Pharmaceutical Benefits Advisory Committee (PBAC)
An independent expert committee that assesses the clinical effectiveness, safety and cost-effectiveness of a medicine and recommends to the Minister whether it should be listed on the Pharmaceutical Benefits Scheme.
Responsibilities
- Assess submissions for PBS listing against comparators
- Recommend for or against listing, or defer
- Advise on the conditions and restrictions of a listing
Operates under
- National Health Act 1953 (Cth)
The PBAC is a genuinely well-regarded institution and this database has no criticism of the assessment it performs. Cost-effectiveness assessment by an independent expert committee is the reason Australia pays what it does for medicines, and weakening it would cost more than any delay it causes.
What is worth recording is its cycle. The committee meets three times a year
— March, July and November. A submission that misses a deadline waits for the
next round, which is roughly four months of scheduling in which nobody is
assessing anything.
For a first submission that is a known cost of doing business. Its significance compounds on resubmission: a medicine rejected or deferred at one meeting cannot simply be reconsidered when the additional evidence is ready. It waits for a meeting. Two resubmissions is not unusual, and two resubmissions is most of a year in cycle time alone, before any assessment or negotiation.
The TGA and PBAC parallel process already allows registration and reimbursement assessment to run concurrently for eligible submissions, which is exactly the kind of design this database argues for and which was implemented long before this project existed. It is worth noting where the good work has already been done.
Where this body appears in a process
Every point at which Pharmaceutical Benefits Advisory Committee can hold something up, and why.
| Process | Step | Why it waits | Clock | Typical |
|---|---|---|---|---|
| A new medicine is listed on the Pharmaceutical Benefits Scheme | Wait for a PBAC meeting registration | scheduling | — | 60 |
| A new medicine is listed on the Pharmaceutical Benefits Scheme | PBAC evaluation and recommendation assessment | assessment | — | 120 |
| A new medicine is listed on the Pharmaceutical Benefits Scheme | Resubmission after a rejection or deferral application | scheduling | — | 240 |
