Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

This patient is a 37-year-old male who was evaluated in October 2004. He presents with symptoms of fatigue, decreased libido, inability to lose weight, joint pain and difficulty concentrating. The patient was felt to have hypogonadism. His baseline testosterone level in November 2004 was 284 (350-1030); free testosterone 58 (52-280); percent free testosterone (dialysis) 2.2% (1.5-3.2%); sex hormone binding globulin 0.2 (0.5-1.5); and LH-level 3.6 (1.5-9). He has been treated with Androgel 1% since the initial evaluation. Several subsequent testosterone evaluations have been performed and there has been no marked increase despite treatment with Androgel. The percent free testosterone levels remained normal and the sex hormone binding globulin remained low. A testosterone level from June 2005 showed a total testosterone of 128, percent free testosterone of 2.1% and a free testosterone of 27.  The patient had normal thyroid function test, indicating appropriate TSH secretion.  Cushing's disease and adrenal insufficiency were ruled out, and an MRI of the pituitary was normal.  It was felt that the patient might have growth hormone deficiency. His initial IGF-1 level was 202. Subsequent IGF-1 levels were 161 and 181. A GHRH-Arginine stimulation test demonstrated a baseline growth hormone level of 1.1. with a peak level of  7.7 after two hours. A request has been made for authorization and coverage for growth hormone therapy. The Health Plan has denied the request on the basis that the requested therapy is not medically necessary for treatment of the patients condition.This 37-year-old male patient does not have panhypopituarism. His TSH and ACTH secretions are appropriate. His LH level was 3.2 which is considered to be in the normal range. Most patients with central hypogonadism have LH secretions of 2 or less. The patient has low testosterone levels; he has a normal percent of free testosterone by dialysis and a low sex hormone binding globulin. A low sex hormone binding globulin will lower the total serum testosterone levels, however, the free testosterone level by dialysis should be normal. This patient's percent free testosterone levels by dialysis were always within the normal limits. Based on these results, the diagnosis of central hypogonadism may be questionable.This patient has a GHRH-Arginine stimulation test with a peak of 7.  In the papers of Colao et al. and Aimaretti et. al (1997, 1998) the peak level for this stimulation test was 9. The 2002  Biller et. al study indicated the peak level of growth hormone secretion after this test was set at 5.1 in patients with pituitary deficiencies. In this paper it was also mentioned that obesity could lower the growth hormone response. This patient has a BMI greater than 30.IGF-I levels are a consideration when evaluating patients for growth hormone deficiency. Most patients with growth hormone deficiency have a below normal IGF-I level. However, there are some patients who have low normal or normal IGF-I levels. It has been shown that patients who have an IGF-I level below 80 have a 95% probability of being growth hormone deficient. This probability declines rapidly with higher levels.In summary, this is a patient with hypogonadism, which may not be central, and no other pituitary deficiencies. His peak growth hormone response was 7, which is above 5.1. He had normal IGF-1 levels. Based upon the evidence provided, it does not appear that growth hormone therapy in this patient is warranted.Therefore, I have determined the requested growth hormone therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.