Growth Hormone Deficiency Learning Zone
Transcript: Health economics and biosimilars
Professor Mehul Dattani, Dr. Charlotte Höybye, Professor Steven Simoens, Dr. Shankar Kanumakala and Dr. Robert Murray
Interview recorded Jul 2023. All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.
Move to the final topic, which is health economics and the role of biosimilars in GHD. So that's going to be a very important topic for us to finish on. So I'd like to welcome Steven to give the talk. Thank you very much Steven. Thank you, Mehul. In my presentation I will touch on a different topic. I will focus on the health economic role of biosimilars and I will address specifically the value that biosimilars can bring to the table when it comes to growth hormone deficiency management. So I will give you an overview of my disclosures. I am not going to go through the whole list but if anything, I hope this convinces you that I have some expertise when it comes to health economic aspects of biosimilars. So let's get started. Why could there be potentially a role for biosimilars in GHD? I think there are two main reasons. First of all, we have already heard that GHD is associated with a significant clinical burden, but in addition to that, it is also accompanied by a significant cost of illness. And to illustrate that when we look at adult GHD, the single most important driver of the cost of illness is actually the productivity loss. And that originates from the fact that GHD adults have a lower employment rate than the rest of the population and incur a higher number of days of absence from work.
A second reason which is important to remember that even at this time, we noticed that in a number of European countries existing GHD treatments are not always reimbursed or they are being made available or reimbursed subject to some restrictions. And you can see a number of examples at the bottom of the slide where I single out Romania, where treatments are currently not being reimbursed and Hungary where prescription is limited to endocrinologists who work in accredited treatment centres. Maybe I should also give some brief explanation about what biosimilars are. These are products that can enter the market once the patent and other exclusivity on the reference biologic have expired. And these products have to demonstrate that they have a similar safety, efficacy and quality as the reference biologic. So that in practise means that biosimilars are clinically equivalent with the reference of biologic. So what potential benefits can biosimilars offer? First of all, they can generate cost savings. These can stem from the lower price of the biosimilar products themselves or they may also potentially induce competition with the reference biologic, which in turn can reduce its price in response to the market entry of biosimilar competitors. And as a result of the cost savings generated by biosimilars, they may actually expand treatment access to biologic therapies. In Europe, we have experience with biosimilar products since 2006. The first biosimilars were then launched on the European market and approved by the European Medicines Agency.
So we have now more than 15 years of experience with using these products. And it is important to highlight and to emphasise that none of these products have been withdrawn for reasons of safety or efficacy. Currently, there are more than 86 biosimilars authorised on the European market across a variety of indication and disease areas, some of which are shown on the right hand side of the slide. So now let's focus specifically on GHD and somatropin treatment. Currently, there is one biosimilar product available in European countries and as I promised, I will focus on different values that these products can generate. First of all, there is clear evidence that somatropin biosimilar has generated substantial savings to healthcare systems throughout time. In this figure, you see depicted the cumulative savings of the biosimilar entry across 26 European countries over the time periods running from 2005 till 2021. And those cumulative savings amounted to nearly $2 billion over that entire time period following biosimilar entry. And that accounts for about 14% of overall somatropin expenditure. And as a result of the lower price of somatropin biosimilar, the cost per defined daily dose of somatropin has actually decreased over time by almost 33%. And these cost savings resulted from two factors. On the one hand, the lower price of the biosimilar product but on the other hand as well, the fact that the reference biologic reduced its price in response to the the market entry of this competitor. Looking at a second benefit that biosimilar can generate is that they actually expand patient access to treatment. And that is illustrated on the right hand side where you see that the volume of somatropin use has increased has nearly doubled since the entry of the first biosimilar in 2006.
So the volume has come up, but as you will undoubtedly remember, prices has also come down. So if you take those two factors together, that explains why you see on the left hand side that annual sales and expenditure has relatively remained constant over time. In addition to those two benefits that biosimilars bring, it is also important to highlight that the market entry of a cheaper somatropin biosimilar actually improves the cost effectiveness of GHD treatment, which in turns makes it more acceptable for reimbursement agencies to recommend such a treatment. And I illustrate that with two cases. The first case comes from the UK where the reimbursement agency, if you will, the National Institute for Health and Care Excellence actually recommends somatropin treatment for GHD in children but only if the least costly product is chosen. Then if we move to Poland, the Agency for Health Technology Assessment and Tariff System, it's striking to notice that the Polish HTA agency did not grant reimbursement to reference somatropin but it did award reimbursement to the biosimilar version as a result of its improved cost effectiveness profile. For the sake of completeness and full transparency, I also have to say that other somatropin biosimilars have been launched. They were previously authorised in Europe but they have since been withdrawn from the market. One of these products was already withdrawn in 2012 for commercial reasons. And another product was withdrawn more recently in 2017 where the validity ceased on its marketing authorization because the company did not actually market the product during a three-year period following its initial date of authorization because it was unable to supply the product. And then finally, as a health economist, you will not be surprised that I focus on price and effectiveness, but this is obviously not the full story. Price is one of the criteria that should be taken into account when choosing a treatment option. But in addition to that, there are other criteria that matter. So price is not the only criterion and probably not the most important criterion to consider.
And on this slide you see a number of criteria that may play a role that relate to convenience and preference of patients with respect to, for example, the administration form, whether they prefer a short or a long acting form and other elements. I would also like to mention one particular study carried out in the UK which indicated that patient preferences may actually play a more important role in the choice of treatment than price in itself. So I think it is very important that all of these criteria are taken together when a choice is made for a particular treatment, for a specific patient, in a particular situation. So that concludes my presentation and I think we still have time left to open up the discussion. Maybe I can kick off the discussion and address a question to the clinical faculty members, to ask them what your experience has been with somatropin biosimilars to date and under which circumstances you would prescribe such a product. So I think... So for biosimilars, when they were launched in the UK, the biosimilar growth hormone the pen device didn't go down well with the patients. So it came into that preference of the patients because they really didn't like the pen device and therefore it never really took off in the first few years of launch. They later updated the pen and now, probably, most of our patients, because of cost and the patients, like the pen are now on biosimilar. So it has made a big difference. But initially we found the pen device to be of poor quality and the patients didn't like it.
And I don't know if anyone else noted that when it first came out. Charlotte, did you have a similar experience? Yes, it's similar here in Sweden, so most of the patients are on biosimilar. So there's only a few who either doesn't want, for some reason are reluctant to change or have some issues with the pen. The device we use. The other thing that's been their advantage is they've had a very good supply chain recently whereas there's been other products which have had manufacturing problems and therefore haven't been available. So a lot of people have been switched, Yeah. Their traditional, whatever they've been on, over to the biosimilar simply because we're using a lot of it, we're familiar with it, and the supply chain has been very good. Yes, and I think you're right, Rob, that initially there was a bit of bias against it, but I think people have got very, very comfortable now with its use and although maybe the pen is not as sophisticated as some of the others, if one's honest. The price differential and the availability now has really sort of led to them being a very strong contender for taking over big share of the UK market. So certainly, and I'm sure that's probably true in the rest of Europe as well. And in fact, and certainly in our unit, in the adult endocrinology unit, the preference is to use the biosimilar because of the price differential.
And also, in others, you often do the fixed dose. It's not that often that the dose is changed, and you can fix it on the pen, so it's easy for them to use. Yeah, yeah. Shankar? Yeah, I mean, the pen as you said was a stumbling block. And what is that, the company launched a new pen that it went through but I believe the first biosimilar ever to be licenced was a growth hormone biosimilar. And when a new class of drugs was introduced, there is a cautious whatever approach by the clinicians across the world and with the passage of time and when the accumulation clinical experience accumulated with... No side effects or more side effects or whatever it is accumulated. I think the... perceptions of the health profession towards using this one with more confidence increased over time and also the second factor I think that came into play was more and more biosimilars came into the market or came into the medical world after the growth hormone biosimilar which also helped us to, what is that, have more confidence in this new class of medications over the last 15 years. I think that's a very important point but if you look at the market share of somatropin biosimilar, it's about 30% by volume across European countries and that is much lower than the market share of biosimilar that we see in other disease areas. But that probably stems from the fact that growth hormone deficiency was one of the first diseases for which biosimilars entered the market. There was little awareness about biosimilars.
There was maybe some initial caution for clinicians to switch patients to biosimilars. So, that is a very important factor. Maybe I can put additional question to the faculty and that is that we have already talked on multiple occasions about the availability of long-acting forms of GHD therapies. Do you think that will have an impact on somatropin biosimilar use? I mean, I think to be honest, we're still, and I think from the discussion this afternoon, I think everyone thinks where long-acting might be a positive addition but it's probably too early to sort of say that they're gonna take over a big share of the market at the moment. 'Cause I think people are still a little bit anxious about several elements including the monitoring and the safety. And I think it'll be a while before we know exactly how much of an impact they will have. So I would say probably not for a few years certainly. And I think, you know, one has to take into account the current economic climate worldwide.
I mean, I don't think any country is in a very comfortable position economically following COVID particularly. And, you know, cost savings certainly are a big consideration now, particularly in the UK with the NHS being very, very challenged right now. So, you know, managers in hospitals, commissioners of healthcare are all looking at how do you save money and biosimilars are one very effective way of doing so at the moment. Shankar. Thank you. I agree. I mean, as we move forward, the indications for long acting or growth hormone, there is a specific reason or there are specific advantages with it. But when we come to what is that cost savings or to the distributive principle of justice, i.e., treating the maximum number of patients with the available pot of money, then cost savings becomes more important as we go forward especially with the challenges we are facing across many countries, including the impact of COVID. Now, there are... in any health economy or whatever it is, the pot of money is, what is that, limited. And as Steven showed that with the same amount of money, nearly double the number of patients were treated when the biosimilars entered into the market. So I believe... there is still a good reason why the principles around using biosimilars are going to be valid as we go forward in time.
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