phenylketonuria
Metabolic · 2014–2026
49decisions
23medicines
3carried consumer input
925individual submissions
Every decision
| Medicine | Meeting | Outcome | Consumer input |
|---|---|---|---|
| glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine Dietary management of phenylketonuria (PKU) in children from 3 years of age and adults. | Mar 2026 | Recommended with restriction | no section in document |
| pegvaliase Treatment of patients aged 16 years and older with hyperphenylalaninemia due to phenylketonuria (PKU) who have inadequate blood phenylalanine control despite… | Mar 2026 | Deferred | no section in document |
| amino acid formula with vitamins and minerals without phenylalanine Dietary management of phenylketonuria (PKU), particularly for those requiring a lower-calorie option. | Mar 2024 | Recommended with restriction | none received |
| amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine Dietary management of phenylketonuria (PKU) in infants. | Mar 2024 | Recommended | none received |
| amino acid formula with fat, carbohydrate, vitamins and minerals without phenylalanine Dietary management of phenylketonuria (PKU) in children aged 3 years and older, and adults with PKU requiring amino acid supplementation. | Nov 2024 | Recommended with restriction | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Dietary management of phenylketonuria (PKU). | Nov 2024 | Recommended with restriction | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Management of phenylketonuria (PKU). The submission requested that new formulations of these products continue to be listed on the PBS under existing… | Mar 2023 | Recommended | none received |
| sapropterin Extension of current PBS listing for hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) to allow adults aged ≥18 years to be eligible for sapropterin… | Jul 2022 | Recommended | unclear |
| glycomacropeptide formula with amino acids and low phenylalanine Treatment of phenylketonuria (PKU) in children from 3 years of age, and adults. | Mar 2022 | Recommended with restriction | input received |
| glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine Treatment of phenylketonuria (PKU) in children and adults. | Mar 2022 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria (PKU). Continued listing of amino acid formula with vitamins and minerals without phenylalanine as a food for special medical purposes. | Nov 2022 | Recommended | none received |
| glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine Dietary management of patients with phenylketonuria (PKU). | Nov 2022 | Recommended with restriction | none received |
| amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine, supplemented with docosahexaenoic acid Dietary management of phenylketonuria (PKU) or hyperphenylalaninaemia in children from 10 years of age or adults. | Jul 2020 | Not recommended | none received |
| amino acid formula with vitamins and minerals without phenylalanine Dietary management of phenylketonuria (PKU). | Mar 2020 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid Dietary management of phenylketonuria (PKU) in older infants and young children. | Jul 2019 | Recommended | none received |
| glycomacropeptide formula with docosahexaenoic acid and low phenylalanine Dietary management of phenylketonuria (PKU). | Jul 2019 | Recommended | none received |
| tyrosine with carbohydrate Dietary management of phenylketonuria (PKU) in patients aged 3 years and over. | Jul 2019 | Recommended with restriction | none received |
| amino acid formula with carbohydrate without phenylalanine Dietary management of phenylketonuria (PKU). | Nov 2019 | Recommended | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Phenylketonuria. The submission requested a change to the formulation to include docosahexaenoic acid (DHA), a lower level of phenylalanine, and other changes… | Nov 2019 | Recommended with restriction | none received |
| amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids, without phenylalanine Dietary management of phenylketonuria (PKU) in infants. | Jul 2018 | Recommended with restriction | none received |
| sapropterin Treatment of hyperphenylalaninaemia (HPA) caused by phenylketonuria (PKU) in sapropterin-responsive patients. | Mar 2018 | Deferred | 919 individuals Metabolic Dietary Disorders Association |
| glycomacropeptide and essential amino acids with vitamins and minerals Treatment of phenylketonuria (PKU). | Nov 2018 | Recommended with restriction | unclear |
| glycomacropeptide formula with docosahexaenoic acid with low phenylalanine Treatment of phenylketonuria (PKU) in patients aged 3 years or older. | Nov 2018 | Recommended with restriction | unclear |
| sapropterin Hyperphenylalaninaemia (HPA) caused by phenylketonuria (PKU) in patients demonstrating responsiveness to sapropterin. | Nov 2018 | Recommended with restriction | 6 individuals |
| amino acid formula with vitamins and minerals, without phenylalanine Dietary management of phenylketonuria in patients aged four years and older (for the liquid formulation) and eight years and older (for the powder formulation). | Jul 2017 | Recommended with restriction | none received |
| glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low phenylalanine Dietary management of phenylketonuria. The submission requested listing of a new sachet size (PKU Sphere15) and renaming of the existing product (PKU Sphere to… | Jul 2017 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid Treatment of phenylketonuria (PKU) in infants and young children aged 6 months to 5 years as a concentrated, low volume protein substitute to support the… | Mar 2017 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals without phenylalanine Dietary management of phenylketonuria (PKU). | Mar 2017 | Recommended | none received |
| amino acid formula with vitamins and minerals without phenylalanine Dietary management of phenylketonuria (PKU). | Mar 2017 | Recommended | none received |
| amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine, supplemented with docosahexaenoic acid Dietary management of phenylketonuria (PKU) or hyperphenylalaninaemia in children from 10 years of age or adults. | Nov 2017 | Not recommended | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Treatment of Phenylketonuria. Two formulations are presented: PKU Build 10 (10 g protein equivalent) and PKU Build 20 (20 g protein equivalent). | Nov 2017 | Recommended | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Phenylketonuria (PKU) in children aged 12 months and above, as well as pregnant or lactating women. | Jul 2016 | Recommended with restriction | none received |
| amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid Phenylketonuria (PKU) in infants requiring oral nutritional support. | Mar 2016 | Recommended with restriction | none received |
| amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine Phenylketonuria. The product is an amino acid formula designed for dietary management of PKU across the age range of 6 months to 10 years. | Mar 2016 | Recommended | none received |
| glycomacropeptide and essential amino acids Treatment of phenylketonuria (PKU). | Nov 2016 | Recommended | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Phenylketonuria (PKU) in patients 10 years and older. A nutritional formula for patients with proven diagnosis of PKU. | Nov 2016 | Recommended with restriction | none received |
| amino acid formula without phenylalanine Treatment of phenylketonuria (PKU) in adult patients. The submission requested an increase in maximum quantities to better meet the monthly protein… | Nov 2016 | Recommended | none received |
| amino acid formula with vitamins and minerals without phenylalanine Management of phenylketonuria (PKU). | Mar 2015 | Recommended with restriction | no section in document |
| Amino acid formula with vitamins and minerals (three formulations: without phenylalanine; without phenylalanine and tyrosine; without valine, leucine and isoleucine) Nutritional management of phenylketonuria (PKU), tyrosinaemia, and maple syrup urine disease (MSUD) in children. These are formulation upgrades (pack size… | Mar 2015 | Recommended | no section in document |
| glycomacropeptide and essential amino acids with vitamins and minerals Phenylketonuria (PKU) — new dose presentation of ready-to-drink oral liquid formulation. | Mar 2015 | Recommended | no section in document |
| amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria (PKU). Medical food for special medical purposes. | Nov 2015 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria (PKU). A medical food formulation containing 15g protein equivalent per dose. | Nov 2015 | Recommended with restriction | none received |
| amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria (PKU). Medical nutrition for patients with PKU across the age range of 6 months to 10 years. | Nov 2015 | Deferred | none received |
| amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine Phenylketonuria (PKU) in infants. An amino acid-based medical food formulation designed to provide essential nutrition while excluding phenylalanine. | Nov 2015 | Deferred | none received |
| amino acid formula without phenylalanine Phenylketonuria (PKU) treatment. A modified-release amino acid tablet formulation providing essential and non-essential amino acids without phenylalanine for… | Nov 2015 | Recommended with restriction | none received |
| glycomacropeptide and essential amino acids with vitamins and minerals Phenylketonuria (PKU). This is a pack size upgrade from 28 to 30 sachets per pack. | Nov 2015 | Recommended | none received |
| amino acid formula with vitamins and minerals without phenylalanine Treatment of patients with phenylketonuria (PKU). | Jul 2014 | Noted | no section in document |
| amino acid formula with vitamins and minerals without phenylalanine Phenylketonuria (PKU). A medical food for patients with PKU requiring amino acid supplementation without phenylalanine. | Nov 2014 | Deferred | no section in document |
| amino acid formula with vitamins and minerals without phenylalanine Nutritional support for phenylketonuria (PKU) — an upgrade in nutritional formula, flavour and packaging change from 29 g sachets to 36 g sachets. | Nov 2014 | Deferred | no section in document |
Who spoke
Metabolic Dietary Disorders Association
Conditions are classified by a language model from the indication text of each submission, so an individual label here can be wrong. Consumer input is read from the document's own consumer comments section: 3 of 49 decisions since 2014 carried some. Silence means no comment reached the committee through that facility, not that nobody was affected. More on how this was built.