The 'Dispatched' Podcast - Special Episode

In this special episode, the focus is on the official plan to force a 'consensus' on health technology assessment reforms through a process conducted in secrecy under the guise of ethics approval. The problem with running this policy process like a clinical trial is that we do not and will not know the identities of participants, how they were selected, their input, how it is used and weighted, or even the study protocol.

Transcript

Paul 0:08

Hello and welcome to the Dispatch Podcast. This is a special edition. We're recording this on Sunday the 3rd of May. My name is Paul Cross. I'm delighted to be joined by Mark Uhus, Felicity McNeil, PSM, Chair of Better Access Australia. Hi, Felicity.

SPEAKER_01 0:23

Hi, Paul. Good to chat to you on a weekend of well, normally I'd just be focused on sport, but this is something that's definitely worthy of as much consideration as the F1.

Paul 0:32

Yes, and we're in different locations, so here's hoping the technology holds up.

SPEAKER_01 0:38

I'm sure it will.

Paul 0:39

Seems to be working. Right, so there's there's a lot to talk about, and it's in relation to the Health Technology Assessment Review. No one will be surprised. We saw the publication of a patient engagement draft framework for consultation late last week, but there was also two other pieces of correspondence sent to targeted stakeholders for selective consultation. And this is the targeted consultation that Mark Butler referenced a few weeks ago. He said that the department had engaged the appropriate experts and they were were going to conduct some targeted consultation and he would be provided with an update. So we now we now have uh line of sight as to what it's meant by that. So briefly, there's two processes here. One has been run by the University of Technology Sydney, which is the uh Centre for Health Economics, Research and Evaluation, and they are doing a consultation, a more broad consultation on the uh PBAC guideline update as it relates to comparators and discount rate, and people will be unsurprised to know that well uh there's a lot more wording and uh that they're proposing, and uh I think people generally would be pretty disappointed. The other one is probably more interesting and frankly more worrying, and that is a process being led by the University in Adelaide and Adelaide Health Technology Assessment, and this is on the definitions of high added therapeutic value and high unmet medical need. Now, this is uh operating under the requirements of an ethics approval, so it's essentially been run like a clinical trial. 85 stakeholders have been selected to participate. We do not know who they are, they will not know who the other people are. We don't know the process that was gone through which is described as a stakeholder mapping process to select these people. The protocol uh is not being made public. I've requested it and it has not been made public. And we don't know exactly what this process is going to involve beyond being what is you know euphemistically or described as a Delphi process where you basically squeeze out a consensus. Now, obviously, anything like that is susceptible to being rigged by the stakeholder selection. This is a critical issue for a critical public health program, and this reform, much anticipated I would say, is going to be determined by a group of unidentified stakeholders, and in fact, because it's been run under the auspices or the or the requirements of a clinical trial protocol, they're effectively treating these stakeholders as if they are patients in a clinical trial. And this to me is deeply problematic and indefensible.

SPEAKER_01 4:10

So a lot to unpack there. I think uh firstly, thank you to you for um raising this with people like us at Better Access Australia who I just want you to know haven't been invited to either process.

Paul 4:23

Some have and some haven't.

SPEAKER_01 4:25

Yeah. So uh I think that's that's a very interesting point. How how have some obviously some patient groups have been invited as you as you've alluded to, some haven't. Um, obviously some industry groups have will have been invited and some won't have been. Um, and obviously some companies will have been invited and some won't have been. And so your point about how we came to this moment is an interesting one. You're taking it two steps back. So I remember you reporting when you went to the Medicines Australia event at Parliament last year when Minister Butler announced that his response to the HTA review was a guidelines review, which was welcomed. Well, that's good to say that that letter's finally come out. But in respect of this, I guess for me as a as a patient advocacy group, it's not just that it's only that we have no transparency about who is being consulted on these definitions. But as we at Better Access have been talking about for years, our concern about this HTA review and how it is controlled and consulted upon within the medicine sector will have significant ramifications for the devices sector. Because whatever PBAC does, MSAC likes to follow suit. I mean, we even had the Medical Services Advisory Committee comment on the HTA review as much as PBAC did. So it's a real concern for me that after all these years of transparency coming to get consumers as an afterthought in some agreements, that the definition about what I think might be my high unmet clinical need and high therapeutic added value to me as a patient or as a clinician, or heaven forbid as a company, that that is going to be decided off to the side without full transparency and consultation, given everything that's taken so long on this HTA review.

Paul 6:15

What on earth is going on here now and why well the the documents, the relevant documents, emphasize consensus. And that's the purpose of a Delphi study, is to force a consensus.

SPEAKER_01 6:31

But obviously, I thought you should explain that a bit more to people about what a Delphi study really is.

Paul 6:35

So basically it goes through three rounds of iterative questions to get to a consensus outcome. It forces a consensus. So people answer the first round of questions, it gets summarized, and the questions get refined, they go through it again, and they go through it a third time. Obviously, it's manufactured, completely manufactured consensus. Uh it all obviously also depends on who the stakeholders are. Now we know that the stakeholders include government. We we know that it includes the advisory committees. Actually, it includes individual committee members, and it includes Department of Health officials.

SPEAKER_01 7:19

So what are they as a percentage of the 85?

Paul 7:21

So we we don't know. So we don't know, and we're not allowed to know because though we say, well, well, there's an ethics, and we obviously we can't, you know, we're required under the approval to maintain their confidence. So the process is completely rigged, completely rigged. And it's again another example of I I know some medical device companies, some pharmaceutical companies, and some patient groups have been invited to participate amongst the 85. But I also know others who are not privy to it, not aware of it. So I I just let's just take a step back. This review was announced in September 2021. It took 18 months to formally, or another 12 months to formally establish itself, another took another six months after that to actually get underway. The report was delivered to Mark Butler in the second half of 2024. He announced his rapid response in uh September last year, which was this guideline review. We're now another eight months down the track, and so we're getting a effectively a clinical study, a start type a clinical stuff stand a clinical trial standard study of a review of a review of a review. So it's taken us six years to get to a point where we can try and reach consensus. And I'm sorry, if you know I suppose if I'm being kind, may maybe the idea is that we haven't been able to reach consensus, so we're going to force one. Okay. I I don't think I don't think, given the way this process has meandered over many, many years, I don't think the people running the process have earned anything other than cynicism. And so my cynicism is that this is a rigged process. The stakeholders via stakeholder mapping process have been identified and their identities will not be released.

SPEAKER_01 9:18

Well, and I would encourage those who have been identified, I mean, to actually self-identify, um, you know, a bit like you can when you're in a job, I identify as. I identify as one of the 85 stakeholders. But I think what's really important to me is someone who spends a lot of time with both the rare disease community and with the chronic disease community. If you've chosen in your 85 a heavy uh bias towards those that supply to uh the cancer areas or the rare disease areas or our patient groups in the cancer and rare disease areas, you're going to further persuade and end up with a bias in respect of rare cancers, rare diseases instead of chronic disease. Because what's one of the one many things that we've seen the PBS struggle with over the last 10 years, and in particular the last five, it hasn't been small niche patient high clinical need populations. It's been chronic disease that is actually uh crippling the system's capacity to actually provide access because it doesn't want to because it costs so much money. So if we elevate and we have um, like I said, a consultation bias here that elevates those groups immediately over others, then we're going to perpetuate that it's going to be impossible for second and third classes of drugs or extensions of indications, or heaven forbid, chronic disease, look at what's happening with the GLP ones. We need to see, we need to know that you know what is high unmet clinical need in chronic disease and high therapeutic value in chronic disease is being given the same weight and the same experience of understanding as cancer and other rare diseases. Because it it actually is a really important point to me because it sometimes can become so much easier to explain why there's high unmet need in a rare situation or um a life-threatening disease as opposed to a chronic, slowly um debilitating, deteriorating disease which affects half a million people instead of half a dozen.

Paul 11:19

Yeah. Well, there are so many. So identifying one is one to really focus on is a is a challenge. This is this is a new low in policy making for me because uh there are so many problems with the Delphi approach. Obviously, participant selection is critical, and that's not something we're ever going to be privy to at this stage. The wording of the questions and the framing, that's potential risk. Uh, how is the feedback going to be summarized and how is it going to be weighted? We don't know that. We do have an information sheet on it, and and like clinical trials, patient participants in clinical trials are not automatically entitled to see the protocol. This is not that. They are trying to sort of reverse this into a clinical trial standard, so we we can't get access to the information, and it's gonna be outside a lot of FOI requirements. What is the consensus? Like who determines the consensus? And how is it going to be determined? It's certainly not going to be done transparently. So so there are so many problems with this, and uh, and this is before you get to the issue around comparator, the the the the similar process, a little bit broader, the similar process being done on comparators and discount rates, which is well, if people have been holding out hope on those issues, move on, forget about it. Uh, because it's it's essentially, as we've been saying, is is the exception is going to prove the rule. It's essentially status quo with more detail. More detail on on the basis on which they might make an exception. So, yes, I think the people who are participating should identify themselves, but I think more broadly they should refuse to participate, just on principle. Just on principle. You shouldn't participate. This is no way to do this. If this was critical to the process, it should have been done five years ago when this review started. Surely. I mean, has there not been a consensus? I think there has been a consensus, they don't like it. So they're going to create a new consensus. I think that's that's what's happening here.

SPEAKER_01 13:32

I think it's a really interesting perspective, which I hadn't thought about until you mentioned it, which is that has the implementation group, which was after the advisory group, come to the same outcome and same approach? And so this is another way of getting around that. So that would be also useful if that implementation advisory group were to also be transparent about what they signed off on, what they um what they'd already thought had been agreed to, or if they have agreed to this process and were part of the selection of who should be consulted. Um, I think it's beholden on a system that is, you know, starved of transparency. You know, why do we at Better Access always ask for all PBSC decisions should be appellable uh through the administrative review tribunals? Because as patients, as individuals, we have no visibility, we have no say. And once again, that those who are uh consulted or those who were part of decision making uh have a an advantage and a perspective that the rest of the community would actually really appreciate. So um I'm curious. I mean, I don't know, maybe your um uh questions to the advisory group participants for implementation will say that this is what they recommended and maybe why. But we need more behind this. The fact that you found out about it and it's not something that's been made transparently by a community.

Paul 14:51

No, and like the consumer, the patient engagement framework. I mean, but the irony is someone's pointed out to me on Friday, I thought patients were at the center of the framework.

SPEAKER_01 15:02

I'm guessing it was a patient group that like us wasn't consulted.

Paul 15:05

It wasn't consulted, that did weren't part of the consultation. And so obviously not part of the framework. I think the issue here is that this is a massive trap. This is a massive trap. So this is going to be used against the the advocates for change for years. If this is allowed to continue, it's gonna be used because officials at the Senate will say, or at a Senate hearing will say, Well, we consulted all the way through this process. And in fact, the final step of the process was a Delphi study where we secured consensus from all stakeholders. The stakeholders were the industry, you know, uh medical device infirmity, patient groups, the clinic clinical groups are all involved in it, and we reached a consensus that way. So this is what you wanted, people. This is this is how this is going to be weaponised. And I don't think anyone thought for a second that this is how it would end. And I am I am cynical, I am cynical. I am deeply cynical. I'm deeply cynical because I've been in and around this system for such a long time, and I started my career in it. And in fact, some of the most cynical people about this system are the people who've worked in it. Okay, so so because we we're realistic, but this is this is deeply sit deeply cynical. You know what makes this particularly bad is that the the the senior official who signed this these letters to the targeted stakeholders about this clinical trial the Department of Health is funding is the one who who who lamented industry-funded clinical trials as biased a few weeks ago in a in a in a in a public forum. The diabetes. Yeah, in a public forum. Well, you know, pot kettle. And so I think I think the risk here is that again, because it's uh it's a fight club kind of environment, institutional framework where stakeholders are pittig pitted against each other, there'll be a reticence to say, I'm not participating in this, I don't want to be part of it. I think this is outrageous. Uh the people who have been invited are probably so pleased to be part of the process that they'll just happily sign up to it. But I have to tell you, I have to tell you that this is a death warrant. And I'm sorry to use that language, but uh you know, if you sign up to this and you go through the process and you don't resist it, I don't want to hear any complaints when it goes bad because it is going to go bad.

SPEAKER_01 17:29

So are you gonna publish the documents?

Paul 17:32

Yeah, of course.

SPEAKER_01 17:34

Excellent.

Paul 17:35

Of course, of course we've published it. Uh this will be you know, we're recording this on Sunday, but this won't this podcast will not go live until Monday morning. And by that time uh the relevant documents properly protected to protect sources, as they have them from a few sources now, will be in the public domain. And that's that's where they belong. The but the problem is that the people who are determining the future uh on this issue on these issues, and and make no mistake, we're gonna be stuck with this outcome for decades. Really? The people who are going to determine this are not known to us. And I'm sorry, that's just not acceptable. And the fact they're hiding behind an ethics-approved protocol, which also isn't known to us. We don't we can't see the protocol, they're not obligated to give it to us. I asked for it, no response. I've asked for it from three sources, and I and I did speak to a particular person working at one of those universities via email who said they wouldn't answer questions on the issue. And I said, Well, is that part of is that part of the uh a limit or an obligation of the contract? And they said no. And I said, Well, there's nothing stopping you from talking then. I want to know how you went through this process, and no no response to that. It's just appalling.

SPEAKER_01 19:05

Maybe we can get a couple of senators to ask them into a period estimate.

Paul 19:08

Yes, well, that's exactly what should that's exactly what should happen. The the nature of this is just not how policy should be formulated, particularly after a five or six year process. And and I I'm I'm pretty matter-of-fact about this. I think there has been a consensus. I think a consensus has been reached on the need for change, but they don't like the consensus. So they're going to create a new one. And and and they're doing it by rigging the process. And anyone who thinks that that's not happening, well, more fool you.

SPEAKER_01 19:41

Yeah, but I hope your listeners who have been uh invited to participate, and I do understand there's the guidelines one which has got quite a broad audience versus this um 85 stakeholder consultation one, um, will actually, like I said, be transparent or actually call for something better. Because, you know, people do need to be part of this. And I'm very concerned for the devices sector and or the uh uh testing sector, anywhere, anyone that has to go through MSAC, because this will flow through. It will become the new standard, the new, the new benchmark hurdle. And one of the things we consistently see when we try to put the the gold standard of um clinical trials in in medicines into other areas where uh patent and and life, you know, shelf life of a diagnostic or a device is so short that we simply don't have the time and opportunity to actually collate all the information or the high standards of what is added therapeutic value compared to a medicine. And so I think for the devices sector and diagnostic sector, this is something they really need to be front and center on as well, too, because it will change anything that has access to HGA. And you've got to remember that's not just the PBS, it's the MBS, it's the NIP, authority, it's national health reform agreements where anything is done through that space where they consistently want to go into that area.

Paul 21:05

So just to be clear to everyone, device companies are involved in this process, they have been invited to participate. Okay, so that's good. Yes, yes. So and and the MTAA, because the MTAA confirmed to me that they've been invited to participate. So uh obviously they do plan to stretch it across to MSAC. Okay, so that that's that that's what they need, that's definitely what what they need to know. But also remember that this is not confined to industry and patient groups, the advisory committees, the individual members, and government are participating in these processes. And by government, individual officials at the Department of Health are participating.

SPEAKER_01 21:48

Yeah, that's um so very interesting. And I like I said, I assume that it's going to be like in the um HTR review and other post market reviews where individual state and territories participate. Yes, and like I said, because it will link to the The assessment processes for new items under the national health reform agreements, I'm sure they will be most robust in articulating what they think those standards should be. And that should be a concern to everybody, whether you're working in the MBS or the prescribed list or even just in public hospitals. This could be a game changer. So evaluate in Australia.

Paul 22:24

This is I I don't think we can overstate how significant this is and the need for a response to it.

SPEAKER_01 22:31

Yeah, because of what they are seeking to define. Those two terms are the game for everybody. Because I know everybody thinks that their device or their medicine is, you know, meeting a high unmet clinical need or high added therapeutic value. I get that. And I know not all of them do. But the reality is you're going to live with the consequences of these definitions, as you've rightly pointed out, across our entire healthcare system for the next decade or so. So it's time to actually call it out and get involved and make this a different consultation and make it a different process, because otherwise it's patients that are going to suffer. And I particularly think it's going to be those in chronic disease. Yes.

Paul 23:10

They're forcing a consensus for a rigged process. They might deny that it's rigged. If it's not rigged, then I'd identify the participants. What's the harm? Well, what's the harm? Generally, you publish submissions. Okay. And I'm I'm sure I'm sure if I went to all the companies in industry and said, would you happen happily be identified? They'd probably go, Yeah, yeah, fine. Um But they're not the ones we need to worry about. They're not the ones. We need to know if there's 85 participants in that in that particular Delphi study, we can probably together you and I could probably work identify 50 off the top of our heads. But it's the other 20 or 30 or 35 that we need to know. Because I I I would be very surprised if there isn't some putting the finger on the scale here to ensure there's a particular outcome.

SPEAKER_01 24:03

And look, let's let's let's keep an open mind. If it's not a finger on the scale, if it's not it's the secrecy, it's the lack of transparency that leads to concern and mistrust. Yeah. I mean, the greatest way for a conspiracy theory to come about is because you aren't transparent about what's gone on and why and who's being consulted. Most of the time, if you share information with people and you show that it was done properly, people go, oh, okay, well, maybe I understand it, or I still disagree with it, but I understand it. But when you won't share information, when you won't disclose how you came to a particular outcome, that is when the community, patients, clinicians, uh, companies, anybody, researchers, has a right to be concerned and say, if you can't be open and transparent with us, then we can't trust you. So show, show us and let us see the colour of your money.

Paul 24:49

Yeah, prove us wrong.

unknown 24:51

Please.

Paul 24:51

Please, prove us wrong. Prove us wrong. Tell us that we're all being cynical, that it's actually really open. It's going to be a great process. Prove us wrong. Please, prove us wrong. And you can only prove us wrong by revealing the names of the participants. Not the individual names, just the companies, the organizations, whatever.

SPEAKER_01 25:07

Yeah, well, the types on and how they were selected.

Paul 25:10

Yes, and the stakeholder mapping process, which again, because it's all part of the protocol, they're not obligated to release the protocol because they're treating it like a clinical trial. It's absolutely barking. But I think hopefully this helps to energize some people because this is this is where the rubber hits the road and stuff's about to get real. But Felicity, thank you for doing this on Sunday. I know you're away and you've got a big afternoon. And uh uh good luck at the SCG.

SPEAKER_01 25:39

Yeah, thanks for that one, and um commiserations for yesterday.

Paul 25:44

Alrighty. Go, Oscar. Yeah, yeah. See ya, see ya.