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:
NOC Status at Filing:
Post NOC

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 posted April 30, 2019
Patient group input closed June 19, 2019
Clarification:

- Patient input submission received from HAE Canada

Patient input summary sent for review to patient input groups July 24, 2019
Patient group comments on input summary closed July 31, 2019
Clarification:

- Patient input summary feedback received

Submission received May 29, 2019
Submission accepted June 12, 2019
Review initiated June 14, 2019
Draft CADTH review report(s) sent to sponsor September 04, 2019
Comments from sponsor on draft CADTH review report(s) received September 13, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor October 04, 2019
Canadian Drug Expert Committee (CDEC) meeting October 16, 2019
CDEC recommendation sent to sponsor and drug plans October 29, 2019
Embargo period ended November 12, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans November 19, 2019
CDEC Final Recommendation posted November 22, 2019
Redaction requests from sponsor on draft CADTH review report(s) received December 03, 2019
Redacted CADTH review report(s) sent to sponsor and drug plans December 13, 2019
Validation of redacted CADTH review report(s) received December 20, 2019
Final CADTH review report(s) posted January 09, 2020