Last Updated : June 22, 2018
Details
FilesGeneric 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
Performance Metric:
Achieved
Biosimilar:
No
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
Last Updated : June 22, 2018