mecasermin


( Last Updated : May 14, 2021)
Generic Name:
mecasermin
Project Status:
Received
Therapeutic Area:
Severe primary insulin-like growth factor-1 deficiency
Manufacturer:
Ipsen Biopharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Increlex
Project Line:
Reimbursement Review
Project Number:
SR0692-000
Call for patient/clinician input closed:

Details


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:
Pending
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 rece...
  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 open14-May-21
Call for patient/clinician input closed12-Jul-21
Submission received14-Jun-21
Submission accepted