Last Updated : February 1, 2023
Details
FilesGeneric 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
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:
- 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 open | February 16, 2022 |
| Call for patient/clinician input closed | April 08, 2022 |
| Clarification: - Patient input submission received from Canadian Neuroendocrine Tumour Society | |
| Submission received | March 23, 2022 |
| Submission accepted | April 06, 2022 |
| Review initiated | April 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 27, 2022 |
| Deadline for sponsors comments | July 07, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 23, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 28, 2022 |
| Final recommendation posted | October 17, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 13, 2022 |
| CADTH review report(s) posted | January 31, 2023 |
Files
Last Updated : February 1, 2023