crisaborole

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Generic 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:
  1. 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