Damoctocog alfa pegol (1) – Jivi®
Hemophilia A, ≥ 12 years
Characteristics
| Start date | 01.01.2019 – Marketing authorisation: 22.11.2018 |
|---|---|
| Resolution | 20.06.2019 |
| INN | Damoctocog alfa pegol |
| Brand name | Jivi® |
| Pharm. company | Bayer Vital GmbH |
| G-BA Procedure ID | D-425 |
| ATC code | B02BD39 Blood coagulation factors (B02BD) |
| ICD-10 codes (AIS) | D66Hereditary factor VIII deficiency |
| Alpha-ID codes (AIS) | I27819Hemophilia A |
| DDD | 1 TU P |
| Therapeutic area | Hematopoietic diseases Hemophilia (Hemophilia A /Hemophilia B) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged 12 years and older with haemophilia A (congenital Factor VIII deficiency). | Recombinant or human plasma-derived blood coagulation factor VIII preparations |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Uncontrolled study) |
- Clinical trials
- Study 13024 was an open-label, four-arm, partially randomised study comparing on-demand treatment with prophylactic treatment (three different treatment regimens) using damoctocog alfa pegol in previously treated adolescents (aged 12 to < 18 years) and adult male patients (aged ≥ 18 to 65 years) with severe haemophilia A.
- The single-arm, non-randomised Phase I study 13401 investigated previously treated male patients with severe haemophilia A.
Patients aged 12 years and over with haemophilia A (congenital factor VIII deficiency)
- For the treatment and prophylaxis of bleeding in patients aged 12 years and over with haemophilia A (congenital factor VIII deficiency), the additional benefit compared with the appropriate comparator therapy is not proven.
- The pharmaceutical manufacturer has not provided any relevant data for the assessment of the additional benefit of damoctocog alfa pegol.
- The G-BA considers that, taken as a whole, the results presented are not sufficient to allow the derivation of patient-relevant effects regarding the additional benefit of damoctocog alfa pegol compared with the appropriate comparator therapy.
- On balance, therefore, no additional benefit is proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Damoctocog alfa pegol (1) | Jivi® | Bayer Vital GmbH | Hemophilia A, ≥ 12 years | 2,840–3,190 | 100% additional benefit not proven |
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