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
- 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 |
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|---|---|
| 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 |