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.

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.

Evaluating the Impact of Sample Medication on Subsequent Patient Adherence.

BACKGROUND: Medication nonadherence is problematic throughout health care practice. Patient nonadherence is a result of several factors, such as financial issues, confusion about the medication, or concerns about possible side effects. Efforts to improve adherence have been implemented, but new strategies are needed to ensure that patients fill their medication prescriptions and adhere to their prescribed use. OBJECTIVE: To investigate whether providing patients with a free 30-day supply of medication at the point of care via a dispensing kiosk-a secure, computerized cabinet placed in the prescriber's office-that provides sample medication and educational materials had a measurable impact on adherence and health care cost. METHODS: The study sample consisted of patients drawn from the electronic health records of a large health care provider who were prescribed medications to treat diabetes, hypertension, and dyslipidemia. The comparison groups included a treatment group of patients who each received a 30-day generic sample of medication and a control group of patients who did not receive a sample. The study outcome was primary medication non-adherence (PMN), defined as whether a patient filled a prescription within 90, 180, or 365 days of prescribing. Only patients receiving a prescription for the first time were considered; patients on a medication before receipt of the sample were dropped. Postprescription medication adherence (PPMA), measured as proportion of days covered (PDC) and proportion of days covered ≥ 80% (PDC80), was also examined. Propensity score methods and multivariate regression models were used to examine the outcomes and group differences. Costs to the patient before and after the prescription were also analyzed. Key informant interviews were conducted with physicians, and qualitative analyses were performed. RESULTS: Patients who received a 30-day generic medication sample had a higher probability of filling a first prescription within 90 days (72.2% for treatment patients vs. 37.6% for controls, P < 0.001); 180 days (79.1% vs. 43.3%, respectively, P < 0.001); and 365 days (85.5% vs. 48.6%, P < 0.001). The medication sample had a positive effect on PDC for 90 days, with treatment patients having 72.8% adherent days versus 35.1% adherent days for controls (average treatment effect [ATE] = 37.5%, P < 0.001). At 180 days, PDC adherence was 57.1% for treatment patients versus 35.4% for controls (ATE = 21.5%, P < 0.001), and 43.6% versus 33.9%, respectively (ATE = 9.5%, P < 0.001) for the 365-day period. PDC80 was significantly better among treatment patients at 90 days (53.5% vs. 31.2%, respectively, ATE = 22.4%, P < 0.001) and 180 days (38.4% vs. 29.1%, ATE = 9.2%, P < 0.001), but not at 365 days (23.7% vs. 23.7%, ATE = -0.02, not significant). Costs were reduced by $395 for the treatment group. Interviews with clinicians indicated a positive view of the program. CONCLUSIONS: Providing a free sample medication improved the probability of patients filling their initial prescriptions and adhering to those medications. This program can affect health care costs, as evidenced by lower costs for the treatment group. DISCLOSURES: Financial support for this study was provided by MedVantx. UMPC Health Plan reviewed and commented on the manuscript. Hogue is an employee of MedVantx and also reviewed the manuscript. Manolis is employed by UPMC Health Plan. The remaining authors report no other conflicts of interest. Study concept and design were contributed by Pringle. Aldridge took the lead in data collection, along with Kearney. Data interpretation was performed primarily by Radack, along with Kearney and Grasso. The manuscript was written by Kearney, Aldridge, and Radack and revised by Kearney, Manolis, Hogue, and Radack.

Review of the cost of venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) is the second most common medical complication and a cause of excess length of hospital stay. Its incidence and economic burden are expected to increase as the population ages. We reviewed the recent literature to provide updated cost estimates on VTE management. METHODS: Literature search strategies were performed in PubMed, Embase, Cochrane Collaboration, Health Economic Evaluations Database, EconLit, and International Pharmaceutical Abstracts from 2003-2014. Additional studies were identified through searching bibliographies of related publications. RESULTS: Eighteen studies were identified and are summarized in this review; of these, 13 reported data from the USA, four from Europe, and one from Canada. Three main cost estimations were identified: cost per VTE hospitalization or per VTE readmission; cost for VTE management, usually reported annually or during a specific period; and annual all-cause costs in patients with VTE, which included the treatment of complications and comorbidities. Cost estimates per VTE hospitalization were generally similar across the US studies, with a trend toward an increase over time. Cost per pulmonary embolism hospitalization increased from $5,198-$6,928 in 2000 to $8,764 in 2010. Readmission for recurrent VTE was generally more costly than the initial index event admission. Annual health plan payments for services related to VTE also increased from $10,804-$16,644 during the 1998-2004 period to an estimated average of $15,123 for a VTE event from 2008 to 2011. Lower costs for VTE hospitalizations and annualized all-cause costs were estimated in European countries and Canada. CONCLUSION: Costs for VTE treatment are considerable and increasing faster than general inflation for medical care services, with hospitalization costs being the primary cost driver. Readmissions for VTE are generally more costly than the initial VTE admission. Further studies evaluating the economic impact of new treatment options such as the non-vitamin K antagonist oral anticoagulants on VTE treatment are warranted.

Disease Burden in the Treatment of Age-Related Macular Degeneration: Findings From a Time-and-Motion Study.

PURPOSE: To examine the time burden of managing neovascular age-related macular degeneration (AMD) imposed on physicians, staff, patients, and caregivers. DESIGN: Mixed-methods, prospective, observational time-and-motion study. METHODS: The multicenter study was conducted from March 2011 through August 2012. Retina specialists administering ≥50 vascular endothelial growth factor (VEGF)-inhibitor injections monthly were surveyed and completed records for ≥5 patients scheduled for office visits within 3 weeks for anti-VEGF injection or monitoring. A survey was administered to 75 neovascular AMD patients aged ≥50 years who received ≥1 anti-VEGF injection in the past 6 months. Telephone interviews were conducted with 13 neovascular AMD patient caregivers. RESULTS: Fifty-six physicians provided data for 221 patients with neovascular AMD. Patients accounted for 20% of the health care staff's time per week, with an average of 23 staff members. An average patient visit for neovascular AMD was 90 minutes (range: 13 minutes to >4 hours). Patients reported an average time per visit of almost 12 hours, including preappointment preparation (16 minutes), travel (66 minutes), waiting time (37 minutes), treatment time (43 minutes), and postappointment recovery (9 hours). Patients stated that caregivers took time away from work (22%) and personal activities (28%) to provide transportation to appointments. CONCLUSIONS: Neovascular AMD management imposes a substantial time burden on physicians, staff, patients, and caregivers. There may be a need for additional support and/or reimbursement for services required by patients and caregivers and provided by physicians.

Review of challenges in optimizing oral anticoagulation therapy for stroke prevention in atrial fibrillation.

Oral anticoagulant therapy is the mainstay of stroke prevention in patients with atrial fibrillation; it is highly effective at reducing stroke risk, but its use can be limited by increased risk of bleeding. As new oral anticoagulants are available, barriers to optimal use of oral anticoagulation therapy warrant consideration by healthcare professionals and administrators who are seeking to optimize the quality of care for patients with atrial fibrillation. Suboptimal use of oral anticoagulation therapy constitutes an important health problem with significant humanistic and economic consequences. Based on a review of the medical literature published between 2000 and 2011, this article summarizes the literature on the barriers to optimal use of oral anticoagulation therapy, describes the clinical and economic burdens that these barriers add to the burden of atrial fibrillation, and discusses how well the new oral anticoagulants may address some of these issues.

Review of economics and cost-effectiveness analyses of anticoagulant therapy for stroke prevention in atrial fibrillation in the US.

OBJECTIVE: To summarize the available evidence on the issues in health economics related to oral anticoagulation for stroke prevention in atrial fibrillation (AF) in the US. DATA SOURCES: A literature review was performed using PubMed, EMBASE, Cochrane Library, and International Pharmaceutical Abstracts, as well as the websites of professional organizations. STUDY SELECTION AND DATA EXTRACTION: The search was conducted according to a prespecified protocol, limiting articles to those published in English from 2001 to October 2012 and focused on the economics associated with AF and AF-related stroke in the US. Data from 27 studies were extracted and included in the review. DATA SYNTHESIS: Strokes in patients with AF are more debilitating and have higher recurrence rates and mortality compared with strokes unrelated to AF. However, data describing the long-term cost of AF-related stroke and stroke subtypes remain limited. The costs of major gastrointestinal (GI) bleeding and intracranial bleeding related to warfarin are significant, whereas the costs of the more frequent minor GI bleeding are relatively low. Overall, the cost-effectiveness of warfarin versus aspirin or no treatment in patients with at least 1 risk factor for stroke is well established. Economic evaluations based on results from randomized controlled clinical trials generally found that new anticoagulants were a cost-effective alternative to warfarin for stroke prevention in AF. However, these cost-effectiveness results are highly sensitive to how well optimal international normalized ratio control is maintained (within target of 2.0-3.0) for warfarin and the time horizon used for analysis. Time in therapeutic range for warfarin in routine clinical practice was lower than in clinical trials, as shown by previous studies. CONCLUSIONS: This review identified several areas of uncertainty regarding the economic benefit of anticoagulants. The generalizability of cost-effectiveness results of anticoagulant therapy in AF based on clinical trial data must be confirmed by comparative effectiveness research conducted in the real-world setting.

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.

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.

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.

Better patient persistence with once-daily bupropion compared with twice-daily bupropion.

Evidence suggests that improving adherence and persistence to antidepressant therapy could enhance clinical and economic outcomes in depression. This study was conducted to assess the impact of dosing frequency (once daily with bupropion XL vs twice daily with bupropion SR) on adherence to bupropion therapy in a nationally representative prescription database in the United States. Demographics of patients with a prescription for bupropion XL or bupropion SR between October 1, 2005, and October 31, 2005, were similar between the XL group (n=257,049; 69% female) and the SR group (n=12,468; 67% female). Refill adherence over a 1-year period was greater with bupropion XL than bupropion SR. The percentage of patients with >or=1 refill over 1 year was 60.1% with bupropion XL compared with 51.3% with bupropion SR (P < 0.0001). The percentage of patients with >or=6 refills over 1 year was 25.3% with bupropion XL compared with 9.5% with bupropion SR. Bupropion XL was associated with significantly greater likelihood of refilling a prescription than bupropion SR as shown by Kaplan-Meier curves (P < 0.0001, log-rank test). The medication possession ratio over a 9-month period was higher for bupropion XL (0.26) than it was for bupropion SR (0.16). Logistic regression analyses show that patients with a prescription for bupropion SR were significantly less likely to fill a future prescription than were patients with a prescription for bupropion XL. These data show that adherence to bupropion therapy in this sample was better with the once-daily XL formulation than with the twice-daily SR formulation across several measures.

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.