the latest research and management strategies for PBC.

    Main Results:

    • Obeticholic acid, a farnesoid X receptor agonist, demonstrates promising results as a novel monotherapy.
    • New therapies for PBC are anticipated to be managed by specialty pharmacy due to orphan disease status.

    Conclusions:

    • PBC significantly impacts liver transplant rates and mortality, necessitating improved treatment options.
    • Prior authorization criteria for new PBC therapies will focus on clinical efficacy, safety, and response to UDCA.
    • Specialty pharmacy plays a crucial role in managing access to novel orphan drugs for PBC.