Cholbam

Drug - Cholbam™ (cholic acid) [Manchester Pharmaceuticals]

August 2011

Therapeutic area - Bile acid synthesis disorders

Approval criteria

Bile acid synthesis disorders:

• Patient must have a documented diagnosis of bile acid synthesis disorders due to single enzyme defects AND
• Patient is prescribed Cholbam by a liver specialist

Peroxisomal Disorders:

• Patient must have a documented diagnosis of peroxisomal disorders, including Zellweger specitrum disorder in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption AND
• Patient is prescribed Cholbam as adjunctive therapy by a liver specialist 

Initial approval will be limited to 4 months in duration

Renewal criteria

Documented evidence of improved liver function

Quantity limit

• 50 mg capsules: Maximum of 136 capsules per 34 days
• 250 mg capsules: Maximum of 136 capsules per 34 days

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411