lanadelumab


( Last Updated : January 9, 2020)
Generic Name:
lanadelumab
Project Status:
Complete
Therapeutic Area:
Hereditary angioedema, prevention
Manufacturer:
Shire Pharma Canada ULC
Call for patient/clinician input open:
Brand Name:
Takhzyro
Project Line:
Reimbursement Review
Project Number:
SR0618-000
Call for patient/clinician input closed:

Details


Manufacturer Requested Reimbursement Criteria1:
For routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hereditary angioedema, prevention
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 postedApril 30, 2019
Patient group input closedJune 19, 2019
Clarification:

- Patient input submission received from HAE Canada

Patient input summary sent for review to patient input groupsJuly 24, 2019
Patient group comments on input summary closedJuly 31, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 29, 2019
Submission acceptedJune 12, 2019
Review initiatedJune 14, 2019
Draft CADTH review report(s) sent to sponsorSeptember 04, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 13, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 04, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 29, 2019
Embargo period endedNovember 12, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansNovember 19, 2019
CDEC Final Recommendation postedNovember 22, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedDecember 03, 2019
Redacted CADTH review report(s) sent to sponsor and drug plansDecember 13, 2019
Validation of redacted CADTH review report(s) receivedDecember 20, 2019
Final CADTH review report(s) postedJanuary 09, 2020