Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Nivolumab
État du projet:
Terminé
Domaine thérapeutique:
Metastatic Melanoma
Fabricant:
Bristol-Myers Squibb Canada
Brand Name:
Opdivo
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0063-000
Statut de l’AC au moment du dépôt:
Pré AC
Strength:
40mg/4mL and 100mg/10mL vials
Tumour Type:
Peau et mélanome
Indications:
Metastatic Melanoma
Funding Request:
For the treatment of both first-line and previously-treated advanced adult melanoma patients, regardless of BRAF status
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Bristol-Myers Squibb Canada
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Demandée et accordée
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommandation:
Remboursement sous critères cliniques ou conditions
Clarification:
An expanded scope of review has been granted for nivolumab (Opdivo). In accordance with the pCODR Procedures, the pCODR Provincial Advisory Group (PAG) requested additional information on nivolumab (Opdivo) which extends beyond the submitted scope of the review. Revision of review scope may be considered by pCODR in very limited instances, based on jurisdictional input, feasibility to conduct the revised review and clinical importance. All three criteria for scope modification were met in this case. The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided and a new target pERC date has been set by pCODR.
pERC Meeting:
Final Recommendation Issued:
Fichiers
‡ 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