The Institute prepares guidance on good clinical practice for the NHS to ensure access to effective care for people in England and Wales. Our recommendations are considered and objective and take account of the patient's perspective as well the views of professionals who care for them.
Sibutramine is a licensed medicine for obesity. The Medicines Control Agency (MCA) licence medicines in the UK on the basis of their safety and efficacy. The MCA's advice is available to NICE and prescribers.
Andrew Dillon Chief Executive of NICE said: The Institute considers that sibutramine has a place in has a role in treating obesity. We reached this conclusion after an extensive review of the evidence and following widespread consultation, involving organisations that speak for people with the condition and those that represent the doctors who treat them. This drug is not a cure for the condition but some patients will benefit. Since the treatment is both clinically and cost effective, patients should not be denied access to it.
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Notes for Editors:
The Nice Guidance
1. Copies of the full guidance and supporting documentation have been available on the NICE web site (www.nice.org.uk) from midday on Wednesday 17 October 2001.
2. NICE advised the NHS in England and Wales that sibutramine should be available as one part of an overall treatment plan for the management of obesity for people aged 18-65 years who have made serious attempts to lose weight by dieting, exercise and/or other changes in their behaviour, and who:
- have a body mass index (BMI) of 27.0 kg/m2 or more as well as other significant diseases (e.g. Type 2 diabetes, high cholesterol).
- or have a BMI of 30.0 kg/m2 or more.
When people are prescribed sibutramine they should also be offered advice, support and counselling on diet, exercise and behaviour changes.
- Sibutramine should be prescribed in accordance with the summary of Product Characteristics (in effect the license)
- People taking sibutramine should only continue with treatment for more than 4 weeks if they have lost 2 kg in weight. People should only continue on this treatment beyond 3 months if they have lost at least 5% (5kg for each 100kg) of their body weight from the start of the drug treatment. Sibutramine should be stopped if patients do not lose weight as described. Treatment is not recommended for more than 12 months. •
- Because sibutramine can lead to increases in blood pressure, people taking it should have their blood pressure checked regularly. Increases in blood pressure should be considered carefully, and may be a reason to stop treatment. Sibutramine is not recommended for patients who already have high blood pressure (145/90 or above).
Background
3. Obesity is defined as a Body Mass Index (BMI) of 30 kg/m2 or more. BMI is calculated by dividing your weight in kg by your height in metres squared. (‘Overweight' is defined as a BMI between 25 and 30 kg/m2.) For example a BMI of 30 represents about 3 stone of excess weight.
4. In 1980, 6 out of 100 adult males and 8 out of 100 of adult females in England were obese. By 1998, this had increased to 17 out of 100 adult males and 21 out of 100 of adult females. Similar increases have occurred in Wales. Currently about half of the adult population is overweight or obese.
5. During the 20 years from 1980, self reported calorie intake has changed little. However the change to a lower proportion of carbohydrates and a higher proportion of fats may have altered perception of food intake, particularly with the increase in food consumed outside the home. People are also now using less energy.
6. Obesity has a major impact on a person's physical, social and emotional well-being. Besides this, obesity can lead to an increased chance of illness including type 2 diabetes and high blood pressure (hypertension) that can that can lead to other cardiovascular diseases and stroke. Obesity can also play a role in cancer, problems with sexual-function, mental health, muscle and bone disorders and psychological problems.
The technology
7. Some other drugs for obesity, which work by changing the way the stomach or intestines (gut) work and absorb fats, sibutramine (Reductil) works in the brain by altering the chemical messages that control how the person taking it feels and thinks about food. It mainly affects two chemicals called noradrenaline and serotonin and promotes a feeling of being full or having eaten enough.
8. Sibutramine causes increases in the blood pressure of some of the people who take it. Therefore people who are prescribed sibutramine must have their blood pressure checked before they take it and at other times during treatment.
9. There is no evidence to show that prescribing sibutramine with other drugs used to treat obesity has any benefits for the person with obesity Current treatments and costs to the NHS
10. Currently, treatment options for obesity include dietary advice, behavioural modification and exercise. Surgery to restrict the size of the stomach is occasionally used as a last resort. Direct NHS costs in 1998 for the treatment of obesity have been estimated to be £50 million per year, while the indirect costs of treating co-morbidities (such as diabetes and cardiovascular disease) amount to a further estimated £1,700 to £1,900 million, between 3.5% and 4% of all NHS expenditure.
11. The manufacturers of sibutramine predict that, in the first year of launch (2001), 19,400 patients will receive sibutramine on the NHS, resulting in total costs (drug and monitoring costs) of approximately £8.4 million. It is expected that the number of patients receiving sibutramine will rise to 45,100 after 3 years. This figure represents 0.6% of the population of adults in England and Wales who are obese. This would result in approximate total costs (drug and monitoring costs) of £19.2 million after 3 years. The amounts estimated above are additional to current NHS spending for obesity.
Associated NICE guidance
12. In March 2001 NICE recommended that the a drug called orlistat should be available as one part of the management of obesity in adults. This guidance can be accessed on the NICE websites at www.nice.org.uk, or through the NHS Response Line on 0870 1555 455, ref: 23358.
13. The Institute is currently undertaking an appraisal of surgical treatment for people with morbid obesity. The final appraisal meeting is scheduled for April 2002. Please see www.nice.org.uk for further details of the scheduled timetable. General Information
14. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
15. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
16. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
17. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales.
18. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.
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