Voretigen Neparvovec (2, reassessment) (Luxturna®) – Hereditary retinal dystrophy
Characteristics
| Start date | 01.04.2022 |
|---|---|
| Resolution | 15.09.2022 |
| INN | Voretigen Neparvovec |
| Brand name | Luxturna® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA procedure ID | 2022-04-01-D-803 |
| Therapeutic area | Eye diseases ORPHAN |
| Reason for procedure |
Reassessment: G-BA limitation
Original resolution: Voretigen Neparvovec (17.10.2019) |
| G-BA resolution "Anwendungsgebiet des Beschlusses" (German) |
|---|
|
Luxturna is used to treat adult and paediatric patients with Vision loss due to hereditary retinal dystrophy resulting from proven biallelic RPE65 mutations and who have sufficient viable retinal cells. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult and paediatric patients with visual loss due to hereditary retinal dystrophy based on proven biallelic RPE65 mutations and who have sufficient viable retinal cells. | Not applicable |
9. Associated procedures
| Resolution | INN | Brand name | Indication | Patients | Additional benefit |
|---|---|---|---|---|---|
| 15.04.2019 – 17.10.2019 | Voretigen Neparvovec | Luxturna® | Hereditary retinal dystrophy |
0
100
–
530
|
|
| 01.04.2022 – 15.09.2022 | Voretigen Neparvovec (2, reassessment) | Luxturna® | Hereditary retinal dystrophy | 100 – 530 |
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