Upadacitinib (7) – Rinvoq®
Morbus Crohn, pretreated
Characteristics
| Start date | 01.05.2023 – Marketing authorisation: 12.04.2023 |
|---|---|
| Resolution | 19.10.2023 |
| INN | Upadacitinib |
| Brand name | Rinvoq® |
| Pharm. company | AbbVie Deutschland GmbH & Co. KG |
| G-BA Procedure ID | D-926 |
| ATC code | L04AF03 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | K50.0Crohn´s disease of small intestine, K50.1Crohn´s disease of large intestine, K50.80Crohn´s disease of both small and large intestine without complications, K50.81Crohn´s disease of both small and large intestine with rectal bleeding, K50.82, K50.9Crohn´s disease, unspecified |
| Alpha-ID codes (AIS) | I115933Crohn´s disease of the stomach, I115934Crohn´s disease of the esophagus, I18518Crohn´s disease, I5642Crohn´s disease of the small intestine, I5646Crohn´s disease of the large intestine, I87913Crohn´s disease of the small intestine and colon |
| Therapeutic area | Digestive system diseases Crohn's disease |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
RINVOQ is used for the treatment of moderate to severe active Crohn's disease in adult patients who have had an inadequate response, no longer respond or have not tolerated conventional therapy or a biological treatment |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe active Crohn's disease who have had an inadequate response, lost response or failed to tolerate conventional therapy | A TNF-α antagonist (adalimumab or infliximab) or integrin inhibitor (vedolizumab) or interleukin inhibitor (ustekinumab) |
| b) | Adults with moderate to severe active Crohn's disease who have had an inadequate response, lost response or failed to tolerate a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor) | A change of therapy to a TNF-α antagonist (adalimumab or infliximab) or integrin inhibitors (vedolizumab) or interleukin inhibitors (ustekinumab). |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: H2H vs. non-ACT + no ITC) |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
- 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.
Associated procedures
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