CDA | Evidence Driven
CDA | Evidence Driven

Acalabrutinib (Calquence) for previously untreated chronic lymphocytic leukemia - Details

Details

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Generic Name:
Acalabrutinib
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Calquence
Project Line:
Reimbursement Review
Project Number:
PC0210-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Strength:
100 mg
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia (CLL) (previously untreated)
Funding Request:
With or without obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) for whom a fludarabine-based regimen is inappropriate.
Sponsor:
AstraZeneca Canada 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:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

Acalabrutinib (Calquence) CLL (previously untreated) – pERC Final Recommendation Final Recommendation January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Final Economic Guidance Report Guidance Reports January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Final Clinical Guidance Report Guidance Report January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – pERC Initial Recommendation Initial Recommendation October 29, 2020 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – PAG Feedback on Initial Recommendation Feedback January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Manufacturer Feedback on Initial Recommendation Feedback January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Patient Advocacy Group Feedback on Initial Recommendation Feedback January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Clinician Feedback on Initial Recommendation Feedback January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Patient Advocacy Group COI Declarations COI Declarations January 8, 2021 View PDF
Acalabrutinib (Calquence) CLL (previously untreated) – Clinician COI Declarations COI Declarations January 8, 2021 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 : January 25, 2021