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DepenMedica

Wilson’s disease

Preferred products

  • penicillamine tablets (generic)

Initial criteria

  • Diagnosis of Wilson’s disease is confirmed by ONE of the following: (i) genetic testing results confirming biallelic pathogenic ATP7B mutations; OR (ii) confirmation of at least TWO of the following: presence of Kayser-Fleischer rings; serum ceruloplasmin level < 20 mg/dL; liver biopsy findings consistent with Wilson’s disease; 24-hour urinary copper > 40 mcg/24 hours; AND
  • Patient meets ONE of the following: (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 a penicillamine product; AND
  • Patient meets ONE of the following: (i) generic penicillamine tablets are requested; OR (ii) if brand Depen is being requested, patient has tried generic penicillamine tablets AND cannot take generic penicillamine tablets due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction; AND
  • Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Approval duration

1 year