100: Hot Take with Sonya and Johanna
100: Hot Take with Sonya and Johanna
Join Johanna Wicks and me in today's Hot Take as we unravel the complicated process of getting treatments added to Australia's PBS, sparked…
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Dear Menopause
Dec. 12, 2024

100: Hot Take with Sonya and Johanna

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Dear Menopause

Join Johanna Wicks and me in today's Hot Take as we unravel the complicated process of getting treatments added to Australia's PBS, sparked by a recent breakthrough announcement about endometriosis medication.

We explore the pivotal, yet often misunderstood, roles that pharmaceutical companies and the government play in this process and why modern menopause hormone therapy (MHT) hasn't yet made it to the PBS despite public demand.

Delving deeper, we contrast MPA, a synthetic progestin, with body-identical progesterone and critique the Pharmaceutical Benefits Advisory Committee's (PBAC) tendency to group these therapies together. This sheds light on the broader issue of insufficient research funding in women's health.

As we look forward, our anticipation builds around the government's response to the Senate Inquiry report and its potential impacts on women's health policy, especially with an upcoming election.

Will Australian women receive an early Christmas gift from the Government? We hope so!

Jo shares about attending Em Rusciano's impactful "Outgrown" show. And to wrap the year up, have you checked out our creative "Menopause Myths Advent Calendar 2024" on Instagram — a fun, festive initiative aimed at busting menopause myths with a sprinkle of Christmas joy.

Thank you for your continued support and here's to more insightful discussions in the new year!

Links:
Pharmaceutical Benefits Advisory Committee (PBAC)
Em Rusciano
The Holderness Family - Instagram Christmas Reel
2024 Advent Calendar - Instagram


Thank you for listening to my show!

Join the conversation on Instagram

🤝 You can connect with Sonya here

💬 Send me a message here

❤️ Loved this episode? Share with a friend and don't forget to leave us a review and rating here 

 

Chapters

00:01 - Understanding the Pharmaceutical Benefits Scheme

13:42 - Comparing MHT Drugs on the PBS

19:30 - Improving Women's Health Funding and Access

27:11 - Upcoming Government Response and Hot Topics

36:23 - Menopause Myths Advent Calendar 2024

Transcript
WEBVTT

00:00:01.582 --> 00:00:04.107
Welcome to the Dear Menopause podcast.

00:00:04.107 --> 00:00:06.772
I'm Sonia Lovell, your host Now.

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I've been bringing you conversations with amazing menopause experts for over two years now.

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If you have missed any of those conversations, now's the time to go back and listen, and you can always share them with anyone you think needs to hear them.

00:00:21.143 --> 00:00:26.309
This way, more people can find these amazing conversations, needs to hear them.

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This way, more people can find these amazing conversations.

00:00:29.032 --> 00:00:32.615
Welcome everybody to this week's episode of Hot Take with Joanna Wicks and myself.

00:00:32.615 --> 00:00:39.581
Welcome, joanna.

00:00:39.581 --> 00:00:40.002
Hi Sonia, how are you?

00:00:40.002 --> 00:00:40.384
I'm good, thank you.

00:00:40.384 --> 00:00:41.728
I'm very excited about our chat this week for a couple of reasons.

00:00:41.728 --> 00:00:44.637
One, it's our last chat before Christmas and two, we've got some juicy, juicy topics to dive into yes, I know, and you before Christmas.

00:00:44.637 --> 00:00:46.743
And two, we've got some juicy, juicy topics to dive into.

00:00:46.984 --> 00:00:59.274
Yes, I know, and you may have to like stop me or shut me up if I keep going too much, because some of these topics I well, I've done a deep dive into and they're quite complicated, but I'm hoping to break it down and make it easy for everyone.

00:00:59.917 --> 00:01:05.808
I'm really excited when you pitched this idea to me, that this was like one of the topics that we should chat about on today's episode.

00:01:06.049 --> 00:01:12.412
I was really, really pleased that this is one that we can, because I do know how much work you have done in this space.

00:01:12.412 --> 00:01:33.400
It's also something that I'm getting a lot of questions about by email people I chat to on the street in my DMs on Instagram because there was a recent government announcement, which we'll dive into in a second, which doesn't impact menopause or perimenopause, but is absolutely a precedent for something that should.

00:01:33.400 --> 00:01:41.153
I'm going to preface this conversation by saying that Jo is the one that knows lots and lots and lots and lots of details about what we're going to talk about.

00:01:41.153 --> 00:01:45.466
She's done an absolutely huge deep dive into all things to do with this topic.

00:01:45.466 --> 00:01:47.311
It is going to be a robust conversation.

00:01:47.311 --> 00:01:55.441
It's a little bit tricky to understand, but we need you, the listeners, to be really across what we're talking about today.

00:01:55.441 --> 00:02:01.013
So, jo, we are going to talk about getting treatments added to the PBS.

00:02:01.013 --> 00:02:05.671
Now, for anybody that doesn't know what the PBS is, jo, tell us what the PBS is.

00:02:06.500 --> 00:02:27.153
So PBS stands for the Pharmaceutical Benefits Scheme, and it is part of the kind of the healthcare sort of safety net, I guess, whereby drugs that are often super expensive, once they go through a rigorous process by PBAC, which is the Pharmaceutical Benefits Advisory Committee, I think you know, can be assessed as to whether or not the government subsidises their cost.

00:02:27.153 --> 00:02:34.191
So there's many, many, many medications that are on the PBS, but it is quite a challenging process to get drugs on there.

00:02:34.191 --> 00:02:40.121
And, yes, so, whilst Sonia, you are correct, I've done a massive, deep dive into this because I wanted to get my head around it.

00:02:40.121 --> 00:02:43.927
You know, as a consumer, I'd always just gone oh, some drugs are on the PBS, some drugs aren't.

00:02:44.088 --> 00:02:58.186
But when I was working for Besins, I wanted to learn more about how drugs got on there, and so I certainly don't know everything, but there is a lot that kind of blew my mind and made me go, wow, more people should know about this.

00:02:58.186 --> 00:03:01.426
This should be part of health literacy, understanding how this aspect works.

00:03:01.426 --> 00:03:13.828
So the thing we were sparked because I think it was it last week that Ged Kearny and and the government announced a new drug that went onto the PBS for endometriosis I think it's called Visanne.

00:03:13.828 --> 00:03:26.634
And what was really interesting about that is it's the first drug for endometriosis to be approved on the PBS in 30 years, and that got us, you know, what's happening.

00:03:26.735 --> 00:03:38.102
It did and, of course, the other thing that happened, like I mentioned before, off the back of that announcement and all the media coverage that it got, was a lot of questions from women going okay, so when is HRT going to be added to the PBS?

00:03:38.102 --> 00:03:41.870
Why is, you know, aspects of HRT still so expensive?

00:03:41.870 --> 00:03:45.568
And it really is, and it was talked about in the Senate inquiry.

00:03:45.568 --> 00:03:48.319
It was one of the recommendations that was tabled.

00:03:48.319 --> 00:04:10.965
So let's talk about why HRT, or you know, the different components of HRT, the different drugs, aren't on the PBS right now, how they can go about being on the PBS and how long that can all take go about being on the PBS and how long that can all take.

00:04:10.985 --> 00:04:13.834
Okay, so, in a nutshell, pharmaceutical companies apply to have their drugs put on the PBS.

00:04:13.834 --> 00:04:20.730
So the first step is that a pharmaceutical company has to decide to make that investment to do that application.

00:04:20.730 --> 00:04:21.812
The application is massive.

00:04:21.812 --> 00:04:33.091
It's usually, you know, could be 70 to 100 pages, as they outline absolutely everything to do with the drug and why they think it's important for Australians to have access to it through the subsidised system.

00:04:33.940 --> 00:04:46.882
Okay, I'm going to stop you there for a second, because I think that's really important to highlight, because a lot of the questions that I get and a lot of the commentary I've noticed around the media is why isn't the government putting HRT onto the PBS?

00:04:46.882 --> 00:04:57.791
So the government can put pressure onto the pharmaceutical companies, but that very first step has to actually be taken by the pharmaceutical company, correct?

00:04:58.293 --> 00:05:05.841
And there is a cost I think it's actually about a quarter of a million dollars, I think it's around $250,000 to actually put in the application.

00:05:05.841 --> 00:05:27.230
Now you can put in an application and then it goes off to be assessed by an independent committee which is called PBAC so the Pharmaceutical Benefits Advisory Committee and you can go onto the website and you can see all the drugs that get looked at every quarter and there's, you know, there's often like 40 drugs, you know, and they've all got 100 pages of technical detail.

00:05:27.230 --> 00:05:29.372
So it's a big undertaking.

00:05:29.372 --> 00:05:36.250
But obviously getting on to the PBS is huge because it makes drugs more accessible and more affordable.

00:05:36.250 --> 00:05:50.684
Now, obviously, some of the drugs that are applying to go on the PBS cost half a million dollars for one individual per year, and so it is absolutely imperative that those sorts of drugs you know are really assessed and looked at so that, you know, your average Australian can afford them.

00:05:51.185 --> 00:06:00.603
Where it gets a little bit more complicated and where I've, you know, really wrestled with this deep dive is when you're talking about drugs that are taken by large amounts of people every month.

00:06:00.603 --> 00:06:03.829
There's a lot of emphasis on cost and cost benefit.

00:06:03.829 --> 00:06:07.595
Now, for example, I'm going to go back a little bit before we talk about MHT.

00:06:07.595 --> 00:06:16.701
But for example, there aren't any modern contraceptives that have been put onto the PBS for over 25 years Now.

00:06:16.701 --> 00:06:17.964
One might ask why?

00:06:17.964 --> 00:06:22.185
Because there is a lot of amazing new modern contraceptives for women to use.

00:06:22.185 --> 00:06:25.754
But this is where you start to unpack what happens.

00:06:25.754 --> 00:06:28.204
So the PBS looks at cost.

00:06:28.204 --> 00:06:30.269
It's very cost focused.

00:06:30.269 --> 00:06:36.908
You know I thought it would look more at healthcare savings and health outcomes, and it does, but they're sort of secondary.

00:06:36.908 --> 00:06:48.423
So if you're looking at contraceptives, some of the contraceptives on the PBS have been there in Australia since 1992, which is sort of when the PBS was created.

00:06:48.423 --> 00:06:58.194
Now some of these drugs were actually approved by, say, the FDA in America in the late 90s or 1960s and so these are really old drugs.

00:06:58.194 --> 00:07:08.795
So when they were approved in the Australian context go onto the PBS back in 1992, 1993, the cost of those drugs is now extremely cheap.

00:07:08.795 --> 00:07:15.706
So we're talking maybe it costs the government $5 or less per month for these drugs.

00:07:15.706 --> 00:07:29.627
So if you take a new modern drug that has only been developed in the last couple of years and you think about all the manufacturing and the logistics and the R&D and the raw ingredients that go into making that drug and they apply to the PBS.

00:07:29.627 --> 00:07:34.007
They pay their quarter of a million dollars and apply to get their drug on the PBS.

00:07:34.007 --> 00:07:42.492
The PBS looks at it and goes but there's another contraceptive pill already on here and women can just use that because that one is super cheap.

00:07:42.492 --> 00:07:45.870
It's $5 a month and you want $17 a month?

00:07:45.870 --> 00:07:49.168
No, so I'm going to give you a real life example of this.

00:07:49.168 --> 00:07:50.331
So this actually happened.

00:07:50.350 --> 00:08:01.105
In July this year, Bayer Australia put forward two of their drugs contraceptives Yaz and Yasmin for consideration by PBAC.

00:08:01.105 --> 00:08:04.291
Yaz and Yasmin are more modern contraceptives.

00:08:04.291 --> 00:08:09.221
So this was, you know, this was potentially exciting to those of us that were looking at what was happening in the PBS space.

00:08:09.221 --> 00:08:13.033
Yay, some modern contraceptives finally making it onto the PBS.

00:08:13.033 --> 00:08:22.663
Now the committee met and the PBAC outcome has been published, and the PBAC outcome actually recommends that Yaz and Yasmin go onto the PBS.

00:08:22.663 --> 00:08:25.512
Yay, you might say, but there's a caveat.

00:08:25.512 --> 00:08:27.146
There's a big fat caveat.

00:08:27.146 --> 00:08:28.738
Of course there is.

00:08:28.738 --> 00:08:30.125
Of course there is.

00:08:30.125 --> 00:08:34.009
So I'm just going to read this out because I think it's quite important.

00:08:34.009 --> 00:08:45.811
It says the PBAC considered that Yaz and Yasmin did not provide significant benefits in terms of greater efficiency or reduction in toxicity compared to other PBS listed oral contraceptives.

00:08:45.811 --> 00:08:57.393
So the PBAC therefore recommended listing Yaz and Yasmin on a cost minimization basis to the lowest cost contraceptive currently PBS listed.

00:08:57.393 --> 00:09:08.246
So in layperson terms that means they will only list Yaz and Yasmin at the price of the cheapest contraceptive currently on the PBS.

00:09:08.246 --> 00:09:14.013
Now that's extremely cheap and that's an extremely old contraceptive.

00:09:14.379 --> 00:09:18.572
So the next layer of that, I guess, is you might go well, what are the difference?

00:09:18.572 --> 00:09:20.125
And as women, I think a lot of us know.

00:09:20.125 --> 00:09:26.292
If you think about the old contraceptive, when I think about when the first contraceptive I took, it was a PBS listed one and it made me sick.

00:09:26.292 --> 00:09:30.812
It turns out I can't tolerate a lot of progestins.

00:09:30.812 --> 00:09:32.605
They make me very unwell.

00:09:32.605 --> 00:09:45.326
So very quickly I had to come off that PBS listed contraceptive and as a 19-year-old I had to go onto a private script for a low-dose progesterone pill which cost $35 a month.

00:09:45.326 --> 00:09:50.731
So it was a massive, massive difference for an 18 year old working for $7 an hour in a cafe.

00:09:51.620 --> 00:10:11.549
So what happens is all these modern contraceptives that are great for women tend to be newer synthetics which have less side effects, or they tend to be body identical and so therefore they don't have as many sort of side effects or interruptions on the human body.

00:10:11.549 --> 00:10:12.562
So there's lots of you know.

00:10:12.562 --> 00:10:17.586
You talk to people about contraceptive and they say, oh, it gave me acne, it gave me bloating, I gained weight, it gave me headaches.

00:10:17.586 --> 00:10:23.285
So a lot of people actually come off the oral contraceptives on the PBS because of the negative side effects.

00:10:23.285 --> 00:10:28.354
But what you see in the way that the PBAC looks at these drugs is none of that is taken into consideration.

00:10:28.354 --> 00:10:34.235
They just look and go same same, no difference, even though there's a big difference.

00:10:34.235 --> 00:10:41.253
What will be interesting to see and I couldn't find anything on this is when it comes to something like Yaz and Yasmin.

00:10:42.160 --> 00:10:51.133
I suspect that the pharmaceutical company is probably going to not progress with this PBS listing because it is not financially viable.

00:10:51.133 --> 00:10:59.753
Like a company in 2024 can't sell drugs for the price of a drug that was invented in the 1960s.

00:10:59.753 --> 00:11:01.883
It's just, it's not feasible.

00:11:01.883 --> 00:11:14.153
So then what happens is, even though PBAC has recommended the drug, it doesn't end up on the PBS because there is no acknowledgement of the decades of research or the increased costs of manufacture.

00:11:14.153 --> 00:11:17.169
So why this has, you know, sparked my interest?

00:11:17.410 --> 00:11:24.825
Is PBAC actually considered a whole lot of MHT in their November meeting and those results.

00:11:24.825 --> 00:11:27.282
Those outcomes are due on the 20th of December.

00:11:27.282 --> 00:11:34.913
So if you go on to the PBAC website, if you're going to nerd out on this sort of stuff, you can see all the drugs that they considered in November.

00:11:34.913 --> 00:11:38.828
So they considered slinder, which is a modern contraceptive.

00:11:38.828 --> 00:11:43.142
They considered estrogel, which is a body identical estrogen.

00:11:43.142 --> 00:11:54.072
They considered prometrium, which would be the first micronized progesterone to make it onto the PBS, and Estrogel Pro, which is the combination of estrogen and progesterone.

00:11:54.072 --> 00:12:01.591
All of these drugs were considered in November and all of them could be recommended to go onto the PBS in the next week.

00:12:01.591 --> 00:12:08.221
So this would be huge in the next week.

00:12:08.221 --> 00:12:09.745
So this would be huge.

00:12:09.745 --> 00:12:18.924
But obviously there's going to be that caveat around will they be recommended with a discussion on cost, or will there be this comparison to the lowest cost denominator?

00:12:19.186 --> 00:12:21.153
And I think what's interesting here for MHT?

00:12:21.153 --> 00:12:23.782
Mht is very similar to oral contraceptives.

00:12:23.782 --> 00:12:24.817
There has been very little modern MHT put onto the PBS.

00:12:24.817 --> 00:12:24.927
I think the last MHT.

00:12:24.927 --> 00:12:25.418
Mht is very similar to oral contraceptives.

00:12:25.418 --> 00:12:27.613
There has been very little modern MHT put onto the PBS.

00:12:27.613 --> 00:12:46.020
I think the last MHT related product was Vagifem, possibly about 10 years ago, but there's very few of the body identical products have been put onto the PBS recently and there are no progesterones on the PBS currently, and that's been one of the big issues that came up in the inquiry.

00:12:46.542 --> 00:12:54.527
Yeah, and for anybody that is taking Prometrium look, I am it really does add a significant amount onto your monthly costs for your MHT.

00:12:54.527 --> 00:12:56.051
So there's that Okay.

00:12:56.051 --> 00:12:59.205
So question that came up for me while you were talking about that.

00:12:59.205 --> 00:13:06.809
So let's just talk about Prometrium, because obviously we've got the four drugs that you mentioned that could potentially be added to the PBS.

00:13:06.809 --> 00:13:08.192
But let's talk about prometrium.

00:13:08.192 --> 00:13:29.753
What precedent is there already set on the PBS, like that example that you gave about the oral contraceptive, that could mean that they might say, yeah, sure, this can go on, but it's going to be at this ridiculously low price and therefore the pharmaceutical company might go yeah, no, sorry, not worth our while perfect question.

00:13:30.014 --> 00:13:30.917
Perfect question, sonia.

00:13:30.917 --> 00:13:34.769
Um, and because this is where my whole deep dive into the pbs started.

00:13:34.769 --> 00:13:42.221
Um, and it started in, you know, may last year and I think I've mentioned this before on the podcast I was at a workshop with dr jenny mansberg.

00:13:42.221 --> 00:13:44.586
She asked people um in the room.

00:13:44.586 --> 00:13:45.028
You know what?

00:13:45.028 --> 00:13:50.982
What it was on MHT, what MHT people were taking and a number of women put their hand up and said that they were on MPA.

00:13:50.982 --> 00:13:52.624
Which gosh, it's like.

00:13:54.870 --> 00:13:56.836
It's the not so good progesterone.

00:13:56.836 --> 00:13:57.605
It's a progestin.

00:13:57.605 --> 00:13:58.948
Yes, it's a progestin.

00:13:58.948 --> 00:14:00.071
That's the one, sorry.

00:14:00.191 --> 00:14:01.514
Something, something Acid.

00:14:01.514 --> 00:14:04.058
Yes, Long name Actually.

00:14:04.058 --> 00:14:04.438
You know what?

00:14:04.826 --> 00:14:06.421
I'm going to Google that while you keep talking.

00:14:06.421 --> 00:14:10.850
You Google that, so that we can actually be professional and I'll come back and say what it actually is.

00:14:11.225 --> 00:14:19.097
Actually so, mpa, I think on the PBS it's called Provera, so this is a fascinating drug.

00:14:19.097 --> 00:14:22.808
It was approved by the FDA in 1959.

00:14:22.808 --> 00:14:26.397
So it's probably one of the oldest drugs that women still take.

00:14:26.397 --> 00:14:28.287
It's been around an extremely long time.

00:14:28.287 --> 00:14:40.716
It is also the drug in Depo-Provera, so you can use it for contraception through Depo injections and you can use it as your progestin in MHT, and it is synthetic.

00:14:40.716 --> 00:14:42.099
It is a synthetic drug.

00:14:42.500 --> 00:14:42.620
Yep.

00:14:42.620 --> 00:14:44.326
Okay, let me tell you what it is Now.

00:14:44.326 --> 00:14:48.793
My pronunciation here is going to get tested Medroxyprogesterone acetate.

00:14:48.793 --> 00:14:50.730
That sounds exactly right.

00:14:51.371 --> 00:14:52.115
Yeah, there you go.

00:14:52.115 --> 00:15:00.044
So MPA has been on the PBS since day dot, before 1992.

00:15:00.044 --> 00:15:08.034
You know, it's kind of like there's no data from before 1992 that I could find and it is extremely affordable.

00:15:08.034 --> 00:15:16.289
I think the, you know, I think it's around, you know, $5 for the government per packet, and that's not even per month.

00:15:16.289 --> 00:15:19.707
I think you get 56 tablets per packet, so it lasts two months.

00:15:19.768 --> 00:15:21.734
Oh wow, so it's a good two months yeah.

00:15:21.874 --> 00:15:32.750
Yeah, so you know, I think the government you know I might be incorrect here because you know I can't see everything that the government can see, but what I as a consumer can see, it's probably around $2.50, you know, a month Unbelievably cheap.

00:15:32.750 --> 00:15:39.134
Now this is a drug that anyone who is knowledgeable in the menopause space doesn't prescribe.

00:15:39.134 --> 00:15:44.418
In fact, you know I have heard people say you know, get off it if you're on it.

00:15:44.418 --> 00:15:50.942
Yeah, now there are some women for whom it works when the other progesterones or progestins don't work.

00:15:50.942 --> 00:15:54.676
So there is a small percentage that still find MPA extremely beneficial.

00:15:54.676 --> 00:16:12.692
But for the majority of women it has a lot of side effects, most of which aren't pleasant, and in fact, if you're using it for contraception, it actually comes with some pretty significant warnings around, actually causing bone density loss Loss okay, yeah, so it's a pretty serious drug and it's MPA.

00:16:12.812 --> 00:16:16.888
That was used in the WHI studies as well, wasn't it Correct?

00:16:16.908 --> 00:16:17.129
yes.

00:16:17.129 --> 00:16:24.793
So it's the progestin that was linked to a very slight increase in breast cancer Breast cancer so it's really not recommended.

00:16:24.793 --> 00:16:35.875
In fact, you'd be hard-pressed to find any menopause doctor who actually prescribes, prescribes, and in fact, if your doctor suggests MPA, it's usually an indication that they're not up to scratch.

00:16:35.875 --> 00:16:47.125
So MPA cheap, it has a lot of side effects, it's synthetic and it doesn't have all of the benefits that a body identical progesterone do.

00:16:47.125 --> 00:16:49.631
But this is where it gets tricky.

00:16:49.631 --> 00:17:02.131
Like you said, sonia, it's been around for a long time and so if PBAC comes back and says, yes, we recommend Prometrium, but it's got to be cost compared, then we're going to have a very big issue.

00:17:02.131 --> 00:17:11.425
Now I have a number of issues from this, but one of them is, again, I find it so hard to break this stuff down and I still don't really get it.

00:17:11.425 --> 00:17:16.915
So Prometrium is a progesterone, it is a body identical drug.

00:17:16.915 --> 00:17:18.699
Mpa is a progesterone, it is a body identical drug.

00:17:18.699 --> 00:17:19.079
Mpa is a progestin.

00:17:19.079 --> 00:17:20.782
It is a synthetic drug.

00:17:20.782 --> 00:17:22.852
But they're lumped in together.

00:17:22.852 --> 00:17:38.009
They're lumped in as though they're the same product and I remember talking to people and saying, but but one is a progestin and one is a progesterone and they're very different what they do to the, to women's bodies, and they they have very different you know sort of side effects and benefits.

00:17:38.009 --> 00:17:41.086
So, so why are they being considered together, sort of like?

00:17:41.086 --> 00:17:43.634
Sort of like, I mean, with mineral water?

00:17:43.634 --> 00:17:45.949
Yeah, they've both got bubbles.

00:17:45.949 --> 00:17:47.875
They've both got bubbles Exactly.

00:17:47.875 --> 00:17:51.724
But PBAC doesn't take those sorts of differences into account.

00:17:51.724 --> 00:18:07.402
It sort of just goes well, you both used this and so we're going to compare you like as like when to anyone you, you know, immersed in this space, like the gps and the clinicians that you know I've spent two years talking to, they're like, they're not like for like, they're very different.

00:18:07.402 --> 00:18:18.038
They have very different side effects and you know progestins do have these you know this slight increased risk factors and they may negatively impact bone density.

00:18:18.038 --> 00:18:22.291
So there's a lot of argument that they are actually different and they should be considered differently.

00:18:22.291 --> 00:18:30.171
But this is what we're going to find out in a week as to whether or not PBAC has, I guess, looked at those broader considerations other than cost.

00:18:30.171 --> 00:18:32.278
Wow, but I have got something then.

00:18:32.278 --> 00:18:34.786
So this is going to lead down a slightly other little rabbit hole.

00:18:34.786 --> 00:18:37.289
So goody, when you about it.

00:18:37.329 --> 00:18:53.531
You know one of the things that I just read out in relation to Yaz and Yasmin was you know, this big submission that the pharmaceutical company put in did not provide significant benefits in terms of greater efficacy or reduction in toxicity compared to others.

00:18:53.531 --> 00:18:59.226
So this brings us back to another issue, and this is how it's all very cyclic and very frustrating.

00:18:59.226 --> 00:19:07.214
This is where the lack of research into women's health directly impacts what medications women can access via the PBS.

00:19:07.214 --> 00:19:12.094
So if you think about it, you've got very little money given to women's health for research.

00:19:12.094 --> 00:19:13.701
There's very little research done.

00:19:13.701 --> 00:19:17.170
So there's this massive black hole when it comes to hormones and women's health.

00:19:17.170 --> 00:19:18.571
So then we have no data.

00:19:18.571 --> 00:19:26.560
So then the pharmaceutical company, when it's going to do its submission, doesn't have any new data or anything to draw on because no one's done any research for decades.

00:19:26.560 --> 00:19:30.451
So if there's no new data, no new information, pbac just goes.

00:19:30.451 --> 00:19:51.916
Well, these drugs, you know they're the same and, for example, I was watching something this morning that Mary-Claire Haver had just put on her Insta, I think, in the last 24 hours, which was specifically talking about in the US, less than 9% of the National Institutes of Health's budget went to women's health.

00:19:52.679 --> 00:19:58.096
Of that 9%, the majority of it went for breast cancer, then it went to pregnancy and infertility.

00:19:58.096 --> 00:20:13.367
When you got down the list of women's health things that received funding and you got to menopause, it was 15 million, which equaled 0.03 percent of the National Institute of Health's budget that was looking at this.

00:20:13.367 --> 00:20:19.261
So you think 15 million for a population of 300 million, it's just nothing.

00:20:19.261 --> 00:20:31.176
So a recent committee in the US has recommended that to try and reduce this research gender gap, the US look at spending 11 billion into women's healthcare.

00:20:31.176 --> 00:20:38.893
Now I know that Research Australia are looking at what those figures are for Australia and I suspect they're going to be equally dire.

00:20:39.493 --> 00:20:40.234
I would imagine so.

00:20:41.155 --> 00:20:42.679
Because there's this big gap.

00:20:42.679 --> 00:20:49.586
And I know when, two years ago, I had a look at what NHMRC funding was happening for menopause in Australia and, yes, it was very, very small.

00:20:49.586 --> 00:20:57.172
And the other thing that I found fascinating about it is when you know, I had someone at the NHMRC pull it together and send it to me in an Excel spreadsheet.

00:20:57.172 --> 00:21:02.914
When I read the descriptions of what they considered menopause funding, I was like that's a bit of a stretch.

00:21:02.914 --> 00:21:07.015
Just because it includes a couple of middle-aged women does not make it menopause specific.

00:21:07.015 --> 00:21:09.704
So it was very broad.

00:21:09.785 --> 00:21:13.974
So they're being very broad with their description of buckets.

00:21:14.256 --> 00:21:19.991
Buckets, yep, and you know I can talk about research another time because there's a lot of interesting stuff there.

00:21:19.991 --> 00:21:24.289
I don't even think in HMRC funding in Australia, like if it's women-focused.

00:21:24.289 --> 00:21:27.530
That's not even a box that gets ticked so you can't even really search by.

00:21:27.530 --> 00:21:33.214
You know what's specifically for women's health, which of course keeps everything nice and murky, doesn't?

00:21:33.275 --> 00:21:39.326
it, don't?

00:21:39.365 --> 00:21:47.778
we love it when the government sent gives people funding, and then they're very murky with what the data has actually been spent on and so, for example, you know there was a bit of excitement with the budget this year and so I'm just going to squash that excitement.

00:21:48.381 --> 00:22:06.590
Yeah, so the government announced 53.6 million for women's health research, which you know you might initially go, oh, that sounds really good, but then, when you break it down, it was for pregnancy loss, infertility, chronic pain, menopause and treatment for alcohol and drugs.

00:22:06.590 --> 00:22:15.092
That's 53 million across one, two, three, four, five different areas over, I think, five years.

00:22:15.092 --> 00:22:18.518
So it starts to become very, very, very small.

00:22:18.518 --> 00:22:29.901
And if you're looking at the kind of information that PBAC needs to influence or make decisions on, we're not talking about a small survey, we're talking about really robust data.

00:22:29.901 --> 00:22:37.134
So they want to see, you know, randomized clinical trials which cost tens of millions, not 200,000.

00:22:37.134 --> 00:22:52.227
So 53 million, of which a tiny percent is going to be for menopause, is not going to fill any of these data gaps, which are going to be what helps change information when it comes to what drugs get on the PBS and what drugs we, as the consumer, get access to.

00:22:53.148 --> 00:23:08.155
Yeah, wow, it's really complex, it's very layered, it seems so antiquated and caught up in red tape and it's just so out of touch with the shift in treating this change in a woman's life.

00:23:09.028 --> 00:23:09.971
And it gets kind of worse.

00:23:09.971 --> 00:23:16.297
So the other thing that shocked me as a Commissioner, mayor, as I was diving into here, was so there's no review mechanism for the PBS.

00:23:16.297 --> 00:23:21.410
So that blew my mind as well, you know, having being involved with, with- government.

00:23:21.431 --> 00:23:24.298
So what you mean by that is once something's on the pbs?

00:23:24.846 --> 00:23:35.692
yes, no review system, they just stay there till the pharmaceutical company takes it off right, okay, wow, uh, there's no review mechanism to go.

00:23:35.692 --> 00:23:43.778
Is MPA still the best drug to be giving women for this, you know, health condition?

00:23:43.778 --> 00:23:45.829
It's been on there since 1992.

00:23:45.829 --> 00:23:46.573
So what are we talking?

00:23:46.573 --> 00:23:53.750
That's 32 years and as a result, I mean, I guess you know, in many ways it's in the government's favour.

00:23:53.750 --> 00:23:54.573
It keeps drugs cheap.

00:23:54.684 --> 00:24:05.632
They can say, well, we're not putting anything else on unless they price match this ridiculously cheap drug that doesn't have great side effects and that women don't really like using and it kind of makes women feel a bit well, but we'll just keep it on there because it's cheap, which is just.

00:24:05.632 --> 00:24:07.085
It's kind of not good enough.

00:24:07.085 --> 00:24:16.840
Because when you think about it, I think about all the women that come off the contraceptive pill when they're young because it makes them feel so bad and and then they may not go back on it, they might have an unintended pregnancy.

00:24:16.840 --> 00:24:22.204
You know then there are a lot of other potential ramifications down the track for that decision.

00:24:22.204 --> 00:24:24.513
It's not just about that cost at that time.

00:24:24.513 --> 00:24:34.191
So if you think about MHT, if women can't afford to take MHT and they choose to forego it, then they're more at risk of osteoporosis, they're at greater risk of heart disease.

00:24:34.191 --> 00:24:37.259
They're at greater risk of cognitive decline.

00:24:37.259 --> 00:24:39.186
You have things like leaving the workforce.

00:24:39.930 --> 00:24:42.336
Yeah, loss of relationships, but the list goes on.

00:24:42.336 --> 00:24:49.674
But, really the cost overall to the government for the public health system as a result is higher.

00:24:50.316 --> 00:24:52.948
Yes, exactly, but that is not taken into consideration.

00:24:52.948 --> 00:24:55.653
There is not that big picture view.

00:24:55.653 --> 00:24:57.727
It's literally like we have this much money.

00:24:57.727 --> 00:24:58.730
How much will this cost?

00:24:58.730 --> 00:25:02.011
You know, we're just going to go with that and who oversees PBAC?

00:25:02.265 --> 00:25:06.935
Is it a government-aligned organisation or are they private?

00:25:07.577 --> 00:25:16.291
Yes, no, I think it's sort of affiliated with the Department of Health and the Minister for Health sort of sits at the top, but it is very independent.

00:25:16.766 --> 00:25:16.846
Okay.

00:25:16.846 --> 00:25:26.356
So even if we could get in the ears of some senators and, you know, really make enough noise to request some changes to this, it's not really going to be very impactful.

00:25:27.510 --> 00:25:40.590
Well, it's going to take some time and I think there was some hope with the health technology assessment review process that this is some of the things that might get looked at process, that this is because some of the things that might get looked at.

00:25:40.590 --> 00:25:47.450
But you know to to to change it from just being so focused on cost, um, I think would scare a lot of the government because it could potentially blow out costs.

00:25:47.450 --> 00:26:07.270
But if they actually then looked at the long-term costs you know we've spoken in in the past about how much um, uh, you know urological conditions cost, osteoporosis costs you know there is actually for a for a small cost now to make sure that women have body identical mht is going to actually have be a massive cost saving down the track.

00:26:07.270 --> 00:26:14.596
But the system, how it is set up now and how it is legislated, is not designed to look at those broader long-term impacts.

00:26:14.696 --> 00:26:20.144
It's it's very here and now single focused and, yeah, very, very disappointing really.

00:26:20.185 --> 00:26:26.797
Yes, but it is, which leads us in a way, to another point, like one of the recommendations, as you said before, sonia, was recommendation 19.

00:26:26.797 --> 00:26:39.505
The committee recommends that the Pharmaceutical Benefits Advisory Committee, pbac, reforms comparator selection during evaluation of new MHT items to include quality of life health impacts.

00:26:39.505 --> 00:26:50.916
The committee also recommends that the PBAC regards body-identical hormone therapy products in a separate drug class to remove the lowest cost comparator to synthetic therapies.

00:26:51.657 --> 00:26:52.038
Okay, cool.

00:26:52.038 --> 00:27:10.827
So they did literally outline in the Senate inquiry report exactly what needs to change to benefit both women, people born with ovaries and the public health system long term correct now all there in black and white.

00:27:10.888 --> 00:27:11.269
All there.

00:27:11.269 --> 00:27:13.922
And when is the government supposed to respond to?

00:27:13.961 --> 00:27:15.686
the inquiry, the next topic.

00:27:15.686 --> 00:27:22.468
So shall we segue across to our next topic that we were going to touch on today the Senate inquiry.

00:27:22.468 --> 00:27:30.884
The government was given three months to reply to the Senate inquiry report that was tabled on the 18th of September.

00:27:30.884 --> 00:27:37.423
That means the 18th of December another little potentially early Christmas present.

00:27:37.423 --> 00:27:40.098
The government is due to reply now.

00:27:40.098 --> 00:27:43.019
Again, this is going to be a little bit like the PBAC conversation.

00:27:43.019 --> 00:27:45.637
What does that actually really mean, jo?

00:27:45.637 --> 00:27:53.642
Should we get really excited and expect a whole bunch of early Christmas presents, or is that not really how it plays out in the real world?

00:27:55.554 --> 00:27:59.346
I'm an eternal optimist, sonia, and I'm going to go with yes.

00:27:59.346 --> 00:28:04.159
The government is going to respond on the 18th of December and give us all an early Christmas present.

00:28:04.159 --> 00:28:05.611
I think it's in their best interests.

00:28:05.611 --> 00:28:28.239
We do have an election sometime in the next six months and as a voting bloc, women are quite influential and you know, given the sort of the level of interest in this inquiry, I feel that it would be definitely in the government's interest to respond, also because there's a lot in the recommendations that could quite easily and readily be addressed, as I think we've spoken about previously.

00:28:33.490 --> 00:28:41.518
So my take from that, then, would be that potentially, there could well be a response, but it may be that they cherry pick the easy, quick fixes to respond to.

00:28:41.518 --> 00:28:50.823
That give them a win at a time of the year when they kind of need it and potentially sets them up for good election promises.

00:28:51.872 --> 00:28:55.089
Correct, correct or they don't have to respond.

00:28:55.089 --> 00:28:58.539
There was a Senate inquiry into reproductive health care.

00:28:58.539 --> 00:29:08.700
Last was it last May and the government was supposed to respond in August 2023 and my understanding is they still haven't responded.

00:29:09.549 --> 00:29:12.836
So not May this year, may last year yes yes.

00:29:13.017 --> 00:29:21.796
So look, if they don't respond, I mean, then that's something that we can always talk about next time and about what we could all do to put a little bit of pressure on.

00:29:21.796 --> 00:29:33.023
Let's go with the government's going to respond, because this is a big issue that affects a massive amount of Australians and you know, the recommendations weren't too, on the whole, too challenging.

00:29:33.023 --> 00:29:50.817
Obviously, if the report's due on the 18th of December, that's two days before we get the results of the latest PBAC meeting, which comes on the 20th of December, and we get to find out what happens to all the body identical MHT that we are hoping will be recommended for PBS listing.

00:29:50.817 --> 00:29:57.141
And so what happens then once they list, if they recommend it and they don't say lowest cost, okay, let's do the two things.

00:29:57.141 --> 00:29:59.838
So they say recommended but lowest cost comparator.

00:30:00.770 --> 00:30:23.021
Well then the pharmaceutical company who put forward for the treatment will have to make a decision as to whether it is happening to price mat just, and you know, I obviously don't know the answer to that, but I can suspect anyone making modern medicine is not going to be able to match the price of drugs from 1959.

00:30:23.021 --> 00:30:32.396
The other option is that they recommend and they make some sort of statement around how they recognise that body identical hormone therapy is in a separate drug class.

00:30:32.396 --> 00:30:40.461
So then they enter into negotiations with the pharmaceutical company to come to an agreement about what would be what that price would be Okay.

00:30:41.391 --> 00:30:46.563
So even if they do make an announcement on the 20th, that's in our favour.

00:30:46.563 --> 00:30:51.998
It's not going to be an overnight impact to the wallets of anybody taking these therapies.

00:30:51.998 --> 00:30:57.795
There'll be a process of negotiation with the pharmaceutical companies that we'll have to wait for.

00:30:59.093 --> 00:31:00.278
And that depends how long that takes.

00:31:00.278 --> 00:31:07.016
So for example, the drug that just got announced for endometriosis it got recommended in the July PBAC, so that hasn't taken too long.

00:31:08.369 --> 00:31:13.617
So that's like a better kind of five month or so process, if you want to use that as a benchmark.

00:31:14.539 --> 00:31:20.480
Yeah, exactly so you know it's going to be very exciting to see what comes out on the 20th.

00:31:20.480 --> 00:31:24.715
I mean obviously they could not recommend the drugs, of course.

00:31:24.836 --> 00:31:26.961
Yeah, there's lots of potential outcomes there.

00:31:26.961 --> 00:31:38.306
I think you know like we've got three potential outcomes on the table, but definitely worth keeping an eye on the media on the 20th of December to see which of those outcomes actually plays out.

00:31:38.306 --> 00:31:48.653
So some potential good news to end the year on there with, obviously, PBAC, which we've just wrapped up, and also the government's response to the Senate inquiry.

00:31:48.653 --> 00:32:01.234
So for everybody that's listening, keep an eye out next week in the media for the responses on that, and Jo and I will obviously be keeping a very close lookout on that.

00:32:01.234 --> 00:32:08.840
So keep an eye on our socials as well, because we're not going to be jumping back into the recording studio here Unless something really super big and exciting does happen.

00:32:08.840 --> 00:32:20.555
Then I think we'll definitely make some time over the christmas break to jump on and record a bonus, bonus episode, because the whole purpose of these hot take episodes is to be reacting to what's actually happening right here and now in the zeitgeist.

00:32:20.555 --> 00:32:22.419
Um, okay, so let's wrap up.

00:32:22.459 --> 00:32:30.403
jo, you recently Em Rusciano yes yes, so I went and saw Em Rusciano's Outgrown finale on Saturday night.

00:32:30.403 --> 00:32:39.855
It was an incredible show, all about ADHD and autism and perimenopause, and I mean there was a lot I could relate to in the show.

00:32:39.855 --> 00:32:52.037
But she did do a fabulous bunch of songs and one in particular which was all about perimenopausal rage, and I think if you go onto her socials you can see some snippets of the show and the song.

00:32:52.037 --> 00:32:57.996
But I'm really, really, really hoping that she will release these songs on Spotify.

00:32:57.996 --> 00:33:02.325
I also saw her Rage and Rainbows show back in 2019.

00:33:02.325 --> 00:33:11.638
And that has basically been my mantra in the last five years my life is all rage and all rainbows and you just never know which day which one's going to be winning.

00:33:11.638 --> 00:33:27.117
But she did put a bunch of those songs on Spotify and I'm really, really hoping these songs from Outgrow and end up on Spotify, because I think there is a lot that your audience, sonia, could really relate to and really play very loudly in their kitchens and stomp around to.

00:33:27.920 --> 00:33:28.962
Excellent, thank you.

00:33:28.962 --> 00:33:36.539
I'm so glad you shared that with everyone because it sounded like a fabulous show and, yeah, if anybody can get their hands on those songs, I think they'll benefit.

00:33:36.539 --> 00:33:42.858
But there's some amazing, actually little things floating around at the moment in the whole social media land.

00:33:42.858 --> 00:33:44.041
Can we talk for a bit?

00:33:44.041 --> 00:33:45.554
This is totally going off script.

00:33:45.554 --> 00:33:48.280
But the Holderness family oh my God.

00:33:48.280 --> 00:33:50.531
If for a very, this is totally going off script.

00:33:50.531 --> 00:33:51.836
But the Holderness family oh my God.

00:33:51.836 --> 00:33:54.240
If you're not on social media, this will not make any sense to you whatsoever.

00:33:54.240 --> 00:33:58.477
But I started following the Holderness family, which is a mom and dad.

00:33:58.477 --> 00:34:10.360
Basically they're American, they're a couple, they're, like you know, middle-aged, but I started following them gosh years ago, when their social media account, their Instagram account particularly, was all about raising a family.

00:34:10.360 --> 00:34:12.318
It was all about parenting and being kids.

00:34:12.318 --> 00:34:27.338
But they've done this little segue I've noticed in the last few months where the mum and I don't know their first and last names I feel like I should, or maybe they're anonymous on purpose, who knows has started talking openly about her experiences with perimenopause and they have been hilarious.

00:34:27.338 --> 00:34:33.599
She did a great piece where she filmed in her car and it was all about feeling stabby and how.

00:34:33.599 --> 00:34:38.940
I think one of the great takeaway lines in it was that eating protein had become her full-time job, and it was just really clever.

00:34:38.940 --> 00:34:40.293
But they have just released it.

00:34:40.333 --> 00:34:45.373
If you are on social media, I don't know how you can have not seen this, because everyone has shared it.

00:34:45.373 --> 00:34:49.619
My DMs just blew up yesterday with everyone going oh my God, have you seen this?

00:34:49.619 --> 00:34:50.760
Oh my God, have you seen this?

00:34:50.760 --> 00:34:53.143
And it's so good.

00:34:53.143 --> 00:34:54.684
They do this beautiful.

00:34:54.684 --> 00:34:55.246
He sings.

00:34:55.246 --> 00:34:57.432
He's actually got a beautiful voice.

00:34:57.432 --> 00:35:01.949
They do this beautiful Christmas carol kind of pantomime.

00:35:01.949 --> 00:35:07.759
That is a mix of so it's like a mashup, but all the lyrics have been changed to like.

00:35:07.759 --> 00:35:08.693
It's like instead of here comes Santa Claus.

00:35:08.693 --> 00:35:13.893
It's like a mashup, but all the lyrics have been changed to like it's like instead of here comes Santa Claus, it's like here comes perimenopause, here comes perimenopause, sliding down the whatever.

00:35:13.893 --> 00:35:15.076
Sorry, sorry to everyone.

00:35:15.155 --> 00:35:18.903
It's so good, but it's so, so good.

00:35:18.903 --> 00:35:25.313
So if you are on social media and that hasn't crossed your path, please go seek it out, because it's a really good belly laugh.

00:35:25.574 --> 00:35:32.096
It's really funny and, interestingly, the day before someone had sent me one of their other ones, they've done one on no libido.

00:35:32.096 --> 00:35:33.259
But have you seen one?

00:35:33.259 --> 00:35:34.081
I haven't seen that one.

00:35:34.081 --> 00:35:36.295
You've got to go find that one.

00:35:36.295 --> 00:35:38.557
It's also a very middle-aged, appropriate.

00:35:38.557 --> 00:35:41.155
If you can't see yourself in that, I'd be surprised.

00:35:42.519 --> 00:35:43.969
Yeah, okay, cool, good tip, okay.

00:35:43.969 --> 00:35:47.619
So check out the Holderness family on Instagram and Facebook, I would imagine, as well.

00:35:47.619 --> 00:36:04.351
Talking about social media, let's wrap up with what I've been up to in December outside of making podcasts, and that is I collaborated with the wonderful Dr Ceri Cashell and her team within Healthy Hormones and also the amazing Julie Dutton, who was my guest on here a couple of weeks ago.

00:36:04.351 --> 00:36:07.605
So if you don't remember Jules' episode episode, go back and listen to that.

00:36:07.605 --> 00:36:10.353
Um, we've been working on another advent calendar.

00:36:10.353 --> 00:36:14.581
So we did our first perimenopause advent calendar last year.

00:36:14.581 --> 00:36:16.614
It was hugely successful.

00:36:16.614 --> 00:36:18.824
Last year's ended up going around the globe.

00:36:18.824 --> 00:36:23.396
It was wonderful, and we got asked to do it again this year, and so we have done it again.

00:36:23.518 --> 00:36:27.132
Slightly different theme we've gone with um menopause myths this year.

00:36:27.132 --> 00:36:28.755
Well, well, there's plenty of those.

00:36:28.755 --> 00:36:31.500
There is lots of those 25 of them In fact.

00:36:31.500 --> 00:36:34.864
We've rolled out for December Actually, it's not true.

00:36:34.864 --> 00:36:39.086
24, 25 is a Merry Christmas one and I've done all the creative for them.

00:36:39.146 --> 00:36:51.655
So I've made them a little bit more fun and a little bit lighthearted this year with some sneaky little Christmas elves that have appeared on the creative creative, and we've brought some more lightness and positivity into the content that we're sharing as well.

00:36:51.655 --> 00:36:57.018
So if you have not seen those, then I highly recommend that you go check them out.

00:36:57.018 --> 00:37:20.224
Not because I want you all to admire the creativity, because, um, I get a lot of messages back from people saying, oh my gosh, I'm so pleased you're doing this again this year, because I only learned because of your advent calendar last year that you know, let's say, I think we talked about tinnitus that tinnitus was actually a symptom of perimenopause and menopause.

00:37:20.224 --> 00:37:28.320
So it's educational, it's a bit of fun, it's a nice way to wrap up the year and all the work that we've been doing in this crazy perimenopause and menopause space.

00:37:28.320 --> 00:37:31.264
So, yeah, check out our 2024 accent calendar.

00:37:31.809 --> 00:37:34.780
And I think it's a great way to share with people that you know.

00:37:34.780 --> 00:37:48.193
If you don't want to necessarily share them something too full on, it's a great way to kind of introduce them to you know, have a bit of a chat about menopause or perimenopause or start a conversation, I think, and they're just, they're very aesthetically pleasing, thank you.

00:37:48.474 --> 00:38:02.083
Okay, Jo, now we are not, unless something extremely out of the ordinary happens that we are both beside ourselves with excitement or rage about, we won't be back for another Hot Take episode until about mid-January.

00:38:02.083 --> 00:38:07.648
I'll be back with a couple of episodes before then, but we both wish you all a very merry and safe Christmas.

00:38:08.929 --> 00:38:22.351
if you celebrate Christmas, If you don don't have a fantastic holiday and break and enjoy some time with your loved ones, and then we'll be ready for 2025 and, hopefully, all the amazing things that will happen in the menopause space for midlife women.

00:38:22.351 --> 00:38:23.672
I hope so.

00:38:23.891 --> 00:38:24.751
Merry Christmas Jo.

00:38:24.751 --> 00:38:26.092
Merry Christmas Joe.

00:38:26.092 --> 00:38:27.813
Merry Christmas Sonia.