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
- 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 |
| Draft recommendation issued to sponsor | September 20, 2021 To September 22, 2021 |