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Collagenase for Dupuytren's contracture: Added benefit not proven
Date:7/12/2012

Collagenase extracted from Clostridium histolyticum (trade name: Xiapex) was approved in the beginning of 2011 for the treatment of people with Dupuytren's contracture. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether collagenase offers an added benefit in comparison with conventional regimens. However, such an added benefit cannot be inferred from the dossier, as the drug manufacturer presented either no data or unsuitable data.

Collagenase is to break down thickened connective tissue fibres

Dupuytren's contracture is a disorder of the hand in which connective tissue fibres in the palmar side of the hand (fasciae) thicken and harden. As a result, one or several fingers become permanently bent and can no longer be straightened. Collagenase is injected into the lesions to break down the thickened connective tissue fibres. One day later, the rupture of these fibres through passive digital extension is attempted in order to restore the stretching ability of the affected finger.

G-BA specifies different comparator therapies depending on disease stage

When specifying the appropriate comparator therapy, the Federal Joint Committee (G-BA) assumed that the choice of (conventional) treatment depends on how severely the function of the fingers and hand is impaired.

Hence, the G-BA stipulates four treatment alternatives and assigns them to different disease stages. The appropriate comparator therapies are specified as follows:

  • no treatment" in stage N, where no contracture yet exists;
  • percutaneous needle fasciotomy" (PNF), a minimally invasive technique, in stages N/I, I and II;
  • partial fasciectomy" (PF), open surgery of the hand, in stages III and IV.

If PF is not suitable for advanced-stage patients, a PNF can be p
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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