ArginineARGININE HYDROCHLORIDE
Not recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of urea cycle disorders (UCD).
1
Submissions
2017–17
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Mar 2018 Not recommended Urea cycle disorders (UCD) no PSD
- Meeting Nov 2017 Deferred Indication not stated
Access path
- TGA registered · ARGININE HYDROCHLORIDE
- Nov 2017Not recommended
Clinically inappropriately high and undocumented protein content in the formulation, lack of clinical need for an…
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC decided to defer its decision on whether to recommend the listing of arginine for the dietary management of urea cycle disorders. The PBAC considered there was a lack of clinical justification for the higher protein content compared to the comparator. The PBAC also noted that the product may come under the definition of a therapeutic good in the Therapeutic Goods Act 1989 and may 3PSD · Nov 2017
6.2 The PBAC noted that the NPWP supported the decision of deferral on the listing of the product to allow the sponsor to provide justification for the issues raised above.PSD · Nov 2017
Cost-effectiveness
Minor submission; no economic evaluation or ICER calculated.
Decision context
PopulationPatients with urea cycle disorders requiring dietary management with arginine supplementation.
Why it was knocked back
- Clinically inappropriately high and undocumented protein content in the formulation, lack of clinical need for an additional formulation of arginine on the PBS, high protein levels (up to 20% of daily protein intake) could be detrimental to patients on highly restricted protein diets
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Not recommended | Arginine 500 | — | Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
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