Examination of Witnesses (Questions 540
THURSDAY 18 OCTOBER 2007
Q540 Dr Stoate: I thought it might
Professor Devlin: Obviously, there
is a difference between what NICE might say about its thresholdbecause
what we have been discussing so far is the means by which it expresses
that thresholdand what it actually does. They may be two
different things. In the evidence we provided to the Committee
reference was made to a study also done at City University. That
study looked at the thresholds implied by NICE's own decisions.
The results suggested that the actual threshold was considerably
higher than £30,000 because of the number of special cases
and decisions made in favour of drugs which were a lot higher
than £30,000 per QALY.
Q541 Dr Stoate: But whatever the
figure is do you have any research evidence that other treatments
are being crowded out because PCTs have to provide these drugs
whether they like it or not? Is there any evidence that other
treatments are being effectively sidelined, marginalised and pushed
out altogether because of NICE's decisions?
Professor Devlin: We were very
interested in exploring this question. Methodologically, it is
incredibly challenging because it is difficult to track through
exactly what is crowded out as a result of the introduction of
new products because of NICE-mandated decisions.
Q542 Dr Stoate: Clearly, there must
be some evidence of it. Obviously, there is an opportunity cost
for every new drug that comes in. If you spend money on one thing
you cannot spend it on something else. As PCT budgets are effectively
ring-fenced, as is the entire NHS budget, there must be a squeezing
out somewhere. If you have to spend £1 million on Herceptin,
for example, you have to find that sum from elsewhere. What work
has been done to find out where that money has come from and what
effect it has had on the wider NHS?
Professor Devlin: I do not think
there is any direct evidence. You are preaching to the converted
with respect to opportunity cost, and that would be an extremely
interesting and important question to answer.
Q543 Dr Stoate: Why do you suppose
no one has looked into it before?
Professor Devlin: I think that
NICE guidance is part of a package of pressures that are binding
on PCTs and include a wide range of targets and other imperatives
that it faces. It is very difficult to disentangle any one aspect
of that bundle of pressures and identify its specific impact.
Q544 Dr Stoate: But it is essential
that we do. For example, how can the public decide whether or
not they want a particular treatment if they have not understood
the implications of other treatments?
Professor Devlin: What has to
be foregone in favour of them? The only evidence of which I am
aware in this context is anecdotal and it comes from consultants,
reports in the media and things of that nature. As far as I am
aware there is no hard evidence on opportunity costs associated
with specific guidance.
Q545 Dr Stoate: That is of concern
to me. The other matter that concerns me is whether there has
been any modelling of the effect of future NICE decisions. If
NICE goes on making decisions in future at the rate it is now
making them is there any modelling on what the effect may be on
Professor Devlin: Not to my knowledge.
Professor Appleby: There is very
short-term "modelling". The Department of Health would
claim that it makes an estimate of how much NICE decisions will
cost the NHS in the next year or two, so that is as far as it
goes. The figures we have had for England over the past four or
five years have been in the £300 million to £400 million
range. What the Department says to PCTs is that when it makes
its allocations part of the extra £300 million to £400
million is to cover this very issue, namely that NICE will be
making recommendations and they will have to abide by them and
commit funds to them. There is an opportunity cost in some sense,
but existing services should not be stopped to fund new ones.
That is the Department's argument. It is almost universally believed
in the NHS that that is not the case and that money is not ring-fenced
but is notionally in the big lump of money that PCTs get. In our
research with NICE we interviewed directors of public health and
their colleagues in PCTs. We asked them questions about the effect
of a decision by NICE and so on. PCTs will not directly link a
decision that it takes about NICE with something else that it
does. Every decision seems to be separate. The only evidence is
anecdotal evidence from directors of public health. For example,
a particular director of public health was very concerned about
a cessation of smoking clinic which was stopped. He felt that
that was a cost-effective use of the PCT's resources, but it was
all mixed up with the then current climate of deficits and the
need to cut back a bit. This was seen as a bit of an easy target;
it was not affecting people's health today and so on.
Dr Stoate: The bottom line is that we
do not know, and do not seem to have any method to find out, whether
or not it is affordable. As a committee where are we supposed
to go if we do not know whether or not NICE's decisions are affordable
and do not appear to have any method of finding out? It is hopeless.
Q546 Charlotte Atkins: For instance,
a number of PCTs do not fund IVF treatment despite the fact that
they have a NICE guideline to say they should. Is that being crowded
out or is some sort of value judgment made by PCTs that that is
not the kind of service they want to provide?
Professor Appleby: I do not know
what the decision of those PCTs is. NICE guidance is that it must
be complied with. I do not know what excuse a PCT would have for
not complying with that guidance.
Q547 Charlotte Atkins: Certainly
the ones that you have investigated or observed have not disinvested
from that sort of treatment?
Professor Appleby: Not as far
as we are aware.
Professor Devlin: There is also
a very complex issue specifically around IVF because the provision
of that service across the country was already uneven prior to
guidelines being issued on it. You may well have some PCTs moving
towards it from different directions. Amongst our sample we had
some that had altered their provision of this service. It was
not a question of whether or not IVF would be provided; there
were more subtle ways to deal with it, for example in relation
to the eligibility criteria but also the number of cycles that
might be funded.
Professor Appleby: Often decisions
were not that they had been funding the service but they then
decided not to fund it at all. A lot of it came within the phrase
"managed access". Therefore, PCTs came up with criteria
which perhaps changed the age range for eligibility for a service,
the severity of the illness had to be at a certain level before
they would agree to fund and so on. There was shaving around some
of the services. The service still existed but in a slightly reduced
Charlotte Atkins: My PCT has perhaps
been slightly more honest in saying that it will not fund IVF
treatment until it reconsiders it in the next financial year.
Q548 Mr Scott: Do you agree that
if services are squeezed out and patients do not receive the treatment
and drugs they needindeed, if there is even loss of lifeit
is fundamental that such a report should be produced to show the
Professor Appleby: I absolutely
agree. The big assumption here perhaps is that everything the
NHS currently does is absolutely great, is being provided efficiently
and is of maximum benefits to patients. We should not assume that.
Maybe some things are being crowded out because they need to be
in that they are less value for money and so on. One cannot assume
that all the NHS does at the moment is right.
Professor Devlin: I agree that
much more evidence is required around that. In general, there
is inferior evidence about the cost-effectiveness of a lot of
what the NHS does compared with the kind of evidence that exists
on the new drugs at which NICE looks. I believe that that is part
of the challenge faced by PCTs. The cost-effectiveness of a lot
of what PCTs commission simply remains unknown, so it is extremely
difficult for them to make decisions about what should be foregone
when confronted with an imperative handed to them by NICE.
Professor Appleby: That was reflected
in another finding in our work. PCTs appear to spend an inordinate
amount of time fretting about rather small amounts of money. They
control hundreds of millions of pounds of NHS money, most of which
flows straight to hospitals and other providers, yet PCTs set
up exception panels to deal with individual patient cases and
treatments because they have managed access policies and certain
criteria have to be fulfilled. It needed almost all the time of
a couple of public health officials to deal with that. Some of
the decisions might involve perhaps £50,000 or £100,000
and yet behind them millions of pounds were flowing through the
system. It was something that we knew about. It is really shocking
that that happens. In part it is to do with their resources. They
do not have the staff, skills and so on, but they also do not
have the information about cost-effectiveness.
Q549 Sandra Gidley: As a follow-up,
has anybody looked at the cost of these panels and compared it
with the cost of the technologies that they turn down? That might
be quite an interesting study.
Professor Appleby: Yes. Nobody
has looked at it as far as I know. All the PCTs we looked at,
I think, devoted considerable amounts of time to it.
Professor Devlin: I believe that
they are required to do so. There cannot be a blanket exclusion;
there must always be a process around allowing exceptions. The
management of that process is extremely time-consuming. We could
perhaps talk of more general issues to do with the management
of disinvestment generally. I absolutely accept what you say about
the opportunity cost of NICE guidance which is crucial. There
are also difficulties faced by PCTs in relation to disinvestment
generally, not just what information should inform that, but also
the sensitivities that surround any attempt to disinvest from
Q550 Sandra Gidley: How can NICE
encourage more disinvestment decisions because it appears that
is part of the equation that is not being dealt with very effectively
Professor Devlin: It can help
inform those decisions. One of the aspects of PCT decision-making
that we found was a desperate demand for information on what services
were poor value for money, what should it be disinvesting from,
what would be the appropriate responses to cost pressures and
so on. We found instances of PCTs working together to try to create
some sort of information and evidence base on which to do that.
Clearly, there is scope to do that on a much greater scale to
improve the information available to PCTs on services that are
demonstrably poor value for money that perhaps they ought not
to be funding. Perhaps NICE or some other organisation can play
a greater role in that. PCTs simply do not have the analytical
workforce to make that sort of effort and it would be ridiculous
for each PCT to duplicate it. Maybe some sort of clearing house
to assist in and inform those decisions would be a good idea.
Professor Appleby: There is another
bigger issue here about the state of commissioning within the
system which is an apparent failure. I gave the example of PCTs
worrying over relatively small amounts of money. One would hope
they would be looking at their whole budget and making decisions
on how to get the biggest amount of health and reduce inequalities
with all the money they use. There is an issue about the inequality
between the purchasers and providers in the system. The latter
have a lot of power. Another issue to emerge from PCT decision-making
was that cost-effectiveness might be a criterion but political
acceptability was another. Could they get hospitals and others
to change what they did? I believe there was a good deal of pessimism
on the part of PCTs. They felt relatively powerless. They were
the ones with the money which they handed over, but it was just
flowing through the system as if they did not have much control
Q551 Sandra Gidley: NICE is supposed
to be doing some of this but it has done comparatively little.
Should it do more? Should any disinvestment recommendations have
the same weight as a new technology that is approved? Would that
Professor Appleby: Yes. Relatively
recently, they have set up or at least assigned some resource
in terms of people and effort to look at disinvestments a little
more thoroughly. It is much easier to introduce a new service
or have more of something than to say it should be stopped, especially
when the argument in the public mind is perhaps not that clear
cut. The idea that if something is not killing you and may be
doing you some good it is probably worth having is not how NICE
or the NHS should operate. The area of disinvestment is a much
more difficult area to go into, and that is why I believe PCTs
need a lot more support. NICE could do more on that front, and
I am sure it wants to.
Professor Devlin: The answers
to your question are yes and yes. I think PCTs would find it enormously
helpful if perhaps they were empowered to make decisions by having
an evidence base to support them, whether that is provided by
NICE or some other organisation.
Professor Appleby: NICE collects
evidence but it is of an average nature and does not necessarily
apply to a particular service in Colchester bought by a specific
PCT. The cost-effectiveness evidence will vary from area to area
and that is to do mainly with the way the service is provided.
As we know, hospital efficiency varies. That is another issue
for individual PCTs to grapple with. They may have evidence from
NICE that something is cost-effective, but locally it may not
be that cost-effective because of the way it is supplied. That
means gathering data about the efficiency of local hospitals and
so on. It is not simply a case of having a leaflet saying that
it should buy this but not that. That is also where they need
Q552 Dr Naysmith: A good number of
our witnesses and the evidence we have received suggest that there
should be a lot more public discussion in a broad sense about
the rationing of healthcare, healthcare facilities and so on.
Do you believe that that should happen more, and can you suggest
mechanisms by which it may be achieved? We all know about things
that have happened in the past, for example the ranking of services
and creating lists with mental health ending up at the bottom
and heart surgery at the top. How does one get an open discussion
about resources in the National Health Service and what can be
done with them?
Professor Appleby: I absolutely
agree with you. I hope we have made clear that the issue about
the threshold is absolutely fundamental. I cannot think of a more
fundamental issue to do with the NHS given the way it is funded
and so on. It is not merely of academic relevanceI apologise
for using that term pejorativelybut of absolute relevance
to individuals in terms of the services they get and so on. It
is their money, frankly, and they need to be involved in these
things. I do not mean that necessarily they should be involved
in decision-making in a fantastically detailed way, although there
could perhaps be more room for that, thus bringing some of these
issues to the fore, but they need to be aware of the decisions
that the NHS has to take on their behalf. One idea at the back
of our minds is the creation of an independent threshold-setting
group. That would then bring these issues out into the open much
more and lay out the trade-offs and difficulties. PCTs and the
NHS are not bad people who are trying to deny treatment; they
seek to do the right thing. NICE also tries to do the right thing
in difficult circumstances, and people also need to understand
Professor Devlin: The involvement
of the public has perhaps been seen as rather difficult. The idea
of a cost-effectiveness ratio is not necessarily the easiest concept
for people to come to grips with; nor is the idea of a quality
adjusted life year, but perhaps more effort needs to be devoted
to trying to explain those concepts in easily accessible ways,
engaging the public in what is acceptable value for money. These
debates should be more explicit and there should be more discussion
on very difficult decisions, for example on third line cancer
drugs that extend life by a month. What exactly should society
be prepared to pay for that? What is that health gain worth? There
are ways to express these things so that people can become engaged.
I believe that it would help tremendously to try to get the public
to acknowledge that when a new drug is developed it can be purchased
and it can be benefited from, but that something else is necessarily
foregone as a result.
Q553 Dr Naysmith: That is the crux
of the matter, is it not? I quite liked Professor Appleby's earlier
statement that NICE had almost a technical function to perform.
It should say that something is value for money and its threshold
for the value is such and such. There should then be another body
that looks at it and decides that if that is to be paid for it
will push out something else and not everything can be paid for.
What should be the role of NICE in this rationing debate, if any?
Professor Devlin: I suppose the
response to that depends in part on whether one believes that
the threshold should be decided by NICE or a body somewhat external
to it. Certainly, everything that NICE does provokes and informs
that debate and provides an opportunity to raise public understanding.
Every time a new piece of NICE guidance comes out we receive calls
from the media asking us to comment on what it means, what will
be foregone and so on.
Q554 Dr Naysmith: Part of the problem
is that some of the evidence is not that easy to use for the purposes
of decision-making. You mentioned end-of-life cancer drugs. They
will not say that they will prolong life for a month but that
on average they will prolong life by between a month and three
years. Maybe a month is not of much use, but many argue for three
years and yet you do not know which it will be for you. That is
a very difficult decision on that sort of evidence.
Professor Appleby: There is always
uncertainty in these matters. There is an issue about what NICE
looks at and what its agenda is, as it were. Why does it look
at certain treatments and not others? Why is one treatment considered
before something else? There may be an issue here about who sets
NICE's agenda. In part, it is not just about individual treatments
and cancer drugs, which are expensive and require decisions, but
there are other things that go on in the NHS. For example, the
dominant policy aim of this Government and previous ones has been
to reduce waiting times. I am not aware of any figures to show
how much money we have spent doing that, but it must run into
billions over the past seven or eight years. That is a lot of
health money to spend and it has an opportunity cost. I am also
unaware of how many quality adjusted life years have been generated
by that money; I have seen no research on that. There may be an
issue here about at least demanding of government that in producing
policy it also says something about the benefits and how much
they will cost.
Q555 Dr Naysmith: If one goes down
that route one will end up saying that the answer is democracy.
One lays out everything one knows and then says, "You want
to do this and you want to do that." That is where it ends
Professor Devlin: But that has
to be facilitated by information and evidence.
Q556 Dr Naysmith: We are all agreed
that more information is needed, but how do we get the discussion
going? I agree that evaluating the worth of some of the more political
matters is very important but it is difficult.
Professor Appleby: We have had
cycles about the debate on rationing. For the past seven years
it has gone a bit quiet. I suspect that that is because so much
money has been coming into the NHS. There is perhaps a feeling
that there is no need to ration; it has the money to employ people,
to expand and so on. It will come back again. The NHS has a new
settlement for the next three years, but it is less than half
the real rate that it has received over the past seven years.
That may focus some people's minds as well.
Professor Devlin: It is a very
difficult debate to get going in the current climate. A big policy
theme within the NHS has been improving patient choice. Patients
are encouraged to choose what treatments they get, where and when.
That sort of theme around responsiveness and individualisation
of treatment alongside a debate on rationing in the health service
is somewhat uncomfortable, is it not?
Q557 Dr Naysmith: Let me change the
focus slightly to the level of the PCT. You will remember that
Primary Care Trusts were set up to reflect local needs. Each Primary
Care Trust would be able to use its budget to do what is best
for its locality. NICE guidelines and directives remove that sort
of ability and one ends up with a postcode lottery. Is there any
way that we can incorporate NICE guidelines and advice and still
reflect local needs?
Professor Devlin: My colleague
touched on this earlier. Any piece of advice that comes down from
NICE is based upon a cost-effectiveness ratio with evidence around
both costs and improvements in health outcomes. Clearly, there
are opportunities to tailor that sort of data to local settings
to reflect different cost conditions, different patterns and modes
of delivery and different epidemiology in a PCT. That sounds quite
ambitious. Knowing what we know now about the way PCTs go about
making their decisions and the nature of the evidence they have
at their disposal, the idea that evidence is either widely used
or is tailored in that way is an over-optimistic description of
what is actually done.
Q558 Dr Naysmith: But if PCTs were
obliged to explain their decisions to the local community and
what evidence they used to make them and get feedback would it
Professor Devlin: Yes, absolutely,
and they should do so. Some work has been going on in the Department
of Health over the past few years to collect and publish information
on the amounts of money PCTs spend on different disease areas.
The national programme budget project has produced some very interesting
information, not the least of which is to show the enormous variation
in spending between PCTs. Even when account is taken of different
needs and areas one still ends up with two or three-fold differences
in spending on different disease areas. I believe that PCTs are
hard pushed to explain why they are doing this but they should
Q559 Dr Naysmith: Should they have
more local or public meetings or ask people how it should be done?
They are appointed rather than elected bodies.
Professor Appleby: You may have
attended some public meetings of PCTs.