WHC (2004) 042
WELSH HEALTH CIRCULAR
Parc Cathays
Caerdydd CF10 3NQ
Cathays Park
Cardiff CF10 3NQ
Issue date: 17 June 2004
Status: Information
Title: National Institute for Clinical Excellence: tenth wave work programme
For Action by: See attached list
Action required : See
paragraph 2
For Information to: See attached list
Sender: Carl Eley, Head of Healthcare Standards Branch, Quality, Standards and Safety
Improvement Directorate, Health and Social Care Department, Welsh Assembly Government,
Cathays Park, Cardiff CF10 3NQ. Tel: 029 2082 6842. E-mail carl.eley@wales.gsi.gov.uk
Contact: Dominic Worsey, Healthcare Standards Branch, Quality, Standards and Safety
Improvement Directorate, Health and Social Care Department, Welsh Assembly Government,
Cathays Park, Cardiff CF10 3NQ. Tel: 029 2082 3083. E-mail:
dominic.worsey@wales.gsi.gov.uk
Enclosures: List of topics included in the tenth wave work programme.
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National Institute for Clinical Excellence: tenth wave work programme
Dear Colleague
Purpose
1. To draw your attention to the tenth wave work programme which has recently been
referred to the National Institute for Clinical Excellence (NICE) by Ministers.
Action
2. Chief Executives are asked to note the topics which are being referred and
ensure that systems are in place to prepare for the guidance as and when issued
by NICE.
Background
3. NICE appraises the clinical benefits and costs of health care interventions
notified to it by the Welsh Assembly Government and the Secretary of State for
Health. Health Ministers in Wales and England jointly set the NICE work
programme. Approximately every six months, Ministers refer to the Institute a
batch of appraisals and guidelines topics, known colloquially as a “wave”. Nine
waves have already been referred, and this will be the tenth.
4. The tenth wave is split into two areas under which the Institute will produce
guidance:


Technology appraisals - guidance on the use of new and existing medicines
and treatments within the NHS in England and Wales. This guidance is
subject to the three month funding Direction issued by the Minister for
Health and Social Services on 23 October 2003.
Clinical guidelines - guidance on the appropriate treatment and care of
people with specific diseases and conditions within the NHS in England and
Wales.
5. NICE will factor these new topics into its existing work programme and begin
work on the guidance as soon as logistically possible. There will be several
opportunities to comment on drafts of each individual piece of guidance produced
by NICE, before the final guidance is issued in approximately two years time.
6. Details of NICE’s existing work programme can be found on their website:
www.nice.org.uk
Attachments
7. Attached are:


List of the technology appraisals to be included in the tenth wave (Annex A):
and
List of the clinical guidelines included in the tenth wave (Annex B).
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Further Information
3. For further information please contact Dominic Worsey, Healthcare Standards Branch,
Quality, Standards and Safety Improvement Directorate, Health and Social Care
Department, Welsh Assembly Government, Cathays Park, Cardiff CF10 3NQ. Tel: 029
2082 3083. E-mail: dominic.worsey@wales.gsi.gov.uk
Yours sincerely
Carl Eley
Head of Healthcare Standards Branch
Quality, Standards and Safety Improvement Directorate
Health and Social Care Department
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DISTRIBUTION LIST
Academy of Royal Colleges in Wales
All Wales Committee for Healthcare
Professions
All Wales Dietetic Advisory Committee
All Wales Health Care Professionals
All Wales Medical Directors' Group
All Wales Medicines Committee
All Wales Medicines Strategy Group
All Wales Principal Pharmacist
Association of Welsh Community Health
Councils
British Dental Association in Wales
British Medical Association (Wales)
Centre for Health Leadership
Commission for Health Improvement
Community Pharmacy Wales
Diabetes UK Cymru
Health Authorities
IHSM Welsh Division
Local Health Groups
Local Research Ethics Committee
Multi Research Ethics Committee
Multiple Sclerosis Society Wales
NHS Confederation in Wales
NHS Trusts
Patients’ Association
Royal Colleges (Wales)
Royal College of General Practitioners
Royal College of Nursing
University of Wales College of Medicine
Wales Association of Community and Town
Councils
Wales Council for Voluntary Action
Wales TUC
Welsh Dental Committee
Welsh Consumer Council
Welsh Executive, Royal Pharmaceutical Society
of Great Britain
Welsh Industry Group
Welsh Local Government Association
Welsh Medical Committee
Welsh Pharmaceutical Committee
Welsh Scientific Committee
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Annex A
Technology Appraisals
Atrasentan for hormone refractory prostate cancer
Prostate cancer is the most common male cancer, with about 18,000 new cases
and 9,300 deaths each year (England & Wales). Advanced (metastatic) disease
usually responds at least initially to hormone treatment, but the prognosis for
hormone refractory disease is poor. Atrasenten (ABT-627, Abbott) is an oral drug
in a new pharmaceutical class (endothelin A receptor antagonists) which inhibits
the process leading to the production of cancerous cells in prostate and other
cancers.
Cetuximab for head and neck cancer
There are 4,000 new case of head and neck cancer per year. This group of
tumours includes cancer of the mouth, tongue, salivary glands, sinuses and
pharynx. The 1-year survival rate for head and neck cancer is an estimated 70%,
with 5-year survival between 44-52%. Cetuximab is a new treatment in the same
drug class as Iressa (lung cancer, proposed for 8th wave).
Pemetrexed disodium in the treatment of mesotheliomia
There were about 1,600 cases of mesothelioma in England and Wales in 1999,
and approximately 1,600 deaths in 2001. The incidence is currently rising and will
continue to do so over the next few years, expecting to peak around 2010 with
around 3000 new cases per year. Pemetrexed disodium is a multi-targeted
antifolate (MTA) in clinical trials for a variety of cancers.
Oxaliplatin, irinotecan and capecitabine as adjuvant therapy in colorectal
cancer
Colorectal cancer is a common disease with about 31,000 new cases reported in
England and Wales in 1999, and just over 14,000 deaths in 2001. At least 8,060
patients with Dukes’ stage C cancer may be eligible to benefit from adjuvant
therapy for early stage disease. Oxaliplatin, irinotecan and capecitabine are
already licensed for use in advanced and metastatic colorectal cancer and have all
been reviewed by NICE for that indication. They are now in clinical trials for use as
adjuvant therapy in early colorectal cancer.
Docetaxel for hormone-refractory prostate cancer
There were over 22,400 cases of prostate cancer registered in 1999 and 8,900
deaths due to prostate cancer in England and Wales during 2001. Men with
hormone-refractory prostate cancer (HRPC) currently have a poor prognosis and
require palliative care and periodic hospitalisation for pain management. Docetaxel
(Taxotere®) is an anti-neoplastic agent already licensed for breast cancer and
non-small cell lung cancer in the UK and is in ongoing trials for head and neck,
gastric and ovarian cancer.
Carmustine implants (Gliadel Wafers) for newly diagnosed high grade glioma
Primary malignant brain tumours make up about 1.5% of all cancers in adults in
England and Wales, but over 7% of years of life lost from cancer before the age of
70. There are many different types of brain cancer presumed to arise from different
cell types. Gliomas make up the majority of primary brain tumours (50-60%).
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Carmustine implants (Gliadel Wafers) are biodegradable polyanhydride polymer
(polfeprosan 20) implants that deliver carmustine directly into the excision cavity of
a surgically removed tumour.
Biventricular pacing (cardiac resynchronisation) for heart failure
Heart failure – failure of the heart to pump an adequate flow of blood – is a major
cause of CHD morbidity and mortality, with 106,000 hospital admissions in
England in 2000-01. Biventricular (BiV) pacing, or cardiac resynchronisation, aims
to restore synchronous cardiac contraction. Biventricular pacing entails pacing the
right atrium and right ventricle (as in conventional dual chamber permanent
pacing) and additionally the left ventricle. Combined biventricular pacemakers and
implantable cardiac defibrillator (ICD) devices may be used in patients who have
ventricular dyssynchrony and who are also at risk of ventricular arrhythmia’s that
could lead to sudden cardiac arrest.
Methadone & Bupenorphine as opiate substitutes
It is estimated that there are between 230,00 and 280,000 problem drug users and
approximately 145,000 in treatment in any year with a Government target of
ensuring 200,000 are in effective treatment in 2008. The majority of those
requiring treatment are opiate dependent (usually illicit heroin). The number of illicit
opiate users is largely stable. Many opiate dependent users regularly use cocaine.
Methadone and buprenorphine are the most commonly used Opiate substitution
therapies and allow the addict to replace street heroin with a longer-acting, less
euphoriant and safer drug whilst avoiding the withdrawal syndrome. Once
stabilised many patients remain on maintenance treatment (with consequent
improvements in illicit drug use, physical health, well-being, social stabilisation and
very substantially reduced criminality and costs to society). Buprenorphine is
substantially more expensive than oral methadone and it takes longer to supervise
its consumption.
Naltrexone as a treatment for relapse prevention
It is estimated that there are between 230,00 and 280,000 problem drug users and
approximately 145,000 in treatment in any year with a Government target of
ensuring 200,000 are in effective treatment in 2008. The majority of those
requiring treatment are opiate dependent (usually illicit heroin). The number of illicit
opiate users is largely stable. Many opiate dependent users regularly use cocaine.
Oral naltrexone is a long-acting opiate antagonist that effectively blocks the effects
of all opiates so that a patient taking naltrexone will feel no benefit from taking illicit
heroin for some days after the last dose was taken. There is very varied use of this
as a treatment and lack of clarity for whom it may be most appropriate. It is also
recommended that a relative supervises its use to aid compliance.
Pegaptanib for age-related macular degeneration
Age-related macular degeneration (AMD) is one of the leading causes of
irreversible visual loss in people over the age of 50 years in the western world.
“Wet” AMD accounts for 10% of all cases (110,000 patients in England) but about
90% of the blindness associated with AMD. Wet AMD is caused by a proliferation
of blood vessels beneath the retina (“choroidal neovascularisation” or CNV).
These new blood vessels are very fragile, leak blood and fluid, and lead to retinal
scarring and permanent loss of vision in affected areas. The affected areas often
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include the fovea with the consequent loss of sharp, central vision. Pegaptanib is
new drug currently in clinical development for the treatment of wet AMD. It is
administered as an injection into the eye every 6 weeks.
Natalizumab for multiple sclerosis
Multiple sclerosis (MS) is a debilitating disease of the central nervous system that
usually begins between the ages of 20 and 40 and is the most frequent cause of
neurological disability in young adults. Around 63,000 people have MS in England
and Wales. Natalizumab is a monoclonal antibody under development for the
treatment of relapsing-remitting and secondary progressive MS. It has a different
mode of action from interferon beta and could potentially be used in combination
with it.
Adalimumab for rheumatoid arthritis
RA affects between 0.5% and 1% of the population. It is characterised by
inflammation of the joints, which causes swelling and stiffness and can lead to joint
destruction. A wide range of anti TNF products are available for the treatment of
RA. Adalimumab is a fully human anti-TNF-α monoclonal antibody. Adalimumab is
administered either subcutaneously or intravenously once a fortnight. It was
launched in the USA in January 2003 for reducing the signs and symptoms of
disease and inhibiting the progression of structural damage in adults with
moderately to severely active rheumatoid arthritis who have had insufficient
response to one or more disease modifying anti-rheumatic drugs.
Lerdelimumab (CAT-152) for prevention of scarring after glaucoma filtration
surgery
Glaucoma, one of the commonest causes of blindness in the developed world, is
usually associated with a high build-up of pressure in the front of the eye. This can
be treated by drug therapy or by surgery to drain away the excess fluid. Surgery
can however lead to scarring in and around the eye. Lerdelimumab is a new drug
currently in phase III trials for the prevention of scarring following glaucoma
filtration surgery. It was awarded European Orphan Drug status in May 2001.
Lerdelimumab could potentially be given to all patients to improve their outcome
instead of antiproliferative drugs such as mitomycin or 5-fluoracil.
Strontum ranelate for osteoporosis
Osteoporosis is a progressive deterioration of bone mass increasing the risk of
fractures. It affects 1 in 3 women and 1 in 12 men over 50 (3.8 million patients
E&W) and causes 40,000 fractures each year. Strontium ranelate is an oral drug
in a new class which stimulates bone formation and reduces bone resorption.
Inhaled insulin
There are about 1.3 million patients in England and Wales with diagnosed
diabetes, of whom around 15% have Type 1 diabetes and 85% Type 2 diabetes.
All those with Type 1 diabetes, and around 30% of patients with Type 2 diabetes those whose blood glucose levels can no longer be controlled by diet, exercise or
oral treatments alone – require insulin treatment. In all, about 500-550,000 people
in England are currently being treated with insulin.
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Corticosteroids For Asthma
Asthma is a very common condition in both children and adults, with an overall
prevalence of about 8-10% (4-5m people in England and Wales). Although for
many patients it is well controlled, it can be severely disabling or life-threatening in
severe cases. Treatment with inhaled corticosteroids is the mainstay of current
treatment strategies; in 2001 some 12 million prescriptions were dispensed at a
cost of over £300m. There is a wide variation in the price of available
corticosteroids, but it is not clear that the more expensive drugs are more effective
than the cheaper in the majority of patients.
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Annex B
CLINICAL GUIDELINES
Care and management of osteoarthritis
Osteoarthritis (OA) is a degenerative joint disease characterised by the breakdown
of the joint’s cartilage causing pain and loss of movement. OA is the most common
form of arthritis affecting primarily middle aged and older people. Pain and joint
stiffness are the primary complaints – in the most severe cases people find it
difficult to move and use the joint. The clinical guideline will consider the best
available evidence for the cost-effectiveness of interventions to reduce pain,
improve mobility, improve psychological well being, social participation, and the
extension of healthy active life.
Drug treatment
It is estimated that there are between 230,00 and 280,000 problem drug users and
approximately 145,000 in treatment in any year with a Government target of
ensuring 200,000 are in effective treatment in 2008. The majority of those
requiring treatment are opiate dependent (usually illicit heroin). The number of illicit
opiate users is largely stable. Many opiate dependent users regularly use cocaine.
The guideline will cover what the evidence tells us about the effectiveness and
cost-effectiveness of methadone and buprenorphine and the appropriate patient
groups for each treatment. The guideline should also make clear the key
components of the effectiveness of the treatments (such as dose, supervision,
being given within a wider package of care/psychosocial interventions).
Management of faecal incontinence
It is estimated that incontinence (both urinary and faecal) accounts for 2% of the
total annual healthcare budget of the UK. The annual NHS bill for treating and
managing incontinent persons is estimated at £500 million. Annual costs relating to
the elderly include £22 million for drugs, £58 million for appliances, and £27
million for containment products. Optimal management of the conditions will
reduce the considerable morbidity associated with this condition, the negative
impact on psychological health and lifestyle, and improve quality of life.
Attention Deficit Hyperactivity Disorder (ADHD) in children, young people
and adults
Attention Deficit Hyperactivity disorder is defined by the ‘core’ symptoms of
inattention, hyperactivity and impulsivity that are more frequent or severe than is
typically observed in individuals at a comparable level of development.
Approximately 10-20% of children with ADHD will not benefit from stimulant
medication, even in expert hands, due to lack of effect or adverse effects. ADHD
frequently occurs co-morbidly with other conditions such as oppositional defiant
disorder, learning disabilities, conduct disorder, Tourettes syndrome, depression,
autism spectrum disorders, anxiety disorders, and bipolar disorders.
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