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voretigene neparvovec

Last Updated: December 17, 2020
Result type: Reports
Project Number: SG0643-000
Product Line: Reimbursement Review

Generic Name: voretigene neparvovec

Brand Name: Luxturna

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Vision loss, inherited retinal dystrophy

Indications: ​Indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: November 12, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 issued to sponsorOctober 22, 2020
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

End of embargo periodNovember 05, 2020
Final recommendation issued to sponsor and drug plansNovember 12, 2020
Final recommendation postedNovember 16, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 26, 2020
CADTH review report(s) postedJanuary 14, 2021