Download Increlex (mecasermin [rDNA origin] injection) 21122, J-2170

PHARMACY PRE-AUTHORIZATION CRITERIA
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Increlex (mecasermin [rDNA origin] injection)
21122, J‐2170 Increlex™ (mecasermin [rDNA origin] injection) is indicated for the long‐term treatment of growth failure in children with severe primary IGF‐1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. ConnectiCare considers Increlex™ to be medically necessary when the following criteria are met:  Patient must be evaluated by a pediatric endocrinologist  The child is diagnosed with severe primary insulin‐like growth factor‐1 (IGF‐1) deficiency. (Primary IGFD) must meet the following criteria (a through c). a. Height standard deviation score is ≤ ‐3.0 b. Basal IGF‐1standard deviation score ≤ ‐3.0 c. Growth hormone is normal or increased. OR  The child is diagnosed with growth hormone (GH) deletion and has developed neutralizing antibodies to GH. If the above criteria are met initial authorization is limited to 3 months. Subsequent authorization (up to 1 year) will be granted with documented efficacy. The quantity is limited to a maximum of a 30 day supply per fill. REFERENCES
1. Increlex full prescribing information. Brisbane, CA: Tercia Inc. 2. U.S. National Institutes of Health. Clinical Trials. Prepubertal Children with Growth Failure Associate with Primary Insulin‐Like Growth Factor‐1 (IGF‐1) Deficiency. Available at: http://www.clinicaltrials.gov/ct/gui/show/NCT00125164. P&T REVIEW
HISTORY
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12/05, 6/07, 6/08, 9/09, 9/10, 12/11, 10/12, 10/13, 10/14, 11/15, 5/16 5/16