Examination of Witnesses (Questions 400
- 419)
WEDNESDAY 30 JANUARY 2002
PROFESSOR SIR
MICHAEL RAWLINS,
MR ANDREW
DILLON AND
PROFESSOR DAVID
BARNETT
400. So if something was discussed—I am
just trying to get a handle on the process—at a meeting
and you needed some evidence how long would it be before it would
be looked if that was provided the next week?
(Professor Barnett) The answer to that question is
two-fold. One is how easily available that information is, and
of course we have to take advice on that from whoever is answering
the question. The second is how easy it is to make committee time.
My view and the view of the Committee members is that we will
spend as much time as is necessary on the day we meet in order
to achieve our goals. We will do everything we can to make space
for an urgent request as much as we possibly can, but all committees
work to timetables, all committees have certain agendas which
they have to fulfil. Where we might be fulfilling the agenda for
a particular technology, somebody else will be missing out. That
balance is a very difficult one.
401. So on average, if you assumed that nothing
was that urgent?
(Professor Barnett) A present appraisal which we are
doing, which does not need to be mentioned, requires additional
information. That was decided at the Committee meeting last week
and we will review it again in one month.
Jim Dowd
402. I want to follow this Herceptin issue for
a moment. This Committee received a very strong submission last
week that there had been an inexplicable six-month delay (and
"inexplicable" was the word used) in the assessment
being published. First of all, that rather seems to contradict
your view that all those involved were fully informed, and the
assertion we got was from a range of individuals, not just one.
It also in my mind creates possible confusion between the view
you have of how you relate to your stakeholders and how they understand
your performance. I am not quite sure whether you are both equally
misinformed or whether you both think you are doing the right
things on your side of the equation, but it is just not communicating
to the other. Was there a delay, this six-month "inexplicable"
delay, in Herceptin, because it was put to us quite forcefully,
if not quite directly as near as makes no difference, that women
were dying because of the failure to use this drug? That was clearly
the import of what was said to us.
(Professor Barnett) There are two components to this
and I think that the process issue and the issue about the timings
perhaps Andrew would like to comment on first.
(Mr Dillon) All the stakeholders involved in the appraisal,
as David said, are told—and this is true for all appraisals—if
there is any variation to the process that we have previously
published in the standard appraisal process that we have. In the
case of this appraisal it was the consultees themselves who encouraged
us to look for, or rather to look at, further evidence, essentially
a case series that they considered was appropriate evidence for
the Appraisal Committee, so it was at the request of consultees
that we had to consider whether or not we should plough on with
the standard time line for the appraisal and not give the Appraisal
Committee the opportunity to look at the evidence, or to take
the time to do that. We decided that it was appropriate in the
case of this appraisal that we looked at the further evidence
that we were being directed to see. To enable us to gather that
evidence we had to suspend the time line for the appraisal, so
we had to give ourselves sufficient time to find out where the
data was, to get the data evidence supplied to us in order to
enable us to present that data in a form that could be used by
the Appraisal Committee. Once we had taken that decision we made
sure that all the consultees were aware of this, and furthermore
we put the information on the Institute's web site. Anybody who
seriously wanted to know what the new time line was, why the Institute
had to change the original projected timetable, could find out
either by looking at the web site or by reading the letters that
we sent to the consultees or simply by getting in touch with us.
Dr Naysmith
403. I want to move to another area now. We
are interested in the appeal process. Can you tell me what are
the grounds for appeal?
(Professor Sir Michael Rawlins) There are three grounds
by which the Institute is directed to hold appeals, and these
are the directions of the Secretary of State. The first is that
the Institute has acted unfairly in the way it has conducted the
whole process; secondly, that its findings are perverse, that
they are so unreasonable that no reasonable Appraisal Committee
could possibly have come to that conclusion, are the words the
lawyers use; and, finally, that the Institute is acting beyond
its legal powers. It is these three things, and it is very similar
to the appeal in the criminal or civil courts.
404. What happens next?
(Professor Sir Michael Rawlins) Any of the consultees
may appeal except the Health Authorities and the Technology Board
for Scotland, and we can come back to that a bit later. The Department
of Health can appeal, and manufacturers, professional organisations,
patient bodies, have all appealed at one time or another. The
consultee or groups of consultees request an appeal. It comes
to me. I invariably seek legal advice and those appeal requests
that meet the legal criteria for an appeal are granted. There
is an oral hearing with myself or another non-executive director
in the chair. There are always two or three non-executive directors,
one independent member from the industry and one individual representing
patient and care organisations. The proceedings are inquisitorial,
not adversarial.
405. You say the appeals come to you first of
all?
(Professor Sir Michael Rawlins) Yes.
406. Can you turn them down?
(Professor Sir Michael Rawlins) Yes, on two occasions—
407. Only on legal advice?
(Professor Sir Michael Rawlins) On two occasions.
Neither appeal was on grounds on which we could hear appeals and
the legal advice was that we should not have an appeal and the
appellants said, "Thank you very much" and went off.
408. How many appeals have there been?
(Professor Sir Michael Rawlins) We have had 13 that
have been allowed, four have been upheld and nine have been rejected.
Chairman
409. Where your advice was that the appeals
did not meet the criteria, did you feel in fairness that perhaps
the criteria could be changed in future at some point to reflect
a genuine grievance? Are you happy with the criteria?
(Professor Sir Michael Rawlins) I tended to veer the
other way and there have been a number of occasions when, on strictly
legal grounds, probably it was not necessary to hold an appeal
because there really were not appropriate grounds, but on the
other hand it did seem to me that this was an opportunity to allow
the particular organisation, which in one case was actually a
patient organisation, to explain what their problem was and we
could explain what our problem was and I think they were reasonably
satisfied. Although the specific appeal was rejected I think they
were satisfied that their point of view had been put and we had
explained why we could not meet their demands.
410. Do you feel the criteria are appropriate,
the three points?
(Professor Sir Michael Rawlins) I think they are.
The industry have made suggestions that criterion two, this business
about perversity, ought to be widened so that the whole case could
be re-heard. I do not think it is appropriate for a new trial
as it were to happen. We would have to assemble a panel that replicated
the original appraisal committee with all the range of expertise
and then what do you do if one group disagrees with another? The
Board then have to make a decision. The industry draw analogies
with the Medicines Act and appeals before the Committee on Safety
of Medicines that go on to the Medicines Commission. Having chaired
the CSM for six years I am very familiar with that process. What
of course happens at the end of the day is that it is not the
Medicines Commission overruling the Committee on Safety of Medicines.
The licensing authority, the Secretary of State, has to decide
which committee's advice he is going to take. I think that it
would just end up in a more difficult situation even if we could
assemble another appraisal committee to consider it all again.
Dr Naysmith
411. It has been suggested to us that the number
and variety of successful appeals throws a bit of doubt on the
credibility of your organisation. What do you say to that? Is
it fair?
(Professor Sir Michael Rawlins) When I chaired the
Committee on Safety of Medicines 40 per cent of the decisions
that we made were appealed against. We are seeing something like
a similar number.
412. How many of those were as a result of new
evidence being brought?
(Professor Sir Michael Rawlins) On this occasion none,
at NICE.
413. But on the other occasions there were quite
a lot?
(Professor Sir Michael Rawlins) I cannot remember
off hand. The fact that appeals are going to the Medicines Commission
is never in the public domain.
414. I do know that sometimes fresh evidence
is brought.
(Professor Sir Michael Rawlins) Oh yes, sometimes
it is, but I cannot tell you how often.
415. Would that be allowed in this system?
(Professor Sir Michael Rawlins) In this system if
there is fresh evidence that is clearly relevant we would ask
the Appraisal Committee to re-examine their conclusions in the
light of this fresh evidence.
416. Has that ever happened?
(Professor Sir Michael Rawlins) Yes, it has.
417. What happens if you get to a situation
where you cannot really make a decision? I know there are one
or two recent cases where that might be the case. What would you
do in that situation? What would you say? This is before the appeal
stage and you get to a situation where the Appraisal Committee
cannot make a decision. The company would be entitled, would they
not, to make an appeal against that kind of situation? What would
you do?
(Professor Barnett) There are several possibilities
that the Appraisal Committee have. One is to come to a decision
yea or nay. Another is to say that the evidence base on which
they are basing the decision is inadequate and they wish for further
evidence, and that has happened on a number of occasions, or that
it is obvious that new evidence is appearing at the time during
which the appraisal is going on which would mean that a delay
in the appraisal process is appropriate. I have to point out that
trying to convince the Chief Executive of the organisation that
that is an acceptable way of going is very difficult because he
takes quite seriously the importance of keeping to our time lines.
Therefore, if that is necessary, we will do that. We will move
it appropriately. It is not usual that we would leave it in the
air. There would be a forward move of some sort.
418. I wonder if the need to take the availability
of finance and the cost effectiveness into account comes into
this at all. I say that because scientifically you are probably
very rarely going to come to the wrong conclusion, unless we are
talking about really big shifts, so the number of appeals that
are successful purely on scientific grounds I would suggest would
be lower than you are reporting now, but the fact that you have
to bring cost effectiveness into it, does that often constitute
grounds which help the appeal to be successful?
(Professor Sir Michael Rawlins) It is certainly an
element of the appeals that the Committee had been perverse in
their interpretation of cost effectiveness data and sometimes
it has been alleged that the Committee has adopted a threshold
of cost effectiveness. The Committee Chairman comes to all the
appeals and explains what the Committee's thinking has been and
whether this has been asked about. It is always hotly denied that
they have adopted a particular threshold. The cost effectiveness
does contribute but it is really not a matter of re-hearing evidence.
It is a matter of seeing whether they were making a reasonable
decision, not necessarily a judgement we might make but whether
it was reasonable in the light of the prevailing circumstances
and evidence.
419. How much discussion of all this is there
at the appeals procedure?
(Professor Sir Michael Rawlins) They last two or three
hours or, in the case of beta-interferon, it lasted a whole day,
the second appeal.
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