Emtricitabin / Rilpivirin / Tenofoviralafenamid (1) – Odefsey®
HIV infection
Characteristics
| Start date | 15.07.2016 – Marketing authorisation: 21.06.2016 |
|---|---|
| Resolution | 05.01.2017 |
| INN | Emtricitabin/Rilpivirin/Tenofoviralafenamid |
| Brand name | Odefsey® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-248 |
| ATC code | J05AR19 Antivirals for treatment of HIV infections, combinations (J05AR) |
| DDD | 1 U O |
| Therapeutic area | Infectious diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- No results from clinical trials were submitted for the benefit assessment for patient populations a), b), c) and d), and these could therefore not be taken into account.
a) Adults not previously treated with antiretrovirals (treatment-naive)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven in each case.
- Consequently, no comparison is possible, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
b) adolescents aged 12 years and over who have not previously received antiretroviral therapy (treatment-naive)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either direct or indirect. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
c) Adults who have previously received antiretroviral treatment (treatment-experienced)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
d) Adolescents aged 12 years and over who have received prior antiretroviral treatment (treatment-experienced)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Emtricitabin / Rilpivirin / Tenofoviralafenamid (1) | Odefsey® | Gilead Sciences GmbH | HIV infection | 56,800–59,300 | 100% additional benefit not proven |
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