Last Updated : December 16, 2021
Details
FilesGeneric 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:
- 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 open | 14-May-21 |
| Call for patient/clinician input closed | 12-Jul-21 |
| Clarification: - Patient input submission received from ICOSEP | |
| Submission received | 14-Jun-21 |
| Submission accepted | |
| Review initiated | 29-Jun-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 14-Sep-21 |
| Deadline for sponsors comments | 23-Sep-21 |
| CADTH responses on draft review report(s) provided to sponsor | 12-Nov-21 |
| Expert committee meeting (initial) | 24-Nov-21 |
| Draft recommendation issued to sponsor | 06-Dec-21 |
| Draft recommendation posted for stakeholder feedback | 16-Dec-21 |
| End of feedback period | 07-Jan-22 |
| Final recommendation issued to sponsor and drug plans | 21-Jan-22 |
| Final recommendation posted | 08-Feb-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 04-Feb-22 |
| CADTH review report(s) posted | 01-Mar-22 |
Files
Last Updated : December 16, 2021