Breaking news: Cladribine tablets will be made more accessible for people with MS

Hi there. I’m speaking today with Prof G
at the Blizard Institute and I’m asking today about
cladribine and the very recent decision by NHS England that cladribine is named as a
‘rapid uptake’ product, which will be made more
accessible through the Accelerated Access Collaborative, AAC. What does this actually
mean for people with MS, Gavin? For me, testing means a lot because the whole
idea about this Accelerated Access scheme is to try and improve the uptake of innovative
products in the NHS. The NHS is criticised for
slow adoption, so a new innovation comes out and it takes years really for the NHS to
implement it. So Simon Stevens from the NHS has decided to create this initiative and
put NHS funding behind it to speed up adoption.
So it’s remarkable that oral cladribine –
Mavenclad is the trade name – has been selected for this. I think the reason why it’s been
selected, because it’s quite an innovative drug, in the sense that it’s oral, it’s
given as short courses, the monitoring requirements are low
and it’s got a very good safety profile. So a
wide adoption of this agent would improve the outcome for people with MS massively.
I mean our biggest problem in the UK is so few
people are on treatment relative to what we would expect them to be. So we under-treat
MS massively. I don’t know if you’re aware though, within NHS England network, prescribing
of the high cost drugs are limited to what they would call regional neuro-science centres,
and there are about 25 or maybe slightly more than 25 on the list, so to get access
to those treatments you have to go to a specialist centre. That creates enormous delays. I was
recently involved in an audit of two centres actually, and if you get referred directly
into what they call ‘the hub’, you get on to a
treatment within about two months, which some people would say is too slow anyway. If you
have to get referred in from one of the district generals into the hub, time to treatment is
over nine months. So there’s a seven month gap
there. Now that to me is unacceptable. So maybe if the NHS put some weight behind this
and said, well actually, oral cladribine doesn’t have to be prescribed in the hub, you know,
MS experts or even general neurologists all over the country can prescribe it and it means
that people with MS who fulfil the criteria for
the drug could get on to it very quickly, without having to be referred in and be assessed
within specialist clinics. So I’m hoping they do that. The other thing that needs to
be done is some of the criteria are a little bit archaic
in terms of who’s eligible for the drug. So I’m
hoping that when they assess what can be done to improve the access to oral cladribine,
they tweak the criteria, what are called eligibility criteria. But I think the message is, the
NHS has identified MS as an area of unmet need,
they want to improve access to treatments, they want to speed up access to treatments,
and they’ve promised to put resource behind 2 this, and so it’s good news. I think we
should celebrate the fact that an MS drug got on to
the shortlist. And there’s only seven products that have been identified, and one of them
happens to be an MS product, so it’s very good news. Can you tell me about the role that Barts
had in this? Oh, so, Barts. Yes, I mean I’ve been involved
with this product since 2002, so I can give you
a, it’s a whole history lesson. But anyway, the company at the time were Serono and they
were deciding to repurpose this drug and buy the technology to convert it from an injection
form to an oral form. So they decided after having this advice from a whole lot of experts
that it was a drug that should be taken forward and they bought in the technology. And I was
invited to be the principal investigator, I have been for the last 15 plus years as
a PI on the project. And so we had to design the trial,
set up the study. And the trial was positive, we
put it through the regulator, the regulators turned it around- they rejected it initially.
They rejected it because of a, in retrospect, a
false signal. There was a signal of possible malignancy risk and we at Barts, particularly
my colleague, Klaus Schmierer, and Julia Pakpoor, did analysis of the data and realised
that the reason why there was a cancer signal, because there were zero cases in the
placebo, there was a false signal. So by reanalysing the data, you know, made the case
for the company to go back to the regulators and resubmit it, and that’s what they did,
2014/15 they went back with the data package, which was now much bigger, and I was involved
with that. Also, what had happened, that whole environment had changed. I think what
really changed the environment was another drug called alemtuzumab, Lemtrada. It got
a licence and a very liberal licence to be used as
a first-line agent, and all of a sudden, people said, well if Lemtrada got licensed with its
risk profile, because it’s got quite a lot of
adverse events attached to it, then surely cladribine
could get licensed. And so that kind of also stimulated the company to reopen the
discussion, they looked at it and said, well, of course. So in, we went back in 2015, actually
it was from 2015 the discussion started, it only got given approval last year by the European
Medicines Agency. This time it got a unanimous decision, there wasn’t a single member of
the, what they call the CHMP, the voting committee and the EMA, had turned it down, so it
got through without any problems. And now we’ve got the tablet, so- and NICE approved
it first time as well, so NICE assesses whether
it’s cost effective, and they approved it first
time. And I think the reason why they approved it, because Merck, who manufactures and
markets the drug, went to NICE and said to them, we will do a deal with you. If the drug
doesn’t work, in other words if people fail this therapy, then we’ll reimburse the money
that you spent on it. So it’s kind of a risk-sharing
scheme in a way. The NHS is paying a certain amount of money, if the drug doesn’t work,
the company reimburses it. So this is the way I 3 think healthcare, particularly on high cost
drugs, is going to go in the future. So there’s that
in place, this reimbursement scheme if it doesn’t work. And now we’ve got the NHS
behind us saying, actually, we think this is going
to- it actually is going to revolutionise MS
treatment, because what’s really affecting us in our centres now is the monitoring
requirements, you know, these patients, particularly people who had like alemtuzumab, for
example, have to come back for monthly blood tests, monthly urine tests. There’s this
whole lot of autoimmune diseases that happen. So
there’s lots of burden attached to the monitoring, and even giving the drug, it’s
a complicated infusion over five days. The other
therapy’s, natalizumab is once monthly. Then we have ocrelizumab that’s every six
months. So those burdens are going to completely,
they’re going to disappear with oral cladribine, so
I think what probably drove this drug getting through is the impact it’ll have on freeing
up services. And what people don’t realise
is if you free up NHS staff they can do other interesting things. So, I suspect there were
quite a few reasons why it was green-lighted for
this Accelerated Access programme. But it’s exciting for us.