Examination of Witnesses (Questions 440
- 448)
WEDNESDAY 30 JANUARY 2002
PROFESSOR SIR
MICHAEL RAWLINS,
MR ANDREW
DILLON AND
PROFESSOR DAVID
BARNETT
Chairman
440. You may be interested to know that about
a fifth of the memoranda we received came from individual members
of your Appraisals Committee and other people directly connected
with NICE, so we wondered whether there had been some organised
attempt to offer a positive view of your work. We may be very
naive people on this Committee but that suspicion crossed our
minds.
(Mr Dillon) I am very flattered that they bothered,
at the most difficult time of the year for anybody to put anything
together, to make the effort to do that. They may have already
known that you were conducting your inquiry through your own press
release. They may have known as a result of us telling them, but
it was their decision, those of them that did respond, to do so
and the words that they used must be their own since we have not
given them any.
Jim Dowd
441. What about the career prospects of those
who did not?
(Professor Sir Michael Rawlins) Members of the Appraisal
Committee do not get paid. We do not employ them. We do not even
pay them an attendance fee, only their expenses.
(Professor Barnett) I was going to make that point.
It is pretty obvious that members of the Appraisal Committee did
know that this was happening and were very keen to do anything
they could to make their views known. I have no idea whether they
have made adverse comments or positive comments, but they were
very keen to make their views known.
Mr Amess
442. Gentlemen, what do you think of the all-Wales
Medicine Strategy Group?
(Mr Dillon) It is a good idea because it can provide
a service to Wales across the full range of pharmaceuticals in
a way that the Institute is not set up to do. We have heard earlier
that what we get is a selection essentially of the pharmaceuticals
that are introduced into the NHS. Groups like the one you have
described, and there is a similar consortium being established
in Scotland, have the ability to look at everything that comes
into the Service and to provide some very rapid and co-ordinated
information about the nature of those pharmaceuticals. A member
of that group in Wales is also a member of the Institute's Appraisal
Committee and at the time the National Assembly for Wales was
establishing it they talked to us about its purpose. It was pretty
obvious from the way they described it that there is no overlap
between the functions of NICE and that group but that they complement
each other.
443. So there is no overlap and there will be
a clear difference between your work and the work of this strategy
group?
(Mr Dillon) Yes.
444. I am fascinated by your evidence because
clearly, when we deliberate on your organisation, we will have
to decide if we have been given some duff evidence because there
seems to be a huge contradiction in the stuff that we have been
sent and what you gentlemen have been telling us today, so somewhere
someone is not being truthful.
(Professor Sir Michael Rawlins) We too have read your
transcripts with amazement about some of the things you have been
told.
Sandra Gidley
445. Most people, when they have heard of NICE,
it is in connection with beta-interferon and the interim guidance
has been rather negative, much to the disappointment of the patient
groups. What then is your feeling as professionals when all of
a sudden there is an announcement apparently out of the blue from
the Secretary of State announcing that there will be some money
to carry on treating, when your guidance seems to indicate the
contrary? I am sure all the people who are getting the treatment
will be delighted, but I wondered how you felt.
(Professor Sir Michael Rawlins) We produced guidance
about beta-interferon in a provisional form last August and in
that provisional document we asked the Department of Health to
start engaging with the manufacturers to see if beta-interferon
could be acquired for patients in a manner that was to be considered
cost effective because the Appraisal Committee concluded that
under the present pricing—and we have no control over prices—it
could not be regarded as cost effective. Those negotiations started
at the same time the appraisal process continued and the final
appraisal determination was released late in the autumn and there
was an appeal at the end of November which I chaired. All the
way through the emphasis has been that although this is not clinically
and cost effective we would wish the Government to engage in discussions
to make it cost effective. One of the things that happened was
that we are unaware of how those negotiations are going on the
detail but we do know that the model that we commissioned has
been used in those discussions. We are not feeling as if we have
been cast aside or ignored. In fact, we are pleased that the Government
has taken our suggestion in hand.
Sandra Gidley: Does this not have interesting
implications for drugs budgets if you recommend this in future?
Dr Naysmith
446. Can I just add something before you answer
that? Did you say that it was not clinically and not cost effective?
(Professor Sir Michael Rawlins) No. It is clinically
effective but it is not cost effective. I beg your pardon if I
misled you.
Sandra Gidley
447. It does have some interesting implications
for future negotiations with the drug companies, I suspect. If
I could come back to something that has been touched on but we
have not really got on the record from you, you mentioned that
you have been accused of setting a level for the quality adjusted
life years and it is reckoned to be around £30,000 unless
there is overwhelming evidence that it is over that. It is a very
nebulous concept in lots of ways. The example you gave about lung
cancer was very straightforward and clear but with other drugs
and other conditions it is not so clear. Would you comment on
what guidance you have been given or by whom on the use of QALYs
and how can you improve that in future so that that process is
more transparent?
(Professor Sir Michael Rawlins) In essence the health
economic evaluations have been very much based on the advice of
health economists, and one is of course the Vice Chairman of the
Institute. I think however it would be more appropriate if David
Barnett described to you how the Appraisal Committee uses the
health economic data.
(Professor Barnett) There are two components to your
question. Perhaps I may just address the first part which is the
issue about a nebulous threshold. The Appraisal Committee does
not consider the threshold and has not been given instructions
about a threshold and has not discussed a threshold per se at
all. If I might just give you an example as to the concern that
the Appraisal Committee has about the range of health economic
evaluations that it gets about a particular technology, the example
which I and the Committee were faced with a year ago last October,
when the first appraisal of beta-interferons had been concluded,
was that the published and unpublished estimates of cost effectiveness
of the beta-interferons internationally range from £10,000
per QALY to three million dollars per QALY. I am just an ordinary
chap and I am not a health economist; I practice medicine. Even
I thought this was just not acceptable. There was a problem here
and we needed to have better evidence, more data and a more refined
answer to this. Irrespective of some nebulous threshold it did
not match up at all. That is the first situation. The second is
the issue about QALYs. QALYs are not the answer, definitely not.
They are, however, the only thing we presently have which is internationally
recognised and gives us a handle on comparisons across technologies,
across disease states and across individuals and age groups. They
are not the final answer and I think the health economy world
understands that. I believe that NICE in its present format should
catalyse the debate about how to do this better in the future,
but I am afraid we are stuck with what we have. Therefore we do
our best with it. It is pretty obvious from some of the appraisal
examinations that it is not possible to represent a QALY which
is why we use cost per life again as some surrogate for that.
It is not good enough but it is the best we have got at the moment.
Jim Dowd
448. Just on that very last point, I first came
across QALYs when I was on the health authority in North Suffolk
back in the 1980s. Everybody accepted that they were a good idea
but the problem with them was that nobody could decide on a uniform
definition of what should be included, how information could be
collected. Are you saying that we have now resolved that?
(Professor Barnett) Oh no. I do not think
we have resolved it at all, far from it. What we have, however,
is a movement towards wanting to resolve it and a movement towards
the Institute hopefully being one component to catalyse that debate
internationally. We have our own impressions of what we should
be doing and I believe that we will move in that direction.
Chairman: If there are no further questions,
can I thank you for a very interesting session. We are very grateful
to you.
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