Ocaliva — CareFirst (Caremark)

Primary biliary cholangitis (PBC)

Preferred products

Diagnosis of PBC is confirmed by at least two of the following: biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months; presence of antimitochondrial antibodies (AMA) (titer >1:40 by immunofluorescence or immunoenzymatic reactivity) or PBC-specific antinuclear antibodies (ANA) (e.g., anti-gp210, anti-sp100); histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts).
Member has an elevated serum ALP level prior to initiation of therapy with Ocaliva.
Member meets either of the following: (a) inadequate response to at least 12 months of prior therapy with ursodeoxycholic acid (UDCA)/ursodiol and member will continue concomitant UDCA/ursodiol, OR (b) intolerance to UDCA/ursodiol.
Member does not have decompensated cirrhosis (Child-Pugh Class B or C) or a prior decompensation event.
Member does not have compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).
Medication is prescribed by or in consultation with a hepatologist or gastroenterologist.

Member has achieved or maintained clinical benefit from Ocaliva as evidenced by at least one of the following: at least a 15% reduction in serum ALP level; serum ALP level less than 1.67 times the upper limit of normal (ULN); total bilirubin less than or equal to ULN.

12 months