Concizumab (3) – Alhemo®
Haemophilia A, aged ≥ 12 years, without factor VIII inhibitors
Characteristics
| Start date | 01.10.2025 – Marketing authorisation: 22.08.2025 |
|---|---|
| Resolution | 19.03.2026 |
| INN | Concizumab |
| Brand name | Alhemo® |
| Pharm. company | Novo Nordisk GmbH |
| G-BA Procedure ID | D-1237 |
| ATC code | B02BX10 Other systemic hemostatics (B02BX) |
| ICD-10 codes (AIS) | D66Hereditary factor VIII deficiency |
| Alpha-ID codes (AIS) | I27819Hemophilia A |
| Therapeutic area | Hematopoietic diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Concizumab is used for the routine prophylaxis of bleeding in patients aged 12 years and over with severe haemophilia A (congenital factor VIII deficiency; FVIII < 1 %) without FVIII inhibitors. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene und Jugendliche ab 12 Jahren mit schwerer Hämophilie A (FVIII < 1 %) ohne Faktor-VIII-Inhibitoren mit Indikation zur Routineprophylaxe |
Studies and Results
Adults and adolescents aged 12 years and over with severe haemophilia A (FVIII < 1 %) without factor VIII inhibitors, with an indication for routine prophylaxis
- For adults and adolescents aged 12 years and over with severe haemophilia A (FVIII < 1 %) without factor VIII inhibitors, who have an indication for routine prophylaxis, an additional benefit is not proven.
- In its dossier for the assessment of the additional benefit of Concizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Overall, on the basis of the study submitted, no added benefit of Concizumab compared with the appropriate comparator therapy can be inferred for adults and adolescents aged 12 years and over with severe haemophilia A (FVIII < 1 per cent) without factor VIII inhibitors, for whom there is an indication for routine prophylaxis, no additional benefit of Concizumab compared with the appropriate comparator therapy can be inferred.
- On balance, for adults and adolescents aged 12 years and over with severe haemophilia A (FVIII < 1 %) without factor VIII inhibitors, who have an indication for routine prophylaxis, the additional benefit of Concizumab compared with the appropriate comparator therapy is not proven.
- Overall assessment
- Overall, for adults and adolescents aged 12 years and over with severe haemophilia A (FVIII < 1 per cent) without factor VIII inhibitors, who have an indication for routine prophylaxis, the additional benefit of Concizumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Concizumab (4) | Alhemo® | Novo Nordisk GmbH | Haemophilia B, aged ≥ 12 years, without factor IX inhibitors | 290–490 | 100% additional benefit not proven | |
| Concizumab (3) | Alhemo® | Novo Nordisk GmbH | Haemophilia A, aged ≥ 12 years, without factor VIII inhibitors | 1,800–2,000 | 100% additional benefit not proven | |
| Concizumab (2) | Alhemo® | Novo Nordisk GmbH | Haemophilia B, aged ≥ 12 years, with factor IX inhibitors | 2–12 | 57% Hint for considerable additional benefit | |
| Concizumab (1) | Alhemo® | Novo Nordisk GmbH | Haemophilia A, aged ≥ 12 years, with factor VIII inhibitors | 80–125 | 100% additional benefit not proven |
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