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Depen — Cigna

Wilson’s disease

Preferred products

  • generic penicillamine capsules
  • generic penicillamine tablets

Initial criteria

  • For Cystinuria: Approve for 1 year if BOTH of the following (A and B) are met:
  • A) According to the prescriber, patient has tried increased fluid intake; restriction of sodium and protein; and urinary alkalinization; AND
  • B) Patient meets ONE of the following (i or ii):
  • i. Generic penicillamine (capsules or tablets) are requested; OR
  • ii. If brand Cuprimine (capsules) or brand Depen (tablets) is being requested, patient has tried generic penicillamine and cannot take the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) between brand and bioequivalent generic product which, per prescriber, would result in a significant allergy or serious adverse reaction.
  • For Wilson’s Disease: Approve for 1 year if ALL of the following (A, B, C, and D) are met:
  • A) Diagnosis of Wilson’s disease is confirmed by ONE of the following (i or ii):
  • 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
  • B) Patient meets ONE of the following (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 appropriate; OR
  • iv. Patient has been started on therapy with a penicillamine product; AND
  • C) Patient meets ONE of the following (i or ii):
  • i. Generic penicillamine (capsules or tablets) are requested; OR
  • ii. If brand Cuprimine (capsules) or brand Depen (tablets) is being requested, patient has tried generic penicillamine and cannot take the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) between brand and bioequivalent generic product which, per prescriber, would result in a significant allergy or serious adverse reaction; AND
  • D) Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.

Approval duration

1 year