Last Updated : May 7, 2024
Details
Generic Name:
leniolisib
Project Status:
Active
Therapeutic Area:
Activated phosphoinositide 3 kinase delta syndrome
Manufacturer:
Pharming Technologies BV
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0792-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pharming requests reimbursement for leniolisib for the treatment of APDS in adults and adolescents 12 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Indicated for the treatment of activated phosphoinositide 3 kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older.
- 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.
| Call for patient/clinician input open | March 07, 2024 |
|---|---|
| Call for patient/clinician input closed | April 30, 2024 |
| Clarification: - Patient input submission received from the Canadian Immunodficiencies Patient Organization (operating as Immunity Canada) | |
| Submission received | April 19, 2024 |
| Submission accepted | May 06, 2024 |
| Review initiated | May 07, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 22, 2024 |
| Deadline for sponsors comments | July 31, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | September 13, 2024 |
| Expert committee meeting (initial) | September 25, 2024 |
| Draft recommendation issued to sponsor | October 08, 2024 To October 10, 2024 |
| Draft recommendation posted for stakeholder feedback | October 17, 2024 |
| End of feedback period | October 31, 2024 |
Last Updated : May 7, 2024