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Nexavar for Metastatic Progressive Differentiated Thyroid Carcinoma - Details

Project Number PC0049-000
Brand Name Nexavar
Generic Name Sorafenib
Strength 200 mg tablet
Tumour Type Endocrine
Indication Metastatic Progressive Differentiated Thyroid Carcinoma (DTC)
Funding Request Treatment of patients with locally advanced or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine
Review Status Complete
Pre Noc Submission No
NOC Date June 27, 2014
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date December 19, 2014
Submission Deemed Complete January 5, 2015
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ January 12, 2015
Check-point meeting (target date) February 18, 2015
pERC Meeting April 16, 2015
Initial Recommendation Issued April 30, 2015
Feedback Deadline ‡ May 14, 2015
pERC Reconsideration Meeting July 2, 2015
Clarification Due to the number of items for deliberation, the pERC meeting was conducted over two days. Unable to reach quorum for either day around the target reconsideration meeting date of June 18, 2015, pERC held deliberations for all reconsideration items, including sorafenib, on July 2, 2015.
Final Recommendation Issued July 16, 2015
Notification to Implement Issued July 31, 2015
Therapeutic Area Metastatic Progressive Differentiated Thyroid Carcinoma (DTC)
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.