BELGIUM: Belgian Medical Genomics Initiative – Gert Matthijs
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BELGIUM: Belgian Medical Genomics Initiative – Gert Matthijs


Gert Matthijs:
Good morning. I am Gert Matthijs from the Center for Human Genetics in Leuven in Belgium,
and I’m presenting this contribution on Belgium together with Marc Abramowicz, who is the
chairperson for the College of Medical Genetics in Belgium. After two big countries, this
is a report from a small country, so the numbers will vary accordingly. But what I want to do, actually, is rather
than to give you a vision on what we think should happen, I want to evaluate the vision
of the previous generation of geneticists in Belgium who have created a framework which
has allowed genetics to grow and to flourish. And the point for us now is to see how we
can build genomic medicine on what’s available. So this is why I’m taking you back to how
we are organized currently in Belgium, how the reimbursement system works. I won’t mention
the Rare Disease Plan. We’re all working on these things. I won’t mention somatic cancers.
I’ll just keep it — keeping to monogenetic — monogenic diseases, and I’ll give you a
few examples on how we think we will be able to move into genomics. And then finally I
would like to talk about what’s happening in Europe, but I would rather refer to Dr.
Irene Norstedt who is here from the European Commission. I can limit myself to cherry-picking
on what I think is interesting at the European level and useful for the nations actually. So, basically, genetic testing in Belgium
is — we have a public healthcare system. This is a social healthcare system. Don’t
be confused. It’s not a socialist healthcare system. It’s a — [laughter] — social healthcare system, which means that
everybody complies to the healthcare system, but the individual doctors earn more money
if they see more patients. This is how it works. [laughter] We have eight genetic centers, so all genetic
testing is limited to genetic centers which have been established by law back in ’87,
and that’s where our former generation has been visionary, I believe. And we have four
centers in Flanders and four in Wallonia because everything in Belgium has to be dividable
by two. [laughter] And we do have at the same — by the same
token, we have a specific reimbursement system for the genetic tests which has been in place
since ’88 as well, and which I would like to present to you. So here’s Belgium. We have, as I said, on
the North, we have the Netherlands. We’re at the heart of Europe, with Germany and Luxembourg
on the east and France in the south, and just across the water there is the U.K. So Belgium
is split into two parts, Flanders and Wallonia, and in total, these are — the yellow sites
are the ones where the — we have the genetic centers. So there are three genetic centers
in Brussels, two French-speaking and one Flemish, and then the others are the sites in Belgium.
And I also would like to introduce our new king, because Belgium is a kingdom, and the
king took over last summer from his father. Now, politics in Belgium is complicated. As
you can see here, this is at the funeral of Nelson Mandela. This is our king in the middle
saying, “Look, guys, we outnumber the American delegation.” [laughter] And there is your former president saying,
“Who are these guys?” [laughter] And he’s right because the politics in Belgium
are quite complicated, and we have lots of prime ministers and vice presidents and so
on. [laughter] But in genetics, we keep it simple, and that’s
the message. So at the national level, as I mentioned,
we have these eight centers, and they’re all associated to academic hospitals, which means
we do integrate research and clinics and laboratory activities. Funding comes from the regions
as far as it’s about prevention, it’s about development, and funding comes from the national
healthcare system as far as tests are being reimbursed, and, of course, we have to add
grant money to make it operational. The reimbursement system has been very simple.
Back in the ’80s, we have a reimbursement system for cytogenetics as well as for DNA
tests as for biochemical tests, and it includes prenatal tests as well. So for the past two
decades, prenatal tests have been reimbursed in Belgium. The system was a bit outdated, so now we have
a new system which is stratified where we have a stratification of the different tests
where we have a separate reimbursement of consultations, which wasn’t the case previously.
We were kind of depending on testing to also be able to offer counseling. And we do have
a specific reimbursement system now for samples sent abroad. You know in Europe, a lot of
samples travel, and we do have a cross-border system right now. And one thing I want to underline is that
in Belgium, labs have to be accredited according to the ISO 15189. This is unique in Europe,
I think. We should push hard on getting this through in all the countries. This is the extract from the old law which
says like a karyotype is reimbursed at €327 — that’s the latest reimbursement rate — prenatal
diagnosis is possible. And you’ll see at the bottom that even before PCR was invented,
the law in Belgium said that anything that was about hybridization — hybridizing DNA
would be reimbursed as a genetic test. This was, of course, built on Southern blotting,
but it happened to also apply for PCR. So, all genetic tests have been reimbursed for
the past 25 years. Of course, the system has been criticized.
People were blaming us that we would get €327 for cystic fibrosis or for Factor V or Factor
II, or hyperchromatosis. No one ever blamed us for offering breast cancer testing for
€300. [laughter] But it just indicates that the system only
works when you have that system in place with a limited number of laboratories who then
mix the two kind of things. So, the new system now which is in place this year has this stratification
of the tests, and in total, the budget for genetics in Belgium is €40 million for 11
million inhabitants. This is how the budget has grown over the
past 15 or 20 years. It seems like we’re reaching a level at about €40 million. This is because
the government is of course putting limits on what we can expend, and we’ll try to push
hard to get across that limit because genomic medicine will need more than classical genetics. Other people also claim that they can do a
lot for €4. Well, in Belgium, we offer genetics for €4 per inhabitant per year. We would,
of course, like to see this double if genomics come in, but keep that in mind, €4 per year
per inhabitant, that’s not a lot, and there’s a lot you can do if you structure that well.
That’s the main message. So what does the new reimbursement system
look like? I mentioned it is now stratified, so we still have reimbursement of karyotypes
whenever we want to do it. We have reimbursements for CGH arrays. But we stratified the DNA
system in a way that the cost is closer — the reimbursement rate for a specific cost is
closer to the effective cost for this specific test. And what the genetic centers do is put,
year after year, just see which test fits in which category. So the flexibility is on
our side now, and as a result, we’ve now been reimbursing breast cancer testing at €1,300,
almost €1400, so we’re making a lot of money in breast cancer right now in our laboratories.
But it may well be that this test next year moves into a cheaper one. But at the same
time, because it’s an open system, we can instantly insert gene panels. So the gene
panels have entered in our reimbursement system in that top category. So, no one would question
whether these tests would be reimbursed, yes or no. We just put them in there, and the
patient will only pay what is called [speaking foreign language], which is about €8.7.
That’s all the patients have to pay. Of course, we don’t have reimbursement for
exomes and genomes, and I personally refuse to squeeze that into this budget, because
if we do, the government will be very happy, but we will killing — be killing ourselves.
So we want an extension of at least half of the budget with at least 50 percent to make
— to be able to also cope with exomes and genomes. But nevertheless, I think I’m, as I said,
thankful to the previous generation that we have a system which is flexible, which is
cheap, which allows us to do a lot with not too much money. We work together to try and
develop national guidelines, and we have — we’re about to submit a model for reimbursement
of exomes. Of course, the system is challenged, not in the least by private companies who
think they can now reap the benefits of the — I would say the best part of the thing,
but we’ll try and fight back to make sure that they don’t get started in these things. Now, one other thing is that we have this
Belgium Medical Genomics Initiative, and that’s actually built on a research project. It’s
the only leftover money we have in Belgium at the national — at the federal level for
research. It’s small money, I don’t even give you the numbers, but all the genetic centers
have put their forces together into a research project to look at genomics and research.
And what we — I want to just hijack this to also make sure that we use it for standardization
of how we treat data for education of young geneticists as well as the public. So it’s
going to be added on. The initiative to deal with it at the healthcare level is mingled
with an initiative to deal with it at the research level. And again, it’s not big money,
but we’ll try to make the best out of it. So, one way to do this now is to put together
a plan that will go to the healthcare system, to the Minister of Health, where we will say,
“Okay, this is what the genetic centers commit to be doing to make sure that we introduce
genomics in the way it should be introduced.” And all the buzzwords that are on here on
the board that we’ve heard already this morning like, yes, we have to deal with ethics, yes,
we have to deal with informed consent, it’s not a coincidence that we have divided this
into eight tasks because there’s eight genetic centers and I want the eight groups to commit
to the same big project. So, each one of us will be in charge of one of the tasks and
make sure we all move together to getting this accepted by the Minister of Health and
get the budget accordingly. As I mentioned, I wanted to just look at the
European level. There’s a few things there. For instance, there is that the Council of
Europe has issued, two years ago, a recommendation that prescribes the way in which genetics
should be offered in the individual countries. It’s a document which is not often cited,
and that’s why I kind of refresh it here because it tells people exactly or tells nations exactly
how Europe think that the genetic health care should be organized. Again, I won’t go into
details. The other thing is that together with the
support of the European Commission, we have been able to run a European project which
was called EuroGentest for the past seven years or eight years, and one of the things
we do in EuroGentest is to try and harmonize genetic testing to try and improve the quality.
And the latest thing we’re doing now is to issue guidelines on NGS for diagnostics. They
are built on the American guidelines. We’re using the Dutch guidelines. We’re stealing
from the U.K. guidelines. We just want to put together things which are useful and which
can be used by accreditation bodies to say, “Yes, your system fulfills those criteria.” Most important things there are diagnostic
routing, diagnostic utility, referred to this morning. And I would like to propose a scoring
system as well so that people can compare the quality of exomes of gene panels between
laboratories, between companies, so that people don’t start to say, “Mine is better because
it has 100 genes.” If there’s no clinical utility, it doesn’t make sense. So these are
the kind of things which we would like to propose, but because I’m here now, I’m not
sitting down and writing the final version of those guidelines. [laughter] I don’t blame you for that. And the final thing I would like to say is,
and that’s all too fast, but we would like to lift those guidelines to the level of IRDiRC,
and IRDiRC has agreed that yes, indeed, the Diagnostic Committee would definitely be ready
to adopt the guidelines. And I think we should also include IRDiRC in most of the commitments
we try to make here to get this at the global level. So, thank you very much for listening to this
small country contribution. [applause] Marc Williams:Marc Williams, Geisinger. I
was really impressed by this. I think it was very visionary in terms of the approach that
you’re taking, and really like the idea of the goals that you’ve set forward in terms
of the European efforts related to some standardization. I think those are going to be groundbreaking
and hopefully something that this group can begin to work on. I wanted to get a little additional information
relating to the testing information that you presented. So, as I understand it, the government
sets a budgetary target. It says, “You have this much money to spend.” But then it sounds
like you have the discretion to say, “This is how we’re going to spend it.” Could you
talk a little bit more about the representation of the group that makes the decisions related
to the budgetary allocations? Who’s involved in that process? How do you manage issues
that we’re struggling with in this country like the molecular genetics community versus
the pathologists for — you know, that everybody wants to have their little piece of the pie. Gert Matthijs:
That’s a lot of questions or a lot of answers. [laughter] The first thing is if it’s about going to
the healthcare system and the government and trying to defend genetics, it feels like going
to the Coliseum in Rome where you know they play a little bit before they kill you eventually. [laughter] And this is because the geneticists have no
formal representation in these groups where the pathologists and the clinical chemists
and the cardiologists have a seat. Nevertheless, we’ve learned that if the documentation is
good, if you can convince the government that whatever you do is efficient and helpful,
I’m still here, I survived, or at least the system survived. So this is the way to go. The other thing is that the — we do accept
samples from neurologists, from pediatricians, so it’s not limited in a way that only geneticists
can provide genetic testing because that would be outdated. But we have written in that reimbursement
system that we can refuse tests. So the geneticist or the laboratory person says, “This is ridiculous.
This is lottery testing.” We can say, “Hey, this — we don’t accept your test.” But basically,
it’s on a peer review basis, which definitely only works if you — if there’s mutual trust,
and if you have piracy coming in along in a system like this, it’s bad. So it’s based on mutual trust, and also based
on the fact that we shouldn’t eat each other because we are eight centers and the budget
is limited. We should start and compete amongst us. This would kill ourselves. Rather, we’ll
try and fight together to get a bigger budget. This is the only way out. Bruce Korf:Bruce Korf from UAB. The system
of more or less centralizing the testing to a handful of centers and the reimbursement
system grew out of a kind of rare disease paradigm where it was possible to concentrate
patients in these centers. But as now we move to an era where maybe everybody with cancer
will have their genome or at least their cancer genome sequenced, or pharmacogenetic testing
may be done on every patient, how does this scale so that it encompasses the entire health
system? Gert Matthijs:
Well, it — that’s the true challenge. And first, I think at the academic centers, we
try and open it up in the sense that no — it’s no longer the geneticists only who have access
or the right to sequence a genome. That’s outdated. So, at the academic hospital, we
will make sure that anyone can use that same framework, and in Leuven, we call it a hub
where everybody can just use it — the laboratory and say, “Here’s my data.” At the national level, it’s going to be a
battle mostly between academic centers and private centers. Well, private — again, the
ones that work within the healthcare system but do it on a private basis. And this is
not solved yet, but I hope that — the nice thing about this monopoly — monopolies have
never — are never right, and I’m one of the guys who I’ve been fighting the breast cancer
monopoly, so I should not say monopolies are right. But the monopoly is right in the case
you do as much as you can with as few money as possible. And in that case, I think from
a political standpoint, this is where you need monopolies. This is where you need to
limit the number of people who can offer this or this test. And we will just offer it as
a service and let the interpretation be done by the experts, which are the cancer geneticists. Rex Chisholm:Rex Chisholm, Northwestern. So
you talked a little bit about the reimbursement system, but can you talk a little bit about
who decides which tests actually fall in those panels, for example, might be reimbursable? Gert Matthijs:
But I think this is the beauty of the system. Historically, we had a system where the geneticists
didn’t even have to argue about which was a genetic test. Of course, the government
got upset about this — not the government itself, but the guys who didn’t have access.
So that’s why we have introduced this stratified system, and the stratified system allows us
to put, as I said, different tests or different diagnoses into different categories. This
is now entirely in the hands of the genetics ourselves. I mean, it’s me together with my
colleagues who draft that list, hand it over to the government, the government stamps it
for this year, and it’s going to be reviewed next year. The thing is if you put that in
law, it takes you ages before it’s changed. This is true in France. If you have to get
something in what is called the nomenclature, it takes you ages. So this is a flexible system and that’s why
I’m defending it. It allows you to adjust — on the side of geneticists, change the
list year after year. And then the discussion becomes between peers. If my peers or my colleagues
don’t agree that, yes, this test is efficient, then I’ll have to give in, because otherwise,
it wouldn’t work. So I think it has to do with clinical utility eventually, but right
now it’s like a small men’s club defining the job. But it’s transparent for sure, and
it’s flexible, and that’s why I’m a strong defendant of this stratified system. I want
to export it actually to everybody. Rudi Balling:Okay. Rudi Balling from Luxembourg,
just a stone’s throw from Belgium. Gert Matthijs:Yes. Rudi Balling:You made some very strong comments.
You hardly addressed it about industry — private companies moving in, and you used the word,
“So we definitely fight back.” I just wonder whether that’s the right strategy, and whether,
at least in some cases, an alliance might be the better way to go instead of fighting
back. Gert Matthijs:Yeah. Rudi Balling:It sounds very strong. Gert Matthijs:Well, I’m a street fighter.
But — no, no. The fighting back — [laughter] — the fighting back is against the piracy
of one man’s companies who say, “Okay, we’ll offer genomics to the public.” This is where
we have to fight, I believe. If genuine companies would come in and say, “We can offer on a
joint basis,” as you said, “cheaper exomes, cheaper genomes,” I think this is to be considered.
The fighting is against the piracy cases of companies that say, “Yes, we’ll offer carrier
testing to the whole population,” and then just leave the population with problems. So
that’s a — Rudi Balling:Yeah. Gert Matthijs:– different issue.

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