A ROW over a “breakthrough” treatment for diabetes broke out yesterday as it was rejected for NHS use by the Government’s drug watchdog on the grounds that it was not cost effective.

The new product, insulin that is inhaled, could transform the lives of sufferers, who have to inject insulin up to five times a day. However, it costs about £500 a year more per patient.

This latest example of “drug rationing” came as Tony Blair insisted that the NHS was not facing disaster despite thousands of job losses and cutbacks in expensive treatments as a result of a financial squeeze. Mr Blair also defended soaring pay rises for doctors that will see some earn more than £250,000 this year.

The Prime Minister admitted that the NHS was at a “crunch point” but insisted he was still on course for an historic “end to traditional waiting” by 2008.

About 800,000 people in Britain use insulin injections to control symptoms of diabetes, a disease that can have very serious effects. Health experts are giving warning of an explosion in type 2 diabetes of 10 per cent of cases a year as the population becomes fatter and takes less exercise. Inhaled insulin has been heralded as the greatest potential advance in treatment for 80 years.

Simon O’Neill, director of care and policy at Diabetes UK, said: “The Government has put patient choice on the NHS agenda. Diabetes UK is disappointed that the guidance on inhaled insulin does not reflect this as we believe it could offer an alternative treatment in improving the lives of some people with diabetes.

“We believe that new treatments should not be restricted because of costs and greater emphasis should be placed on patient choices and preferences.”

The draft guidance, from the National Institute for Health and Clinical Excellence (NICE) was “perverse and short-sighted”, said Pfizer, the drug company that markets Exubera, the first form of insulin that can be inhaled rather than injected. “NICE must not be allowed to undermine clinicians’ ability to work with their patients to improve management of this debilitating long-term condition,” it said.

Diabetes UK also urged NICE to reconsider the guidance, which is now up for consultation before a final decision is taken. “This is a medical breakthrough and it is the potential first step to improving the lives of some people with diabetes,” the charity said. “It will be unfortunate if people in England have limited access while it becomes available in other countries.”

Ever since the 1920s, diabetic patients have had to inject themselves with insulin, sometimes as often as five times a day, to control the disease. Exubera represents an alternative approach in which insulin in a fine, dry powder form is taken from an inhaler. Pfizer argues that its trials show inhaled insulin to be as effective as injected insulin, and that many people who are developing diabetes are too slow to acknowledge and control it. They do not want to start injecting insulin, but are willing to start inhaling it.

“The choice here is quite simple,” Pfizer said. “Force patients to keep enduring the burden of multiple daily injections, or give them an alternative. In a clinical trial, three times as many patients chose to start on insulin therapy when the inhaled option was made available.”

Kate Lloyd, Medical Director of Pfizer UK, said: “This is a terrible decision. It could deprive clinicians of the opportunity to benefit patients by starting insulin much earlier and cutting future costs of diabetes and its complications including heart disease, amputation, blindness and kidney failure.

“NICE has rejected Exubera on the grounds of cost-effectiveness. But if people aren’t willing to inject, injected insulin can’t be cost-effective either.

“They accept that inhaled insulin might be effective for some patients, but say it is difficult to identify them. We find that desperately concerning. NICE takes the view that because they can’t identify suitable patients, nobody else can.”

In its draft guidance, NICE says that using injected insulin is “not usually a concern for the majority of people with diabetes, given the availability of patient support and education, modern small needle types and insulin pens.” It adds that inhaled insulin would not fully replace the injected form and that people would still need to use needles for measuring glucose levels in the blood.

It accepts that inhaled insulin is as effective as the injected form, and says it would cost just over £1,100 per patient per year, about twice the average cost of injected insulin. Patients might prefer it, but patient preferences were only relevant if they translated into real health benefits. The fact that patients who need insulin are more likely to take it if they can get inhalers “is insufficient to provide support for a cost-effective use of this therapy”.

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