The 'Dispatched' Week in Review - 6 February

Mark Butler’s four 'pillars' on medicines policy and the argument that Australia prioritises low prices over preventing shortages and ensuring access. Do we need smarter, targeted incentives to address shortages that often reflect global challenges? Is there a risk of 'process creep' that actually slows access? Aged-care reforms that unintentionally removed funding for dose administration aids and glucose monitoring.

Transcript

Paul 0:07

Hello and welcome to the Dispatched Podcast. It's Friday, the 6th of February. Who knew? February already. My name's Paul Cross. I'm delighted to be joined by Felicity Neal, PSM, Chair of Better Access Australia. Hi Felicity.

Felicity 0:20

Hi, Paul. How is your week on the hill?

Paul 0:23

Oh went up to Parliament House, got a park. Two hours of parking costs$14. Yeah. What's that about?

Felicity 0:32

I know you wouldn't want to, you know, empower democracy. I'm sorry, we can talk to you. And I'm sorry, you should feel free to come in and see your politicians at work, but everyone race out and move that car. It's very expensive to participate in democracy these days. Just ask anyone who doesn't have a lobbyist or advocate working for them.

Paul 0:48

I uh it's very triggering. I find it very triggering going by house. I was telling you this because we were at the same event. I don't know why. I actually enjoyed working there, to be honest. But but uh there's a lot of self-important people up there.

Felicity 1:05

There are a lot of um orange lanyards, but um as well as blue lanyards and green lines.

Paul 1:11

Well, I did have a blue. Yours, too.

Felicity 1:16

Oh I'm not worthy to be a meal present.

Paul 1:20

That is correct. No, um it would look, it was a really interesting event. It was the Generic and Biosimular Medicines Association summit and the focus was on medicine shortages, and honestly, I thought it was pretty good. I found it interesting, very informative the sharing of information on the supply chain challenges, the global supply chain challenges was interesting. I thought Mark Butler's presentation was interesting for a a few reasons.

Felicity 1:57

Well, why don't you step your way through them? Why don't you do Mark, then Jane, then the other stuff.

Paul 2:02

Okay, so the minister spoke for twenty minutes without notes. He's clearly very comfortable in the portfolio. It's quite self-deprecating, it was quite it's quite funny, but he outlined his four core priorities or pillars as he described them of of the Albanese government's approach to medicines policy. One was timely access. That word timely. He talked about the HTA review. He talked about the ongoing the rolling review of PBAC submission guidelines, but also the redefining, the work they're doing on defining unmet need and higher added therapeutic value. We'll come back to that because I thought that was interesting. He talked about affordability, obviously reducing the general copay. We've made our views on that pretty clear. Security of supply, which was the subject of the day, and also the sustainability of the PBS, which was code for spend. He specifically referenced the GLP ones, of course, and Alzheimer's Medicines on most favoured nation pricing, which is the Trump administration's more assertive US posture on pricing. That is, they're doing what we've been doing for 30 years. We still seem committed to complaining about it, which I find very odd and frankly hypocritical. But he's he said what you would expect him to say. I'm going to protect the integrity of the PBS. Well, he can't he's got to say that. He can't say publicly, oh well, I'm gonna have to change all the policies in response to that. So I thought I thought that was interesting. We'll come back to the linking of HTA review and the security of supply issue because we want to talk about that. Uh Jane Halton, who's the chair of the GBMA. I thought her presentation was very really interesting. She she went through and she talked at really a strategic level about the global challenges of supply, uh how Australia focuses on pricing rather than supply. It's generally like most most countries pretty good at addressing discrete supply shortages but not very good at preventing them, and that's because it puts pricing as its priority. So it's it creates a safety net through policies, but it doesn't really work to prevent them. And she's been pretty consistent for a number of years now. She's been shadow for three or four years. It's all very polite between her and my buttler. It's all very compli complimentary of each other, which I suppose is nice given the the nature of politics these days. But uh she talked about how she went raised norm life being it campaign, which is obviously been reading your publication.

Felicity 4:45

Congratulations.

Paul 4:46

I still encourage the way that guy was fat shame in the 1970s. Uh and then she talked about prevention, the need to invest more in prevention, which which I think is it prevention to me can mean almost anything. We've been in trying to encourage prevention from a weight loss and weight management perspective for over 50 years, and it's obviously failed terribly. Uh so as Jane said, the GP she speaks to said say, well, the GLP ones are the first thing they've had in their arsenal that actually makes a difference. So I I thought I thought that was really, really interesting, and and I thought the GBMA did a did a really good job. Look, unfortunately, I have to say the audience wasn't as big as it should have been. And and I I thought that was disappointing. You had the minister, the shadow minister, you had many government health department officials there, up to and including a deputy secretary and first assistant secretary, really interesting presentation or participation in a panel by an assistant secretary. I thought he spoke first assistant. Oh, first assist sorry, sorry, Mr. Henderson. My apologies to him.

Felicity 5:52

You're wrong.

Paul 5:53

But but he just got he just got demoted. But I thought he spoke about as well as you could, given the constraints that are always on officials. I thought he did a really good job. And I thought Anthony Tosoni, who's uh from the pharmacy guild, I thought he was great on the shortage issue in talking about from the pharmacy perspective, that his view and he really is at literally at the front line, he was talking about he in his view, patients and consumers, however we want to characterize them, you know I have the personal dread of the word consumer. So it m makes pay it makes makes it out like we're buying TVs. But he particularly in a system that doesn't actually give patients much agency, let's not assume that's not let's let's not give them it through nomenclature when they don't have it. Uh he talked about the baking in of shortages, that patients have a certain level of expectation now that they're going to be met by shortages, and pharmacists are having to work very hard to address them. So I thought I thought that was interesting. So we we got the global disc we got the policy discussion, we got the global challenges, and then we got the front line from the pharmacy, the wholesaler view, and then from the officials about how they manage it. I th I I thought it was really interesting.

Felicity 7:14

Yeah. Um look, I'd like to comment on all of that. So how do I just go? Yeah, no, I know, but your listeners will get bored. Um so how do I uh right, so let's start with uh the Mark Butler. Yes, look, he's very much like the Mark Butler I used to see when he was my minister and he was in TGA, etc. His strength is his ability to be across his portfolio, to engage with the community and make them feel a sense of space. Um maintaining the integrity of the the system, I I always find it funny. He's there, you know, we will defend our PBS and our PBAC against, you know, those evil people from overseas. Sorry, how many times in the last three years since he's been health minister has he quietly intervened to say the system isn't working for patients and fix it for me? So when we talk about defending the integrity of our systems, let's be really clear here right now. He knows it's not working all the time. And something more fundamental than the desperation of a health minister to intervene because the system won't move as it should. Let's have that more grown-up conversation, please, in the future. Likewise, let's talk about the whole pricing in. Well, this is the man that stood up to the community and said, My job is not to list medicines, my job is to get the best price. So loved his his presentation, but let's let's do some home truths. Because that to me is what was missing in the whole day was, and you know, what we'll talk through um Jane's presentation and many of the pieces of information were really good, and the the panel discussion. The counterfactual was never presented, and that's where full credit to GBMA and full missed opportunity for those who are elsewhere in the sector to not actually say, but what about this? And how does this work with this? And when you look overseas, is this really what's going on? So I want to unpick a few of those things. Jane, with her global expertise, did talk a lot about what is going on globally, um, and we talked about the vaccines. Now, that one I did get the giggles on because she talked about the crisis of what it was to get a vaccine and the uncertainty of that. The reality is, what did we learn was when COVID came, there was a capacity in the entire global network to do something if you paid the right price. So it was a competition and it was actually about funding it to get something done immediately. So the resilience and the innovation and the capacity of the innovative sector, supported by the generic sector, is really strong. So we need to sort of stop um making it sound too much like doom and gloom. And the the thing Australia got wrong is that we thought we were too smart by half. We ignored what was going on and we just thought that we knew better about how quickly vaccines could be done and what kind of prices we could argue about. And that's why we ended up being first in a queue of two after the original queue of 64. And she was 100% right about that. But I didn't accept the assertion or the premise that it can be really difficult to get things in a crisis because in the end the money transacts and that's how we got everything. The second thing that I wanted to talk about with respect to, and I'm gonna leave pharmacy to the end because I actually agreed with a lot of what they were saying. We talked about these problems that were going on. When we talked about the the medicine supply shortages we have, the majority that we that are causing problems for community pharmacy and for patients are global supply shortages. They are supply shortages that have, you know, if you read the UK's reports or the US reports, 20% of them are all in the actual manufacturing, which is usually about the the primary source ingredient. So whether Australia pays$10 or$2, if that API and that manufacturing failure has happened, everybody is having that problem. And I think we need to disaggregate that because GBMA did a brilliant job of saying we've been given all this money for all these medicines. It was just a carte blanche, easy, spread across the system, and we're going to review it. They put up the data that said, hey, you know, we're still having problems, but they're not as bad. But did we target it appropriately? Did we actually do what we used to do, which says these are the ones that are in genuine, you know, supply chain risk? And if you look at the UK and the type of analysis they do, looking at not only global supply chains, but looking at how each country is actually rewarding, incentivizing, and prioritizing access to medicines. So for example, in the UK they only use their buffer is eight weeks. Whereas we used to have six months for innovators, you have to do six months of supply and for generics, and now we've extended that threshold even further. So we have all these things going on, but we framed it as in it's just because Australia doesn't pay enough for generics. And we had people saying, you know, this is why we need more, you know, biosimilars, because, you know, we run out of medicines. My experience is that actually it's the single brand medicines that tend to not have the shortage of supply because they're actually being paid for appropriately. And we have to remember that the reason these medicine prices all went down is because of the trade deals that both the generic providers, the innovator providers, and the wholesalers are all providing to pharmacy in order to get the to get their business. So we have some tensions there, which is irrespective of how much I pay for the medicine, and if I take the the$1.51 to$4, we have some things going on here. We need a more sophisticated conversation about where we incentivize, how we support, and how we manage. And like I said, there's a lot of work going on in Europe and the UK about that, and I wanted to hear and see more of that because it's not we used a blunt instrument, and now we actually need to get smart about it. So it's a growing point, but I give the GBMA a full 100% you know thumbs up because they framed everything beautifully to make sure that the minimum dollars they have, whether that gets reapportioned, we have to accept that that's the money that needs to be maintained within the system. Going to the pharmacy experience and going to what the TGA talked about, which is trying to improve their online stock shortage notifications and being able to understand is it really in shortage or is it kind of almost in shortage? And that the coal face of being a pharmacist, which is by the time you're at that moment, whether it's somewhere, you know, if you're me in the ACT and they can see that it's in shortage or it's somewhere in New South Wales and they might be able to get it or it's in Queensland or it's not altogether. That is a real issue because of the just-in-time nature of filling a script. And you know what? Our system actually pushes for that. So many of your listeners may not realise that if you get a script dispense and it isn't covered by the early supply rule, it means that therefore if you try and fill your script beyond the earlier than the 28 days or sometimes 20 days, it doesn't count towards your safety net. So for someone who actually needs their medicines, that's a big risk. So do I just pay and hope and not have it count, or do I just wait? So we have some other incentives in the system that are problematic. And it's like when we introduced everyone welcomed that the TGA's efforts to allow for the Section 19 so that we can immediately substitute something that's in short supply in Australia, and that doesn't automatically transfer through to the PBS. And that is a real issue for people, and as someone who deals with that myself personally all the time, it's not available this week. We've got this one, but you you're just gonna have to pay for it because it hasn't done that automatic transition through, because we now have such a complex process for the PBS and PBAC that heaven forbid it can't do anything off the back of uh you know an immediate indicator where it should be stock standard if S19's been given. It should be coming straight through. There is no excuse for the PBAC and the department to just go, no problem. TGA said it's safe and efficacious to swap this over. It's automatically available. We all know that it requires a few codes through to Services Australia and you know some some reconciliation there afterwards, but it isn't actually rocket science, and it is something that really would facilitate better support and a lot of less time wasting by a pharmacist to actually dispense the medicine a patient needs. And you know, some of the offensive things that were accused at uh pharmacy in that room about you know the amount of money they get for dispensing these days. If you have to dispense a medicine that's in short supply, the money that the government is paying you is absolutely not enough because by the time you're looking, chasing, putting things forward, uh there there is a real issue there. So I think there's some great opportunities for the harmonisation. I think we need a bit more of a grown-up conversation about what do we really mean by medicine supply shortages, which ones are causing us more problems than after. And like I said, we saw that beautiful example of the I completely respect that some of the generic providers, when they are trying to source uh alternatives overseas, are going through an unnecessary laborist process, and I think that the system can actually be more flexible and adaptable. But as to the whole, you know, we definitely need more money for all of this. Well, I think we definitely need to think about what is the rest of the world doing in this, and it's they're doing some fascinating work. What are we doing? We we actually have much more generous insistence on on materials that are kept here in Australia and volumes, and how can we actually structure that better to make the best use of that money? Because you're right, something may be worth said six dollars, not four dollars, and something that's four dollars really should maybe only be two dollars, and we should be looking at these consistent variabilities we see in things like um anti-infectives and um antibiotics because they are very seasonal, and then finally we need to have a grown-up conversation about we all talked about the saline, and let's be really clear when state governments tender, we all have to pick up the pieces. Yeah, I it's sorry, you can all get another cup of tea before you listen to the next section.

Paul 17:27

Well, people who assume that pharmacy and spend on medicines are from the same bucket of money don't understand the system. They don't understand that services always gets more money. Because it has to. The cost of services is always rising. That's why pharmacy fees go up, it's why doctor fees go up, services always attract more money. What's more, pharmacists never in the history of their eighth community pharmacy agreements have never negotiated away their money. The reason that the PBS the innovators spend within the PBS is struggling is because the industry continually negotiates it away. Nothing happens in this system, or nothing has happened in this system for 20 years without the industry agreeing to it. So all the pricing policies they've agreed to since probably 2002 or three. So anyway, let's set set that aside. My view of the day and the agenda was that it was constructed around the review.

SPEAKER_02 18:34

Correct.

Paul 18:34

And that's a two-year review. So there's a lot of effort and resources obviously going into that, and the minister said it will be on his desk. So who knows what it says? The GBMA said to me that they don't know what's in it. They must have some sense of what's in it.

Felicity 18:53

Be able to feel the void.

Paul 18:54

It it was a very clunky policy, and you will recall my criticism at the time, because it was the first time in living memory, or certainly my memory, and that dates back to the mid-1990s on those things, that a government has never disaggregated a package, a a savings package within the PBS. If there were ten distinct measures like you did in 2015, you broke them all out in terms of budget impact. This one did not. All we know is that the net save was 1.9 billion. So we don't know what the spend on these medicines was. But I think it's much more than people realise.

Felicity 19:32

I suspect it is. And as you know, full disclosure, Better Access Australia lobbied for that to actually go to a parliamentary inquiry, both because it was fine if you were a uh an off if you're a concessional patient, your medicine prices you saw no change, but for general patients, which is one in three scripts, which the majority of those, of course, are the off-patent medicines, your your prices all went up without any consultation.

Paul 20:01

I think the stat on the day was that there are now no shortages for medicines priced under$2?

Felicity 20:06

Yeah, because there's because there are no medicines priced under under$2.

Paul 20:09

Yeah. So so the shortages have kind of shifted up the price range. But you're right, I completely agree with you that I'm sure that the review has looked at this in detail and that there is some nerves within the GBMA about that. So my I don't know, am I being cynical? No, I'm not I don't think this is particularly cynical. I think there is an element, let's try and cut this off at the pass. I've said to a couple of people, I think it's entirely reasonable that the government considers this and says, Well, hang on a minute, we want some of that money back. So there's maybe there's an element of the GBMA saying, Don't touch us, don't touch us, look, it's still bad, it could get much worse. So there's a bit of deflection, all of that. I think more broadly the takeaway for me was that the minister will be considering the two reviews at the same time, they're on his desk at the same time. And I think history, and I I stand to be proven wrong, history would suggest that they will consider them together. That the spend or the save required will be a single package or a single process. And thinking about it in purely political terms, security of supply is potentially a much bigger political problem than patients not getting medicines they've never heard of before.

Felicity 21:32

Absolutely. So and one of the reasons this has been so efficacious for uh the generic sector is that one of the biggest shortages in this country completely derailed aspects of this government's priority of women's health. So it's not much good if we go and put all this effort into suddenly making medicines available on the PBS for a subsidy in perimenopause, menopause, and contraception. if those medicines are continually out of stock. And so you're either being told to use the private one or you just simply can't get anything at all. And that has been a really we always talk about the opportunity, you know, as finance for me it was always waiting for having, you know, savings initiatives in my bottom drawer for when some minister was cranky about something and would let me do something to something. The same goes here that they got the money in a hurry. It was a quick, easy solution rather than the the unrealistic expectation of onshore manufacturing we'd had during COVID for the first time the community really understanding what a shortage of supply was. And again shout out to um Anthony who did remind people that when a chief health officer gets up and says go and stock up on six months worth of paracetamol just in case people literally do that. And we have a problem. So and that importance about how we we message in the community. So genuine medicine shortages is something that the community now understands under COVID. So it's a really good branding opportunity and good policy opportunity and awareness. Like you said, so most people's experience will be and for women I couldn't get my my my contraception or my menopause medication and once again I got told to either wait or try something different and go back to the GP to get something prescribed or use something and pay for something. Or it'll be people that saw some things with you know the cardiovascular or the saline and people who were in hospital and experienced that. So it's real to people as opposed to another version of another medication coming or a new treatment that might be made available and affects a small number of people and they do not realize that it's a missed opportunity until the PBAC application is put in and then it gets rejected. That's when they start to focus on that one.

Paul 23:48

Yeah it's well it just affects many, many more people potentially and it's one part of the health system that's always been pretty solid in terms of you don't you don't really have to worry about it. And fixes like the CSO, I'm sure there are people in government absolutely hate the CSO, hence the$10 million for the review in a few years but I think it's been successful. I mean it's I think it's hard to say that it's that it's not been successful. The problem is the the more global the the check the the global challenges in terms of supply and hopefully the review has has got its uh has has looked into that. I think the the the the HCA review and I look I hate to talk about it but how can we not? Because it because it's been dominating everything for four years. And I think some people are a bit grumpy with me for you saying it's longer than World War II.

Felicity 24:38

But but Well can I just say I did like your reference to the Royal Commission on Robodap which got done in 450 days with the recommendations and the average listing time for medicines is still apparently 460.

Paul 24:52

And this goes to the broader channels it's my my view has been and remains that the HTA review is a symptom of the problem. Not not not a solution to it. That if you are talking I mean you listen to what the minister said at the GBMA summit and again a shame that there weren't many companies there obviously all the generic companies were there shout out to AstraZeneca they were there Moderna was was there I'm sure sure there were others obviously all the GBMA companies were there. They were well represented the Minister's his first response to the HTR review final report was to initiate another review a targeted review of the submission guidelines where they were going to look at the wording around particularly comparative selection and my understanding is that the wording is just going to clarify the operation of the the legal framework there's never been any suggestion that the legal framework will be changed and in effect that will create the basis for exceptions. Now we all know that the exceptions generally prove the rule so nothing is realistically going to change there. He talked about that redefining or clarifying the def this is what he said on Wednesday clarifying the definition of high and high unmet need and high added therapeutic value. Now I'm sorry I I think I think the history of the PBS shows that medicines that are address a high in met medical need and have a high added therapeutic value, i.e really really good breakthrough medicines, generally get through the system pretty well generally, not all the time. The system shows remarkable flexibility for those my concern is that if they're going to throw all of these new processes around those therapies, it's just going to it's just going to slow them down.

Felicity 26:46

Well I agree with you 100% and I've said it more times than people want to ever hear me say again. But that pricing pathway and the categorization that was negotiated and we as patients were informed of in 2018 as it was being done and as the SES officer who literally said if you are in a category D we don't really care about you anyway, quote unquote that has been the most deleterious reform for patient access I have ever seen. It the irony of what used to be that if you're a minor listing and we we tried to get you in within you know on the PBS within six weeks or 14 weeks depending on the complexity and then it was just that if it was a cabinet submission it could take up to six months based on the value. We lost all of that. And now the system grinds to a halt there is no rush on anything and when a first time treatment in 40 years for um eczema or dermatitis can be told you're not a priority because we've got cyclosporin from 40 years ago, that tells you that when you enshrine those terms and those terms are now enshrined in the cost recovery regulations, which means for any patient to dispute that it's so hard, it requires legal change. I've never seen um the interest in the system of actually making that access easier it terrifies me that it will make it even more extreme. So to get into this new special special HTA process for the for for the rare as hens teeth um molecules that the rest of us will be further pushed down pushed down the the food chain and it and we will continue to define these things. Who is it? Why are we always defining what higher met clinical need is and what was the other a higher therapeutic value.

Paul 28:34

Can you think of an example in the history of this scheme, this program where more process and nomenclature around definitions led to faster outcomes. I can't I can't and and the submission pathways which were meant to change the world five years ago slowed it down even further. Slowed it down even further. So what what it meant was that it was status quo for those top category and everything else got slowed.

SPEAKER_02 29:05

Yeah.

Paul 29:06

So it what and because it's inevitable and this is I'm not I I think often the wrong people are in the room and I said this this morning that the problem is the intellectual conversation is rarely had it generally ends up being a process conversation and that worries me because if you get one group of HTA people in a room talking to another group of HTA people what's the inevitable outcome? We definitely need more HTTP you get more HTA you get we should do a part everything can be solved by a process and I'm sorry it's not so I don't know why in some of those pre-budget submissions the intellectual point is not even addressed which is that why are we accepting the framework?

Felicity 29:44

I know I just want 100 days.

Paul 29:46

Yeah so so the HTA review itself has been from the start it was wrong and people have a go up and say well Paul what would you what would you do what would you do well and that's it's a really hard it's a fair question but it's also a hard question to answer because I would never have agreed to an HTA review in the first place. Correct. And I and I said I said this and so I just we can't wind the clock back five years. I'm not Superman but but this this is the problem in my view that you agreed to something that was fundamentally dangerous. And that and that people said to me at the time well what what what what what no review would be better than any review.

SPEAKER_02 30:21

Correct.

Paul 30:21

Because because government uses these in a particular and I'm sorry to labour the point but now now we're in a situ a pretty obvious situation where the minister is considering these things together. Now is it going to be in this year's budget? Maybe not but there's plenty of history of things being negotiated hidden in the budget and then negotiated and announced in my EFO that that wouldn't be that wouldn't be un unusual. Obviously the government has got a huge fiscal challenge based on the based on the industry's ask around the HTA review if you look at the Medicines Australia pre-budget submission I can't see where the cost is I mean they're basically asking for the the comparative wording change and that has already been distributed. Okay so crazily enough crazily enough you know I love Andrew Wilson. I consider him a friend he's a Swan supporter I don't hold that against him but they're working off the language that he produced so the process the outcome's already polluted and I I mean I mean that's just a very cla clever tactic which is that the government effectively puts the language on the table.

Felicity 31:26

Just like the GBA put the language on the table.

Paul 31:28

And the GBMA made I think they made a pretty strong case this week for at least don't touch it. It's too risky. There's a lot of risk here and when it comes to a lot of these things in public health and as I wrote this morning and I've said it many times Australia is a status quo environment because it's complex and the Commonwealth has limited responsibilities. And there's no better example in the pharmaceutical supply chain where the states exercise a lot of power and a lot of authority a lot of legal authority it's hard. It's often protective and the example I used was the National Commission of audit which essentially recommended that we disestablish the PBS as we know it. Status quo stops that from happening but what happens is in these review processes it basically pushes you into a funnel. Now I think there's at the GBMA event there was an element of don't touch it. It was just leave us alone leave us alone but it was well pitched because it was it created fear. It created fear we need more we need more and so so the the status quo instinct will be oh just let them keep what they've got so who knows what that review says but it may not be very good. On the HTA review the problem is the industry's position is constantly responding to the processes refusal to engage on meaningful reform. So they're essentially constantly modifying and shrinking their their ask. And that's certainly the case in some of these pre-budget submissions where they won't change on the comparator selection and discount rate and that only leaves the PBAC 50 other believers to pull.

Felicity 33:09

Yeah well like they said if we modify the discount rate then we'll just fix something else.

Paul 33:13

We'll fix something else and they've said they're going to do it. So I I you know I think people need to you know is it too late but no and I know that you know the research based sector is not inclined to negotiate early and that's fine. They've got the wording of the agreement they should absolutely stand by that but my comment on that this week was well yeah just plan it. Please plan so what are you going to do if the GBMA already talking?

Felicity 33:37

But also assume that you've actually workshopped sorry I was going to say war gamed but after all your analogies this week people might think but if you've war game what are your issues what are your priorities what if this happens and that happens what what are you ready to actually do and and to to to turn over so I mean just because the GBA may may be engaging doesn't mean that you need to and in fact it just means that you need to be ready and have your sort of counterfactuals and have your um ideas ready to go when when you do decide to to walk to a table that will you will inevitably be asked to sit at. So um yeah it'll be interesting.

Paul 34:12

Yeah and please please I don't know this for sure please please be working on savings options because what you don't want so that the problem with the comparative wording now is that they're working off the model essentially designed by the interlocutor because the government's very smart and if you don't develop pricing and savings proposals they I I 100% guarantee you that the health department has worked with finance to develop new proposals. Now that may be as simple as re-legislating refreshing and extending the anniversary price cuts. That might that that might be okay because companies have have planned for that I assume but the industry it behooves the industry to be working on its own proposals not because you have to present them not because you're going to present them proactively but it's just due diligence. You would never launch a product into the market without understanding what your competitor is doing.

Felicity 35:14

Yeah definitely and look I I wanted to pick up something else that was at the GBMA presentation which was the opening address by a patient. Oh yeah um which again those of us who've those people who've been listening to the podcast and watched estimates last year would know a lot about the issue of children getting access to biological DMADs for for Crohn's disease and being made to go through some fairly horrific um old medications in order to then try and qualify for access uh in the the juvenile indications and this was a good story about a gentleman who who's done all the usual medicines, went onto the biologic and I loved the way he articulated that you know it didn't mean give him his life back I mean he could read a book on the on sorry to be you know talk about frankly read a book on the on the toilet instead of being in agonizing pain for four hours. But how it started to give his life back and how the medicines work. And one of the things that really struck with him is he said and then and then there's the three months every three months I have to show that it's working exactly as they intend it to work because it's at any point in time like you might fail a test and you know be called to the principal's office and lose lose your right to access and at what that's like and and the reality that every clinician who works in chronic disease knows and there's someone you know I've I've had asthma since I was 15. So my asthma medications that I started on aren't the ones that work for me anymore. You know you you you cycle through as you need as you need to and you need something stronger and more efficacious. And you talked about that the inevitability that as the body adjusts it doesn't always become quite the same standard of response but for him it's a game changer. They're so good and the ability to to keep using those until such time as he works out that it's not working appropriately for him and the artificial restrictions we have. And I thought it was a great patient conversation but it's my call out again to the generic industry I have been talking to you as a member of BAA on a regular basis about the fact that we were promised as patients that when these medicines came off patents the PBAC and the PBS would expand our access so that children didn't have to suffer the way they're suffering now and adults didn't have to get so sick to get access to to a biologic which are increasingly being found to have extraordinary impact. I appreciate that people are on them for a long time but that was the deal that was the deal and so far no one is actually particularly in the generic sector moving to make that deal happen. So I've seen a lot of the applications from the innovators and I want to thank some of them who over the years have tried to expand indications with some flexibility but if we want to expand access we we actually really need that we need the generics industry as well as much as you're getting your money for your cheap molecules we all know you want to get access to that by a similar lucrative market. What are you doing to make the PBAC own up and say you know what it's time for us to let the flexibility be here. I don't mind if it means that you're the primary medicine first and you know the innovator has to I don't mind what you do but it's not enough for you to just try and save you know your money on your your two to four dollar medicines right now. I want you to have a grown-up policy on what it takes to expand access to the standard of care globally which is biological medicines in both musculoskeletal and gastrointestinal diseases.

Paul 38:44

Well and there are consequences biosimilar policy has been a complete mess for 10 years, 11 years now since 2015 when the last sort of effort was made we tried and it didn't work. And but you know the history of policy is that particular in public health programs where you don't really want to pull heavy leaders you sort of you've got to sort of tinker with it. And it wasn't tinkered with in 2017 wasn't tinkered with so what happens you end up with 2023 massive catch-up price reductions targeting off-patent originator biologics who had not had any price disclosure. Price disclosure is not appropriate no longer appropriate for those community dispensed biologics. I think we can all agree on that but we need to have a conversation about it because it goes to all of the conversation we've been having on this podcast is that if you don't come up with something constructive, the government will come up with its own ideas and it will look something like those 36% catch-ups and they all have unintended consequences. What's more is you miss the opportunity to build some credibility to be able to trade that off with something that you might want.

SPEAKER_02 39:50

Yes.

Paul 39:51

You get punished if if they don't trust you on something like biosimilars they're not going to trust you on something like HTO. It's as simple as that.

Felicity 39:58

So hopefully anyway I I enjoyed the conversation and you know what it was great to be at a forum and not talk about HTO for a I know I I want I want you to know that sitting next to Paul his his brow furrowed both times that uh Minister Butler and Senator Rustin mentioned it and it was like okay but thankfully it's yeah well the big move now is that we're redefining terms.

Paul 40:19

That's the big move. Yeah I know and I I th I thought I mean I just again on Mark Butler he is very comfortable on that portfolio now. Now is there a big reform appetite well besides nationalising general practice appears not so uh will he be allowed to take on a lot of these things? No but I uh it was a shame there weren't more research based companies there because you really needed to hear that stake in the ground they said don't forget about us and the minister put them on the same priority level yeah and and I quite you know thank you for talking about Senator Rustin and her focus on prevention and she's been focused on prevention for years.

Felicity 41:00

And we're the same but I guess we've put it in our budget submission too is your definition of prevention is not just about sending someone out for a walk. And so we've said that a lot of um the the medicines that intervene in chronic disease early so whether that's obesity or diabetes or cardiovascular disease these are effectively in a modern society that is what prevention is too prevention isn't about stopping you having to take any medicine at all prevention is about giving you the right medicine in the primary care setting that stops the deterioration that leads to all the complexities and we do have a system that when you know you've written about the the 1980s and the 1990s and you know people you know the the bias of the parliament in how dare people want to take medicine say oh I just want to take a medicine for something I think we've finally grown up and realised through you know again hopefully COVID that if you have a chronic disease its impact on your productivity is deleterious its impact on your the you know the earlier you were diagnosed and as the Productivity Commission has report reported over and over again the age of the um diagnosis of a chronic disease is getting younger and younger. So the ability to live with minimize the impact and still work productively is becoming more of a challenge. And we kind of need to grow up and say that a national preventive health strategy which is all about screening and vaccination and walk around the block, we have to understand that medicines are a critical part of prevention in the primary care setting and I don't see the industry doing a lot of work on that space and I think it's a very important area to draw those linkages.

Paul 42:40

Well we have to make the intellectual case about prevention. By the way just back on GLP1s there was a story in the age this week which I did share with you and I don't know how to characterize it without getting in trouble but it was about a new form of eating disorder and the eating disorder was someone who'd been taking a GLP1 and lost a lot of weight and so they reduced their food intake which was triggering and they described the condition as someone formerly in a large body and I'd like to say a lot about this fever. But look eating disorders are serious things.

Felicity 43:34

They are they're very serious things this article's unserious I think it's what what I'm noticing in the press um you excluded of course and some a a few others is that because everyone's trying to prosecute this demonization of these weight loss medications and in particular how they're made available at the moment, I mean I'm sure if it was On the PBS, all these articles would stop tomorrow. They'll be like, oh, it's so great because it's a public health thing and people need access to this. But because it's being paid for privately, because of the way it's being um considered and used, because Australia is many years behind what's going on, in particular the US and the beneficial impacts, but all the they are kind of about trying to devalue the the value of the medicines. And it is that classic fear, it's that episode of the Holoman where they think that the pharmaceutical industry can just drive massive reform and massive amounts of money and spending. And we'll talk about that another day because I know I'd price you nuts. A lot of it was true. Um but that's what seems to be happening to me. So we're we're trying to, what what do you do to defeat something when it's not making a lot of sense? You're going for the extremity which says this could happen to some vulnerable people. But as I've, you know, you and I've talked about it and you've written about it. Well, if I'm concerned about that, then I'm worried about people ordering those food products that get delivered to your house so that they control your portions each day, because that could also trigger. And I'm worried about the fact that, you know, if you're you're going to go and do the you joined the gym and you you're doing the online Pilates or the, you know, what is it? Military Pilates is all the rage now.

Paul 45:14

What the hell is military Pilates?

Felicity 45:16

For another episode. Um but I can guarantee you. Or an Asian P Asian Pilates, which is probably where the PBOC got their idea of the other.

Paul 45:24

The only Pilates people in the military are doing are in the ads, the recruitment ads.

Felicity 45:27

Yeah, but anyway, so what I'm saying is there's all sorts of things that go on and we let it ride and we let it uh flow through. And again, it has got to do with the fact that the the pseudo-advertising and the fact that it, you know, we need to have a grown-up conversation about that. But this is what it really seems to be focused on. And I'm a hundred percent certain that the moment the PBS includes some form of a GLP one for weight loss, we'll all be being told how amazing it is, and this will also be.

Paul 45:59

Well, especially because the number of people the people who have been they've been recommended for is tiny.

Felicity 46:04

Well, that's what I'm saying. It's the people that tried Asian Pilates and it didn't work because it's you know you have to be a BMI of um thirty-five thirty-eight and the cardiovascular or thirty five or thirty two.

Paul 46:15

I think it's thirty five and thirty-two. Yeah, or I thought it was thirty-eight and stroke, but it could be thirty-five and stroke and heart disease and uh yeah, I I just let's let's let's be frank here. Uh some people are just unhappy that some companies are making a lot of money.

unknown 46:33

Yeah.

Paul 46:36

So there's nothing you know, and and the f and the stigma that we've spoken a lot about is that what so people don't have to you know eat broccoli and have their dressing on the side and don't eat a burger. They can they can take a very effective intervention and that will naturally ameliorate their appetite. Who cares how their appetite is reduced? I mean, honestly, if it works, it works, and clearly it's working based on what's happening overseas and private demand. But people just it's just this sort of Marxist view of the world that people people shouldn't be allowed to make money out of those things. And and when you look at what happened to the Lily share price this week when they issued their forecast, it was insane. But uh good on them. But good on them. I say, look, isn't they're meeting it they're meeting a demand. But anyway, uh it was a very strange article, but uh amongst many at the moment. Uh aged care assessment.

Felicity 47:30

Yeah, I wanted to just um raise this one because it's as we know that there were significant reforms to the aged care sector and they're you know the home packages and you know, thanks to the Senate, and that included Senator Rustin, Senator Pocock, Senator Tyrrell, who really fought for additional access to home care packages. If you have um an elderly relative and you need to access one of those packages, I can't tell you how long awaited is. And of course we've introduced all these new uh co-pays and contributions, and we've transitioned people from their existing plans to their new plans for their home care packages in the home. And what have we done? We've um accidentally removed access to things like dose funding for dose administration aids for people who are living at home, or medical devices like you know, continuous glucose monitoring or flash glucose monitoring where it's not subsidized on the NDSS.

Paul 48:22

Why, why? So if you if you've got a your ad ho at home aged care package. Or dose administration aid, as they're called now, and your local pharmacists will do it for you, or the wholesalers do it. So they don't fund that anymore.

Felicity 48:42

No, it's uh out of out of pockets on these things don't don't get funded. So you need in in some circumstances, um no d the dose administration aid issue is is slightly complex in that some people qualify and it's covered by the government because there's a program and certain people can have access to that. But those that didn't have access to that were meeting the cost themselves, and many people who are meeting that cost themselves were able to claim those costs on their home care packages as recognizing that that's something that helps them stay healthy, take their medications as they need to, which as the health minister said, we we realise that compliance is really incredibly important for keeping people healthy. And we've had other things such as devices that people were using, such as you know, continuous glucose monitoring or flash glucose monitoring, that are now if you don't have access to that on the NDSS, which means basically you've got type 2 diabetes or type 3C, you no longer have access to that. And so we've had patients, we at BAA have been approached by patients who said, I can't get access anymore, and then they've been sent to a new, we've got a new additional therapies process where you can try and apply. And I don't I don't think this works for dose administration aids, but it's something that they're looking at for uh CGM, which is you try and apply for an additional funding process, and then you have to get a doctor to do that, and it's you're eligible for it for 12 months and it has to be reviewed. Well, why, what, why, what's what's what's driven all of this? I think there's a classic example about when you have one system that's designed and it was all encompassing, and then you move to a new model, and you don't see how to actually fit it into the different, you know, there's four tiers of a home care plan, and it's that classic moment when you change something and then you realize something drops out, and so then you create an extra process to try and keep it back in. And I guess the problem is the problem's been around now for a few months. People are trying to move through that additional process. And like I said, I I first learned about this through CGM, and now they can't get their access. So that one Let me can I ask you a couple of questions about it. The CAA ones really bothers me too.

Paul 50:45

Yeah, can I ask you a couple of questions about this? So if you've got an elder elderly parent who's got one of these packages, so if they've got type two and they've run CGM, I could have the app on my phone and monitor them off-site. Okay.

Felicity 51:01

And there are quite a number of newspaper reports about how that's the same.

Paul 51:03

So that's high utility for that. Uh that's really, really important. Dose administration aid, so these are seniors who would otherwise be in an aged care, residential aged care facility.

Felicity 51:17

Potentially, yes.

Paul 51:19

So they probably have some vision challenges, they've got some physical challenges, maybe arthritic cancer. So the dose administration aid.

Felicity 51:26

They're just aging.

Paul 51:27

Yeah, they're aging. Hey, I've got vision problems and problems with my hands. Uh but but the dose administration aid is a huge tool, is just a very helpful tool for them, but also their families in terms of peace of mind. It's understanding it's standard of care.

Felicity 51:45

A dose administration aid for the elderly on multiple medications is a standard of care. So I know like when my mum went, you know, I was first managing all of her medicines and things, and I was doing the dose administration packs myself until we could actually get her sorted and onto a program. Because once you're taking more than a couple of medicines a day, and you know, even if you don't have, you know, cognitive decline from you know something like dementia or Alzheimer's, cognitive decline as you get older and forgetfulness sometimes just happens. So that ability to have a Webster pack and you push them out, or for someone else to be able to see and assist in that is is so important. Yes. Um and that's the thing when we always talk about medication misadventures and inappropriate hospitalizations, you know, these are medications for cardiovascular disease, these are medications for diabetes, these are medications for renal, and what are the top two possible preventable hospitalizations costing Australia last year? Diabetes was first and cardiovascular disease was second. Majority of people in that age group are over 65 in those hospitalizations that could have been prevented. So why on earth have we designed something? Look, I get it, I'm a bureaucrat. Sometimes you design a new idea and a new process to reflect what's being changed, and you get it wrong. But this is something that can't be something that progresses through over the next four or five months. So, particularly for me, I I get concerned if any of these people are taking diabetes medications on their Webster packs and people who are taking CGM. This is a disease that can ver naturally in your older age becomes uh more debilitating and and can progress very quickly.

Paul 53:21

So Well hopefully it gets er raised the Senate estimates.

Felicity 53:25

One can only hope that's this way.

Paul 53:27

Although I've had a look at the pro the programme and it looks uninspiring. But there's there isn't much going on. Have you noticed that?

Felicity 53:34

Like these Well Parliament was so quiet.

Paul 53:37

There's a couple of events, but I just I think maybe because it's a pre pre-budget, they're obviously working away on that. Um Yeah, I just thought yeah it was it was very quiet.

Felicity 53:49

Yeah, it'll be interesting to see next week, obviously, Senate estimates. But also um I mean this is kind of the first week when everyone's just getting their kids back to school. I do find that tends to impact the number of FIFOs that are around.

Paul 54:01

Right, Fulcity, thank you.

Felicity 54:03

Thanks, Paul.

Paul 54:04

It's nice to uh see you at the GBMA summit.

Felicity 54:07

It was lovely.

Paul 54:09

Um yeah, if they do it again, they should definitely do it again. And I think a lot more companies should attend.

Felicity 54:15

Yeah, definitely.

Paul 54:16

Uh because you need to hear what the other other other people in the room are are talking about and what their priorities are. So uh know your interlocutors. Know your interlocutor, yeah, yeah. And there was a lot of health department officials there. Truck leads. Yeah, truck loads. All right, everyone. Have a great weekend, and thanks again. See ya.