Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

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:
PC0274-000
Tumour Type:
Head and Neck
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
Non
Manufacturer Requested Reimbursement Criteria1:
Retevmo is indicated as monotherapy for the treatment of: RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Retevmo is indicated as monotherapy for the treatment of: • RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib.
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 Milestones

Call for patient/clinician input open14-Sep-21
Call for patient/clinician input closed19-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 accepted09-Dec-21
Review initiated10-Dec-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment07-Mar-22
Deadline for sponsors comments16-Mar-22
Canada's Drug Agency review report(s) and responses to comments provided to sponsor29-Apr-22
Expert committee meeting (initial)11-May-22
Draft recommendation issued to sponsor25-May-22
Draft recommendation posted for stakeholder feedback02-Jun-22
End of feedback period16-Jun-22
Final recommendation issued to sponsor and drug plans29-Jun-22
Final recommendation posted18-Jul-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)14-Jul-22
Canada's Drug Agency review report(s) posted05-Oct-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : October 6, 2022