Minister for Health and Aged Care – interview on 3AW Mornings – 30 May 2023

NEIL MITCHELL, HOST:  Last week I began a campaign which has been driven by a number of very senior cancer specialists here, and in fact, I’ve talked to them around the world. The good news: they say within a matter of years, 80% of cancers will be curable. Now, the number is increasing each year, they say within 20 years to 30 years, 80% of cancers will be curable. Already, leukaemia, lymphoma, myeloma are showing excellent results. It has been used here for leukaemia and lymphoma but not frontline myeloma. These people have been treated with emerging immunotherapy, particularly CAR-T cell therapy, which is showing enormous promise. In very simple terms, they take the cells out of your body, reprogram to attack the cancer and put them back in – the immune cells – the fighting cells. I asked Professor Miles Prince from Peter Mac and Professor of various universities around here, and very well respected internationally, 're people dying from myeloma in Australia who need not die?'

 

PROFESSOR MILES PRINCE, PETER MACCALLUM CANCER CENTRE: Well, we know that for patients who would be eligible for the CAR-Ts that are available in the US and the UK, for example, those patients without CAR-Ts would die within, on average, 4 months. With CAR-Ts, 70% of them are alive at 3 years.

 

MITCHELL: Some are cured, some are cured, it is good, some are cured, it is a lot, well, most of them live a lot longer. Now that opens a prospect, it’s very expensive, though. It opens a prospect as this develops, that with money, people will be able to buy treatment that saves their life, and without money they won't, and they’ll die. The therapy will reasonably soon be an effective treatment for other cancers, like breast cancer, prostate cancer, other blood cancer, even diabetes. Some of the scientists describe it to me as the holy grail in cancer treatment. Doctors are normally very cautious in their predictions. Not with this one, they are enormously optimistic but worried, and they describe it – Miles Prince describes it – as a financial tsunami headed here and we are not ready, I spoke to him about it at some length and I told him at the time, we will approach the Federal Health Minister Mark Butler. We've done that, Mr Butler thanks for talking to us.

 

MINISTER FOR HEALTH AND AGED CARE, MARK BUTLER: Morning Neil.

 

MITCHELL: Two issues here, the present and the future. I'm told 886 patients a year with myeloma could use CAR-T treatment in Australia, do you agree lives could be saved here?

 

MINISTER FOR HEALTH AND AGED CARE, MARK BUTLER: I do. We're living through what is a turbo-charged period of discovery, particularly around the cell and gene therapy of the type you're discussing. CAR-T is one of them, it’s not the only one. There are medicines that boost the immune system to fight cancers in a way that were frankly unthinkable 10 or 20 years ago, people surviving cancers that were a pretty short-term death sentence 10 or 20 years ago. But CAR T-cell therapy is certainly one of them and it is being considered and being approved progressively here in Australia, as it is in the US and the EU. I've read the reports of your program last week. I've looked particularly at the case of Mr Nyssen and the applications of CAR-T cell therapy to myeloma here in Australia, so pleased to come on your program to talk about it.

 

MITCHELL: Ok. Well if lives can be saved, why is it not subsidised? Why is not being used?

 

BUTLER: We've had a system in place in Australia for not years, but decades, whereby new medicines or new therapies like CAR-T cell therapy are considered by a group of experts, not by politicians by something called the Medical Services Advisory Committee in the case of CAR T-cell therapy, or the Pharmaceutical Benefits Advisory Committee in the case of medicines, and they consider the clinical effectiveness and cost-effectiveness to make sure that therapies that are being considered, particularly for subsidy by taxpayers, are first of all and most importantly, clinically effective and safe, but secondly also a cost-effective investment by taxpayers. So that is the system we've had for some decades.



I think it is clear to me and to most, frankly, that system is a little clunky in terms of dealing with just the speed of technology that's coming through Australia and the rest of the world, so there is a review under way about whether our technology assessment systems are fit for purpose, but that won't be completed until the end of the year. I inherited that from the former government, I supported it when I was in opposition. I think it's the first time we've had that really deep systemic review for 30 years, and it is trying to come to grips with how we deal with this fast-evolving technological revolution that we're dealing with – that we're confronting. But also just the very hybrid, different nature of therapies we get today, that are very different to the sort of blockbuster medicines that we might have been dealing with 20 or 30 years ago.

 

MITCHELL: I'd like to get to that review in a moment, I've been reading quite a bit about that. But what do you say about Geoff Nyssen and other people like him at the moment? Have you seen the letter he wrote you by the way?

 

BUTLER: I have. I had a look at a draft response over the weekend which I'll be sending to him today or tomorrow when it's finally printed. His case is obviously a deeply distressing one, and there are many of them in Australia. He's fought so hard, not only for himself and for his family, but for the community: fundraising and lifting awareness, clearly a great citizen and we want to do everything to help people like Mr Nyssen. We do have these systems in place though to consider what is a vast number of applications coming in to the government for new medicines and new technologies like CAR-T cell therapy. It's not appropriate that politicians decide which medicine or which therapy should get taxpayer subsidy or not. I've always been a strong supporter of having an arms-length expert assessment process for these things.

 

MITCHELL: Yeah. So, is Mr Geoff Nyssen under consideration for one of those grants to go overseas and get treatment or is he under consideration for the possibility of the use of this CAR-T cell therapy with myeloma being extended in this country?

 

BUTLER: As I understand it, the particular therapy – cilta-cel it’s called – that is a therapy that was approved last year in the US and in Europe has been before the Medical Services Advisory Committee, wasn't approved in the form that the drug company Janssen submitted. That’s not really unusual, sometimes these things will have to go before that Advisory Committee 2 or even 3 times, but 2 times is more usual for the company to respond to some of the issues set out by the Committee, about either its clinical, or cost-effectiveness. Obviously, we would welcome Janssen putting another application to the Advisory Committee, if that’s their view, obviously it being approved in the US and the EU is a strong foundation. This is generally what happens, usually these drug companies will start in the US with the FDA, then move to Europe, then move to jurisdictions like ours. So at the moment it's not approved for subsidy. You've mentioned a program called the Medical Treatment Overseas Program whereby taxpayers effectively provide funding for someone to go overseas and receive a treatment that would be lifesaving, and that is not otherwise available here in Australia. I'm not sure whether Mr Nyssen and has made that application.

 

MITCHELL: He's in the process of making that application, yes.

 

BUTLER: So again, there’s a very clear process that’s been under way for some time, that is essentially a clinical decision about whether that treatment would make a very big – this is not necessarily the wording – a material difference to his survivability and is not one available here in Australia.

 

MITCHELL: Well, yeah, we did under this system when Greg Hunt was Minister, we managed to get a young woman to the United States who is thankfully still in remission after having the treatment there. But it just seems so bureaucratic. We've got people that today – and do you accept this – who are dying who need not die?

 

BUTLER: I completely understand why, to many of your listeners, it would sound bureaucratic, and understand even more forcefully, why for someone like Mr Nyssen and his family it would sound bureaucratic as well. But I do come back to the point that I think, on reflection, most of your listeners would want these decisions to be taken on a clinical basis, not by politicians, according to factors other than whether that clinically was a good use of taxpayers' funds and would make a material difference to a person's survivability. I mean, these are applications made pretty regularly under this overseas program, often for – particularly for children, but sometimes for adults as well. And it's a system that has worked well. I think it’s balanced that well. So I encourage Mr Nyssen to make that application.

 

MITCHELL: But it seems strange. You can go and make an application for $500,000 or $600,000 dollars to be sent overseas to get the treatment which could be available here to him and others. Now, I noticed reading the Medical Services Advisory Committee report from middle of last year, they say that it doesn't provide value for money. Now I know, bureaucratically, you put a value on the cost effectiveness, the value on life – what is the value on life the medical system puts on it? Because I know it's different to other parts of the bureaucracy. What is the value of a life, financially?

 

BUTLER: The Advisory Committee has as an actuarial formula that they apply to all of these applications, and often that is really the basis of companies coming back, according to the funding that they want for their medicine, or in this case for their CAR-T cell therapy, and I think that is what your listeners would expect, that this is a proper use of taxpayers funds in an area that I think all your listeners would recognise, costs billions and billions of dollars. You know, it is frustrating, we are getting so many applications in a period that is genuinely a turbo-charged period of discovery. We can't get through all of them as quickly as we would like. But I think having that arms-length expert assessment process has served us very well for decades. Now I'm not sure it's completely fit for purpose now, given the nature of the technological developments we’re getting, and we're looking at that for the long-term, but at the moment I think it is serving Australia well.

 

MITCHELL: Well, I disagree. We've got people – you do accept people are dying who do need not die, do you accept that?

 

BUTLER: Well, these things...

 

MITCHELL: I know you don’t want to say it as a politician, but it’s fact isn’t it?

 

BUTLER: It is a fact. I don't want to say it, I don’t like saying it, because none of us like considering this. There are medicines coming on to the table almost constantly at the moment and sorting out the ones that are clinically effective and serve the nation's interest – the wheat from the chaff if you like – is an incredibly difficult process for those experts. They are coming on so fast. It's not just CAR-T cell therapy...

 

MITCHELL: No of course.

 

BUTLER: There is just this vast array of cell and gene therapies – increasingly personalised as well – so it's not like you get a single big statin that lowers everyone's cholesterol that is a cookie-cutter tablet that everyone takes in exactly the same way. This is highly specialised, highly personalised medicine that takes a level of analysis that's quite different to work that these people were doing 20 or 30 years ago.

 

MITCHELL: And if the system of assessing that – you accept that, well, the word of Miles Prince was that a tsunami is coming – if you accept that there is that tsunami coming, and therefore a cost tsunami, as well, and you accept that the system is not fit for purpose. It is urgent to fix that system so it looks to the future and starts to prepare for this tsunami. What are you doing about that?

 

BUTLER: Well, as I said, I inherited a root-and-branch review of the assessment processes for all of these things, not just medicines, but the sort of therapies that we've been talking about: CAR-T cell therapy which is an incredibly complex, complicated system. Now, quite what the tsunami looks like in the future, I think is a little unclear, because generally the cost of these things come down. And I think that is certainly what all of us would like to see happen, these CAR-T cell therapies right at the moment are highly personalised. So as you said in your introduction, they take the T cells out of each individual person and modify them and put them back in. There is research going on right now to see whether that could be more off the shelf, rather than utterly individualised. That would certainly cut down the costs in the medium to long term, but that's pretty early-stage research. So, often in these areas there is a lot of catastrophising about the cost. Because what we do is look at the cost in the early stage of technology and sort of extend that out over 10 or 20 years, when in actual fact, costs come down very significantly.

 

MITCHELL: I was talking to a scientist in the US about this issue and he said exactly that. He said that mapping the genome cost $3 billion. I can now do it for $300. So that's a point, but we’ve got to get through that gap. Are you looking at the possibility of getting into the area of manufacturing, of working in T-cells in the technology here in Australia? Of getting in on the ground floor?

 

BUTLER: Peter Mac down in your city, obviously Neil, in Melbourne – such a leader in Australia and globally in cancer research and treatment will be doing some work.

 

MITCHELL: Professor Prince is one of the main people at Peter Mac and he's ringing alarm bells.

 

BUTLER: They were provided with funding by the former government which is reaching its latest stage of being put into place for Peter Mac to be a nation leader in cell and gene therapy, including manufacturing. Again, it's early days, the case numbers that we have in these therapies need to build to provide the sort of scale that would underpin a manufacturing operation. But I think there has, for a couple of years, been a vision for Peter Mac to lead that way. Funding was put in place, to his credit, by Greg Hunt my predecessor as Minister for Health, we've continued on with that, and I'd like to see Peter Mac take that step in the very, very near future.

 

MITCHELL: I know you're aware of these various bodies set up to examine the technologies. One is an international one meeting in Adelaide a couple of weeks' time. Were you aware of that?

 

BUTLER: Yes, I am.

 

MITCHELL: Are you going?

 

BUTLER: I’m trying to. At the moment I’m booked in to go. The only thing that would interfere with that is a Cabinet meeting which always takes priority in our diaries but I'm desperately keen to go to this. I've been talking to the organisers about this for some time.

 

MITCHELL: The experts are telling me that there’s an urgent need for an immunotherapy think tank, and as you say, going beyond CAR-T cell therapy, because they're talking about something that cures cancer, effectively, within decades. And each year – as you’ve said – more and more and more cases coming along – look we can cure that, are we ready? Would you look at establishing some sort of advisory think tank on immunotherapy, or at least have a talk to Miles Prince, who is one of the country's leading experts in the area.

 

BUTLER: I'd be very keen to talk to Miles Prince, and my office is thinking about when I'd be able to do that when I'm in Melbourne next in June, once I get through all these parliamentary sittings.

 

MITCHELL: He told me he’d jump on a plane at a minute's notice.

 

BUTLER: I'm sure we can organise something pretty quickly. Again, we're in the process of trying to sort of set up the structures for government to take account, just of the new nature of this technology. We're in the process of setting up a process that allows us to look across the board of genomics because, as you pointed out, the cost of mapping the human genome has come down so dramatically that genomic therapies, as well as cell therapies are increasingly the way of the future, and we've got to regear all of our thinking. I mean, the industry, the universities, institutes like Peter Mac, they are racing ahead. And so often government takes some time to catch up and make sure that our systems of assessment and approval and subsidy or reimbursement properly reflect this sort of incredible pace of technological development, to make sure that as many Australians as possible get the benefit of it.

 

MITCHELL: Meeting Miles Prince, and people like him will be a huge step in the right direction. There’s the funding application for Geoff Nyssen, to come back to the individual case, if he can get the drugs and the treatment necessary can he have it in Australia? I mean if the drug company will give him the drugs?

 

BUTLER: Well they will usually do that either on a clinical trial basis, I'm not sure...

 

MITCHELL: No he’s ineligible for that...

 

BUTLER: ...that after reading his letter he’s eligible for that. They can do it on a compassionate supply basis, again that's really a matter for the company. Often they do do that pending approvals for subsidy. But that is usually something discussed between the patient and the company.

 

MITCHELL: And when, how quickly will be a serious review of, in simple terms, the availability of CAR-T cell therapy to people like Geoff Nyssen. It is urgent, how soon will that be reviewed?

 

BUTLER: As I said, these things are going up to these expert advisory committees pretty regularly, and I think you said in your introduction, Neil, there are 3 CAR-T cell therapies already approved and subsidised for leukaemia and lymphoma, myeloma is really the next step in that.

 

MITCHELL: And myeloma is showing even better results than the other 2 at the moment.

 

BUTLER: Yeah, I’ve read the studies of this Janssen drug in particular – cilta-cell – and the response is extraordinary, even better than the first CAR-T cell therapy for myeloma that was approved in America. That had good results, but these results from the Janssen drug are very, very good.

 

MITCHELL: I can see why, and you’re aware of Sandy Roberts, the legendary sports broadcaster here who is in – his treatment is working, but his doctor has said: the sooner you get CAR-T therapy, the better chance you have of living. And he's sitting there waiting. And a lot of people like them, they're just the high-profile ones.

 

BUTLER: That’s right.

 

MITCHELL: What do we say to them? Wait?

 

BUTLER: I know how distressing it is for patients and their families. In this job I get to talk to them a lot. It is a constant frustration and a real challenge for government to keep up with the pace of this technological development. But again, it is important that we make sure that our systems ensure that the therapies that are being approved for use in Australia, and particularly therapies that are being approved for taxpayer funding, are up to scratch. And I think that's a system that's served us very well here in Australia.

 

MITCHELL: But it’s broken and we’re fixing it, I understand that takes time, I understand that. Look, thank you so much for your time, just quickly, I was talking to a young mother of a 17-year-old, just before the news, who was telling me her son had got nicotine poisoning from vaping. He took 20 puffs, being a stupid 17-year-old. Have you ever heard of nicotine poisoning for kids out of vaping?

 

BUTLER: The Victorian Poisons Hotline reported that in the last 12 months, they had 50 cases reported to them of children under the age of 4 being poisoned with nicotine vapes. This is a public health menace for young people. That was under the age of 4, not teenagers, but toddlers been poisoned from these things, grabbing them off the coffee table or something like that. And this is a public health menace that is deliberately designed to create a new generation of nicotine addicts. Which is why across the jurisdictions we have agreed to take action on it.

 

MITCHELL: Thank you so much for your time. I appreciate it. Thank you for talking to us.

 

BUTLER: Thanks.