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:

March 22, 2021

Brand Name:

Piqray

Project Line:

Reimbursement Review

Project Number:

PC0247-000

Call for patient/clinician input closed:

May 14, 2021

Tumour Type:

Breast

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

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:

January 26, 2022

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 open	23-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 received	21-Apr-21
Submission accepted	05-May-21
Review initiated	06-May-21
Draft CADTH review report(s) provided to sponsor for comment	21-Jul-21
Deadline for sponsors comments	30-Jul-21
CADTH responses on draft review report(s) provided to sponsor	26-Aug-21
Expert committee meeting (initial)	08-Sep-21
Draft recommendation issued to sponsor	22-Sep-21
Draft recommendation posted for stakeholder feedback	01-Oct-21
End of feedback period	18-Oct-21
Clarification: - Reconsideration: major revisions requested by sponsor
Expert committee meeting	12-Jan-22
Final recommendation issued to sponsor and drug plans	26-Jan-22
Final recommendation posted	11-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	09-Feb-22
CADTH review report(s) posted	21-Mar-22