CDA | Evidence Driven
CDA | Evidence Driven

Larotrectinib for Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours – Details

Details

Files
Generic Name:
Larotrectinib
Project Status:
Complete
Therapeutic Area:
NTRKplus solid tumours
Manufacturer:
Bayer Inc.
Brand Name:
Vitrakvi
Project Line:
Reimbursement Review
Project Number:
PC0159-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
25 mg, 100 mg & 20 mg/mL
Tumour Type:
Other
Indications:
Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours
Funding Request:
For the treatment of adult and pediatric patients with locally advanced or metastatic solid tumours harbouring a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Additional criteria: Age ≥ 1 month; ECOG score of ≤3; Tumour harbouring NTRK1, NTRK2 or NTRK3 gene fusion confirmed by a validated diagnostic testing method; Patients eligible for larotrectinib should have no satisfactory alternative treatments or have progressed following treatment
Pre Noc Submission:
Yes
Sponsor:
Bayer 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:
Do not reimburse
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – pERC Final Recommendation Final Recommendation October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Final Economic Guidance Report Guidance Reports October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Final Clinical Guidance Report Guidance Reports October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – pERC Initial Recommendation Initial Recommendation October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – PAG Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Manufacturer Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Patient Advocacy Group Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Clinician Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
arotrectinib (Vitrakvi) NTRK+ solid tumours – Patient Advocacy Group COI Declarations COI Declarations October 31, 2019 View PDF
Larotrectinib (Vitrakvi) NTRK+ solid tumours – Clinician COI Declarations COI Declarations October 31, 2019 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 : November 15, 2019