Tenofoviralafenamid (2) – Vemlidy®
Chronic hepatitis B, ≥ 12 years
Characteristics
| Start date | 01.10.2018 – Marketing authorisation: 09.01.2017 |
|---|---|
| Resolution | 22.03.2019 |
| INN | Tenofoviralafenamid |
| Brand name | Vemlidy® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-394 |
| ATC code | J05AF13 Nucleoside and nucleotide reverse transcriptase inhibitors (J05AF) |
| ICD-10 codes (AIS) | B18.0Chronic viral hepatitis B with delta-agent, B18.11, B18.12, B18.13, B18.19 |
| Alpha-ID codes (AIS) | I100035Chronic viral hepatitis B, I126275Chronic viral hepatitis B without delta virus, phase 1, I126279Chronic viral hepatitis B without delta virus, phase 2, I126287Chronic viral hepatitis B without delta virus, phase 3, I29600Chronic viral hepatitis B with delta virus |
| DDD | 25 mg O |
| Therapeutic area | Infectious diseases Hepatitis B / Hepatitis D (HBV / HDV) |
| Reason for procedure |
Reassessment: G-BA limitation
Original resolution: Tenofoviralafenamid (1) (21.09.2017) |
| Therapeutic indication of the resolution |
|---|
|
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Treatment-naïve adult patients with chronic hepatitis B | (Peg-)interferon alfa or tenofovirdisoproxil or entecavir |
| b) | Therapy-experienced adult patients with chronic hepatitis B | Patient-specific therapy, with choice of (peg-)interferon alfa, tenofovirdisoproxil, entecavir, adefovirdipivoxil, lamivudine and telbivudine. |
| c) | Therapy-naïve adolescent patients aged 12 years and older with chronic hepatitis B | Tenofovirdisoproxil or entecavir |
| d) | Therapy-experienced adolescent patients aged 12 years and older with chronic hepatitis B | Tenofovirdisoproxil |
Studies and Results
|
No. of studies
(best subpopulation) |
4 (GS 108, GS 108-C, GS 110, GS 110-C) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
yes |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Age |
- Clinical trials
- To demonstrate the additional benefit, the pharmaceutical manufacturer has submitted interim results from the randomised, double-blind and multicentre clinical trials GS108, GS108-C, GS110 and GS110-C.
- These studies are regulatory trials comparing tenofovir alafenamide with tenofovir disoproxil in treatment-naïve and treatment-experienced adult patients with chronic hepatitis B infection who tested positive (GS110/-C) or negative (GS108/-C) HBe antigen status, respectively.
b) treatment-experienced adult patients with chronic hepatitis B
- For treatment-experienced adult patients with chronic hepatitis B, the additional benefit of tenofovir alafenamide over the appropriate comparator therapy is not proven.
- No relevant data are available for assessing the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy.
- Although treatment-experienced patients were also included in studies GS108, GS108-C, GS110 and GS110-C, the appropriate comparator therapy tailored to the individual patient was not implemented for these patients.
- It is therefore not possible to infer any additional benefit from the available data.
c) Treatment-naive adolescent patients aged 12 years and over with chronic hepatitis B
- For treatment-naive and treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B, the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy is not proven.
- No results from clinical trials were submitted for the benefit assessment for patient populations c) and d).
- The pharmaceutical manufacturer’s search failed to identify any relevant studies, meaning that no comparison with the appropriate comparator therapy is possible.
- No conclusions regarding additional benefit can be drawn.
d) treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B
- For treatment-naïve and treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B, the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy is not proven.
- No results from clinical trials were submitted for the benefit assessment for patient populations c) and d).
- The pharmaceutical manufacturer’s search failed to identify any relevant studies, meaning that no comparison with the appropriate comparator therapy is possible.
- No conclusions regarding additional benefit can be drawn.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tenofoviralafenamid (2) | Vemlidy® | Gilead Sciences GmbH | Chronic hepatitis B, ≥ 12 years | 12,400–38,100 | 100% additional benefit not proven | |
| Tenofoviralafenamid (1) | Vemlidy® | Gilead Sciences GmbH | Chronic hepatitis B, ≥ 12 years |
0
12,400–38,100 |
100% additional benefit not proven repealed |
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