Last Updated : July 27, 2020
Details
FilesGeneric Name:
glycopyrrolate
Project Status:
Complete
Therapeutic Area:
chronic severe drooling, neurologic (pediatric)
Manufacturer:
MEDEXUS Pharmaceuticals, Inc.
Call for patient/clinician input open:
Brand Name:
Cuvposa
Project Line:
Reimbursement Review
Project Number:
SR0613-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Cuvposa (glycopyrrolate) is indicated to reduce chronic severe drooling in patients aged 3-18 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
chronic severe drooling, neurologic (pediatric)
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient input posted | April 11, 2019 |
| Patient group input closed | June 03, 2019 |
| Clarification: - No patient input submission received | |
| Submission received | May 31, 2019 |
| Submission accepted | June 14, 2019 |
| Review initiated | June 24, 2019 |
| Draft CADTH review report(s) sent to sponsor | September 16, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | September 25, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 08, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | November 20, 2019 |
| CDEC recommendation sent to sponsor and drug plans | December 04, 2019 |
| Embargo period ended | January 23, 2020 |
| Clarification: - Embargo extension granted - Reconsideration requested | |
| Sponsor's request for reconsideration placed on CDEC agenda | June 17, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | June 24, 2020 |
| CDEC Final Recommendation posted | June 26, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | July 09, 2020 |
| Clarification: - No redactions requested by the sponsor | |
| Final CADTH review report(s) posted | July 24, 2020 |
Files
Last Updated : July 27, 2020