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Navigating the Reimbursement Process in EU | LSI Europe '22


Edmund White

Edmund White

Global Chief Commercial Officer, ECLEVAR
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Pr. Luc Teot

Pr. Luc Teot

Medical Expert, ECLEVAR
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Yann Gouëffic

Yann Gouëffic

Medical Expert, ECLEVAR
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A practical overview of routes to reimbursement in EU. This session will include case studies and challenges for vascular and wound care devices. A vital session for anyone looking to understand the key requirements to gaining reimbursement.


Edmund White  0:03  

Thank you very much, Erica. And good afternoon. Welcome to this session. I hope it will be good appetite before lunch. So, in our session today, we've invited a distinguished medical expert panel, we're going to give you a practical overview of the routes to reimbursement in the EU. Eklavya medtech works closely with our medical expert panel who helped supervise and guarantee the clinical scientific and clinical validity of studies that we run. They're helping to support initiatives such as our global international vascular registry, our panel today, we'll discuss case studies and challenges for the reimbursement of vascular and wound care devices. And we'll get you to understand their key requirements for understanding reimbursement in Europe. So without ado, I'd like to introduce you to our distinguished panel today. First on our panel, he is a professor of vascular surgery at the Vascular Center Group hospital, Paris St. Joseph. Before that he was former chief department of vascular surgery at Nont until 90 2019. He has over 20 years of experience performing endovascular and open procedures for arterial disease. His clinical interests include low extremity arterial disease, endovascular, revascularization, wound healing, Amputation Prevention, he has performed numerous studies in these areas and authored numerous peer reviewed original articles. He has consulted on the regulatory pathway and has provided advice for many HAE s and FDA panel meetings. He is a member of the French society of vascular endovascular surgery and the European Society of Astra surgery. He is co director of the Paris vascular insights meeting and he is the editor of the international magazine. He is also President of the French university hospital for clinical research. So a very warm welcome to Professor Yann Goueffic. Second on our panel today, he is the head of the burns and wound healing unit of Montpellier Haas University Hospital in France. He has authored over 100 publications and an editorial board member of eight journals, and former president of the World union of wound healing societies and the European tissue repair society. He teaches his professor for the Universities of Montpellier, non Limoge entities and lateral union, his passion for wound healing and scarring has led them to organize the international conference called scar club and the international workshop on wound technology. He is qualified in general orthopedic and plastic surgery. So very warm welcome to Professor Luc Teot. Okay, so let's get started today. So first question to you, professors in general, what do you see as the sort of overall global reimbursement situation in France,


Prof. Luc Teot  2:42  

The process starts from conception, and then it comes to the first difficulty, which is CE marking for CE marking rules are changed. And now it's needed to have a trial. So this trial is more or less in relationship with what will happen after. So when you go after CE marking, you are in charge of proving to the authorities that reimbursement is needed. And then you have to go step by step through different processes. And these processes include, first, which is an authorization to come on the market, which is given by the NSM, which is the French authorities controlling what is on the market. And then you have to prove going to the stadiums, which is the name of the of the Commission, which is depending on the high authority of health. And these claims will analyze the added value of the new medical device compare to others. This analysis is mainly based on randomized control trial, and is close to what is needed for drugs. So this is the first step which is an obstacle for many medical devices. Even if they provide some CE marking. A second step is I think, a see going to the commission of pricing, which is another step, but which is something which will come later. The main obstacle, the main difficulty is the Canadians and the demonstrating that this new medical device as an added value, which is considered by the authorities has been a source of reimbursement


Edmund White  4:31  

brain and what do you see as the two three most important considerations for reimbursement in France at the moment today? So if you're looking to get your wound care device or a vascular, what are the considerations that should be there,


Yann Goueffic  4:43  

Um, quality really this pathway, you know, some people should consider that pretty painful to get your endorsement in France, but after that, it's a huge market also. Clearly, it's based on clinical evidence. And you can develop the market, if you are able to demonstrate, in fact, this clinical evidence is not just based on marketing. And if you are able to show the clinical evidence, you are able to get your investments. But it's not so simple, of course. It's also like pricing. And the pricing is directly related to the level of clinical evidence. And it's easy levels, you have different kinds of the level of easy. In fact, four, five levels, from the higher one to the lower one without any difference, in fact, between the control and the experimental device. And according this level, in fact, you have different pricing, of course, with the higher is easy obtain the higher price, and the lower one, you have to lower price. It's very simple on the paper, but in fact, it's why in this case, the methodology is very important, sure, to rise to higher evidence, and to get the higher price.


Edmund White  6:17  

So what kind of process timewise? Is that going to take? It sounds like it's quite an extensive process to get there. So for a device manufacturer, what's the timing of that in terms of going through that whole, rigorous review?


Yann Goueffic  6:30  

In fact, we are speaking in Europe about clinical study. So we know that it depends, in fact of the follow up in technical studio, in some cases, we can as answer the primary endpoint after one month of follow up. In some cases, it takes for two or three years to get the answer. It's why when a company try to get this HELOC, for example, the company should think about the next step to start already the designs, the methodology and perhaps the first inclusion. And I know that some company include the CE mark patient into the dossier to apply as soon as possible at the.


Edmund White  7:21  

Yeah, yep. Good. Good. So let's kind of move on to some of the practicalities. So we talked about a little bit about the general process here. Some of the key considerations in practice, what does this really mean for vascular and Winnacunnet device in terms of I have a device today? And I want to come to the French market? How How should I get that reimbursed and get shares some examples? You know, we hear the success stories are also other stories that devices don't get reimbursed? It's a pretty scrutiny. It's pretty rigorous process here. Can you talk us through some some practical,


Yann Goueffic  7:54  

We can go through some slides. Yes. I can share with you an example about the heartburn, but perhaps not everybody's urine is filled with targeting balloon. So targeting balloon is very simple. It's a drug and the balloon. And the purpose of these devices is to treat stenosis as the location of artery like for example, the femoral artery located at zero. And so, you want to enlarge with this balloon, the artery and to keep in larger czar to read due to the drug. And you have the example here you can see the inflation and during the inflation, we have a drug uptake into the arterial wall to avoid the risk noses. So, we can go ahead in the next slide. And so, in fact, mostly these targeting balloon has been assessed by Exedy RCT and in this first RCTs comparator was a balloon just balloon without any drug which was at this period in 2015. The main comparator that we know that superiority design has been also performed, we know that there is another kind of design such as noninferiority like us design, but for friends, the main value so far, but it can be discussed is acity. For in this proposal of vascular disease, I know that we discuss already of this point that was a kind of design could also be variable, depending of the pathology.


Prof. Luc Teot  9:39  

Yeah, if we speak about when dealing, the difficulty is to realize you've got a randomized control trial, many difficulties. The first one is to either a normal genius population when dealing is chronic ones chronic when mainly means diabetic foot ulcer, leg ulcer and pressure ulcer. In diabetic foot ulcer, the vital risk is very important because with a simple, just a small hole under the foot, the risk is very high in terms of the metal outcomes, five years after an amputation, the level of the die half of the patients that so this is something into which we there is a strong investment. But the difficulty is to find an emerging population. So a randomized control trial is really difficult. And it focused so much on on a very tiny population, that afterwards when you want to extend the use in the general population becomes really complex and non adapted. So this is why this is just an example. But this is why concerning methodology, I completely agree with what you said the difficulty of the methodologist to protocol is something which is adapted to the real randomized control trial. So defining the protocol is really strong difficulty, you need experts, you need experts in protocol isation, you need expert in modeling, and real so it becomes so hard and seen the difference in terms of investment, when you you when you sell a stent, the value of the stent may cover the randomized control trial, which has been previously realized, when you sell a dressing, which is five volts 10 euros Max. This is another difficulty. So there is a philosophy of the companies to invest in a randomized control trial, which will cost millions and, and the outcome. But on the contrary, we have a counter example. For instance, Hugo, we developed a splendid randomized control trial some years ago, on a on a dressing which was advanced racing, including some active product, small part, but active product. And they went with 40 centers all over Europe, a cost of three millions of euro, but they finished with a lancet. And this was a first racing coming with a randomized control trial. So it's not impossible, but it needs a lot of energy and a lot of investment. And it's quite, it remains quite difficult for a startup or small company to go through this process. 


Yann Goueffic  12:22  

And as you say, that is to also to focus on the population, which population which is the target population for the device. And of course, most of the company wants to have a wider wrasse population to sell more, that in this case is quite difficult, you know, and challenging to have a positive response, if you enlarge so much. It's why in some cases, the consultants the physician, the PI, should also discuss with the company why we could start with niche wraps and then progressively to enlarge as an issue. Of course, as a beginning, you have noticed this large indication of the device that, you know, you have, you should have in this case, because you you target a niche, a positive response in the RCT, you know, we have some good and bad example, for example, TV, they start with a niche communication of open surgery, and they enlarge with time, the negation of TV and no TV is quickly adapted for all patient or the country. We have some bad example with venues denervation it was a device you know, to decrease the IP attention on the vasculature it by endovascular treatment, and they have a large indication. But in fact, the RCT failed to show the superiority. And we know according expert in this field, that if you target a niche, it works that and I think it's at the beginning a very important discussion between the company and the consultant.


Prof. Luc Teot  14:05  

And if I may, the other in one dealing you have the basic devices, dressings, which are mainly absorbent, more or less absorbent, but absorbent, it's very basic mechanical action. But at the other end, you have very active machines, which cost a lot of money and can be used in specialized centers. These are not going through the process of reimbursement. But the process of allowance so means in a global budget, you can choose to use these highly high cost devices or machines, including in the DRG which is another aspect of the reimbursement. It's not specifically reimbursement. This DRG you can use them in France in Germany. No, no. I think in UK it is the same thing. So it's included in a global process. says of therapeutic actions. And it goes to using a machine for a specific timeframe on a complex wound, for instance. So it's adapted, but these machines will not be reimbursed on the global level at the level of the GP in a small village. Never. So I think the need for I think a smooth adaptation and contacts between the experts, the scientific societies, and the deciders is very important.


Edmund White  15:34  

So the message is strong collaboration there between the different stakeholders. So coming on to the next question, obviously, is a lot a lot of investment in in an RCT for companies and obviously the larger companies can probably fit the bill there. For smaller companies, it's challenging, which stage of the process should accompany think about to about their reimbursement? Is it pre CE or should be off to see what's your opinion on that side of things from the lifecycle, the device and the reimbursement stage?


Yann Goueffic  16:00  

You know, usually it starts with what people told us to the single the first in mind study, you know, by history showing the feasibility and the safety of the technique. And after that, the next step usually is RCT. So what I set out to see, you can use this first patient, including the study in the CE mark study, to be part of offers the main three, I have an example, I think, to share with you in the next slide. Yes, for example, Medtronic, in fact, SFA, use the first you know, patient in a pivotal trial, to include in the final three, all to show the superiority of, of docketing balloon, they excuse balloon. And again, here, you see I show a different kind of study, both today, in fact, achieve the primary endpoint and for vascular diseases, often primary patency. But in fact, the level of evidence was quite difference. In some studies, they show a difference in term of target lesion revascularization which, which was, in fact, as reintervention as the location of the disease, and in those are one, even if they didn't show any difference. This one was published in New England Journal of Medicine that didn't obtain the same level of evidence, and we start to speak about the easy is a I mean, and SOS is a was different between both study as a tree for the event, but it's with all and as for foster live and tutorial. So the objective and design point are crucial to obtain the endorsement that to obtain also pricing.


Edmund White  17:57  

Interesting. And have you got examples of where things have not really worked out for manufacturers? And what lessons could they learn from it? So where they've done a trial, and then it's been reviewed? And then it's has to go back? Again? Is there any examples where things haven't really planned out?


Yann Goueffic  18:14  

Yes, it's not as successful every day, I have example, to share. And I think for company is very important to know that, at this period, you know, the launch in different cities, and some company was particularly done to lauch our city, so they make a registry about their own DCB. And they were thinking that because DCB was too successful in the level two and intact, that we'll be able to get the reimbursement in France. But in fact, when z applies the dossier, they just say no, because there is no class effects on your device, you should show you your your efficacy, because your balloon is different from those ones without the balloon is not the same amount of drugs is not the same coating stuff. And so it was in 2017, this company decided to set up our city but at this time, it was not any more ethical to compare DCD versus proba, which was the standard of care in 2015. And so it tickled me to say no, you are not able to set up the. We are between DCB and proba and so you should perform in this case, non inferiority RCT comparing your own DCB versus the Medtronic one was about one, but what we know in this case, when you have to set up a non inferiority study, usually you you have to include more patients. And so in this case, is more costly to set up this nullify this RCT than the To buy Udacity. And finally, source history is from 2015 2017. No, in 2022, that just finished RTC and didn't get so far zero does not soon, I hope for them that they lose in fact, five or six years before obtaining the reimbursement because they're niche, with little to no evidence


Prof. Luc Teot  20:23  

I have another case where it went to failure. And it's not as the same story is not the same story of rar RCT and methodology is the question of what what is the right price of medical dressing, or a medical device. And it came with the previous product comparable to the one I evoked with Hugo was an American one. His name was promo Gran promo grand went through the first commission Canadians with obtaining and as a free, which means high level of reimbursement. But when they came to the next Commission, which is pricing, they didn't get the right prey price, and they refused to refuse to refuse the product in our territory. So, this is also another limitation for foreign companies to come to France, because at the end of the day, the price will not may not be the one they expected. So they are they know that they will sell well, considerable amount of products, but they know that the price will be reduced because there is a kind of constriction of the during the pricing deal. For our so globally. I asked you about that, would you? We are in windy Ling and I'm not speaking about France, I'm speaking about global QL. In we're dealing all over the world, there is a reluctance to consider that RCT is a key element for reimbursement, we have the we would like to get to provide an alternative evidence and this alternative evidence could could be done by a series of cases and cohorts of patients correctly analyzed, correctly collected. And we are really pushing for that because everybody all over the world is following the primary outcome which is written in the model, which is an off link. But if you make a consensus meeting with 10 kol in wandeling. And you tell them you show slides and you say is it and a feeling you will have 10 different answers. So it's not the it's something which was well built around when dealing because he didn't know what to do. But here it's time to reconsider all these topics and analyze differently the evidence and this is what the wound healing world is proposing to redefine a little bit the product and to not to miss because we in France, we missed some some products that are efficient in US or in in other parts of the world. Because of this very rigid considering


Yann Goueffic  23:21  

I am totally agree to the we have the same experience with critical limb ischemia. So ischemia offers a limb but we've wound the problem. And I think we have to break, in fact, the dogma in some cases of acid RCT rise a high level evidence that in some cases with some endogenous population is very difficult. And it's not so important to have this RCT because if you want to have a successful RCT, you just to have a pick up very selective population. And you don't have the answer to the problem. It's why I believe, like you that if you have a cohort, that very informative, very well done prospective cohort, you can have also very important information. In France, for example, the French government has set up the SNGs code data in fact, and you have you are able to have information about patient that for all the countries 65 (....) of people, which is huge, in fact, depends on the question, of course, that in this kind of quotes, you have very informative data. Also you can set up for your own proposal, some perspective code and also is a court is well done to have very informative data and to rise evidence, I am compensated with


Edmund White  24:44  

this point. So just going on a couple more points before we move around the wider your area region. Once you've got your device reimbursed as a five year renewal process, what happens at that stage and to the products on the market so at five years do they matter? factor I have to go through that whole process again in France.


Yann Goueffic  25:03  

It's a boss market, which is sweet. Yeah. So he is asked for post market registry. You know, I get said some company thing that is boring to pay again for history. I think there are some tips and tricks to make some postmarket which will see not so expensive. But it is also a very important question because as we said, in RCT, we have a very selected population. I can give share with you, for example, with summer city we include for the LDCs, mainly Caucasian male, and in international STD we exclude the woman and black for example. But what happens in this population? And we have no response, in fact, with RCT, it's why to see if the RCT is what comes after the RCT are consistent with post market data. It is also the resisting because it's about real life data. And I think that is not so boring to have also, this data and to see if it's consistent with produce outcomes


Prof. Luc Teot  26:07  

Completely agree. And wendling is exactly the same. So because as you as Yun said, You are your RCTs considering a very small population, and when you come to post marketing studies, you get a wide range of what was used after. And we can come back on that if we analyze what happens in Europe? I don't know if you


Edmund White  26:32  

Yes, yes. Oh, yeah.


Prof. Luc Teot  26:36  

So in UK, the very much more smooth means a product has gone through the CE marking has been approved by the NHS, it comes to the drug tariffs. And if it is used, if there is a feedback, which is positive, considering the dressing, it will stay reimbursed. If nobody use it, it will come down very quickly. So it's much more adapted to the reality of the market. In, in Italy, it's complex, because decisions in terms of health are made region by region. So medical device will be highly reimbursed in Sicily, and not in Lombardy or in Tuscany. So this is, I think one of the nightmare we have in Italy. For Germany, Germany is very similar to France, but they add something else, which is the responsibility of the of the prescriber. So if you prescribe too much one product, the insurance system will come to you saying well, why do you prescribe this product so, so often? So this is another aspect, which is? Well, I think it makes sense. And in in Spain, it's they they have a they don't have private nurseries, so they have a kind of local centers for dressing. So the patient comes to the center, he has his dressing, very basic dressings, and all what is little bit advanced is in sent in hospital in the hospital. So there is very heterogeneous, I don't know in your area, but in my area, it's it's complex to homogenize and to try to find out really a consensus among the because the evidence is not so high. So we lacking evidence. And we lacking the capacity to provide this evidence because of the complexity of the randomized control trial.


Yann Goueffic  28:31  

It's similar, not the same field. But we have exactly the same. The same thing about this country.


Edmund White  28:40  

Where do you see this sort of evolving here? Because obviously, Europe's pretty patchwork of different systems is complicated for manufacturers to have a market entry strategy when it's different. It's not a unified market. Where do you think this could potentially evolve in the future in terms of making pathway a bit smoother for for manufacturers to get the devices in a reimbursed? Or do you think this is going to stay as it is the status quo.


Prof. Luc Teot  29:06  

I'm pushing actively to two European registries because this is a way in which everybody will have the same information. The database is accessible by all the country deciders and then we can provide certainly something which is much better than what is given now.


Yann Goueffic  29:28  

The last month I am in contact used to be in contact with NEAA market access responsible in Europe. And it seems that you know, we standardized the French system showing that zero Bosmans was based on level of evidence. It seems that there is a trend in Europe to copy paste the French system, copy paste that you get zero investment, according to evidence where For example, in Germany, if that's the case, you start by opening the market. And you can use the market, you have a temporary investment joining several years. And during this time you should arise evidence is not the case in all the country, perhaps in Germany in UK is more based on the cost effectiveness. But definitely, it seems to have a trend to make a copy paste on the French liberal cements pathway and to rise evidence before zero investment.


Edmund White  30:34  

Yeah, interesting. So I'm gonna move on to another topic here. There's like some new pathways, innovation pathways just come out in France last year to sort of accelerate new technologies for reimbursement. Can you shed some light on some of these programs, because I think a lot of the companies here today have very compelling innovations. And I think this is something which could help. 


Yann Goueffic  30:55  

I think you have a huge experience with Article 51, perhaps you can share that we can go because I have no experience. And few people have this experience with huge programs very important that Luke share with us this experience.


Prof. Luc Teot  31:10  

So we have the two first we evoke that. So it's a forfeit innovation, which is funding for innovation and startup can go to the court to the commission and say, well, we would like to be helped to determine the efficacy and evidence and give evidence, this is very restricted, temporary coverage, you spoke about Article 51 is a niche that was open in 2018, allowing some experimentations on new organizations and new funding system. Schematically, if we compare what is done, now, you go to the doctor, you pay the doctor. And the doctor will say you take a date with biology, radiology and come back to me into one month. With his new article 51, what is proposed, what we proposed at the level of 6 million of people in Occitanie, where I live is to have a lump sum, which comes immediately, and this lump sum will be spread into the experts at the normal rate of payment of doctors and nurses. But with point which is interesting, which is coordination means you get out from the doctor, it's a complex situation, somebody will help you to have a date with radiology to date with the biologist, or date with what is needed. And and then you shorten the period of waiting, losing time in a wound healing trajectory. So pathway of cares. and determining what is right pathway of cares is really what is changing. And it's not reimbursement of medical device. But it's reorganization around the way to be treated and the prognosis of healing for us, which is completely different. If you use these intercalary interventions, and you provide something which is much more efficient in terms of well, lengths of feeling.


Yann Goueffic  33:19  

It's impressive, because it's not just that with the device also it's about organization. Yeah, it's organization and coordination, just you heard about the first for for innovation and temporary coverage. In fact, what I know is it has been done, in fact, to fill the gap with Germany. In Germany, as I said, usually during two or three years, the devices itself and company are able to develop also some study to assess the device. And so now in France using this for fine innovation operate coverage, it's also possible to get benefit of the cells, and at the same time that us as a company to rise evidence. So it's also interesting, it's a possibility to develop this kind of study.


Edmund White  34:07  

So things are moving in a positive direction here. There's a glimmer of light here in terms of the process here. Yeah, so we've got a few more minutes left here. Just to find someone that on the sort of future considerations here. Just going back to that, is there any other comments you'd like to make about the future and where this is evolving for reimbursement before we take some questions from the audience?


Prof. Luc Teot  34:27  

Yeah, the last word, telemedicine is a medical device is just a medical device. So it's not something which is complex is something which is coming progressively during the COVID It was absolutely mandatory to get contact. So the telephone was considering was considered as telemedicine the year WhatsApp was considered the main tool to communicate. But now we coming back and France as I think has invested a lot in this development. And even if we have, for the moment, less than 5% of the physicians doing telemedicine, this will take more and more because it's easy. During the postdoc period, for instance, the patient doesn't, doesn't need to come back to wait three hours in your waiting room to have to see you for 10 minutes saying it's okay. Everything is okay. You can come back home and back home, you lose one day, if you if he sees a child, you lose one one day for the child one day for the mother. So it's there is a lot of advantages to simplify the pathway. So I think yes, this is coming in terms of reorganization of the folder system. And these two medical device.


Edmund White  35:43  

Yeah. Great. That's excellent. So we got few minutes. Any questions from the audience? Before we wrap up as opportunity for one or two questions? This one question, gentleman over there.


Audience Question  36:02  

Thank you very much for for this information. So I just have a question regarding the type of evidence I know that in to get reimbursement in France, or in other European country dividends to be collected is very high. Do we always need randomized clinical trials to obtain reimbursement? Or it depends on on the therapeutic area or the device itself?


Prof. Luc Teot  36:33  

You need a randomized controlled trial to have a brand reimbursements. I mean, so the first one, then you need something which is if you want to be considered as a generic, you have to demonstrate that you are equivalent in terms of capacities are in terms of results. It's another randomized control trial, but it's well, I would say it's more easy. I don't know if you agree with that.


Yann Goueffic  36:59  

And noninferiority is not so easy. In some cases, it depends of the margin that you you define. And so it's also admitted, it's tricky in terms of methodology. So I think it's very important to have a good methodologies board and to have an open discussion with him because also, you know, the choice of the primary endpoint, as we see secondary endpoints is choose of the population. You know, it should be discussed at different levels, company physician, methodology level is not one decision from one person.


Edmund White  37:33  

Yeah, yeah. Great. So let's just quickly wrap up a few final remarks from your end, on today's session. 


Yann Goueffic  37:44  

thing that we are still we still need is this level one evidence. It should be launched to the Europe I think, as soon probably think about the design of the RCT also, and Sukkot will be also more and more important is the future to answer to a two minute question.


Edmund White  38:04  

Right. Thank you. And Luc Teot?


Prof. Luc Teot  38:06  

Yeah. When do you think is is a far west for the moment. And there are many opportunities, but it's complex, and I think needs to be more structured from the beginning, the biology also. So there is a lot to do in wondering. And it's becoming more evident for everybody to that this is an interesting area.


Edmund White  38:29  

Great. Thank you very much. So that's time up now for us. So just want to say a big thanks to LSI, Scott and the team for organizing this event and putting us on the program. Big thank you to Professor Goueffic and professor Teot, our panel today. And also big thanks to the audience here. Thank you very much for listening. I appreciate it's before lunch and probably that's something to consider now. And a big thank you to everyone else here and have a great rest of the day. Thank you again.


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