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