| Assessment Status | Assessment process complete |
| HTA ID | 19041 |
| Drug | Voretigene neparvovec |
| Brand | Luxturna® |
| Indication | For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. |
| Assessment Process | |
| Rapid review commissioned | 24/09/2019 |
| Rapid review completed | 23/10/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of voretigene neparvovec compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 29/10/2019 |
| Pre-submission consultation with Applicant | 10/02/2020 |
| Full submission received from Applicant | 03/04/2020 |
| Preliminary review sent to Applicant | 15/05/2020 |
| NCPE assessment re-commenced | 09/06/2020 |
| Factual accuracy sent to applicant | 26/08/2020 |
| NCPE assessment re-commenced | 03/09/2020 |
| NCPE assessment completed | 18/09/2020 |
| NCPE assessment outcome | The NCPE recommends that voretigene neparvovec (Luxturna®) is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
