Trientine tetrahydrochloride (Cuprior®) the treatment of Wilson’s disease

Zorginstituut Nederland has completed its assessment whether trientine tetrahydrochloride (Cuprior®) is interchangeable with a product that has been included in the Medication Reimbursement System (GVS). The Zorginstituut'sadvice is to include trientine tetrahydrochloride (Cuprior®) in Appendix 1B and Appendix 2 of the Health Insurance Regulation and to impose additional conditions.

Registered indication

Cuprior® is indicated for the treatment of Wilson’s disease (WD) in adults and and children older than 5 years who are intolerant to therapy with D-penicillamine. Cuprior® is available as a film-coated tablet containing trientine tetrahydrochloride (trientine 4HCL), equivalent to 150 mg trientine.

Assessment

The Zorginstituut has come to the final conclusion that trientine tetrahydrochloride (Cuprior®) has an equal therapeutic value for the treatment of patients with Wilson's disease who are intolerant to therapy with D-penicillamine compared to trientine dihydrochloride (Cufence®). Because Cufence® is not included in the GVS, Cuprior® is eligible for placement on List 1B.

Zorginstituut's advice

Based on the considerations mentioned in the report, the Zorginstituut advises the Minister for Medical Care to include trientine tetrahydrochloride (Cuprior®) in Appendix 1B and Appendix 2 (with additional conditions).

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.