Memorandum by Cancer Research Campaign
Thank you for the opportunity to submit to the
first inquiry into the progress of NICE in respect of the key
goals outlined in your press notice. The Cancer Research Campaign,
shortly to become Cancer Research (UK) with the merger to the
Imperial Cancer Research Fund, has had a substantial input to
NICE indirectly through its Clinical Directors and a direct submission
during the assessment of the Campaign's brain cancer drug Temozolomide
(Temodol). Technologies within the field of oncology have made
up a substantial portion of the assessments carried out by NICE
to date. Our combined submission reflects the assessments of those
Clinical Directors and NCRI Clinical Study Group Chairmen who
were able and willing to reply over the Christmas holidays. In
order to keep within the remit of the Committee we have addressed
each of the key goals envisaged in "A First Class Service".
Q. Is NICE providing clear and credible guidance?
The concensus is that the guidance has been
clear, however, there are issues in relation to credibility where
a lack of expertise in oncology has led to a perception that the
appraisals lack specialist "clinical common sense".
This problem is also believed to have contributed to certain idiosyncrasies
in some determinations, for instance, why "approve"
Fludarabine and not Rituximab for lymphoma when the qualitative
evidence is very similar?
Other issues have also arisen which reflect
on the credibility of the guidance. It is often difficult to see
how decisions are made when no explicit criteria are set out against
which decisions are made, for instance how much weight is attached
during deliberations to the various sources of information from
trials through to ad hoc patient experience?
Q. Has it ended confusion by providing a single
Again the consensus is that it has ended confusion
in that there is now a single national focus for decision making,
however, again there have been instances where Department of Health
decisions have preceded the deliberations of NICE, eg Imatinib
Q. Have the guidance's been locally owned
and acted on in an appropriate manner?
There have been considerable local variations
in the way in which NICE guidelines have been interpreted, particularly
with regard to funding (after the failure to ring-fence 2001-02
National Cancer Plan monies). The comment has also been made that
guidance issued as central edict cannot, by definition, ``locally
owned'' since it is acted upon out of compulsion. However, the
major issue relates to the lack of extra monies available to the
Trusts to enable implementation of the technology appraisals.
Q. Has NICE chosen the right technologies
It is recognised that the choice of the right
technologies to assess is very difficult and by necessity NICE
has appraised a number of new anti-cancer drugs. A number of issues
though have arisen. Firstly, it is unclear how technologies are
chosen, in particular it has been notable that appraisals of capital
equipment and procedures (therapeutic and diagnostic) have not
been as prolific as drugs. It is clear that NICE need a much larger
task force to increase capacity and tackle the other issue which
has been the rather slow pace at which the appraisals are done.
There is also a serious concern about the time lag between granting
a product licence and the earliest NICE appraisal, especially
when an agent demonstrates substantial efficacy in a disease with
few therapeutic options, eg Imatinib in the treatment of Gastro-Intestinal
Stromal Tumours (GIST).
Q. Is the NICE committee perceived to be independent?
The perceptions about the independence of NICE
are mixed. The major point raised with respect to a perceived
lack of independence is the suggestion of an excessive influence
of the Department of Health due to NICE's emphasis on costs rather
than efficacy. The perception is that NICE have to keep the impact
of total cost of implementing any one technology a very high priority
in their deliberations.
Thank you for your consideration. NICE has been
an important initiative and, in conclusion the recommendations
we would like to make are:
The secondment of clinical cancer
experts onto NICE when appraising the relevant technologies.
The publication of explicit thresholds
for efficacy and cost, as well as a transparent system for judging
the submitted data.
Parallel appraisal with the Competent
Authority of technologies which address urgent clinical needs.
Dedicated extra funding to Trusts
to follow the final appraisal determinations.