A new medicine is listed on the Pharmaceutical Benefits Scheme

The assessment is already parallelised and the committee is well regarded. The delay sits after both assessments are finished, in a three-meetings-a-year cycle and a Cabinet approval reported to have grown from 6.7 months to 10.

healthA new medicine with a financial impact above the Cabinet threshold, from submission to a patient filling a subsidised script draft compare across jurisdictions

930 days elapsed
longest dependent chain

8 discrete steps
across 3 bodies

39% waiting on availability
scheduling or queue, not assessment

330 days saved by concurrency
vs. 1260 if run end-to-end

Where the time goes

Critical-path days only. Steps that run alongside others are real work but do not lengthen the process, so counting them here would overstate the prize.

scheduling	360d	Waiting for a person or committee to become available.
applicant	270d	Waiting on the applicant to supply or fix something.
assessment	240d	Someone is genuinely evaluating the merits.
statutory	60d	A legislated period that must elapse regardless of readiness.

360 of 930 elapsed days are spent waiting for a person or a meeting rather than for a judgement to be formed. Removing that time changes no assessment standard and lowers no bar -- it is the cost of scheduling alone.

The process, step by step

Applies when: A sponsor seeks PBS subsidy for a medicine that must also be registered on the ARTG.

#	Step	Who	Why it waits	Clock	Typical	Basis
1	Prepare the submission application Clinical and economic evidence establishing comparative effectiveness and cost-effectiveness against the relevant comparator.	—	applicant	—	270 estimate	—
2	TGA evaluation for registration assessment Evaluation of quality, safety and efficacy for entry on the ARTG. after Prepare the submission 330d slack	Therapeutic Goods Administration	assessment	—	330 estimate	Therapeutic Goods Act 1989 (Cth)
3	Wait for a PBAC meeting registration Submissions are considered at three meetings a year, in March, July and November. after Prepare the submission 600d slack	Pharmaceutical Benefits Advisory Committee	scheduling	—	60 published	—
4	PBAC evaluation and recommendation assessment Assessment of comparative clinical effectiveness and cost-effectiveness, and a recommendation to the Minister. after Wait for a PBAC meeting 480d slack	Pharmaceutical Benefits Advisory Committee	assessment	—	120 estimate	National Health Act 1953 (Cth)
5	Resubmission after a rejection or deferral application only if triggered Additional evidence or a revised price, considered at a later meeting. Triggered when: The PBAC does not recommend listing at first consideration, which for new medicines is common. after PBAC evaluation and recommendation 240d slack	Pharmaceutical Benefits Advisory Committee	scheduling	—	240 estimate	—
6	Price negotiation with the department assessment Agreement on price and any special arrangements following a positive recommendation. after PBAC evaluation and recommendation 360d slack	Department of Health, Disability and Ageing	assessment	—	120 estimate	—
7	Cabinet approval decision Listings with a financial impact above the threshold require Cabinet agreement rather than ministerial approval. after Price negotiation with the department 60d slack	Department of Health, Disability and Ageing	scheduling	—	300 reported	—
8	Listing takes effect registration The medicine appears on the Schedule and can be dispensed with a subsidy. after Cabinet approval, TGA evaluation for registration	Department of Health, Disability and Ageing	statutory	—	60 estimate	—

on the critical path scheduling/queue = delay not caused by the assessment itself

Proposed changes

Let a resubmission be considered when the evidence is ready, not at the next of three meetings resequence ~180d
The PBAC meets three times a year. A medicine rejected in March cannot be reconsidered when the additional evidence is ready in May; it waits for July, or more realistically November. Two resubmissions is most of a year in calendar time alone.
Index the PBS Cabinet threshold, which has been widening its own coverage for years threshold ~300d
Listings with a financial impact above $20 million go to Cabinet rather than the Minister. The threshold is not indexed, so inflation moves medicines across it without anyone deciding they should cross. Cabinet approval time has reportedly grown from 6.7 months to 10.

Sources

PBS, TGA and PBAC parallel process factsheet: registration and reimbursement evaluation undertaken in parallel for eligible submissions; PBS listing cannot occur before ARTG listing
PBS, published PBAC meeting calendar: three meetings a year
The Minister approves listings with a financial impact below $20 million; above that the listing requires Cabinet approval
Reported increase in Cabinet approval time from 6.7 months to 10 months, with Cabinet approval able to delay listing by 12 months or more
Senate committee recommendation that the Cabinet threshold be increased

Something wrong here?

This page is wrong in some way -- every page like it is. If you have run this process, the most useful thing you can do is tell us which step took longer than we say and why. Edit data/processes/au-pbs-listing.toml and open a pull request, or send us the correction.