Last Updated : July 14, 2020
Details
FilesGeneric Name:
burosumab
Project Status:
Complete
Therapeutic Area:
Treatment of X-Linked Hypophosphatemia
Manufacturer:
Kyowa Kirin Limited
Call for patient/clinician input open:
Brand Name:
Crysvita
Project Line:
Reimbursement Review
Project Number:
SR0602-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Treatment of X-Linked Hypophosphatemia
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | January 24, 2019 |
| Patient group input closed | March 15, 2019 |
| Clarification:
- Patient input submission received from Canadian Organization for Rare Disorders |
|
| Patient input summary sent for review to patient input groups | August 22, 2019 |
| Patient group comments on input summary closed | August 29, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | July 23, 2019 |
| Submission accepted | August 07, 2019 |
| Review initiated | August 08, 2019 |
| Draft CADTH review report(s) sent to sponsor | October 25, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | November 05, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | December 11, 2019 |
| CDEC recommendation sent to sponsor and drug plans | December 23, 2019 |
| Embargo period ended | February 11, 2020 |
| Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | May 20, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | May 27, 2020 |
| CDEC Final Recommendation posted | May 29, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | June 10, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | June 12, 2020 |
| Validation of redacted CADTH review report(s) received | June 19, 2020 |
| Final CADTH review report(s) posted | July 10, 2020 |
Files
Last Updated : July 14, 2020