mecasermin

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Generic Name:
mecasermin
Project Status:
Complete
Therapeutic Area:
Severe primary insulin-like growth factor-1 deficiency
Manufacturer:
Ipsen Biopharmaceuticals Canada, Inc.
Brand Name:
Increlex
Project Line:
Reimbursement Review
Project Number:
SR0692-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Increlex (mecasermin) is indicated for the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD). SPIGFD is defined by: • Height standard deviation score ≤–3.0 and; • Basal IGF-1 levels below the 2.5th percentile for age and gender and; • GH sufficiency. • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. SPIGFD includes patients with mutations in the GH recep...
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. 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 Milestones2

Call for patient/clinician input open14-May-21
Call for patient/clinician input closed12-Jul-21
Clarification:

- Patient input submission received from ICOSEP

Submission received14-Jun-21
Submission accepted
Review initiated29-Jun-21
Draft CADTH review report(s) provided to sponsor for comment14-Sep-21
Deadline for sponsors comments23-Sep-21
CADTH responses on draft review report(s) provided to sponsor12-Nov-21
Expert committee meeting (initial)24-Nov-21
Draft recommendation issued to sponsor06-Dec-21
Draft recommendation posted for stakeholder feedback16-Dec-21
End of feedback period07-Jan-22
Final recommendation issued to sponsor and drug plans21-Jan-22
Final recommendation posted08-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Feb-22
CADTH review report(s) posted01-Mar-22