No proof of any added benefit. This is the conclusion that the German Institute for Quality and Efficiency in Healthcare (IQWiG) has drawn regarding the use of rapid-acting insulin analogues in children and adolescents with type 1 diabetes. There are assurances, however, that these types of insulin will continue to be covered by public health insurance companies. Can the new government act towards this? You can help.

On the 16th November, 2009, the IQWiG issued its final statement on the use of rapid-acting insulin analogues in children and adolescents with type 1 diabetes. The anticipated and feared conclusion: The IQWiG can find no proof of additional benefit in the use of insulin analogues over human insulin*. The IQWiG also came to this conclusion in 2007, whereby the German Federal Joint Committee (G-BA) wanted to exclude rapid-acting insulin analogues from the list of treatments eligible to be reimbursed by the public health insurance.

The BMG takes action
In May 2008, the Ministry of Health (BMG) informed the G-BA that, despite the report, children and adolescents with type 1 diabetes would still receive cover for the use of rapid-acting analogues until the age of 18. Changing all children from rapid-acting analogues to human insulin would pose an undue added burden on the families.

This decision was made due to public reaction—the BMG had been presented with a petition containing over 4000 signatures of parents from all over the country, and had witnessed a major demonstration that had taken place in March right in front of the Ministry.   

IQWiG reaches same conclusion in 2009 as in 2007
Against all pleas from renowned paediatric diabetologists, the IQWiG’s stance in 2009 could not be changed. Several comments were made that the procedures that were used in the analysis differ from those used in other health technology assessments and appear not to follow international standards.

For example, the English National Institute of Clinical Excellence (NICE), at www.nice.org, recommend the use of rapid-acting insulin analogues and pumps in the therapy of children with type 1 diabetes on the basis of their proven therapeutical benefits. In the recently published evidence-based paediatric diabetes guidelines (to be found under www.diabetesde.org), thorough scientific studies have been presented that prove otherwise. Strangely, they were not referred to in the IQWiG’s report.  

Assurances create hope
But there is still hope! There have been reports from the petitions committee to insure that rapid-acting insulin analogues will continue to receive insurance coverage. On the 9th September 2009, the former State Secretary to the Minister of Health, Dr Klaus Theo Schröder, stated that the issue of an undue burden on the families remains a concern and needs to be addressed when the G-BA looked into the issue once again.

What about the parents?
Now we ask the parents to get involved in making sure the new government understands the importance of this situation. If, in January, the G-BA reaches a new decision, the sustainability of any previous decisions must be requisitioned. 

The benefits of insulin analogues

The statistics in Germany speak strongly for the use of analogues:

• More than half of the 25 000 children and adolescents with diabetes use rapid-acting insulin analogues. Should these now have to change to normal insulin?
• Around one-third of these children wear pumps. Rapid-acting insulin analogues are used with pumps as they make for easier metabolic adjustment. The German Health Report 2010, issued by diabetesDE, stated that pump therapy is now the preferred form of treatment in very young people with diabetes, with 52% of all diabetes patients under the age of five in 2008 now wearing pumps. If these difficult-to-treat kids had to change their therapy, what would be the result?

Already today we are seeing the effects of what happens in adults when the range of insurance cover is reduced. Around two-thirds of privately insured patients use rapid-acting insulin analogues as opposed to only one-third of publicly insured patients. And, whereas in Sweden 91% of diabetic patients were using rapid-acting insulin analogues in 2006, in Germany this figure is less than half.  

Contact your local MP
Diabetes treatment for children is constantly being developed. One just needs to think of the recent advances in the development of glucose sensors. This is why it is about time that the politicians are made aware of the special needs of children with diabetes.

Many paediatric diabetologists recommend, therefore, annual end-of-year meetings with their regional members of parliament to inform them as to the advantages of rapid-acting insulin analogue use in children or, for example, why insulin pumps are so essential in the treating small children with type 1 diabetes. And remember: The more attention this issue receives, the more likely we are to succeed.

What about Minister Rösler?
What would Dr. Rösler, the new national Minister of Health and father of two small children, do? We recall well his inspiring visit at the Children's Hospital auf der Bult in Hanover, where he showed great sensibility in relating to sick children. In understanding the needs of children with diabetes and acting on their behalf, however, he is sure to need your help.

All documents relating to the ongoing discussion can be found on the German website www.diabetes-eltern-journal.de. In order to locate your regional MP, go to bundestag.de. On this internet site, you can find a list of MPs with their contact details and appointments. Consulting hours are published in the local newspapers.

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Prof. Thomas Danne, MD
Diabetes Centre for Children and Adolescents
Kinderkrankenhaus auf der Bult
Hannover, Germany