[A20-45] Naldemedine (opioid-induced constipation) - Benefit assessment according to §35a Social Code Book V

Last updated 17.08.2020

Project no.:

Commission awarded on 12.05.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:
Digestion, metabolism and hormones


Adults with opioid-induced constipation who have previously been treated with a laxative

Result of dossier assessment:

Added benefit not proven for either of both research questions (further laxative not subject to medical prescription or prescribable medical device still [RQ1] or no longer [RQ2] an option).


After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

05.11.2020 A G-BA decision was published.

G-BA documents on this decision


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