Senate Community Affairs Legislation Committee, , 1:25:48 to 1:53:04
The committee debates the implementation speed of Health Technology Assessment (HTA) reforms and election promises regarding Pompe disease screening.
Topics: Health, Child safety
Speakers: Hon Anne Ruston, Duncan Mcintyre, Penny Shakespeare, Dr Liz Develin, Hon Jenny McAllister, Blair Comley PSM, Dorinda Cox
Uh so the department is uh getting on with work uh to implement um some of the recommendations from the HTA review that were announced by the minister last year. Uh there's been further advice provided to the minister since then from the implementation advisory group that was established to uh provide more um context about implementation of some of the recommendations and and uh work out which ones were uh should be prioritized. Uh so there's been a a lot of work and a lot of work continuing on um implementing reforms.
>> Seems to be a lot of talk but not a lot to be seen for it. So the thing that concerns me is that, you know, you've seen a there's a lot of announcements about new medications. We understand how the back end of the system works. We've, you know, seen concerns raised about um u medicine shortages um in this country and and obviously um the impact of decisions out of the US in relation to um favored nation status. I'm interested to see you like it appears to me that the continued refusal to actually implement the HTA review with any great urgency, you know, all of these things are happening around us. So, we're spending less on the PBS. We've got medicine shortages that are increasing. We've got threats um coming out of the US um on the back of um many issues that relate to um matters that are contained in the HTA review. it. So, can we expect um measures in the up and cominging budget in relation to HDA reform?
>> So, uh Senator, if I can talk you through some of the recommendations from the HTA review that we are currently working on implementing. Um because I I just don't think that your characterization that we're not implementing HTA review recommendations is is is accurate. Um so there were uh uh immediate pieces of work announced by the minister in response to the hta review last year which we now have underway. Uh so for instance recommendation three from the hta review streamline and simplify health technology assessment processes by removing unnecessary complexity and redundancy. Restructure and develop health technology assessment processes including level of evaluation. So maybe
you could tell us through those. I mean
>> that's just one recommendation. I can go
through many many more about processes. >> I mean that that that really is the crux of the whole issue with HDA, isn't it? It's about the streamlining of of the process to make sure that people that we're getting quick and easy access or timely and safe access to to new treatments and um in Australia. So where is that actually hitting the road
my colleague to take you through some of the the work we're doing uh at the moment. But I also think that you need to understand the context of the pathways and and PBAC processes that have been developed with the medicines industry um through strategic agreements since 2017. So, we've been on a a path for nearly 10 years now with streamlining PBAC processes.
>> I think that's the point, Miss Shakespeare. We've been on a pathway for nearly 10 years. and the sector is is is screaming out for action.
>> The sector needs to work with us on this and that's how we are implementing the the the the changes and streamlining of the assessment pathways. The pathways have been put in place in consultation with the medicine's industry uh and and through agreement um through under the access to medicine's working group. Before we can restructure those processes, we need to do that in with the medicine's industry, including because of our commitments in the current strategic agreement with medicines Australia uh clause six for instance. um you know the the strategic agreement commits us to working with uh the medicine's industry uh to continue the current important dialogue uh to to deliver improvements in relation to health technology assessment. So we're working in consultation with the industry to do that at the moment. Now if I can um get Miss Norris, Mr. Mentai to talk about how we're doing that.
>> Yeah. get to that point, you know, to enter into an important dialogue. I mean, I'm trying to work out where the rubber hits the road here in terms of Australians getting um a quicker safe access to medicines. It just seems like a whole heap of bureaucratic gobbledegook. Um and you know, that is what the sector is telling us is that it's just bogged down in the bureaucracy. So, um, you know, maybe this is a a conversation for, um, a a Senate committee because it strikes me as we have been talking about reform to HDA for an incredibly long time. I mean, yes, there is the strategic agreement in place, but this was this whole process was supposed to come out at the other end of it with um an improvement in how
>> so
>> Australians got access to to
pathways, which is the the ones we're now going to be um streamlining, uh have been developed with the medicine's industry to meet commitments, including to reduce the um uh time between PBAC recommendations to listing by an average of 3 months under the last strategic agreement, which was achieved. Uh we've had uh four different categories of assessment pathways developed for the pathways These are the things that we're now reforming.
>> Okay. Could I just ask some questions about it? So you're saying
>> so Shakespeare is actually responding to your questions. So we do not we fundamentally do not share that view that has been put to you. We feel we're constructively working with the industry on what are quite complex issue which go down to the matter of detail on streamlining. It's also the case that we would take the view that PBACK is already adjusting its process in a range of ways. A good example of that was last year in considering um contraceptives and listing oral contraceptives for the first time where they really took to heart recommendations of the HDA review on how you dealt with comparators and what was effective practice. So we just don't accept the characterization that people are sitting on their hands in this one. We're working through those things. They are quite complex.
>> Yeah. Okay. Thank you. Um I'm just sort of trying to get to the bottom of what appears to be a access to medication problem at the moment in terms of the number of medications that are we've got shortages of the impacts of international changes etc etc. Um because at the end of the day the only thing that really matters here is that Australians are getting efficient access to treatments. Um, and the amount of times that you hear the story that there are treatments that are available in other parts of the world and they're not available in Australia because of the, you know, the 466 average day it t it takes to to get a medication listed in this country and just and I'm sure you're working on things, but it just seems to be inordinately
well, as we previously discussed, so I'm happy to go through it, but I won't volunteer it unless you wish me to. On international benchmark studies, Australia continues to uh demonstrate that we do provide timely access to a broad range of medications. Um, it is a challenging process. We've been able to successfully reduce the time. We are continuing to continuously work on a range of measures within Peback to streamline that. most recently uh just a couple of weeks ago are um two major subcommittees of peback dusk and esque which look at the clinical um aspects of a drug and the economic aspects of a drug. In the past they've tended to meet separately and then bring that together in a third meeting. Uh they met together most recently as a trial um to see whether we could find that as a way to deal with things more expeditiously. We have a range of medications that um have um tests that need to be done to see whether or not those medications are appropriate and we have a different committee MSAC that assess the tests and peback assess the drugs. Those two committees are working increasingly well together and we're ensuring uh that the information between those committees can flow quickly. All of these were matters were things that were discussed in the HTA review and are uh embedded in quite a number of their recommendations and we are continuing to evolve those um those mechanisms and finding ways to speed those up for particular medicines where it can be helpful in their assessment.
>> Sure. Um what advice have you given the government in relation to the potential threat of most favored nations?
>> Uh Senator, we've um had some discussions about this in the past. It's a little bit uh challenging to talk about uh some of the current um uh advice that we provided to government but you can rest assured that we're providing comprehensive advice to government uh about a range of issues that come up internationally including uh the US administration's policies related to pharmaceuticals. Um of course specific questions related to our trade arrangements with the US matters for the department of foreign affairs and trade.
So in in relation to like any impact that's flown through to date to your area, I mean I understand the trade negotiations of this afternoon I think we've got as estimates um but have you seen any impact so far in terms of um um drugs into Australia as a result of
MFN? So, uh, Senator, of course, this is an issue that we're, uh, monitoring very closely. Um,
>> but have you seen anything? I assume you aren't monitoring it, but have you seen any impact?
>> Well, what I can say is that consistently we're seeing a a um a steady stream of applications for our committees and that the the rate of applications is very close to its historic averages. we can take you through uh those. But what we're not seeing um a reduction in the number of um of requests that we get to the committee. Um it is of course an easy thing for companies to uh say that um uh their international arrangements are altering their behavior. We're trying to look at the behavior rather than uh what's being said. Um and what we can say is that there continue to be uh incentives in the Australian system to uh make it um profitable for companies to bring forward new medicines. Um and most companies where there is a profit to be made um would be keen to have us assess their medication and make it available and that's what we seem to be seeing.
>> So the other the flip side of that um still registering getting applications to to provide or supply into the Australian market. What about existing medications that are in the market? Have there's been no no threat of withdrawal of any of those?
>> Senator, there's um for forever on the PBS there are reasons companies give why they um suggest
>> they might reason. No, no, I understand that there's obviously going to be always they're going to withdraw, but has there been anything that has been related to this in terms of you know the pricing threat and impacts of of MF?
We've certainly had companies that have said that they are concerned that they might be put in that position and I think some of those companies made uh statements in the press to that regard as well. Um however in terms of the pattern of uh Dlists on the PBS um that pattern appears basically in line with its um longer term uh longer term expect the longerterm patterns we've seen. So at this stage we've heard a lot of people talking about this. Um but in terms of uh what we're seeing in the system um the system is continuing to operate. We do get medicines delisting. We get new medicines coming on. The number of new medicines coming on tends to exceed the number that are delisted.
>> Yeah. Okay. All right. Well, we'll just keep watching this space and hope nothing um detrimental impacts on Australia's access to their medications. So um just finally um Any update in relation to Pompei disease?
>> Yes. Wonderful promise. Yes.
>> Um wonderful promise made by the prime minister in 2022. >> Unless Wendy has her.
>> uh good morning Senator Litz Delin, Deputy Secretary of Primary and Community Care Group. There is no further update to what we discussed at last estimates. The MSAC recommendation has been uh published. That is yet to go to health ministers which we anticipate happening in the first half of this
>> Um minister, is the government still committed to um having newborn squat screening for all 80 conditions including Pompei disease.
>> I think the officials have talked to you about the uh the work that we're going through. It's obviously something that requires the engagement of states and territories and Miss Develin has previously advised the committee about progress on that and her update now is really about the timing of uh when we expect that to be put before all of the ministers.
So the commitment by the prime minister in the 2022 election campaign while he was holding a baby with Pompei disease uh to launch um Labour's policy to end the postcode lottery and screen 80 conditions nationally including Pompei disease. Um did he mark that promise without the ability to deliver it? Uh
Senator Ruston, I think the officials have talked to you about the way that we are seeking to deliver that process, that promise through the existing processes.
>> MSAC have recommended um or advised against um new board newborn screening program for Pompei disease. Does the government not agree with MSAC and is it intending to continue with this process despite that recommendation?
Uh, Senator, I don't have anything to add to the advice that's already been provided to the committee by Miss Develin, last estimates and now.
>> So, what do we tell the parents of children with Pompei disease today?
>> Uh, Senator, the officials have talked to you about the work that is underway. uh there will be an opportunity for um uh ministers to consider this um later this year as Miss Develin has indicated. Uh I I don't have anything to add to the material that has been provided to committee previously.
>> So just to be clear um is it still the position of the Albani Labor government to pursue the inclusion of Pompei disease in new blood screening program? I think the
officials have talked to you about the process that is being worked through
>> No, I understand that, Minister. I understand that very clearly. I'm just keen to understand if it is still your government's position that the process for the listing of Pompei disease on this program is still the position of your government.
>> I think the government has been very clear about the significance of newborn blood screening, about our determination to expand access. officials are talking to have talked to you about the process that we are working through.
>> So, it's still on the agenda.
>> Senator, I think I've answered your question.
>> Well, I suggest you haven't answered my question. Um because right now I don't know what to go and tell um the parents of children what the future is for the screening of Pompei disease because you've given me no indication. The only information that I have since the prime minister made a promise to Australian parents uh in 2022 that there would be 80 conditions screened nationally. um you now tell me that um well the officials have just told me that you know it's a matter that needs the support of the states and territories and we don't know whether they're going to give us that support. So that would suggest that the prime minister made a promise that he didn't have the capacity to deliver on um and as I'm standing here today all I know is that MSAC has recommended against including Pompeies in the newborn um screening program. Um can does that I mean so we are continuing to pursue the inclusion of Pompei disease on the the screening is that is that a matter that will be put to the the state ministers at the end of the year I mean we're talking sick it was four years ago this promise was been made
>> uh senator just to add to previous conversations we've had around this the decision-making pathway has been that states and territories would agree the conditions that would go to ISAC because they felt there was sufficient level of evidence appropriate for MSAC consideration after the MSAC process that obviously makes its way through to health ministers. Some additional information that we haven't discussed in previous estimates is an ongoing process to consider conditions even if they do not make it onto the screening program. Now there is a continual process should evidence change, should the test become more effective or efficient. uh and we have recently had the public call for new or other conditions and we see this as a continual process that as the evidence continues to grow the reconsiderations can be made of further conditions to be considered if they haven't if their evidence wasn't sufficient previously. So I don't think we've described that previously, but we have recently gone for the public call for further conditions to be considered and that will be an ongoing process
>> and and that's that's fantastic for the ongoing the the other conditions but we quite talking here specifically about Pompei disease. Um and so from what I've just taken from what you've just said is that um prime minister makes a promise newborn blood screening this baby's condition will be included in that program. We're now three and a half years after that promise has been made. Um, and the process has included going through MSAC where a recommendation has been made not to include it. So, you're now telling me that unless evidence changes, Pompei disease is out of the
obviously considered the evidence around the available test, whether conditions are treatable at the age which it might be discovered, uh the onset of the disease, those sorts of considerations. And yes, they have made a recommendation which has been published. As I said, that is yes to go yet to go to health ministers. The agreed decision-making pathway between all states and territories in the Commonwealth is that health ministers will jointly consider the recommendations of MSAC.
seems pretty callous of a prime minister to hold a baby and make a promise and then know that knowingly that this whole process needed to take place the process has taken place and now we got you know there's a recommendation not to list it but you've only done your job Dr. Devil and I think it's a sad indictment on the prime minister that he would use a baby as a prop and then failed to deliver because he didn't have the ability to deliver and the process hasn't allowed him to deliver. I'd really like to know from the prime minister what he would like me to say or what he intends to say to the mothers and fathers of children with Pompei disease that he promised in 2022 would be included in this program. >> Chair, I'm happy to go to NDIA.
>> Okay, great. Thank you very much, Senator Ruston. Um we will now move to suspend for a short time um to allow witnesses of the next outcome to be called for outcome for disability and Thank you uh everyone. We are