Cotellic for Metastatic Melanoma – Details

Details

Files
Generic Name:
Cobimetinib
Project Status:
Complete
Therapeutic Area:
Metastatic melanoma
Manufacturer:
Hoffmann-la Roche Ltd.
Brand Name:
Cotellic
Project Line:
Reimbursement Review
Project Number:
PC0070-000
NOC Status at Filing:
Pre NOC
Strength:
20 mg tablet
Tumour Type:
Skin and Melanoma
Indications:
Metastatic Melanoma
Funding Request:
In combination vermurafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-la Roche Ltd.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

‡ 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.