Somatropin Davis Pdf

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  • Growth Hormone (GH) and Growth Hormone Antagonists
  • NZSAP | New Zealand Society of Animal Production
  • Growth Hormone (GH) and Growth Hormone Antagonists

    somatropin davis pdf Aetna considers growth hormone GH medically necessary for the treatment of members in the following diagnostic categories who meet the criteria set test e deca dbol cycle pics below:. Aetna considers GH replacement medically necessary for children and adolescents with the following indications:. This includes over-night hospitalization of children for testing of spontaneous GH secretion. Measurement of insulin-like growth somatropin davis pdf I IGF-I is considered medically necessary to determine somatropin davis pdf of GH therapy in adults and children. However, the diagnosis of GH deficiency should not rely solely on IGF-I measurements, but must be confirmed by provocative tests solely for GH secretion. Aetna considers GH replacement prior to renal transplantation medically necessary for children with chronic renal insufficiency and growth retardation who meet both of the following criteria at initiation of treatment:.

    NZSAP | New Zealand Society of Animal Production

    somatropin davis pdf

    Aetna considers growth hormone GH medically necessary for the treatment of members in the following diagnostic categories who meet the criteria set forth below:. Aetna considers GH replacement medically necessary for children and adolescents with the following indications:. This includes over-night hospitalization of children for testing of spontaneous GH secretion. Measurement of insulin-like growth factor I IGF-I is considered medically necessary to determine adequacy of GH therapy in adults and children.

    However, the diagnosis of GH deficiency should not rely solely on IGF-I measurements, but must be confirmed by provocative tests solely for GH secretion. Aetna considers GH replacement prior to renal transplantation medically necessary for children with chronic renal insufficiency and growth retardation who meet both of the following criteria at initiation of treatment:. Consistent with established guidelines for children with chronic renal insufficiency after renal transplantation, Aetna does not consider resumption of GH therapy medically necessary until at least 1 year after the transplant to allow time to ascertain whether catch-up growth will occur.

    Aetna considers GH replacement medically necessary for children with Turner's syndrome and growth retardation who meet all of the following criteria at initiation of treatment:. Aetna considers GH replacement medically necessary for children with Prader Willi syndrome and growth retardation who meet all of the following criteria at initiation of treatment:. Aetna considers GH supplementation medically necessary for children born small for gestational age, and who meet all of the criteria below:.

    Growth curves plotting growth from birth through age 3 should be submitted for evaluation. Aetna considers GH therapy medically necessary for prepubertal children with short stature associated with Noonan syndrome who meet all of the following criteria at initiation of treatment:. Aetna considers GH therapy medically necessary for the treatment of short stature or growth failure in children with SHOX deficiency whose epiphyses are not closed. In children and adolescents, GH therapy will be considered not medically necessary if any of the following discontinuation criteria is met:.

    At completion of linear growth i. Aetna considers GH treatment of adults with documented GH deficiency medically necessary when all of the following criteria are met at initiation of treatment as an adult:. Aetna considers this treatment medically necessary for an initial 9 months, allowing for an initial 3-month period of GH dose titration, followed by a 6-month therapeutic trial period.

    Subsequent GH treatment is considered medically necessary only if, upon subsequent testing of the effect of this treatment, the member demonstrates a QoL improvement of 7 or more points in QoL-AGHDA score see Figure 4 below. According to available guidelines, for the first 2 to 3 months dosage adjustments should be made after monthly assessments of serum levels of IGF-1, and in response to the presence of adverse effects, until a maintenance dose is achieved.

    As a condition of continued authorization, Aetna requires at least annual reassessment of serum levels of IGF-1 in adults and appropriate dosage adjustments, as GH requirements in adults may decrease with age. The continued medical necessity of GH therapy is reviewed at least annually to determine whether GH therapy continues to be medically necessary.

    The annual medical necessity review focuses on response to therapy, whether discontinuation criteria are met, whether there are any major changes in clinical status affecting the medical necessity of GH supplementation, and verification that the person continues to follow-up with the provider and receive appropriate re-evaluations and care.

    Aetna considers GH supplementation to be medically necessary for persons with short bowel syndrome who depend on intravenous parenteral nutrition for nutritional support.

    Growth hormone treatment of short bowel syndrome for more than 4 weeks is considered experimental and investigational as administration of GH for more than 4 weeks duration has not been adequately studied for this indication.

    There is insufficient evidence of the effectiveness of repeat courses of GH for short bowel syndrome. Aetna considers GH therapy experimental and investigational in persons with any of the following contraindications for which the safety of GH therapy has not been established:. There are several brands of GH on the market see appendix. There is a lack of reliable evidence that any one brand of GH is superior to other brands for medically necessary indications.

    Consequently, because other brands e. Aetna considers GH therapy to be experimental and investigational for the following indications because its effectiveness for these indications has not been established:. GH therapy will be considered medically necessary for persons who meet medical necessity criteria; even if they are also diagnosed with a co-morbid medical condition for which GH therapy is considered not medically necessary or experimental and investigational.

    For example, GH therapy would be considered medically necessary for a child with cystic fibrosis an experimental and investigational indication if the child was also severely GH deficient according to the criteria set forth above. Accordingly, coverage would not be available under most plans, which provide coverage only for treatment of illness, injury or disease.

    When GH is not a covered plan benefit, medical necessity language should not be included within the review determination rationale. This a contractual denial and not based upon medical necessity.

    Mecasermin Increlex and Mecasermin Rinfabate Iplex uyftcvyuffwtzvdutrywwxtx. In addition, the diverse metabolic actions of GH include its anabolic and lipolytic effects. GH also induces insulin resistance. GH has now been shown to be produced throughout adult life and to have important physiologic and metabolic effects long after final height has been reached.

    Growth hormone has been approved by the U. There are several brands of GH somatropin on the market, and there is a lack of reliable evidence that any brand of GH is more effective than others for any indication.

    The skin is thin and dry, and sweating is reduced. Muscle strength and exercise performance are reduced. The diagnosis of adult GH deficiency is established by provocative testing of GH secretion. At present, the insulin tolerance test is the diagnostic test of choice; this test distinguishes GH deficiency from the reduced GH secretion that accompanies normal aging and obesity. The test is contraindicated in members with electrocardiographic evidence or history of ischemic heart disease or in members with seizure disorder.

    The syndrome of GHD characteristically manifests with deficiencies in bone density, reduction in muscle strength and exercise tolerance, decreases in vitality and energy, emotional lability, feelings of social isolation, and increases in body fat and higher serum lipid concentrations.

    The usefulness of GH treatment in adults with pituitary disease who have completed their statural growth is based on the role of GH in increasing bone density and in improving mood and motivation. A Committee convened by the National Institute of Clinical Excellence concluded, however, that it was uncertain what impact GH treatment had on the longer-term clinical outcomes and mortality related to cardiovascular risk factors and changes in bone mineral density.

    In addition, there are other more effective, better established and less costly therapies to reduce cardiovascular risk factors and increase bone mineral density. Upon examination of available evidence, the Committee found that the subgroup of adults with GHD for whom treatment may be clinically justified are those who have an improvement in QoL equivalent to an absolute change in their baseline QoL-AGHDA score of at least 7 points.

    The Committee stated that re-assessment of the need for GH replacement should take place after a trial treatment period of 9 months 3 months for dose titration and 6 months for assessment of response. For GH treatment to continue after this trial period, it should be necessary to demonstrate a sustained improvement in QoL.

    Growth hormone levels continue to decline through adulthood, and the proportion of adults who may be considered GH deficient increases with age. Some investigators have claimed that idiopathic GHD in adults is common and that most cases of idiopathic adult-onset GHD go undetected.

    Clinical studies of elderly persons with relatively low levels of endogenous GH have shown small increases in lean body mass and bone mass, as well as improvements in plasma lipid profile with GH supplementation.

    However, the long-term oncogenic effects and other potential adverse consequences of GH supplementation in adults with idiopathic GHD are unknown. In addition, improvements in lean body mass, bone mass, and plasma lipid profile may be better achieved with other treatments in adults with idiopathic GHD.

    Random samples of GH are usually meaningless. In most academic medical centers, the insulin tolerance test ITT has been the validated study of choice. However, the literature indicates the test has an inherent risk of profound hypoglycemia, and is contraindicated in patients with abnormal electrocardiographic findings, with a history of ischemic heart disease or cerebrovascular disease, or with seizure disorders. According to available guidelines, the ITT is not generally recommended for patients older than 65 years of age.

    In patients in whom insulin-induced hypoglycemia is contraindicated or unsafe or where appropriate testing arrangements are unavailable, the literature states that alternatives to ITT should be used. Information is now emerging that intravenously administered arginine, either alone or in combination with GH-releasing hormone GHRH , may be useful. When only intravenously administered arginine is used, cut-off values for a normal response are similar to those expected with ITT.

    Available literature suggests tests that use of glucagon, propranolol, or levodopa has a lesser established diagnostic value in comparison to ITT.

    Although useful as a diagnostic procedure in children, the literature states that a test that uses clonidine is of dubious value for the diagnosis of GH deficiency in adults. In adults with childhood onset isolated GHD no evidence of hypothalamic pituitary abnormality or cranial irradiation , 2 diagnostic tests should be recommended, except for those having low insulin-like growth factor-1 1GF-1 a marker of GH response concentrations standard deviation score less than -2 who may be considered for one test NICE, The product labeling further states that this dose should be increased gradually on the basis of clinical and biochemical responses assessed at monthly intervals.

    Values of IGF-I should be maintained in the normal age- and sex-adjusted range. The literature indicates that the dose may be increased, on the basis of individual patient requirements, to a maximum of 1. Of note, this dose is substantially less than GH replacement doses in children and adolescents, in whom the dose is based on weight.

    According to the FDA-approved labeling, Zorbtive should be used in conjunction with optimal management of short bowel syndrome. Specialized nutritional support may consist of a high carbohydrate, low-fat diet, adjusted for individual patient requirements and preferences. Nutritional supplements may be added according to the discretion of the treating physician. Optimal management of short bowel syndrome may include dietary adjustments, enteral feedings, parenteral nutrition, fluid and micronutrient supplements, as needed.

    The primary endpoint was the change in weekly total IPN volume defined as the sum of the volumes of IPN, supplemental lipid emulsion SLE , and intravenous hydration fluid. All 3 groups received a specialized diet. The dosing of GH was approximately 0. Mean reductions in IPN volume in each patient group were significantly greater in both the group treated with GH reduction of 2. Administration at doses higher than 8 mg per day or for more than 4 weeks has not been adequately studied.

    According to the FDA-approved labeling, injections should be administered daily for 4 weeks. According to available guidelines, GH therapy is contraindicated in patients with active malignant disease, benign intracranial hypertension BIH , and proliferative or pre-proliferative diabetic retinopathy.

    Potential for child-bearing is not a contraindication, but accepted guidelines caution that GH therapy should be discontinued when pregnancy is confirmed. The guidelines further caution that GH should not be used in critically ill patients who have acute catabolism.

    Growth hormone deficiency involves abnormally short stature with normal body proportions. Growth hormone deficiency can be categorized as either congenital or acquired. An abnormally short height in childhood may occur if the pituitary gland does not produce enough growth hormone.

    GHD, Turner syndrome, chronic renal insufficiency before transplantation, and children born small for gestational age. An advisory committee to the FDA also recommended approval of GH for children with idiopathic short stature.

    An assessment conducted for the National Institute of Clinical Excellence suggests the following criteria be used to define subnormal growth in children with GHD:. Diagnosis of GHD in children is confirmed by measurements of GH secretion, commonly in several samples following stimulation by a provocative agent such as insulin or clonidine NICE, The literature states that the standard method of assessing GH secretion in children is to measure the serum GH response to insulin and other stimuli.

    Another method is to make frequent measurements of serum GH during the day and night, but this is no more effective than the standard method for detecting GHD. Instead, accepted guidelines indicate the diagnosis should be based on very short height, as defined by the standard-deviation score more than 2. If thyroxine is insufficient, then the literature indicates tests of GH secretion should be postponed until the thyroid deficiency is adequately replaced because GH secretion may be subnormal merely as a result of the hypothyroidism.

    If GHD is suspected in a peripubertal person with a growth pattern that resembles constitutional delay of growth and development, sex steroid priming before testing of GH secretion has been recommended by some investigators.

    Available literature states that GH stimulation tests and indirect measures of determining endogenous GH secretion measurement of serum IGF-1 and IGFBP-3 or urinary GH are often subject to questionable specificity, false failure rates, and lack of published age- and sex-specific normal ranges.

    Due to the inadequacies of these tests, a subnormal growth velocity often becomes the deciding factor in choosing to initiate GH therapy.

    somatropin davis pdf

    somatropin davis pdf

    somatropin davis pdf