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CDA | Evidence Driven

Idhifa for Acute Myeloid Leukemia – Details

Details

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Generic Name:
Enasidenib
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia (AML)
Manufacturer:
Celgene Inc.
Brand Name:
Idhifa
Project Line:
Reimbursement Review
Project Number:
PC0144-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
50 mg and 100 mg
Tumour Type:
Leukemia
Indications:
Acute Myeloid Leukemia (AML)
Funding Request:
For the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation
Sponsor:
Celgene 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
Enasidenib (Idhifa) AML – pERC Final Recommendation Final Recommendation October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Final Economic Guidance Report Guidance Reports October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Final Clinical Guidance Report Guidance Reports October 31, 2019 View PDF
Enasidenib (Idhifa) AML – pERC Initial Recommendation Initial Recommendation August 29, 2019 View PDF
Enasidenib (Idhifa) AML – PAG Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Manufacturer Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Patient Advocacy Group Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Clinician Feedback on Initial Recommendation Feedback October 31, 2019 View PDF
Enasidenib (Idhifa) AML – Patient Advocacy Group COI Declarations COI Declarations October 31, 2019 View PDF
Enasidenib (Idhifa) AML – 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