Thyroidectomy for euthyroid patients with Hashimoto thyroiditis and persisting symptoms: A cost-effectiveness analysis.

BACKGROUND: Despite thyroid hormone replacement, some euthyroid patients with Hashimoto thyroiditis will continue to experience persistent symptoms that reduce their quality of life. Recent studies indicate that total thyroidectomy is superior to medical therapy alone in improving these symptoms. However, there is a high complication rate after total thyroidectomy in patients with Hashimoto thyroiditis. This study evaluates the cost-effectiveness of total thyroidectomy for euthyroid patients who have Hashimoto thyroiditis with persistent symptoms. METHODS: We utilized a Markov model to compare total thyroidectomy and medical therapy alone over the lifetime of the cohort. Costs, probabilities, and utility parameters were derived from literature and Medicare cost data. A willingness-to-pay threshold of $100,000/quality-adjusted life years was used. We performed sensitivity analyses to ascertain model uncertainty. RESULTS: On average, medical therapy alone costs $12,845, produced 16.9 quality-adjusted life years, and was dominated. Total thyroidectomy costs $1,490 less and produced 1.4 more quality-adjusted life years. Probabilistic sensitivity analysis confirmed total thyroidectomy as the optimal strategy in 89% of cases. Medical therapy alone will become cost-effective if the cost of uncomplicated thyroidectomy increases by 25%, if the probability of permanent complication after total thyroidectomy increases 12-fold, or if there is no gain in quality of life after thyroidectomy. CONCLUSION: Total thyroidectomy is more cost-effective than medical therapy alone for the management of euthyroid patients who have Hashimoto thyroiditis with persistent symptoms.

The impact of the introduction of generic aromatase inhibitors on adherence to hormonal therapy over the full course of 5-year treatment for breast cancer.

BACKGROUND: High out-of-pocket costs (OOPCs) often are found to be inversely associated with adherence to medical treatment. The introduction of generic aromatase inhibitors (GAIs) significantly reduced the OOPCs of patients. The objective of the current study was to explore the impact of the introduction of GAIs on adjuvant hormone therapy (AHT) adherence over the full course of breast cancer treatment. METHODS: Women aged ≥65 years who were diagnosed with hormone receptor-positive breast cancer from 2007 through mid-2009 were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database. Multivariate logistic regression was used to estimate the likelihood of AHT initiation and an interrupted time series model was used to predict the association between the introduction of GAIs and AHT adherence. The model was stratified further using Medicare low-income subsidy (LIS) status. RESULTS: A total of 10,905 women were included, approximately 62.8% of whom initiated AHT within the first year of their breast cancer diagnosis. Adjusted adherence among LIS beneficiaries was 11.4% higher than among non-LIS beneficiaries (P < .001). Non-LIS beneficiaries had an overall decreasing trend of adherence (-0.035; P < .001) prior to the introduction of GAIs. They experienced a 3.4% increase in the slope 6 months after the first GAI, anastrozole, entered the market, and an additional 0.8% increase in the slope 6 months after letrozole and exemestane were introduced (P < .001). Adherence change among LIS patients was small and statistically insignificant. CONCLUSIONS: With the introduction of GAIs, the decrease trend of adherence to therapy atteunated over the course of treatment. Although the successful implementation of the Medicare LIS program minimized the OOPCs for financially vulnerable patients, policymakers should be cautious not to introduce disparities for those who may be of low income but ineligible for such a program.

Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals.

Purpose: Although pharmacologic hormone therapy represents one of the mainstays of gender-affirming therapy for transgender individuals, there are many access barriers for these therapies, including insurance coverage of these drugs. The purpose of this study was to examine Medicare coverage of hormone therapies used by transgender individuals. Methods: Using Centers for Medicare and Medicaid Services prescription drug plan formulary files, we determined plan coverage, coverage restrictions, and out-of-pocket (OOP) costs for all 10 drugs recommended in the 2009 and 2017 Endocrine Society treatment guidelines for transgender patients. Results: For masculinizing therapies, the proportion of plans providing unrestricted coverage ranged from 22% to 79% in 2010 and from 5% to 75% in 2018. For feminizing therapies, the proportion providing unrestricted coverage ranged from 24% to 100% in 2010 and from 13% to 100% in 2018. Median annual OOP costs for masculinizing therapies ranged from $232 to $1112 in 2010 and from $180 to $2176 in 2018. For feminizing therapies, OOP costs ranged from $84 to $2716 in 2010 and from $72 to $3792 in 2018. Conclusion: Our findings highlight the variability in access to guideline-recommended hormone therapies for individuals insured through Medicare.

Paediatric hypopituitarism: a case report and management challenges in a resource poor setting.

Hypopituitarism, a deficiency of one or more of the hormones produced by the pituitary gland, is a rare disorder. It can be congenital or acquired. Case report on childhood hypopituitarism is rare in Nigeria. We present a 15-year-old boy, second of a set of twins, who presented with short stature and delayed puberty. Subtle difference in stature, was noticed on review of their childhood pictures by 2 years of age though disparity in stature became obvious to the parents at 6 years of age and it became embarrassing at 15 years of age when parents decided to seek medical attention. He was a product of term gestation with birth weight of 3.2kg; there was no history suggestive of birth trauma. Developmental milestone in the first two years of life was essentially normal like his unaffected twin brother. At presentation both height and weight were below 3rd percentile for age, he had a low blood pressure of 80/50mmHg, infantile male external genitalia with testicular volume of 2ml, bone age of 7 years, very low serum testosterone, growth hormone, adrenocorticotropic hormone, thyroxine, follicle stimulating hormone, leutenizing hormone, Cortisol and high thyroid stimulating hormone. He achieved remarkable improvement in physical activity, height, weight and hormonal profile within the first 7 months of hormone replacement therapy but could not sustain therapy because of financial constraint. Paediatric hypopituitarism is a rare and treatable disorder. Early presentation, diagnosis and appropriate hormone replacement therapy at affordable price is essential for survival and good prognosis.

A will and a way to fund medicines for rare diseases: the story of human growth hormone replacement for adults with growth hormone deficiency.

Growth hormone (GH) replacement therapy was recently recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme for adults with severe GH deficiency and impaired quality of life. This approval was significant for two reasons. First, the application was initiated and coordinated by a health professional working group, who prepared a 'public interest' submission to PBAC. Second, it resulted in a recommendation to subsidise therapy for a rare disease after two prior rejections on the basis of uncertainty about efficacy and cost effectiveness. There are important lessons to learn about the power of professional groups to drive health policy and attain funding for rare diseases.

Cost effectiveness of population based BRCA1 founder mutation testing in Sephardi Jewish women.

BACKGROUND: Population-based BRCA1/BRCA2 founder-mutation testing has been demonstrated as cost effective compared with family history based testing in Ashkenazi Jewish women. However, only 1 of the 3 Ashkenazi Jewish BRCA1/BRCA2 founder mutations (185delAG[c.68_69delAG]), 5382insC[c.5266dupC]), and 6174delT[c.5946delT]) is found in the Sephardi Jewish population (185delAG[c.68_69delAG]), and the overall prevalence of BRCA mutations in the Sephardi Jewish population is accordingly lower (0.7% compared with 2.5% in the Ashkenazi Jewish population). Cost-effectiveness analyses of BRCA testing have not previously been performed at these lower BRCA prevalence levels seen in the Sephardi Jewish population. Here we present a cost-effectiveness analysis for UK and US populations comparing population testing with clinical criteria/family history-based testing in Sephardi Jewish women. STUDY DESIGN: A Markov model was built comparing the lifetime costs and effects of population-based BRCA1 testing, with testing using family history-based clinical criteria in Sephardi Jewish women aged ≥30 years. BRCA1 carriers identified were offered magnetic resonance imaging/mammograms and risk-reducing surgery. Costs are reported at 2015 prices. Outcomes include breast cancer, ovarian cancer, and excess deaths from heart disease. All costs and outcomes are discounted at 3.5%. The time horizon is lifetime, and perspective is payer. The incremental cost-effectiveness ratio per quality-adjusted life-year was calculated. Parameter uncertainty was evaluated through 1-way and probabilistic sensitivity analysis. RESULTS: Population testing resulted in gain in life expectancy of 12 months (quality-adjusted life-year = 1.00). The baseline discounted incremental cost-effectiveness ratio for UK population-based testing was £67.04/quality-adjusted life-year and for US population was $308.42/quality-adjusted life-year. Results were robust in the 1-way sensitivity analysis. The probabilistic sensitivity analysis showed 100% of simulations were cost effective at £20,000/quality-adjusted life-year UK and the $100,000/quality-adjusted life-year US willingness-to-pay thresholds. Scenario analysis showed that population testing remains cost effective in UK and US populations, even if premenopausal oophorectomy does not reduce breast cancer risk or if hormone replacement therapy compliance is nil. CONCLUSION: Population-based BRCA1 testing is highly cost effective compared with clinical criteria-driven approach in Sephardi Jewish women. This supports changing the paradigm to population-based BRCA testing in the Jewish population, regardless of Ashkenazi/Sephardi ancestry.

Menopausal hormone therapy: a systematic review of cost-effectiveness evaluations.

BACKGROUND: Several evaluations of the cost-effectiveness (CE) of menopausal hormone therapy (MHT) have been reported. The aim of this study was to systematically and critically review economic evaluations of MHT since 2002, after the Women's Health Initiative (WHI) trial results on MHT were published. METHODS: The inclusion criteria for the review were: CE analyses of MHT versus no treatment, published from 2002-2016, in healthy women, which included both symptom relief outcomes and a range of longer term health outcomes (breast cancer, coronary heart disease, stroke, fractures and colorectal cancer). Included economic models had outcomes expressed in cost per quality-adjusted life year or cost per life year saved. MEDLINE, EMBASE, Evidence-Based Medicine Reviews databases and the Cost-Effectiveness Analysis Registry were searched. CE evaluations were assessed in regard to (i) reporting standards using the CHEERS checklist and Drummond checklist; (ii) data sources for the utility of MHT with respect to menopausal symptom relief; (iii) cost derivation; (iv) outcomes considered in the models; and (v) the comprehensiveness of the models with respect to factors related to MHT use that impact long term outcomes, using breast cancer as an example outcome. RESULTS: Five studies satisfying the inclusion criteria were identified which modelled cohorts of women aged 50 and older who used combination or estrogen-only MHT for 5-15 years. For women 50-60 years of age, all evaluations found MHT to be cost-effective and below the willingness-to-pay threshold of the country for which the analysis was conducted. However, 3 analyses based the quality of life (QOL) benefit for symptom relief on one small primary study. Examination of costing methods identified a need for further clarity in the methodology used to aggregate costs from sources. Using breast cancer as an example outcome, risks as measured in the WHI were used in the majority of evaluations. Apart from the type and duration of MHT use, other effect modifiers for breast cancer outcomes (for example body mass index) were not considered. CONCLUSIONS: This systematic review identified issues which could impact the outcome of MHT CE analyses and the generalisability of their results. The estimated CE of MHT is driven largely by estimates of QOL improvements associated with symptom relief but data sources on these utility weights are limited. Future analyses should carefully consider data sources and the evidence on the long term risks of MHT use in terms of chronic disease. This review highlights the considerable difficulties in conducting cost-effectiveness analyses in situations where short term benefits of an intervention must be evaluated in the context of long term health outcomes.

The appropriateness and persistence of testosterone replacement therapy in Ontario.

PURPOSE: To examine the concordance between testosterone replacement therapy (TRT) use and established reimbursement criteria, as well as compare the persistence of use among available formulations (injectable, oral, topical gel, transdermal patch) among elderly men in Ontario, Canada. METHODS: We conducted a retrospective cohort study of men aged 66 years or older in Ontario newly treated with testosterone between 1 January 2009 and 31 December 2012 using linked health administrative data. Continuous use was defined on the basis of prescription refills issued within 180 days of the preceding prescription. We studied men who received at least two consecutive TRT prescriptions. We estimated the prevalence of hypogonadism, human immunodeficiency virus, specialist visits and lab tests for serum testosterone prior to initiation of TRT to investigate concordance with prescribing criteria. We also performed a Kaplan-Meier analysis to test for differences in the median time to discontinuation among formulations. RESULTS: Among the 4797 men who received at least two TRT prescriptions, only 38.7% met the reimbursement criteria for use prior to initiating therapy. The median time to discontinuation differed significantly among formulations and was longest among recipients of oral TRT products (383 days), and lower for recipients of topical gels (319 days), injectable (283 days) and transdermal patches (160 days; Log-rank test p < 0.001). CONCLUSIONS: A large proportion of older men in Ontario do not appear to meet reimbursement criteria prior to commencing therapy, and many discontinue TRT within a year of initiation. Copyright © 2016 John Wiley & Sons, Ltd.

[Treatment costs of localized prostate cancer in Germany : Economic results from the HAROW observational study]. / Behandlungskosten des lokal begrenzten Prostatakarzinoms in Deutschland : Ökonomische Ergebnisse der HAROW-Beobachtungsstudie.

BACKGROUND: Prostate cancer (PCa) is the most common cancer in men. For medical treatment of PCa, a number of therapies are available. The economic consequences associated with these individual treatment options in routine care in Germany are unclear so far. METHODS: The present analysis was based on the Germany-wide HAROW observational study, which was conducted from 2008-2013. During this study, all participating physicians and involved patients reported and documented individual health care resource consumption. These data were evaluated in monetary terms stratified by treatment regime (hormone therapy, HT; active surveillance, AS; radiotherapy, RT; radical prostatectomy, RP; watchful waiting, WW). RESULTS: Overall, the data of 2672 patients were available for analysis. Based on the observational study design, the included patient groups were heterogeneous in their baseline characteristics. The annual total costs from the societal perspective were the largest for patient undergoing RP (9254 €; 95 % CI 8353-10,154), mainly driven by the costs for the initial hospital stay for surgery. HT, AS, RT, and WW seem to be comparable in terms of direct costs, ranging from 805 € (95 % CI 154-1455) for WW up to 1115 € (95 % CI 826-1405) for RT. The highest indirect costs were observed for patients receiving RT (3928 €; 95 % CI 0-10,675), which can be justified by the frequent incapacity to work in this patient group. CONCLUSION: The treatment of prostate cancer can lead to significant economic follow-up costs which vary greatly depending on the type of treatment. The analysis indicates a need for the implementation of a long-term health economic study in the future, which will be more suitable to show treatment-specific differences in the temporal occurrence of costs.

Variations in costs and use of provincially-funded testosterone replacement therapy across Canada: a population-based study.

INTRODUCTION: Provincial drug-program policies for the reimbursement of testosterone replacement therapy (TRT) vary across Canada, which may result in marked regional variability in use. METHODS: We conducted a population-based cross-sectional analysis of provincially funded TRT spending and utilization in eight provinces across Canada in 2012. We reported the annual cost per user, total cost, and rate of use of TRT overall and by formulation. RESULTS: We identified 23,544 provincially-funded recipients of TRT in 2012 in the eight provinces studied. Average annual cost per person varied by 3-fold, ranging from $173 (Prince Edward Island) to $485 (Ontario). Ontario also had the highest rate of use (1,105 users per 100,000 eligible) and the most liberal listing. Provinces with more restricted access (Alberta, British Columbia, and PEI) had lower annual costs per user ($293, $206, $173, respectively). CONCLUSIONS: Differing reimbursement policies for TRT products across Canada are likely contributing to variation in the rate of use and cost per recipient.

Compounded Testosterone Troches TO OPTIMIZE HEALTH AND THE TESTOSTERONE CONTROVERSY.

As men age, testosterone levels progressively fall and inflammatory biomarkers increase. The gradual decline in testosterone production with aging, known as andropause, is common and may have deleterious effects on men including decreased overall well-being, increased sarcopenia, increased risk of cardiovascular disease, reduced sexual function, and bone loss. Therefore, it comes as no surprise that an increasing number of men worldwide have begun requesting testosterone replacement therapy from their physicians. Occasionally, physicians discourage male patients from getting testosterone replacement therapy based on a few recent studies indicating the therapy causes cardiovascular events, including myocardial infarctions. Yet, an extensive review of the testosterone replacement therapy literature reveals that the majority of clinical studies show that properly administered testosterone replacement therapy, in which estradiol and dihydrotestosterone levels are also controlled, has no adverse effects on myocardial infarction risk. The current state-of-the-art in testosterone replacement therapy comprises compounded testosterone troches; an aromatase inhibitor, such as generic Anastrazole, to control estradiol levels; and a 5α-reductase inhibitor, such as beneric Dutasteride or Finasteride, to control dihydrotestosterone. Compounded testosterone troches easily raise serum testosterone levels to the optimal range, are highly cost effective at $82 for a 180-day supply, and provide affordable access to testosterone replacement therapy to millions of men requesting it. Yet, the Blue Cross Blue Shield-associated firms have largely denied requests for coverage of compounded medications, including testosterone troches. Despite data demonstrating strong links between testosterone deficiency and significant comorbid conditions (including Type 2 diabetes and other metabolic syndrome diseases) as well as the health benefits of testosterone replacement therapy, some physian have been swayed against prescribing testosterone replacement therapy to their aging male patients. The testosterone controversy stems largely from poorly designed clinical studies in which patients were subjected to testosterone replacement therapy without having their estradiol and dihydrotestosterone levels properly controlled.

Three-year experience with access to nationally funded growth hormone (GH) replacement for GH-deficient adults.

OBJECTIVE: Treatment of growth hormone (GH)-deficient adults with GH has been shown to improve a range of metabolic abnormalities and enhance quality of life. However, the results of access to nationally funded treatment have not been reported. DESIGN: Retrospective case series auditing nationally funded treatment of defined GH-deficient adults in New Zealand, with carefully designed entry and exit criteria overseen by a panel of endocrinologists. PATIENTS: Applications for 201 patients were assessed and 191 approved for funded treatment over the initial 3 years since inception. The majority had GH deficiency following treatment of pituitary adenomas or tumours adjacent to the pituitary. RESULTS: After an initial 9-month treatment period using serum IGF-I measurements to adjust GH dosing, all patients reported a significant improvement in quality of life (QoL) score on the QoL-AGHDA(®) instrument (baseline (95%CI) 19 (18-21), 9 months 6 (5-7.5)), and mean serum IGF-I SD scores rose from -3 to zero. Mean waist circumference decreased significantly by 2.8 ± 0.6 cm. The mean maintenance GH dose after 9 months of treatment was 0.39 mg/day. After 3 years, 17% of patients had stopped treatment, and all of the remaining patients maintained the improvements seen at 9 months of treatment. CONCLUSION: Carefully designed access to nationally funded GH replacement in GH-deficient adults was associated with a significant improvement in quality of life over a 3-year period with mean daily GH doses lower than in the majority of previously reported studies.

The impact of drug reimbursement policy on rates of testosterone replacement therapy among older men.

BACKGROUND: Despite a lack of data describing the long-term efficacy and safety of testosterone replacement therapy (TRT), prescribing of testosterone to older men has increased with the availability of topical formulations. The magnitude of this increase and the impact of formulary restrictions on testosterone prescribing are poorly characterized. METHODS: We conducted a time series analysis using the linked health administrative records of men aged 66 years or older in Ontario, Canada between January 1, 1997 and March 31, 2012. We used interventional autoregressive integrated moving average models to examine the impact of a restrictive drug reimbursement policy on testosterone prescribing and examined the demographic profile of men initiating testosterone in the final 2 years of the study period. RESULTS: A total of 28,477 men were dispensed testosterone over the study period. Overall testosterone prescribing declined 27.9% in the 6 months following the implementation of the restriction policy (9.5 to 6.9 men per 1000 eligible; p<0.01). However, the overall decrease was temporary and testosterone use exceeded pre-policy levels by the end of the study period (11.0 men per 1000 eligible), largely driven by prescriptions for topical testosterone (4.8 men per 1000 eligible). Only 6.3% of men who initiated testosterone had a documented diagnosis of hypogonadism, the main criteria for TRT reimbursement according to the new policy. CONCLUSION: Government-imposed restrictions did not influence long-term prescribing of testosterone to older men. By 2012, approximately 1 in every 90 men aged 66 or older was being treated with TRT, most with topical formulations.

Is testosterone replacement therapy in males with hypogonadism cost-effective? An analysis in Sweden.

INTRODUCTION: Testosterone replacement therapy (TRT) has been recommended for the treatment of primary and secondary hypogonadism. However, long-term implications of TRT have not been investigated extensively. AIM: The aim of this analysis was to evaluate health outcomes and costs associated with life-long TRT in patients suffering from Klinefelter syndrome and late-onset hypogonadism (LOH). METHODS: A Markov model was developed to assess cost-effectiveness of testosterone undecanoate (TU) depot injection treatment compared with no treatment. Health outcomes and associated costs were modeled in monthly cycles per patient individually along a lifetime horizon. Modeled health outcomes included development of type 2 diabetes, depression, cardiovascular and cerebrovascular complications, and fractures. Analysis was performed for the Swedish health-care setting from health-care payer's and societal perspective. One-way sensitivity analyses evaluated the robustness of results. MAIN OUTCOME MEASURES: The main outcome measures were quality-adjusted life-years (QALYs) and total cost in TU depot injection treatment and no treatment cohorts. In addition, outcomes were also expressed as incremental cost per QALY gained for TU depot injection therapy compared with no treatment (incremental cost-effectiveness ratio [ICER]). RESULTS: TU depot injection compared to no-treatment yielded a gain of 1.67 QALYs at an incremental cost of 28,176 EUR (37,192 USD) in the Klinefelter population. The ICER was 16,884 EUR (22,287 USD) per QALY gained. Outcomes in LOH population estimated benefits of TRT at 19,719 EUR (26,029 USD) per QALY gained. Results showed to be considerably robust when tested in sensitivity analyses. Variation of relative risk to develop type 2 diabetes had the highest impact on long-term outcomes in both patient groups. CONCLUSION: This analysis suggests that lifelong TU depot injection therapy of patients with hypogonadism is a cost-effective treatment in Sweden. Hence, it can support clinicians in decision making when considering appropriate treatment strategies for patients with testosterone deficiency.

Patient satisfaction with testosterone replacement therapies: the reasons behind the choices.

INTRODUCTION: Testosterone replacement therapy (TRT) for male hypogonadism is rapidly gaining popularity and acceptance. Options include gels, injections, and implantable subcutaneous pellets. AIMS: The aim of this study was to determine rates of patient satisfaction and reasons for patient preferences in hypogonadal men on TRT. METHODS: An anonymous, prospective survey was distributed to men presenting for TRT at an academic urology clinic. The survey was organized into multiple domains including patient satisfaction and treatment motivation. MAIN OUTCOME MEASURES: Patient satisfaction responses obtained via anonymous survey. RESULTS: Average patient age was 49 ± 0.7 years (n = 382). Injectable testosterone was chosen by 53%, gel-based regimens by 31%, and pellets by 17%. Overall, 70% of patients were satisfied with their TRT and 14% reported dissatisfaction. Satisfaction rates were similar between gels (68%), injections (73%), and implantable pellets (70%). Doctor recommendation was the sole significant reason for patients preferring gel-based TRT (66% vs. 37% injection users vs. 31% pellet users). Injectable TRT was favored because of lower cost (35% vs. 21% gel users vs. 19% pellet users). Pellets were favored for ease of use (64% vs. 44% injection users vs. 43% gel users) and convenience (58% vs. 26% injection users vs. 19% gel users). Pellets had increased rates of satisfaction within the first 12 months. Improvements in concentration and mood occurred at higher percentages in satisfied patients. CONCLUSIONS: Patients are satisfied with TRT. Lower costs are important to patients on injections. Convenience and ease of use are central in choosing pellet therapy. Men on TRT should be questioned about mood and concentration because these factors exhibited the greatest improvements in satisfied patients.

Global trends in testosterone prescribing, 2000-2011: expanding the spectrum of prescription drug misuse.

OBJECTIVE: To provide the first multinational survey of temporal trends in testosterone prescribing, given that anecdotal evidence indicates that it is increasing in some countries, including Australia. DESIGN: Sales data for all testosterone products were obtained for 41 countries for each year from 2000 to 2011. For each testosterone product type (injectable, implantable, oral, transdermal), units sold were converted into defined monthly doses per year, reflecting total testosterone prescribing per product. MAIN OUTCOME MEASURES: National testosterone prescribing rate overall and per product type on a per capita basis. RESULTS: For every region and 37 of 41 countries, there was a major and progressive increase in defined monthly doses per year per capita over the 11 years surveyed. In most countries, the increases were steeper for the last half of the survey period. The proportion of testosterone prescribing represented by transdermal testosterone products, a surrogate measure of prescribing for older men, increased even more than did the total usage of testosterone products. CONCLUSIONS: In the absence of any new indications, off-label testosterone prescribing has increased in most countries in 2000-2011, especially over the last half of the period. The increased testosterone prescribing appears to be primarily for older men and driven by clinical guidelines that endorse testosterone prescribing for age-related functional androgen deficiency (andropause). By eliminating the fundamental distinction between pathological and functional androgen deficiency, these guidelines tacitly promote increased testosterone prescribing, bypassing the requirement for high-quality clinical evidence of safety and efficacy and creating dramatic increases in prescription of testosterone products.

Promoting "low T": a medical writer's perspective.

Despite progress in raising the level of transparency about funding, conflicts of interest, and ghostwriting, drug companies remain free to pursue subtle and, therefore, effective means of marketing. Continuing medical education programs and "consensus" panels continue to be funded by companies selling products directly tied to the messages being conveyed by the resulting "educational" materials. And patient education materials continue to be created that, while factually accurate, subtly shift attitudes by including only selected facts and/or omitting ideas that would undermine the funder's preferred paradigm.

Factors influencing patient decisions to initiate and discontinue subcutaneous testosterone pellets (Testopel) for treatment of hypogonadism.

INTRODUCTION: A variety of modalities for testosterone replacement therapy (TRT) are available, including topical gels, injections, and Testopel subcutaneous testosterone pellets (STP). STP are becoming more commonly utilized in the United States; however, patient preferences, expectations, and usage patterns regarding this therapy remain poorly characterized. AIM: To identify factors influencing patients' decisions to initiate or discontinue STP. METHODS: A total of 175 men from an academic urology clinic who were currently using or who had previously used STP for hypogonadism received a 32-item electronic survey. MAIN OUTCOME MEASURES: Assessment of the impact of convenience, efficacy, side effects, cost, and symptom relief on initiation and discontinuation of STP. RESULTS: One hundred and thirteen men (64.6% response rate) of mean age 51.4 years who previously underwent a mean of 2.8 STP implant procedures completed the survey. Fifty-nine (52.2%) and 40 (35.4%) men had switched to STP from topical gel and injection therapy, respectively, whereas 14 (12.4%) men initially started TRT with STP. Convenience (68.8%) was the most important factor in patients' decision to start STP, while cost of the previous form of TRT (14.7%) was least important. At the time of the survey, 32 men (28.3%) had discontinued STP therapy. Cost of therapy (50%) was the primary factor in discontinuing STP. There was no difference in serum testosterone levels between men who continued STP and those who discontinued therapy (642.8 vs. 629.0 ng/dL, P = 0.83). Overall, 68.1% of patients continued STP therapy at the time of survey completion. CONCLUSIONS: Convenience is the most important factor in a patient's decision to initiate STP; however, physician recommendation also plays a substantial role. Cost was the primary reason for discontinuation. Upon survey completion, greater than two-thirds of respondents elected to continue STP therapy. STP are a viable treatment option for hypogonadal men seeking a convenient and efficacious alternative modality of TRT.