An Analysis of a Commercial Database on the Use of Erectile Dysfunction Treatments for Men With Employer-Sponsored Health Insurance.

OBJECTIVE: To investigate the annual erectile dysfunction (ED) prevalence among men enrolled in an employer-sponsored health insurance (ESHI) plan and evaluate ED treatment profiles among those with an ED diagnosis. METHODS: A cross-sectional claims analysis was conducted using the IBM MarketScan Commercial Database, a nationally representative sample of US workers enrolled in ESHI plans. Patients aged 18-64 with at least one ED medical diagnosis claim and continuous enrollment in a given year between 2009 and 2017 were included. Among those with an ED diagnosis, utilization rates of the following ED treatments were determined: phosphodiesterase type 5 inhibitors (PDE5I), penile prosthesis implantation, other ED treatments (eg, vacuum pump, intraurethral suppositories), combination treatment, and no insurer-paid treatments. RESULTS: Between 2009 and 2017, the annual prevalence of men with ESHI suffering from ED increased by 116%. However, in 2017, only 23% of men with an ED diagnosis received an ED therapy paid for by their ESHI plans. The proportion of men taking PDE5Is ranged from 18% in 2012 to 26% in 2015. The proportion of men with ED undergoing penile prosthesis implantation has declined in recent years (0.23% in 2009 to 0.11% in 2017). Similarly, the rate of men who received other ED treatments or combination treatment has decreased from 2009 to 2017 (0.94%-0.30% and 0.65%-0.19%, respectively). CONCLUSION: ED prevalence among men insured by an ESHI plan has notably increased, yet approximately three-quarters of these men had no claims for ED treatments, indicating substantial access gaps to treatment.

A Review of Economic Evaluations of Erectile Dysfunction Therapies.

INTRODUCTION: Erectile dysfunction (ED) is a common and costly urologic condition with increasing prevalence as men age. Cost-effectiveness of ED therapies and whether cost-effectiveness varies for different populations of men remains underexplored. AIM: To review and summarize available published data on the economic evaluation of ED therapies and to identify gaps in the literature that still need to be addressed. METHODS: All relevant peer-reviewed publications and conference abstracts were reviewed and incorporated. RESULTS: There are a number of medical and surgical treatment options available for ED. The economic evaluation of phosphodiesterase-5 inhibitors, particularly sildenafil, has been well described. However, minimal research has been conducted to assess the cost-effectiveness of intracavernosal injections, intraurethral suppositories, penile prosthesis surgery, vacuum erection devices, and other emerging therapies in men with different causes of ED. CONCLUSION: Available economic evaluations of ED therapies are dated, do not reflect present-day physician, pharmaceutical, and device costs, fail to account for patient comorbidities, and may not be generalizable to today's ED patients. Substantial research is needed to evaluate the cost-effectiveness of ED treatments across different patient populations, countries, and reimbursement systems. Rezaee ME, Ward CE, Brandes ER, et al. A Review of Economic Evaluations of Erectile Dysfunction Therapies. Sex Med Rev 2019;8:497-503.

Self-Regulation in the Pharmaceutical Industry: The Exposure of Children and Adolescents to Erectile Dysfunction Commercials.

CONTEXT: Spending on direct-to-consumer advertising (DTCA) for prescription pharmaceuticals has risen to record levels, five times as much as in 1996 in inflation-adjusted dollars. Major health care provider organizations have called for additional regulation of DTCA. These organizations argue that the negative impact of such advertising outweighs the informational value claimed by the pharmaceutical industry. The industry maintains that further restrictions on DTCA are not warranted because it is successfully self-regulating via "guiding principles" for DTCA as certified by firm executives. METHODS: The authors measured recent industry spending on DTCA and used regression models of Nielsen Monitor-Plus data to assess pharmaceutical firm self-regulation after the public disclosure of noncompliance with industry self-regulatory principles, specifically regarding the exposure of children and adolescents to broadcast advertisements for erectile dysfunction drugs. FINDINGS: Public disclosure of noncompliance with self-regulatory DTCA standards did not bring advertising into compliance. Results demonstrate that firms failed to meet the industry standard during every quarter of the six-year period of this study. CONCLUSIONS: Results support previous research findings that pharmaceutical self-regulation is a deceptive blocking strategy rather than a means for the industry to police itself. Policy recommendations include broadcast restrictions on adult content and deincentivizing DTCA via tax reform.

Variability in Prices for Erectile Dysfunction Medications-Are All Pharmacies the Same?

BACKGROUND: Variability in prices of medications is a well-known phenomenon; however, this variability has not been quantified in the realm of erectile dysfunction (ED) medications. ED medications are ideal for this quantification, because they are often not covered by insurances; therefore, the cost is the most direct reflection of price variability among pharmacies as they affect the patients. AIM: To evaluate the variability in cash prices for phosphodiesterase type 5 inhibitors (PDEIs) for ED. We also evaluated whether certain types of pharmacies consistently offer better pricing than others, and whether there was any correlation with demographic factors. METHODS: 331 pharmacies were contacted within a 25-mile radius of our institution to obtain the cash price for 4 commonly used ED medications with prespecified doses. After exclusion, 323 pharmacies were categorized as chain, independent, wholesale, or hospital-associated. Cash prices for the specified medications were evaluated. In addition, we identified demographic and socioeconomic factors to determine if these had an impact on median drug pricing within each zip code. MAIN OUTCOME MEASURE: The main outcome was the cost for patients to fill each prescription. RESULTS: Independent pharmacies provided the lowest cost for 3 of 4 of the PDEIs. The largest price difference for 10 tablets of 100 mg sildenafil between all pharmacies was 38,000%. The median cost difference between independent pharmacies and chain pharmacies for sildenafil was >900%, and >1,100% for independent pharmacies vs hospital-associated pharmacies. Demographic and socioeconomic factors had no impact on the cost. CLINICAL IMPLICATIONS: Our goal is to promote patient counseling among practitioners and to empower patients to shop for the best prices for their medications. STRENGTH AND LIMITATIONS: A strength of the study is the large cohort that was surveyed; however, a weakness is that the large majority of the cohort was comprised of chain pharmacies. Mail pharmacies could not be evaluated as they required a valid prescription before offering prices. CONCLUSION: The drastic differences in cash prices for the PDEIs give us an insight into the variability and cost-inflation of medications in the United States. These patterns hold true for other essential medications as well, and improved transparency will allow patients to make informed decisions when choosing where to purchase their medications. It may also encourage certain pharmacies to provide medications at more affordable prices. Mishra K, Bukavina L, Mahran A, et al. Variability in prices for erectile dysfunction medications-Are all pharmacies the same? J Sex Med 2018;15:1785-1791.

Analysis of Hospital Readmissions After Prosthetic Urologic Surgery in the United States: Nationally Representative Estimates of Causes, Costs, and Predictive Factors.

BACKGROUND: The surgical treatment of urinary incontinence and erectile dysfunction by prosthetic devices has become part of urologic practice, although sparse data exist at a national level on readmissions and hospital costs. AIM: To assess causes and costs of early (≤30 days) and late (31-90 days) readmissions after implantation of penile prostheses (PPs), artificial urinary sphincters (AUSs), or PP + AUS. METHODS: Using the 2013 and 2014 US Nationwide Readmission Databases, sociodemographic characteristics, hospital costs, and causes of readmission were compared among PP, AUS and AUS + PP surgeries. Multivariable logistic regression models tested possible predictors of hospital readmission (early, late, and 90 days), increased hospital costs, and prolonged length of stay at initial hospitalization and readmission. OUTCOME: Outcomes were rates, causes, hospital costs, and predictive factors of early, late, and any 90-day readmissions. RESULTS: Of 3,620 patients, 2,626 (73%) had PP implantation, 920 (25%) had AUS implantation, and 74 (2%) underwent PP + AUS placement. In patients undergoing PP, AUS, or PP + AUS placement, 30-day (6.3% vs 7.9% vs <15.0%, P = .5) and 90-day (11.6% vs 12.8% vs <15.0%, P = .8) readmission rates were comparable. Early readmissions were more frequently caused by wound complications compared with late readmissions (10.9% vs <4%, P = .03). Multivariable models identified longer length of stay, Charlson Comorbidity Index score higher than 0, complicated diabetes, and discharge not to home as predictors of 90-day readmissions. Notably, hospital volume was not a predictor of early, late, or any 90-day readmissions. However, within the subset of high-volume hospitals, each additional procedure was associated with increased risk of late (odds ratio = 1.06, 95% CI = 1.03-1.09, P < .001) and 90-day (odds ratio = 1.03 95% CI = 1.02-1.05, P < .001) readmissions. AUS and PP + AUS surgeries had higher initial hospitalization costs (P < .001). A high hospital prosthetic volume decreased costs at initial hospitalization. Mechanical complications led to readmission of all patients receiving PP + AUS. CLINICAL IMPLICATIONS: High-volume hospitals showed a weaker association with increased initial hospitalization costs. Charlson Comorbidity Index, diabetes, and length of stay were predictors of 90-day readmission, showing that comorbidity status is important for surgical candidacy. STRENGTHS AND LIMITATIONS: This is the first study focusing on readmissions and costs after PP, AUS, and PP + AUS surgeries using a national database, which allows ascertainment of readmissions to hospitals that did not perform the initial surgery. Limitations are related to the limited geographic coverage of the database and lack of surgery- and surgeon-specific variables. CONCLUSIONS: Analysis of readmissions can provide better care for urologic prosthetic surgeries through better preoperative optimization, counseling, and resource allocation. Pederzoli F, Chappidi MR, Collica S, et al. Analysis of Hospital Readmissions After Prosthetic Urologic Surgery in the United States: Nationally Representative Estimates of Causes, Costs, and Predictive Factors. J Sex Med 2017;14:1059-1065.

Management of ED under the "severe distress" criteria in the NHS: a real-life study.

INTRODUCTION: The United Kingdom is unusual in that a significant proportion of patients with erectile dysfunction (ED) have their treatment fully reimbursed by the National Health Service (NHS). This may have consequences for the choice of treatment and for compliance with treatment. AIMS: The aim of this study was to evaluate the use and cost implications of phosphodiesterase type 5 inhibitor in an NHS setting. METHODS: Basic demographics and data on ED management for patients treated from January 2000 to April 2011 were obtained from a prospectively accrued database. We reviewed drug usage and costs as well as switching between drugs. Patients were given the choice of all available therapies and were followed up annually. MAIN OUTCOME MEASURES: Switching, compliance, and costs of treating ED under the "severe distress" criteria in the NHS were reviewed for this study. RESULTS: Two thousand one hundred fifty-nine patients qualified for reimbursed therapy. Two hundred twenty-six patients were excluded from further analysis owing to missing data. Patients were followed up on an annual basis. The mean patient age was 60.2 years (min 23, max 90), and the mean follow-up was 50.8 months (min 1, max 127). Six hundred ninety-six were started on sildenafil, 990 on tadalafil, 163 on vardenafil, and 84 on intracavernosal alprostadil. Eighteen percent of patients initially started on the scheme and stopped medication unilaterally. Of the patients, 12.3% changed their medication during follow-up. The cost of drugs increased year by year from £257,100 in 2007 to £352,519 in 2011. CONCLUSIONS: Our real-life observational study shows that in our institution, dropout of therapy is unusual. We hypothesize that this reflects, in part, the reimbursement issue. We also found that switching between drugs was unusual, although there are several possible explanations for that. Although this is a successful system for the patients, the hospital, which bears the costs of medication, is finding this an increasing economic drain.

Patient time and out-of-pocket costs for long-term prostate cancer survivors in Ontario, Canada.

PURPOSE: Time and out-of-pocket (OOP) costs can represent a substantial burden for cancer patients but have not been described for long-term cancer survivors. We estimated these costs, their predictors, and their relationship to financial income, among a cohort of long-term prostate cancer (PC) survivors. METHODS: A population-based, community-dwelling, geographically diverse sample of long-term (2-13 years) PC survivors in Ontario, Canada, was identified from the Ontario Cancer Registry and contacted through their referring physicians. We obtained data on demographics, health care resource use, and OOP costs through mailed questionnaires and conducted chart reviews to obtain clinical data. We compared mean annual time and OOP costs (2006 Canadian dollars) across clinical and sociodemographic characteristics and examined the association between costs and four groups of predictors (patient, disease, system, symptom) using two-part regression models. RESULTS: Patients' (N = 585) mean age was 73 years; 77 % were retired, and 42 % reported total annual incomes less than $40,000. Overall, mean time costs were $838/year and mean OOP costs were $200/year. Although generally low, total costs represented approximately 10 % of income for lower income patients. No demographic variables were associated with costs. Radical prostatectomy, younger age, poor urinary function, current androgen deprivation therapy, and recent diagnosis were significantly associated with increased likelihood of incurring any costs, but only urinary function significantly affected total amount. CONCLUSIONS: Time and OOP costs are modest for most long-term PC survivors but can represent a substantial burden for lower income patients. Even several years after diagnosis, PC-specific treatments and treatment-related dysfunction are associated with increased costs. IMPLICATIONS FOR CANCER SURVIVORS: Time and out-of-pocket costs are generally manageable for long-term PC survivors but can be a significant burden mainly for lower income patients. The effects of PC-specific, treatment-related dysfunctions on quality of life can also represent sources of expense for patients.

Assessment criteria for compensation of occupational bladder cancer.

In Germany, more than 100 bladder tumor cases are annually recognized as occupational disease and compensated, given that medical experts regard exposure to carcinogenic aromatic amines as a likely cause of cancer. The amount of compensation is initially based on the tumor staging and grading at the time of initial diagnosis ("basic MdE") (MdE--reduction of earning capacity) and is adapted after a recurrence-free period of 2 and 5 years, respectively. In the event of treatment or tumor-related secondary conditions, the monthly compensation increases based on the severity of the objectified functional disorder. In the following article, medical experts specializing in this field provide a complete list of all known disorders, including treatment-related loss of a kidney or erectile dysfunction. In addition, the weighting of medical criteria in the assessment and calculation of the compensation is analyzed in greater detail. Since the given criteria are based on comprehensible experiences of urologists with their patients, they also provide medical experts in other countries with valuable points of reference for the calculation of the compensation.

A systematic review assessing the economic impact of sildenafil citrate (Viagra) in the treatment of erectile dysfunction.

INTRODUCTION: Sildenafil was the first oral phosphodiesterase type 5 (PDE5) inhibitor introduced as primary therapy for erectile dysfunction (ED). In the 7 years following its market launch, sildenafil was prescribed by more than 750,000 physicians to more than 23 million men worldwide. To date, few studies have evaluated the economic impact of sildenafil in treating ED. AIM: To evaluate the cost-effectiveness and impact of sildenafil on health care costs for patients with ED in multiple countries. MAIN OUTCOMES MEASURES: Economic outcomes including cost, cost-effectiveness, cost of illness, cost consequence, resource use, productivity, work loss, and willingness to pay (WTP) were investigated. METHODS: Using keywords related to economic outcomes and sildenafil, we systematically searched literature published between July 2001 and July 2011 using MEDLINE and EMBASE. Included articles pertained to costs, WTP, and economic evaluations. RESULTS: In the last 10 years, 12 studies assessed economic outcomes associated with sildenafil for ED. Most studies were conducted in the United States and the United Kingdom, with one study identified in Canada and one from Mexico. Six studies evaluated cost of illness, cost consequence, or cost of care, and four studies evaluated WTP or drug pricing by country in the United States and the United Kingdom. In the United States and the United Kingdom, costs to health care systems have increased with demand for treatment. Cost analyses suggested that sildenafil would lower direct costs compared with other PDE5 inhibitors. U.S. and U.K. studies found that patients exhibited WTP for sildenafil. The two cost-effectiveness models we identified examined ED sub-groups, those with spinal cord injury and those with diabetes or hypertension. These models indicated favorable cost-effectiveness profiles for sildenafil compared with other active-treatment options in both Mexico and Canada. CONCLUSIONS: The relative value of sildenafil vs. surgically implanted prosthetic devices and other PDE5 inhibitors, is underscored by patients' WTP, and cost-effectiveness in ED patients with comorbidities.

The cultural moral right to a basic minimum of accessible health care.

(1) The conception of a cultural moral right is useful in capturing the social-moral realities that underlie debate about universal health care. In asserting such rights, individuals make claims above and beyond their legal rights, but those claims are based on the society's existing commitments and moral culture. In the United States such a right to accessible basic health care is generated by various empirical social facts, primarily the conjunction of the legal requirement of access to emergency care with widely held principles about unfair free riding and just sharing of costs between well and ill. The right can get expressed in social policy through either single-payer or mandated insurance. (2) The same elements that generate this right provide modest assistance in determining its content, the structure and scope of a basic minimum of care. They justify limits on patient cost sharing, require comparative effectiveness, and make cost considerations relevant. They shed light on the status of expensive, marginally life extending, last-chance therapies, as well as life support for PVS patients. They are of less assistance in settling contentious debates about screening for breast and prostate cancer and treatments for infertility and erectile dysfunction, but even there they establish a useful framework for discussion. Scarcity of resources need not be a leading conceptual consideration in discerning a basic minimum. More important are the societal elements that generate the cultural moral right to a basic minimum.

Incremental cost-effectiveness of various monthly doses of vardenafil.

OBJECTIVE: To compare the cost-effectiveness of four, six, and eight doses per month of vardenafil in the context of pharmacy benefit decision making. METHODS: A Markov model was used to estimate the incremental cost-effectiveness of zero, four, six, or eight doses of vardenafil per month in hypothetical cohorts of 60-year-old male veterans with erectile dysfunction. Efficacy values for vardenafil were obtained from the literature, and vardenafil costs were obtained from Veterans Affairs pharmacy data. The analysis was conducted from a third-party payer perspective with a lifetime horizon, and the effect of parameter uncertainty was explored in one-way and probabilistic sensitivity analyses. RESULTS: In the base case analysis, the cost per quality-adjusted life-year gained for four doses of vardenafil per month compared with no therapy was $576. Six doses per month compared with four cost $2585/quality-adjusted life-year gained, and eight doses per month compared with six cost $5169/quality-adjusted life-year gained. In one-way sensitivity analyses of six doses per month compared with four, variation of two parameters caused the incremental cost-effectiveness ratio to cross a willingness-to-pay threshold of $20,000: when the increased utility associated with giving two additional doses/month was less than 0.001 (baseline 0.01) and when the cost per dose increased to $15.00 (baseline $1.69). CONCLUSION: Although four doses per month of vardenafil was the most cost-effective strategy, the use of six or eight doses per month also compares favorably with other accepted medical treatments. The results were stable across a range of inputs and help to support the current Veterans Affairs policy on the number of vardenafil doses provided per month for erectile dysfunction.

Where cost, medical necessity, and morality meet: should US government insurance programs pay for erectile dysfunction drugs?

Spending for the three most popular phosphodiesterase (PDE) inhibitor drugs to treat erectile dysfunction (ED) tops $1 billion worldwide annually. Using Medicaid and Medicare Part D as examples, we explore here whether US government insurance programs with limited budgets should reimburse for this class of ED drugs and review the common bases for justifying and denying reimbursement. We conclude that the clinical usefulness and costs of such drugs should be the primary drivers of coverage decisions, not moral attitudes toward sexual performance.

Services for erectile dysfunction in the UK - a 12-month review of referrals to a west Midlands NHS clinic.

INTRODUCTION: Few studies have addressed the health economics of the provision of services for sexual dysfunction within the National Health Service. AIM: To evaluate the referral patterns, workload and prescribing costs in secondary care resulting from government guidance on erectile dysfunction (ED). METHOD: A review of 324 consecutive referral letters to the Good Hope Hospital Erectile Dysfunction Clinic was conducted to assess the purpose of referral. Prescribing data and costs were assessed over the same 2-year period. RESULTS: Severe distress was the main reason for referral in 54% of referrals. Long term prescribing according to government guidance doubled the cost of care and created an unsustainable increase in clinic and pharmacy workload. CONCLUSIONS: Existing regulations designed to control costs of ED therapy have created health inequalities, waste of resources and have increased the overall cost of care.

Outcomes of simultaneous placement of an inflatable penile prosthesis and a male urethral sling through a single perineal incision.

INTRODUCTION: Synchronous implantation of an inflatable penile prosthesis (IPP) and a bulbourethral sling single via a single perineal is a unique approach in managing erectile dysfunction and stress urinary incontinence. AIM: This article describes our surgical approach and reviews the operative time, length of hospital stay (LOS), estimated blood loss (EBL), and cost of synchronous dual prosthetic implantation compared with the implants performed individually. Additionally, we review the short-term outcomes in patients with dual sling and penile prosthesis synchronous implants. METHODS: Fifty-eight patients with IPP, 53 slings, and eight simultaneous dual implantations between January 2000 and July 2008 were retrospectively reviewed. Operative times, EBL, length of stay, cost, and complications were compared in three groups (group 1, IPP; group 2, slings; group 3, dual implants). Additionally, we reviewed pre- and postoperative Sexual Health Inventory for Men (SHIM) scores and pad use in group 3. MAIN OUTCOME MEASURES: Review of operative times, EBL, LOS, cost, and complications. RESULTS: Dual implantation had similar operative times compared with the total time for the individual procedures (98 +/- 24 minutes for IPP; 86 +/- 24 minutes for sling; 177 +/- 17 minutes for dual implant, P > 0.05). EBL was reduced (57 +/- 30 mL for IPP; 48 +/- 59 mL for sling; 49 +/- 5 mL for group 3). LOS was also reduced (1.2 +/- 0.45 days for IPP, 0.7 +/- 0.48 days for sling; and 1.1 +/- 0.50 days for dual implant). Dual implantation was associated with approximately $9,000 in savings. With a mean follow-up of 13.6 months, group 3 reported SHIM increase from 1.3 +/- 0.5 to 23.5 +/- 0.6 and a decrease in pad use from three pads per day (range 2-6) down to a mean of one pad per day (range 0-2). One sling erosion and one sling infection occurred in group 2. One patient in group 3 had acute urinary retention resolved with 5 days of catheter drainage. CONCLUSION: Dual penile prosthesis and bulbourethral sling implantation through a single perineal incision is safe, efficient, and cost-effective.

[Erectile dysfunction after radical prostatectomy : patient information, contact persons, postoperative proerectile therapy]. / Erektile Dysfunktion nach radikaler Prostatektomie : Aufklärung, Ansprechpartner, postoperative proerektile Therapie.

BACKGROUND: Postoperative erectile dysfunction (ED) is one of the potential after-effects of radical prostatectomy. The aim of this study was to learn which caregivers inform the patients prior to the intervention about the risk of ED, which individuals the patients discuss this issue with, and whether the patients preoperatively consider use of a PDE5 inhibitor for proerectile therapy after the operation. METHODS: Using the IIEF-5 questionnaire, the preoperative erectile function of 110 patients was evaluated after the hospital admission interview. The patients were asked who had informed them about the risk of postoperative ED. They were also asked in whom they had confided to discuss this issue and whether they were prepared to undergo postoperative proerectile therapy with a PDE5 inhibitor. The patients were subsequently assigned to one of two groups: group I, consisting of those with a preoperative IIEF score > or = 21, or group II, those with a preoperative IIEF score <21. RESULTS: The answers given by groups I and II did not differ significantly. The median patient age was the same, 68, in both groups. In addition to being informed about postoperative ED by the hospital doctor on admission (100%), the patients were informed about this by the following individuals (results for group II in parentheses): board-certified urologist, 81.8% (74%); general practitioner (GP), 27.3%; partner, 12.1% (11.7%); self-help groups, 0% (2.6%); and friends, 3% (6.5%). Patients also discussed the risk of postoperative ED with the following individuals (results for group II in parentheses): local urologist, 66.7% (63.4%); partner, 45.5% (42.9%); hospital doctor, 39.4% (42.9%); GP, 21.2% (23.4%); friends, 9.1% (14.3); or no one, 3% (5.2%). Regarding whether patients were willing to undergo postoperative therapy using a PDE5 inhibitor, 36.4% in group I and 32.5% in group II said yes, 12.1% in group I and 11.7% in group II said no, and 51.5% in group I and 55.8% in group II were undecided. CONCLUSION: Irrespective of the patient's erectile status, the hospital doctor and the local urologist informed the patients about the risk of postoperative ED. Satisfactory information delivered by at least two people occurred in over 70% of all cases. The most frequent confidant of the patient for discussing this issue was his local urologist. Fewer than 50% of the patients discussed this topic with their partners. Possible reasons for underestimating the importance of sexual function could be the frequent taboo status of sexuality as a discussion topic in relationships, as well as preoperative distress. These circumstances should be taken into account by offering sufficient information, including that on the availability of postoperative proerectile therapy, for both the patient and his partner as early as possible, i.e., at the stage of choosing a treatment option.