CDA | Evidence Driven
CDA | Evidence Driven

Lutathera for Gastroenteropancreatic neuroendocrine tumors – Details

Details

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Generic Name:
Lutetium Lu 177 dotatate
Project Status:
Complete
Therapeutic Area:
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Manufacturer:
Advanced Accelerator Applications
Brand Name:
Lutathera
Project Line:
Reimbursement Review
Project Number:
PC0142-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Strength:
370 MBq/mL
Tumour Type:
Gastrointestinal
Indications:
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Funding Request:
For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults whose disease has progressed and is unresectable.
Pre Noc Submission:
Yes
Sponsor:
Advanced Accelerator Applications
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – pERC Final Recommendation Final Recommendation August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – Final Economic Guidance Report Guidance Reports August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – Final Clinical Guidance Report Guidance Reports August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – pERC Initial Recommendation Initial Recommendation May 31, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – PAG Feedback on Initial Recommendation Feedback August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – Manufacturer Feedback on Initial Recommendation Feedback August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – Patient Advocacy Group Feedback on Initial Recommendation Feedback August 1, 2019 View PDF
Lutetium Lu 177 dotatate (Lutathera) GEP-NET – Patient Advocacy Group COI Declarations COI Declarations August 1, 2019 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : August 19, 2019