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Row breaks out over German funding of short acting diabetes treatment

BMJ 2006; 332 doi: http://dx.doi.org/10.1136/bmj.332.7546.874-c (Published 13 April 2006) Cite this as: BMJ 2006;332:874
  1. Annette Tuffs
  1. Heidelberg

    The German independent Institute for Quality and Economic Efficiency in Health Care has come under fire from doctors, patients, politicians, and the drugs industry for questioning the use of short acting insulin analogues for late onset (type 2) diabetes. The institute is Germany's equivalent of the National Institute for Health and Clinical Excellence (NICE) in England.

    Following the institute's report, a federal committee has announced that it intends to forbid health insurance companies from paying for costly short acting insulin analogues rather than insulin.

    No other institution in Europe has published recommendations on the use of these drugs, but NICE published recommendations on long acting insulin in December 2002 (www.nice.org.uk/page.aspx?o=43424).

    The institute was commissioned by the German Federal Joint Committee of doctors, health insurance companies, and patients, to study three different types of short acting insulin analogues available in Germany. The institute was founded in August 2004 to research diagnosis and treatment of selected diseases and to provide expertise on quality and economic efficiency (BMJ 2004;329:307).

    The institute analysed seven controlled trials, with a minimum duration of 24 weeks. None found any evidence, however, that short acting insulin analogues have additional benefits, such as patients' satisfaction and quality of life. No relevant parameters in the trials, such as risk of hypoglycaemia, had significant results, and the designs of the studies had serious faults.

    Glycaemic control was no better with short acting insulin analogues than with human insulin. And the studies did not rule out a carcinogenic effect after long term application (www.iqwig.de).

    The German Association of Research Based Pharmaceutical Companies in Berlin has criticised the institute's report, saying that it was too theoretical.

    “Important aspects and information have been dismissed,” said Ulrich Vorderwülbecke, one of the association's managers. He claimed that only 0.7% of the available data was used and that the institute was merely providing support for healthcare cuts.

    The association also quoted a study that it commissioned from Bengt Jönsson, of the Stockholm School of Economics, which compared the methods of drug benefit analyses in Sweden, the United Kingdom, and Germany.

    That study stated that the Swedish Pharmaceutical Benefit Board as well as NICE based their recommendations not only on randomised clinical trials but on other trials as well, which gave a better representation of the situation (www.vfa.de/de/politik/artikelpo/public_nutzenbewertung).

    Peter Sawicki, the head of the institute, said that he was not impressed by the massive public criticism. Attacks were commonly used to discredit the work of similar institutions, he said, pointing out that truly independent scientists and doctors had not criticised the recommendations.

    “In fact, the institute does include non-randomised trials in the evaluation of products and procedures, and we have considered non-randomised trials during the hearing. However, these trials were of poor quality and did not show additional benefit for short acting insulin analogues. The Swedish study by Jönsson is criticising that we do not take the economical aspects into account,” said Professor Sawicki.

    “However, unlike the other two institutes, by German law we are not allowed to look at the cost efficiency ratio of drugs, as we do for medical procedures. Only the joint committee can analyse this aspect. The institutes' sole task is to determine the patient relevant benefit on the basis of clinical trials.”

    A final decision by the joint committee is expected for June 2006.