Pancreatic ExtractCreon
Pancreatic enzyme replacement in paediatric and adult patients with Pancreatic Exocrine Insufficiency (PEI), often associated with cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery, and ductal obstruction of the pancreas or common bile duct.
Decisions on record
- Meeting Jul 2024 Noted Cystic fibrosis no PSD
- Meeting Mar 2023 Noted Cystic fibrosis no PSD
- Meeting Nov 2022 Noted Pancreatic exocrine insufficiency no PSD
- Meeting Nov 2020 Recommended Pancreatic exocrine insufficiency
- Meeting Nov 2008 Recommended Enzyme replacement no PSD
Access path
- TGA registered · Creon
TGA label equal than the PBS population
- Nov 2020Recommended
vs Creon capsules
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of two new strengths of pancreatic extract (Creon®), 20,000 and 35,000 lipase BP units modified release capsules, under the same conditions as the currently PBS listed Creon products. 5PSD · Nov 2020
6.2 The PBAC considered that the new listings may reduce pill burden and lead to greater adherence and improve clinical outcomes.PSD · Nov 2020
5.5 The submission’s proposed approved ex-manufacturer price is $38.82 for Creon 20,000 and $67.93 for Creon 35,000, resulting in a dispensed price for maximum quantity of $94.68 and $160.39, respectively. The proposed price is based on the price 3PSD · Nov 2020
Cost-effectiveness
No economic evaluation presented; minor submission with cost-minimisation approach only
The PBAC considered that there may be savings to the Government associated with the listing of Creon 25,000 and 40,000 units, due to the lower price per unit of the new strengths compared with Creon 10,000. PBAC · 2020
Decision context
PopulationPaediatric and adult patients with Pancreatic Exocrine Insufficiency (PEI) requiring pancreatic enzyme replacement therapy, including those with cystic fibrosis, chronic pancreatitis, post-pancreatic/gastrointestinal surgery, or ductal obstruction.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2020 | Recommended | Creon capsules | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both indications cover the same PEI population across identical associated conditions; PBAC wording is merely restated without population restriction.