Mecasermin (Increlex)

Abstract

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses mecasermin (Increlex), 10 mg/mL (40 mg/4mL vial), sterile solution for subcutaneous injection. Indication: Treatment of growth failure in children and adolescents from 2 to 18 years with confirmed SPIGFD. SPIGFD is defined by: height standard deviation score ≤ −3.0 basal IGF-1 levels below the 2.5th percentile for age and gender growth hormone 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 GHR gene/Laron’s syndrome, post-GHR signalling pathway, and IGF-1 gene defects.