Senate Community Affairs Legislation Committee, , 8:48:07 to 8:56:24
Professor Joe Watson explains the complexities of updating PBS criteria for pediatric use and the historical lack of commercial interest in pediatric drug submissions.
Topics: Health, Government spending
Speakers: Ms Jo Watson, Senator David Pocock, Prof Michael Kidd, Mr Daniel McCabe, Unknown Speaker, Ms Sonja Stewart
So, sir, I think Mr. Richard will start to go there. We have um implemented uh changes for um pediatric patients with severe to moderate uh Crohn's disease, and that was done in October. Uh, and then we're on track to broaden um uh changes for patients with ulcerating colitis, and that will we're aiming to have that done by the end of this year.
I understand some changes have been made, but uh what I struggle with is we have specialists who are treating these these children who understand their individual circumstances, a concern about the consequences of delaying uh treatment, and yet the PBS restrictions can mean that those children must first trial other medications. Just in terms of um yeah, why can't we give treating the specialist greater discretion to make these decisions based on clinical needs of the child in front of them? As we do for a bunch of drugs.
Thanks, Senator. So um, as you know, prescribing decisions are a decision for each of the treating specialists to make with the patient and their family. But I think the the issue you're getting to is about um the cost of these uh treatments if the uh specialist is prescribing outside of the PBS. Is that correct?
But Professor is that a bunch of these are now off patent and there are um alternative. So it's not something like this is these are hugely costly um experimental drugs.
They're experiment they're expensive treatments if they are uh purchased privately. That's correct.
Can I um say Celia Street here, Deputy Secretary for Assistance Strategy Group? And I hope Professor Watson doesn't mind me throwing to her because there has been a lot of consideration in terms of when for first line,
Thank you. So since 2024, PVAC's been working closely with the clinical experts through their Kraft Giza and through Crohn's and Colitis, the Australian Patient Network. We've been trying to revisit all the indications and restrictions as they have been setting the schedule now for a number of years. There are only two biologics that are actually available at the moment for pediatric use. And what we've been trying to do is find ways to open up the prescribing capacity for those two drugs for a population where we've noted urgent clinical need, where we've tried for many years to attract new entries into the market and see sponsors bring forth submissions. PBAC with the help of our stakeholder groups has actually attempted to myth methodically work through these restrictions that are quite complex because they're across a broad spectrum of disease, not just Crohn's, not just colitis, not just moderate, all the way through to severe and acute. And what we've tried to do is make sure that there are no unintended consequences where we are giving discretion to prescribers to prescribe out of indication that it's going to be on the basis of evidence of safety and effectiveness, and that we ensure that our clinicians are working with us and that the guidelines are contemporary and are based on guidelines not just here in Australia but also reflect international practice. I think the frustration is well noted about how long this is taking, but I think there is good intention here to make sure they are best suited and fit for purpose for the Australian clinical sitting uh setting and also for the age groups across the pediatric spectrum.
Yeah, I mean it has it has taken three years and and the chief medical officer said that it's up to the discretion of the doctor, but clearly it's not in this case. And so is it what why are there restrictions on the use where clearly this is an effective treatment or are there legal reasons
or is it a cost of the other thing? I think there's reasons in terms of historical legacy. I think there's reasons in terms of lack of evidence in some age groups and some spectrums of disease. And I think there's reasons of restrictions still in place while we untangle again this unintended consequence of delinking and then uh inadvertently excluding those who are already cap uh already able to uh actively um be prescribe these uh because of the acute nature of their disease before we open it up to a whole of population.
Okay, but we I mean we've we've recently seen um broader PBS access to certain cancer treatments, including some really expensive on patent medicines with far greater discretion for um treating clinicians. Um my team brought up an example of Minister Butler uh announced the general listing of on patent cancer treatments worth 5,000 plus per month that provide for clinical discretion. Um and there's a release on the PBS website saying a number of low-cost antidepressants have been moved from restricted to unrestricted benefits with eligibility criteria removed. Why do we seem incapable of doing that for these drugs that are affecting children where you know they don't get those years back and parents rightly want access to these treatments?
Yeah, I I don't think it's a useful comparison, Senator, because I think the broad spectrum work that went on for cancer listings was in the presence of new technology and broadening access or uh very small subtypes of cancer disease and rarer cancers that we're never going to see submissions come forward. There's something quite different going on here. If you like, we're trying to do a catch-up for pediatric access in the presence of years of where pediatrics has actually been ignored across many diseases and conditions. Uh, with good faith again, I think the stakeholders and the committee and the department are trying to undo this legacy of a forgotten area of a population where sponsors are just not commercially enticed, if you like, to do a lot of work in the pediatric populations across multiple areas.
And I really I really appreciate your your work on this. But to come back to the patients that want access to this children who don't get these years back, and in the absence of this sort of decision, uh being forced to go through all sorts of treatments which can leave permanent uh damage, lifelong um side effects that they have to deal with. Can you give us a timeline? Surely there's something that can be done to expedite this process.
Yeah, so I I think there's a commitment that can be seen in the public summary documents to this being involving piece of work. Uh while recommendations and advice has been provided to government and to the department, that work is ongoing and due for implement implementation in the very near future. The future work of PBAC itself continues in a rolling way, and we've invited both sponsors and stakeholders to continue that work with us.
Um, thank you. I really encourage everyone involved to expedite the work and come up with a solution for for people who desperately want access um to