Last Updated : January 9, 2020
Details
FilesGeneric 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
Performance Metric:
Achieved
Biosimilar:
No
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:
- 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 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 |
Files
Last Updated : January 9, 2020