mecasermin


( Last Updated : September 23, 2021)
Generic Name:
mecasermin
Project Status:
Active
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

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:
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 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 openMay 14, 2021
Call for patient/clinician input closedJuly 12, 2021
Clarification:

- Patient input submission received from ICOSEP

Submission receivedJune 14, 2021
Submission accepted
Review initiatedJune 29, 2021
Draft CADTH review report(s) provided to sponsor for commentSeptember 14, 2021
Deadline for sponsors commentsSeptember 23, 2021
CADTH responses on draft review report(s) provided to sponsorNovember 12, 2021
Expert committee meeting (initial)November 24, 2021
Draft recommendation issued to sponsorDecember 06, 2021
To
December 08, 2021