metreleptin

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Generic 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.
  1. 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 open13-Jun-23
Call for patient/clinician input closed04-Aug-23
Clarification:

- Patient input submission received from the Lipodystrophy Canada Foundation

Submission received25-Jul-23
Submission accepted09-Aug-23
Review initiated10-Aug-23
Draft CADTH review report(s) provided to sponsor for comment26-Oct-23
Deadline for sponsors comments06-Nov-23
CADTH review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor22-Jan-24
Draft recommendation posted for stakeholder feedback01-Feb-24
End of feedback period15-Feb-24
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determined