מתוך medicontext.co.il
LONDON (Reuters Health) – Abbott Laboratories Inc.'s anti-obesity drug sibutramine (Reductil/Meridia) was cleared by Britain's cost-effectiveness watchdog on Wednesday.
The National Institute for Clinical Excellence (NICE) said that the drug should be available for adults between the ages of 18 and 65 years who have made serious attempts to lose weight and who have a body mass index (BMI) of 27 coupled with diseases such as diabetes and high cholesterol, or who have a BMI of 30.0 or more.
With about half of the adult population in Britain either overweight or obese, concern has been raised about the financial impact of the new medications. However NICE said estimates by Abbott suggested that even 3 years from launch only 45,100 patients would be taking sibutramine in the UK.
NICE's guidance is similar to its recommendation earlier this year of Roche's obesity drug Xenical (orlistat). However, it stressed that because sibutramine–unlike orlistat–can lead to increases in blood pressure, patients 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," the agency advised.
The guidance adds that patients should only continue with sibutramine for more than 4 weeks if they have lost 2 kg in weight and only beyond 3 months if they have lost at least 5% of their body weight. Treatment was not recommended for more than 12 months.
The document disputes the manufacturer's estimate of the cost of treatment of £10,500 per quality adjusted life year, saying a more realistic may be between £15,000 and £30,000.
Discussing the financial implications for the National Health Service, it says that according to sales data from other countries provided by the manufacturer, only 3% to 3.7% of obese patients receive sibutramine within 3 years of launch.
"The manufacturer's sales forecasts predict that, in the first year of launch, 19,400 patients will receive sibutramine on the National Health Service, resulting in total drug and monitoring costs of approximately £8.4 million," the document states. "It is expected that patient numbers will rise to 45,100 at year 3, resulting in approximate total costs of £19.2 million."
The agency notes that this projection is low compared with the sales experience in countries where the product is already available.
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