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crisaborole

Last Updated: April 18, 2019
Result type: Reports
Project Number: SR0570-000
Product Line: Common Drug Review

Generic Name: crisaborole

Brand Name: Eucrisa

Manufacturer: Pfizer Canada Inc.

Indications: atopic dermatitis

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: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: March 27, 2019

Recommendation Type: Do not reimburse

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 26, 2018
Patient group input closedJune 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 groupsJune 28, 2018
Patient group comments on input summary closedJuly 06, 2018
Clarification:

- Patient input summary feedback received

Submission receivedMay 25, 2018
Submission accepted for reviewJune 11, 2018
Clarification:

- Submission was not accepted for review on 8 Jun 2018

- Revised category 1 requirements received on 8 Jun 2018

Review initiatedJune 12, 2018
Draft CADTH review report(s) sent to applicantAugust 29, 2018
Comments from applicant on draft CADTH review report(s) receivedSeptember 10, 2018
Redaction requests from applicant on draft CADTH review report(s) receivedSeptember 21, 2018
Clarification:

- Extension requested by applicant

- Request granted

CADTH review team's comments on draft CADTH review report(s) sent to applicantOctober 04, 2018
Canadian Drug Expert Committee (CDEC) meetingOctober 17, 2018
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansOctober 31, 2018
Embargo period ended and validation of redacted CADTH review report(s) receivedDecember 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 agendaMarch 20, 2019
CDEC Final Recommendation issued to applicant and drug plansMarch 27, 2019
CDEC Final Recommendation postedApril 02, 2019
Final CADTH review report(s) and patient input postedApril 17, 2019