Examination of Witnesses (Questions 380
- 399)
WEDNESDAY 30 JANUARY 2002
PROFESSOR SIR
MICHAEL RAWLINS,
MR ANDREW
DILLON AND
PROFESSOR DAVID
BARNETT
Dr Naysmith
380. I want to pick up on something that Sir
Michael said a moment ago. You said there were instances of successful
appraisal before licensing or very early on in licensing.
(Professor Sir Michael Rawlins) Yes.
381. The pharmaceutical firms told us that this
was very difficult and not easy to achieve. I wonder why you think
they said that? This Committee wants to make positive recommendations
because I like NICE, unlike one of my colleagues, and I want NICE
to function better than it does now. How can we try and make sure
that that does work?
(Professor Sir Michael Rawlins) I am not quite sure
why originally the pharmaceutical industry did think it would
be impossible, but right from the very beginning, even before
there was a board of NICE or anything, they used to tell me that
it would be quite impossible to make a fair appraisal of new remedies.
I found it very difficult to understand it and I argued with them
in discussions about it. I think that their position is somewhat
changing from what it was two years ago because I think they are
realising that positive appraisals, where we are actively as it
were promoting cost effective, clinically effective new treatments,
are to their advantage. I suspect, to be honest with you, that
the pharmaceutical industry would rather that NICE had never been
started. I think it is another difficulty for them and I do understand
that. If I were in the industry I suppose I would think the same
sort of thing. However, I do think their position has shifted
over the last couple of years and they are no longer as adamant
as they were about the possibility of doing early appraisals and,
as I said, we have done them and they have worked.
382. Presumably one thing they would have against
you would be that adverse indications at that stage could be the
kiss of death for a particular product.
(Professor Sir Michael Rawlins) That of course is
a possibility, yes.
Sandra Gidley
383. I have to pick up on a comment that was
made when you responded to David Amess, I am afraid, because I
cannot let this go. In fact, there was a change in answer. This
is to Professor Rawlins. You made a very robust statement that
you were tackling the postcode lottery and then that was almost
retracted later on and you admitted that in some ways NICE had
not tackled it. We had a submission from the ABPI which showed
the take-up for taxel and the use before and after the NICE appraisal.
There was not much of a shift. We all want it to work. We would
love there not to be a postcode lottery and we would love the
NICE recommendations to be taken up fully but life ain't like
that. Question one: what audit have you made of the effect you
have had on prescribing patterns? Has that work been done and
have the technologies been used? We all know that some of them
have been taken up, but maybe only for six patients in a health
authority. Then we had the recent announcement by the Secretary
of State which says "no ring-fenced money", and I would
like to ask if you think there should be ring-fenced money for
NICE guidance, but authorities now have a responsibility to accept
the NICE guidance and prescribers can prescribe those technologies.
Will that not in fact lead to another form of postcode lottery
in that, okay, fine, so you have got an approved drug, but you
have only got so much money in your drugs budget. Will other treatments
be denied? How do you get round that because at the end of the
day we all want the best for the patients?
(Professor Sir Michael Rawlins) There are three questions
there. One is that you asked if we had done an audit of prescribing.
We have done some. We have had some information on prescribing
primary care from the Prescription Pricing Authority, but very
few of our appraisals have concerned primary care. It is secondary
care. Unfortunately we do not have a robust system in the Health
Service to collect data—as I am sure you are aware—on
secondary care drug usage. It has different systems, in different
hospitals, based almost entirely on purchase data and there are
all sorts of difficulties about it. I am afraid we do not have
a robust answer to that question. We have, however, commissioned
independent research from Trevor Sheldon at York to undertake
a very detailed review of the consequences of our appraisals.
It is not a very satisfactory answer.
384. But it is honest.
(Professor Sir Michael Rawlins) I have been in the
Health Service for 35 years now and ring-fenced money in my experience
is not a terribly good idea. Ring-fenced money tends to have a
habit of being used in all sorts of funny ways outside the supposed
ring-fencing. I would rather not go into it in detail but you
probably know what I mean. All sorts of creative fences are moved
around it. It seems to me that it would be much better for the
sorts of technologies that we advocate, the sorts of conditions
that we make the guidelines for in the treatment of individual
conditions, should be part and parcel of the general money that
is available in the Health Service. It has been suggested that
NICE should have a pot of £100 million a year and when we
get to the end of the pot that is it. I would be very cautious
about that too. The Appraisal Committee are human beings and what
if it were February and there was £10 million left in the
pot and they were facing a rather difficult decision (and in other
health care systems in the world this difficulty had arisen) I
would be rather cautious about going that route. You asked about
the consequences of the directions and it is our impression, although
it is only anecdotal, that in large part where there have been
varying uptakes it has been because of the difficulty of the health
authority's funding of a particular treatment. It has not been
health professionals disagreeing with NICE advice. It has been
the availability of the funding. As Mr Dillon was saying a little
bit earlier in our discussions, if you want to have a standard
form of access to treatment that covers England and Wales, then
the inevitability is that the sorts of treatments that NICE is
recommending would become available and would form a major priority.
The important thing is to ensure that what we do is a real priority
for the service.
385. Will there be a postcode lottery, I was
asking, for the drugs that have not undertaken appraisal?
(Professor Sir Michael Rawlins) No.
386. You said you had got a huge catch-up process.
(Professor Sir Michael Rawlins) Not for the other
drugs, no. For the services it might distort local priorities
but not for other drugs. What I would like us to do is to appraise
all new innovative pharmaceuticals but we do not need to appraise
the 22nd beta-blocker or the 39th fireside diuretic. They can
make their place on the market and fight on the price competition
or quality competition or whatever.
Dr Taylor
387. We are going to move on to specific drugs
if we may. Relenza, the 'flu drug. We have slightly touched on
this but I thought we ought to say specifically that the Drug
and Therapeutic Bulletin did really complain rather that they
gave you a detailed report listing all of their concerns and that
was in February last year and they have never had a reply. When
you us details on some of your rebuttals we would like you to
include the Drug and Therapeutic Bulletin.
(Professor Sir Michael Rawlins) I will indeed send
you copies of the correspondence I had with Professor Collier,
Editor of the D&TB, in particular the letter I wrote on 29
January in response to his sending me a draft article, and then
he responded to that letter in April, by which time the DTB article
had been published two months, with a series of questions he wanted
me to answer running to nine pages. At that stage, to be honest
with you, we were having a dialogue with the deaf, and I did not
think it was worth spending a lot of time responding to nine pages
or asking the staff of NICE to do it in view of the fact that
it was two months after the publication of the original article.
388. So you have in fact responded?
(Professor Sir Michael Rawlins) We have in fact responded.
(Mr Dillon) I also responded.
389. Changing on to the colorectal drugs with
absolutely unpronounceable names, that is another source of great
worry because there do appear to be some really significant advances
there and those are delayed, people would say. Is that fair, or
is there any way round that delay?
(Professor Sir Michael Rawlins) There were two appeals
on colorectal cancers, and I chaired the second appeal last week
and the decision of the Appeal Panel should be available in the
next two or three weeks.
390. So that will be out very soon?
(Professor Sir Michael Rawlins) That will be out very
soon.
Sandra Gidley
391. Last week we had quite a vigorous debate
about Herceptin. My understanding is that the drug is being appraised
for use as a mono therapy and also as a combination therapy. I
have been told that one set of guidances is to all intents and
purposes approved and ready to go, but the whole thing is being
held up because the other set of balances is not available. Would
it not have been helpful to the patients out there who need the
treatment to have released to some sort of interim guidance too
the effect that you are happy with part of it?
(Professor Barnett) I think you have been ill-informed,
if I may say so. It is not true to say that one component of the
guidance is being held up because the other part of the guidance
is not available. We were asked initially to appraise two drugs,
trastuzumab, which is Herceptin, and vinorelbine, for the management
of advanced breast cancer. Following consultation it became obvious
that the information base should be extended and, the evidence
base, for those two different drugs it was quite different, not
surprisingly, and therefore they were separated. The information
base we were informed would take longer to collate for one of
those drugs than the other and so they had been separated in their
appraisal process. Both appraisals are ongoing, trastuzumab has
gone through the appropriate process and the final guidance for
that I hope should be out in March provided there is no appeal
against the final decision.
392. When was that finished, the appraisal process?
(Professor Barnett) Last week, I think.
393. Was that for use by itself?
(Professor Barnett) That was for use in breast cancer
both as a mono therapy and in combination.
394. When did you have the results for mono
therapy and when did you have the results for the combination
use?
(Professor Barnett) Both of the two components of
that appraisal (trastuzumab and vinorelbine)required an additional
evidence base and in particular significant consultation with
both the manufacturers and professionals about the use of the
drugs. They will go if you like in parallel with development.
It is fairly obvious, at least to me, that the two uses of these
drugs, in mono therapy and in combination, are inter-related.
They are not separate components. Therefore, delivering the guidance
in the best way for the oncologists who use the drugs with the
two together is important. It was not one drug holding up another.
In extending the evidence base for breast cancer we need to be
conscious that until analysed we can't be clear about the impact
of new evidence, it may be positive, it may be negative or it
may support the original data.
395. It has worried me how much this Committee
seems to have been misinformed over the past couple of weeks.
Does that not say in fact that maybe the bodies that are out there
are not getting sufficient feedback from you as to what is happening
to hold up these processes? I am a little concerned at some of
the conflicting evidence we have been having.
(Professor Barnett) I understand your concern and
I would feel the same way. I think the bodies who were involved
in the appraisal, the consultees themselves, were fully informed
of exactly what the Appraisal Committee had in mind. I think it
is the Institute's job to do that, not the Appraisal Committee's
job, and on advice that is exactly what they did.
396. So you would say that all the drug companies
were happy with the length of time that the process took?
(Professor Barnett) I do not think the drug companies
are ever happy with the length of time that we take over our appraisals.
What I think they are happy with is the rigour with which we address
our requests.
397. And the patients' groups are similar?
(Professor Barnett) I think the patients' groups are
unhappy too and I am not surprised because, like any patient,
as a clinician I want everything yesterday, but that is not the
way in my view to effectively appraise the correct use of these
very complex medications in a rather tortuous pathway of care.
398. Is there any way that can be speeded up
a little? Is it right that you only have hearings every so often
so that if you miss one you have to wait a few months for the
next?
(Professor Barnett) Hearings? I am not sure what you
mean. The Appraisal Committees meet fortnightly.
399. Surely that is timetabled so people know
it is coming up.
(Professor Barnett) Absolutely.
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