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.

Downstream Revenue Realized by Facilities Placing Inflatable Penile Prosthesis in Medicare Beneficiaries to Treat Erectile Dysfunction.

OBJECTIVE: To quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED. METHODS: The 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and 5 years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported. RESULTS: After matching, there were 2905 men with ED who received an IPP and 7462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2646 for diabetes, $2013 for urology, and $1043 for prostate cancer. Significantly more IPP patients had at least 1 health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% vs 7.8% for circulatory, 46.7% vs 16.8% for urology, 19.3% vs 3.6% for diabetes, and 19.0% vs 3.0% for prostate cancer). CONCLUSION: Men with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly 10 times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED.

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.

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.

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.

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.

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.

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.

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.

The demographic burden of urologic diseases in America.

The National Institute of Diabetes and Digestive and Kidney Diseases initiated the Urologic Diseases in America project in 2001 with the goal of quantifying the immense demographic burden of urologic diseases on the American public, in both human and financial terms. This effort was renewed in 2007 with the aim of expanding and deepening analyses of the epidemiology, costs, and quality of medical care in urology. This ongoing commitment recognizes the major public health impact of urologic conditions in the United States. A thoughtful policy response to these changes requires a thorough understanding of the health care resource use and clinical epidemiology relevant to urologic diseases in America. This article details major initial findings from the Urologic Diseases in America project with respect to the demographic impact of the most common benign, malignant, and pediatric urologic conditions.

[Cost effectiveness of screening for prostate cancer].

According to most experts, problems of prostate cancer (PC) have reached world-wide social and economic resonance at the turn of the 21st century. Costly programs of diagnosis and treatment of generalized PC and its complications require most spending. The general demographic situation and increased aging of male populations, both worldwide and in this country, make it clear that the total costs of medical aid to PC patients will inevitably grow. However, programs of screening for PC can help.

Utilization and cost of sildenafil in a large managed care organization with a quantity limit on sildenafil.

OBJECTIVE: Erectile dysfunction (ED) affects approximately 30 million men in the United States. The objectives of this study were to (1) assess the cost and utilization of sildenafil citrate (Viagra), an oral therapeutic agent for ED, in a large managed care organization (MCO) with a quantity limit of 6 units per 30-day supply and (2) describe the incidence of comorbid conditions and the severity of cardiovascular disease in adult male users of sildenafil. METHODS: Pharmacy claims for sildenafil were identified from an administrative database of claims with dates of service in calendar year 2001 for male members aged 18 years or older. Medical claims for MCO members who had sildenafil claims were used to identify comorbid diseases and categorize patients by degree of cardiovascular risk. High risk was defined as having at least 1 medical claim with a diagnosis of diabetes mellitus, ischemic heart disease, abdominal aortic aneurysm, or peripheral arterial disease, and medium risk was defined as not having any diagnosis in the high-risk category but at least 1 cardiovascular risk factor that included smoking, hypertension, hypercholesterolemia, family history of premature coronary heart disease, or being aged 45 years or older. RESULTS: There were 67,914 pharmacy claims for sildenafil during 2001 for 20,281 MCO members, an average of 3.3 pharmacy claims per patient. The prevalence of sildenafil use was 54.1 per 1,000 male MCO members aged 18 years or older. The total allowed charges for sildenafil pharmacy claims in 2001 were 3.56 million US dollars, of which patients paid 26.6% in average cost-share, and the net MCO cost per member per month (PMPM) was 0.18 US dollars. A total of 1,681 patients (8.3%) exceeded their quantity restrictions for sildenafil tablets in 2001, of which 1,362 (81.0%) paid cash and 319 (19.0%, or 1.6% of all sildenafil users) appealed and received approval from the MCO for additional sildenafil tablets beyond the restriction of 6 tablets per month. Medical claims were available for 15,644 sildenafil patients (77.1%), and 12,720 sildenafil users (81.3% of those with medical claims) were judged to be at high or medium cardiovascular risk. CONCLUSIONS: A quantity limit of 6 tablets of sildenafil per 30-day period was associated with a drug cost to users and the MCO of 0.25 US dollars PMPM. Sildenafil users paid an average cost-share of 26.6%, resulting in a net drug cost of 0.18 US dollars PMPM to the MCO.

Erectile dysfunction in spinal cord injury: a cost-utility analysis.

BACKGROUND: There is a high incidence of erectile dysfunction after spinal cord injury. This can have a profound effect on quality of life. Treatment options for erectile dysfunction include sildenafil, intracavernous injections of papaverine/alprostadil (Caverject), alprostadil/papaverine/phentolamine ("Triple Mix"), transurethral suppository (MUSE), surgically implanted prosthetic device and vacuum erection devices. However, physical impairments and accessibility may preclude patient self-utilization of non-oral treatments. METHODS: The costs and utilities of oral and non-oral erectile dysfunction treatments in a spinal cord injury population were examined in a cost-utility analysis conducted from a government payer perspective. Subjects with spinal cord injury (n=59) reported health preferences using the standard gamble technique. RESULTS: There was a higher health preference for oral therapy. The cost-effectiveness results indicated that sildenafil was the dominant economic strategy when compared with surgically implanted prosthetic devices, MUSE(R) and Caverject. The incremental cost-utility ratios comparing sildenafil with triple mix and vacuum erection devices favoured sildenafil, with ratios less than CAN$20,000 per quality adjusted life year gained. CONCLUSION: Based on this study, we conclude that sildenafil is a cost-effective treatment for erectile dysfunction in the spinal cord injury population.

[Cost of fertility and erectile dysfunction therapy: who has to pay what in the GVK?]. / Kosten einer Fertilitäts- und ED-Therapie Wer zahlt was in der GKV?

From 1 January 2004 new legislation changed the liability of the public health insurance regarding diagnostic and therapy both of erectile dysfunction and infertility. Before 2004 medical therapy of erectile dysfunction (autoinjection therapy, PDE5 inhibitors) was included in the coverage of the general health insurance; however, it is now excluded by law. Before 2004 sterilization was covered by public health insurance only if medically indicated. The costs of vasovasostomy or artificial fertilization after sterilization were only covered by health insurance if the sterilization was carried out for medical reasons. In the field of infertility the liability of statutory health insurance has only been restricted concerning artificial fertilization. Since 2004 there have been restrictions concerning the age of the insured person, and 50% of the costs have to be payed by the patient herself. Moreover, for the different methods of artificial fertilization, the number of trials and the indications have been defined by the Federal Committee. The statutory health insurance is not liable if the number of trials exceeds the limit.

Cost-effective evaluation of impotence.

Two hundred consecutive men presenting with a chief complaint of impotence have been evaluated with a protocol involving one or two outpatient visits. The initial evaluation for all patients consisted of a history taken in a conventional manner and supplemented by a patient-completed sexual function questionnaire, physical examination, serum testosterone and prolactin, and two-night nocturnal penile tumescence studies. Following the initial evaluation the patients were placed in one of three categories: (1) organic impotence, (2) functional impotence, (3) ambiguous impotence (mixed functional and organic impotence or organic impotence of undetermined etiology). Patients in the latter group underwent additional testing including penile vascular studies, two-hour oral glucose tolerance test, and psychiatric consultation. With this protocol, patients can be efficiently and effectively evaluated as outpatients with costs ranging from +250 to +450.