Diabetics in the UK hoping to get some relief from the daily insulin injections required to manage their blood sugar levels with a new inhaled formulation of the drug look set to be disappointed.
The National Institute of Health and Clinical Excellence (NICE), which decides which drugs can be prescribed on the UK National Health Service on cost-effectiveness grounds, has decided not to endorse Pfizer’s inhaled insulin Exubera in a preliminary ruling.
The decision echoes the view - expressed by analysts at the Bruckner Group in February - that Exubera could be a disappointment for Pfizer because of resistance from healthcare payers that are now firmly-focused on evidence-based medicine in their decision-making.
They suggested that there is a major discrepancy between Exubera’s clinical and marketing profile and revenue expectations of more than $1 billion at peak, as payers are simply not prepared to fork out a premium for products that provide increased convenience for patients.
Pfizer has always argued that Exubera’s benefits go way beyond increased convenience, claiming that the by-product of this will be increased patient compliance with treatment, and a reduction in the burden of illnesses associated with poor control of blood sugar in diabetics, such as heart disease, amputation, blindness and kidney failure.
“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,” said Pfizer in a statement.
This poor compliance, it continues, means that diabetes and its complications cost the NHS a phenomenal sum, estimated at £158 every second. Clinical trials have shown that patients were three times more likely to start insulin therapy if an inhaled option was available, according to Pfizer, citing data from a study published in the February 2005 issue of Diabetes Care.
The problem for Pfizer is that it has no data to prove that making inhaled insulin available can lead to a reduction in diabetes-related costs. The NICE preliminary report concludes that this sort of information should be provided through clinical trials, but the drugmaker argues that this should be provided by allowing Exubera to be used in clinical practice, thereby establishing 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,” said Dr Kate Lloyd, medical director of Pfizer UK Ltd.
Exubera was the first non-injectable formulation of insulin to be approved for marketing in the USA and Europe, and is delivered via a hand-held inhaler. It is designed to be used in place of short-acting insulin injections before meals in patients with both type 1 and type 2 diabetes. Most patients will still have to use a long-acting injectable insulin to provide background cover, but Exubera can cut the overall number of injections they need to control their blood sugar each day.
