Reviews and reports

IQWiG: Rapid-acting analogues are not superior to ‘human’ insulin for Type 1 diabetes

June 2007

Report from the Institute for Quality and Efficiency in Health Care [IQWIG]
Yet again we are reliant on Germany for another review that helps to inform our decisions about insulin treatment. Unlike the UK where the Dept of Health has refused our lobbying request for a National Institute of Clinical Excellence [NICE] assessment of all insulins, the German Federal Joint Committee actually commissioned IQWiG to compare the benefit of rapid-acting insulin analogues versus human insulin for Type 1 diabetes. So one has to wonder why this doesn’t happen in the UK?

The insulins investigated were, Humalog [lispro], NovoRapid [aspart] and Apidra [glulisine].

What did the review find?

Adults – there is currently no evidence available to demonstrate a superiority of rapid-acting insulin analogues in the treatment of adults with Type 1 diabetes. The value of the evidence and design of studies so far are inadequate and do not allow conclusions regarding most important patient goals, such as the reduction in long-term complications or overall mortality.

Children and adolescents – due to lack of data, the benefit of rapid-acting insulin analogues in children and adolescents is unclear [an uncertainty!]. Novo Nordisk has carried out long-term comparative studies in this group of patients but they are withholding some of the results.

Pump therapy – no long-term studies were available therefore it remains unclear whether adults would benefit and what advantage patients would have by using analogues with insulin pumps [an uncertainty!]. The same applies to children and adolescents as only fully published short-term studies are available. Novo Nordisk sponsored 2 long-term studies in children and adolescents but to date, both studies have only been partially published and unlike Sanofi-Aventis and Lilly, Novo Nordisk were not prepared to provide the information needed for the review.

Quality of life, not a fair comparison – in some studies patients treated with insulin analogues assessed their quality of life as higher and they were more satisfied with treatment than those using human insulin. IQWiG did not evaluate this finding as evidence of an additional benefit, because it was not based on a fair comparison – patients in the human insulin group were asked to adhere to a fixed injection-meal regimes but the analogue group were not. [As we know, it is quite possible to use a flexible regime with all types of insulin.] So it is unclear whether the patient satisfaction was due to the insulin or to the more flexible regime prescribed by the physicians.

What conclusions can be drawn from this?
Basically it is simple, there is no evidence that rapid-acting insulins are any better than human insulins for adults with type 1 diabetes. It is unclear whether they are of any benefit to children and adolescents. It is also unclear whether they are of benefit any groups of pump users. They are, of course, significantly more expensive to the NHS! So once more, we this review raises big questions:

  • Why is the Dept of Health so unwilling to follow Germany’s lead and have all insulins assessed by NICE for risks/benefits and cost effectiveness?
  • Why are Primary Care Trusts that are so obviously short of funds, spending unnecessary amounts on insulin analogues that have no proven benefits over less expensive human and animal insulins?
  • Why are adults and children with diabetes being changed to insulin analogues when they have no proven benefit?
  • Could all this be anything to do with heavy marketing of insulin analogues because they are the only insulins in patent, therefore more expensive and more profitable?