netupitant / palonosetron


( Last Updated : June 22, 2018)
Generic Name:
netupitant / palonosetron
Project Status:
Complete
Therapeutic Area:
Nausea and vomiting (chemotherapy induced) prevention
Manufacturer:
Purdue Pharma
Call for patient/clinician input open:
Brand Name:
Akynzeo
Project Line:
Reimbursement Review
Project Number:
SR0548-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details

Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Nausea and vomiting (chemotherapy induced) prevention
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2
Call for patient input posted November 16, 2017
Patient group input closed January 12, 2018
Clarification:

- No patient input submission received
Submission received December 08, 2017
Submission accepted for review December 22, 2017
Review initiated January 02, 2018
Draft CDR review report(s) sent to applicant March 16, 2018
Comments from applicant on draft CDR review report(s) received March 27, 2018
Redaction requests from applicant on draft CDR review report(s) received April 04, 2018
Clarification:

- No redactions requested by the applicant
CDR review team's comments on draft CDR review report(s) sent to applicant May 04, 2018
Canadian Drug Expert Committee (CDEC) meeting May 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans May 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received June 13, 2018
CDEC Final Recommendation issued to applicant and drug plans June 20, 2018
CDEC Final Recommendation posted June 22, 2018
Final CDR review report(s) and patient input posted June 22, 2018

Files

Recommendations and Reasons

Clinical Report

Pharmacoeconomic Report