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Midostaurin (Rydapt) for Systemic Mastocytosis

Project Number PC0193-000
Brand Name Rydapt
Generic Name Midostaurin
Strength 25 mg
Tumour Type Other
Indication Systemic Mastocytosis
Funding Request For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Review Status Complete
Pre Noc Submission No
NOC Date October 3, 2018
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date August 13, 2019
Submission Deemed Complete August 27, 2019
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ August 27, 2019
Check-point meeting October 16, 2019
pERC Meeting January 16, 2020
Initial Recommendation Issued January 30, 2020
Feedback Deadline ‡ February 13, 2020
pERC Reconsideration Meeting March 19, 2020
Final Recommendation Issued April 2, 2020
Notification to Implement Issued April 20, 2020
Therapeutic Area Systemic Mastocytosis
Recommendation Type Do not reimburse

‡ 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.