Pharmacoepidemiology of testosterone: Impact of reimbursement policy on curbing off-label prescribing.

OBJECTIVES: To estimate the impact on testosterone prescribing over 3 years following the 2015 tightening of Pharmaceutical Benefits Scheme (PBS) criteria. DESIGN: Analysis of testosterone prescribing data from PBS and private (non-PBS) sources between 2012 and 2018 covering 2015 change in PBS prescribing criteria. MAIN OUTCOME MEASURES: New and total PBS testosterone prescriptions estimating usage by quarter analyzed by product type, patient age-group, indication and prescriber type. Total national testosterone prescriptions (private plus PBS) was verified from an independent data supplier (IQVIA). RESULTS: PBS usage peaked in 2014 declining by 30% in 2017-8 with PBS prescribing covering a fall from 97.6% by usage in 2014 to 74% in 2017-18 of all testosterone prescribing. The tighter 2015 PBS restrictions sustained the selective reduction in GP initiation of prescriptions for middle-aged men without pathological hypogonadism whereas specialist initiations and prescription for adult hypogonadism or pediatric/prepubertal indications were largely unaffected. CONCLUSIONS: The tightening of PBS criteria from 1 April 2015 to curb off-label prescribing remained effective and selective over 3 years yet total national testosterone prescribing continued with little change, reflecting a shift to private prescriptions. The continuation of off-label testosterone prescribing for unproven indications suggests that long-term androgen dependence is created in men without pathological hypogonadism who commence testosterone. This highlights the need to avoid prescribing testosterone to men without pathological hypogonadism in the absence of sound evidence of efficacy and safety, the latter including the little unrecognized risks of long-term androgen dependency when trying to quit.

Marketing and Testosterone Treatment in the USA: A Systematic Review.

CONTEXT: Testosterone replacement therapy (TRT) is currently approved by the Food and Drug Administration only for classic hypogonadism, although off-label indications have resulted in a dramatic expansion in prescriptions in the USA. Marketing may significantly affect prescriber behavior. OBJECTIVE: To systematically review all available evidence on marketing and TRT in the USA. EVIDENCE ACQUISITION: PubMed, Embase, and Scopus were searched up to July 2017 for all relevant publications reporting on assessments of the TRT market size, economic costs associated with hypogonadism, trends in TRT prescriptions, drug discontinuation rates, and advertising and sales efforts in the USA. EVIDENCE SYNTHESIS: Twenty retrospective studies were included in the final analysis. The market size for hypogonadism constitutes 5.6-76.8% of men in the USA, with the lower end of the range representing the strictest criteria for diagnosis. Men with a diagnosis of hypogonadism consume $14 118 in direct and indirect costs to the payer. Over the last 2 decades, TRT prescriptions have increased between 1.8- and 4-fold. After 1 yr, 80-85% of men discontinue TRT. There is an association between direct-to-consumer advertising and testosterone testing, TRT prescriptions, and TRT without testosterone testing. There is a high prevalence of misinformation on Internet advertising. CONCLUSIONS: Off-label indications have driven the dramatic expansion of TRT prescriptions over the last 2 decades. Direct-to-consumer advertising poses a unique challenge in the USA. Overtreatment can be avoided by applying strict diagnostic criteria for hypogonadism, which limits the addressable market for TRT. PATIENT SUMMARY: In this report, we reviewed the relationship between marketing and testosterone therapy in the USA. We found that many patients are prescribed testosterone without an appropriate diagnosis of hypogonadism, which may be related to the marketing efforts for off-label prescribing.

Pharmacoepidemiology of testosterone: Curbing off-label prescribing.

OBJECTIVES: To estimate the impact of the first year of new Pharmaceutical Benefits Scheme (PBS) prescribing criteria that dictate eligibility for national health scheme subsidy of testosterone prescribing. DESIGN: Analysis of cumulative PBS data. SETTING: Retrospective analysis of testosterone prescribing from PBS data. PARTICIPANTS: Nil MAIN OUTCOME MEASURES: PBS expenditure analysed by total expenditure, by state, and by product type as well as the age, indication, and prescriber type for new testosterone treatment. RESULTS: Total PBS expenditure continued to exceed $20 million in 2014 before declining from 2015 with changes that were uniform by state and product type. Prior to 2015, over 80% were for men aged over 40 years of age for low circulating testosterone in the absence of reproductive system disorders ("Low T") initiated by GPs. From 2015, these features were markedly reduced without changing the numbers of new prescriptions for pathological reproductive disorders or specialist initiations. CONCLUSIONS: The short-term impact of 2015 PBS criteria showed highly effective and well-targeted curbing of off-label testosterone prescribing. The findings indicate that the main driver for the recent upsurge in testosterone prescribing was treatment of middle-aged men for "Low T" initiated by GPs.

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.

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.

Treatment preferences and outcome in male hypogonadotropic hypogonadism: an Indian perspective.

This retrospective study assessed treatment preferences and outcome with testosterone or HCG / HCG-FSH combination in Indian male idiopathic hypogonadotropic hypogonadism (IHH) subjects (n = 31) above 18 years of age. 38.7% of IHH study subjects had no fertility plans and chose 3 monthly intramuscular testosterone undecanoate. 73.7% of subjects with fertility plans chose human chorionic gonadotropin (HCG) alone due to cost considerations. Spermatogenesis occurred in 21.4% on HCG alone and 60% of subjects on HCG with follicle-stimulating hormone (FSH) combination. Treatment failure is higher than published Western rates. FSH and HCG combination regimen is costly but superior to HCG alone. However, treatment failure still persists, suggesting unknown testicular defect in IHH.

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.

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.

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.

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.

The direct and indirect costs among U.S. privately insured employees with hypogonadism.

INTRODUCTION: While previous studies have noted that hypogonadism (HG) may pose a significant economic and quality-of-life burden, no studies have evaluated the impact of HG on healthcare utilization and costs in the United States. AIM: Compare direct (health care) and indirect (disability leave or medical absence) costs between privately insured U.S. employees with HG and controls without HG. METHODS: The study sample included 4,269 male employees, ages 35-64, with ≥ 2 HG diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification: 257.2x) or ≥ 1 HG diagnosis and ≥ 1 claim for testosterone therapy, 1/1/2005-3/31/2009, identified from a large, private insurance administrative database that includes medical, prescription drug, and disability claims data. The index date was the most recent HG diagnosis that had continuous eligibility for at least 1 year before (baseline period) and 1 year after (study period). Employees with HG were matched 1:1 on age, region, salaried vs. nonsalaried employment status, and index year to controls without HG. MAIN OUTCOME MEASURES: Descriptive analyses compared demographic characteristics, comorbidities, resource utilization, direct and indirect costs inflated to USD 2009. Multivariate analyses adjusting for baseline characteristics were used to estimate risk-adjusted costs. RESULTS: HG employees and controls had a mean age of 51 years. HG employees compared with controls had higher baseline comorbidity rates, including hyperlipidemia (50.2% vs. 25.3%), hypertension (37.7% vs. 21.1%), back/neck pain (32.0% vs. 15.7%), and human immunodeficiency virus/acquired immunodeficiency syndrome (7.1% vs. 0.3%) (all P < 0.0001). HG employees had higher mean study period direct ($10,914 vs. $3,823) and indirect costs ($3,204 vs. $1,450); HG-related direct costs were $832 (all P < 0.0001). Risk-adjusted direct ($9,291 vs. $5,248) and indirect ($2,729 vs. $1,840) costs were also higher for HG employees (all P < 0.0001). CONCLUSIONS: Employees with HG had higher comorbidity rates and costs compared with controls. Given the low HG-related costs, a primary driver of costs among HG patients appears to be their comorbidity burden.

A critical appraisal of accuracy and cost of laboratory methodologies for the diagnosis of hypogonadism: the role of free testosterone assays.

The biochemical diagnosis of male hypogonadism remains a controversial issue. The problem is compounded by the variety of laboratory assays available to measure serum testosterone (T) and the limited understanding, among clinicians, of their relative diagnostic validity. It is widely accepted that only the testosterone not bound to sex hormone-bounding globulin is metabolically active. Therefore, for diagnostic purposes it is frequent practice to order the measurement of free T (FT) or bioavailable T (BAT). Our objective is to describe the methods available for measuring FT and to review the literature to determine the relevance of ordering FT as a diagnostic laboratory tool in cases of suspected hypogonadism. We also provide our biochemical approach in evaluating men with T deficiency. The limited information available in this regard is frequently confined to the biochemistry literature. The few reliable studies indicate that analog-based measurement of FT offers no diagnostic or financial advantage over automated assay for total T. The manuscript also describes "How we do it." For optimal diagnostic accuracy and financial responsibility, total T and calculated FT (cFT) should be the tests employed for initial and confirmatory diagnosis respectively. Measurement of bioavailable T is an alternative option but not germane to the points to which we are calling attention in this paper. While clinicians should be discouraged from ordering FT assays, laboratories performing it should indicate what method was used and warned about possible reliability concerns. FT assays should no longer be a reimbursable test.

Pharmacoepidemiology of testosterone prescribing in Australia, 1992-2010.

OBJECTIVE: To describe patterns of testosterone prescribing in Australia over the past two decades by state or territory and by product type. DESIGN AND SETTING: Observational analysis of testosterone prescribing data obtained from two independent data sources--the Pharmaceutical Benefits Scheme (PBS) and IMS, a source of commercial pharmaceutical sales data. MAIN OUTCOME MEASURES: Temporal trends in testosterone prescribing--measured as units prescribed (converted into monthly defined doses) and expenditure--to state or territory and product type (injectable, implantable, transdermal and oral). RESULTS: Over two decades, total annual expenditure on testosterone products increased ninefold to $12.7 million according to PBS data and fivefold to $16.3 million according to IMS data. When adjusted for inflation and population growth, expenditure increased 4.5-fold according to PBS data and 2.5-fold according to IMS data. The patterns of testosterone prescribing according to PBS and IMS data were highly congruent. When converted into monthly defined dose units, testosterone prescribing increased over the two decades with approximately twofold differences in total testosterone prescribed per capita between the states and territories with the highest and lowest rates of prescribing. When analysed by product type, the stable market patterns over the first 15 years were disrupted by sharp changes to create market dominance owing to introduction of two new testosterone products--a depot injectable testosterone and a transdermal testosterone gel. CONCLUSIONS: The progressive increase in PBS-subsidised testosterone prescribing without changes in proven medical indications or improvements in diagnosis of pathologically based androgen deficiency are likely to be due to promotion-driven non-compliance with PBS prescribing criteria, indicating that more effective implementation of the criteria is needed.

Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome.

AIM: To investigate efficacy and safety of two different preparations of testosterone undecanoate (TU) in 52 hypogonadal men [mean age 57 yr and mean testosterone (T) < 320 ng/dl] with metabolic syndrome (MS). SUBJECTS AND METHODS: Randomized, double-blind, double-dummy study with three parallel treatment arms [oral TU; transdermal placebo gel (P); im TU] administration for 12 months (mo). Each subject was randomized (1:1:3) to receive either oral TU (2 capsules of 40 mg/twice per day at breakfast and dinner, equalling a total dose of 160 mg/day; no.=10) for 6 mo and continued with im TU for further 6 mo, or P (3-4 g/day; no.=10) and im TU (1000 mg/12 weeks from week 6; no.=32) for 12 mo. RESULTS: After 6 mo, im TU increased T and free- T levels (p<0.0001), and improved metabolic parameters [reduction in Homeostasis Model Assessment (HOMA) index, p<0.0001; waist circumference and fat mass, p<0.001, respectively], in International Index of Erectile Function-5 and Aging Males' Symptoms scores (p<0.01, respectively). After 12 months, im TU produced further increases in T and free- T levels (p<0.0001) and metabolic parameters (reduction in HOMA-index, p<0.0001; waist circumference p<0.0001; fat mass, p<0.001). No major adverse event due to T treatment occurred. CONCLUSIONS: Clinical efficacy of T replacement therapy in hypogonadal men with MS is reached when its plasmatic levels approach into the medium-high range of normality (>5 ng/ml), although subjective threshold values may be different. Administration of im TU was more effective than oral TU to reach the target for T levels and to improve MS parameters. TU was safe over 12 months and discontinuation rates were similar to placebo.

Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost.

INTRODUCTION: The efficacy of oral clomiphene citrate (CC) in the treatment of male hypogonadism and male infertility (MI) with low serum testosterone and normal gonadotropin levels has been reported. AIM: The aim of this article is to evaluate CC and testosterone gel replacement therapy (TGRT) with regard to biochemical and clinical efficacy and cost. MAIN OUTCOME MEASURES: The main outcome measures were change in serum testosterone with CC and TGRT therapy, and change in the androgen deficiency in aging male (ADAM) questionnaire scores with CC therapy. METHODS: Men receiving CC or TGRT with either Androgel 1% or Testim 1% for hypogonadism (defined as testosterone < 300 ng/mL) or MI were included. Serum values were collected 1-2 months after treatment initiation and semi-annually thereafter. Retrospective data collection was performed via chart review. Subjective follow up of patients receiving CC was performed via telephone interview using the ADAM questionnaire. RESULTS: A hundred and four men (65 CC and 39 TGRT) were identified who began CC (50 mg every other day) or TGRT (5 g). Average age (years) was 42(CC) vs. 57 (TGRT). Average follow up was 23 months (CC, range 8-40 months) vs. 46 months (TGRT, range 6-149 months). Average posttreatment testosterone was 573 ng/dL in the CC group and 553 ng/dL in the TGRT group (P value < 0.001). The monthly cost of Testim 1% (5 gm daily) is $270, Androgel 1% (5 gm daily) is $265, and CC (50 mg every other day) is $83. Among CC patients, the average pretreatment ADAM score was 4.9 vs. 2.1 at follow up (P < 0.05). Average pretreatment ADAM sexual function domain score was 0.76 vs. 0.23 at follow up (P < 0.05). There were no adverse events reported. CONCLUSION: CC represents a treatment option for men with hypogonadism, demonstrating biochemical and clinical efficacy with few side effects and lower cost as compared with TGRT.

The burden of testosterone deficiency syndrome in adult men: economic and quality-of-life impact.

INTRODUCTION: Testosterone deficiency syndrome (TDS) causes a wide range of symptoms that can lead to significant morbidity. Preliminary evidence has also linked TDS with premature mortality and with a number of comorbid diseases including diabetes and metabolic syndrome. Such associations can lead to substantial economic and quality-of-life implications, the magnitude of which remains largely unknown. AIM: To review the economic and quality-of-life consequences of a largely untreated condition and to consider the likely health economic benefits of testosterone treatment. METHODS: A systematic review of four main areas: epidemiological evidence of the magnitude of TDS, estimates of cost of illness, impact on quality-of-life, and cost-effectiveness of testosterone treatment. MAIN OUTCOME MEASURE: Review of peer-reviewed literature. RESULTS: The lack of clear universally accepted diagnostic criteria and the uncertainty surrounding the link between TDS and some of its consequences complicate the estimation of the burden of illness of TDS. Consequences of TDS that potentially lead to increased economic burden include depression, sexual dysfunction, mild cognitive impairment, osteoporosis, cardiovascular disease, and mortality. However, although good evidence exists demonstrating an association between TDS and sexual dysfunction and cognitive impairment, evidence is less strong for depression, the incidence of fractures and mortality, and highly controversial for cardiovascular disease. The consequences that are likely to impact on patients' quality of life include sexual function, energy levels, body composition, mood, and cognitive function. CONCLUSION: Understanding the burden is only the first step decision makers need to take to decide whether to allocate scarce resources to treat the condition. To make informed decisions on when and who to treat information is also needed on the cost-effectiveness of available treatments. Such data would highlight the benefits of treatment of TDS to physicians, patients, and to society as a whole.

Program savings associated with switching testosterone intramuscular injections to topical gel in HIV infected males.

BACKGROUND: HIV-1 infected male patients commonly require testosterone supplementation and intramuscular testosterone (IM) is the most frequently used supplementation method. Currently, the economic burden of testosterone supplementation is borne to a large degree by the clinic providing services to the HIV infected male. Increasingly, clinics are seeking alternative methods to provide supplementation. This analysis describes the economic trade-offs associated with the utilization of topically applied testosterone supplement relative to current supplementation techniques within the clinic setting. METHODS: Twenty-three patients that had been receiving IM were switched to topical testosterone gel (TOP). A 1-month time-and-motion study, identification of IM administration specific supplies, and costs for acquisition and disposal of these supplies were conducted or gathered to quantify costs of providing bi-weekly IM to patients. The analysis describes potential resource savings by switching 23 HIV patients served in a safety-net provider setting from IM to TOP. The analysis considers both a pre and post-evaluation period whereby patients received IM in the pre-evaluation period and then were switched to TOP in the follow-up period. Economic assessments considered direct medical costs for the preparation and administration of the product but did not incorporate other outcomes in the analyses. RESULTS: Only one of 23 patients switched experienced recurrence of symptoms and no patients developed adverse effects associated with the switch. In contrast, substantial resources could be realized with the utilization of the topically applied testosterone relative to the injectable formulations with approximately $80,938 fewer dollars spent on provision of IM. CONCLUSIONS: Switching patients from IM to TOP resulted in no deleterious affects and is estimated to have saved the clinic considerable resources, even if TOP had to be provided by the clinic.

Use of alternative and hormonal therapies in male infertility.

OBJECTIVES: To examine the patterns of use of alternative and hormonal therapies in men presenting for infertility evaluation. METHODS: We administered a questionnaire on the use of alternative and hormonal therapies to 500 consecutive men presenting for infertility evaluation at our male infertility clinic. The questionnaire asked about the use of specific therapies (eg, vitamins, herbal medicine, or hormones), the monthly cost of these therapies, and whether the principal healthcare provider had been made aware of the use of therapies. RESULTS: Of the 481 men who completed the questionnaire, 147 (31%) admitted to using one or more alternative therapies. Most of the men using alternative therapies (92 of 147, 63%) were taking one or more antioxidant vitamins or minerals (ie, vitamins C, E, selenium, zinc), and 18 men admitted to using herbal medicines. Of concern, 25 men reported using agents with clear hormonal activity (testosterone, clomiphene citrate), and 6 of these men had not informed their principal healthcare provider of this. CONCLUSIONS: Our data suggest that a significant percentage ( approximately 30%) of men presenting for infertility evaluation do use alternative therapies. It is important to inquire about the use of these therapies because some of these treatments may be toxic to the gonads.