Proposal to list trientine for the treatment of Wilson disease

Medicines Consultation Closed

What we’re proposing 

We are seeking feedback on a proposal to list trientine dihydrochloride 250 mg capsules on the Pharmaceutical Schedule for the treatment of Wilson disease.

Trientine was included in the 2021/22 Annual Invitation to Tender. The specific brand and pricing would be announced in a notification of a tender award. We welcome your feedback on this proposal. We are specifically seeking feedback on:

  • the proposed eligibility criteria for trientine.
  • the proposed 250 mg capsule trientine dihydrochloride presentation.

Trientine dihydrochloride 300 mg capsules are currently listed on the Hospital Medicines List (HML) with no brand or pack specifications. We are proposing to delist the 300 mg capsule as part of this proposal.

To provide feedback, please submit it via email by Monday 25 March at 9 am to:

What would the effect be?

Trientine 250 mg capsules would be listed on the Pharmaceutical Schedule with eligibility criteria from 1 May 2024.

Currently there is a group of people receiving funded trientine via the Named Patient Pharmaceutical Assessment (NPPA) pathway. Trientine would be easier to access for people with Wilson disease if listed on the Pharmaceutical Schedule. We are also proposing to remove any renewal requirements. This would reduce administrative burden on prescribers and make funded trientine access easier.

People receiving treatment via the NPPA pathway would need to transition to the listed brand of trientine 250 mg capsules. They would need to transition between 1 May and 1 October 2024.

For Community Pharmacies

As a contracted trientine product would be available, pharmacies would be less likely to experience continuity of supply issues or other stock management issues relating to stocking a high price product.

For Hospital Pharmacies

Trientine dihydrochloride 300 mg capsules are currently listed on the HML with no brand specified. Pharmac does not currently have a supply contract for trientine dihydrochloride. As a result of this proposal the 300 mg capsule would be delisted from HML and replaced by the 250 mg capsules.

Current hospital usage is very low. We understand it is generally used to initiate or continue treatment on a short-term basis for inpatients.

For Prescribers

The proposal to move from funding via the NPPA pathway to a listing on the Pharmaceutical Schedule would provide clinicians with a simpler, more streamlined way to apply for funded access to trientine. Special Authority approvals would be life-long. There would be no renewal requirements.

We are exploring providing automatic Special Authority approvals for people currently receiving funded trientine via the NPPA pathway.

Who we think will be interested

  • People with Wilson disease and their families and whānau
  • Support & advocacy groups for people with Wilson disease
  • Healthcare professionals involved in the management of Wilson disease
  • Te Whatu Ora, wholesalers and suppliers of trientine capsules

About Wilson disease

Wilson disease is a rare inherited condition that reduces a person’s ability to remove copper from their body. People need two copies of the faulty gene to have Wilson disease. Wilson disease can cause copper to build up in the body. Copper can build up in the brain, part of a person’s eye (cornea) and the liver. This can mean people need a liver transplant.

Trientine is a copper chelator. Copper chelators help remove copper from your body. It is approved for people with Wilson disease who are intolerant of penicillamine. It is funded, via the NPPA pathway, for people with Wilson disease who do not receive sufficient benefit, or experience unacceptable side effects, to the funded treatment options. The current funded treatment options are D-penicillamine and zinc.

Access criteria

Trientine would be listed in the Alimentary Tract and Metabolism therapeutic group in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application only from a relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

  1. Patient has confirmed Wilson disease; and
  2. Treatment with D-penicillamine has been trialled and discontinued because the person has experienced intolerable side effects or has not received sufficient benefit; and
  3. Treatment with zinc has been trialled and discontinued because the person has experienced intolerable side effects or has not received sufficient benefit, or zinc is considered clinically inappropriate as the person has symptomatic liver disease and requires copper chelation.

Similar restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the HML).

The trientine dihydrochloride 300 mg capsules listing on the HML would be delisted from 1 October.

Principal Supply Status would apply to the funded brand in the community and in Te Whatu Ora hospitals from 1 October 2024 until 30 June 2025.

To provide feedback

Consultation closes 9 am Monday 25 March 2024 and feedback can be emailed to

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.