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lanadelumab

Last Updated: December 13, 2019
Result type: Reports
Project Number: SR0618-000
Product Line: Common Drug Review

Generic Name: lanadelumab

Brand Name: Takhzyro

Manufacturer: Shire Pharma Canada ULC

Indications: Hereditary angioedema, prevention

Manufacturer Requested Reimbursement Criteria1: For routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults.

Submission Type: New

Project Status: Active

Biosimilar: No

Date Recommendation Issued: November 19, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 accepted for reviewJune 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) posted-