Imbruvica for Chronic Lymphocytic Leukemia (previously untreated) – Details

Details

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Generic Name:
Ibrutinib
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia (previously untreated)
Manufacturer:
Janssen Canada Inc.
Brand Name:
Imbruvica
Project Line:
Reimbursement Review
Project Number:
PC0085-000
NOC Status at Filing:
Pre NOC
Strength:
140 mg Capsule
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (previously untreated)
Funding Request:
For patients with previously untreated CLL/SLL for whom fludarabine-based treatment is considered inappropriate
Pre Noc Submission:
Yes
Sponsor:
Janssen Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
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:

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‡ 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.