Hundreds of thousands of people with diabetes will have to continue to inject themselves with insulin up to five times a day after the National Institute for Clinical Excellence ruled out a new insulin inhaler. In draft guidance yesterday, the health watchdog Nice, which rules on the clinical and cost-effectiveness of drugs, said it did not believe the benefits of using an inhaler to deliver insulin was worth the £1,102 annual cost. Injected insulin costs about £300 a year.
Nice acknowledged that a "small group" of patients were so scared of needles they could benefit, but said it was not possible to separate needle-phobes from those who simply had a preference. It also said most of the 800,000 people who injected insulin would still need daily injections, and that all would have to use needles each day to test for glucose.
The preliminary judgment - which could be overturned before a final decision in October - was condemned by diabetes campaigners, who view the inhaler, marketed as Exubera, as the biggest step forward in treatment since the discovery of insulin in 1923.
The patients' group Diabetes UK said Exubera was a "medical breakthrough" but Nice's decision seemed "to have been driven by cost". Simon O'Neill, the charity's director of care, said: "We would like to urge Nice to reconsider its recommendations to take more account of the patients' perspective and meet individual needs and preferences."
He said adults who had the more common type-2 diabetes, as opposed to type-1 usually diagnosed in childhood, were often so fearful of injections they put off moving off insulin tablets, which lose their effectiveness, for years.
Exubera, manufactured by Pfizer, is a rapid-acting dry powder form of insulin inhaled before meals through a handheld device similar to an asthma inhaler.
People with type-1 diabetes would still have a daily injection of insulin, but three to four "top-up" shots a day could be replaced by the inhaler. People with type-2 diabetes could use only an inhaler.
The treatment has been licensed by the European Medicines Evaluation Agency, but the licence restricts children, pregnant women, smokers or those with poorly controlled asthma from taking the drug.
About 40% of the 800,000 people who inject are thought to suit an inhaler, but that figure looks set to rise. There are an estimated 2 million diabetics in the UK , but the figure is expected to increase to 3 million by 2010.
Andrea Sutcliffe, Nice's deputy chief executive, said: "Our review of the evidence indicated that inhaled insulin should not be recommended for the diabetic (type 1 or type 2) population as a whole because it could not be proven to be more clinically or cost effective than existing treatments."
Pfizer called the decision "perverse and short-sighted. The choice here is quite simple: force patients to keep enduring the burden of multiple daily injections and poor compliance, as they have since the 1920s, or give them an alternative."
Tony Barnett, professor of medicine at Birmingham University, who conducted two trials on Exubera for Pfizer, said that for those patients who refused to inject five times a day, the treatment was "a fantastic advance.
"I can't comprehend how Nice could say no to everyone. This is not a safety issue. This is pure economics," he said.
