New NICE (National Institute for Clinical Excellence) Work UK
NICE is also being asked to develop clinical guidance on the care and management of osteoarthritis and Attention Deficit Hyperactivity Disorder in children and young adults.
Lord Warner said:
"This is an extremely important programme of work that we are sending to NICE and it includes clinical areas that we have not asked the Institute to consider before, specifically the two technology appraisals and clinical guideline on the treatment of drug misuse. This is a matter of growing clinical concern in the UK and it is only right that we ask NICE to provide guidance in this area, as this will have benefits, not just to the NHS, but to the wider society as a whole.
"The rest of the 10th wave focuses on other key issues, treatments for cancer and heart failure for example, which will assist the NHS in continuing to provide clinical and cost effective care to its patients, irrespective of where they live."
The NHS is now required to make drugs available throughout England where NICE advises that they are clinically and cost effective.
Notes to editor
1. Drawing on top experts in each field and consulting widely with patient groups, NICE has produced guidance on 124 pharmaceuticals, 20 procedures, 17 diagnostics, 1 Health Promotion and 106 devices. The majority of NICE appraisals have suggested partial or full use of technologies.
2. For further information, please contact NICE press office: 0207 067 5900
3.NICE also develops clinical guidelines, broader guidance on best care for all aspects of the treatment of specific conditions. Over the next few years NICE will be developing guidelines covering many of the conditions responsible for the greatest burden of ill-health, disability and premature death in the UK. To date NICE has issued 13 guidelines on clinical areas such schizophrenia, chronic heart failure, eating disorders, multiple sclerosis and fertility.
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%). 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 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- 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.
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.
CLINICAL GUIDELINES
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.
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.
Contact Press Officer
Phone Alison Langley
(UK) 020 7210 5649
Press Release from the UK Dept of Health
View drug information on Gliadel Wafer; Iressa; Naltrexone Hydrochloride Tablets.
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