Last Updated : April 23, 2024
Details
FilesGeneric Name:
metreleptin
Project Status:
Active
Therapeutic Area:
Leptin deficiency in lipodystrophy
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Myalepta
Project Line:
Reimbursement Review
Project Number:
SR0784-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per the anticipated indication: As an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above with confirmed familial partial LD (PL) or acquired PL (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Anticipated indication: As an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above with confirmed familial partial LD (PL) or acquired PL (Barraquer-Simons syndrome), in adults and children 12 years of age and above with persistent significant metabolic disease for whom standard treatments have failed to achieve adequate metabolic control.
- 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 | June 13, 2023 |
|---|---|
| Call for patient/clinician input closed | August 04, 2023 |
| Clarification: - Patient input submission received from the Lipodystrophy Canada Foundation | |
| Submission received | July 25, 2023 |
| Submission accepted | August 09, 2023 |
| Review initiated | August 10, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 26, 2023 |
| Deadline for sponsors comments | November 06, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | December 08, 2023 |
| Expert committee meeting (initial) | December 20, 2023 |
| Draft recommendation issued to sponsor | January 22, 2024 |
| Draft recommendation posted for stakeholder feedback | February 01, 2024 |
| End of feedback period | February 15, 2024 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | April 24, 2024 |
Files
Last Updated : April 23, 2024