Letermovir (5) – Prevymis®
CMV infection, prophylaxis following kidney transplantation, < 18 years of age, ≥ 40 kg
Characteristics
| Start date | 15.05.2025 – Marketing authorisation: 25.04.2025 |
|---|---|
| Resolution | 06.11.2025 |
| INN | Letermovir |
| Brand name | Prevymis® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-1185 |
| ATC code | J05AX18 Other antivirals (J05AX) |
| ICD-10 codes (AIS) | Z94.0Kidney transplant status |
| Alpha-ID codes (AIS) | I86714Condition after kidney transplantation |
| Therapeutic area | Infectious diseases Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Prevymis is used for the prophylaxis of CMV disease in CMV-seronegative paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-]. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| CMV-seronegative Empfänger [R−] im Alter von 0 bis < 18 Jahren mit einem Körpergewicht von mindestens 40 kg nach Nierentransplantation von CMV-seropositiven Spendern [D+], für die eine Prophylaxe einer Cytomegalievirus (CMV)-Erkrankung angezeigt ist |
Studies and Results
CMV-seronegative recipients [R−] aged 0 to < 18 years with a body weight of at least 40 kg following kidney transplantation from CMV-seropositive donors [D+], for whom prophylaxis against cytomegalovirus (CMV) disease is indicated
- An additional benefit is not proven.
- In its dossier, the pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of letermovir compared with the appropriate comparator therapy.
- Consequently, there are no data available to enable an assessment of the additional benefit of letermovir for the prophylaxis of CMV disease in CMV-seronegative paediatric patients weighing at least 40 kg, who have received a kidney transplant from a CMV-seropositive donor.
- Overall assessment
- The pharmaceutical manufacturer has not submitted any data to demonstrate the additional benefit of letermovir compared with the appropriate comparator therapy. Consequently, the additional benefit of letermovir for the prophylaxis of CMV disease in CMV-seronegative paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor No proof has been provided.
Courtesy translation only, please refer to the German original.
Associated procedures
| Letermovir (5) | Prevymis® | MSD Sharp & Dohme GmbH | CMV infection, prophylaxis following kidney transplantation, < 18 years of age, ≥ 40 kg | 13 | 100% additional benefit not proven Orphan (turnover limit) | |
| Letermovir (4) | Prevymis® | MSD Sharp & Dohme GmbH | CMV reactivation/disease, prophylaxis following stem cell transplantation, < 18 years, ≥ 5 kg | 160–240 | 100% Hint for non-quantifiable additional benefit Orphan (turnover limit) | |
| Letermovir (3) | Prevymis® | MSD Sharp & Dohme GmbH | CMV reactivation/disease, prophylaxis after stem cell transplantation | 1,400–1,800 | 100% Hint for non-quantifiable additional benefit Orphan (turnover limit) | |
| Letermovir (2) | Prevymis® | MSD Sharp & Dohme GmbH | CMV disease, prophylaxis after kidney transplantation | 320 | 100% additional benefit not proven Orphan (turnover limit) | |
| Letermovir (1) | Prevymis® | MSD SHARP & DOHME GMBH | Cytomegalovirus infection |
0
1,000–1,800 |
100% non-quantifiable additional benefit Orphan repealed |
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