Amino Acid Formula With Vitamins And Minerals Without Methionine
Dietary management of pyridoxine non-responsive homocystinuria (HCU).
Decisions on record
- Meeting Jul 2021 Recommended Homocystinuria
- Meeting Mar 2012 Recommended Medicinal food no PSD
- Meeting Mar 2012 Recommended Medicinal food no PSD
- Meeting Nov 2010 Recommended Medicinal foods no PSD
- Meeting Mar 2010 Recommended Medicinal food no PSD
- Meeting Mar 2010 Recommended Medicinal food no PSD
- Meeting Nov 2007 Recommended Inherited metabolic disorders no PSD
Access path
- Nov 2015Recommended
vs HCU Gel® and XMET Maxamaid®
- Jul 2020Recommended · restricted
Comparator changed: HCU Gel® and XMET Maxamaid® → HCU Express 15, HCU Cooler 20, HCU…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the Restricted Benefit listing of amino acid formula with vitamins and minerals without methionine, HCU Lophlex, for the management of pyridoxine non-responsive homocystinuria (HCU) on a cost-minimisation basis per gram of protein with the nominated comparators.PSD · Jul 2020
7.2 The PBAC noted that the NPWP accepted that HCU Express 15, HCU Cooler 20, HCU Lophlex LQ 20 and XMET Maxamum were relevant comparators.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The PBAC recommended the Restricted Benefit listing of amino acid formula with vitamins and minerals without methionine, HCU Lophlex, for the management of pyridoxine non-responsive homocystinuria (HCU) on a cost-minimisation basis per gram of protein with the nominated comparators. PBAC · 2020
Decision context
PopulationPatients aged 3 years or over with pyridoxine non-responsive homocystinuria; the PBAC noted that prescribing is usually by specialists and nutritionists, and due to the formulation, HCU Lophlex will likely be used in teenagers and adults.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | HCU Express 15, HCU Cooler 20, HCU Lophlex LQ 20, XMET Maxamum | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended | HCU Gel® and XMET Maxamaid® | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to pyridoxine non-responsive HCU and age ≥3 years; TGA label covers all HCU without these qualifiers.
Listed in law
PBS listings commencing 1 Mar 2021 were made by these 4 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 13 of 2021 | 24 Feb 2021 | Repealed | PDF ↗ |
| PB 13 of 2021 | 24 Feb 2021 | Repealed | PDF ↗ |
| PB 14 of 2021 | 24 Feb 2021 | Repealed | PDF ↗ |
| PB 15 of 2021 | 24 Feb 2021 | Repealed | PDF ↗ |