Isofluran (1) – Sedaconda®
Sedation of mechanically ventilated patients during intensive care therapy (ICT)
Characteristics
| Start date | 01.02.2022 – Marketing authorisation: 24.09.2021 |
|---|---|
| Resolution | 21.07.2022 |
| INN | Isofluran |
| Brand name | Sedaconda® |
| Pharm. company | Sedana Medical AB |
| G-BA Procedure ID | D-765 |
| ATC code | N01AB06 Halogenated hydrocarbons (N01AB) |
| ICD-10 codes (AIS) | U07.6 |
| Therapeutic area | Other diseases Sedation |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Sedaconda is used for the sedation of mechanically ventilated adult patients during intensive care therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult mechanically ventilated patients for whom sedation is indicated | Therapy as prescribed by a physician, taking into account propofol, midazolam and dexmedetomidine |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (SED001) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
Adult patients on mechanical ventilation for whom sedation is indicated
- For adult mechanically ventilated patients for whom sedation is indicated, the additional benefit of isoflurane compared with the appropriate comparator therapy is not proven.
- Overall, there are no suitable data available to assess the additional benefit of isoflurane compared with the appropriate comparator therapy. An additional benefit is therefore not proven.
- The SED001 study is not suitable for benefit assessment due to the limitation of the treatment duration with the study medication to 48 hours (± 6 hours) and the subsequent switch to standard local treatment for patients requiring further sedation.
- The pre-defined treatment period with the study medication of 48 ± 6 hours covers only part of the actual sedation period for a significant proportion of the included patients.
- Furthermore, the switch to standard local therapy following the end of the study medication must be viewed critically, particularly in the isoflurane arm, as sedation with isoflurane is not limited to a specific period according to the summary of product characteristics (SmPC).
- Furthermore, it cannot be assumed that a change of sedative without any apparent reason is consistent with the clinical context.
- Overall assessment
- On balance, there are no suitable data available to assess the additional benefit of isoflurane compared with the appropriate comparator therapy. The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Isofluran (1) | Sedaconda® | Sedana Medical AB | Sedation of mechanically ventilated patients during intensive care therapy (ICT) | 146,000–219,000 | 100% additional benefit not proven |
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