CDA | Evidence Driven
CDA | Evidence Driven

Tafinlar & Mekinist in combo for Metastatic Melanoma - Details

Details

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Generic Name:
Dabrafenib & Trametinib in combo
Project Status:
Complete
Therapeutic Area:
Metastatic Melanoma
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Tafinlar & Mekinist in combo
Project Line:
Reimbursement Review
Project Number:
PC0053-000
Performance Metric:
N/A — Predated performance metrics
Strength:
Dabrafenib: 50mg and 75mg capsules;Trametinib: 0.5mg and 2.0mg tablets
Tumour Type:
Skin and Melanoma
Indications:
Metastatic Melanoma
Funding Request:
Dabrafenib and trametinib in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF 600 mutation.
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
GlaxoSmithKline Inc.
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:

Files

Provincial Funding Summary View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - Final pERC Recommendation Final Recommendation July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - Final Clinical Guidance Report Guidance Reports July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - Final Economic Guidance Report Guidance Reports July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - Initial pERC Recommendation Initial Recommendation July 3, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - PAG Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma - Manufacturer Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma – Patient Advocacy Group (MNC) Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma – Patient Advocacy Group (SYSF) Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma – Patient Advocacy Group (MNC) COI Declarations COI Declarations July 21, 2015 View PDF
Dabrafenib (Tafinlar) Trametinib (Mekinist) Metastatic Melanoma – Patient Advocacy Group (SYSF) COI Declarations COI Declarations July 21, 2015 View PDF

‡ 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.

Last Updated : September 29, 2015