Cuprimine — Medica
Wilson’s disease
Preferred products
- penicillamine capsules (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 capsules are requested; OR (ii) if brand Cuprimine is being requested, patient has tried generic penicillamine capsules AND cannot take generic penicillamine capsules 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