Thank you very much. The Cancer Drugs Fund was set up in 2010 to address some very specific
issues, and that was requests from patient groups and charities to ensure that patients
got drugs which were deemed to be useful but had either received a no from NICE, or were
for rare cancers that were not being assessed by NICE, or for off-label use. The budget
was originally £200 million, and it has been expanded twice and is now £340 million for
the financial year 2015/2016. The Cancer Drugs Fund is due for renewal in
2016, and there have been several things that have become clear, but basically the Cancer
Drugs Fund is not really working in the way that people would like. First of all, there
are issues of cost control. Secondly, the Cancer Drugs Fund has demonstrably produced
a perverse incentive in terms of enabling some companies to bypass the rigorous assessments
by NICE and get drugs into the Cancer Drugs Fund at a higher price. The third area is
that it has not provided the level of evaluation, I think, that many people would like. Then
the fourth area is that on top of all of this, there are a whole bunch of new drugs on the
horizon which may be much more curative than some of the ones we are looking at at the
moment, which may apply to smaller groups of people and which are more expensive. We
have to address all of these if we are going to bring the benefit of new drugs to as many
people as possible. Given that there was a widespread feeling
that the Cancer Drugs Fund could be improved, I brought together in December 2014 a group
of charities, the MHRA, the Department of Health, NHS England and others who were interested
in the Cancer Drugs Fund, to see how we could start to flesh out some thoughts as to how we could get a
sustainable Cancer Drugs Fund. This included the Association of British Pharmaceutical
Industry. That was against a background of quite a lot of moving parts, because the licensing
process in Europe for drugs was changing, which meant that, with something called adaptive
licensing, some drugs would become available earlier but with less evidence. The MHRA had
a scheme for early access to medicines, and we had the Cancer Drugs Fund. On top of that,
we had a Cancer Drugs Fund which functioned outwith the framework of NICE, and of course,
NICE was established 1999/2000 with a view of trying to bring rigour to the evidence
and evaluation of clinical effectiveness and utility of specific drugs.
I think there was a strong view that we needed to bring all of these moving parts together
in a way that would create at least some form of functioning, coherent machine. I should
declare an interest in the sense that I have a very, very strong view of the value of charities;
I am on the Council of the British Heart Foundation, I am a member of the CRUK company. One thing
that charities bring is they bring independence. The second thing they bring is credibility
to their constituents. The third thing they bring is that they understand what their constituents,
their patients, their members want. The fourth thing they bring, particularly the big ones,
is really cutting-edge research, which helps you to understand the direction of travel
in that particular area. In my mind, the charities were absolutely key towards helping us find
that sustainable solution. We brought this group together. We became
concerned about how we could integrate that work with a new thing called the Accelerated
Access Review, which was a plan by the Department of Health to see how, across the board, we
could bring earlier treatments to patients in this country, so it seemed sensible that
we did not have deliberations on the Cancer Drugs Fund happening in one place and deliberations
on all other drugs happening elsewhere. Therefore, last month we paused that work while we spend
a bit of time trying to work out how some of these moving parts fit together, but it
is absolutely clear to me that once we understand some of those issues, we continue to engage
strongly with colleagues in the third sector. I think the ultimate vision – and I will
simplify this, because otherwise we could get into quite a technocratic discussion – is
that the Cancer Drugs Fund needs to be an evaluative incubator, a place where we can
put drugs and resolve uncertainty about their effectiveness and utility through data collection;
that we would, with all drugs in the Cancer Drugs Fund, collect information that is of
clinical, commercial and regulatory value, which would enable us to determine fairly
early on whether those drugs are worthy of funding in our National Health Service. The
second thing is that that incubator function needs to be linked into NICE, so that we need
a way of taking drugs where NICE may feel that there is a degree of uncertainty and
solving that problem with real-world data. Then the third issue is that we need to be
sure that whatever fund we have fits within the £300 million budget that we have allocated
for it. There is some complex work that needs to be
done between now and 2016 to ensure that we have a working model for the new Cancer Drugs
Fund. That is quite a tight timeline, and there are some very complex issues to be resolved
amongst a number of different organisations. I think you have put the context very clearly.
The context is that you, Bruce, have been through a process of informal engagement and
discussion with various groups, including charities and the pharmaceutical industry.
There have been some technical discussions as to how a new fund approach might be created,
and we are being invited today to approve the issuance of a consultation paper with
a broader remit for consultation as to the future operation of the fund.
We need to go out to public consultation on the future of the fund, and we need to get
ourselves into a good position; both in terms of the technocratic issues of that, as well
as ensuring that prior to that consultation we have had good engagement with everybody
who has a vested interest in the Cancer Drugs Fund.
I might just underline one point, which obviously is that nothing about changing the way the
fund works per se either increases or cuts the amount of money in it. So if we are going
to do what Bruce has described, and which I think will actually have a strong degree
of support, we may well end up with different drugs being funded in the Cancer Drugs Fund,
but it is not going to be an open-ended resource, so there are still going to be difficult decisions.
It is possible that, as a result of overcoming some of the perverse pricing incentives, with
NICE more heavily engaged, we will be able to get more value for patients, more patient
access from the money that we are spending, but I do not think we should be under the
illusion that there are not still going to be incredibly difficult choices and trade-offs
however the new Cancer Drugs Fund is structured. Therefore, all the more reason for good stakeholder
engagement. I think a lot of the feeling that is out there at the moment is that, as the
technocratic thing started to rear its head, then all of a sudden the other stakeholders
were left outside the room. Whether it’s charities, ABPI or anyone else, they want
some reassurance that the principles that the working party came up with have not stopped,
and that before any technocratic decisions are nailed the re-engagement actually happens.
Because if we go back to the origins again, this was around a decision which was made
that, if NICE was not going to adapt its process to what either patients or politicians were
saying, then there was a workaround put in place. So there is a bit of suspicion that
NICE needs to come to the table and everybody be in the room at the same time, so that whether
you are a charity or the ABPI, you hear NICE talking, rather than something happening behind
a locked door which will generate the suspicion. Thank you for that. There are a couple of
things. Firstly, I think what became clear fairly early on in these discussions is that
I think we got to a place where NICE and the charities were talking in a constructive way.
The second thing I would like to say is that the work that has been done by that working
group, which included the charities, the ABPI, NICE, the Department of Health and others,
has been absolutely fundamental in informing the technocratic discussions. You are absolutely
right; we need to go back to that group now and engage with them in terms of where those
technocratic solutions are beginning to emerge. For me, there is a generic message here for
us as NHS England. If we are talking about a fundamental transformation of the way that
the National Health Service operates, then sleek stakeholder management has to be part
of that, and genuine authentic engagement with people has to be part of that, and not
leaving people for whatever reason feeling that they have been left out. It just has
to be part of who we are, because we keep saying it is part of who we are, and so we
cannot afford the cognitive dissonance. I think the point is well made, Ciarán, and
thank you for doing so. As I understand it, the consultation paper will pick up some of
the machinery; I do not like this word ‘technocratic.’ It is the machinery as to how you have drugs
flowing through funding, through the Cancer Drugs Fund, for the future. It is machinery
as to how we and NICE are engaged in the technical evaluation of the drugs, and it is machinery
as to how we hold down cost. I think that once these details are clear and the consultation
paper is issued, then we have the opportunity for the full engagement with others, but it
is, as far as I am concerned, an open consultation, but with a timeline; we must get this nailed
down in advance of 2016/2017. What I am going to do then is to invite the
Board to do the two things which are mentioned on the front of the paper, which is to note
the future proposals, but in particular, to delegate authority to the Chair and the Chief
Executive. I like this phrase, ‘We may act jointly and/or individually, where either
of them is unavailable.’ We will both be available, thank you very much, but we will
of course consider the consultation paper and approve it for taking out for consultation.
Are we all content with that? Good. Thank you very much indeed.