Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pediatric Growth Hormone Deficiency. 
Treatment: Norditropin. 

The insurer denied the Norditropin. 
The denial is overturned. 

The patient is a male. He has a diagnosis of GHD (growth hormone deficiency) based on a height at the 1.3 percentile, failed two GH (growth hormone) stimulation tests. He had very low levels of GH  (growth hormone) at < [less than] 0.1, and a peak of 5.7 ng/dl (nanograms per deciliter). The patient had a height SDS (standard deviation score) of -2.20, and -2.36 over an approximate three year period.  He had a Height Velocity of 4.77 centimeters per year. His Height Velocity SDS (standard deviation score) was -0.48. He had normal bone age, and possible microadenoma of the pituitary gland.

Yes, the treatment with Norditropin is medically necessary. 

The drug is being requested for a medically accepted indication as supported by current medical literature and any applicable diagnostic/treatment guidelines. The use of growth hormone therapy is considered medically necessary if the criteria for growth hormone therapy is met. Per the Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone Deficiency (GHD) in Childhood and Adolescence by The GH (Growth Hormone) Research Society (reference #1): Diagnosing  GHD (growth hormone deficiency) requires a multifaceted process including comprehensive clinical and auxological assessment, combined with biochemical tests of the GH (growth hormone)-insulin-like growth factor (IGF) axis and sometimes radiological evaluation which includes the following: 
1- Clinical and Auxological Criteria: Criteria to initiate immediate investigation include the following: 
	 1) Severe short stature, defined as a height more than 3 SD (standard deviation) below the mean; 
	 2) Height more than 1.5 SD (standard deviation) below the mid-parental height; 
	 3) Height more than 2 SD (standard deviation) below the mean and a height velocity over 1 year more than 1 SD (standard deviation) below the mean for chronological age, or a decrease in height SD (standard deviation) of more than 0.5 over 1 year in children over 2 yrs. of age; 
	 4) In the absence of short stature, a height velocity more than 2 SD (standard deviation) below the mean over 1 year or more than 1.5 SD (standard deviation) sustained over 2 years; this may occur in GHD (growth hormone deficiency), presenting in infancy, or in organic acquired GHD (growth hormone deficiency); 
	 5) Signs indicative of an intracranial lesion; 
	 6) Signs of multiple pituitary hormone deficiency (MPHD); and 
	 7) Neonatal symptoms and signs of GHD (growth hormone deficiency). 
2- Biochemical Assessment of GHD (growth hormone deficiency): 
	 1) A combination of 2 provocative growth hormone (GH) testing can be used to test for GHD (growth hormone deficiency) and failing both tests has traditionally been used to support the diagnosis. An IGF-1 (insulin-like growth factor 1) value less than -2 SD (standard deviation) suggest an abnormality in the GH (growth hormone) axis.
3. Radiological Evaluation: 
	 1) Showing evidence of delayed bone age or abnormal pituitary gland. 

This patient was diagnosed with growth hormone deficiency (GHD). Based on review the records, the patient did meet many of the key criteria for the diagnosis of an isolated growth hormone deficiency including the above Clinical and Radiological criteria. The patient did meet the biochemical findings for GHD (growth hormone deficiency) including failure of 2 GH (growth hormone) provocative testing with very low GH (growth hormone) levels. This patient also has significant short stature. In addition, the patient is growing at average of less 5 cm (centimeters) per year. His height SDS (standard deviation score) deteriorated from -2.20 SDS (standard deviation score) to -2.36 SDS (standard deviation score) over approximately three years. These findings are consistent with growth hormone deficiency per the above Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone (GH) Deficiency in Childhood and Adolescence by The GH (growth hormone) Research Society and the referenced medical literature. 

Therefore, given the above, the drug is being requested for a medically accepted indication as supported by current medical literature and any applicable diagnostic/treatment guidelines, and is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.