Insulin analogues have been getting a bad press over the past 12 months and the latest revamp of NICE guidelines is expected to outlaw their routine use in type 2 diabetes. This follows a Channel 4 News investigation and subsequent publication in ‘BMJ’ http://bmjopen.bmj.com/content/1/2/e000258.full suggesting savings of more than half a billion GBP over the last 10 years if only human insulin had been prescribed. So why have insulin manufacturers found their position so hard to defend?
The first problem is the nature of the licencing trials, which Pharma companies argue are dictated by regulatory authorities. These are ‘treat-to-target’ studies in which patients on new analogue insulins are compared to those taking human insulin (termed NPH – neutral protamine Hagedorn). Trial participants aggressively titrate their therapy to reach low fasting glucose levels and in the setting of a clinical trial, they are generally able to do this whatever the insulin. The reason for their success is that trial patients are typically fit and well, highly compliant with treatment, have close expert supervision and within the relatively short time window of a study (usually 24 weeks) are willing to tolerate episodes of hypoglycaemia. So, a superior insulin in this setting usually demonstrates equivalent reduction in HbA1c but with fewer hypos…
The second issue is the nature of the hypo events which, although increased (especially at night), are typically ‘mild’, requiring no third party intervention, hospitalisation etc. This means that in a health economic analysis, they have no cost.
So, although there is little dispute that analogue insulins have clinical advantages, trials showing equivalent HbA1c reductions with cost-neutral side-effects cut no ice with payers looking to radically trim budgets….
Professor Steve Bain