Trientine DihydrochlorideTRIENTINE-DR.REDDY'S
Chelation of elevated copper levels in patients with Wilson disease who are intolerant of penicillamine.
Decision on record
- Meeting Mar 2022 Not recommended Wilson disease
Access path
- TGA registered · TRIENTINE-DR.REDDY'S
TGA label equal than the PBS population
- Nov 2021Recommended · restricted
vs no active treatment
- Mar 2022Not recommended
Economic evaluation continued to compare trientine 2HCl versus no active treatment rather than versus DPA as PBAC had…
- ↻ resubmittedMay 2022Recommended
Comparator changed: no active treatment → D-penicillamine (DPA)
- Jul 2023Recommended
Comparator changed: D-penicillamine (DPA) → Trientine Waymade (same active substance…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of Dr. Reddy’s for the chelation of elevated copper levels in a patient with WD under the same circumstances as Waymade on a cost- minimisation basis.PSD · Jul 2023
6.2 The PBAC agreed that Waymade is an appropriate comparator.PSD · Jul 2023
5.11 The submission did not present an economic analysis. The submission proposed that Dr.Reddy’s has the same AEMP as Waymade. 5PSD · Jul 2023
5.8 The submission stated that the bioequivalence between Dr.Reddy’s and Syprine and between Waymade and Syprine has been determined by the TGA. The bioequivalence between Dr.Reddy’s and Waymade has not been determined by the TGA as a direct bioequivalence study between the two products has not been provided to the TGA for evaluation.PSD · Jul 2023
5.9 The submission claimed that Dr.Reddy’s can be considered therapeutically equivalent to Waymade.PSD · Jul 2023
5.2 The PBAC noted and welcomed input from the National Paediatric Medicines Forum via the Consumer Comments facility on the PBS website. The comments highlighted that there have been continuous issues with medicine shortages affecting paediatric patients and welcomed the listing of an additional brand of trientine. The PBAC noted that this advice was supportive of listing Dr.Reddy’s.PSD · Jul 2023
No risk-sharing arrangement (RSA) was proposed. A RSA may be required given the dose used in the economic model and financial estimates was based on Weiss 2018 and may not represent use in clinical practice. In addition, the results of the financial impact sensitivity analyses indicated that there was potential for considerable alteration in the estimated net cost.PSD · Nov 2021
Finally, there is potential for use beyond the requested listing.PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as Dr.Reddy's proposed the same AEMP as Waymade and listing expected to be cost-neutral to Government.
Decision context
PopulationPatients with Wilson disease who are intolerant of penicillamine.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended | Trientine Waymade (same active substance, strength, and formulation) | — | Single-arm · Other |
| May 2022 | Recommended | D-penicillamine (DPA) | $45k–55k | Single-arm · Cost-minimisation |
| Mar 2022 | Not recommended | no active treatment | $45k–55k | Single-arm · Other |
| Nov 2021 | Recommended · restricted | no active treatment | — | Single-arm · Improvement of hepatic and/or neurological symptoms |
Consumer voice
The National Paediatric Medicines Forum highlighted ongoing issues with medicine shortages affecting paediatric patients and welcomed the listing of an additional brand of trientine, supporting the listing of Dr. Reddy's.
there have been continuous issues with medicine shortages affecting paediatric patients Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation specify treatment of Wilson disease patients intolerant of penicillamine; mechanistic detail (chelation) does not narrow the population.