Upadacitinib (7) – Rinvoq®

• Clinical trials
  • The pharmaceutical manufacturer submitted a dossier in due time on 24 April 2023 in accordance with Section 4(3)(2) of the Medicinal Products Benefits Assessment Regulation (AM-NutzenV) in conjunction with Chapter 5, Chapter § 8(1)(2) of the G-BA’s Rules of Procedure (VerfO) concerning the active ingredient upadacitinib with the new indication “RINVOQ is indicated for the treatment of moderate to severe active Crohn’s disease in adult patients who have had an inadequate response to, have lost response to, or have been unable to tolerate conventional therapy or a biologic.”

a) Adults with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy, have lost response to it, or have been unable to tolerate it

• An additional benefit is not proven.
• For adult patients with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy or a biologic, no longer respond to it or have been unable to tolerate it, there are no direct comparative studies of upadacitinib against the appropriate comparator therapy.
• Consequently, there are no data relevant to the benefit assessment of upadacitinib.

b) Adults with moderate to severe active Crohn’s disease who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), have lost response to it or have been unable to tolerate it

• The additional benefit is not proven.
• For adult patients with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy or to a biologic, no longer respond to it, or have been unable to tolerate it, there are no direct comparative studies of upadacitinib against the appropriate comparator therapy.
• Consequently, there are no data relevant to the benefit assessment of upadacitinib.

Courtesy translation only, please refer to the German original.