Senate Community Affairs Legislation Committee, , 38:26 to 1:08:41
The department discusses PBS listings for pediatric Crohn's disease and strategies to address rising out-of-pocket costs for specialist medical services.
Topics: Health, Public service staffing
Speakers: David Pocock, Penny Shakespeare, Hon Anne Ruston, Duncan Mcintyre, Hon Jenny McAllister, Andrew Reel, Blair Comley PSM, Dorinda Cox, Dr Nick Simpson, Speaker 6
>> Thank you, Chair. Um morning again. Uh I've I've got some questions on PB PBS access to biological medicines for pediatric patients. Just following up on some some of the questions from last um last estimates. Uh and really wanted to thank the minister's office for um engagement on this issue and I know there's a lot of work happening in the department. I really want to acknowledge that. Um, I note that the the PABAC uh updated its agenda on um Monday the 9th of February to now include seeking um and I'll quote the peback advice on the appropriateness of the current prior therapy requirements specified in the PBS listings for um and I don't want to do a trump here um adelimab and uh inflammab for the treatment of pediat pediatric patients with Crohn's disease and um ulcerative uh colitis and to seek advice on matters relating to the administration of these PBS listings. Um so the issue we talked about last year so so thank you. Um, however, I'm concerned that the opportunity for consumers provide input to this item or any pback matter under consideration at the March meeting closed on the 21st of January. Um, the department issued updates to the March agenda on the 9th of January, but didn't include this um referring to your your testimony and your subsequent responses to my quanss which foreshadowed this item being included on the March um 2026 agenda. I'm interested why this item wasn't included on the update on the 9th of January to give consumers and clinicians a chance to provide input to this important issue. What happened and why was it added after consultation?
Senator uh Duncan McIntyre, first assistant secretary, technology assessment and access division. Um uh Senator, the PABAC has a long-standing process for do for demonstrating how it puts together its agendas. Um and there is a challenge in providing um uh insight into the things that the committee is discussing, but also ensuring that we're consistent in the way we do that. Um when companies bring forward submissions that's the main business for the committee and that's the main um business that is routinely listed on the agenda uh so that uh uh all participants including consumers and um uh as well as uh the companies concerned understand how their submissions are going to be treated. PEBAC also considers other issues related to um existing medicines and that's where um these considerations fall um and those matters tend to be much more dynamic. Um the committee is keen to be able to uh ensure that they discuss any matters that are related to the PBS that are deserve their attention but it's not always possible to um schedule those in the same way because they're not based on a flow of documents and submissions. Um so so that broadly explains the situation. I might pass to my uh colleague um Mr. Rintel to give you an outline of this specific issue at that meeting.
>> Can I maybe just jump in there? I appreciate that that context, Mr. McDar, but I don't think you've answered my question as to why was this added to the agenda after um the time frame where people could actually make a comment um on this on this important issue. You said on Aquan this would be discussed in March, so we knew it was coming, but then you've updated it updated the agenda to include it after the period where people can actually make comments. So, what happened with the timing there? Was it a oversight? Was it something that slowed it up? Why why we're in the situation?
>> Senator, I think we we need to explain that there has been consultation with consumer groups here and this was in fact what has led to the listing uh I think in in in March, but my colleagues have more details. So the deputy chair of uh the pharmaceutical benefits advisory committee has certainly met with patient groups including Crohn's and colitis Australia to discuss the issues around pediatric uh access to biologics. Um perhaps Mr. rental can can talk some more about the detail but this is not being driven by a particular submission uh which then generates uh you know those periods that you're talking about where people can put in um information about particular submissions but there has certainly been consultation with patients and patient groups
>> okay that's good to know
>> um Andrew Rel assistant secretary technology assessment and access division um the department and the PBAC are well aware of the um severity of um issues related to inflammatory bowel disease like Crohn's and the major and lifelong impact they have on um patients. Um there's been a lot of um consultation as Miss Shakespeare indicated with the deputy chair as well and with patient groups over a number of years and the committee um and the department are well aware of the issue. um have received a a wide range of correspondents that will be taken into account um when the committee considers this.
>> Brilliant. Thank you. Maybe just on notice if you could just provide a list of who was who was consulted that would be great. But I really appreciate um also note in your response to um one of my Quans SQ25003146. um uh you say uh and again I'll quote for people listening um the companies that supply uh adelimab and in inflammab uh do not have approvals from the TGA to market them as first-line therapy for severe Crohn's disease current approvals require conventional therapy to be tried first this is consistent with regulatory approvals for those medicines in Europe and the US um inflammab is approved for use after conventional therapy uh While adelimmaab has no such restriction, uh consulting with um people in this space, an expert pointed out to me that over the last 3 years, the peback in its reviews has been seeking to make recommendations for offpatient PBS medicines uh not limited by uh the ARTG registration. um noting that there's there's often no commercial incentive for companies to go through multiple additional artg registration processes and and peback submission costs. And to to quote the peback work plan directly uh in September 2023 as part of its consideration of the postmarket review work plan, the PEAC supported a proposal that the department would consider on a rolling basis where the medicines that have moved to the F2 uh formulary would be suitable for restriction review. the peback notes of this work may support the TGA's medicines repurposing program. Um, and sorry, I know this is a long a long sort of way to get to the question, but one further point, another expert has pointed out uh to me that in the reviews to have broad cancer listings to ensure um rare cancer patients can access PBS subsidize F1 medicines, not currently PBS or ARTG listed for their cancer. The peback is also setting aside the ARTG registration endorsing clinical guidance and and expertise based on the individual p patient. Um so I'm interested is the department going to give the peback briefings or advice that it supports or requests that this approach be taken for pediatric um Crohn's disease.
>> Uh Senator, thank you. There there um there is indeed discussion about these issues um at um Peback. Um the challenge is always to ensure that we understand the evidence that's available about the likely impact on population health and to ensure that um any changes to restrictions are going to ensure the safety as well as the e efficacy of those treatments um and that they can be supported by the company in the way they supply the um the therapy. Um but we have with us uh Dr. Nick Simpson who is our expert as a chief as a senior medical officer that supports these discussions. Um and I'd like to give him the opportunity to give you a bit more guidance about these.
>> Thank you. Uh Nick Simpson, medical officer in the um technology assessment and access division. So I think um there are examples where the uh PBS restrictions uh are broader than the TGA indication and a good example of that is actually where the PBS listing is unrestricted. So then the clinician can use medicines um as they see fit um and and that can be um uh off label so outside of the TGA indication. when it comes to um the biological medicines for um inflammatory bowel disease um the uh current PBS restrictions are broadly in line with the TGA indication but I guess the um consideration at the March um PBAC that's coming up is an opportunity for the um committee to um look into that aspect and decide whether that should remain the case or not.
>> Thank you. Um part of the challenge here is that a lot of the clinical trials that have been done on these drugs were done on patient populations that had already tried traditional therapies. So a lot of the discussion is about um whether we know enough about what would happen if those therapies have not been tried first um about patient uh safety. And so that's a big part of the discussion um and where the p where the um uh committee uh can assure itself that there is sufficient information about safety and efficacy in the absence of that and in the absence of sufficient clinical trial data. That's where they'll consider a relaxation of the
>> M Thank you. That that's good to know. But my understanding is that there's nothing to stop the minister um and the the department advising the government's opinion on the matter. um you know they're the decision makers. Um PAC provide advice and I'm wondering if that's if that's going to happen. Are you are you working on that? What is what is the the view on on doing that?
>> Uh yes, Senator, the um department supports uh peback uh with all of its deliberations and uh seeks to help the committee to uh have access to the information and evidence that would inform their deliberations. Um the minister um who is the decision maker for these matters ultimately uh seeks to be guided by medical and economic advice in making um those final decisions. Um and therefore the minister would not presuppose himself to have a the clinical experience to make those decisions in the absence of advice. That's why he has peback to advise him. The government has committed to accepting the recommendations that PEBACK make and uh legislative provisions within the um the acts that uh outline how the PBS operates restrict the government from making decisions in the absence of a recommendation of PEAC to protect um the public from potential both safety and um uh and fiscal um >> blowouts that would occur if ministers did not have have to take advice.
>> Thank you. But that doesn't preclude the the the minister and the department providing your opinion on a matter to PBAC. Um and I'm interested if is the minister of the department going to do that or are you just going to step back and wait for peback to provide you with advice?
>> Senator, the department provides our um advice consistently to PABAC to inform their decisions. I' I'd like to urge that uh to to stress that the department doesn't have its own independent opinion. Our job is to reflect the evidence um to understand risk to understand uh the impact on different groups. Um we uh have certainly ensured that uh members of PABAC understand the importance of this and indeed many other issues uh to patient groups and uh um ensure that they're in a position to make decisions in as timely a fashion as
>> Okay. Thank you. Again, I appreciate all your work on this and I really just wanted to go back to where we started last year. We we have currently have a case here in in in Canra where we have two young boys, brothers with Crohn's disease and their mother has watched um one of her son's health destroyed by the older medicines and then vastly improved by bi biologics um and she's now watching her other son go on the same journey um and I think she's very sensibly asking why why are we doing this to children when we have this new technology which clearly um is proving uh effective. Uh their doctor wants to get him onto uh biologics but is hamstrung because of the rules that are that are in place. Um and so their only option at the moment is to watch this this poor young man's um health suffer and and potentially have lifelong uh consequences. Um so I guess this this is a political question. Minister, can can we get a some sort of commitment from the government that you're you're going to sort of follow this through and make sure that we do have a system that I guess takes these cases into account um and can make changes to to avoid this sort of um what seems to me unnecessary
>> Thanks very much, Senator PCO. And uh the suffering of children in particular is a very hard thing for uh any parent to endure. I know that um I indicated I think in the last hearing that Minister Butler's office would be um very pleased to hear um from the family that you referred to and I understand that Minister Butler's office did meet with um that family or at least that parent uh along with her local member Mr. David Smith. Um I think there has been then ongoing contact um between that family and Minister Butler's office since which is to say that the government takes representations of this kind very seriously. I think the officials have talked to you about the options that are now being pursued uh in relation to formal consideration of these questions. I think you heard from the officials evidence that um when we are talking about a populationwide application of a medicine, there are important questions of safety and efficacy and cost effectiveness to consider. That's the foundation of the PBS. Um and and I I would be very hesitant to intervene in a way that undermines very ser the the technical advice that we receive about a very serious set of questions as was outlined to you by Mr. McIntyre.
>> Thank you very much represent and again thank you to everyone in the department for working this. Hopefully we have something to celebrate the next estimates.
>> Thank you Senator PCO. Uh Senator
you very much. Um just um quickly um on the the bulk billing um targets in relation to the 50% decrease in out-of- pocket costs by 28 to 29. Can you just confirm whether this refers to a 50% decline in average out of pocket costs or the total quantum of co-pays co-ayments that Australians will be expected to pay when they visit
Uh Senator, it's the overall uh cost to patients. So total quantum.
>> So the total quantum of co-ayments Australians pay when they visit a GP.
>> Uh so it would look at the amount of money patients have been paying for all services um non-referred >> non-referred Y uh services uh before and after implementation. So it include looking at how many patients are receiving free services with no additional cost. How many are >> paying the co-ayments?
>> Okay. So in terms of those people that are paying an out of pocket cost, so where what is the um anticipation in terms of the trajectory of that particular figure? Uh cuz in in the impact analysis I find is there is there is there a suggestion that's going to be reduced because I think at the last estimates some not quite sure but somebody said that they thought it was going to go up.
>> The the objective of these measures is to increase the number of patients who are able to access uh critical primary care services at no cost. Yeah. >> So that that's what we'll be aiming to to measure and you know I think we also discussed last time if there are further interventions that need to be made perhaps in particular communities or areas uh where the bulk billing uh rate is not moving as as as much as we would like. Uh really the objective is to try and ensure that there are bulk billing practices available to more patients so that they can um access services without cost.
>> Yeah look I understand that. I'm just trying to understand um where where would I or what is the um the government's or the department's analysis of what is going to happen to out-ofpocket costs for those that do have to pay an out-of- pocket cost. Uh
so as as part of the evaluation we were discussing uh earlier today, we'll be looking at the overall impact of these measures on out-ofpocket costs for Australian uh patients accessing non-referred um services under Medicare. So we'll be looking at that. That would be an aggregate uh assessment. Yeah. >> Um and you know, as I said, if there are um uh further things we need to do to to get to 90% bulk billing by 2030, um then the government would be looking at additional measures.
>> So you've got you've got three measures that your or metrics or targets which are the bulk billing rate, the number of practices that are fully bulk bill and this 50% decrease in out-of pocket costs which is the total quantum. I'm just keen to understand is there where has the department is the department doing anything in relation to understanding what the trajectory they're expecting for out-of pocket costs for those who actually pay to go to the doctor. Notwithstanding everything you've just said about what the purpose of these measures are may not have anything to do with these measures but what is what is the expectation do you have um as you have with these projections? Do you have projections on what you think is going to happen to out of pocket cost for those who do pay?
>> Uh I'm not aware of any projections. I'm not aware of any um >> projections targets that have ever been set for those sorts of things. We publish regular data about those cost.
>> What is your expectation?
pocket cost that is a decision that that doctor will make. Uh we can't anticipate
>> Well, one of your officials told me at the last estimates they were anticipating that it was going to go up. So um maybe you should perhaps get
>> we are expecting that overall um costs for non-referred attendances for primary care services for the Australian population will reduce as a result of these measures and that's what we'll be tracking because patients will be getting you know that you were being
very tricky in your answer because I'm asking about something completely different to the question that you are attempting to answer. I am asking you quite clearly about the out-ofpocket costs for those people who will continue to pay to see a GP. That is what I'm talking about. You're talking about something completely different. So, if you don't have an answer, I'm happy to move on um as to what your expectation is, but I just draw to your attention that your agency at the last estimates told me that they were expecting that they would go up and now you're saying you don't track them. Mr. McCabe just said he's got no idea. I'm happy to move
on. certainly track those figures. They are published regularly.
>> Yeah. In retrospect, there's nothing into the future. Okay. Can I move on perhaps now to medical specialist fees? Same people. Okay. Um, so do you have a breakdown of the average out of pocket costs for specialists on the most recent data? Senator, department of public website the last Medicare. I'm just trying to see if I So just be keen to understand how much the average out of pocket cost for specialist fees has increased over the past three years in a dollar figure.
>> Um so we're looking for a figure for all specialist services excluding non-referred. >> Including diagnostics.
Um you can exclude diagnostics if you
>> I'm just I'm not sure how we've got the
>> But you mean give me the data in the
So, Senator, I have data. There is more data and my colleague will hopefully have it for you on terms of how it's gone over time, but I have um data uh from the last 6 months compared to the previous period in 2024. >> Uh and for specialist attendances, um the average patient contribution for the last 6 months was $12348.
And what does that compare to in the same six-month period of the year before?
>> Uh the previous period was um in 2024 was $114.92. Senator
>> 92. Okay. So the minister indicated um in a press release um and subsequent media that um he and and I quote, "All options are on the table." They're his words to address specialist out of pocket costs. So what options has the department modeled so far in relation to the options on the table in relation to addressing the uh co increasing costs of specialist out
of pocket cost? Uh senator we are working on a range of different uh options. So there there are things that have already been announced and are being implemented. Uh so um the government's commitment uh to increase uh more information in the medical costfinder websites so that patients can get access to information about uh individual specialist charges before they uh seek uh specialist care and if you're interested in more detail about that we've got offices here information the minister uh attended a roundt in October last year with uh patients and patient groups uh specialists and their representative organizations, private health providers to discuss options um to go.
>> I was actually asking you what options that the department had prepared for
them. So as a result we were also at that round table of course
>> but but you this was your recommendation that he did that what what
>> so following that round table and the discussions we had with with patient groups specialist groups and private health providers uh we have been working on other options. Now one of those particular um pieces of work relates to making uh the medical costfinder website information more valuable to patients. So there's a lot of uh misunderstanding uh around referrals to specialists at the moment and whether or not >> can shop around.
>> Yeah, I haven't got a lot of time. I understand what the medical cost finder is and I also understand that because it's been a matter of public um I'm just trying to understand um you know what what are the option I need explanation.
The department released a discussion paper about improving uh referrals to specialists so that patients can uh more effectively um shop around for specialists if they if they want to make sure that they that they're getting access to an affordable um specialist. Uh so I won't go into detail. there is a a discussion paper but that that involves you know potential digital referral uh options making it clear uh that patients don't have to attend a particular named specialist under Medicare they can go to another one which is not widely understood at the moment we talked
>> Russ maybe it's helpful if we let Miss Shakespeare um give a foolsome answer to her question just so that I know that you're you're wanting to to seek a particular answer But uh it's helpful if the witness is able to complete their answer and then you can ask your
question.
>> So we're continuing to um work on on supply side approaches as well to make sure that we're increasing the supply of specialists. Uh so um uh working on expanded expedited pathways uh for international specialists which followed recommendations from the CRUK review a few years ago uh to make sure that we um have have easier access uh for international specialists in need uh to u migrate and and be registered in Australia to provide care. Uh we've been consulting for um several months uh on reforms to the specialist training program which is the Commonwealth investment in training specialists to make sure that that's appropriately targeted at increasing the supply of specialists. Uh we're also looking at scope of practice reform. So if we've got uh patients needing to see specialists at the moment and that's limited by supply and that's leading to higher costs. Um we've been looking at uh measures to uh improve patient access to things like medicines. We discussed yesterday ADHD prescribing. If there's problems with patients affording uh or getting access to psychiatrists uh they will be able to get access to the medications they need through other uh health professionals. So there is a whole range of work that we are doing uh and advice we're providing to the government on how we can address specialist out of pocket costs. And I do
want to just add, I know Senator Ruston, you indicated that you're very aware of the cost finder, but I mean this has been a project established by the Morrison government that really hasn't worked. So at the end of 2022, I think there were sort of some, you know, 6,300 eligible specialists and just six of them had voluntarily published their information to this costfinder. This was a $24 million project under the Morrison government that really didn't work. And the minister has today introduced legislation to fix up this project. Um information actually is one of the relevant tools that we can use to improve circumstances. The officials have talked you through about some of the other work they're undertaking. But this intervention is significant.
>> Thank you very much, Minister. Um the minister, not this minister, the minister for health has it um has indicated legal enforcement of fees but has cited potential constitutional constraints as why that can't happen. Um to your knowledge, is the minister intending um to pursue a constitutional amendment as part of his options that are on the table?
>> I don't know what you're quoting from, Senator. >> I mean, I I think the I mean, happy for you to table the quote.
Yep. Okay. Well, I can I can do that. That's fine. I'm happy for you to have a look at it and then maybe answer it after you've had the chance to contextualize it. Just that I mean I'm assuming that the whole constitutional requirement that you cannot constrict doctors is impacts on any um constraint on fees. You can't stop a doctor from
charging. Well, I I think Senator um many stakeholders make reference to constitutional constraints, but but I I don't I I would like to see the quote you've got before for before for you >> because there is a lot of um uh to conscription is a very quite a specific thing.
>> Yeah. Okay. Well, maybe I could ask the minister, can do you rule out a referendum on doctor's fees, minister?
Senator, I think the officials have spoken to you about the work underway. I think that the officials have talked to you about the work that's underway. The minister has asked the department to provide advice to him about options.
>> So, you're not ruling out a referendum on Dr. Space.
>> Senator, we're back somewhere in the vicinity of the bedroom tax when you are making up policies and then asking the government to rule them in or out. Uh the officials have been really clear about what they're doing. They've been asked for advice and they're providing it.
approaches to uh regulating um fees and patient information about fees. It wouldn't necessarily need to be through
>> No, I understand that. I was actually asking a specific question about that.
>> We've provided advice about a a range of different approaches to ensure that that fees are regulated or that patients um received informed financial consent.
>> Thank you, it's super important would be
>> I was just going to make the point that the other thing that we're trying to do to support um patients with specialist fees is improve um informed financial consent and we're consulting with all of the specialist colleges to make sure they have >> um stronger processes on form financial consent as well. Senator