pemigatinib


( Last Updated : June 9, 2022)
Generic Name:
pemigatinib
Project Status:
Complete
Therapeutic Area:
Cholangiocarcinoma
Manufacturer:
Incyte Biosciences Canada Corporation
Brand Name:
Pemazyre
Project Line:
Reimbursement Review
Project Number:
PC0252-000
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with a FGFR2 fusion or other rearrangement.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Gastrointestinal
Indications:
For the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with a FGFR2 fusion or other rearrangement.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Procedural review: CADTH accepted a procedural review request, submitted by the Canadian Gastrointestinal Oncology Evidence Network (CGOEN), for the PC0252 Pemazyre pERC Final Recommendation.

Status: Concluded.

Description: The procedural review request alleged that Pemazyre had not been considered under the deliberative framework for significant unmet need, as described in the CADTH Procedures for Reimbursement Reviews (the “Procedures”). This matter was concluded following a case conference meeting between CADTH and CGOEN. Mutual agreement was reached that no deviation from the Procedures had occurred for the reimbursement review of Pemazyre. 

Outcome:  The pERC Final Recommendation of Do Not Reimburse is upheld for Pemazyre.

Key Milestones2

Call for patient/clinician input open 26-May-21
Call for patient/clinician input closed 16-Jul-21
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders, Canadian Liver Foundation, and Cholangiocarcinoma Foundation.

Submission received 23-Jun-21
Submission accepted 08-Jul-21
Review initiated 09-Jul-21
Draft CADTH review report(s) provided to sponsor for comment 23-Sep-21
Deadline for sponsors comments 04-Oct-21
CADTH review report(s) and responses to comments provided to sponsor 29-Oct-21
Expert committee meeting (initial) 10-Nov-21
Draft recommendation issued to sponsor 24-Nov-21
Draft recommendation posted for stakeholder feedback 02-Dec-21
End of feedback period 16-Dec-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting 09-Mar-22
Final recommendation issued to sponsor and drug plans 23-Mar-22
Final recommendation posted 08-Apr-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 06-Apr-22
Procedural review accepted 27-may-22
Procedural review concluded 10-June-22
Clarification:

-Final Recommendation Upheld

CADTH review report(s) posted 09-Jun-22