Ursodeoxycholic AcidAPO-Ursodeoxycholic Acid
Treatment of primary biliary cholangitis (previously known as primary biliary cirrhosis). This is a request to increase the maximum number of repeats from 2 to 4 for existing PBS listings.
Decisions on record
- Meeting Mar 2023 Recommended Primary biliary cholangitis
- Meeting Mar 2017 Recommended Primary biliary cirrhosis
- Meeting Nov 2008 Recommended Bile acid preparation no PSD
Access path
- TGA registered · APO-Ursodeoxycholic Acid
TGA label narrower than the PBS population
- Mar 2017Recommended · restricted
- Mar 2023Recommended
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended a change to the listings of ursodeoxycholic acid (Ursofalk®) 250 mg capsule and 500 mg tablet forms on the PBS to increase the maximum number of repeats for the PBS listings from 2 repeats to 4 repeats.PSD · Mar 2023
6.2 The PBAC noted the change would provide most patients on standard dosing at least 6PSD · Mar 2023
5.11 The submission did not include an economic analysis. The submission asserted that the proposed change will not impact the cost-effectiveness.PSD · Mar 2023
5.6 Based on recommended weight-based dosage ranges, the current listings for ursodeoxycholic acid provides PBC patients with only 3 to 5 months’ treatment per prescription at maximum quantity and repeats (depending on dose and weight of the individual).PSD · Mar 2023
5.7 Increasing the number of repeats would allow female patients on the upper and lower dose range and male patients on the lower dose range to have access to over 6 months of supply per prescription. The PBAC is asked to advise if this is appropriate. 3PSD · Mar 2023
5.2 The PBAC noted and welcomed the input from health care professionals (3) via the Consumer Comments facility on the PBS website. The comments described that increasing the number of repeats of ursodeoxycholic acid prescriptions will reduce specialist visits and increase the capacity of relevant specialists and clinics.PSD · Mar 2023
Cost-effectiveness
No economic analysis was submitted. Category 4 submission (administrative change to repeats only).
The submission asserted that the proposed change will not impact the cost-effectiveness. PSD · 2023
Decision context
PopulationPatients with primary biliary cholangitis requiring chronic long-term treatment with ursodeoxycholic acid.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Healthcare professionals noted that increasing repeats of ursodeoxycholic acid prescriptions will reduce specialist visits and increase specialist capacity. They also indicated that the treatment does not require regular safety assessments and patients will self-initiate contact if disease progresses.
increasing the number of repeats of ursodeoxycholic acid prescriptions will reduce specialist visits and increase the capacity of relevant specialists and clinics Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to primary biliary cholangitis only, while TGA label covers all chronic cholestatic liver diseases.
Listed in law
PBS listings commencing 1 Nov 2023 were made by these 3 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 105 of 2023 | 30 Oct 2023 | Repealed | PDF ↗ |
| PB 105 of 2023 | 30 Oct 2023 | Repealed | PDF ↗ |
| PB 106 of 2023 | 30 Oct 2023 | Repealed | PDF ↗ |