The UK’s clinical cost effectiveness watchdog has ruled that only patients who suffer from a proven phobia about needles should be eligible for treatment with Exubera, Pfizer’s recently licensed inhaled insulin for diabetes.

The latest ruling from the National Institute for Health and Clinical Excellence (NICE) represents a relaxation of its earlier tough stance on the issue, first issued in April, at which it proposed a blanket ban on prescriptions for the product under the National Health Service on the grounds that Pfizer had no data to support its hypothesis that using Exubera would increase treatment compliance among diabetics, and reduce the overall cost of managing the disease.

The drugmaker believes that Exubera could be given to diabetics earlier in the course of their disease, reducing their chances of going on to develop costly complications such as nerve and eye damage and cardiovascular disease.

But in its second appraisal consultation document, the NICE suggests that Exubera should only be used in patients with seriously uncontrolled blood glucose (haemoglobin A1c level of more than 9%) and either “a proven injection phobia diagnosed by a psychiatrist or psychologist, or severe persistent problems with injection sites.”

The Institute also estimates that the average annual cost of delivering Exubera treatment would be around £1,102 per patient, almost twice the cost of injectable-only insulin therapy. Around 800,000 diabetics in the UK use insulin injections to control their blood sugar levels.

Industry observers say the decision reinforces the view that Exubera may not live up to its lofty sales projections of $1 billion or more a year, because healthcare payers are increasingly unlikely to endorse the use of new drugs that have no evidence to support their increased clinical benefits over established therapies, even if they are more convenient for patients.

A final decision from the NICE is expected in October.

- Meanwhile, the NICE has arranged a public hearing on July 13 to 14 to listen to five appeals raised as a result of its controversial decision to limit prescribing of four drugs approved to treat Alzheimer’s disease.

The Institute's initial proposal, unveiled in March last year, to reject the use of Pfizer and Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine), Shire's Reminyl (galantamine) and Lundbeck's Ebixa (memantine), on the basis that they would not be cost effective for use under the NHS, was widely criticised, and it has since relented and said patients severe but not mild disease should be eligible for treatment.