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Xenical gains approval from the National Institute for Clinical Excellence (NICE) in UK

Basel, 9 March 2001

Today, the UK's NICE has announced its decision to recommend that Roche's weight management treatment, Xenical (orlistat), remains reimbursed by the National Health Service (NHS) for weight management in overweight and obese patients. This reconfirmation is a landmark decision, highlighting the importance the UK is placing on treating excess weight as a serious medical condition, and recognising the epidemic that excess weight has now become.

Xenical is a unique weight management treatment, that acts locally by preventing fat being absorbed in the gut. Xenical not only helps patients lose weight, it also encourages more healthy eating habits, so helping them maintain their weight loss.

Worldwide, it is estimated that 100 million people are clinically overweight, with the annual number rising so fast that the World Health Organization (WHO) recently declared that obesity had become a global epidemic. Such an epidemic poses a serious threat to public health due to the increased risk of associated health problems, including type 2 diabetes, coronary heart disease and hypertension. In the UK alone, one in two people are overweight and about 20 percent of the population are clinically obese. In addition, four out of five patients suffering from diabetes are overweight.

In terms of cost, a recent report by the National Audit Office in England, has estimated that the direct and indirect costs of obesity cost the UK at least £2.5 billion a year. Using data from developed countries such as the Netherlands, France, the USA, Australia and Sweden, conservative estimates suggest the cost of obesity in these markets is between 3-8% of total health care expenditure.

Commenting on today's decision, Professor Aila Rissanen, Obesity Research Unit, Helsinki University Central Hospital, Finland, said: "As the number of people who are overweight or obese continues to soar, it is imperative that we do something to address the significant burden that this will inevitably cause our local healthcare systems. Countries around the world should take the lead from today's ground-breaking UK decision, and take a more proactive stance in the battle against excess weight."

Since its UK launch in September 1998, Xenical has been available on the NHS. Today's decision will mean that patients in the UK will continue to benefit from reimbursed treatment with Xenical, Roche's breakthrough weight management treatment.

A five percent reduction in weight can result in significant health care improvements, which in turn can translate into a reduced burden on healthcare systems. Studies with Xenical have demonstrated that twice as many patients taking Xenical achieve ten percent weight loss compared to with diet alone. In overweight and obese patients who also suffer from type 2 diabetes, its use is associated with significant improvements in blood sugar control. Additional data have also shown that Xenical can improve risk factors for cardiovascular disease, such as serum lipid profiles and blood pressure.

Speaking on behalf of Roche, Dr Paul Brown, Lifecycle Leader for Xenical commented, "Today's announcement is a milestone in recognising that obesity is a serious issue that must be tackled. I am delighted that NICE have acknowledged the severity of this condition, and that they have endorsed the use of Xenical as an effective weight management treatment in this appraisal. Recommending the use of Xenical in patients who are overweight or obese recognises the value Xenical can have, both in terms of managing excess weight and in reducing the co-morbidities associated with this condition."

About Xenical

Xenical is a breakthrough in weight management treatment. It is an effective and safe therapy which not only helps patients lose weight, but also helps them maintain their weight loss. It is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by about 30 percent. Xenical is well tolerated and unlike other weight loss medications it does not act on the central nervous system. In clinical trials, people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Since it was first marketed in 1998, there have been more than 8.5 million patient treatments with Xenical worldwide.

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people’s well being and quality of life.

Editor's notes

The National Institute for Clinical Excellence was established in the UK in April 1999 in order to provide patients, health professionals and the public with authoritative, robust and reliable guidance on current 'best practice'. As part of NICE's ongoing review of individual health technologies (including medicines, medical devices, diagnostic techniques and procedures), it has just completed a review of the use of Xenical (orlistat) in managing overweight and obese patients in the UK. Guidance from NICE is also used to advise the UK government on what interventions and procedures should be provided free to the general population (in England and Wales), via funding from the National Health Service.

References:
  1. World Health Organization, Obesity: Preventing and Managing the Global Epidemic, Geneva, 3-5 June 1997.
  2. Department of Health: Health Survey for England; Report 1998.
  3. National Audit Office, UK: Tackling Obesity in England. Report by the Comptroller and auditor general, HC 220, Session 2000-2001; 15 February 2001.
  4. The Lancet, 8th August 1997
  5. Goldstein DJ. Beneficial health effects of modest weight loss. International Journal of Obesity, 1992, 16:397-415.
  6. Kelley D, Effect of orlistat in overweight type 2 diabetic patients receiving insulin. Roche Satellite Symposium Abstract book;18. International Diabetes Federation Congress, Mexico City, November 5 – 10, 2000.
  7. Hollander PA et al. Diabetes Care 1998, 21: 1288-94.
  8. Miles J, Role of orlistat (Xenical) in overweight metformin-treated type 2 diabetes patients. Roche Satellite Symposium Abstract book; 11-12. 17th International Diabetes Federation Congress, Mexico City, November 5 – 10, 2000.

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