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Pfizer scathing at NICE Exubera decision

Cost effectiveness body says inhaled insulin drug does not offer 'sufficient benefits'

In a preliminary opinion, the National Institute for Health and Clinical Excellence (NICE) has recommended that Pfizer's inhaled insulin drug, Exubera, should not be prescribed on the UK National Health Service (NHS).

The UK watchdog, whose function is to assess whether treatments are cost effective for the NHS, said Exubera did not offer sufficient benefits over conventional insulin injections to be worth the estimated cost of £1,102 per patient per year.

The NICE appraisal committee said that while the price might be justified for patients with severe fear of injections, there was no way of identifying those who would gain sufficient benefit for the drug to be cost effective.

ìOur 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,î said Andrea Sutcliffe, the panel's deputy chief executive.

A Pfizer spokeswoman told PMLive the firm was ìoutragedî by the decision, describing it as ìperverse and short-sightedî. The firm dismissed suggestions that Exubera's benefits were limited to increased convenience, arguing that the drug can help improve patient compliance as well as reduce illnesses associated with the poor control of the condition.

ìWe have sent NICE comprehensive information and they seem to have come back with an opinion that is not based on any data,î said the Pfizer spokeswoman. ìWe will be putting a strong rebuttal in but it is difficult as we're not really sure what NICE's decision is based on.î

In a statement, the US firm said the ruling would deprive patients of the first alternative to insulin injections since the 1920s.

ìRather 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,î said Pfizer medical director, Dr Kate Lloyd.

Exubera won marketing approval in both Europe and the US as the world's first inhaled treatment for patients with type 1 or type 2 diabetes.

Exubera is one of six drugs Pfizer hopes to launch in 2006 and with projected peak annual sales of $1bn, it is seen as a key one.

NICE said it would issue its final guidance on Exubera in October.

30th September 2008


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