Growth Hormone Utilization Research Articles

SUN-249 Growth Hormone Utilization By US Youth: Trends as Insurance Pushes Back after FDA-Approved Expansion

In 2003 US FDA approved growth hormone (GH) treatment for idiopathic short stature (ISS), expanding potential eligibility for GH treatment from 1:3500 children with GH deficiency to the shortest 1.2% of the US population, at a potential estimated national cost of $40 billion. In response, over the last decade or so, the insurance industry has been instituting progressive restrictions on coverage for GH treatment, adopting formulary preference coverage strategies as a cost-containing measure, adopting more stringent plan-specific criteria for coverage, and denying any coverage for GH treatment of ISS. Using Optum administrative claims data (Clinformatics DataMart™ 7.0, 2017), which covers an annual 18 million individuals enrolled in commercial health plans, we sought to investigate how utilization of GH drugs by youth has changed in response to FDA approval of GH treatment for ISS, and secular changes in utilization as insurers have imposed greater barriers to GH treatment reimbursements. For our analysis, we included individuals aged 0-18 years who had insurance coverage between 2001 and 2016 for 6 or more months in any given year. Linear time trends in prevalence and financial burden were tested using t-tests with Bonferroni correction. Because of the long time frame covered, we analyzed payments in both nominal dollars and real dollars (1982-84 CPI-deflated). The number of members with GH prescriptions per 10,000 beneficiaries under age 18 rose steadily from 5.1 in 2001 to14.6 in 2016 (total on GH=38,857), without a dramatic change around 2003, the ISS approval date. The proportion of females receiving GH treatment dropped (34% to 28%) as did the proportion of white youth (80% to 77%), while proportions of black (3% to 4%) and Asian (1% to 4%) youth increased. Mean and median ages were 12-13 throughout. Total GH expenditures decreased (by 6% in nominal and 27% in real dollars), as did the estimated insurance-paid amount (by 8% in nominal and 28% in real dollars). However, mean copayments, deductibles and total patient financial burden increased (total up by 234% in nominal and 161% in real dollars). Between 2001 and 2007, beneficiaries switching GH brands at least once in the year ranged from 1.4 to 3.6%. After 2007, the range rose to 5.1-8.8%, with 25.6% switching in 2009 and 13.9% switching in 2015. In conclusion, the FDA ISS approval was not a watershed event in the steady increase in GH utilization by US youth. Progressive restrictions on coverage and formulary preference coverage strategies appear to have succeeded in lowering the total cost and insurer burden of GH treatment. However, those savings were not passed on to patients, who bear higher burdens financially and from brand switches. These patterns are consistent with broader US trends of increased patient cost-sharing and aggressive use of formularies and coverage restrictions to limit insurer exposure to high specialty drug prices.

Growth Hormone and Aging: Updated Review.

Role of growth hormone (GH) in mammalian aging is actively explored in clinical, epidemiological, and experimental studies. The age-related decline in GH levels is variously interpreted as a symptom of neuroendocrine aging, as one of causes of altered body composition and other unwelcome symptoms of aging, or as a mechanism of natural protection from cancer and other chronic diseases. Absence of GH signals due to mutations affecting anterior pituitary development, GH secretion, or GH receptors produces an impressive extension of longevity in laboratory mice. Extension of healthspan in these animals and analysis of survival curves suggest that in the absence of GH, aging is slowed down or delayed. The corresponding endocrine syndromes in the human have no consistent impact on longevity, but are associated with remarkable protection from age-related disease. Moreover, survival to extremely old age has been associated with reduced somatotropic (GH and insulin-like growth factor-1) signaling in women and men. In both humans and mice, elevation of GH levels into the supranormal (pathological) range is associated with increased disease risks and reduced life expectancy likely representing acceleration of aging. The widely advertised potential of GH as an anti-aging agent attracted much interest. However, results obtained thus far have been disappointing with few documented benefits and many troublesome side effects. Possible utility of GH in the treatment of sarcopenia and frailty remains to be explored.

Shared decision making and patient choice for growth hormone therapy: current perspectives

Shared decision making and patient choice for growth hormone therapy: current perspectives Belinda George, Vageesh Ayyar Department of Endocrinology, St. John’s Medical College Hospital, Bangalore, Karnataka, India Abstract: Growth hormone has now been available in medical practice for close to 50 years. Its use has provided dramatic results in patients with growth hormone deficiency and it is associated with an overall favorable safety profile. Over the years, the utility of growth hormone has expanded to include treatment for short stature associated with conditions other than growth hormone deficiency, and this situation warrants greater involvement of the child and parents in the shared decision-making process. Shared decision making is in good conformance to the principle of informed consent, and it also improves the compliance and adherence to therapy as the patient fully understands the benefit and safety of the treatment. In the pediatric-care setting, the decision-making interactions usually occur between the health care provider, patient, and parents. The process may range from an autonomous decision-making pattern, where the patient or parents are fully responsible for the decision taken, to the paternalistic decision-making pattern, where the health care provider assumes full responsibility for the decision taken. However, the ideal situation is one where a truly shared decision-making process happens, in which the doctor and patient/parents work together to choose an evidence-based option, in line with the patient’s preferences and wishes. The limited data available on shared decision making with regard to growth hormone replacement, however, is not very encouraging and suggests that the actual involvement of the parents as perceived by them is less than optimal. Introduction of a simple structured model for a shared decision-making process that can be easily incorporated into clinical practice and familiarization of health care providers with the same is essential to improve our shared decision-making practices. Keywords: growth hormone deficiency, idiopathic short stature, informed decision making

Diagnostic efficacy of 0, 30, 45, 60, 90 and 120 min growth hormone samples in insulin tolerance test: utility of growth hormone measurement at different time‐points and a cost‐effective analysis

Objective. To determine the utility of growth hormone (GH) measurement with the insulin tolerance test (ITT), and to carry out a cost‐effective analysis of the diagnosis of GH deficiency. Material and methods. Ninety‐nine patients clinically suspected of GH deficiency were evaluated over a period of 14 months (January 2005 to April 2006). Post‐insulin samples of GH and blood glucose (BG) samples were drawn at six different time‐points. Serum GH levels of <10 µg/L (prepubertal) and <6.1 µg/L (adolescents) were taken as cut‐off for the normal response. Results. Ninety‐nine ITTs were carried out during the study period, and GH levels were found to be deficient in 47 subjects. Specificities at different time‐points were 0 %, 54 %, 77 %, 62 %, 39 % and 23 % for 0, 30, 45, 60, 90 and 120 min, respectively, in the prepubertal group, and 5 %, 41 %, 80 %, 87 %, 77 % and 46 % at the same time‐points for the adolescent group. Accuracy was highest at 45 and 60 min in both the prepubertal and adolescent groups. The receiver operating characteristic curve showed that the highest area under the curve was found in samples drawn at 45, 60 and 90 min in both the prepubertal and adolescent groups. Conclusion. Our data suggest that 0, 45, 60 and 90 min samples are sufficient for diagnosing GH deficiency, which could lead to potential cost reductions of up to 29.8 %.

Introduction to the special issue of pituitary: “Utility of growth hormone and IGF-I assays”

Introduction to the special issue of pituitary: “Utility of growth hormone and IGF-I assays”

The use of growth hormone treatment for ovulation induction.

The use of growth hormone in enhancing the ovarian response to gonadotropins is reviewed. The data support the utility of growth hormone in reducing the effective gonadotropin dosage and in most cases, increasing the ovulatory quota.