Chorionic Gonadotropin and Pregnyl will be approved when ALL of the following are met:
- The requested medication will NOT be used to promote fertility
AND - The requested medication will NOT be used to treat erectile dysfunction AND
- ONE of the following:
- The patient has a diagnosis of prepubertal cryptorchidism not due to anatomic obstruction
OR - The patient’s sex is male with a diagnosis of hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency) AND BOTH of the following:
- The patient has a measured current or pretreatment total serum testosterone level that is below the testing laboratory’s lower limit of the normal range or is less than 300 ng/dL OR a free serum testosterone level that is below the testing laboratory’s lower limit of the normal range
AND - The patient has measured luteinizing hormone (LH) AND follicle-stimulating hormone (FSH) levels that are at (low-normal) or below the testing laboratory’s normal range
OR
- The patient has a measured current or pretreatment total serum testosterone level that is below the testing laboratory’s lower limit of the normal range or is less than 300 ng/dL OR a free serum testosterone level that is below the testing laboratory’s lower limit of the normal range
- The patient has an indication that is supported in CMS approved compendia for the requested medication
AND
- The patient has a diagnosis of prepubertal cryptorchidism not due to anatomic obstruction
- The patient does NOT have any FDA labeled contraindications to the requested medication
Length of Approval: 12 months
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