Livdelzi (seladelpar) — CareFirst (Caremark)

Primary biliary cholangitis (PBC)

Preferred products

Diagnosis of PBC is confirmed by at least two of the following criteria: biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months duration; 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 the requested drug.
Member meets either of the following criteria: (a) inadequate response to at least 12 months of prior therapy with ursodeoxycholic acid (UDCA)/ursodiol and the member will continue concomitant therapy with UDCA/ursodiol; OR (b) intolerance to UDCA/ursodiol.
Medication must be prescribed by or in consultation with a hepatologist or gastroenterologist.
Coverage will not be provided for members who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Member has achieved or maintained a clinical benefit from therapy with the requested drug, such as at least a 15% reduction in serum ALP level, serum ALP level less than 1.67 times upper limit of normal (ULN), or total bilirubin less than or equal to ULN.

12 months