Last Updated : October 20, 2015
Details
FilesGeneric Name:
Ponatinib
Project Status:
Complete
Therapeutic Area:
Chronic Myeloid Leukemia/ Acute Lymphoblastic Leukemia
Manufacturer:
ARIAD Pharmaceuticals, Inc.
Brand Name:
Iclusig
Project Line:
Reimbursement Review
Project Number:
PC0056 -000
Strength:
15 mg and 45 mg tablets
Tumour Type:
Leukemia
Indications:
Chronic Myeloid Leukemia/ Acute Lymphoblastic Leukemia
Funding Request:
For the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance.
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
ARIAD Pharmaceuticals, Inc.
Submission Date:
Submission Deemed Complete:
Submission Date (Target Date):
Prioritization Requested:
Not Requested
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
Clarification:
Due to the number of items for deliberation, the pERC meeting was conducted over two days. pERC held deliberations for reconsideration items, including ponatinib, on September 18, 2015.
pERC Meeting:
Final Recommendation Issued:
Files
‡ 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 : October 20, 2015