Last Updated : June 9, 2022
Details
FilesGeneric 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
Performance Metric:
Achieved
Biosimilar:
No
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:
- 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.
Procedural review:
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 |
Files
Last Updated : June 9, 2022