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voretigene neparvovec

Last Updated: September 16, 2020
Result type: Reports
Project Number: SG0643-000
Product Line: Common Drug Review

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

  1. 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 openMarch 25, 2020
Call for patient input closedMay 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 receivedApril 23, 2020
Submission acceptedMay 07, 2020
Review initiatedMay 08, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentJuly 23, 2020
Deadline for sponsors commentsAugust 04, 2020
CADTH responses on draft review report(s) provided to sponsorSeptember 03, 2020
Expert committee meeting (initial)September 16, 2020
Draft recommendation issuedSeptember 28, 2020
To
September 30, 2020