The 'Dispatched' Podcast - Series 5. Ep.28

For more than a decade, Public Summary Documents have been presented as evidence of system transparency, but in fact, they are an affront to it. What was the discussion about transparency that ended with an impenetrable 50-page technical document as the solution? Who remembers that the PBS still has 'Special Patient Contributions'? Also, a new guide on talking about the deception that are the agreements euphemistically described as 'risk shares'.

Read the BAA guide to risk share arrangements.

Transcript

Paul 0:08

Hello and welcome to the Dispatched Podcast Week in Review. A couple of days late, so we're sort of already into a next week, I suppose, because we're doing it on a recording on a Sunday. My name's Paul Cross. I'm delighted to be joined by Felicity McNeil, PSM, Chair of Better Access Australia. Hi Felicity.

Felicity 0:24

Hi, Paul. Should we timestamp it by saying we're actually recording this in the break of Carlton versus the Bulldogs?

Paul 0:33

Well, you just said it.

Felicity 0:34

I did just say it. And to your listeners, I can just Paul's really excited that I mentioned that. But um I like to think that it's still a week in review because when you've got a a sitting week in Canberra with everything that's going on, it's it's quite exhausting.

Paul 0:48

Oh yes.

Felicity 0:49

The week doesn't really end.

Paul 0:50

So let's let's get into it. I want to talk about a few things today. And I suppose this is going out uh with a story uh sort of a polemic, it might it might might be the best description on Monday about public summary documents. My argument is the fact that these we need to get rid of these things because they really don't serve any purpose. Uh really the only purpose for them can be to support patients. These are 50-page impenetrable documents. No patient has ever said, Oh, now I know I've seen the Kaplan May curve, so I know why I'm not getting access to this medicine. And in fact, rather than being about transparency, uh they're an affront to transparency. Now I went back and had a look at a a Senate inquiry, a hearing, a uh evidence provided by former PBIC Chair Professor Lloyd Sansom. This is in 2010. The inquiry was not into public summary documents, it was it was into something else. But he was talking about them as them as a transparency tool. But implicit in his comments is the assertion that if only you understood what we do and the way we make decisions, then there'd be fewer complaints. Now that's a that's an argument that we continue to hear to this day. Sometimes sometimes rather remarkably articulated by patient organizations in defence of this rather broken institution. But well if if that's if that's the rationale, if the basis for these documents is to provide this technical gibberish, it hasn't lessened the complaints, so by their own measure they failed. What's more, and you know better than I do, these are highly selective marketing tools.

Felicity 2:46

Oh, absolutely. Um I think it's quite funny and I start to f feel my age or my duration in in the system, which is actually not as long as most people, which is quite scary. But if you read a public summary document from 2006 or 2010 and then you go and try and read one today from 2025, you will find it extraordinary. We made it simpler and easier for patients to understand what it was we were doing 15 years ago. And the complexity is you've written about and where we're going here is to try and explain and uh justify and excuse the delays and what why we why we can't proceed as people would like us to. So I I always love it when I'm I'm doing some work, whether it's for patients or organizations, and I have to look at something from 2006, I get a little, you know, skip in my heart because it's literally four pages.

Paul 3:52

Yeah.

Felicity 3:53

And it talks about the evidence and it talks about what they did, and it talks about what they recommended and why. PBAC recommendation was three or four paragraphs, not twelve pages.

Paul 4:01

Well, they're 50 pages now.

Felicity 4:03

Oh no, I'm just talking about the actual PBAC recommendation. Oh, yes. You know how you've got to go through, you know, items one to seven before you get to what PBAC recommended uh and then your addendums. Uh so yeah, I I do find it interesting. I I like your idea of of be done with them. I mean, one of the things we did at Better Access, because we have a full repository, is that we have turned those into plain English for people. What did this mean? This is actually what it meant. It doesn't it's not that hard.

Paul 4:33

Well, they all say the same thing. It's all price.

unknown 4:35

Yes.

Paul 4:36

Like every objection is price. Remember, I did that presentation at the ARCS meeting or they're called Life Sciences Australia now, and I had these are the 10 or 11 highlighted reasons for a rejection. And they're all price related, they're just different ways of describing it. Price was the solution, a lower price was the solution. And even where it was for a therapy that was recommended for a higher medical need because it provided higher therapeutic value, the solution was still a lower price.

Felicity 5:04

Yes, we discount for uncertainty on everything. So one of the things we're going to talk about later when I explain to patients, oh, they said this. So one one paragraph will say, you know, we think that the company has significantly underestimated the potential patient population, which will cost us more secular. We think they've significantly overestimated the patient population that we should be funding. So yes, it's it's become it's a tool and it's a it's a weapon of the system. Uh the process is the weapon of the system, which is why we have better access in the the forthcoming negotiations have zero interest in a discussion about that three-letter acronym and the processes that surround that as part of determining what uh our PBS and our access to PBS and MBS will look like in the next 10 years.

Paul 5:50

Well, these documents are mostly voyeurism, they're peepholes for institutional insiders to see what other companies are doing or or or not doing. So that's that's not a meaningful purpose. If they're 50 pages, really the only important outcome for patients is the yay or the nay, is the outcome that's on one page. The other 49 pages are essentially useless information. They are full of always full of massive disconnects. So this is where it's the selective one side of transparency that I don't like and why I think in a system where we're always talking about the resourcing constraint inside the bureaucracy to support this process, we're always hearing every year in the cost recovery impact statement, we hear about the gap between revenue collected and the cost. Well, here's a solution. They can get rid of this. Because it's not providing any anything meaningful. Create uh, and I think an independent entity should do it is to create one page plain language summaries about this is this is it. I don't think the PBAC or the department, the PBSC should certainly not be constructing these because there's an obvious conflict of interest.

Felicity 6:53

Oh, what you mean like the letter that we get from the chair and the deputy chair now of PBAC saying, let us tell you what we had to put up with at the last meeting.

Paul 7:01

Well, AI can be used in lots of different ways. So I so and that's and that's obviously one, judging when you read it. The thing for me is that what do we don't get that I think we should have? I want to see what the discussants present. Where there is a significant variation, and this is more common than than not, or more often than not, where they note patient clinician input strongly in support of something and then completely ignore it. Like why? What's your reason for ignoring that or for setting that aside? And I don't think that's good enough. I I personally do want to know who the discussants are. Uh the reason I want to know who the discussants are and what they present is because uh they are apparently independent experts, they promote these positions for professional gain. Why wouldn't they want to speak publicly and be identified? That really doesn't make any sense to me. There's lots of information we don't get. We don't get what the executive is doing, we don't get agendas, we don't, we don't get outcomes, and I think that's really, really problematic. I want to know where when when an opinion, when it when a view is put that that an outcome or a medicine or other health technology has significant stakeholder support, that means clinicians and patients, and they choose not to incorporate that or reflect that in the outcome. I want to know what the two so-called consumer representatives said. What did they they intervene on behalf of patients in that conversation? Why what why can't we know that? It doesn't make any sense.

Felicity 8:29

I think it's a very fair point. I'm I'm with you on discussance, as I've said, under the FOI Act, these people are they just the minister says they're independent experts, setting aside that they're not independent. He defines them as experts. Under the FOI Act, as experts, they are supposed to have their advice, their minutes, their details disclosed because everything else is inconsistent with the FOI Act, and we we hope people will support us on that one. The the second thing that often I get from patients and clinician groups is they put in a huge amount of effort, whether they've been told how to put in a HTI submission as a consumer or a patient, so that it's easier for these independent experts to understand plain English and what it is to like live with something. But the thing that I always get back is the disrespect of I spent all this time and effort. No one ever comes back to me and says why that didn't matter or why it did matter. And not just to whether it's a big patient group or a small patient group, but to individual patients who spent all that time, no even basic email acknowledging it saying thank you. It was considered here was the outcome. It's like, oh well, good luck to you, you know, see if you can find it yourself. Occasionally the um consumer consultative committee will reach out to organizations to say, just a heads up, this is where it is on the website. But that is intrinsic as to why this our PBS is not our PBS. The interest in the patient and the the health system is zero. And you're you're right whether what a a PSD is being used as a surrogate for uh in this process to to determine certain things to provide certain answers. It's symptomatic of just why. You know, you even have to read 30 pages into one of the things you'll see in there now is something that we started with in 2014, which is for every thousand patients I treat, I will help, you know, prevent this many heart attacks or this many hospitalizations, or I will have this many adverse events, which we thought was a really important thing to do. Because when you are talking about Kaplan Meyer curves and discounting for uncertainty and, you know, clinical trial A versus B, one of the things we used to get back from the community was I don't understand what that means. So the reason we recommended it is because of this, this or this. The reason we're concerned about it is because of this, this, and this. You know, all this extra money for only one or two people, you know, in a in a broader population, or because of all the adverse events, etc. Not saying it was right or wrong, but articulating it clearly for the community. But yes, these are weaponised documents and yes, you can see them as a voyeuristic opportunity for competitors, but they're only being voyeuristic because that's what the system wants. So I think it's the system is controlling information complexity, reaffirming that this is such a specialised area, that it is the fortress. This is, you know, Edward III's fortress. You cannot get into it because we have so many things here in the, you know, the the moat and the keep to protect our castle, which is our determining, you know, 18 to 21 people, plus some people in the department who say this is my PBS and I'll decide what goes on it.

Paul 11:49

Well I think the Edward III analogy is is a good one because obviously he w went through France absolutely wailing on the French on the on the French. Uh so and that's that's how I feel about this sometimes. I mean, this is just this is this is transparency. The word transparency in the case of these sorts of documents is actually uh a euphemism for no accountability. So implicit in these public summary documents in their presentation is that these HTA advisory committees can't make errors. And that's just obviously ridiculous. I I don't understand how anyone could have a conversation about transparency and end up with these things. It makes absolutely no sense to me. It is a vanity exercise, as you say, look how brilliant we are, how complex and amazing this is. You're not building rockets, guys. You know, this is this is really, really, really simple. It's really, really simple. And so I don't I don't understand the point. Let's just ask the question. What's the point of producing documents that virtually no one can understand? It it make it makes what it makes no points. What's the point of including in these documents redacted information? What's the point? I mean, there is that FOI and the health department last week with the entire document is redacted. I mean, it's just completely ridiculous to do with like light and easy food or something. It was quite weird. But you know, so I don't know what point they're trying to make. And all of this conversation that's taken place over the years between the industry and the PBAC and MSAC and officials about including more information, including more information, the nadir of which was the attempt to remove the confidentiality protections. Do people remember that?

Felicity 13:35

Yeah, 2021.

Paul 13:36

Yeah, yeah. And so so the fact is that more and more of these documents have not been published because companies are exercising their lawful powers. Now, my instinctive reaction to that is good. It also makes me believe that the department might have another crack at removing those confidentiality protections. But I do think the industry needs a far more assertive posture here. Unless you start including this information, like why have they chosen to ignore consumer? We want to have an explanation as to why they've ignored the patient input here. Now they might say they disregard it, but there's they dis they disregard it all the time. The classic being newborne screening and Pompeii disease, where they just completely substituted patient input for their own belief of what patient uh beliefs are. And so I have a real problem with it. So I think industry should just say we're withholding permission on you to do this anymore. Mark Butler, if you want to issue a public interest certificate, go right ahead. You're gonna set a new standard that'll be applied broadly. But but to me, I think they need to muscle up.

Felicity 14:37

I I wish they would. I think there is significant opportunity there. So companies know that they will be given a summary as well as the the verbatim of the comments that are put in by different organizations, whether they're at MSAC or they're at PBAC. So they as a company are seeing it. But no one else is. And no one else can understand the the personal pain or the perspectives that someone has put in or an organization has put in and how that influenced. There should be a response. I mean, there's a response to everything else there. Dusk considered this about this response, and S considered this, and PBAC considered what Esk and Dusk said and thought something different, and company said this. We have so much of that, but we don't have any of it with respect to the actual lived experience of the patient. And I I guess I'm I'm with you, which is that this has just become a toll story volume of, for most people, gibberish to articulate and to make excuses for why something isn't happening. You know, I read OSPARS, uh, there's another great acronym, but reading the documentation and the the summations that information that the Therapeutic Goods Administration puts out, I find them much easier to read because they actually have slides and summarise and humanize it so that whether you are a highly expert individual or you're a patient trying to find out why something isn't available yet or will be available in the questions, it's there. So we we can learn a lot from different systems.

Paul 16:07

And you know, a lot of what we have today Well it's in the same building virtually.

Felicity 16:11

Yeah, and a lot of what we have today in TGA's processes and efficiencies and transparency came about because Prime Minister Abbott insisted on the review of the TGA and trying to harmonise globally. And the PBAC was specifically carved out at that point in time saying don't mess with this part of the system at the moment. The the sad thing is that that was independent. Um Will Dillat, Professor Samson AO also on that, came up with some ideas and things that have really made the TGA an organization we can be incredibly proud of and tries very hard to make it more about what the community and the patients need to see and clinicians, not just what they need from a technical point of view, which is what they do behind the scenes.

Paul 16:58

So, my my objection on these documents is that, and you know I've been writing about this all year, about the uh the institutionalized sense of itself and how it is incredibly self-serving. And PSDs are a classic example of that, where basically the institution sees this, and unfortunately the industry is part of this as well, the institution sees PSDs as part of what it does, and it's a bit like you know, it's the Overton window argument where this is what we're allowed to talk about, but often so often in this system the discussion, any f any sort of change discussion looks like an underage football game. You know how they start in positions and then everyone just follows the ball?

Felicity 17:46

Yeah, it's like um honey's yeah flies around honey.

Paul 17:49

Yeah, that's that's unfortunately how the system uh operates, and it's unfortunate, it's really unfortunate because it's how it it protects itself.

Felicity 17:59

Yeah, like I said, it's this is the ultimate, this is the keep, this is the moat to to keep things at bay. So I I would love it if the industry took a stand. I'm always highly supportive of companies that choose to dispute their PSDs and what's included and how it will be included, and the right to control the information. I mean, the secrecy provisions of the National Health Act are there for a reason. They are yours. No matter what an officer emails you about, it isn't true. And I think Yeah, they should do it on math. Yeah. And I, you know, I was reflecting to again explain to patient groups about uh MSAC and PBAC and time frames and that they don't understand, you know, back in the old days, we would basically ring up, tell a company what the recommendation was, explain next steps, do all the various bits and pieces. You would get a lot of information three days after MSAC or PBAC met. So you knew what was happening and off we would go. Now they're lucky if they get a phone call to say rejected, deferred, recommended with caveats, wait three weeks, wait six weeks. There is all this controlling of the information and the power to leave the uh supplier in a state of flux and uncertainty as the system controls how you have access to these things.

Paul 19:11

Yeah, and my particular annoyance about that is the idea that these outcomes are confidential, even when they're communicated to the company. They're not.

Felicity 19:17

No, they're not.

Paul 19:18

You could do the company can basically put it on LinkedIn.

Felicity 19:20

They can.

Paul 19:21

The minute they get the outcome, this act but but there is this this is the institution that constantly seeks to control, and all the different PSDs are just one way that's that sort of sort of takes effect. Uh and it frustrates me, and I I really wish I'm I'm glad more companies are exercising their rights. We've been telling them for years that they need to do that, they're finally doing it. But if if officials are going to push for more information, and they have got very sloppy, I I've seen one PSD where it's got a net price in it. And a certain Melbourne company might want to look at that. And I just Melbourne-based company that is, but but the for me, I just think, well, the proper response to companies doing that is for the institution to reflect on what it's doing and contemplate whether, you know, have these had their time? Do we need to be, you know, do doing this a little bit differently, including information that people might actually need. We do not need all of the redacted tables. We don't need reference to insert swear word. Kaplan My Kers, we don't need any of that. All pay all that matters to patients is the the yay or the no and what now. And the fact is that implicit in the creation of these documents was the idea that, well, if Annie knew what we did Well Are the complaints less than what they were 15 years ago? No, they're not. They're they're more. So I think it's an opportunity. I think it's an opportunity. And uh, you know, and further to that, because earlier in the week, this is you know, in relation to the inst institutional sense of self and the overdom window and the the the the the the underrated football analogy I applied HTA to public education. Yes if we did that, if we applied the thinking of health technology assessment to what education people get, well it would be pretty ugly. It wouldn't look good. It wouldn't look good. And a lot of people would be denied education. Now that's in some ways, certainly for an extended period after World War II, that's how the education system worked. You know, working class kids got lesser education, you know, and it was largely vocational to trades and things like that. But you know, I can imagine a situation where if you applied any sort of economic modelling to it, some people would be told, well, university, you know, basically the the the population cohort you're in suggests that it's really not worth it for us to fund you into university. And Regardless of hex or whatever it's called now, the Commonwealth does fund people into university through debt arrangements. Which costs tax base because a lot of it doesn't get it doesn't get repaid. But but that that's that's the reality. That's the reality. So I would like us to think in sort of more more human terms about how this system works. And that means we've got to stop talking about HTA. And I'm more guilty than most because all I ever seem to do is talk about it. But that's because I just find it really offensive. Very offensive. Oh my gosh.

Felicity 22:49

We would never be doing it. Um or their solar panels through, or even if yeah, even as someone who has uh worked in roads infrastructure as well as health, and I used to always laugh and say, I can get any road in this country to have a cost-to-benefit ratio of greater than one based on what we need to do in funding areas. And in the end, it's a judgment about what we need to do. There's no artificial premise overlaid to say that this is, you know, the most important thing that we do in analysis in respect of infrastructure in Australia. And yet we put this, I'm not going to use the acronym, as the point about this is how we decide to invest in this part of healthcare. And instead of actually controlling it and using it as a tool, not as an absolute, we are let it's worse because we are stretching that brand not from just medicines but into devices and into the broader MBS and into the the the hospital systems, etc. Where at least, like I said, I know if I if I'm a patient in a hospital, I have a right of appeal. If I need better treatment for my mum, I've got an opportunity. There are progress there are ways to progress to make sure that she is seen as an individual. But if she needs it and that's a medicine that she needs somewhere in the uh PBS or if it's something in the MBS, then I'm beholden to a group of people who will never ever consider the individual patient. And as we've always said that, can you imagine saying that too? You know, you walk into your GP and they're like, just hang on a minute, let me couplin my curvy before I decide whether or not to treat you. Like, come on.

Paul 24:19

Well, as you've always said, it's just a it's a just a way to say no.

Felicity 24:23

It is, it's a way to say no and to deliver.

Paul 24:26

Now, speaking of no, I wanted to uh give you an opportunity because you at Better Access Australia have done this fantastic document explaining wrist share arrangements. And it's really the kind of fur I'm I mean, maybe there is another version of it out there, but it is a fantastic document that's been load downloaded several thousand times now.

SPEAKER_02 24:48

Yeah.

Paul 24:49

Uh and which just goes to the level of curiosity about those things. So maybe you could share with our listeners, you know, why and what the document includes and where they can get it. Oh yeah, sure. Because I'll include a link to it in the Oh thanks.

Felicity 25:04

Yeah, look, we we did this because obviously when Natasha Robinson and the Australian were starting their their medicine wars, etc., we would be talking a lot about risk shares and people don't understand what it means and that the the concept that you can actually say that you're funding six billion dollars worth of medicines in the budget, but it really only be two billion, and not understanding why companies can end up losing money on the PBS if they're still selling more. Well, surely you're still making something. So we put something together to show the gross on the net PBS spend, and we split it up to show you where the money goes, which is in F1 and F2, uh, and in wholesaler remuneration and dispensing fees. And then we actually did a model, um, a sort of step through using an actual PSD and de-identifying it, showing the exact things that we talked about, which is first of all the special pricing arrangement. So when you're paying a higher, the gut government's pretending to pay a higher price than it really is. But then secondly, risk shares, when, and this is the real nasty part of the system, which is the system says, I know there's this many patients, but I'm only going to pay for this many, and seeing how that happens and what that translates like. And patients still think that even if you're doing like a bulk arrangement, like you know, it's purchasing, you know, 4,000, you know, bottles of water instead of 2,000, that the company's still making a profit. And they don't. And so we step through how it works. What happens when you're offered $500, you know, for your for each box of your medicine. And by the time it's actually the the actual rebates in, you know, PBAC will dispute how many scripts will be filled a year, they will dispute how many patients will stay on it, they will dispute how many patients will start on it, they will they will dispute how uh continuance and and compliance is. And what you end up with is, you know, the example we used and showed that Dusk will say overestimated the utilization, and then Old Ev underestimated the utilization. So you've got both sides of the system working, and then we check what that happens when you put you know nominal numbers into it. And I think that's why it's been quite shocking for people to say, hang on, so a $500 a box drug suddenly becomes a $130 a box drug, when when is that okay? And as we keep reminding people, you know, in the last uh decade, milk and uh bread have gone up 67 to 80% in price. But medicines are actually going down in price, and medicines are going down in price based on how many people use them. And so when you try to explain to patients why, if they got a recommendation on a price, why won't they list if there's gonna be lots of patients use it? So we've done that one. We've actually started to do another one as well explaining um specifically in the obesity medicines because it's such such a huge issue. I mean, we yeah, the Finn Review said, Oh, apparently we're gonna every single person who ever's been overweight is gonna get it.

Paul 27:57

It's a crazy headline because the story itself was was good, right? But the headline was a bit out there.

Felicity 28:03

Yeah, well if you want to if you want to if you want to grab attention, you just say 10 bit.

Paul 28:07

Obviously, that's a subject. Yeah.

Felicity 28:09

But uh yeah, so we've we've put that on the website and we've just been shocked as to how many people have wanted to download it and to understand it. And and hopefully it helps people. We're as part of our reforms that we're asking for, we've started out you people have been shocked to realise that we've actually written the draft legislation to actually give patients uh genuine place uh on the PBS, and we're gradually going to be rolling out each of our policy positions and the evidentiary bases for it uh in support of that. So we've worked out a template on how would you actually make risk share arrangements fair for government, for industry, and to give transparency to consumers and patients about what's going on and some agreed uh parameters.

Paul 28:50

So I think people have got to do a bit more work too on addressing the name because they're not risk share.

Felicity 28:55

They're not anymore.

Paul 28:56

There's no there's that they used to be. They're not but with 100% rebates and those ridiculous continuation caps, page total and continuation, it's just there's the there's absolutely zero risk for taxpayers.

Felicity 29:08

Well, absolutely. So I mean look, if you look at the Wagovi public summary document from last year, it's quite clear, it's not often that they are so transparent that they'll put out there saying it's a hundred percent rebate over anything that's in the agreed numbers. They said, Oh, look, you know, people won't be compliant, they're not going to use it 12 times a year, they'll use it seven to eight point five times a year.

Paul 29:27

Which is just a complete crapshoot by the Amazon.

Felicity 29:30

Oh, and people won't stay on it for as long as they're supposed to. And and you look at all these discounts, and I think it's really important for people to understand this is actually the second part of the system that's really, really breaking. And as we're always saying to people, it it can be, it should be all not and. So you can start a little bit higher with prices in Australia and actually have fair risk shares. And you know, let's all agree on what patient populations are, it's not that hard. AIHW tells us all the time. And then you do have all these secondary opportunities with price cuts coming down the line that you can use. But when you actually start with a low price, too low a price, and then you try and cut that by another 30, 50, 80% with these risk shares, this is why we don't get medicines.

Paul 30:13

I wonder if people and I think the the beauty of the document you've done is you help explain why when they say they're only gonna use 7.5 uh times a year or all of these things, not everyone's gonna use it. That that's that's all price cuts.

SPEAKER_02 30:30

Yes.

Paul 30:30

That's all that's what they used to establish the caps.

Felicity 30:33

They call it discounting for uncertainty.

Paul 30:35

Yeah, yeah. So these are all the reasons why companies just go, yeah, we're not accepting that. And so the and the and the crazy thing is, why is the PBSA even doing this? This is a relatively recent thing. It never used to do this.

Felicity 30:48

We used to, I mean, we've had risk shares since they used to be price volume agreements. The the the late 90s. Yes. Um, we have had them. And I think the the variability that we'd had over time is what was genuinely risk share. So we used to have multiple tiers as well, too. So, you know, it's going to be 10,000 patients. Let's we think, but let's be clear, it might get up to 12,000. They're probably still within indications. So between 10 and 12,000, we'll have a a small cut that's a genuine sharing, and then if we get to the next tier, a higher cut. But it was really in um sort of between 2010 and 2015 where some interesting recommendations came out of the PBAC to go all or nothing. Like it was an absolute science of exactly how many patients. And then the argument became about which data or evident tree base you were using, whether it was coming from the clinical trials, whether it was coming from Australia, or whether it was coming from overseas, again, how to keep adding in discounting for uncertainty. So they have got very um extreme. And I think because they kept being accepted, it's a bit like, you know, when we say if I do this price cut, you know, I might have to delist and no one delists. The system can keep going and keep going.

Paul 31:59

Well, that's what I always say is that you accept the status quo. Why would the government change it? Now obviously companies are increasingly saying, and this is because of global issues, not just the US, they're just saying and and the fact is that these deals are ridiculous.

Felicity 32:12

Yes.

Paul 32:13

That that Australia wants to pay sort of sub-OECD level pricing. Like, well, you're gonna get sub-OECD level medicines then. If we're not gonna if we're not if we're not gonna pay what Egypt is willing to pay, then these are the consequences for patients. And I I congratulations on doing this. It's a really, really good document. Just so the listeners know I'll include a link to it uh in the podcast email, and it's just a it's a fantastic thing to read, and I would encourage everyone to take a look at it, but not just not just in terms of well, this is the this is the reality, and what can we learn from that, but also how should we be changing how we talk about those things?

Felicity 32:55

Absolutely, and you know, one of the things that majority of these really difficult listings are in chronic disease because that's the that's the growth numbers, and the system's always had been a bit nervous nelly ever since it first started with uh biological DMARTs and musculoskeletal and thought it's gonna be two years, that'll be it, and the these drugs can continuing on, and yet we still have some of the most appalling access to them.

Paul 33:20

Yeah, and one of them's off patent for 12 years next month.

Felicity 33:23

And we still can't give earlier access. But one of the things I've been reminding people this week is that in 2011 and 12, the PBS was spending $1.2 billion on statins to treat heart disease, and that was one in less than every $8 on the PBS. So 15 years ago, we were happy to spend a billion, 1.2 billion. And what have we got? Some of the lowest rates of uh cardiovascular disease, significant reductions in uh heart attacks, and significant reductions in death from cardiovascular disease. We invested and it was the right thing, and we're still spending $250 million a year for concessional patients to access these medicines on the PBS. So, what I find bizarre with the arguments that we're having right now on the weight loss and obesity treatments is we've understood the value of early intervention in chronic disease and we we succeeded in cardiovascular. We are talking about dollar values, and it's not $10 billion a year. We are talking about dollar values in today's terms that are nothing compared to the investment we put into heart disease. And so it's not just about risk shares and how much government is making companies give us charity. It's the second, it's the second question, which is we've lost perspective on what it is to genuinely invest in primary care and recognise that that's actually okay. The numbers that we invest in dollars these days, we've lost all sense of uh moderation and perspective as to what really that dollar investment today means in the terms that we had 15 years ago.

Paul 34:58

Yeah, it's a really well-made point. And I and and there's a bit of incoherence in the government's position on this, particularly Mark Butler, you know, he talked about my expectation is the GLP ones go on the PBS. But then in speeches he's been made saying publicly, he's kind of talked down the broad use of GLP ones. And to me, it just seems that the real opportunity in GLP ones is their broad use. They're use by anyone who would be who would benefit. I get it. They're gonna have that I mean the the addressable market in Australia is several million people. I get the challenge, but that ultimately has to be the goal, like it was with statins. Yeah. We did over a period of years with statins, they started small and they grew very significantly in the early 2000s with the heart protection study, which was the Oxford study that had a hundred thousand people in the trial and it basically found that they should be in the water.

SPEAKER_02 35:50

Yeah.

Paul 35:51

And now they're still one of the most prescribed, if not the most prescribed medicines. Yeah, it is.

Felicity 35:56

And like I said, $250 million alone, but that's just for concessionals because so that the majority use of these medicines is actually by general patients and they're all under the copay these days. But we're happy to be spending $250 million out of $12.5 billion a year on statins alone. I'm not talking about any of the other drugs for cardiovascular lead. So we're happy to spend that. So when we're having a conversation about where do we start with the obesity treatments for weight loss, we're not actually starting to a threshold moment going, well, what is that starting number worth? Yes, you've got to restrict it. One of the things that really got me about the Wagovi PSD is that it's not really for obesity. It's actually as a secondary treatment for established cardiovascular disease where you have the comorbidity of obesity. That's effectively how we're trying to, the system's trying to get around how we start making uh access to these medicines available.

Paul 36:51

Yeah, those people are very sick who've been recommended.

Felicity 36:54

Yes. But we're actually trying to say let's do it for we're effectively saying let's give these medicines for cardiovascular disease.

SPEAKER_02 36:59

Yeah.

Felicity 36:59

Um, which by the way happens to treat obesity because we think we might get some better outcomes there in in the cardiovascular disease treatment. But we've got to be challenging that, saying, you want me to get so sick first.

Paul 37:12

Yes.

Felicity 37:12

Before you will actually help me get healthy. And we don't punish you for anything else. We don't say, well, you shouldn't be having a statin because, you know, you were smoking or you were drinking or you had too stressful a job, or heaven forbid you've got the genomics that make make you susceptible. We've kind of really got to get out of this uh blame game of the patient and this obsession that we might actually have to pay for something. And the I've lived this experience when we first had the uh novel oral anticoagulants for um atrial fibrillation, and we were concerned that it was going to be a $1.2 billion a year listing for a select group of people. In the end, you know, it took us 18 months. But that didn't take us four or six years, it took us 18 months.

Paul 37:57

Yeah, but that review was still a pathway. I I know it was a delay mechanism because of the big money involved, but it was still a quick process compared to the GLP ones.

Felicity 38:07

Yeah, 18 months now.

Paul 38:09

So I just I just think anyway, I look, it's it's a really good document. Well done. Congratulations for doing it. I know it's been downloaded a lot of times and there's a lot of interest in it. And I think that's because there's a big appetite for people to understand because there's not enough public conversation about it. You know, this is oh, there's a ratiogram because you go, oh risk, okay. So it's they split the risk between the government and the company. No, they don't. Ultimately, the patient wears the risk because it either leads to companies not accepting it or it leads to some pretty perverse behaviour. And we saw that with Botox and Migraine. The companies act completely rationally. And if if if their selling of a product means they're gonna lose money, and I'm not and and or if the price is negative, yeah, which for some medicines it is, then there's gonna be some very rational conduct in that. And and so I don't think anyone can really complain, but this this is a system where pricing has become sport.

Felicity 39:05

It does, and and we are happy to pay for delay. So pay for delay in the in the patent system is that you pay for someone to to not bring a patent. But in Australia, we make you pay to be delayed through a system. Because if we like I said, we're at year four, actually, we're in year four and a half of the first time PBAC considered treatments for obesity for consideration on the PBS. We have delayed access to those drugs so far by four and a half years, and we are still going down the pathway. That original diabetes inquiry in 2023 was not about diabetes, it was about trying to delay the issue of the GLP1s for obesity. The system is doing everything it can to slow down an eventual agreement.

Paul 39:52

Yeah, and there's some silly and there's there's plenty of mechanisms. I mean, why doesn't the government consider a special patient contribution?

Felicity 39:59

Yeah, well we propose that.

Paul 40:00

I reckon there are hundreds, if not thousands, of people working in this system who don't know what an SBC is.

Felicity 40:06

No, they used to be standard.

Paul 40:07

They used to be standard, and in fact, there are still two. Yes. So so the government can charge a patient a special contribution above the the designated copay. It's not a brand price premium where there's an alternative without a premium at the copay price. This is a uh this is a single brand drug where basically it's a shared cost between the patient and the government. Now there has been obviously a policy reluctance. I think the last one argued for might have been a novo-nautist drug, I think it was when the great dame was running running the company in Australia. So I think I think to me it's we're just so stuck in this. It is the underrated football game.

Felicity 40:49

It is. And look, we we're with you, we've we've put forward the special patient contribution. And so for listeners, it's not that the government just says, I'm just going to charge you. What the government says is that I cannot agree the price that you want company. So I will let you sell it to me at the price you want to, but I will only pay to this much, so therefore the special patient contribution must be made by the patient. Now, I've had a lot of people say to me, but if people already can't afford these drugs because uh through the private access program, then surely we have to do something different. Well, we can do rebates, so you can actually know how we have solar rebates, Paul? Yeah, we're all getting freebies. Uh, we get our you know childcare rebated, all these things. If we decide that it is something that is about making sure that those who earn a certain amount of money don't have to pay as much out of pocket, we can run programs that rebate that money to them. But what I'm really clear about is first of all, you can't only put the drugs on the PBS for concessionals because that's unconstitutional. But second of all, any attempt to move these drugs out of the PBS and to do a separate program to try and get around this issue is dangerous for the rest of us who are going to need access to chronic disease drugs in the future. We should be actually pushing the PBAC in the PBS right now to say you have to evolve and you have to update to handle what's coming for us in the next year.

Paul 42:09

I'm not necessarily advocating for an SPC. I'm I'm advocating for a discussion about SPCs.

Felicity 42:13

Yeah.

Paul 42:14

Now, because apparently in this system, the only equity that's that's acceptable is the worst equity.

Felicity 42:19

Yes.

Paul 42:20

So as long as no one gets a subsidy, then that's equitable, apparently. I I don't know, that doesn't really make sense to me. I'm reasonably au fay with the English language and what words mean. Doesn't sound very equitable to me. So I think there's an opportunity to have a conversation about it. I know there'd be a lot of opposition to it, but again, let's just have a conversation. And if if at if at the end, because that's what what we're not very good of in this in in this system is having a conversation about it. If at the end of that we say no, because the people who really need this medicine, this particular medicine, are the ones least able to afford it. Okay, well then let's let's not do it. But I do note that one of one of the two remaining SPCs is an antibiotic.

Felicity 42:58

Yes.

Paul 42:59

Now, call me crazy. That's that's that's maybe maybe maybe w w one where you know we should have a conversation about that. But SPCs became a big, big problem and was a big cause of the F1 F2 split in 2006 because after the first statutory price reduction, companies said, I can't accept that.

Felicity 43:21

Yeah, so we had something. Blair Marston was always the big one, that was over $800 for an SPC. And it was during Minister Roxan's time that she was concerned SPCs were actually quite a useful tool. Yeah. But she became concerned about if her if her PBS was going to be about equity, she didn't want people having to pay different prices. Um, we did talk about there were different prices for therapeutic group premiums and brand premiums and all that stuff, but she had a philosophy about trying to minimise how much that was happening. Why we elect governments? And that's okay, and that's what she said. That's what I want to do, that's my priority. So it's time to, like I said, open it up again, which is why we've put forward ideas saying this is how you could solve it. I'm with you. Is it the best outcome? Maybe, maybe not. But we have to do something different here rather than get into year four and a half of still saying, here's this problem, here's that problem.

Paul 44:07

Yeah, I think in the end, what's what's missing is this look, there is not a lot of policy uh flexibility or innovation in this system. And we'll see this with the upcoming agreement negotiations, which is going to talk about statutory price cuts and new new review processes.

unknown 44:25

Yeah.

Paul 44:25

So there isn't there's obviously I mean, I I gather that there isn't much of an appetite for reform in this area. Okay, that's fine, but can we at least have a conversation about it? Before we just choose not to do it and engage in the eight-year-old's football game, and and we all just run after the football. You know, it's the fullback's playing full forward and the full four, I don't think they're playing all over the place because they can't hold positions. So that's that's kind of my my opinion on it. But again, uh I think what you've done with this document, and even in that AFR article, I know you're a bit unhappy about it, but sitting aside the headline, I thought it was pretty good. Anything that raises the issue and has a conversation, but you and I both know, and you've mentioned this to me, that that $10 billion fee is going to be weaponised.

Felicity 45:09

It is. It's it's a disaster for us as patients because now we're we're having to fight against it. Something that looks like it's doubling the cost of the PBS right now. Yeah. And it's not the way it's going to be at all.

Paul 45:19

So particularly as we know from the PBOC, that all these patients you qualify for are not going to bother, they're not going to get all their scripts filled.

Felicity 45:26

No, and they're they're they're laying so lazy they can't even inject themselves. Like, oh come on, guys, like really. So yes. Uh I like I said for me, it's the it's the headline that does the damage. And you know, sometimes if it had been even just half that or a little bit less, you know, and reading all people's comments, people just go, oh, what a waste of money. You know, people should do this.

Paul 45:46

People should just get out and exercise. Yeah, well, we've been saying that about everything since World War II. So alrighty.

Felicity 45:52

Well, another sitting week ahead.

Paul 45:55

Oh, there's a couple of events on this week, isn't there?

Felicity 46:00

There's a trucklet of events on this week. Yeah. Well, there's always events on, but yes, you've got a few and I've got a few. Yeah, yeah.

Paul 46:07

Oh, there we go. Well, thank you, everyone. Thanks for tuning in. Keep coming in with the suggestions about the lunatic phrase of the week. I suppose we didn't really touch on it this week, but it's probably just a public summary document.

Felicity 46:17

Yeah, or risk share arrangement.

Paul 46:18

Or risk share arrangement. That's sort of the ironic statement of the week. Absolute gibberish.

Felicity 46:25

It should just be called the charity agreement.

Paul 46:26

Yeah, yeah, yeah, yeah. Yeah, that's so funny. All right, Felicity. Thank you all. Thanks, Paul.