trientine hydrochloride capsules (generic) — Medica
Wilson’s disease (hepatolenticular degeneration)
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 (TWO of a, b, c, or d):
- a. Presence of Kayser-Fleischer rings; OR
- b. Serum ceruloplasmin level < 20 mg/dL; OR
- c. Liver biopsy findings consistent with Wilson’s disease; OR
- d. 24-hour urinary copper > 40 mcg/24 hours; AND
- Patient meets ONE of the following (i, ii, iii, iv, v, or vi):
- i. According to the prescriber, patient has tried one penicillamine product and is intolerant to penicillamine therapy; OR
- ii. According to the prescriber, patient has clinical features indicating the potential for intolerance to penicillamine therapy (e.g., renal disease, congestive splenomegaly causing severe thrombocytopenia, autoimmune tendency); OR
- iii. According to the prescriber, patient has a contraindication to penicillamine therapy; OR
- iv. Patient has neurologic manifestations of Wilson’s disease; OR
- v. Patient is pregnant; OR
- vi. Patient has been started on therapy with trientine (Cuvrior or Syprine, generic); AND
- The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician.
Approval duration
1 year