The Access Board

All 218 unlisted positive recommendations, classified by the furthest of the register’s five milestones each reached, then by who holds the file there. Years are elapsed from the PBAC meeting to 6 September 2026; 9 records carry no meeting date.

The first step, on recommendations old enough to have listed

Once a sponsor lodges a notice of intent, listing is about 96% certain. Of the 114 that never listed, 86 never took the first step: 47 are records the Department marks “awaiting lodgement from pharmaceutical company”, 38 are minor or secretariat items that never run the chain, and 1 carries another state.

The share sponsors never lodge has roughly doubled

Positive recommendations recorded as “awaiting lodgement from pharmaceutical company”, as a share of that year’s positive recommendations

The register has started closing files

Since 1 September 2026 the register carries, on 24 of the 218, the sentence “The pharmaceutical company has advised that it is not proceeding in the PBS listing process at this time. The process for listing this medicine has ceased.” A terminal state, where before a stalled file sat as “awaiting lodgement” indefinitely. Every one of the 24 was on the sponsor’s side of the chain (14 awaiting a notice of intent, 10 lodged and stopped); none was in pricing negotiation. 6 of the 8 long-stalled and 4 of the 8 Bitter Pill recommendations are among them. Struck-through rows in the lists below are closed.

Two named lists

106 of the 218 are more than two years old: 87 are medicines on the PBS today under another brand, indication or formulation; 3 are nutrition products with no schedule item; 8 are vaccines funded through the immunisation program. 8 remain, 6 of them now closed.

Start from the 94 records awaiting lodgement (including those since closed), remove every molecule on the PBS in any form (69), set aside one amino-acid formula: 24 records, 23 medicines, approved and not on the schedule at all. 15 hold a NICE recommendation for the same indication; comparing the PBAC meeting date with the NICE publication date, the UK moved first in 8, Australia in 6, 1 the same day.

The fifteen medicines named in Bitter Pill, located in the register: 4 never before the PBAC, 3 not recommended for the indication named, 8 recommended and not listed, all 8 awaiting the sponsor’s lodgement and 4 of them now closed.

Every row behind the figures: the 218 positive recommendations not listed as at this reading, one line per submission, with the furthest milestone the register records and who holds the next step. The last column lists NICE’s appraisals of the same molecule, any indication — a count of what was looked at there, not a verdict on the row: a different committee, population and price, and a medicine appraised for one indication in the UK may be waiting here for another. 114 of the 218 rows have at least one.

The mix inverted; the total did not

Published PBAC decisions by meeting year, by submission type. Major and minor are the documents’ own words for whether a full economic evaluation was before the committee, not the Category 1 to 4 filing labels.

Major — full economic evaluation Minor

Six months, and it has stayed six months

Days from PBAC meeting to PBS listing, by meeting year; median, middle half shaded

Access Unlocked names “fewer medicines withdrawn, deferred or abandoned after positive PBAC recommendation” as a return on the package and proposes three measures, none of which counts that outcome. Stage 3 above is that count. Its time-to-listing measure runs on a different clock, TGA registration to listing, and is scorable from public data:

Stage	Measure	Now	Threshold	Reads
1	PBAC deferral share, two years running	14.7% (2025)	12%	Under pressure; 2026 is the test
1	Majors, share of output	72%	75%	Under pressure
1	MSAC decisions a year / deferral share	21 / 29%	20 / 25% twice	Under pressure
2	Meeting to listing, median	178 days	240	Holding
3	Unlisted share of positive recommendations	27.0%	30%	Where access is lost
3	Awaiting lodgement, share of unlisted (with closed files)	37% (48%)	50%	Where access is lost
3	Matured non-lodgement, explicit attribution	9.5% (2023–24)	12%	2025 sits at 17.8% and is the test
3	Long-stalled list	8	12	6 of them closed
3	Records in pricing negotiation	4	15	Would mean the stall had moved to the negotiating table
4	Narrower than label	80.2%	± 3 points	By design
4	Registered, never submitted (2016 on)	27.6%	35%	By design