onasemnogene abeparvovec


( Last Updated : March 29, 2021)
Generic Name:
onasemnogene abeparvovec
Project Status:
Active
Therapeutic Area:
Spinal muscular atrophy (SMA), pediatrics
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Zolgensma
Project Line:
Reimbursement Review
Project Number:
SG0649-000
Call for patient/clinician input closed:

Details


Manufacturer Requested Reimbursement Criteria1:
Zolgensma is an adeno-associated virus (AVV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​Zolgensma is an adeno-associated virus (AVV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Date NOC Issued:
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 openMay 26, 2020
Call for patient input closedJuly 15, 2020
Clarification:

- Patient input submission received from Cure SMA Canada and Muscular Dystrophy Canada (MDC)

Submission receivedJune 25, 2020
Submission acceptedJuly 10, 2020
Review initiatedJuly 13, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentSeptember 29, 2020
Deadline for sponsors commentsOctober 08, 2020
CADTH responses on draft review report(s) provided to sponsorNovember 06, 2020
Expert committee meeting (initial)November 18, 2020
Draft recommendation issued to sponsorDecember 17, 2020
End of embargo periodFebruary 05, 2021
Clarification:

- Request for extension to feedback period received from the sponsor

- Feedback extension request granted

- Reconsideration requested

- Request for Clarification received from DRR Participating Drug Plans

Expert committee meetingMarch 17, 2021
Final recommendation issued to sponsor and drug plansMarch 24, 2021
Final recommendation postedMarch 26, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)April 08, 2021
CADTH review report(s) postedMay 26, 2021