CDA | Evidence Driven
CDA | Evidence Driven

Treanda for Chronic Lymphocytic Leukemia (First Line)

Détails

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Generic Name:
Bendamustine hydrochloride
État du projet:
Terminé
Domaine thérapeutique:
Chronic Lymphocytic Leukemia (first-line)
Fabricant:
Lundbeck Canada Inc.
Brand Name:
Treanda
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0011-000
Strength:
25mg/vial and 100mg/vial
Tumour Type:
Leukemia
Indications:
Chronic lymphocytic leukemia (First Line)
Funding Request:
Patients with Chronic Lymphocytic Leukemia (first line) for whom fludarabine-based therapy is not appropriate
Review Status:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Lundbeck Canada Inc.
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Non demandée
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
Recommandation:
Remboursement sous critères cliniques ou conditions
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
pERC Meeting:
Final Recommendation Issued:

As per pCODR Procedures B5.4, the pERC deliberations for Bendamustine (Treanda) First Line treatment of patients with CLL were deferred to the January 17, 2013 pERC meeting date, once the submitter provided the requested additional economic information. pERC issued a final recommendation for Bendamustine (Treanda) for Relapsed/Refractory CLL separately to the First Line indication. Please see the Bendamustine (Treanda) for Chronic Lymphocytic Leukemia (Relapsed/Refractory) Details page for more information.

Fichiers

Provincial Funding Summary Résumé, financement provincial Afficher le PDF
Bendamustine (Treanda) for CLL (Firstline)- pERC Final Recommendation Recommandation finale 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - Final Clinical Guidance Report Rapports d'orientation 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - Final Economic Guidance Report Rapports d'orientation 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - pERC Initial Recommendation Recommandation initiale 31 janvier 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - PAG Feedback on Initial Recommendation Rétroaction 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - Manufacturer (Lundbeck Canada) Feedback on Initial Recommendation Rétroaction 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - Patient Advocacy Group (CLL PAG) COI Declarations Rétroaction 19 février 2013 Afficher le PDF
Bendamustine (Treanda) for CLL (First Line) - Patient Advocacy Group (LLSC) COI Declarations Rétroaction 19 février 2013 Afficher le 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.

Dernière mise à jour : 02 septembre 2016