Consultation
- interventional procedures programme methods
guide
NICE is consulting on
the interventional procedures programme methods guide, which sets
out the processes that are followed when developing guidance on the
safety and efficacy of interventional procedures. The consultation
period runs from 4 December until 2 March 2007. More information is
available on the NICE website.
NICE
Citizens Council to discuss ‘only in research’
recommendations
The Citizens Council of
the National Institute for Health and Clinical Excellence (NICE),
which provides public input into the Institute’s work, will hold its
next meeting in London from 25 to 27 January 2007.
At this meeting the Citizens Council will be asked for its views on
when it is appropriate for NICE to recommend a treatment or
intervention to be used only in the context of research.
Professor Sir Michael
Rawlins, Chairman of NICE, said: “The Citizens Council
makes an important contribution by enabling NICE to take the views
of the general public into account when undertaking its work. Since
it was set up, the Citizens Council has provided valuable input on a
number of contentious subjects, including social value judgements,
and the ‘rule of rescue’.
“Now we are asking the
Council to discuss ’only in research’ recommendations. NICE produces
guidance for both the clinical and public health fields, based on
the available evidence. However, there are often “gaps” in that
evidence. This can be for a number of reasons, including that too
few studies exist on the topic that NICE is considering, or existing
studies are of poor quality or have investigated inappropriate
patients. Whatever the reason for the gaps, this leads to
uncertainty about the true effects of the intervention under
consideration. But what does this mean for patients, where
treatments appear to be promising? How should recommendations be
made in this case? We will ask the council for their views on when
it is appropriate for NICE guidance to make recommendations that
allow a treatment or other intervention to be used only in a
research setting.”
A limited number of
places will be available to attend the presentations on Thursday 25
January - please contact Clifford Middleton
to request a place. For further information visit the NICE
website.
NICE
publishes final guidance on bevacizumab and cetuximab for the
treatment of metastatic colorectal cancer
The National Institute
for Health and Clinical Excellence (NICE) has today published final
guidance on the use of bevacizumab and cetuximab for the treatment
of metastatic colorectal cancer.
The guidance does not
recommend the use of these drugs for first line therapy for
metastatic colorectal cancer (bevacizumab) and therapy following the
failure of an irinotecan containing chemotherapy regimen (cetuximab)
and means that the joint appeal by Bowel Cancer UK
and Cancerbackup and the appeal by Merck Pharmaceuticals have not
been upheld.
Commenting on the
guidance, Peter Littlejohns, Clinical & Public Health Director,
said : “ The decision of the
Appeal Panel means that the recommendations set out in the final
appraisal determination will form the Institute’s guidance to the
NHS in England
and Wales. The kinds of
decisions the Institute is asked to make are amongst the most
difficult in public life. Those who form our advisory committees are
acutely aware of the responsibility they carry and they form their
recommendations with great care. In this case, our advisory
committee was certainly aware that colorectal cancer is an
aggressive disease and that the treatment options available are
limited. However, the difficult job they have to do is to balance
the additional therapeutic benefit offered by these new treatments
against their cost. The assessment of the evidence shows that
neither of these drugs represents a good use of NHS resources.” Read
the press release.
NICE issues
guidance on treating secondary hyperparathyroidism in patients with
kidney disease
NICE has issued guidance
on the use of cinacalcet in the treatment of secondary
hyperparathyroidism in patients with end-stage renal disease on
maintenance dialysis therapy.
Cinacalcet is not
recommended for the routine treatment of secondary
hyperparathyroidism in patients with end-stage kidney disease on
dialysis. However, the guidance does recommend cinacalcet for the
treatment of refractory secondary hyperparathyroidism in patients
with end-stage kidney disease only in those who:
- have very high levels
of parathyroid hormone in their blood that can’t be lowered by
other treatments, and
- cannot have an
operation to remove the parathyroid glands because of the risks
involved.
The guidance recommends
that people who do receive cinacalcet should have regular checks,
and that treatment should be stopped if the parathyroid hormone
levels in their blood do not fall substantially within 4 months.
Andrew Dillon,
Chief Executive at NICE and Executive Lead for the guidance, said:
“NICE guidance makes
recommendations on the clinical and cost effectiveness of
treatments, to help the NHS make best use of its resources for the
benefit of patients. This guidance, produced by an independent
committee, recommends that cinacalcet should not be prescribed
routinely on the NHS as there isn’t enough reliable evidence that
cinacalcet is more effective than existing treatments for treating
secondary hyperparathyroidism due to kidney disease. However, the
guidance recommends that for patients on dialysis with very high
parathyroid hormone levels that can’t be lowered by other means,
this treatment should be available on the NHS.” Read the press
release.
NICE
response to judicial review proceedings
Commenting of the
application for judicial review by Eisai Limited, supported by their
co-promotion partner Pfizer Limited, of the process by which NICE
developed guidance on the use of drugs for treating Alzheimer's
disease, Andrew Dillon, Chief Executive of
NICE, said:
“We are disappointed
that Eisai Limited have taken this step. We consider their claim
without foundation and it will require us to divert energy and
funding from the work we do to support patients and health
professionals and get the most out of the resources available to the
NHS.
“Health service funding
is limited, and it is our job to assess the clinical and
cost-effectiveness of both drug and non-drug interventions to ensure
the money spent by the NHS is well-spent.
“Our consultation,
decision-making and appeals processes are transparent and fair. We
share our methodology and enable our stakeholders to see the basis
on which our experts arrive at their decisions. We invite patients,
medical professionals and anyone who has an interest to express
their views and comment on our proposals.
“The reality is that,
for Alzheimer's disease, drugs are only part of the care that needs
to be offered. Non-drug interventions have an important part to play
and the evidence indicates that drugs are simply not effective for
some patients.
“That is why, in
November 2006, we issued, with the Social Care Institute for
Excellence, joint guidance on the treatment and care of people with
all forms of dementia and the support that should be provided for
carers.
For the first time,
healthcare professionals working within the NHS are following the
same guidelines as the social workers and care workers in nursing
homes, creating core standards for care that will make a real
difference for patients and their families.” Read the press
release.
Changes to
TA 36 guidance on the use of etanercept and infliximab for the
treatment of rheumatoid arthritis
The Institute has been
informed by the British Society for Rheumatology (BSR) that the
Biologics Registry it established is no longer registering new
infliximab patients (referred to in section 1.5 of the guidance) as the
planned number of patients treated with this biologic therapy has
now been reached.
It is important to note
that for all recruited patients, the collection of follow-up data
will continue.
In light of this, NICE
no longer recommends that clinicians prescribing infliximab register
their patients with the BSR Biologics Registry. All other
recommendations remain the same.
See the NICE
website for further information.
Antenatal
care assessment tool survey
The National
Collaborating Centre for Women’s and Children’s Health (NCC-WCH)
will be running an online survey designed to develop an Antenatal
Care Assessment (ANC) tool. This new national tool will help to
identify the specific needs of women during pregnancy. The
assessment of the needs of pregnant women is a fundamental part of
antenatal care so the development of an acceptable, structured tool
which could be used nationally is likely to be beneficial to both
pregnant women and the professionals caring for them.
The online survey will
run from Wednesday 10 January to Friday 2 February 2007 on the NCC-WCH
website.
The NCC-WCH would like
involvement in the survey from new mothers, mothers-to-be and
healthcare professionals involved in caring for them. A follow up
meeting will be held on Wednesday, 14 March 2007 at the Royal
College of Obstetricians and
Gynaecologists.
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