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26 April, 2006 - 15:29 By Staff Reporter

NHS adviser puts skids under progress of Pfizer- Bespak diabetes inhaler

Plans for the UK roll out of an insulin inhaler that could transform care for diabetes sufferers have hit a major obstacle following a preliminary decision by NHS advisers to not recommend its use in the NHS.

The National Institute for Health and Clinical Excellence (NICE) reached the conclusion that at £1,102 per patient per year, the Exubera inhaler – developed by Pfizer in collaboration with Norfolk’s Bespak and Nektar Therapeutics – was too expensive for the NHS.

Great things have been anticipated from Exubera.

Bespak chief executive, Mark Throdahl, recently said his company was: “increasingly confident in the prospects for growth from Exubera” and Pfizer believed it “will be the most important advance in insulin administration since injections were introduced 80 years ago.”

But while Pfizer and leading British charity, Diabetes UK, have both slammed the NICE recommendation, Bespak has remained silent on the issue despite investing significant money into growing staff and manufacturing capabilities locally to produce the highly anticipated inhaler.

The medical manufacturer’s share price has remained relatively undisturbed by the news, though what kind of effect, if any, the appraisal will have on the expanded Milton Keynes and King’s Lynn premises in terms of jobs remains to be seen.

NICE’s appraisal document concluded that the Exubera inhaler – which has already been approved in the US and in Europe – would only be of benefit to the small minority of diabetes sufferers with needle phobias and that it would only recommend the device’s use in clinical studies.

Pharma giant Pfizer strongly opposed the claim and labelled NICE’s opinion both “perverse and shortsighted.”

In a statement issued by the company it said: “Diabetes is often poorly controlled because many patients delay initiating or increasing insulin treatment due either to fear of injection or to the pain and discomfort they experience as a result of multiple injections. This delay can be as long as four years after insulin should have been started.

“The choice 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.”

Diabetes is a chronic metabolic disorder caused by defects in insulin secretion and action. It is estimated that there are over 2 million people with diabetes in the UK, with around 90,000 newly diagnosed each year. In a clinical trial three times as many patients chose to start on insulin therapy when the inhaled option was made available.

Simon O’Neill, director of care at Diabetes UK, said: “Diabetes UK believes that access to new developments should not be restricted on the basis of cost and should take into account patient choice and preference. This is a medical breakthrough and it is the potential first step to improving the lives of some people with diabetes.”

Dr Kate Lloyd, medical director of Pfizer UK, said: “Rather than allowing the medicine to be used appropriately in clinical practice in order to establish its real world cost-benefit, NICE has concluded that clinicians who have worked in this field for years are incapable of selecting which patients will derive the most benefit from inhaled insulin within their available resources.”

The NICE opinion is not final and its appraisal committee will meet again at the end of May to consider the original evidence with the subsequent consultation process before preparing its final appraisal determination for the NHS.


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