alpelisib

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Generic Name:
alpelisib
Project Status:
Complete
Therapeutic Area:
Advanced or Metastatic Breast Cancer
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Piqray
Project Line:
Reimbursement Review
Project Number:
PC0247-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
alpelisib in combination with fulvestrant for the treatment of postmenopausal women and men, with hormone receptor-positive, HER2-negative, PIK3CA mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen with a CDK 4/6 inhibitor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Piqray (alpelisib), in combination with fulvestrant, is indicated for the treatment of postmenopausal women and men, with hormone receptor-positive, HER2-negative, PIK3CA mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones

Call for patient/clinician input open23-Mar-21
Call for patient/clinician input closed 14-May-21
Clarification:

- Patient input submission received from Rethink Breast Cancer, CanCertainty, and Canadian Breast Cancer Network.

Submission received21-Apr-21
Submission accepted05-May-21
Review initiated06-May-21
Draft CADTH review report(s) provided to sponsor for comment21-Jul-21
Deadline for sponsors comments30-Jul-21
CADTH responses on draft review report(s) provided to sponsor26-Aug-21
Expert committee meeting (initial)08-Sep-21
Draft recommendation issued to sponsor22-Sep-21
Draft recommendation posted for stakeholder feedback01-Oct-21
End of feedback period18-Oct-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting12-Jan-22
Final recommendation issued to sponsor and drug plans26-Jan-22
Final recommendation posted11-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)09-Feb-22
CADTH review report(s) posted21-Mar-22