pralsetinib

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Generic Name:
pralsetinib
Project Status:
Complete
Therapeutic Area:
RET fusion-positive non-small cell lung cancer
Manufacturer:
Hoffmann-La Roche Ltd.
Brand Name:
Gavreto
Project Line:
Reimbursement Review
Project Number:
PC0283-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Lung
Indications:
​Gavreto is indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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/clinician input openFebruary 08, 2022
Call for patient/clinician input closedApril 01, 2022
Clarification:

- Patient input submission received from Lung Cancer Canada

Submission receivedMarch 09, 2022
Submission acceptedMarch 23, 2022
Review initiatedMarch 24, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 16, 2022
Deadline for sponsors commentsJune 27, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 28, 2022
Expert committee meeting (initial)August 10, 2022
Draft recommendation issued to sponsorAugust 24, 2022
Draft recommendation posted for stakeholder feedbackSeptember 01, 2022
End of feedback periodSeptember 16, 2022
Final recommendation issued to sponsor and drug plansSeptember 29, 2022
Final recommendation postedOctober 18, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 14, 2022
CADTH review report(s) postedJanuary 06, 2023