Generic Name: voretigene neparvovec
Brand Name: Luxturna
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Indications: Vision loss, inherited retinal dystrophy
Manufacturer Requested Reimbursement Criteria1: For thetreatment of adult and pediatric patients with vision loss due to inheritedretinal dystrophy caused by confirmed biallelic RPE65 mutations and who havesufficient viable retinal cells.
Submission Type: New
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule E
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient input open | March 25, 2020 |
| Call for patient input closed | May 14, 2020 |
| Clarification: - Patient input submission received from Canadian Council of the Blind, CNIB Foundation, Fighting Blindness Canada, Vision Loss Rehabilitation Canada (Joint Submission) | |
| Submission received | April 23, 2020 |
| Submission accepted | May 07, 2020 |
| Review initiated | May 08, 2020 |
| Clarification: - Selected for CADTH/INESSS Joint Clinician Engagement | |
| Draft CADTH review report(s) provided to sponsor for comment | July 23, 2020 |
| Deadline for sponsors comments | August 04, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | September 03, 2020 |
| Expert committee meeting (initial) | September 16, 2020 |
| Draft recommendation issued | September 28, 2020 To September 30, 2020 |