Depen — Medical Mutual

Initial criteria

• Diagnosis of Wilson’s disease is confirmed by ONE of the following (i or ii):
• i. Genetic testing results confirming biallelic pathogenic ATP7B mutations (in either symptomatic or asymptomatic individuals); OR
• ii. Confirmation of at least two of the following (a, b, c, d):
• a. Presence of Kayser-Fleischer rings;
• b. Serum ceruloplasmin level < 20 mg/dL;
• c. Liver biopsy findings consistent with Wilson’s disease;
• d. 24-hour urinary copper > 40 mcg/24 hours;
• AND Patient meets ONE of the following criteria (i, ii, iii, or iv):
• i. Patient has tried Galzin (zinc acetate capsules); OR
• ii. Patient has tried another zinc product (e.g., zinc sulfate, zinc gluconate, zinc acetate); OR
• iii. According to the prescriber, patient has symptoms of Wilson’s disease and zinc would not be an appropriate therapy; OR
• iv. Patient has been started on therapy with penicillamine tablets;
• AND Patient meets ONE of the following (i or ii):
• i. Generic penicillamine tablets are requested; OR
• ii. If brand Depen is prescribed, patient has tried generic penicillamine tablets AND cannot take generic penicillamine tablets due to a formulation difference in the inactive ingredient(s) [e.g., difference in dyes, fillers, preservatives] between the Brand and the bioequivalent generic product which, per the prescriber, would result in a significant allergy or serious adverse reaction [documentation required];
• AND The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Reauthorization criteria

• Response to therapy is required for continuation of therapy.

Approval duration

1 year