Examination of Witnesses (Questions 460
WEDNESDAY 6 MARCH 2002
HEATH OBE AND
(Mr McKeon) The process is fully set out in the scheme
document which is on our web site and we can make available to
you which will set that out.
461. What is the position?
(Mr McKeon) It is not a trial in the normal sense
of the term.
462. What is it?
(Mr McKeon) We are going to monitor the progress of
a cohort of patients, rather a large cohort of patients, about
9,000 or so, providing we can get the numbers, for about ten years
to assess the disease progression and whether the effect of the
drugs is as calculated to give a certain benefit over those without
treatment. The price of the drugs will be adjusted accordingly
and so on. That is rather different from a clinical trial.
463. It sounds like a trial to me.
(Mr McKeon) It is not a small cohort, and indeed the
intention is that once the numbers who are being specifically
monitored for that purpose
Mr Burns: One minute.
464. Go on, Mr McKeon.
(Mr McKeon) Once the numbers of the people who are
being specifically monitored in order to assess the cost effectiveness
of the drug have been brought into the scheme then all other patients
who meet the ABN guidelines will also be treated but they will
not be subject to that specific monitoring, which is again rather
different from a trial, which is on a small cohort of patients,
that you were putting forward.
465. How many people do you estimate suffer
from MS in this country, roughly?
(Mr McKeon) Probably about 60,000.
466. As a result of any other NICE decisions
has this programme been adopted?
(Mr McKeon) No. They did not recommend that we did
actually explore these facts with its broader pricing and so on
with the companies.
467. Sorry, who did not?
(Mr McKeon) NICE did not.
468. No. The Government decided to.
(Mr McKeon) No. There was a specific recommendation
in the provisional appraisal document that we should do that,
we should look to see whether there was a way in which the drugs
could be acquired on a cost effective basis for the National Health
Service. We therefore entered into discussions with the companies,
and indeed with the ABN, the Multiple Sclerosis Society and so
on, in order to see if that could be done, and ultimately this
469. What measures do your Department take to
verify independently the quality of the work that NICE does?
(Lord Hunt of Kings Heath) I think I explained that
we set the framework in which we expect NICE to operate. We have
set that very clearly. I think it is in our evidence. It is around
the robustness of the processes. It is around the ability of those
who are concerned to have an input into it. NICE also of course
uses a number of academic centres and there are four universities
at the moment involved in work on the appraisals. They have been
commissioned through the NHS Research and Development Directorate.
In addition, particularly in relation to guidelines, there will
be collaboration with I think six of the medical and nursing Royal
colleges. In that sense there is a strong connection between NICE
and centres of academic excellence. I believe also that the very
nature of the NICE process, the fact that provisional appraisals
are sent to stakeholders who are enabled to comment on them, they
then have to be considered, there is the same process in terms
of final appraisals with the ability of those involved with an
interest in a particular appraisal with to appeal; in other words,
the combination of its own rigorous processes, the use of reputable
academic centres and the appeal process, combine to give you assurance
as to the quality of the work they have undertaken.
470. Finally, do you think that NICE has sufficient
in-house expertise to understand and critically review the advice
that is given and to act upon it appropriately in the wider context
of the NHS?
(Lord Hunt of Kings Heath) I certainly hope so. I
think that is really a matter for NICE themselves to answer rather
than the Department. My understanding is that they do have some
high calibre staff. It should be a partnership between in-house
staff and work commissioned from outside academic departments.
One of the issues that I have discussed with NICE is the availability
of expertise int his country for this kind of work, for instance,
issues as to whether we have got enough health economists in this
country to support all that is necessary. One of the points in
the last appraisal of NICE is that I have encouraged them to talk
to universities generally about planning in terms of the number
of students coming through ind the future so that certainly I
would expect and hope that they do have the right in-house expertise,
but I also expect them to ensure that there are people coming
through in universities who will be able to help them either in-house
or working for other academic units.
(Mr McKeon) There is an important point about the
appraisal committees themselves and the membership of those committees,
some 40-odd members of the appraisal committees, who provide a
lot of the expertise quite apart from anything that NICE has through
their own employees.
471. Minister, one of the things which rather
staggered me in our inquiry so far was that the two publications
that are really carried in every doctor's pocket, the BNF and
the Drug and Therapeutic Bulletin, have become so divorced from
NICE, and there seems to be so much antipathy between them and,
as somebody who was a practising doctor until relatively recently,
I just fail to understand that because these two publications
have years of experience and respect behind them and I would have
thought that the first thing they should be doing is building
on a relationship with those two highly respected publications.
(Lord Hunt of Kings Heath) Of course I have read very
carefully the transcript of the evidence NICE gave to you and
I know that the Committee had a full discussion of those matters.
My understanding is that NICE, if they had not already, have responded
to you on some of the specific criticisms that have come from
the BNF and the other bulletin that you mentioned. Let me say
from my point of view that I would encourage NICE to enter into
close dialogue with those organisations and indeed other organisations
who have a part to play here. I think I have said already to the
Committee that my expectation is that NICE will be inclusive in
its consideration of criticisms and discussions and will wish
to engage in constructive dialogue with the organisations you
Chairman: I think it is better to clarify, Richard,
that we did write to the Chairman of NICE after the session that
we had with their witnesses. We have not yet received a reply
to some of the points that were raised. We understand that we
will have them fully by the end of this week.
472. I am pleased you are going to encourage
that co-operation. Just going back to beta interferon, as an outsider
it appeared to me, and I am sure it did to lots of people throughout
the country, that the Government had a tremendous lot of pressure
on it when NICE put a block on beta interferon and it appeared
that really they struggled and thought hard about how they could
get round a decision that did not really go with what so many
of the people wanted.
(Lord Hunt of Kings Heath) I certainly agree that
there has been considerable interest in the beta interferon appraisal
right from the start, no question about that. The point is that
the issue about the Government's discussions with the drugs companies
concerned arose from a fairly early stage when the provisional
appraisal was first published by NICE. All that we have done stems
from that original recommendation which was confirmed in the final
473. So you started work before they made the
(Lord Hunt of Kings Heath) No. We carefully looked
at the provisional appraisal and we certainly started some informal
discussions with the drug companies in terms of whether, if that
were the conclusion, we would be able to reach some agreement.
We worked to do that until NICE produced its final guidance.
474. Do you think in the long term it may bring
down the price?
(Lord Hunt of Kings Heath) Certainly we are in it
for the long term because this is a programme, as Mr McKeon has
said, which goes over ten years, so it has obviously had a positive
impact on the price that the NHS is going to have to pay.
475. Pursuing that line, beta interferon and
MS is very interesting in terms of lots of things to do with NICE
and perhaps its future development. It is clear that the initial
report of NICE and MS was not very positive, shall we say, and
it would have probably indicated that it would not have recommended
it for widespread use. It was also clear that there was confusion,
partly because it was a progressive, degenerative disease that
we were looking at and it was difficult to get a clear and final
answer, apart from the fact that it works on a proportion of patients
and not on others. The point I want to explore is that eventually
a very ingenious solution was arrived at to enable it to stay
on the table and be further examined over a period. In the light
of what you were saying before about NICE appraisals not necessarily
taking place at the same time as things go on the market, (a)
there is this ingenious way of doing things, is it likely to apply
to other drugs and treatments in the future, and I have forgotten
what I was going to say for (b).
(Lord Hunt of Kings Heath) Clearly that is an important
consideration as to whether this is a precedent for the future.
That very much goes back to the advice that NICE gives to the
Government. We would not have gone down this path had not NICE
said in its provisional appraisal that they recommended that the
Government talk to the drug industry about whether it was possible
to reach some kind of agreement, so that in the end if you like
it goes back to NICE and the integrity of their process. This
is very hypothetical but one would have to deal with each appraisal
on its merits. I do not think you can draw many general principles
from what happened with beta interferon.
476. If it has been very difficult to assess
beta interferon by clinical trials why should a maintenance arrangement
give any better evidence?
(Lord Hunt of Kings Heath) I might ask Mr McKeon to
come in on the specifics of that but perhaps I can make a general
point. In relation to the consultation that we have just issued
we have recognised that there may be certain diseases where it
is difficult to come to a definitive view at the time of launch
or shortly after the time of launch. It is certainly in our view
sensible but we are asking for comments on whether, when we go
through the process whereby recommendations are made to ministers
as to which appraisal should be referred to NICE or not, it should
be referred immediately or whether you should delay it in time
for further clinical trial work. That is one of the issues that
we are consulting on at the moment.
(Mr McKeon) Essentially we are doing different things.
Clinical trials, which are essentially there for licensing purposes,
are conducted over a relatively short period, say two years, compared
with the length of the disease itself and the progression of the
disease. Most of the impact of the clinical trials was on the
effect of numbers of relapses and so on rather than on disease
progression, and it is disease progression which has the biggest
effect upon the quality of life measures.
477. Why were there not clinical trials on that?
(Mr McKeon) Because the period of the clinical trials
before it was licensed was not such as to be able to measure what
the overall impact of the disease progression was over a ten-year
period, which is precisely what the scheme is intending to do.
It is also is not intending to have a regulatory absolutism that
the clinical trials require. This scheme is essentially looking
at how much should the NHS pay in the light of the impact of the
drug on the disease progression and that is not something that
a clinical trial would ever look at.
478. It is just those 9,000 people who
(Mr McKeon) Who are being monitored intensively.
479. Is that not a bit rough on the remaining
51,000, or is it a moveable feast?
(Mr McKeon) No. The 60,000 do not all qualify for
treatment under the ABN guidelines. It is only a sub-set of people
with multiple sclerosis for whom treatment with beta interferon
and beta acetate(?) is recommended by the ABN. It is about 10,000.