lutetium oxodotreotide

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Generic Name:
lutetium oxodotreotide
Project Status:
Complete
Therapeutic Area:
Gastroenteropancreatic neuroendocrine tumours (GEP-NETs)
Manufacturer:
Advanced Accelerator Applications (AAA)
Brand Name:
Lutathera
Project Line:
Reimbursement Review
Project Number:
PC0284-000
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of unresectable or metastatic, well-differentiated, somatostatin receptor-positive pancreatic neuroendocrine tumours in adults whose disease has progressed after treatment with a somatostatin analogue, unless there is a contraindication or intolerance.
Submission Type:
Reassessment
Fee Schedule:
Schedule A
Tumour Type:
Gastrointestinal
Indications:
For the treatment of unresectable or metastatic, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults with progressive 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 openFebruary 16, 2022
Call for patient/clinician input closedApril 08, 2022
Clarification:

- Patient input submission received from Canadian Neuroendocrine Tumour Society

Submission receivedMarch 23, 2022
Submission acceptedApril 06, 2022
Review initiatedApril 07, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 27, 2022
Deadline for sponsors commentsJuly 07, 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 23, 2022
Draft recommendation posted for stakeholder feedbackSeptember 01, 2022
End of feedback periodSeptember 16, 2022
Final recommendation issued to sponsor and drug plansSeptember 28, 2022
Final recommendation postedOctober 17, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 13, 2022
CADTH review report(s) postedJanuary 31, 2023