glycopyrrolate

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Generic 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:
  1. 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 postedApril 11, 2019
Patient group input closedJune 03, 2019
Clarification:

- No patient input submission received

Submission receivedMay 31, 2019
Submission acceptedJune 14, 2019
Review initiatedJune 24, 2019
Draft CADTH review report(s) sent to sponsorSeptember 16, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 25, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansDecember 04, 2019
Embargo period endedJanuary 23, 2020
Clarification:

- Embargo extension granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaJune 17, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJune 24, 2020
CDEC Final Recommendation postedJune 26, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 09, 2020
Clarification:

- No redactions requested by the sponsor

Final CADTH review report(s) postedJuly 24, 2020