Tafinlar & Mekinist in combo Melanoma Adjuvant Therapy – Details

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Generic Name:
Dabrafenib & Trametinib in combo
Project Status:
Complete
Therapeutic Area:
Melanoma Adjuvant Therapy
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Tafinlar & Mekinist in combo
Project Line:
Reimbursement Review
Project Number:
PC0152-000
NOC Status at Filing:
Post NOC
Strength:
50 mg & 75 mg and 0.5 mg & 2.0 mg
Tumour Type:
Skin & Melanoma
Indications:
Melanoma Adjuvant Therapy
Funding Request:
For the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection
Pre Noc Submission:
Yes
Sponsor:
Novartis Pharmaceuticals Canada Inc.
Submission Date:
Submission Deemed Complete:
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.