Last Updated : April 18, 2019
Details
FilesGeneric Name:
crisaborole
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Eucrisa
Project Line:
Reimbursement Review
Project Number:
SR0570-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For treatment of mild to moderate atopic dermatitis in patients 2 years of age and older who have failed or are intolerant to a topical corticosteroid treatment.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
atopic dermatitis
Recommendation Type:
Do not reimburse
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 26, 2018 |
| Patient group input closed | June 15, 2018 |
| Clarification:
- Patient input submission received from Canadian Skin Patient Alliance and Eczema Society of Canada |
|
| Patient input summary sent for review to patient input groups | June 28, 2018 |
| Patient group comments on input summary closed | July 06, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 25, 2018 |
| Submission accepted for review | June 11, 2018 |
| Clarification:
- Submission was not accepted for review on 8 Jun 2018 - Revised category 1 requirements received on 8 Jun 2018 |
|
| Review initiated | June 12, 2018 |
| Draft CADTH review report(s) sent to applicant | August 29, 2018 |
| Comments from applicant on draft CADTH review report(s) received | September 10, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | September 21, 2018 |
| Clarification:
- Extension requested by applicant - Request granted |
|
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | October 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | October 17, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | October 31, 2018 |
| Embargo period ended and validation of redacted CADTH review report(s) received | December 12, 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 | March 20, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | March 27, 2019 |
| CDEC Final Recommendation posted | April 02, 2019 |
| Final CADTH review report(s) and patient input posted | April 17, 2019 |
Files
Last Updated : April 18, 2019