New work programme for NICE announced

of 5 New work programme for NICE announced New treatments for prostate cancer, drugs misuse, osteoporosis and heart failure are being referred to the National Institute for Clinical Excellence (NICE), Health Minister Jane Hutt confirmed today. NICE is also being asked to develop clinical guidance on the care and management of osteoarthritis and ADHD. Jane Hutt said: "The programme of work that NICE is going to be undertaking will include new clinical areas that have not been considered by them before. This includes the two technology appraisals and clinical guideline on the treatment of drug misuse. Drug misuse is a growing problem in Wales so it is good news that NICE will be providing guidance in this area. This will bring benefits not just to the NHS but to wider communities across Wales. "The other areas which the 10 th wave will focus on are also of vital importance to us including treatments for cancer and heart failure. This will help the NHS in Wales to provide clinical and cost effective care to its patients regardless of where they live." Notes: The NHS is now required to make drugs available throughout Wales where NICE advises that they are clinically and cost effective. 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. 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

of 5 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

of 5 that could lead to sudden cardiac arrest. Methadone & Bupenorphine as opiate substitutes 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 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

of 5 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. 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 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

of 5 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 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. 16 June 2004