Comment

The focus on listings suggests a healthy and well-functioning PBS. How many people actually believe that?

The irony of proposed changes that will effectively eliminate Special Pricing Arrangements is that they will probably leave government with the choice of paying higher prices or denying patient access.

Dr Amanda Ruth says the Department of Health is taking "huge gamble" with the proposed new criteria for Special Pricing Arrangements.

The industry should worry less about the fatuous statements of the deputy prime minister and more about what will be included in the 'red book'.

Dr Amanda Ruth discusses some of the gene therapies currently in development, questions the use of cost-effectiveness, and whether different evaluation pathways risks inconsistent and inequitable outcomes?

"We must ensure we have the most fit-for-purpose evaluation process,” said Professor Andrew Wilson late last year, a phrase that could have been used by any industry leader.

There are hundreds of 'living therapies' currently in development. What will the PBS look like in a few years and what will the PBAC be doing if it is not given the responsibility to evaluate and consider these new generation medicines

In the first of a two-part series, Dr Amanda Ruth discusses CAR-T therapies and the need for change as current evaluation and funding pathways struggle to deal with the rapidly emerging wave of 'living therapies'.

Based on the experience of stakeholders subject to cost-recovery outside the PBS, surely the industry is entitled to ongoing performance reporting, review, assessment and measurement of impact, and even a commitment to process improvement.

What would stop companies bypassing the TGA and presenting new clinical evidence supporting use in new indications directly to the PBAC?

There will always be a focus on the tonality and language of the sector's relationship with the minister of the day. Yet once that is stripped away what probably really matters is the tonality and language of the sector's relationship with mid-level officials. The relationship, which is transacted through emails, telephone calls and face-to-face meetings, is where the key decisions over patient access are made. It is the relationship that really matters.

Is the obsessive insistence on confidentiality just trivialising the concept with fewer people taking it seriously? This is a worry for when something actually needs to be confidential.