Pfizer vows to fight ‘perverse and short-sighted decision’ on Exubera
pharmafile | April 24, 2006 | News story | Research and Development |
Exubera, the world's first inhaled insulin, has failed to gain NICE approval after manufacturer Pfizer couldnt convince the Institute of its cost effectiveness.
The UK clinical and cost effectiveness body said data submitted failed to show sufficient benefits for the product, which Pfizer plans to price between 956 pounds and 1,245 pounds per patient per year, more than double the estimated annual cost of 400 pounds for injected insulin.
NICE has published its preliminary decision ahead of the product's launch – a new early appraisal system intended to clear up confusion among NHS prescribers.
NHS trusts and prescribers commonly have to wait 18 months after a product is launched before receiving NICE guidance, but the decision may scupper Exubera before it even reaches the market.
The UK industry has always maintained that products need time to prove their clinical and cost efficacy through fast access to markets, but NICE says Exubera needs much more clinical data to demonstrate its value.
Pfizer UK says the decision is 'perverse and short-sighted' and has called on NICE to change its views on the drug, which it says will benefit patients and save the health service money.
"Inhaled insulin has been developed for use by diabetologists who are experts in treating this condition and in understanding the needs of their patients," said Dr Kate Lloyd, medical director of Pfizer UK.
"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."
Dr Olivier Brandicourt, managing director of Pfizer UK, said Exubera's rejection represented a call to action for anyone who wanted to see patients benefit from innovative new medicines.
He said: "Everyone with a role in treating this disease, its terrible complications and its enormous human and economic consequences should speak out against what this draft guidance represents – an attempt to deny patients access to new medicines that have the potential to improve countless lives."
Charity Diabetes UK also urged a re-think, asking NICE to take more account of the patients' perspective and meet individual needs and preferences.
"This is a medical breakthrough and it is the potential first step to improving the lives of some people with diabetes," said Simon O'Neill, director of care at the charity.
"It will be unfortunate if people in England have limited access whilst it becomes available in other countries."
In its detailed appraisal of Exubera, NICE's expert committee indicated that Pfizer had failed to prove the case for use in patients with type I or type II diabetes, identifying what it saw as numerous shortcomings in the clinical data.
It said none of the studies compared inhaled insulin with continuous subcutaneous infusion or rapid-acting insulin analogues, two of the most significant alternatives. NICE added that most of the studies gave little or no detail of patients recruited, and had a large number of exclusion criteria.
Pfizer argues that the NHS spends around 5 billion pounds a year on complications from uncontrolled diabetes, including renal failure, blindness and amputation.
The company had selected the UK as the first country in Europe in which to launch Exubera, which analysts have forecast could reach peak sales in excess of $1 billion globally.
A consultation period on NICE's decision lasts until 10 May, after which a final ruling could be made in October.
