I talk to Pharmac CE about changes to patch supply

Here's what you need to know about what's going to happen

Kia ora koutou

So - in the wake of the decision announced yesterday by Pharmac, that they would be changing the funded brand of Estradiol patch to the Mylan brand, there has been quite a backlash. There are two petitions in the works (here and here) asking for a re-think. And there’s been commentary all over the socials and in the media about this, including some tragic stories, like that of Helen Baxter, who died in October following five years of battling depression triggered by perimenopause, and amplified by changes in patch brands.

There have been lots of questions in the past 24 hours, and I wanted to go to the source to get some answers. This afternoon I was able to interview Sarah Fitt, the Chief Executive of Pharmac. Here’s a quick transcript (slightly edited for clarity) of our conversation. I hope this is helpful.

For a tl;dr - skip to the end where I’ve popped some handy bullet points.

Niki: The decision about the Mylan patches has felt like it's come as a bit of a surprise - to doctors and certainly to women. Can you briefly explain how the decision was arrived at? It didn’t seem like there was any consultation, but I may be wrong about that.

Sarah Fitt: If I explain how we got to this point, that'll probably help. So obviously there's been an ongoing issue, as you well know, for the Estradiol patches for probably about four years now. It started in Covid but actually then got worse probably in 2022. So for the last couple years we've been as you know, sort of trying to resolve this, but it's a global issue, so it's been really challenging.

So what we decided last year is that rather than just constantly living hand to mouth, we needed a bit of a longer term strategy.

So there was two arms to that really. One was trying to secure the [oestrogen] gel, which we managed to do. But we also needed a longer term plan around the patches because we were just going to multiple suppliers, always just constantly trying to keep up.

So what we did is that each year we run a tender process. And then we can go into a contract with a company for three years. We've got a guaranteed supply chain. And so we had started that work last year, and we were able to secure the tender with Viatris who makes the Mylan patches.

Although it's not going to come into place until the middle of next year, we announced it now because we knew people were really anxious about the ongoing issues and we were trying to give some reassurance that we were working on a longer term solution. So that was really the reason for announcing it quite early on. But we also had to contract with the supplier early to give them enough time to get all their stock into the country and manage all the stock, ready for the 1st of July as well.

We understand this last couple of years has been really difficult for people, and we've had so many letters and emails and calls… people are going around pharmacies and changing brands and cutting up patches. It's just not sustainable, and we really have to do something to try and resolve the situation for people.

NB: There's been quite a backlash. Has that surprised you?

SF: It's always difficult with things like patches because there is a lot of patient preference and, you know, one thing doesn't necessarily work for everyone. We wanted to secure the gel, which we did. So that gave us a new option, because we knew that there were some people that the gel would be a really good option for.

And yes, we're well aware that there's different feedback on different patches. Some people are fine with the Mylan patches; other people aren't. And so I guess that's why we want to resolve the issue of the supply. But we are also building in an option that if people really don't get on with the Mylan patches, there will be an option to apply for a different brand. And we're going to be sorting through that shortly.

NB: Okay. Can you explain a bit more about that?

SF: In the past when we used to run a tender, the company would get 100% of the market. So that would be every prescription. But over the last couple of years we’ve realised that there are brands that just don't work for some people. And so we build in what's called an alternative brand allowance. So the main company gets 95% of the market, but we have an allowance for 5% where people just can't tolerate a different brand or it doesn't work for them. And we've done that for a number of medicines over the years. So their doctor can apply and say, look, this just isn't working for them. So that gives an option to use - it doesn't have to be Estradot, but it could be other brands because some people have found some of the other brands work for them. So it gives that option for alternatives.

NB: And would that option then be funded? The Estradot would be funded?

SF: Yes.

NB: So what will happen if that demand for the alternative, which in this case now will be Estradot, is more than 5%?

SF: Yeah, we'll manage that. I mean that's what we contract for. But there's always an option to revisit that with the suppliers, but that would rely on the other company being able to supply more as well. So that's something we'll just have to work with with the supplier; both suppliers. And also other brands. Because there are other brands in the market that people have been using, too.

NB: What would be wrong with funding Mylan and keeping Estradot as well? Why do you need to have just one supplier?

SF: So we did consider that. That was certainly something that we thought about. The problem was that it's been just so difficult to get decent supplies of Estradot and the company themselves have said they've struggled to maintain supplies and they weren't going to be able to give us the guarantee for the amount of stock that we need.

Whereas we went with Viatris - they have given us a really strong reassurance that they have really upped their manufacturing capability globally, particularly in the US. So they were really able to give us that assurance that they could meet our needs, whereas the other company just haven't been able to deliver on the stock that we need.

And we're also not just talking about now. We're talking about the future because the demand is continuing to grow. As you probably know better than me, it hasn't levelled off. The demand is continuing to grow. So we need to be thinking about not just solving this problem now, but actually making sure that we don't end up in this situation again. That we've got that for the next few years.

NB: You'll be aware, I think, that some people have a really hard time when they're changing patches and there's even been an account of a suicide that was published. Were you aware of that? Did you take that into account when you were making this call?

SF: Yeah. I read that story yesterday and it was just awful. We certainly have been aware; I mean it's not just physical issues, it's all the mental health issues. And we have staff impacted by this and we've all got family and friends. So we're very aware of the impact [of changing patches] and it’s certainly it's something we've discussed with our endocrinology subcommittee as well who obviously are seeing patients. So we've got a lot of feedback from the clinicians, but I guess that that's part of the problem. It's just been so stressful and so awful for people that we felt that we needed to do something to try and resolve the situation to stop this continual running around trying to find [patches] and people having to keep changing patches. And the clinicians have said actually, the best thing is for people to go onto one patch and stay on it, not keep chopping and changing.

NB: But there are some people who are now extremely anxious, and some of them have been in touch with me, about having to give up Estradot, because that's the only one that works for them.

SF: That's partly why we wanted to come out today to reassure people that there would be that option if people are really struggling. That there will be an option that wasn't necessarily touched on in our release on Monday. So… because of the feedback we've been hearing, we wanted to reassure people that there would be another option if they, for whatever reason, can't manage with the new patch.

NB: Is there a risk that we end up kind of back where we started, going with one brand only, putting all the eggs in one basket? What happens if they can't supply according to demand?

SF: Well, I guess that's why we've done this, because that was obviously the key thing for us to ensure: that there was this consistent, secure supply. And certainly having met with the suppliers, it's very clear that they have seriously ramped up their manufacturing to meet global demand. It's not just for New Zealand. So that they were able to give us that reassurance that not only could they manage the supply now, but also into the future as it continues to grow. And the other companies just weren't able to do that.

NB: So this is not a money issue? It's a supply issue?

SF: No. It's purely the capacity; the volume and the ability to ramp up the manufacturing to meet the demand. Which is what we want. We want a consistent, secure supply. We don't want people chopping and changing because we know that's really unhelpful and stressful for people.

NB: Yeah. Really stressful. So I just want to understand this. If someone really just doesn't get on with the Mylan patch and really wants to use a different brand, then their doctor has to go through a process? Can you tell me more about that?

SF: We'll be coming out with more details about that shortly. Like I said, we've done it before. It's not the first time we've done it. It's usually quite a simple tick box form for the clinician to complete, and we'll turn it around reasonably quickly.

NB: Okay. So it's a bit more than just them specifying to the pharmacy.

SF: Yeah. It will have to come through us. So it's more like a sort of special authority form… it'll be a simpler version of that. It'll be more like a one pager, quite simple, and we'll get advice from the clinicians around the criteria that we'll we'll be using.

TL:DR

• The decision to go with Mylan brand patches was made, Pharmac says, in order to have a more secure and consistent supply of patches, and avoid the shortages we’ve had for the past few years

• Pharmac says the supplier of Mylan was the only one that was able to guarantee to supply enough medication to meet demand here. The supplier of Estradot could not do that

• Pharmac is aware some people have a terrible time with Mylan patches, but it says most people should be fine

• If women have a real problem with Mylan patches, their doctor will be able to apply to Pharmac for them to access Estradot, which will be funded for them

• The details of that process (to still access Estradot) are to come.

So: what do you think? Are you reassured? Worried? Let me know.