Collagenase aus Clostridium histolyticum (1) – Xiapex®

a) Dupuytren’s contracture, stage N according to Tubiana (palpable nodules or cords, no contracture)

• As the required evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).

b) Dupuytren’s contracture, stages N/I, I and II according to Tubiana (contracture ≤ 90°)

• As the required evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, SGB V).

c) Dupuytren’s contracture, stages III and IV according to Tubiana (contracture > 90°)

• The additional benefit is not proven.
• In particular, the indirect comparisons submitted by the pharmaceutical manufacturer in the dossier were not suitable for providing proof of a benefit due to the absence of a bridge comparator.

d) Dupuytren’s contracture, stages III and IV according to Tubiana (contracture > 90°) with contraindications for partial fasciectomy

• As the required evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code).

Courtesy translation only, please refer to the German original.