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alpelisib

Last Updated: May 27, 2021
Result type: Reports
Project Number: PC0247-000
Product Line: Reimbursement Review

Generic Name: alpelisib

Brand Name: Piqray

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Advanced or Metastatic Breast Cancer

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.

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

Tumour Type: Breast

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule A

  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 openMarch 23, 2021
Call for patient/clinician input closedMay 14, 2021
Clarification:

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

Submission receivedApril 21, 2021
Submission acceptedMay 05, 2021
Review initiatedMay 06, 2021
Draft CADTH review report(s) provided to sponsor for commentJuly 21, 2021
Deadline for sponsors commentsJuly 30, 2021
CADTH responses on draft review report(s) provided to sponsorAugust 26, 2021
Expert committee meeting (initial)September 08, 2021
Draft recommendation issued to sponsorSeptember 20, 2021
To
September 22, 2021