voretigene neparvovec


( Last Updated : January 14, 2021)
Generic Name:
voretigene neparvovec
Project Status:
Complete
Therapeutic Area:
Vision loss, inherited retinal dystrophy
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Luxturna
Project Line:
Reimbursement Review
Project Number:
SG0643-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details

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
Fee Schedule:
Schedule E
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 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 to sponsor October 22, 2020
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.
End of embargo period November 05, 2020
Final recommendation issued to sponsor and drug plans November 12, 2020
Final recommendation posted November 16, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) November 26, 2020
CADTH review report(s) posted January 14, 2021

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Ethics Report

Patient Group Input Submissions