Understanding Payer Perspectives on Value in the Use of Pharmaceuticals in the United States.

BACKGROUND: In recent years, value assessment frameworks have been introduced to inform discussions about how to define and assess value in the U.S. health care system. However, there is uncertainty as to how value assessment frameworks and other approaches to achieve value such as outcomes-based contracting are perceived and used in coverage decisions. OBJECTIVE: To understand how U.S. payers determine value in the use of pharmaceuticals and how it differs from payers outside the United States. METHODS: Qualitative in-depth phone interviews with 13 executive-level public and private U.S. managed care representatives and 6 health technology assessment advisors outside the United States were conducted from September to November 2017. RESULTS: Despite various mechanisms used by U.S. payers to assess value, no consistent definitions of value were provided, and U.S. payers felt limited in what they can do to achieve value in pharmaceutical decision making. Value assessment frameworks are not formally considered in formulary and reimbursement decisions but are used as a reference as they become available by most or all U.S. health plans. U.S. payers expressed concerns, including limited control over pharmaceutical pricing and budget caps, and limited ability to use incremental cost per quality-adjusted life-year thresholds. Outcomes-based contracting could have some utility in specific cases where the treatment has a particularly high cost and a clear outcomes measure, but payers indicated that outcomes-based contracts can be difficult to operationalize, and determination of savings was uncertain. Payers outside the United States-who are enabled by government health care bodies, policy tools, and analytical frameworks that have no counterpart in the United States-have a wider array of instruments at their disposal. U.S. payers were largely open to learning from other health care systems outside the United States, particularly the German health care system, where patient-relevant benefit compared with a predetermined treatment comparator is the primary determinant for price negotiations. CONCLUSIONS: Although there is interest in including value assessment frameworks during the decision-making process in the United States, there are significant challenges to operationalizing them. The current environment in the United States restricts payers' ability to make favorable contracts with manufacturers, and changes to the U.S. health system design are needed to facilitate this effort. Adoption of a value assessment framework in Medicare or Medicaid would accelerate adoption of these tools by private payers in the United States. DISCLOSURES: This study was conducted by RTI Health Solutions under the direction of The Pew Charitable Trusts and was funded by The Pew Charitable Trusts. Vekaria is employed by RTI Health Solutions. Reynolds and Coukell are employed by The Pew Charitable Trusts. Brogan and Hogue have nothing to disclose.

Barriers to the Administration of Epinephrine in Schools.

BACKGROUND: Anaphylaxis is a serious and growing concern in the school setting as the prevalence of food allergies and food-induced severe allergic reactions continues to increase. METHODS: A cross-sectional, web-based survey was conducted regarding anaphylactic events that occurred during the 2014-2015 school year. Eligible schools were enrolled in the EPIPEN4SCHOOLS® program (Mylan Specialty L.P., Canonsburg, PA), which provides free epinephrine auto-injectors to qualifying US schools. Participating schools completed a 29-item survey on anaphylactic event occurrence and treatment, epinephrine stock, school policies regarding anaphylaxis, school staff training, and school nursing coverage. RESULTS: Responses were provided by 12,275 schools. Epinephrine was administered on school property for 63.7% of reported anaphylactic events (1272/1998). In 38.5% (235/610) of events for which epinephrine was not used, antihistamines were cited as the reason. Only 59.4% of schools cited epinephrine as their standard first-line therapy for anaphylaxis. School nurses were most likely to be trained in anaphylaxis recognition and permitted to administer epinephrine; however, just 53.6% of schools had a full-time nurse on staff. CONCLUSIONS: Process-related barriers to the appropriate use of epinephrine go beyond access to medication. Widespread staff training and review of school policies are needed to ensure that anaphylaxis is appropriately managed in schools.

Prevalence and triggers of anaphylactic events in schools.

BACKGROUND: Prevention and management of anaphylaxis in schools is an area of active interest as allergy and asthma rates in children continue to increase. A greater understanding of the prevalence and characteristics of anaphylaxis can help guide preventive and management strategies both within and outside of the school setting, with the goal of reducing morbidity and mortality. OBJECTIVE: This study was performed to elucidate the epidemiology of and management strategies for anaphylaxis in the school setting. METHODS: A cross-sectional, Web-based survey was administered to schools that participated in an initiative that provides stock epinephrine autoinjectors (EAIs) to qualifying U.S. schools. Representatives from participating schools completed a questionnaire regarding anaphylactic reactions that occurred during the 2014-2015 school year. Weighted analyses were performed to account for differential responses between schools that completed the survey and those that did not. RESULTS: A total of 12,275 of the 45,819 invited schools responded to the survey. The occurrence of one or more anaphylactic events was reported by 1358 schools. Most events (89.8% [1803/2008]) occurred in students. High school students accounted for the largest proportion of anaphylactic reactions among students (40.1% [723/1802]). Food was the most commonly identified anaphylaxis trigger across grade levels, seasons, and geographic regions. The trigger was unknown to the individual who experienced anaphylaxis in 21.8% of the events (436/1998). No known history of allergy or asthma was present in 24.5% (491/2001) and 51.3% (1026/2000) of affected individuals, respectively. Transportation to the hospital or clinic for further treatment and/or management was reported for 72.6% of the individuals with anaphylactic events (1450/1997). Results from the weighted analyses were similar to those of the unweighted analyses. CONCLUSION: Anaphylaxis occurred across grade levels and in individuals with or without known risk factors, which reinforced the need for school preparedness in both management of anaphylaxis and stocking of EAIs.

Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples.

BACKGROUND: Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. OBJECTIVES: To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making. METHODS: A 3-part assessment (targeted literature review, qualitative one-on-one interviews, and online survey) was undertaken. Published literature was identified through searches in PubMed/MEDLINE and Embase. In addition, a targeted search was conducted of health technology assessment (HTA) agency websites in the United States, the United Kingdom, France, and Germany. Qualitative one-on-one interviews were conducted with 16 payers from the RTI Health Solutions global advisory panel in 14 markets (Australia, Brazil, France, Germany, Italy, South Korea, Netherlands, Poland, Spain, Sweden, Taiwan, Turkey, the United Kingdom, and the United States [n = 3]). Of the 200 payers and payer advisors from the global advisory panel invited to participate in the online survey, 20 respondents (China, France, Germany, Spain [n = 2], Taiwan, the United Kingdom, and the United States [n = 13]) completed the survey, and 6 respondents (Australia, South Korea, and the United States [n = 4]) partially completed the survey. RESULTS: Reviews of the literature and publicly available HTAs and reimbursement decisions suggested that HTA bodies and payers have varying experience with and confidence in PRO data. Payers participating in the survey indicated that PRO data may be especially influential in oncology compared with other therapeutic areas. Payers surveyed offered little differentiation by cancer type in the importance of PRO data but felt that it was most important to collect PRO data in phase 3 and postmarketing studies. Payers surveyed also anticipated an increasing significance for PRO data over the next 5-10 years. Characteristics of PRO data that maximize influence on payer decision making were reported to be (a) quality, well-controlled, and transparent PRO evidence; (b) psychometric validation of the PRO measure in targeted populations; and (c) publication in peer-reviewed journals. In markets with decentralized health care decision making, PRO data currently have more influence at the local level. Inclusion of PRO data in cancer treatment guidelines is key for centralized markets. Payers surveyed generally considered collecting PRO data postprogression to be useful. Of the 16 interviewees, 11 indicated that it is worthwhile to collect PRO data postprogression and that positive PRO data may support continued therapy at the physician's discretion upon regulatory approval, even in progressive disease. CONCLUSIONS: PRO data may help to differentiate treatments, particularly after clinical progression in oncology. Payers worldwide recognize high-quality PRO data as a key component of their decision-making process and anticipate the growing importance of PRO data in the future. DISCLOSURES: This study and preparation of this article were funded by Novartis Pharmaceuticals. This research was performed under a research contract between RTI Health Solutions and Novartis Pharmaceuticals. Brogan, Hogue, Demuro, and Barrett are employees of RTI Health Solutions. D'Alessio and Bal are employees of Novartis Pharmaceuticals. Study concept and design were contributed by DeMuro, Barrett, Bal, and Hogue. Brogan and Hogue took the lead in data collection, assisted by DeMuro and Bal. Data interpretation was performed by Brogan and Hogue, assisted by the other authors. The manuscript was written by D'Alessio and Brogan, along with the other authors, and revised primarily by Brogan, along with Hogue and assisted by the other authors. The abstract for this article was presented as a research poster at the following meetings: Hogue SL, Brogan A P, De Muro C, D'Alessio D, Bal V. Patient-reported outcomes (PRO) in post-progression oncology: implications in health technology assessments and payer decision making. Poster presented at the ISPOR 18th Annual European Meeting; November 7-11, 2015. Milan, Italy. Hogue SL, Brogan AP, De Muro C, D'Alessio D, Bal V. Influence of patient-reported outcomes (PRO) on market access decisions in markets with centralized healthcare systems. Poster presented at the ISPOR 18th Annual European Meeting; November 7-11, 2015. Milan, Italy. Hogue SL, Brogan AP, De Muro C, Barrett A, D'Alessio D, Bal V. Influence of patient-reported outcomes on market access decisions in decentralized markets (Brazil, Italy, Spain and the United States). Poster presented at the ISPOR 20th Annual Meeting; May 16-20, 2015. Philadelphia PA. Hogue SL, Brogan A P, De Muro C, Barrett A, McLeod L, D'Alessio D, et al. Payer Perspectives of Patient-Reported Outcomes Data: An Online Assessment. Poster presented at the ISOQOL 22nd Annual Meeting; October 21-24, 2015. Vancouver, British Columbia, Canada.

Training and administration of epinephrine auto-injectors for anaphylaxis treatment in US schools: results from the EpiPen4Schools(®) pilot survey.

BACKGROUND: Anaphylaxis is a serious, potentially life-threatening condition. Adequate preparation for anaphylaxis management is imperative for school personnel. This descriptive pilot study assessed preparedness of US schools to manage anaphylactic reactions. METHODS: An exploratory, cross-sectional, web-based, pilot survey assessed the occurrence and characteristics of anaphylactic events, as well as training provided to school personnel for the recognition and treatment of anaphylaxis. Eligible US schools were participants in the EpiPen4Schools(®) program during the 2013-2014 school year. EpiPen4Schools provides EpiPen(®) (epinephrine injection) Auto-Injectors and training materials to qualifying US schools. Survey data were parsed by US Census Bureau region and state and were evaluated using descriptive statistics. RESULTS: Schools from all 50 states and the District of Columbia participated in the survey (N=6,019). Among schools that provided information on anaphylactic events, 11% (607/5,683) reported the occurrence of one or more events, with significant variability in incidence across census regions and among states. A total of 5,613 schools provided information regarding which staff members were trained to recognize the signs and symptoms of anaphylaxis. Thirty-six percent of schools (2,022/5,613) indicated that only the school nurse and select staff were trained in anaphylaxis recognition. The proportion of schools in which most or all school staff received such training differed by region/state (range, 13%-100%). A total of 5,578 schools provided information on which staff were permitted to administer epinephrine. The majority of schools (54%; 3,024/5,578) permitted only the school nurse and select staff to administer epinephrine, although percentages varied by region/state (range, 4%-100%). CONCLUSION: Schools differed substantially in their preparedness to manage anaphylaxis, with significant disparities in staff training and permission to treat. Given the ramifications of delayed treatment, removing barriers to the recognition and treatment of anaphylactic events in schools is an important public health goal.

Anaphylaxis in Schools: Results of the EPIPEN4SCHOOLS Survey Combined Analysis.

A pilot survey described the characteristics of anaphylactic events occurring in an initial set of participating U.S. schools during the 2013-2014 school year. This survey was subsequently readministered to large school districts, which were underrepresented in initial results. A cross-sectional survey was administered to the U.S. schools that were participating in the EPIPEN4SCHOOLS® program (Mylan Specialty L.P., Canonsburg, PA) to assess characteristics of anaphylactic events. Data from large school districts were added to initial findings in this comprehensive combined analysis. A total of 1,140 anaphylactic events were reported among 6,574 responding schools. Of 1,063 anaphylactic events with data on who experienced the event, it was observed that it occurred mostly in students (89.5%, 951/1,063). For students, anaphylactic events were reported across all grades, with 44.9% (400/891) occurring in high school students, 18.9% (168/891) in middle school students, and 32.5% (290/891) in elementary school students. Food was identified as the most common trigger (60.1%, 622/1,035). A majority of schools (55.0%, 3,332/6,053) permitted only the school nurse and select staff to administer epinephrine to treat anaphylaxis. The unpredictability of anaphylaxis is emphasized by its high occurrence in individuals with no known allergies (25.0%). A majority of schools permitted only the school nurse and select staff to treat anaphylaxis. Thus, individuals experiencing an anaphylactic event may frequently encounter staff members not being permitted to administer potentially life-saving epinephrine. Epinephrine auto-injectors provided by the EPIPEN4SCHOOLS program were used to treat 38.0% of events. Anaphylaxis can occur in children with no previously known allergies, illustrating the importance of public access to epinephrine.

Anaphylaxis Triggers and Treatments by Grade Level and Staff Training: Findings from the EPIPEN4SCHOOLS Pilot Survey.

This pilot survey was designed to evaluate the characteristics of anaphylactic events and epinephrine autoinjector (EAI) use in children in U.S. schools. A cross-sectional, web-based, pilot survey of schools participating in the EPIPEN4SCHOOLS® program (Mylan Specialty L.P., Canonsburg, PA) assessed characteristics of anaphylactic events and EAI use during the 2013-2014 academic year. Respondents reported 757 anaphylactic events experienced by students; student grade level was noted for 724 events. Of these events, 32.3% (234/724) were experienced by students in grade school, 18.6% (135/724) by students in middle school, and 49.0% (355/724) by students in high school. Frequency of food-related triggers was consistently high across grade levels. However, many events experienced by students in high school (22.3%, 79/355), middle school (15.0%, 20/135), and grade school (14.1%, 33/234) had an unknown trigger. In 36.0% of schools (2008/5579), only the school nurse and select staff received training to recognize anaphylaxis; most staff or all staff received training in 28.9% (1610/5579) and 30.9% (1722/5579) of schools, respectively. In a majority of schools (54.2%, 3003/5544), only the school nurse and select staff were permitted to administer epinephrine, whereas most staff or all staff were permitted to administer epinephrine in 15.8% (876/5544) and 21.9% (1212/5544) of schools, respectively. Risk of anaphylaxis may be particularly high during adolescence, and some students encounter staff members who are untrained in anaphylaxis recognition or management, or both. These findings support the need for continued anaphylaxis training for the protection of all students, staff, and visitors.

EpiPen4Schools pilot survey: Occurrence of anaphylaxis, triggers, and epinephrine administration in a U.S. school setting.

BACKGROUND: Although epinephrine is the treatment of choice for anaphylaxis, it remains underused. OBJECTIVE: This study was designed to describe anaphylactic events and epinephrine autoinjector (EAI) use in U.S. schools enrolled in the EpiPen4Schools program. METHODS: This exploratory, cross-sectional, Web-based survey of 6019 schools that participated in the EpiPen4Schools program assessed anaphylactic events and EAI use at responding schools during the 2013-2014 school year. RESULTS: A total of 919 anaphylactic events were reported in 607 schools. Of the 852 anaphylactic events with data on those who experienced an event, most 88.8% (n = 757) occurred in students, and 21.9% of events (n = 187) occurred in individuals with no known allergies. Of the 851 events with data on EAI use, 74.7% (n = 636) were treated with EAIs and 8.5% (n = 54) received a second epinephrine injection. Of the 204 individuals not treated with an EAI, 77.0% (n = 157) received antihistamines, 12.7% (n = 26) received another treatment, and 8.3% (n = 17) received no treatment. Of the 850 events with data on hospital transport, 79.6% of individuals (n = 677) were transported to the hospital. Common triggers varied seasonally, with food listed most frequently overall (62.5%). CONCLUSION: More than one in ten schools that participated in the EpiPen4Schools survey reported an anaphylactic event. Approximately 25% of individuals with anaphylactic events were not treated with EAIs, and 20.4% of patients were not taken to the hospital after an anaphylactic event. Analysis of these data supports the value of stocking EAIs and of providing continuing education regarding the recognition and proper treatment of anaphylaxis for school personnel.

Clinical and economic impact of early versus delayed 5-alpha reductase inhibitor therapy in men taking alpha blockers for symptomatic benign prostatic hyperplasia.

BACKGROUND AND OBJECTIVE: Recent clinical trials indicate that combining an alpha blocker for rapid symptom improvement and a 5-alpha reductase inhibitor (5-ARI) to reduce the risk of clinical progression of benign prostatic hyperplasia (BPH) may be an optimal approach to management; however, few studies have evaluated the effect of combination therapy on clinical progression in a real-world setting. The purpose of our study was to assess the clinical and economic impact of early versus delayed 5-ARI therapy in patients treated with an alpha blocker for BPH. MATERIALS AND METHODS: A retrospective database analysis included men 50 years of age and older who were treated for BPH between 2003 and 2007. Clinical outcomes were evaluated for patients using 5-ARIs early (within 30 days of starting an alpha blocker) compared with those using delayed 5-ARI therapy (between 30 and 180 days after starting an alpha blocker). We assessed the likelihood of clinical progression (defined as the occurrence of acute urinary retention or prostate surgery) for each group over a one-year period following the start of alpha-blocker therapy. DATA SOURCE: The MarketScan Database, which was used to identify patients, contains medical and pharmacy claims data obtained directly from Medicare and commercial health plans and employers, representing 18 to 20 million lives annually. RESULTS: Of 8,617 men included in the analysis, 64.5% began 5-ARI therapy within 30 days of alpha-blocker therapy (the early cohort). These patients were less likely than those receiving delayed 5-ARI treatment to have clinical progression (12.8% vs. 17.4% respectively; P < 0.0001), acute urinary retention (10.2% vs. 13.8%, P < 0.0001), and prostate surgery (5% vs. 7%, P = 0.0002). The early group also incurred lower BPH-related medical costs ($572 vs. $730, P < 0.0001). Even though BPH-related pharmacy costs were significantly higher ($1,137 vs. $1,263, P = 0.0313), their total BPH-related costs were lower ($1,834 vs. $1,867, P = 0.0068). CONCLUSION: These results suggest that early 5-ARI therapy for men with symptomatic BPH who receive an alpha blocker may significantly reduce the risk of clinical progression (i.e., acute urinary retention or prostate surgery) over the next 12 months as well as lower BPH-related medical costs and BPH-related total costs.

Benign prostatic hyperplasia: racial differences in treatment patterns and prostate cancer prevalence.

OBJECTIVE: • To compare prostate cancer, prostate-related surgery and acute urinary retention rates, as well as associated healthcare resource use over 11 years in African American and Caucasian men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: • The BPH-related medical and surgical charges and events were determined for 398 African American men and 1656 Caucasian men followed for a mean of 10.2 years within a health maintenance organization. • Racial differences in clinical outcomes were evaluated using time-to-event analysis, stratifying results by baseline prostate-specific antigen (PSA) values. RESULTS: • Risk of a prostate cancer diagnosis was 2.2 times greater in African American than Caucasian men (95% CI 1.48-3.35, P < 0.001) in analyses adjusting for serum PSA level. • Although African Americans were more likely to receive medical therapy for symptoms of BPH than Caucasians (43.5% vs 37.2%, respectively; P= 0.029), there were no clinically meaningful differences with respect to subsequent acute urinary retention or BPH-related surgery between them, or BPH-related medical charges (US $407 vs US $405 per month). CONCLUSION: • As evidenced by this analysis of 'real-world' clinical practice, African Americans with BPH have a much greater risk of developing prostate cancer than similar Caucasian men highlighting the need for education and early detection in this population.

The economic impact of delaying 5-alpha reductase inhibitor therapy in men receiving treatment for symptomatic benign prostatic hyperplasia.

BACKGROUND: Pharmacologic treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia often includes alpha-blockers and 5-alpha reductase inhibitors. Many clinicians use alpha-blockers for rapid symptom control, later adding 5-alpha reductase inhibitors to modify long-term disease progression. Delaying the addition of these medications has been shown to result in reduced clinical outcomes. The economic impact of this practice has not been widely studied or reported to date. OBJECTIVE: The objective of this study was to assess the economic impact of delaying initiation of concomitant 5-alpha reductase inhibitor therapy (≥30 days) in patients receiving alpha-blockers for lower urinary tract symptoms. METHODS: Using 2 nationally representative databases (Integrated Health Care Information Solutions and PharMetrics), 2 retrospective analyses were conducted involving 2636 and 4260 men, respectively, aged ≥50 years treated for benign prostatic hyperplasia between 2000 and 2007. Economic outcomes (ie, the cost of therapy and the use of healthcare resources) were compared for adding 5-alpha reductase inhibitor therapy early (within <30 days of initiating an alpha-blocker) versus delaying these medications (≥30 days after initiating an alpha-blocker). RESULTS: In the Integrated Health Care Information Solutions analysis, patients in the early add-on therapy group (n = 1572) had lower benign prostatic hyperplasia-related medical costs in the posttreatment period than those in the delayed-therapy group (n = 1064), $349 versus $618 (P <.0001). Similar trends were seen in the PharMetrics analysis-the medical costs in the early add-on therapy group (n = 2604) and delayed group (n = 1656) were $344 versus $449, respectively (P <.001). Pharmacy costs were $1068 for the early-treatment cohort and $989 for the delayed-treatment cohort for the Integrated Health Care Information Solutions database, yielding total costs of $1417 and $1606, respectively, for a $189 savings per patient over the initial year of treatment (P <.0001). In the PharMetrics analysis, pharmacy costs were $1391 for the early-treatment cohort and $1237 for the delayed-treatment cohort, resulting in total cost of $1735 and $1686, respectively, yielding $59 in additional costs per patient annually for those treated early (P = .8645). CONCLUSION: These results suggest that patients receiving 5-alpha reductase inhibitor therapy within 30 days after initiating alpha-blocker treatment have lower benign prostatic hyperplasia-related medical costs than those who start combination treatment later. The increase in pharmacy costs associated with early initiation of 5-alpha reductase inhibitor therapy resulted in total costs that were similar or significantly lower than those of delayed combination users.

Impact of delaying 5-alpha reductase inhibitor therapy in men on alpha-blocker therapy to treat BPH: assessment of acute urinary retention and prostate-related surgery.

OBJECTIVE: Pharmacologic treatment of lower urinary tract symptoms from benign prostatic hyperplasia (BPH) commonly includes alpha-blockers (ABs) and 5alpha-reductase inhibitors (5ARIs). Many clinicians use ABs for rapid symptom control and 5ARIs to modify long-term disease progression. The purpose of this study was to assess the clinical impact of delayed 5ARI therapy in patients treated with AB for lower urinary tract symptoms. RESEARCH DESIGN AND METHODS: Using two nationally representative databases, two retrospective analyses were conducted including patients aged > or =50 years treated for BPH between 2000 and 2007. Clinical outcomes for those using add-on 5ARI therapy early (within 30 days of initiating AB) and late (>30 days after initiating AB) were compared. Likelihood of clinical progression, defined as the presence of acute urinary retention (AUR) and prostate surgery, was assessed over 1 year after AB initiation, and modeled as a function of the treatment cohorts and the following baseline covariates: AUR, BPH stage, Charlson Comorbidity Index, age, and number of unique diagnosis codes, unique non-BPH-related classes of prescriptions filled, and specialty care. RESULTS: Of 6896 men included in the analyses, approximately 60% initiated 5ARI therapy within 30 days of AB therapy (the early cohort). Patients in the early cohort were less likely to have clinical progression. Each 30-day delay in starting 5ARIs resulted in an increased likelihood of overall clinical progression (average 21.1%), AUR (average 18.6%), and prostate-related surgery (average 26.7%). CONCLUSIONS: These results suggest that delaying 5ARI therapy in men with BPH increases the risk of AUR and prostate surgery. LIMITATIONS: Confounding factors, such as symptom severity and prostate volume, may have influenced the findings of the study.

5-Alpha reductase inhibitors in men with an enlarged prostate: an evaluation of outcomes and therapeutic alternatives.

This article presents background information and highlights key findings from a managed care perspective related to enlarged prostate (EP) in Medicare-eligible patients. This article does not provide a comprehensive review of EP but instead attempts to increase the current understanding of EP through discussion of its prevalence in men aged > or =65 years, its associated economic burden, and some available treatment options. This supplement includes 3 additional articles, all of which present data from a naturalistic, managed care setting. The article by Fenter et al assesses differences in outcomes between elderly EP patients treated with finasteride and those treated with dutasteride in relation to the risks of acute urinary retention and prostate-related surgery. Issa et al conduct a comparative analysis of the combined use of alpha-blockers and 5-alpha reductase inhibitors to treat EP. The final article compares medical costs incurred within the first year of initiating treatment for EP patients receiving finasteride versus dutasteride. This supplement is intended to assist managed care formulary decision makers in evaluating key clinical and economic data that differentiate dutasteride and finasteride within the Medicare-aged population. Although the information presented is not designed to illustrate the superiority of one product over the other, it answers important questions in relation to treating EP in elderly men and raises substantial issues beyond medication costs.

Cost comparison of finasteride and dutasteride for enlarged prostate in a managed care setting among Medicare-aged men.

OBJECTIVE: To assess cost differences between dutasteride and finasteride use within the first year of initiating treatment for enlarged prostate (EP) among men aged > or =65 years in a managed care setting. METHODS: For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for EP patients aged > or =65 years who were treated with dutasteride or finasteride. Analysis of average monthly costs over each patient's 1-year follow-up period incorporated total charges for EP-related medical care, including physician, inpatient and outpatient hospital care, emergency department, and other ancillary services. RESULTS: A total of 4498 patients met selection criteria, with comparable demographics between treatment cohorts. Patients taking dutasteride incurred $51 less per month in medical expenses than finasteride-treated patients ($122 vs $173; P <.001), attributable to lower monthly inpatient hospitalization costs ($55.84 vs $70.34), outpatient costs ($22.07 vs $44.25), and physician office visit costs ($40.69 vs $51.10). CONCLUSION: Medicare-aged patients treated with dutasteride incurred $51 less per month in medical costs than those treated with generic finasteride, suggesting that the higher price of dutasteride may be offset by decreased medical resource consumption.

Persistence with once-daily versus twice-daily bupropion for the treatment of depression in a large managed-care population.

In this study, the impact of dosing frequency [once daily with bupropion extended-release (XL) versus twice daily with bupropion sustained-release (SR)] on medication persistence was assessed over a 9-month period in a large cohort of patients with depression in a managed-care setting. Administrative claims data from the Integrated Health Care Information Services National Managed Care Benchmark database were analyzed for patients 18 to 64 years old with a documented diagnosis of depression who began treatment with bupropion XL or SR between September 2003 and February 2004. Persistence of use was higher with once-daily bupropion XL (n = 1074) than with twice-daily bupropion SR (n = 1917) across measures assessed by univariate tests of proportions. The mean (+/-SD) number of days between the first and last prescription claims was longer with bupropion XL (128.37 +/- 103.46 days) than with bupropion SR (82.31 +/- 96.86 days) (P < 0.0001). The bupropion XL cohort had higher persistency of use than the bupropion SR cohort (mean +/- SD = 0.47 +/- 0.38 versus 0.30 +/- 0.36) (P < 0.0001) and a higher medication possession ratio (mean +/- SD = 0.50 +/- 0.33 versus 0.36 +/- 0.31) (P < 0.0001). Medication persistency >0.7 and a medication possession ratio >0.7 were almost twice as likely in the bupropion XL cohort (38.5% and 32.0%, respectively) than in the bupropion SR cohort (21.5% and 17.0%, respectively). Results of multivariate analyses adjusted for age, gender, and index date support the univariate analyses. Because better persistence and adherence may be associated with less likelihood of relapse and lower depression-associated health care utilization and economic burden, health care providers should consider the potential benefits of initiating treatment with bupropion XL for bupropion candidates and for switching bupropion SR recipients to treatment with bupropion XL.

Once-daily bupropion associated with improved patient adherence compared with twice-daily bupropion in treatment of depression.

The main aim of this study was to examine the impact of dosing regimens on patients' persistence to bupropion. A nationally representative patient-level database comprising of pharmacy and medical claims was used to identify patients with depression (ICD-9-CM: 296.2, 296.3, 300.4, 311), who had initiated therapy with bupropion sustained release (b.i.d.; 2 doses/d) or extended release (q.d.; 1 dose/d) tablets from September 2003 to February 2004; had no previous antidepressant or benzodiazepine use; and had 9 months of follow-up. Persistence was measured using prescription claims, and calculated using the medication possession ratio [MPR; (total days supply; all filled prescriptions)/270 d]. Multivariate logistic regression compared the likelihood of achieving MPR > or = 0.70 controlling for age, sex, and index date. A total of 3132 patients were included (b.i.d.: n = 2382; q.d.: n = 756). q.d. patients on average had a significantly higher MPR than b.i.d. patients [q.d. 0.52 (+/-0.35), b.i.d. 0.35 (+/-0.26)]; P < 0.001) and had a higher likelihood of achieving an MPR > or = 0.70 (q.d. 35%, b.i.d. 12%, P < 0.0001). After controlling for differences in baseline characteristics, b.i.d. patients were only one-fourth as likely (odds ratio = 0.260, 95% confidence interval: 0.214-0.316) to achieve MPR >0.7. The use of the once-daily, extended release formulation of bupropion appeared to significantly improve patients' persistence to therapy for the treatment of depression.

Impact of comorbid attention deficit disorder on the direct medical costs of treating adults with depression in managed care.

OBJECTIVE: To assess the impact of comorbid attention deficit disorder (ADD) on the direct medical costs of treating adults with depression in a mixed-model health maintenance organization. METHOD: Annual mean and marginal health care costs were calculated for adults who were continuously enrolled at Group Health Cooperative during 2001 and who were diagnosed with depression, ADD, or both ADD and depression according to ICD-9-CM criteria during 2001. RESULTS: Of 249,874 adults continuously enrolled during 2001, 17,792 (7.1%) were diagnosed with depression, 1023 (0.4%) were diagnosed with ADD, and 454 (0.2%) were diagnosed with both depression and ADD. The mean total annual cost for an adult with a diagnosis of depression in 2001 exceeded that for the average adult enrolled in Group Health by 109% ($6029 vs. $2880). Of the $6029 mean total annual cost for treating an adult with a diagnosis of depression, $1872 (31%) was specifically attributable to depression. The presence of comorbid ADD resulted in ADD- and depression-attributed marginal costs approximately 29% higher than the costs specifically attributed to depression alone ($2418 vs. $1872). In fact, among patients with a diagnosis of ADD and depression, ADD- and depression-attributed costs approached the mean total cost of health care in the sample as a whole ($2880). CONCLUSION: Depression is associated with high direct medical costs. The marginal costs of treating comorbid depression and ADD substantially exceed those of treating depression alone. These results underline the importance of considering the costs of comorbidities in estimating the economic burden of depression and developing cost-effective disease-management strategies.

Estimating the prevalence and impact of antidepressant-induced sexual dysfunction in 2 European countries: a cross-sectional patient survey.

OBJECTIVE: Sexual dysfunction is a common side effect of antidepressant treatment, but recognition of the problem is variable. The aim of this study was to estimate the prevalence and impact of sexual dysfunction during antidepressant treatment in 2 European countries. METHOD: A cross-sectional survey of 502 adults in France and the United Kingdom. All participants were diagnosed with depression and taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), starting within the previous 3 months. Information was gathered about other medications and conditions known to impair sexual functioning, recent changes in sexual functioning, and the impact of any changes. The Medical Outcomes Study 12-Item Short-Form Health Survey and the Arizona Sexual Experience Scale were administered to measure health status and sexual functioning. Data were collected from June to July of 2002. RESULTS: Applying a prevalence estimate algorithm, 26.6% of the French sample and 39.2% of the U.K. sample were classified as having antidepressant-induced sexual dysfunction; 34.2% of men and 32.5% of women were classified with antidepressant-induced sexual dysfunction. There was no clear pattern of antidepressant-induced sexual dysfunction related to specific antidepressants. Patients with antidepressant-induced sexual dysfunction reported that changes in sexual functioning negatively affected their self-esteem, mood, and relationships with sexual partners. 23.8% of the French sample and 25.2% of the U.K. sample reported that they perceived that their partner was dissatisfied with their sex life. CONCLUSION: The prevalence of antidepressant-induced sexual dysfunction in this study is similar to previous estimates reported in the literature. The impact of antidepressant-induced sexual dysfunction is substantial and negatively affects quality of life, self-esteem, mood, and relationships with sexual partners.

An assessment of patient preference and adherence to treatment with Wellbutrin SR: a web-based survey.

BACKGROUND: Research has shown that lack of treatment adherence is a serious problem, especially among patients with psychiatric disorders. The current study was conducted to assess adherence and patient preference among individuals taking Wellbutrin SR (bupropion) for depression, as well as their interest in a once-daily formulation of bupropion. METHODS: A 20-item web-based survey was administered to 527 individuals (276 men and 251 women) recruited through an online panel. All participants were at least 18 years of age, diagnosed with major depressive disorder, and had been taking Wellbutrin SR for at least 6 weeks. Survey items addressed treatment regimen, adherence, satisfaction with Wellbutrin SR, and interest in a once-daily formulation of bupropion. RESULTS: The majority of respondents reported taking Wellbutrin SR twice a day (67%). Only 15% of once-daily users were nonadherent compared to 37% of twice-daily users and 65% of thrice-daily users. The most common reason reported for missing a dose of Wellbutrin SR was simply forgetting to take it (49% of twice-daily users and 65% of thrice-daily users). Results indicated that 77% of twice-daily users and 94% of thrice-daily users were interested in a once-daily formula. CONCLUSIONS: A reduction in dosing frequency is favored by Wellbutrin SR users and likely to improve their adherence to treatment. Because greater adherence has been shown to facilitate symptom relief, improvements in quality of life, and reductions in healthcare expenses, the results of this study support the value of the recently released once-daily formulation, Wellbutrin XL.

Impact of smoking on respiratory illness-related outpatient visits among 50- to 75-year-olds in the United States.

BACKGROUND: Although it is generally agreed that tobacco use poses an enormous public health problem, payment and reimbursement for smoking-cessation interventions by financially stretched national health systems remain controversial. OBJECTIVE: The purpose of this study was to estimate the number and cost of excess respiratory illness-related visits attributable to smoking among older adults in the United States. METHODS: The 1995 and 1996 National Ambulatory Medical Care Survey databases were analyzed to estimate attributable risk in the population by age, sex, and smoking status among adults 50 to 75 years of age. Cost estimates for ambulatory physician visits were based on data from a major New England insurer using combined 1995 and 1996 information. Cost estimates were then developed for patients who had a respiratory-illness related diagnosis. RESULTS: Smoking was responsible for 5.1% (1,358,565) and 5.7% (1,452,761) of respiratory illness-related physician visits in 1995 and 1996, respectively. The costs (in 1998 dollars) of physician visits attributable to smoking were $69,205,301 and $74,003,645 in 1995 and 1996, respectively. CONCLUSIONS: Smoking increases health services utilization related to respiratory illness, thereby substantially increasing health care costs. Smoking-cessation programs may help reduce physician office visits related to respiratory illness, as well as the overall societal burden of smoking.