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.