Examination of Witnesses (Questions 220
WEDNESDAY 23 JANUARY 2002
220. To take part in that evaluation process.
There is no other means whereby this independence is compromised
by your industry.
(Dr Jones) We have had a regular dialogue with NICE,
as have others; the patients involved in NICE and so on. That
has been part of a very open process which emerged from the Prime
Minister's initiative on competitiveness where we defined quite
clearly with Ministers, with the endorsement of the Prime Minister
the process to try to discuss together how we would improve the
process of selection and how we would get through the process
of appraisal. That has been a very productive dialogue and one
we think is resulting in significant progress. We do not see that
as any kind of bad way of working together, it is a very productive
way in the interests of the patients and the National Health Service
and the industry.
221. You heard the evidence in the previous
session which related to vested interests being within NICE. What
was meant by that?
(Mr Fullagar) I wish I knew. I share very strongly
the answer you have heard from my colleagues. As far as my company
is concerned, we respond. We were specifically invited to answer
questions which are set down by NICE, quite rightly. The only
other contact with NICE of which I am aware is when we talk to
them about the process in a very open way as other people do to
get the job done, not in any way steering decisions; I am totally
unaware of anything else.
(Dr Patterson) The last group of witnesses called
for people to state any conflicts of interests they may have.
We would have no objection to that at all.
222. Some questions for Mr McKinney and Mr Campbell-Morrison
from the Campaign for Effective and Rational Treatment. You make
some comments about transparency in your submission. Could you
explain the relationship between your organisation and the pharmaceutical
industry and NICE so that it is on the record?
(Mr McKinney) CERT is set up that we come up with
a proposal that we think needs to be addressed within health care
issues, usually in a drug sense. We are looking at better and
more equitable access to drugs. We then go to the pharmaceutical
companies and say "Here is the proposal. Here is what we
are trying to achieve. If you support this then finance it. If
you don't support it then don't finance it". In effect it
is fairly similar to a charity. No matter how much money they
decide to give us they have no rights over the direction we take
or over the policy we take. We decide what the outcomes are, we
decide the methods by which we achieve those outcomes and the
pharmaceutical companies have no say in how we achieve what we
are trying to achieve. We do keep them informed of what we are
doing because they are helping to finance this.
223. I am not quite clear on how you make sure
there is impartiality here. You are saying you have a proposal
and you tout around the drug companies until you find somebody
who likes what you have.
(Mr McKinney) Yes. We discuss with our steering committee,
made up of medical clinicians, what the issues will be in the
Health Service, usually on quality of access to treatment, to
drugs. Then we prepare the proposal designed to try to make sure
people do have access to these drugs. Then we say to the pharmaceutical
companies that this is what we are trying to achieve, if they
agree then they should support it.
224. Would you then be under any sort of pressure
to adapt the process?
(Mr McKinney) We do not. We say this is what we are
doing: accept it or do not accept it.
(Mr Campbell-Morrison) The team doctors would approve
that method of getting those objectives. For instance, in our
cancer programme we used a template produced by Max Somerhayes
and the National Cancer Director when he was at St Thomas's. We
adopted that template which worked out the number of people who
would be eligible for treatment and then worked out a total for
all the different treatments which were looked at and extrapolated
that nationally. Then we got an eminent team of oncologists who
would look at the proposal and say "No, this estimate is
too high", or too low or not a priority in cancer treatment.
225. You are very critical of almost all aspects
of NICE. It has been running for almost two years. You are also
quite clear on the point that any credible assessment body must
be separate from the Government, which puts you at odds with the
submissions we have had from the ABPI and GlaxoSmithKline. Do
you think the fact that Alan Milburn announced last week that
he was not going to sign off the proposals in future will make
the slightest bit of difference?
(Mr McKinney) Can we put that a slightly different
way and go back a bit on that? It comes back to the question initially
asked about independence. We feel that with the status of a special
health authority which is run in effect by career civil servants
from within the NHS and as a body working from the NHS that is
the basis on which we question the independence of NICE. Although
we have been critical of all aspects of NICE, we should provide
a caveat and say that we do support the concept of NICE. We did
not actually mean to be critical of every aspect, but the more
we looked into it, and the more we asked doctors, the more we
asked clinicians, the more we asked consultants, the more we asked
patient groups the worse it got. This is an objective third party
representation of all the difficulties which were represented
to us of NICE. That is how we arrived at that position, not because
we sat down saying everything about NICE is wrong so let us try
to tell people what is wrong with NICE. It was the way it happened:
people came to us when we looked into this and that is perhaps
why we have been seen to be so critical.
226. Is not the problem that if you remove it
from Government control they would basically be all over the place
because there would be no co-ordination with national priorities
for health. I cannot quite see how that would work. Can you explain
to me a little bit more about how you would change the systems
so that it would be better overall.
(Mr McKinney) We call for the independence of NICE
in our submission on personnel within NICE. Rather than using
career civil servants, we said we should look at other methods
of doing this, we should look to some of the experts abroad, we
should look at some of the other objective
experts we have in the UK. Rather than rely on civil
servants to run it, let us use the experts to run it. That is
the sense in which we mean independence on that.
(Mr Campbell-Morrison) Going back to
questions raised last week, one of the questions was whether NICE
is a form of rationing. What we have to look at is that drugs
are licensed in the UK through the MCA or the EMEA. Drugs come
onto the market already proven safe and efficacious. The only
thing NICE could possibly add is this element of whether the drug
is worth it, whether it is worthwhile introducing in the NHS.
In that case, it should be explicit that this is a rationing body
and what Hugh is saying about career civil servants is that if
theyexcuses to civil servants in the roomgo against
the policy line within the Department of Health, their career
is not going to be worth very much. It is important to set up
NICE as a corporate body, to have physicians, to have health economists
and we need ethicists within that body to look at it. It should
be as independent as possible from the Department of Health. That
is the crux of the matter there.
227. You have been very critical in certain
aspects of NICE and in your submission one of the things you have
been critical about is what you describe as the unplanned and
unexplained delays in some of the appraisals by NICE. I should
like to read you the rest of that paragraph of your submission.
You say, "For instance, the appraisal of Herceptin has been
inexplicably delayed by six months, even though this drug can
have a dramatic effect on the survival of women who have an aggressive
form of breast cancer". That is quite a serious suggestion.
You then go on at the end of that paragraph to ask a question.
"How many women with breast cancer have died prematurely
as a result of this delay alone?". I should like to ask whether
you know the answer to that question.
(Mr McKinney) The simple answer is that we do not.
We have posed the question on the process of NICE, to say this
is the problem with the delay and we are asking how many people
have died. We cannot believe they have not, because of the undue
delay in the appeals process for this and it is mirrored later
on in the colorectal drugs as well. We ask because of this delaywe
are raising the question for general debatehow many people
have died. It is perhaps not a question for us and maybe we should
not have asked it in that form.
228. Only you have posed the question.
(Mr McKinney) Yes, we are entering into the debate
to ask how many people have died.
229. It is a pretty serious allegation you are
making. Do you stand by that completely?
(Mr McKinney) Yes.
230. Categorically you think it is fairly convincing
that because of the delay, even if you do not know the numbers,
there will be some people who have sadly died who otherwise may
not have died in that delayed time period because this drug had
not received its appraisal by NICE.
(Mr McKinney) Yes; we think unquestionably.
(Mr Campbell-Morrison) Yes.
(Mr Fullagar) I did ask the company which makes the
product what estimates they make of this. They say that in their
estimates there are 5,000 women a year who would benefit from
this treatment theoretically. Since the product has been in place
with its licence since September of the year 2000, they have a
figure of less than 200 patients treated with the product out
of a theoretical population of 5,000 and they say that the majority
of use is by private patients, so not funded by the Health Service.
This they produced for me figures from other European countries,
big and small, showing that in fact the use was much higher than
the UK, up to eight times higher.
231. Are you saying that the benefit of the
use of this drug would be that the individual patients would live
longer as a result of taking the drug, or that they would not
die at all because of the drug?
(Mr Fullagar) The claim is that they would certainly
live longer and live a better quality of life as well. For whatever
reasons the process has still not ended, although the product
has been available with a licence since September of 2000.
232. Mr McKinney, am I right in thinking that
a minute or two ago you said you had raised this matter with NICE?
(Mr McKinney) No.
233. You did not raise this specifically.
(Mr McKinney) Not as a specific issue, no.
(Mr Campbell-Morrison) It is possible to test whether
a patient is going to respond to this treatment. With most treatments
they have what is called a median survival time. What NICE is
looking for in the cancer field is whether a patient is going
to live at least an extra three months. What happens with this
drug is that you test people, so you are excluding the people
who will not respond to it. Certainly from the people I know who
have been on it, the response has been quite fantastic. I know
a senior executive who had possibly one month to live and she
has been on this drug and she is now still working about two and
a half years after she should have been dead.
234. Do we know roughly what the cost of a course
of this drug treatment is?
(Mr Campbell-Morrison) I am afraid I do not know.
There are various estimations. What happens is that when the drug
is licensed there are negotiations with the NHS for what is called
the NHS list price. Often what happens is that companies will
make negotiations with local health authorities that the price
will be much lower than that.
235. Obviously I do not have a clue what this
drug may or may not cost but the rough figure for what it costs
per patient for Beta-interferon a year is about £10,000.
Whether that is correct or not is another matter but that is the
kind of price tag which is bandied around. Is there any similar
sort of price tag bandied around for this drug?
(Mr Campbell-Morrison) At a guess, if you will accept
that, it is approximately £15,000 per year. The public health
people previously said that a benchmark figure for quality adjusted
life year is around about £30,000. They will put somebody
on the statin drugs to prevent a heart attack and that is the
figure they will use there. The quality adjusted life year is
approximately £15,000 so it is well below that.
236. Is there no other treatment at all for
(Mr Campbell-Morrison) No. It is for a sub-set of
patients who have what is called a Her-2 marker on the tumour.
237. What would happen to these patients if
this drug were not available?
(Mr Campbell-Morrison) They die. It is very aggressive.
238. There would be no treatment at all.
(Mr Campbell-Morrison) There are the cyto-toxic treatments
which you would use possibly by themselves or in conjunction with
a drug, an antibody, but usually it is reserved for people who
have no active choices to make.
239. There are other treatments but not for
this particular sub-cohort of the population.
(Mr Campbell-Morrison) Yes.