What should you do when a pharmaceutical representative who is unknown to you comes into the office?

One of its main roles is to assess medicines to see if they are good value for money and should be listed on the PBS. Good value for money means different things to different people, but for PBAC it means: Is this medicine safe, and clinically and cost-effective compared to an existing treatment?

This evidence must be scientifically robust. It usually includes data from Randomised Clinical Trials (RCTs) which were run to work out if the medicine improves the health status of patients (such as patients living longer or being able to return to normal daily activities).

The evidence will also be data and models which are used to work out if the medicine is better value for money than the existing treatment (called the comparator). It might show which treatment provides more outcomes for the cost of treatment or which treatment costs the least for a given outcome.

The Minister approves the listing of new medicines on the PBS if their financial impact is less than $20 million (if it is more than $20 million it goes to the cabinet).

“Not everything that matters can be measured and not everything that can be measured matters.”

Despite all the evidence and experts involved in PBAC, there are still gaps and uncertainties in the information it must base its advice on.

This may be because something has not been measured in the evidence, or it is unknown how patients would value particular outcomes or trade-offs. Patients’ and caregivers’ lived experiences, preferences and needs can be invaluable when making sense of evidence.

For example, PBAC can see evidence about what happened to people on the clinical trials, but there may be important differences between you and the people on the trial, such as how and when they got the medicine or the stage or subgroup of their disease. And PBAC can see how the medicine compares with another medicine, but is there a more suitable comparator?

17 weeks from start to finish

When you submit a Consumer Comment, it is logged and blinded so the identity of the person who made the comment is not known by the PBAC Committee. It is then read by a Consumer Representative who looks for insights among the comments and groups them in themes. The Consumer Representative may have 1000s of comments to read in the four weeks before PBAC meets.

The Consumer Representative then summarises the insights before the meeting so that all committee members have access to these summaries alongside the evidence reports.

At the moment, there is no formal process for providing feedback on how useful the comments were or how they were taken account of when PBAC formed its advice. But, you can contact the Consumer Evidence and Engagement Unit or speak to a PBAC consumer representative once the decision has been made public.

Your (or your members’) unmet needs on the current treatment.

What outcomes matter most.

Differences in how healthcare/treatment is provided and what that might mean for patients.

Benefits of treatment (if you have tried it) or desired benefits (if you have not tried it).

Consequences of symptoms, side effects and benefits.

Consequences of rules for starting/stopping treatments.

Your usual treatment and if the comparator in the assessment is appropriate.

(e.g. was it hard to find expert clinicians, information, get diagnosis?)

(e.g. I could not work, I could not shop for food, my partner had to give up work to look after me so we both were out of work)