Idaho Medicaid – Therapeutic Criteria for Increlex Approved by Pharmacy & Therapeutics Committee on April 18, 2014 Diagnoses and Criteria Children with Severe Primary igf-1

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  Height standard deviation < -3.0 AND
  
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  Basal IGF-1 standard deviation score < -3.0 AND
  
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  Normal or elevated growth hormone levels (for children with primary IGF-1 deficiency).
  

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  Secondary forms of IGF-1 deficiency including growth hormone deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids
  

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  Active or suspected malignancy.
  
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  Closed epiphyses.
  
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  Children less than 2 years of age (safety and efficacy has not been established).
  

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  Recommended starting dose is 0.04-0.08mg/kg/dose given subcutaneously twice daily
  
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  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.
  

Height 3 or more standard deviations below mean of normal for age and sex

Increase in height of at least 2 cm over the past year

AND

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

AND

No expanding lesion or tumor diagnosis

Chronological age < 18 years.

Endocrinologist is initiating the growth hormone therapy AND

Most recent endocrinologist’s office visit note AND

Current growth chart AND

Most recent bone age

REFERENCES
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