2001/010 - NICE issues guidance on Orlistat for obesity

Press release

NICE 2001/ 010 Issued: 09 March 2001

NICE have today advised the NHS in England and Wales that orlistat should be available as one part of the management of obesity for:

• adults who have lost at least 2.5 kg by diet and increased activity in the month prior to their first prescription and also have either :

o a body mass index (BMI) of 28 kg/m2 or more and have another serious illness which persists despite standard treatment. (E.g. Type 2 diabetes, high blood pressure and/or high cholesterol).

o or a BMI of 30 kg/m2 or more with no associated illnesses

• Therapy should only continue for more than 3 months if the patient has lost at least 5% of their body weight from the start of drug treatment, and similarly it should only continue for more than 6 months, if weight loss has been at least a 10% of body weight. Treatment should not usually continue beyond 12 months, and never beyond 24 months.

Professor Peter Littlejohns, Clinical Director of NICE, said, "Today's guidance is another example of how NICE can help doctors and patients be clear about the value and appropriate use of a new medicine. Obesity has a major impact on a person's physical, social & emotional well-being and future health. Doctors and patients need to work together to manage this condition and today's guidance provides advice on the contribution which orlistat can make"

Ends

Notes for Editors

Background

1. 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.

2. 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.

3. 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.

4. 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

5. Orlistat (Xenical) is a capsule that prevents the absorption of some fat in the intestine. Just under a third of the fat that would otherwise have been absorbed passes straight through the bowel and is excreted in the faeces. As a result it can mean that a person taking orlistat may feel the urgent need to go to the toilet, an increase in the number of times they need to go to the toilet, and when they do go they produce 'fatty stools'. Often they have anal-leakage or oily spotting of their underwear. These effects encourage people taking the drug to limit their fat intake. People taking orlistat may require vitamin supplements because vitamins that are soluble in fat are not properly absorbed when taking orlistat

6. When treatment with orlistat is offered, arrangements should be made for appropriate health professionals to offer specific concomitant advice, support and counselling on diet, physical activity and behavioural strategies.

Current treatments & costs for the NHS

7. 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.

8. The current price of orlistat is £0.49 per capsule. On the recommended dose of 3 capsules per day, the cost per patient would be £537 per year. Total annual drug costs for implementing this guidance in England and Wales are likely to be in the region of £12 million in the first year. This represents an additional £6 million to current drug costs on the basis of approximately an additional 11,000 people being prescribed orlistat. However, if the Institute's guidance is observed strictly, this is likely to be an upper limit on the additional cost.

9. Costs of administering the treatment in England and Wales, including increased visits to GPs, dieticians and/or specialist clinics could be expected to add an estimated 50% to 60% to the drug costs (i.e. between £3 and £4 million on the additional drugs costs compared to present usage).

10. Because of the link between obesity and co-morbidities such as diabetes and cardiovascular disease, the majority of obese people are inclined to be higher than average consumers of primary care resources. The effect of the use of orlistat in off setting this situation in the longer term is impossible to estimate accurately. General Information

11. Copies of the full guidance and supporting documentation will be available on the NICE web site (http://www.nice.org.uk) from 12pm (lunchtime) on Friday 9th March 2001.

12. 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.

13. 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.

14. 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.

15. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and 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.