alpelisib


( Last Updated : September 14, 2021)
Generic Name:
alpelisib
Project Status:
Active
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

Details


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.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open March 23, 2021
Call for patient/clinician input closed May 14, 2021
Clarification:

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

Submission received April 21, 2021
Submission accepted May 05, 2021
Review initiated May 06, 2021
Draft CADTH review report(s) provided to sponsor for comment July 21, 2021
Deadline for sponsors comments July 30, 2021
CADTH responses on draft review report(s) provided to sponsor August 26, 2021
Expert committee meeting (initial) September 08, 2021