Last Updated : October 10, 2024
Details
FilesGeneric Name:
metreleptin
Project Status:
Complete
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
Performance Metric:
Achieved
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
| Call for patient/clinician input open | 13-Jun-23 |
|---|---|
| Call for patient/clinician input closed | 04-Aug-23 |
| Clarification: - Patient input submission received from the Lipodystrophy Canada Foundation | |
| Submission received | 25-Jul-23 |
| Submission accepted | 09-Aug-23 |
| Review initiated | 10-Aug-23 |
| Draft Canada's Drug Agency review report(s) provided to sponsor for comment | 26-Oct-23 |
| Deadline for sponsors comments | 06-Nov-23 |
| Canada's Drug Agency review report(s) and responses to comments provided to sponsor | 08-Dec-23 |
| Expert committee meeting (initial) | 20-Dec-23 |
| Draft recommendation issued to sponsor | 22-Jan-24 |
| Draft recommendation posted for stakeholder feedback | 01-Feb-24 |
| End of feedback period | 15-Feb-24 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 24-Apr-24 |
| Final recommendation issued to sponsor and drug plans | 09-May-24 |
| Final recommendation posted | 28-May-24 |
| Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | 24-May-24 |
| Clarification: - Extension requested by sponsor | |
| Canada's Drug Agency review report(s) posted | 10-Oct-24 |
Files
Last Updated : October 10, 2024