CDA | Evidence Driven
CDA | Evidence Driven

selpercatinib

Details

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Generic Name:
selpercatinib
Project Status:
Complete
Therapeutic Area:
Thyroid cancer
Manufacturer:
Eli Lilly Canada Inc.
Brand Name:
Retevmo
Project Line:
Reimbursement Review
Project Number:
PC0264-000
Tumour Type:
Head and Neck
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Retevmo is indicated as monotherapy for the treatment of: RET-mutant medullary thyroid cancer in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Retevmo is indicated as monotherapy for the treatment of: RET-mutant medullary thyroid cancer in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease.
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 open14-Sep-21
Call for patient/clinician input closed05-Nov-21
Clarification:

- Patient input submission received from GroupCanCertainty, Canadian Cancer Society’s patient panels and networks, and Thyroid Cancer Canada patient networks

Submission received29-Oct-21
Submission accepted17-Nov-21
Review initiated18-Nov-21
Draft CADTH review report(s) provided to sponsor for comment17-Feb-22
Deadline for sponsors comments01-Mar-22
CADTH review report(s) and responses to comments provided to sponsor01-Apr-22
Expert committee meeting (initial)13-Apr-22
Draft recommendation issued to sponsor27-Apr-22
Draft recommendation posted for stakeholder feedback05-May-22
End of feedback period19-May-22
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target EXPERT COMMITTEE reconsideration meeting date to be determined

Expert committee meeting14-Sep-22
Final recommendation issued to sponsor and drug plans26-Sep-22
Final recommendation posted13-Oct-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Oct-22
CADTH review report(s) posted22-Dec-22

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : July 24, 2024