Andrew Laming (Bowman, Liberal Party) Share this | Hansard source

This is an important debate which throws into the spotlight exactly how the PBAC system works. Cystic fibrosis obviously is the most common life-limiting autosomal recessive disease, certainly for those of European heritage. For a long time there has been very little help available apart from supportive care. One hundred years ago, it was almost certainly a life sentence in the first few years of life, and now, thanks to medical advances, we have life-lengthening treatments like the ones we are debating today. We have a very proud PBAC system, which the rest of the world looks at with envy. We were the first developed economy to put a cost-benefit calculation on every new drug, comparing it explicitly not only to the nearest comparator but also to the dollar benefit achieved for each investment of the PBAC. This is a very broad but utterly fair intersectoral way of comparing new pharmaceuticals and their entry into the Australian system, which, while relatively small on a size basis, allows very rapid penetration and accessibility to the patient cohort once a drug is approved.

Whenever the PBAC considers a drug, it looks at all the evidence provided by the manufacturer and then makes a decision on the benefit to our Australian population as a result. As the previous speaker, the member for Oxley, said, we are increasingly seeing large-ambit, non-cost-benefit-related price claims being made by manufacturers. This causes a great deal of frustration for the general population, who think it is government being reluctant to fund as opposed to there being two parties, only one of whom is using an evidentiary base for deciding the price that we pay per patient—and that of course is the PBAC itself. There is nothing stopping a proponent from coming with a price per patient of one, two or any multiple of what has been decided on a cost-benefit analysis. But increasingly where a drug achieves a life-extending or life-saving ability, it does become more complicated because we are not considering a QALY, a quality-adjusted life year, but trying to measure life itself, and that is increasingly hard.

Up until now we have had million-dollar orphan drugs that were used in such rare circumstances, or biospecific drugs that were only used in particular patients, and we could contemplate these on a case-by-case arrangement. But increasingly we have moved from the 2000s and the era of the blockbuster drug, where you could euphemistically say that adding it to the water would benefit the population. It was almost impossible to measure the tiny gains in cardiovascular survival by giving a drug that appeared to help virtually everyone over the age of 40. Those drugs have come and gone and are in the system. We are seeing the new biospecific drugs that can help a very tiny proportion of the population but have absolutely transformative impacts, and this is one that we are discussing today.

There is no doubt we would love to see a resolution, but we can't move away from the system that until now has served us extremely well. To suggest the minister intervene may be wishful thinking but, ultimately, the experts in the field are commissioned to do this work and to come to an agreement. I do hate to say it—and I say it without the other protagonists in the room: if an agreement can't be struck, it is simply because typically there is no agreement on the specific cohort to be treated, or the amount sought is larger than every agreement we have ever drawn up for patients with different conditions. We have to be a little bit dispassionate here. If they are going to strike a deal with other countries and keep that price confidential, it will be hard for Australia to be blamed when we do not see the rapid approval of a drug here.

I go back to why cystic fibrosis is so important. This is a condition that starts early in life with the colonisation of small airways in particular, and other parts of the body, with infections such as haemophilus and strep. As one moves past the teenage years, pseudomonas and other more complicated infections can have an incredible impact on life. While many of those suffering cystic fibrosis may be infertile, they are not sterile. And there is now the potential to have children through assisted technology. So now, increasingly, we need to be able to screen for this recessive condition and give parents information. It is very expensive to do the screening. So, typically, we do one parent and, if they are positive with this recessive gene, a second parent is offered that screening. While it is tempting to have other parties, including the minister, intervene, this system has stood very well. We need to be careful that, if we do intervene, we do not end up with a deal whereby every other current agreement will then need to be renegotiated.

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