Prior Authorization Criteria for Approval

Omnitrope will be approved when criteria below are met.

For Children – Initial Evaluation will be approved when BOTH of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of Turner Syndrome
      OR
   2. The patient has a diagnosis of Prader-Willi Syndrome
      OR
   3. The patient has a diagnosis of panhypopituitarism AND BOTH of the following:
      1. Deficiencies in 3 or more pituitary axes
         AND
      2. Measured serum IGF-1 (insulin-like growth factor-1) levels are below the age and sex-appropriate reference range when off GH therapy
         OR
   4. The patient has a diagnosis of growth hormone deficiency (GHD) or short stature AND BOTH of the following:
      1. The patient has ONE of the following:
         1. Height more than 2 standard deviations (SD) below the mean for age and sex
            OR
         2. Height more than 1.5 SD below the midparental height
            OR
         3. A decrease in height SD of more than 0.5 over one year in children at least 2 years of age
            OR
         4. Height velocity more than 2 SD below the mean over one year or more than 1.5 SD sustained over two years
            AND
      2. Failure of at least 2 growth hormone (GH) stimulation tests (e.g., peak GH value of less than 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab)
         OR
   5. The patient has a diagnosis of small for gestational age (SGA) AND ALL of the following:
      1. Patient is at least 2 years of age
         AND
      2. Documented birth weight and/or length that is 2 or more standard deviations (SD) below the mean for gestational age
         AND
      3. At 24 months of age, the patient fails to manifest catch-up growth evidenced by a height that remains 2 or more SD below the mean for age and sex
         AND
2. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months

For Children – Renewal Evaluation will be approved when ALL of the following are met:

1. The patient has been previously approved for the preferred medication through the plan’s Prior Authorization criteria
   AND
2. The patient has been diagnosed with ONE of the following:
   1. Growth Hormone Deficiency, Short Stature
      OR
   2. Panhypopituitarism
      OR
   3. Prader-Willi Syndrome
      OR
   4. Small for Gestational Age (SGA)
      OR
   5. Turner Syndrome
      AND
3. ALL of the following:
   1. The patient does NOT have closed epiphyses
      AND
   2. The patient is being monitored for adverse effects of therapy with the requested medication AND
   3. The patient’s height has increased or height velocity has improved since initiation or last approval of the requested medication
      AND
4. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months

For Adults - Initial Evaluation will be approved when BOTH of the following are met:

1. The patient has been diagnosed with ONE of the following:
   1. Childhood growth hormone deficiency (GHD) with genetic or organic origin AND ONE of the following:
      1. Low IGF-1 (insulin-like growth factor-1) level without GH replacement therapy
         OR
      2. Failure of at least one growth hormone (GH) stimulation test as an adult (e.g., peak GH value of 5 mcg/L or lower after stimulation, or otherwise considered abnormal as determined by testing lab)
         OR
   2. Acquired adult GHD secondary to structural lesions or trauma AND ONE of the following:
      1. The patient has a diagnosis of panhypopituitarism AND BOTH of the following:
         1. Deficiencies in 3 or more pituitary axes
            AND
         2. Low IGF-1 level without GH replacement therapy
            OR
      2. The patient has failed at least one growth hormone (GH) stimulation test as an adult
         OR
   3. Idiopathic GHD (adult or childhood onset) AND the patient has failed at least two growth hormone (GH) stimulation tests as an adult
      AND
2. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months

For Adults - Renewal Evaluation will be approved when ALL of the following are met:

1. The patient has been previously approved for the preferred medication through the plan’s Prior Authorization criteria
   AND
2. The patient has been diagnosed with ONE of the following:
   1. Childhood growth hormone deficiency (GHD) with genetic or organic origin
      OR
   2. Acquired adult GHD secondary to structural lesions or trauma
      OR
   3. Idiopathic GHD (adult or childhood onset)
      AND
3. The patient is being monitored for adverse effects of therapy with the requested medication
   AND
4. The patient’s IGF-1 level has been evaluated to confirm the appropriateness of the current dose
   AND
5. The patient has had clinical benefit with the requested medication (i.e., body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life)
   AND
6. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months