Generic Name: sebelipase alfa
Brand Name: Kanuma
Manufacturer: Alexion Pharmaceuticals
Therapeutic Area: Lysosomal acid lipase deficiency
Indications: Lysosomal acid lipase deficiency
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: September 26, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 |
|
|---|---|
| Call for patient input posted | October 04, 2017 |
| Patient group input closed | November 23, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | December 04, 2017 |
| Patient group comments on input summary closed | December 11, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | November 02, 2017 |
| Submission accepted for review | November 16, 2017 |
| Review initiated | November 17, 2017 |
| Draft CDR review report(s) sent to applicant | February 16, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 02, 2018 |
| Clarification:
- Extension request received from applicant - Extension granted |
|
| Redaction requests from applicant on draft CDR review report(s) received | March 09, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 29, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | April 11, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 25, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 07, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | September 19, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | September 26, 2018 |
| CDEC Final Recommendation posted | September 28, 2018 |
| Final CDR review report(s) and patient input posted | November 21, 2018 |