The 'Dispatched' Week in Review'- 2 April

In this week's episode, the discussion focuses on Health Minister Mark Butler's address at an event in Sydney and its invocation of history as the framework for pending negotiations over HTA reforms and PBS pricing. Also, strange comments by one senior official about evidence in healthcare decision-making send a clear signal about some of the thinking that might impact the next one to two years. 

Transcript

Paul 0:08

Hello and welcome to the Dispatched Podcast, Partial Week in Review. My name is Paul Cross. I'm delighted to be joined by Felicity McNeil, PSM, Chair of Better Access Australia, amongst other things. How are you, Felicity?

Felicity 0:21

I'm pretty good, thanks, Paul. Yourself?

Paul 0:24

I'm looking forward to a nice long weekend. Yeah.

Felicity 0:28

Am I allowed to say happy Passover? You don't say happy Passover, really, do you?

Paul 0:33

Uh well, no, no, you tend not to say Happy Passover, you say Chuck's Shemuk.

SPEAKER_03 0:38

There we go.

Paul 0:40

Uh, which is Happy Passover in Hebrew. So, yes, the point is that you do say it's fine to say Happy Passover.

Felicity 0:50

Excellent.

Paul 0:51

Uh and you've got Easter.

Felicity 0:53

I do.

Paul 0:54

I suppose we all have an Easter long weekend.

Felicity 0:56

Well, I do feel that people tend to, you know, culturally appropriate that for the um the eggs, the public holidays, and the hot crossbuns.

Paul 1:04

Definitely, definitely. Uh short week, but big week.

SPEAKER_04 1:10

Yeah.

Paul 1:11

And we can't have this discussion without focusing on Mike Butler's address earlier this week at the AFR Healthcare Summit.

Felicity 1:22

Yes. Shot across the bow, line in the sand.

Paul 1:27

I described it as firing the starter game. I think once you it was it was subtle, maybe a little bit too subtle, but to me it was very clear. I wasn't even there, I just got the transcript and it was just instantly, oh at least basically saying we've been doing this for 25 years, and I expect that to continue. Which I don't think is unfair. We can argue the rights and wrongs of the regular assaults on the PBS, policy and pricing assaults. I think certainly 2023 has had a very negative impact on the program. We can talk about the genesis of that and why that happened and the contributors to that. But I think Greg Hunt secured, what, 10 billion in three iterations over five years? Not unfair after four years for Mark Butler to suggest it's time to have a look at the program. And and how he did it was quite clever. He talked about the significance of the program in public health, he talked about the technologies, he talked about its contribution, vital contribution to the economy and things like productivity. He then went all the way back to my time as an advisor. The 2002 Intergenerational Report, which is obviously a completely made-up document, but it did predict this doomsday scenario. Without consulting health, Treasury did it, predict this doomsday scenario for growth in the PBS. He said the second IGR report predicted much the same thing, which didn't quite. They were starting to walk away from those predictions pretty quickly. And then he said actually spending on the PBS as a share of GDP is less than what it was in 2002. He conceded that that's after reboot, so he conceded the fact that rebotes are a very big line item these days. Over six billion dollars. That was not a confession, it was a boast. Because he then went on to say we've worked together. Successive governments have worked with the industry to build in these permanent rolling price savings policies. So what he was doing was saying this is a critical public health program, it makes a vital contribution to the economy, to productivity, to human health, and we've been able to continue it because we've worked together over decades to make it sustainable. It was a boast. Haven't we done a great job? And that to me was the firing the starting gun to the next close look at the program.

Felicity 4:29

Yeah. I I think what jumps out to me is that AFR Healthcare Summit 2026 wasn't a biopharma dispatch or BPD Insights conference, which I know will be predominantly focused on the PBS. It wasn't a Medicines Australia event at Parliament House that will be focused on the PBS. It wasn't a GBMA event at Parliament House focusing on medicines access. It was an AFR healthcare summit for the entire healthcare system, public, private, aging, um Yeah, aged care, disability, everything. It was all of it. But what did um our beloved minister choose to talk about? He decided to make his speech about the PBS. Yeah. In a room full of A lot of industry people there, eh? I I appreciate that. But it wasn't a medicines event.

Paul 5:26

No.

Felicity 5:27

It was a healthcare event. The minister chose to, as you rightly said, fire the starting gun to make it very, very clear that when you're talking about, you know, system overhaul and cost and aging and sustainability, the place he's coming after is the PBS. And I do note that, yes, he mentioned the rebates, and that's good, that's a smart thing, because I know that people have once again picked up that um the US has, you know, included in their their usual statement about their concerns about the PBS from an industry perspective, the the number of 100% rebated medicines there are on the PBS. So that was just good strategic management. Say something so that your arguments in this broader conversation cannot be taken down, as in you're not allowing for this. And he was quite clear that that's exactly what he's allowing for. So yes, I I am with you. We all know that as of 1 July this year, um, the current agreement says that the parties can start to discuss the future of what may or may not be uh included in a future agreement. Um yes, he talked about these structural policies that are in place um that have been agreed to since, you know, feels like time immemorial. But yeah, it it kind of made me laugh, actually, because that's what he chose to talk about. And so yeah.

Paul 6:57

He could have talked about aged care, he could have could have talked about disability, he could have talked about public hospital funding, he could have talked about his beloved Medicare urgent care clinics, he could have talked about all of those things. What he talked about was PBS sustainability.

Felicity 7:12

As in PBS savings.

Paul 7:13

Yeah, sustainability is one of those words, it's a trigger. Now, it was subtle, certainly more subtle than the speech you wrote for Susan Lee in 2015 when she went into that Medicines Australia annual parliamentary dinner with a piece of four by two and smashed them between the eyeballs. They didn't quite get the mess, they got the message but decided not to act on it. Uh, I think this is pretty clear what he's doing, uh and I think it's an opportunity for everyone. Remember, this is a government that doesn't necessarily sit comfortably on the corporate health spectrum with the pharmaceutical industry. They have not gone after the industry over their four years. They tolerated people might forget that the first six months of this government was the industry threatening to remove medicines from the PBS.

Felicity 8:16

Uh with officials saying they say this all the time, you'll be fine.

Paul 8:21

Yes, now m I d I don't think there's been any punishment for that. Uh there were some one-off minor outbreaks, but I think he had every right to be pretty cranky about that. Uh but that hasn't happened. So now he's saying, right, well, now we need to sit down and talk. And obviously he's landing, he's pushed the HTO review beyond this budget into next year.

Felicity 8:47

Yeah. And he's landing publicly done that.

Paul 8:51

Yes, yes. So he's landing all of these things together. Now is could there be something in the budget? Yeah, of course. Of course. But I do think just from a policy perspective, that after four years opportunities build within a system. Opportunities And that could mean efficiencies, i.e. savings opportunities, where the government can have a look and say, we need to move this money within the program. And you you always describe I'm not gonna use your own language, but you always talk about action, reaction, action, reaction.

Felicity 9:28

Yeah. It's it's it's very common. It's it's the reality. You you introduce a policy and uh the the suppliers adjust to it accordingly. Some of it they comply with, some of it they work out where we've left a gap. Combination therapies are probably one of the biggest areas of consistent reform over the time to always get the system to catch up with that area. Um and well done to the companies over the years who would went, well, work that one out, and that's fine. That that's absolutely the way it should be. So look no one in the industry should be surprised if you've got a five-year agreement, something will come at some point.

SPEAKER_00 10:10

The expiry. Yeah.

Felicity 10:11

And you know, we you do have to remember if we're going back to the Founding Fathers principles that uh this government always likes to talk about, they were the first War for Medicines Australia in agreement. They it was a Labour government that started the concept of the memorandums of understanding. It was something that then the coalition government continued with. So um there is bipartisan approach to this, but actually it was a Labour government, and it was a Labour government in which um the current minister was a junior minister for the therapeutic goods administration.

Paul 10:46

And and the the MOU was a reward for the industry, in effect. Because the industry had been very productive and constructive. Certainly the research-based industry had been a good partner with government dating back to the sort of the mid the mid-sort of 2000 to 2010 period. And the MOU, if you if you look at the current pricing agreements, because they're not they're called strategic, but they're pricing agreements, and you compare it to the MOU, they're very different documents. The MOU was a very policy-focused strategic document.

Felicity 11:24

Yeah, now they're much like the UK pricing agreements or what the the Germans are now introducing. So I guess is it a reward? Um those those agreements came out at a time during the global financial crisis. There was a jealousy within the innovative sector that the guild has this amazing agreement and they do all these deals, and we want that kind of thing, and we want that kind of protection. And so then became the piece of paper itself has become the raison d'etre to have an agreement.

Paul 11:56

And I think that Well, I think the MOU was a reward. I'm not saying the current agreements are the rewards.

Felicity 12:02

Yeah, no, and so what I was getting to is that it has become a misunderstood document over time, which is it's the ownership of a piece of paper that is the outcome, as opposed to the content and what is received out of it. And as you've quite rightly pointed out, since then, they have predominantly become pricing agreements as opposed to strategic agreements, because what has the sector asked for in exchange? So the traditional model, and and you've written about this a lot over the last you know four or five years, that sometimes government's just going to do something to you anyway, and you don't have to agree to it. You can just say, that's your right. You can do it, but we don't agree to it. That's it's not in the best interest of our sector. Alternatively, there are times when you can say, if you're going to do this to us, this is what we must get in return. You actually use the the opportunity and you decide whether you can get something for that incurred cost. I think I, in you know, reading Mark's speech and in reading a number of speeches at the Diabetes Summit this week as well, and uh the minister's language and officials' language about how unaffordable this is and how industries always ask for stuff, whether it's uh the medicine sector or the technology sector. The mindset that is being taken in readiness for this is um I I hope that the sector has been spending this for years coming up with ideas and policies that are actually patient-centric. Because what also really jumped out at me in listening to the diabetes conversations was the patient was an afterthought. Oh, we're we're also patient-centric, but this is what the GPs need, and this is the problem with HTA, and this is it. And this is actually when I read Mark's speech, we're about to go to that. That message was not to patients, that message was to the supplier purchaser arrangement, and the patient is going to be an afterthought.

Paul 14:10

It does amuse me, no end, when governments and their officials establish and maintain a system that creates a purchaser-provider institutional framework, and then they complain about it.

unknown 14:25

Yeah.

Paul 14:25

You take this role for yourself, so don't whinge about it when people seek to engage with it. The idea that somehow Well, you know, one official, I understand, basically questioned the veracity of industry industry-sponsored clinical trials.

Felicity 14:41

Well, we can get to that if you want to.

Paul 14:42

I mean, I I with uh Okay, we'll get we'll get to we'll get to that a little bit later because that just amuses me no end. But if you create a system, don't whinge about it when when people seek to engage with the system that you created. For me, I'm glad that Mark Butler said what he did because it was inevitable, and you and I have been saying it for some time, this was coming. That they were going to land all of these things together. The opportunity now is to put forward some good ideas. It's an opportunity, it's not a threat. It's an opportunity to put forward some good ideas and win some credibility. And by doing that, you you avoid, you avoid potentially you have you have the opportunity to avoid what happened in 2023 when what was a maligned administration of the program wanted to seek revenge for what happened in 2017 to 2020 and the savings shortfall. And they did it through a very clunky policy proposal, uh which was not well handled by the industry, but it was one that has done harm to this program, enduring harm. And I don't care what anyone says, the fact that the industry has lost hundreds, if not thousands, of jobs in the last three years is a bad thing. It's a very bad thing. Well, if it's not a bad thing, it would be the only industry in Australia where it's considered okay for there to be mass layoffs. And and I and I don't think even government believes that it's a good thing. Because that reduces the industry's capacity to support the health system. And supporting the health system means a lot of different things, including supplying the medicines. So because supplying a medicine into the PBS is not just a matter of dropping it off at a distribution center.

Felicity 16:33

Oh yeah, ask the former Faz who became the responsible person.

Paul 16:36

Yes, yes, yes. How much that got stuffed up. It's a very complex and a high cost task. So I want to avoid that for the sake of the program. Uh as an Australian, uh this the health of this program is critically important to me, as it is to other 27, 28 million people. So this is really important. So it's an opportunity for good ideas. That's that's how I see it.

Felicity 16:58

Yeah, look, and it's savings. I you you've talked about the delay in the the HTA implementation groups, outcomes, et cetera. And you know, that that's a classic. Hold it out, as the minister has articulated, even though you plan to do something, because you will do a horse trade if you want this, this is what it will cost. This is what you have to buy. This is what it costs to buy.

SPEAKER_00 17:18

It's very obvious.

Felicity 17:19

A litre of petrol.

SPEAKER_00 17:20

Yes.

Felicity 17:20

Um, this this is what you're gonna you paid it to purchase that. So and again, I think the see is as a patient and as someone who works with patients, I don't want the outcomes of the HTA. I don't want you buying with price cuts more HTA for me. I want you buying better access to the biologics. I want you buying me um better access to medicines for chronic diseases that are continually. So, you know, I I I had to laugh at Mark's statement that these days we just do these highly specialized medicines. We don't do big, broad listings like statins anymore. No, because when we need it for migraine and we need it for um broader, you know, arthritic and musculoskeletal and um gastrointestinal issues, we we don't allow you to list it. We we won't expand the indications. So um I I found some of the messaging in that quite disturbing because it was becoming between the purchaser and the provider. And I'm telling you, a lot of patients with chronic disease, just like the patients who are not getting access to CGM in uh support at home anymore, or those that are, you know, doing that budget submission and an event that you and I also went to. Chronic disease is actually what is really concerning people in the primary care space. And I'm I'm very nervous that this is going to become about, well, we'll accept this price cut. You know, we know the statutories in F1 automatically expire, so we'll we'll reagree those status quo. And for this, we'll want a new process for one medicine. And if you ask patients what they need and what they want, that that single trial pilot for one molecule for its first indication is not going to change the lack of access in the PBS and in the broader health system for people with chronic disease. Trevor Burrus, Jr.

Paul 19:22

The Minister was articulating a choice, not a technological fact. So our system has chosen that it's not going to fund chronic conditions the way previous governments did for statins. Now, in fairness, it did take ten years to really broaden the access to statins. But it did happen. It's hard to see a credible path for that happening here. And we'll get to the BD Mard situation. But it's a it's a choice they've made. Now, asking for more HTA is like asking to put hemlock in your drink to me. It just makes absolutely no sense. And I don't know how much more evidence people need to realise that more HTA, which is what you're getting, which is what you're on the verge of getting, is going to make it worse, not better. And when I hear the minister get up in an event and say, m effectively on HTA, my goal is nomenclature. So three years ago he was saying our HTA systems are killing people unnecessarily, these are avoidable deaths. Now he says we just need to change the definition of these things.

Felicity 20:31

Change the definition of death. So voluntary assistant dying in a whole new.

Paul 20:37

So they're discounting, discounting, discounting, lowering expectations, lowering expectations, lowering expectations. And he's finally publicly connected all of these things together. Which I which I think is important. As I say, you know, I have known this was coming. I did I think he would do it this week. I didn't think so because I didn't realize it was a PBS summit. I know it was sponsored by one of the GLP1 companies, so that's so he obviously wanted to honour that. He didn't have to. He could have talked about everything else. I mean, I think it was you that said to me many, many years ago now, everything happens for a reason. Like he sits down with an advisor, he talks about this event. Do I have to do it? Yeah, you've got to do it. Okay, so what's the opportunity? Well, there's going to be a lot of industry types in the room. Right. So what message do we want to communicate? He doesn't just sort of decide the day before, hmm, I think I'm going to talk about this. This is something they've gone back and researched the 2002 IGR. This is a document that would be pretty hard to find online on the Treasury.

Felicity 21:37

I've got to say, I don't think they reach it. I think they just listened to your podcast or use your AI. Yes, yes.

Paul 21:42

I mean, it's to me, it's like this speech would have been prepared over several weeks. And it would in an iterative process where the minister has an objective. I want to communicate something here. And I think that's that to me is really, really critical. And the reality is that this is part of a strategic continuum. This speech could have been given twenty-five years ago, twenty years ago, fifteen years ago, ten years ago, five years ago, and in fact it has been. It has been consistently given. So he's established the framework for a discussion. People don't like it. People misinterpreted it because they don't understand government. I get it. I think people, thanks to some maybe some steering from people such as myself, but not just me, now understand what he was saying. You can believe what you want to believe. But when he says spending on the PBS is lower than forecast and lower than it was in 2002, that is not a concession, is a boast.

Felicity 22:43

Absolutely it's a boast. As a man who's also in charge of the NDIS, the MBS, and I you know, we can talk about I know we're going to get on to some of the other stuff that was said in the Parliament this week, in particular, a particular head of our HTA body lamenting that the MBS just people are abusing these numbers and oh they claim the MBS items when they shouldn't. You know, everyone's coming after the system.

Paul 23:11

So yeah, it uh well can I just say that the day after was it the day after, maybe two days after Mark Butler gave that address where he did what a great what where he said what a great job we've done working together to make the PBS sustainable and we've got to continue doing that. He announced a listing of all these medicines. So so so some people took away from that address that he was conceding that the program's in trouble, we need to invest more. Two days later, he issues a press release and four companies announcing new PBS listings, and four companies sent press releases to me congratulating the minister and the PBOC and thanking them for what a great job they've done to get these medicines on the PBS.

Felicity 23:56

You bloody fools.

Paul 23:57

Well, it's it's no, but it's like, well, what message I get I get why you're doing it. I think I get it. I get part of the reason you're doing that. But I also understand that you've got to that the the Mark's gonna look at that, sorry, the minister is going to look at that and say, huh. So I'm doing I'm actually doing a good job. And I think that's really, really critical. It is very hard for a company, I know, to say we're not gonna issue a press release. But I don't think there's anything wrong to issue a press release and say, This did take this long.

Felicity 24:34

Yeah. I wish it hadn't taken 1,220 days.

Paul 24:37

Yes, yeah. And and and even at the CF event a few weeks ago in Parliament House, which was really good, with all the politicians boasting what a great job they did to get these therapies funded. That was Yeah, okay. The fact is that we we were the one of the last most relevant countries to list a lot of these medicines. That is a reality. And the last one was listed quite quickly because there was no cost to the system, the price was pretty much already sorted. So as in the the name of the one the one I can't pronounce, but but but I think I think we've gotta you've gotta take a step back and look at the system holistically. And I say again, he's invited you to put forward some good ideas. And and I I think it's an opportunity. And yes, put forward ideas that lead to more spending, but also be realistic that you're gonna have to put forward ideas that are reallocated within the program. And I think that's entirely fair.

Felicity 25:48

Yeah, well, I mean this it's just I think the system's got into the because it's always focused on the process and everyone thinks that they've got the one drug that will be the one that's in the pilot that will prove the you know the high clinical need. And we've talked about that with you know the pricing framework and you know when you know JPixant, I'm gonna name it, JPixant got relegated to a category D because you know we've got cyclosporin on the PBS. In the 70s. Yeah, to to treat these kids. So what's the what's the rush here, Peeps?

SPEAKER_03 26:19

Yeah.

Felicity 26:19

Um I I I get really concerned because it's a bit like also this week we saw what was um at Monash University, they were celebrating 30 years of HTA in Australia, and all the people that started on HTA in Australia were there saying, Isn't it great? Look at what we do. This is wonderful, betting it down, and like I said, reading all the stuff from the diabetes summit and the doubling down the it were mostly the same people who attended the 10-year anniversary. Yeah, no, they were there when it started. They were all there. Like it was just come on.

Paul 26:55

Can we just get some people Yeah? I won't get there.

Felicity 26:58

I thought it was quite funny because I uh did hear from people that obviously that um that one of the current chairs of uh committee extolled the virtues of of co-pilot and AI, and here we have her committee. Yeah, I'm giving it away. It's like, oh, we have to really think about how we use it.

Paul 27:16

We're gonna do a pilot in two years' time.

Felicity 27:19

But um just goes to show you how replicable HTA is. If you can actually get co-pilot to write you something the day before, then what on earth do we need all these committees and all these um HTA analysts? Well, but anyway, I I you know that's my view.

Paul 27:32

AI should replace.

Felicity 27:34

Well, my my broader issues I don't actually understand. And it was some of the things that I was reading again in the in the diabetes space where you know we we we can't trust that you know these medicines are you know are safe and work. I'm like, well, what's the TGA doing? Like, you know, read read the minister's stuff on that too, that's why we have this. And I'm like, well, did he want to talk to the TGA about apparently what they're spending all their time and effort on to actually register register a medicine as safe and uh in uh and appropriate for you to be able to do that?

Paul 28:03

Well though we are going to talk about those incredibly callo reflections of one official. Yeah, but I just be polite and calling them callo too.

Felicity 28:11

Yeah, very much so. But there is just a the upside of actually having the opportunity to be strategic, which I think you and I are sometimes blessed with a bit more time to do it because that's our job. But reading the minister's speech at the AFR, reading the minister's speech at the diabetes summit, listening to the conversations that took it place in you know, 30 years of HTA, woo-hoo, how many patients still waiting? Should have actually been the title of that thing. How many patients have missed out under this time frame? Going to uh the event of the Parliamentary Friends of Public Health, going to read the statements from cla clinicians, from patients and from officials and uh HTA body leads at the diabetes summit and seeing how it's all coming together about, you know, government officials good, suppliers bad. And when we take that as the basis of the conversation, the I found it quite distressing reading some of this because inferring distrust, placing fear in patients' um uh sense of the medicines or the technologies that they might have access to. And then the artificial construct of this, we need the perfect data solution to actually finally tell us we can do something. And as one patient said, uh, it's really great that you finally got some evidence, but we've known all this for a long time. We live it every day.

Paul 29:50

And this is Well, what did the officials say about industry-sponsored trials?

Felicity 29:55

Ooh, let me get to that one.

Paul 29:58

Because this person has just talked themselves out of a job, as far as I can tell. Because the whole system is premised on privately funded trials.

Felicity 30:08

So his person says, um because there's someone had asked a question about what we need uh for the system to succeed. And so I'm gonna read verbatim. Can I start by saying that something you mentioned in your introductory remarks stuck with me? I just wrote down you said we need three things advocacy, innovation, and compassion. Can I add a fourth? We need evidence. Because a lot of what the government sort of does doesn't with evidence, doesn't fit into these three things. And I think it's necessary if we're going to solve all the problems that we would like to solve. We have to make sure that we're putting focus on the ones that are most impactful for the community. And the only way we can work that out is through having good quality evidence. And so a big part of the work of government is to try and uncover that evidence and make evidence as broadly available and then use that as evidence for basis for action. Then we move on to about this in individuals work on a project to link all data from the PBS, the MBS, uh various other systems, and said we need to understand the impact in theory and practice associated with interventions. So usually at the time when innovation new innovations come into the system, there's been various kinds of trials that have been run, and there's evidence from that. But the trials are usually run by the proponents of those medicines or treatments or CGMs or whatever it is, and usually in practice they don't have the same impact that they do in the trial. It's not always worse. It often is, but it's not always as beneficial as a better way to say it, but it is often different. And so we need to look back at back hard at the evidence and we know the evidence tends to translate what's in practice, and then we need to go to the real-world evidence and comes out of use and ensure that the way in which we are encouraging people to use different treatments aligns with their real world impact. And some interventions just aren't well tolerated by patients, they may not follow them as well. Others might be well tolerated, and as a result, even though they might be initially seeing less advantage advantageous in practice, they appear more important. We need to balance these things.

Paul 32:11

Yeah, so there's a lot of words stuck together that doesn't really lead to sort of a coherent argument. But I think what they're arguing is there that we don't trust the evidence we're given.

SPEAKER_03 32:25

Mm-hmm.

Paul 32:26

The whole health system and the whole institutional framework for health technologies and much health policy, certainly at the Commonwealth level, is premised on privately funded trials and created evidence. So should we just get rid of the TGA? I mean, is that is that I I don't know. I don't want to be unfair to this person, but it's just it's a completely incoherent argument that goes fundamentally undermines the institution institutional framework they administer.

Felicity 32:58

Well, yeah, but then they've gone and say, but you know, because the evidence is just all over the shop, this is why we need the PBAC and MSAC to bring together health professionals, health economists, and patient advocates and industry experts to debate the evidence and weigh that in order to come up with recommendations about which are the right things for government to fund and how they can be best incorporated into our medical system. And I find this hysterical because this official has mentioned CGM earlier, CGM, which MSAG has never agreed to actually put on the system. Um they've also then misrepresented its expansion, saying it was only because we went to tender that we were able to double the number of patients. Well, actually, no. Then Minister Hunt made an election commitment and said, I will provide better access to CGM for all type 1 diabetes. And then after it was listed, they then went to a tender to try and make that more um cost-effective in in some respects, or just cheaper to on a on a price-volume arrangement. But again, it was something that really showed to me how different bits of the system that they're taking excerpts here and there, and then they're putting it all together and sending this thing, which we we just can't trust you. We cannot trust you to give us information, we cannot trust patients to know what they need to use properly. I mean, there are other statements in there about you know how it's really bad because clinicians can just, you know, use the MBS schedule and just claim those item numbers, and we just don't know if they're doing it honestly.

Paul 34:22

Like what sometimes it sort of doesn't make sense intellectually. Not that not not that we should be surprised, but evidence is by its nature a highly subjective thing.

SPEAKER_03 34:34

Of course.

Paul 34:35

But so is the interpretation of that evidence. You know, the evidence that he's talking about is contested via mainly contested via economic models that are highly subjective and open to interpretation. They are not perfect. They're not even close to perfect. They are I suppose you could describe them as educated guesswork. And the people who assess those economic models, these sort of advisory committees, have no particular expertise, no particular expertise to to um to assess that evidence. What's more those HTA advisory committees are not legally or institutionally required to solely assess the evidence. That's not their job. Their job is to get a good price and to manipulate the evidence to deliver that outcome.

Felicity 35:37

And and that's to me, which is with everything that's come up in the last you know decade or so, and the frustrations and the time delays, it it is just about the price. So could we just stop artificial construct of these long, arduous HDA processes and you know, notifications and then resubmissions, and then you know, two, three years later, can we just sit there go, You're unhit right? Let's let's just sit down and talk for us.

Paul 36:05

Well, but but but but that particular official has redefined the term evidence 25 times in two minutes. I mean, there's constantly presenting evidence in these different terms. I'm I'm I'm just gonna say I'm gonna be unkind, but if that's the level of thinking that's influencing this system, we're in real trouble. We are in real trouble. Are we really going to have a discussion about sponsor-run clinical trials? I mean, really? I mean, that's a discussion from 40 years ago. That is settled. Globally, the world accepts sponsor funded and driven and constructed clinical trials. That's accepted. Our entire health system is premised on it.

Felicity 36:50

Yes.

Paul 36:50

So I don't know why you're introducing that other than as some sort of stupid reflex device to undermine calls for particular things. What he's essentially said is that, well, the decision to fund CGM for type 1 diabetics was a mistake. Because there was no evidence to support it because MSAC didn't recommend it.

Felicity 37:08

Exactly. But that's also where I was concerned, because he said that the only reason we got CGM for type 1 diabetes was because we ran a tender. But it's like, no, that's not true at all.

SPEAKER_00 37:17

We got it because it was an election commitment.

Felicity 37:18

We got an election commitment. And then after it was administered, they decided to go to a tender. And the the community jumped up and down quite vociferously on that one because it was at the same time as the diabetes inquiry, and said, Don't do to us what you did on insulin pumps, which is like single source tender, and no one's got choice for the different devices that we need and use. And you know, you you've got to have a broader. And they worked really, really hard on that to actually but it took strong patient advocacy to say, don't you dare single source this for us, because we all use different products for different reasons, and it's not a one-size-fits-all system. Just like, you know, different forms of metformin with different isomers or salts in it, or different types of insulin mixes are needed for different kinds of treatment regimes for an individual.

Paul 38:11

I also challenge the idea that these officials are allowed to just give their opinion like that. I didn't think that was permitted. I mean, he's basically saying that our system is protective against companies because they do the bad thing and actually sponsor these clinical trials, which we can't trust. I I can tell you, a company-sponsored clinical trial, the administration of which he obviously has no clue. No clue. And it's a he. We probably all know who I'm talking about, but this probably this person, I'd hate to see their social media feed. Uh, but but it's like this this is conspiracy theorist stuff. And it's like and it's to me, it's just nuts. I mean, don't they don't you realize that these are investor-driven organizations and clinical trials and the results they deliver are probably the biggest driver of shareholder value. And if you get it wrong, if the integrity of a clinical trial is challenged, it's devastating for shareholders. I mean, the companies are not motivated to do what he is suggesting. It's absolutely crazy. Government-sponsored clinical trials are a lot more uh would be a lot more iffy than than company-driven ones.

Felicity 39:24

But again, here's also the inconsistent in this. How often does the government, and in particular officials, rely on, you know, what clinic they consider clinical trials as access to medicines or to devices in this country going, oh, but you know, you can get on a clinical we're we're bringing clinical trials to Australia so you get earlier access or, you know, like, well, hang on a minute. So you're you're using that to make sure that certain people get access to life-saving or chronic disease medicines. Um, you're funding clinical trials access in Australia, you're encouraging the standardization of the ethics frameworks because you see the importance of clinical trials for patients as well as for the actual industry itself. But then you're saying, but anything you do in that space we just can't trust. And I don't find the TGA coming out saying, well, we think this medicine's safe, but it was this trial was done by the sponsor itself.

Paul 40:14

So maybe just Well well and the the the tr the truth belies the conspiracy theory. I mean the fact is the majority of health technologies and development fail clinical trials. Yeah. A clear majority. So the biggest scrutiny is of evidence in clinical trials are the sponsors who are deploying investor money. And as you say, clinical trials are consistently represented by, oh I don't know, government in Australia as profoundly important to both patient access and economic growth.

Felicity 40:58

Well, the minister himself at the same diabetes function talked about his investment in clinical trials and MRFF for diabetes and chronic disease.

Paul 41:07

It's just conspiracy theory nonsense. I can I can assure you that the evidence presented, the standard of evidence developed in those clinical trials and its comprehensive nature is the main driver of health technology assessment. This is this is the perverse outcome, my friend. I'm speaking to this person directly. You have your job and the two, three hundred people that work for you because of industry-sponsored clinical trials. That's that's the truth. It is industry-sponsored clinical trials that enables you to construct this ridiculous framework of health technology assessment to ratchet down prices and to manipulate the main manipulators of evidence is the is the institutional framework that this person administers. I just find the level of thinking worrying because you know, I talk about the the the imperative for the industry and other stakeholders to come up with good ideas. Well, I'm presupposing the government's capable of coming up with some good ideas, but I have to tell you the administration of this area, the department, in recent years has been a sinkhole for good ideas. And and and that what and that worries me. That worries me. I mean, you know, maybe statistically they're gonna stumble upon one, you know, because we're all statistical, you know, it's like throwing the ball at the cricket stump. You know, even if you're trying to miss, eventually you're gonna hit. And and in in the world of good ideas, maybe maybe they're gonna come up with one. But but this this is what really worries me is that there's just a dearth of good ideas. Now, I I did, as you know, I did um I was at a uh Sandos hosted a biosimilar event in Canberra this way. And kudos to them because I think biosimilars are just a massive lost opportunity for the past ten years and an example of where we're lacking good ideas or agreement coalescing around some good ideas. And I thought there's some good ideas discussed at the meeting. The agenda was fantastic. We had clinicians, we had pharmacists when actually we had patients Australia, they presented a survey they've recently done, and I thought the results of that were sobering in a way. But that to me is just a massive opportunity, you know, to get that off that spend on off-pattern biologics down and to look at the sort of drivers we need to do that. But we haven't made much progress there. But if this is the level of discussion that's been had, what hope?

Felicity 43:36

Yeah, like I said, I I appreciate at times that when you're in charge of the the financing system, so let's not pretend it's about health access, it's about health financing. It's a financing system, and it even used to be called that a little bit for a while till people realized what that said and meant. You are sometimes there trying to you're trying to justify why we have a universal delay system. And that's what that was about. Because in in the diabetes space, where it took 14 years to get universal access to CGM for type 1, we're now at year five of looking at the GLP ones. We are just going into that diabetes space, let alone, you know, or we won't even start with their insulin pumps and the the the limited access to that after over you know 15, 20 years. And I can say that there's more um you know the NHMRC is funding some more research into insulin pumps.

SPEAKER_00 44:32

Is that a trial?

Felicity 44:33

Yep.

SPEAKER_00 44:34

Well, a government funded trial. Whoa.

Felicity 44:37

NHMRC has done$450 million in grants to diabetes since 2016. Imagine if we just actually funded the tech. Seriously. It's interesting where we, you know, because we also have to understand that, you know, research programs are also in research funding is actually employment for university scholars. So, you know, it's a and and research. So it's it's a bit of a difficult space. But I it it really concerns me because you you should be able to talk about the problems in the system and not double down. And and this is why I found the HTA review such a lost opportunity for the stewards of the system and for patients, because you know, and again, seeing some of the other events this week, it's just universal delay. Watching a m a mum, uh a single mum with type 2 diabetes since she was 16.

Paul 45:38

Who's also got a dis living with disability?

Felicity 45:41

Is also living with a disability, has had to deal with the stigma and the judgment that obviously it's your own fault. You know, I feel it's devastating when the first thing a patient has to say to a room is I got diagnosed, I eat really well, and I exercise as much as I can. And I'm like, who else, when they show up for to talk about their health experience, has to say, please don't judge me for having a disease? We don't even do that for smoking. I come on. So first of all, she has to stand there and talk about that. Then she talks about the fact that it used to be okay to manage, but once she had children, the need for insulin, the fact that if you use insulin, it is such a different experience. And but once you are on insulin, insulin is insulin. The the outcomes, the the risks to your health, the the hospitalizations, everything deteriorates once you're on insulin. You there is no there is no good outcome. And having to stand there and say, you know, I'm I'm lucky I can afford it sometimes. Sometimes I can afford it, but sometimes I can't. And when I can't afford it, therefore I have more hypoglycemic events or low blood sugar events. I can't pick up my kids from school because you can't drive if, you know, if your your blood sugar's not stable. All the things that happen and all the deterioration in her work, you know, even just having to schedule work meetings, worried that, you know, will she be able to test her blood glucose uh when she doesn't have CGM? How does she do all of that?

Paul 47:10

Yeah, because she only pays for CGM when she can afford it.

Felicity 47:12

When she can afford it. Um and because when she does take it, her life is is so much better. Uh and her health is so much better. And she can, you know, fully in engage in actually every part of her life, not just her health care.

Paul 47:28

And that was a good event, actually.

Felicity 47:31

It was. And watching that and then reading, knowing that after that an official got up and said, Look, you don't really know what you're talking about. We we've only had data on this now for for 15 years. Um, and in even in your in type 2 diabetes, probably only 10 years, we're still not ready to get to that point of actually understanding whether this is something we can invest in or not. And yet, you know, you looked at the data presented there, which was, you know, the the hospitalizations, the the complications, the kidney disease, the ocular disease, the circulatory system. I mean, I'm completely biased. You know, my mum is one leg less because her she has poorly controlled diabetes. So I've seen firsthand what it means to the health system to hospitalise her for months on end, to rehabilitate her and to put her into a residential aged care facility because she couldn't afford CGM. So I just look at all of what's going on in the system right now and this week, and it's a system battening down the hatches to argue hard about the savings that might be needed and to push back on everything that the community might ask to be funded in amongst everything else.

Paul 48:41

And blame the Ayotolla.

Felicity 48:43

Yeah, blaming the Ayotolla. I mean, and they're still to blame. Um and a bit of Trump, you know, we we've got the excerpt of Trump there too with the MFN and all that. But we we do need to actually wake up to this as patients and say, no. Well enough is enough.

Paul 48:57

Can I can I connect the two points you've made? The HTO review, people's investment in the HTO review. And I want to connect that to what that official said at a diabetes summit. We don't believe your evidence, we don't trust it. Connect those two. So the official leading that reformer process, or let's call it a change. I don't know what you would call it. It's probably not obviously not the sort of reform people were expecting from a once-in-a-generation trigger warning, once in a generation at the Bio Similar event. I did issue a trigger warning about I'm gonna mention the HTO review. Uh connecting those two things. And this is this is what you and I have been saying since this started. You've got to realize that people who are gonna lead this process fundamentally don't like you, don't trust you, and will never readily accept the sort of things you want. And we got that writ large this week. Yeah, we got it writ large this week. So what we have is a minister saying, I want what you've given every other government for the past 25 years, reintroducing the word sustainability. He must, I don't know how many times he used it, but he used it a lot. Redefining what the PBS is, we don't fund large pay corporations for chronic conditions anymore. He claimed that it's because those therapies don't exist, and then he spent 20 minutes talking about GLP ones. Yeah, so I thought that was a bit odd. He highlighted, yes, because they're only on them for eight to twelve weeks now, and I wouldn't describe that as a success successful listening because the rates of infected reinfection and the fact that there are still a hundred thousand people uncured. Uh so you had all of that, and then you had officials saying, Oh, well, compassion, yes. Oh, yes. But evidence doesn't really compassion, yes, or you know, advocacy, oh yes, but it's all about evidence. Oh, and we don't trust the evidence. Our entire system is premised on our mistrust of your evidence. You know, and when he says Oh, because it doesn't work in real words like it works in a clinical trial. Well well no, that's true and untrue. Okay, it's it's more complex than that because a patient in a clinical trial is being very closely observed. Okay, so it's sort of a nonsense argument.

Felicity 51:26

But it's even worse than that.

Paul 51:27

And an ignorant one.

Felicity 51:28

Yeah, it's even worse than that. Sorry to interrupt you, because we can all talk about some of the medicines that went back on their risk shares with real-world evidence and showed higher utilization and and and health outcomes. And the PBOC said, Oh yeah, but we don't really believe you, and we don't believe the patients, and we just believe you're all just making it up.

Paul 51:47

Yes, migraine being the classic example.

Felicity 51:49

Exactly. And so every time there is real-world evidence, it's then still discounted. So you discount before it comes in, and then you discount when it comes back out again. Which is my my point is like, why are we wasting time on this? Why aren't we just saying, here's this treatment, this is the indication. Let's talk about numbers and let's give you let let's do a deal.

Paul 52:11

But this is this goes to the fact the system is all about price, as you say, it's a financing system. They belled the cat a few years ago when they called the area financing, and then went, oh, that's a bit obvious, let's call it something else. Uh and then you euphemistically include access in the title. The the the thing is that this is the problem with these processes, is it's like negotiating with your jailer. One might say it's like negotiating with a terrorist. You know, it's it's you shouldn't do it. You should not you should not do it. Because it's dangerous for you, because they don't trust what you do, they don't like what you do, they do it under sufferance, and they're gonna put up every roadblock they can. So even if the minister makes some amazing announcement with the HDA review, the person who doesn't trust you is gonna be the one responsible for implementing it. And this is what this is why this is why these processes are under are are very dangerous. You don't get in the boxing ring with Mike Tyson at his peak and expect to walk out. That's that's the truth of the matter. That that is the truth of the matter. You've got to avoid that contact. Now, good on you for having the courage of your conviction. Good on you for thinking that this process would work. The point is that it's always going to come back, come back, come back, and they'll use product-specific agreements to degrade with the outcome you get. That is true. And they've done that with F1, F2 over the years. However, because there was upfront agreement on that and it was legislated, it's a 20-year runway of strong defense. If you s if the starting point is a review of a process with someone who doesn't like you and doesn't want to give you what you want, it's going to be very hard to get success out of that. I I don't want to labour the point, but I think this week has been really useful as a reminder and uh an alert.

Felicity 54:03

Yeah. And you know, I guess I'm I'm the ultimate example of how how deleterious that system can be, because we begged the Prime Minister and the Health Minister to not in making a commitment to expanding and get ri restoring our worldwide standing is some of the best newborn blood spot screening in the world. We begged them, we said, do not go to the MSAC, do it, do your own MBS review and and do it properly because it will never happen. And the reality is babies are dying. And MSAC is fine with that because this is their process and their control, and they are very happy to watch families and patients suffer. Am I talking babies dying of preventable, treatable diseases? So if you don't think the system can really double down and defend itself at all costs, it doesn't realize I've had$107 million committed and not one new disease.

Paul 55:07

Real, really, really important to understand the nature of this system. It is an ideological framework. It is an ideological framework. And what do we know about ideal? What are the characteristics of an ideological framework? They've got to constantly demonstrate their purity.

Felicity 55:23

Yeah.

Paul 55:24

So they see opportunities that everyone else might think as failure, as an opportunity to double down and demonstrate the purity of the program. And in the end it becomes like a style, I mean I've used the phrase style on a show trial. Well, you had these people at their style on a show trials admitting guilt when they knew they weren't guilty. But they did so because, in order to do so, in order to deny their guilt, in order to acknowledge the truth and claim the truth, they invalidated the last 20 years of their life, and in the end, they ultimately stood by the purity of this horrible ideology. And that's what this system does, that's what this institution does. And so that's why you get the people talking about 30-year anniversary or whatever it was of HTA, because they can remember every single moment over that Thursday. They were all there from the start. And I'm as guilty as this is of anyone, but I'm an outsider to the program. I went from being an insider. I was sort of an outsider on the inside because I always looked at it, but I do think a lot of people who've worked on the inside of it are the most skeptical about it because they see the way it's manipulated. Because it is an ideological framework, and it's very hard to beat an ideology. You've got to beat it intellectually. It is a it is a it is a profoundly wrong program. So when a patient or someone talks about compassion, that's critical to our system, and the ideological framework responds by saying, No, no, no, no, no, no, no. What matters is evidence, and we don't trust any of the evidence we get.

Felicity 56:50

And we certainly don't advocates because you're just advocating, I don't know, for yourselves.

Paul 56:54

Or for yourselves.

SPEAKER_03 56:55

How dare you?

Paul 56:56

Because all of the people who work in the system work for free. I mean, it's just absolutely there were so many people, there's so much vested interest in this. But anyway, Felicity, uh, you and I probably spend the rest of the afternoon talking about this because for those of you who don't know, we're generally pretty fired up when we finish recording the podcast. We just sort of take the angry pills during the podcast and then sort of get angrier. And we sort of say, Well, why didn't I say that? I should have said that. Hey, can I just give another shout out to Sandals for their buy a similar event this way? Uh, I particularly want to pay credit to the clinicians and the pharmacists in the room. And the dialogue they had between each other, the agenda was very cleverly put together. They did a great job. But the dialogue between the pharmacists with Anthony, Anthony from the guild, we had Samantha, who's from the award-winning pharmacist here in Canberra, pharmacy in Canberra. We had Mona Marabani, who's a rheumatologist, and a couple of clinicians from Gisa. And the conversation, they had their own little, because I was sort of facilitating this round table conversation. And the conversation they had about their discussions with patients and what might get them, why they're not choosing biosimilars, why they might, it was absolutely fascinating.

Felicity 58:12

Wow, you mean they actually put the patient first to discuss, therefore, how would you actually change the situation?

Paul 58:17

How, how, so the clinicians were saying, Well, this is the conversation I had with my patients about biosimilars. And then the pharmacist would say, Well, yeah, but this is the one I have. And I just, you know, sometimes I give them a biosimilar and I get a call from the clinician and say, Why are you giving them biosimilar? And it's it's it's that to me was really interesting, the drivers of that, and that was all built around a survey that Patients Australia have done that Lisa Robbins from Patients Australia presented. And I spoke to Nick Coatesworth that morning as well, and it was absolutely fascinating. And the challenge is you know, in a world that might be euphemistically, and some will challenge it as a sinkhole of battles. Look, even the health department official who was there, she was very thoughtful. But I think that reflected the thoughtful contributions of the stakeholders that were in the room. So she talked about the need for government to pick away at ideas. And I won't I I won't say who it was, but it wasn't the person who spoke at the dice. But but it was a it was such a good discussion, and I actually really, really enjoyed being being part of it.

Felicity 59:24

Well, I think I mean it's great to to hear that that that took place and glad to hear that there were some really thoughtful people in the room. I think the the biosigners are an interesting thing that you know you want to finish off with. When we talk about, and again, going back to what Mark said about we don't do you know chronic disease listings anymore. When we started using uh statins, which is you know the one that everyone tends to talk about, which even the minister talked about. In 2005, let's go back to them, there's about 1.7 million people on a statin, and today there's about 4.5 million people.

Paul 59:58

Yeah. It should be in the water basically.

Felicity 1:00:00

In 2005, there are about four to six thousand people on a biologic. In twenty twenty-five, there's ninety to one hundred and twenty thousand. Aaron Ross Powell Because the restrictions are still I mean the I'm not including the new ones like you know the on-patent ones. I'm talking off patent.

Paul 1:00:15

They've been off patent for more than five years. And uh the rheumatologist at this event said she and her staff spent an hour each day writing up the restrictions for products that have been off patent for five years. Writing up the authority.

Felicity 1:00:31

So, you know, I I guess I'd encourage the industry and the government to consider they've m-PBAC's made findings on off-pattern medicines and the fact that we should be systemat systematically reviewing these to make them agnostic in indication because there's a greater need. Now, of course, we've seen what's happened with that pediatric Crohn's family, and we're still waiting and waiting and waiting. And and again, senior officials have explained the risks of possibly doing something like that, even though it's available over. But here's the other thing. So Startons have gone down in price about 80 to 85 percent since when they first started in 2005. By logics are down sixty to seventy percent. So it's not a huge difference. It's about the starting cost that was an issue. But the government promised us that once we got those prices down that they would expand access. And there is an opportunity to do that with price volume. If you want to quote that official who talked about how he made CGM available for the community by going through those processes and getting the best value for money from a broader population, there is some genuine innovative policy that should be done. But most importantly, patients deserve this access and enough is enough.

Paul 1:01:43

Enough is enough, it's ridiculous. The last policy intervention on BD MARDs was to try and stop doctors prescribing them.

unknown 1:01:49

Yep.

Paul 1:01:49

And in fact, the government funded an unlawful advertising campaign because they promoted brands, which they are not permitted to do.

Felicity 1:01:57

Nope.

Paul 1:01:58

But and that was millions and millions of dollars.

Felicity 1:02:01

Yeah, it was a hundred and eighteen million dollars.

Paul 1:02:04

Can I just say on the evidence bit? I'm going to end on the evidence bit. The great expansion of access to satins in Australia was based on the Heart Protection Study, which was an industry-sponsored clinical trial conducted by Oxford University. Are we saying that was dubious study? That's one of the most important clinical trials ever conducted.

unknown 1:02:26

Yep.

Paul 1:02:26

Ever conducted.

Felicity 1:02:27

But then I'll say that as we've heard from our officials, it's not not Australian-based, so therefore we have to do something else again, which I've read in a number of documents. Yes, we realize that you've, you know, studied 400,000 people, but that was a hundred it was a hundred thousand people or something. No, but what I'm saying is that you read all these um public summary documents from PBSE and MSA, they're going, yeah, but you don't have evidence in Australia, so we couldn't possibly it's all excuses.

Paul 1:02:49

Yeah. The framework exists for excuse.

Felicity 1:02:51

It does.

Paul 1:02:53

It's an excuse. Alright. Well, uh tomorrow's Good Friday. You eat fish on Good Friday, don't you?

Felicity 1:03:02

We do. I think it's more the fact that we don't eat meat, but someone who doesn't already, that's fine.

Paul 1:03:09

Well, that's good. I hope you get some some Easter bunnies.

Felicity 1:03:12

Thank you. Hope you enjoy your brisket.

Paul 1:03:17

I definitely will enjoy brisket.

Felicity 1:03:20

I'll see you for chocolate eggs on Sunday.

Paul 1:03:21

Yeah, I'll probably we'll have some uh chocolate Easter bunnies and um catch up. And yeah, I hope everyone has a great weekend. A spiritual weekend where it's important for you. It's when it's a rare occasion for Passover and Easter are sort of coinciding. Yeah. Uh it's uh yeah, it's Easter Easter Easter.

Felicity 1:03:41

Passover was the first Easter.

Paul 1:03:44

Well, the the Last Supper is a Seda.

Felicity 1:03:47

Yes.

Paul 1:03:49

So yeah. Yeah, it's a obviously a very important weekend for a lot of people, and I think the Orthodox Easter is next week. So it's an important period for a lot of people, and uh, I hope for those for those of whom it's a very spiritual time, I hope I hope they uh they enjoy it with their loved ones and families.

Felicity 1:04:09

Absolutely.

Paul 1:04:10

Thank you for listening in. Thank you everyone for listening. Keep the feedback uh coming, and I was, I just have to say, I was at an event a few weeks ago that you were at, and uh they knew me, but they only knew you by your voice.

Felicity 1:04:23

Yeah, it was quite funny.

Paul 1:04:25

Oh, I know that voice.

Felicity 1:04:29

That happens a bit now.

Paul 1:04:30

Yeah, yeah, so that's that's good. Thanks everyone, and congratulations to everyone who hosted events. I I have said this to people the events that I've been attending recently have been very, very good. I won't list them all, but I've I've really really enjoyed them. Starting with uh, you know, um I think it was the the GBA, GBMA summits, and then going into all of these others, they've been they've been absolutely fantastic. And congratulations to Nikki's the new CEO of GBMO. Oh yeah, congrats. Yeah. Uh it's gonna be a busy time.

Felicity 1:05:04

Well it is, but hey, Parliament's risen until budget time now. So no one will be in town.

SPEAKER_00 1:05:10

That's right. Thanks, Felicity. Thanks, Paul.