Idaho Medicaid – Therapeutic Criteria for Increlex
Approved by Pharmacy & Therapeutics Committee on April 18, 2014
Diagnoses and Criteria
Children with Severe Primary IGF-1 (Insulin-Like Growth Factor) Deficiency
Children with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.
Height standard deviation < -3.0 AND
Basal IGF-1 standard deviation score < -3.0 AND
Normal or elevated growth hormone levels (for children with primary IGF-1 deficiency).
Increlex should NOT be used for:
Thyroid and nutritional deficiencies must be corrected before initiating Increlex treatment.
Increlex is NOT a substitute for growth hormone for growth hormone approved indications.
Active or suspected malignancy.
Children less than 2 years of age (safety and efficacy has not been established).
Recommended starting dose is 0.04-0.08mg/kg/dose given subcutaneously twice daily
Maximum dose is 0.12mg/kg/dose given subcutaneously twice daily. Higher mg/kg doses have not been studied and should not be used due to potential hypoglycemic effects.
Medical Necessity Documentation for Growth
For initial approval only
Height 3 or more standard deviations below mean of normal for age and sex
For initial approvals AND annual renewals (all of the following must be met)
Increase in height of at least 2 cm over the past year
Bone age: female < 14 years and male < 16 years. The radiology report should include standard deviation and/or confidence intervals
Documentation of open epiphyses within the previous six months
No expanding lesion or tumor diagnosis
Chronological age < 18 years.
Documentation Required for Prior Authorization Requests
Physician notes documenting the diagnosis AND
Endocrinologist is initiating the growth hormone therapy AND
Most recent endocrinologist’s office visit note AND
Current growth chart AND
Most recent bone age
Increlex Prescribing information. Tersica, Inc., Brisbane, CA. Version 2/16/2011.
Corporate Medical Policy: Treatment for Severe Primary IGF-1 Deficiency. Blue Cross Blue Shield, 2011.
Medical Policy Statement: Increlex. CareSource, 2011.
Texas Medicaid: Criteria for Outpatient Use Guidelines for Increlex, 2012.
Summary Growth Factors. Magellan Medicaid Administration. Last revised March 2012.
Initial approval by Idaho Medicaid’s Pharmacy & Therapeutics Committee – 05/11/2012
Reaffirmed by Idaho Medicaid’s P&T Committee with no changes – 4/19/13 and 4/18/14