selpercatinib

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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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openSeptember 14, 2021
Call for patient/clinician input closedNovember 05, 2021
Clarification:

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

Submission receivedOctober 29, 2021
Submission acceptedNovember 17, 2021
Review initiatedNovember 18, 2021
Draft CADTH review report(s) provided to sponsor for commentFebruary 17, 2022
Deadline for sponsors commentsMarch 01, 2022
CADTH review report(s) and responses to comments provided to sponsorApril 01, 2022
Expert committee meeting (initial)April 13, 2022
Draft recommendation issued to sponsorApril 27, 2022
Draft recommendation posted for stakeholder feedbackMay 05, 2022
End of feedback periodMay 19, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target EXPERT COMMITTEE reconsideration meeting date to be determined

Expert committee meetingSeptember 14, 2022
Final recommendation issued to sponsor and drug plansSeptember 26, 2022
Final recommendation postedOctober 13, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 11, 2022
CADTH review report(s) postedDecember 22, 2022