Voretigene neparvovec (Luxturna®). HTA ID: 19041

Assessment Status NCPE 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.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations. August 2023