Amino Acid Formula With Vitamins And Minerals Without Lysine And Low In Tryptophan
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of patients with proven glutaric aciduria type 1 (GA-1) or pyridoxine dependent epilepsy (PDE).
4
Submissions
1 resub
2015–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2024 Recommended Glutaric aciduria type 1; pyridoxine dependent epilepsy
- Meeting Nov 2010 Recommended Medicinal food no PSD
- Meeting Jul 2010 Recommended Medicinal food no PSD
- Meeting Nov 2009 Recommended Medicinal food. no PSD
- Meeting Mar 2009 Recommended Medicinal food no PSD
Access path
- Mar 2015Recommended
vs GA Express 15
- Nov 2015Recommended · restricted
Comparator changed: GA Express 15 → GA Gel and XLYS LOW TRY Maxamaid
- Nov 2020Recommended · restricted
Comparator changed: GA Gel and XLYS LOW TRY Maxamaid → dietary management of pyridoxine…
- Nov 2024Recommended · restricted
Comparator changed: dietary management of pyridoxine dependent epilepsy using a low…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended that amino acid formula with vitamins and minerals without lysine and low in tryptophan sachets containing oral powder 12.5 g, 30 (GA explore5™) be listed on the PBS as a General Schedule Restricted Benefit listing for the dietary management of patients with proven glutaric aciduria type 1 (GA-1) or pyridoxine dependent epilepsy (PDE).PSD · Nov 2024
7.2 The PBAC noted and accepted the NPWP advice that GA gel is the most appropriate comparator for GA explore5 and recommended that GA explore5 be cost-minimised to GA gel at an equivalent price per gram of protein equivalent.PSD · Nov 2024
Economic analysis
5.10 The submission presented a cost-minimisation analysis of GA explore5 compared to GA gel, based on the same cost per gram of PE. The protein equivalent content and proposed price of GA explore5, in comparison to GA gel, are outlined in Table 3.PSD · Nov 2024
5.11 The estimated drug cost/patient per year is $21,979.80 based on 12 scripts per year for the maximum quantity requested at DPMQ of $1,831.65.PSD · Nov 2024
Clinical claim
5.9 The submission claimed that GA explore5 is therapeutically comparable to GA gel.PSD · Nov 2024
Consumer comments
6.2 The PBAC noted and welcomed the input from health care professionals (1) via the Consumer Comments facility on the PBS website. The comment described how current access to appropriate specialised nutritional formulae for patients with PDE is extremely restricted and can result in significant delays in access. 3PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. GA explore5 is cost-minimised to GA gel at equivalent cost per gram of protein equivalent.
The PBAC noted and accepted the NPWP advice that GA gel is the most appropriate comparator for GA explore5 and recommended that GA explore5 be cost-minimised to GA gel at an equivalent price per gram of protein equivalent. PBAC · 2024
Cost-effectiveness accepted ×3
Decision context
PopulationInfants and children aged six months to five years with proven glutaric aciduria type 1 or pyridoxine dependent epilepsy requiring dietary management with a restricted protein diet (low lysine/low tryptophan).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | GA gel (amino acid formula with vitamins and minerals without lysine and low in tryptophan sachets containing oral powde | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | dietary management of pyridoxine dependent epilepsy using a low lysine diet without the inclusion of lysine free protein | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | GA Gel and XLYS LOW TRY Maxamaid | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Recommended | GA Express 15 | — | Cost-minimisation · 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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