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Afinitor for Neuroendocrine tumors of Gastrointestinal or Lung origin – Details

Project Number PC0083-000
Brand Name Afinitor
Generic Name Everolimus
Strength 2.5 mg, 5mg, 7.5mg and 10 mg tablets
Tumour Type Endocrine
Indication Neuroendocrine tumours of Gastrointestinal or Lung origin
Funding Request For the treatment of unresectable, locally advanced or metastatic, well differentiated non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults with progressive disease
Review Status Complete
Pre Noc Submission No
NOC Date May 17, 2016
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date May 30, 2016
Submission Deemed Complete June 6, 2016
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ June 13, 2016
Check-point meeting July 20, 2016
pERC Meeting September 15, 2016
Initial Recommendation Issued September 29, 2016
Feedback Deadline ‡ October 14, 2016
pERC Reconsideration Meeting November 17, 2016
Final Recommendation Issued December 1, 2016
Notification to Implement Issued December 16, 2016
Therapeutic Area Neuroendocrine tumors (NET) of Gastrointestinal or Lung origin
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.