The Silent Killer: Prevention is the next cure

We may have led you on a bit in the first two episodes... kidney disease is still a big problem despite the massive shifts forward in treating it. There is a long way to go to bring medical sectors -- and governments -- along as well. 

This episode features Breonny Robson, general manager of clinical and research at Kidney Health Australia and Richard Lipscombe, managing director of Proteomics International.

Transcript

Rachel Williamson: 0:00

It's episode three in our series on kidney disease, and we might have given you the impression the only way is up for patients of this condition. 

Sorry. This episode is where you get the reality check. I'm Rachel Williamson, and this is Phase III. 

The start of our series on kidney disease was pretty optimistic, wasn't it? Full of news about good changes that are driving new science, bigger investments, and an awareness that yes, we can fix this disease. Here is where we bring you back down to earth. There's been five years of biotech hyperactivity and 18 months of exciting drug approvals. 

But Breonny Robson from Kidney Health Australia says the way we treat kidney disease is still the same as it was 60 years ago: dialysis and kidney transplants. But Australia has run out of dialysis chairs. The number of people needing dialysis has doubled in the last 20 years. And Kidney Health Australia is predicting a growth in that need of 42% by 2030. 

Outside the lab, what this looks like for real people is unequal care. In the rural and regional areas that make up most of Australia, and even the outer city suburbs, people must travel for hours to receive life-saving treatment. Sometimes they must travel past their nearest clinic, and the next one, to find a seat. And they must do that three times a week, five hours a time. It's neither fair nor allows them to live a full life. And yet Breonny believes kidney disease still isn't a top 10 policy issues for government here. 

Breonny, thanks for joining me.

Breonny Robson: 2:06

Thanks for having me, Rachel.

Rachel Williamson: 2:08

From a research and a commercial perspective, there's been a turning point for chronic kidney disease around the late 2010s, which has boosted chronic kidney disease up the priority list for several governments, but you say this hasn't happened here. Why do you think that is?

Breonny Robson: 2:26

I think the situation in Australia, I would definitely say the tide is yet to turn. We haven't seen, large investment in kidney disease. In Australia, we have around 2 million people living with kidney disease. The awareness of kidney disease in the general public is very low and that has the flow on effects to, um, mean that it's often not a priority for policy makers.

Rachel Williamson: 2:51

What about the Australian National Strategic Action Plan for Kidney Disease that was signed off by the government in 2020? Has there been no real impact from that?

Breonny Robson: 3:04

Unfortunately, the National Strategic Action Plan for Kidney Disease was hindered a little bit by timing. So that was released publicly in March of 2020, which you would know is when most of the world went into lockdown with the COVID pandemic. So, the former government commissioned a number of National Strategic Action Plans across different chronic disease areas, and they've sort of been slowly completed and released. But what we've seen in the four years since then is that a lot of the initiatives within that plan have gone unfunded which has really limited the ability to get some of those things that have been identified, out there and into practice. 

The plan still remains relevant but what we really need is for those plans to sort of be taken off the shelf and the initiatives funded. And so the federal government has recently, they're doing a review of their chronic conditions framework, so we're certainly hopeful that in the coming next year or two we'll see some investment in some elements of those plans.

Rachel Williamson: 4:06

What kind of investment does the sector need, from your organisation's perspective, to really get the disease more onto the radar of not only policy makers and regulators, but also those primary health medical professionals? And I, I say this in the context of what I was reading today, which is that between 2015 and 2022 the Medical Research Future Fund, the MRFF invested AU$37 million into kidney disease research. That sounds a lot, but it's only $5 million a year for something that currently costs about $10 billion a year to treat.

Breonny Robson: 4:45

We know kidney disease research is underfunded in Australia. So if you look just on a prevalence level, kidney disease is about twice as prevalent as diabetes. But when you go and look at the research investment through NHMRC, MRFF over the last 20 years, it's about half the amount of funding has gone to kidney disease research. And I believe in the latest round of MRFF funding of the $400 million that was up for offer about $400,000 went to kidney projects.

Rachel Williamson: 5:17

Where do you think you'd get the most bang for your buck?

Breonny Robson: 5:21

Yeah, look, I think, um, the investment varies, it's, scalable. So the more you put in, in terms of investment, the more you're going to get out in terms of outcomes. So, even a relatively small investment, you know, around that $10, 15 million mark could actually make a huge difference.

So there's two areas, I think that, two to three areas that you'd get the most bang for your buck. The first one is investing in targeted screening for kidney disease. As I mentioned earlier, most people with kidney disease don't know that they've got the condition. You can lose 90% of your kidney function before you start to feel unwell and have any symptoms that mean that you go to a GP and say, I'm feeling unwell, and they'd go, oh, let's test your kidneys.

Rachel Williamson: 6:03

Before we get to the second item on Breonny's wishlist, I wanted to highlight what that 90% figure means. As a person loses kidney function, they also have more health events. So preventing kidney damage, isn't just about delaying the push to dialysis. It's also about protecting that person's heart. It's about preventing infections and stopping muscular disease. The blockbuster drugs we covered in episodes one and two can also treat earliest stages of the disease. But what Breonny and others are saying is we're simply not catching enough patients early enough. Back to Breonny.

Breonny Robson: 6:46

I think the second piece is around support for people living with the condition. And so in health, I think over the last 10 to 20 years, we've seen a real shift from being a very clinician-focused, clinician-led approach to health to patients being a real partner in their health care and looking at, um, you know, along with the medications and things that your doctor might give you. Um, what can you do as an individual to improve your health and improve your outcomes and understand your disease and why you've been prescribed medications and what you can do from a diet and lifestyle perspective to, to help your condition. And so there's a whole heap that can be done both at a policy level, um, but also at a program level there.

Rachel Williamson: 7:29

Such as?

Breonny Robson: 7:31

Um, so things like, I guess national pieces of work that it'd be doing are being done at the moment around policies for how do we tackle obesity in the Australian population? And that comes down to food labelling and sugar, and there's all sorts of things, um, that sort of go into that. Um, smoking and vaping is another area where, um, all of these things feed into a lot of chronic conditions and so if we start to work on some of those what we call primary prevention measures, then that's going to, um, reduce the number of people who experience chronic conditions like kidney disease.

Rachel Williamson: 8:05

Okay, that makes sense. What's your number three on your wishlist.

Breonny Robson: 8:11

The third piece is really that research bucket that you mentioned. There's a disconnect between the prevalence of the condition and the worsening outcomes. 1 in 6 hospitalisations is due to kidney disease in Australia. There's huge economic burdens, but we're not investing at that end that's going to lead to the treatments of the, of the future at a scale that is, commensurate with the prevalence of the disease.

Rachel Williamson: 8:38

What do you think actually needs to happen? What are you recommending happens from a regulatory or a policy perspective to support new therapies and diagnostics to not only be developed in Australia, but be made available to people in Australia as well, even if they are developed overseas?

Breonny Robson: 8:58

Yeah. So there's, um, I think generally, any new treatment or device or technology for patients with kidney disease is very welcomed and it's something that, Kidney Health Australia as an organisation is always really keen to get behind and support. There's been a whole, review on how new treatments are brought to market that's been underway, for the last couple of years. And so that is looking at some of those issues around how new technologies are. brought to market and some of the red tape.

Rachel Williamson: 9:27

That review would be the Health Technology Assessment, which wrapped up in May 2024. The federal government is still sitting on that final report. Breonny, what about among biotechs themselves? Are you optimistic about the prospect for more homegrown therapies?

Breonny Robson: 9:44

I think we're seeing some really good innovations in that biotech sort of space. Unfortunately, they, they tend to focus on the rarer kidney conditions and genetic kidney conditions, which is absolutely fantastic for people who are living with those conditions. Um, we know, though, that of all the kidney disease in Australia, um, it's around 8% are caused by these genetic conditions at the moment. So polycystic kidney disease is the largest chunk of that. So it would be fantastic if there were treatments out there or new technologies that could apply more broadly to people with kidney disease. 

Rachel Williamson: 10:19

What exactly are the numbers for the causes of chronic kidney disease here?

Breonny Robson: 10:24

In Australia, around 40% of kidney failure cases where people need dialysis or transplant treatment are caused by diabetes. another 13% is caused by high blood pressure. So they're two really big drivers of the disease. And it would be fantastic to see some of the innovation that's happening in that biotech rare conditions space come across into the more mainstream space because I think that's where we've got the biggest potential to make a difference in the disease, is if we tackle some of those really big drivers of kidney disease.

Rachel Williamson: 10:59

I mentioned in the intro, the lengthening wait lists for dialysis care. So wrapping it all together, what needs to happen to allow patients of all types of kidney disease to not have to rely on that dialysis ambulance at the bottom of the cliff?

Breonny Robson: 11:15

Um, I think one of the things that really needs to happen from that regulatory health system perspective is recognising that we can't continue on the same way that we have been because you can't just keep adding more dialysis chairs into renal units. So it's a growing problem. The system can't keep up. And so this is where from an investment perspective, we need to be investing in the earlier detection and new treatments and technologies that can slow down the progression of the disease so that we can stem the tide of people, reaching dialysis. 

And I think from a policy perspective, we've been for many years very focused on the kidney failure end. Particularly in First Nations communities, where we know that prevalence of kidney disease is up to about 18% of people. We need to take that focus away from just, providing better dialysis and more dialysis, and really looking what proactively can we do to stop people getting kidney disease, and if they have got it, to make sure they get diagnosed and have, um, You know, new medications and treatments that have hopefully been approved through the Australian system, um, that can really halt the disease in its track and mean that, you know, they don't have the high burden of kidney failure.

Rachel Williamson: 12:33

Breonny says we're focused on the kidney failure and of the cycle. And that this is where biotechs are aiming their drugs, even if those drugs can and do treat earlier stages of the disease. But earlier detection is what it'll take it to change patient lives says Richard Lipscombe, boss of diagnostics maker Proteomics International. But neither the money nor the science are quite there yet. 

Richard Lipscombe is the managing director of proteomics, a company whose mission is in its name. The study of proteins, the clearing of which is the kidneys' main job. For more than a decade, the company has been working on a blood test for diabetic kidney disease. This year, it signed a deal to sell it in Europe. The US, however, is proving a little more difficult as they try to work out how to sell a very new type of test for kidney disease. But the challenge is bigger than that. Why test for a disease early, at a stage when the health economics for treating it don't yet stack up? Richard says, few governments are willing yet to take that step. 

Richard, it's lovely to have you here.

Richard Lipscombe: 14:33

Rachel, great to be here as well. Thank you.

Rachel Williamson: 14:35

Now, proteomics was built on the back of PromarkerD, a diagnostic tool that measures protein biomarkers via a blood test to detect diabetic kidney disease in years before current testing can. But my understanding is that it may be unlikely to ever sell in Australia because of low reimbursement rates. What is it about reimbursement rates in the U S versus Australia and similar markets, that might put up other barriers to entry?

Richard Lipscombe: 15:05

Yes. Well, it's certainly fair to say that the test is likely to come into other markets ahead of Australia before Australia sorts its pricing out. It does make it challenging to sell here. We would never say it won't come to Australia. Advantage with a market like the United States is that reimbursement pricing is traditionally much higher than other markets. Europe is also considerably better than Australia. So as a novel test that we've invented, invested a lot of money in, in making. The cost of that is obviously significant, and we do need to be able to generate fair value

Rachel Williamson: 15:45

And what do you mean by Australia sorting its pricing out?

Richard Lipscombe: 15:49

I think it's fair to say that Australia has a reputation for not paying it's way compared to other countries. So whether it's the medical benefit schedule where the test like PromarkerD would come through or the pharmaceutical benefit scheme where drugs come through, Australia does have a reputation for paying less than the market rate.

Rachel Williamson: 16:08

Is this meaning that particularly in kidney disease, Australia is not able to access diagnostics and new drugs in a way that other markets can?

Richard Lipscombe: 16:20

I think the risk is that some of the new drugs come through more slowly or the new tests like ours not target Australia as a first market. So it's not that they won't get here, but that will certainly get here, not as a first choice. And I think that's obviously disappointing.

Rachel Williamson: 16:37

Chronic and diabetic kidney disease. They make up the majority of renal disease globally and they're costing a fortune to treat. Are you seeing a concrete shift amongst policymakers in the markets where you are operating, or hope to operate, towards preventative care for these particular lifestyle diseases where, diagnostics, like PromarkerD will really, really have an impact?

Richard Lipscombe: 17:04

We're seeing an awareness of the benefit of longer term intervention, so longer term policies, but nothing's current. So in many cases, an awareness that diabetes is going to cause kidney disease and kidney disease is going to cause dialysis down the track. It's great that that conversation has now started, but talk has not really caught up with the reality. So, we haven't actually made the change yet. We started talking about it and countries like the United Kingdom and the USA have really started doing more. They're talking about this as a public health emergency in the UK. So they're talking about needing to intervene sooner. And so that's a great start. Actions haven't yet caught up. Even in the UK, they're talking about bringing in better testing, earlier testing, but they're still using a 50 year old test. So that's a little bit contradictory. Australia's really only just started that conversation. So we're a little bit behind.

Rachel Williamson: 18:01

So you're really hoping to land your commercialisation efforts, in these overseas markets, at least at a time when this conversation is really beginning to bear fruit. I guess it wouldn't have really been worth it in some ways to, to get there a couple of years earlier.

Richard Lipscombe: 18:17

Yes, quite right. In fact, there's two, two elements of that. One is the awareness. And so, um, we were a little bit ahead of time in recognising this is a really serious issue. Obviously, our clinical team, they really understand where diabetes is at and the problems that that's causing. Policy's just starting to shift. There's the other benefit, which is worth touching on now, is that there are new drugs that have come onto the market for diabetic kidney disease that didn't exist three or four years ago. When we first developed our test, we could predict who was going to get chronic kidney disease in three or four years time, but there wasn't a pharmaceutical intervention. There was a change of lifestyle that we could recommend, but not pharmaceutical change. Whereas now there are drugs that have been approved in the last couple of years. So now there's a policy shift to recognise that a predictive test like ours or early testing would benefit, and then there's something we can do about it.

Rachel Williamson: 19:07

Now I understand one of the key shifts in, policy and regulatory attitudes was the US Federal Drug Administration, the FDA, accepting a surrogate endpoint for kidney related treatments. And for our listeners, that is a marker, if you like, that indicates the drug is working that you find before the clinical endpoint, which might be, say, a cure. Now, this surrogate endpoint was proteinuria. What impact did that have on drug development and diagnostics like yours?

Richard Lipscombe: 19:39

So there are a number of different ways of measuring kidney disease. From our perspective with a diagnostic is that these tests are really quite, archaic. They've been around for 50 years and they're not very accurate. So one of the benefits of more awareness in this area is that predictive tests like ours, which can do much more subtle, indications. And as you said, our tests can pick up the disease three or four years in advance. We've been working with drug companies to see the benefit of their drugs on people who actually don't have kidney disease yet. So you can imagine a scenario where they have diabetes, but they don't have kidney disease, can we predict who's going to develop it in the future? And can we put them on drugs early so that they won't even go down this path? So there's a range of areas that are coming through. And so from our perspective, it's, it's nice to see these advances.

Rachel Williamson: 20:24

I'm going to hit pause here. The tests that Richard is talking about are for albuminuria and eGFR or estimated glomerular filtration. eGFR tests how well your kidneys are doing at filtering. Albuminuria is a sign a kidney is damaged because it's letting a protein called albumin enter your urine. These tests are widely available and cheap to do, so they can highlight chronic kidney disease. What Proteomics wants to do is test for disease well before it's doing damage. Richard, I'm keen to know what kind of policy lessons Australia might be able to learn from the US and the UK?

Richard Lipscombe: 21:08

Yes, there's a few different areas there to look at. When we look at the American system, the first areas that they look at for early adoption of a test are, is it safe? Then will it save money? And that's led to us achieving a reimbursement pricing in the US, which is potentially US$390 a test. So that really gives an indication of the value that the assessment committee was able to say, well, this test is clearly worth a lot of money because we'll stop people having to spend A$100,000 a year  on dialysis into the future. So you can do the maths and you can save a lot of people's lives going down that path and improving quality of life. 

And it's a similar approach from the UK, where they have their advisory groups that brief the UK's National Health Service as to what could be done. It would be nice to see Australia start to look at these things in the same way and bring these different elements together, meaning how much money we're going to save in the long term and then how we're going to fund it in the near term. And actually get on and do that rather than let the problem effectively drift or kick it down the street for somebody else to deal with in 10 years time when potentially it will overburden healthcare systems.

Rachel Williamson: 22:14

That was Proteomics' managing director, Richard Lipscombe. Policy makers are inching towards the preventative medicine dream, at least in kidney disease where the current options are the drug dialysis and transplant ambulances at the bottom of the cliff. Can governments get there before patients start dying from not being able to access dialysis? We don't know yet. What we do know is that the future could hold some very different solutions to those we've covered so far in the series. Join us for our final episode, as we explore the blue skies of what could happen in the next 20, 40, and even 50 years.