Measuring The Impact Of Air Pollution On Health Care Costs.

Air pollution contributes to the development of numerous adverse human health outcomes. The Environmental Protection Agency's Environmental Benefits Mapping and Analysis Program-Community Edition (BenMAP-CE) tool is widely used in estimating the health care costs of air pollution and in the development of federal and state regulations and policy. Its default features consider only the costs of hospital and emergency department admissions. A more complete accounting of the chain of costs would include ambulatory and other care. In this article we use employer health insurance claims data to infer additional costs that accompany hospitalizations but are not included in BenMAP-CE. Including additional categories increases BenMAP-CE health care cost estimates by approximately 40 percent for respiratory and cardiovascular patients. That is, for each dollar of health care costs captured by BenMAP-CE, a more complete accounting would include an additional 40 cents. These results suggest that because such air pollution costs are underestimated, the health care benefits associated with reducing air pollution may be much larger than previously estimated.

Direct Costs of Opioid Abuse in an Insured Population in the United States.

OBJECTIVE: To (a) describe the demographics of opioid abusers; (b) compare the prevalence rates of selected comorbidities and the medical and drug utilization patterns of opioid abusers with patients from a control group, for the period from 1998 to 2002; and (c) calculate the mean annual per-patient total health care costs (e.g., inpatient, outpatient, emergency room, drug, other) from the perspective of a private payer. METHODS: An administrative database of medical and pharmacy claims from 1998 to 2002 of 16 self-insured employer health plans with approximately 2 million lives was used to identify "opioid abusers"-patients with claims associated with ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification) codes for opioid abuse (304.0, 304.7, 305.5, and 965.0 [excluding 965.01]). A control group of nonabusers was selected using a matched sample (by age, gender, employment status, and census region) in a 3:1 ratio. Per-patient annual health care costs (mean total medical and drug costs) were measured in 2003 U.S. dollars. Multivariate regression techniques were also used to control for comorbidities and to compare costs with a benchmark of depressed patients. RESULTS: 740 patients were identified as opioid abusers, a prevalence of 8 in 10,000 persons aged 12 to 64 years continuously enrolled in health care plans for whom 12 months of data were available for calculating costs. Opioid abusers, compared with nonabusers, had significantly higher prevalence rates for a number of specific comorbidities, including nonopioid poisoning, hepatitis (A, B, or C), psychiatric illnesses, and pancreatitis, which were approximately 78, 36, 9, and 21 (P<0.01) times higher, respectively, compared with nonabusers. Opioid abusers also had higher levels of medical and prescription drug utilization. Almost 60% of opioid abusers had prescription drug claims for opioids compared with approximately 20% for nonabusers. Prevalence rates for hospital inpatient visits for opioid abusers were more than 12 times higher compared with nonabusers (P<0.01). Mean annual direct health care costs for opioid abusers were more than 8 times higher than for nonabusers ($15,884 versus $1,830, respectively, P < 0.01). Hospital inpatient and physician-outpatient costs accounted for 46% ($7,239) and 31% ($5,000) of opioid abusers' health care costs, compared with 17% ($310) and 50% ($906), respectively, for nonabusers. Mean drug costs for opioid abusers were more than 5 times higher than costs for nonabusers ($2,034 vs. $386, respectively, P<0.01), driven by higher drug utilization (including opioids) for opioid abusers. Even when controlling for comorbidities using a multivariate regression model of a matched control of depressed patients, the average health care costs of opioid abusers were 1.8 times higher than the average health care costs of depressed patients. CONCLUSION: The high costs of opioid abuse were driven primarily by high prevalence rates of costly comorbidites and high utilization rates of medical services and prescription drugs. DISCLOSURES: Funding for this research was provided by an unrestricted grant from Janssen Medical Affairs, L.L.C. and was obtained by authors Susan Vallow and Jeff Schein, who are employed by Janssen Medical Affairs, L.L.C. Nathaniel Katz is a consultant to Janssen and numerous other pharmaceutical companies that manufacture branded opioid products and nonopioid analgesics; authors Alan G. White, Howard G. Birnbaum, Milena N. Mareva, and Maham Daher disclose no potential bias or conflict of interest relating to this article. White served as principal author of the study. Study concept and design were contributed primarily by White, Vallow, Schein, and Katz. Analysis and interpretation of data were contributed by all authors. Drafting of the manuscript was primarily the work of White, and its critical revision was the work of White and Vallow. Statistical expertise was contributed by White, Birnbaum, and Daher, and administrative, technical, and/or material support was provided by Analysis Group, Inc., Boston, MA.

Patient Characteristics and Outcomes Associated with Receiving an Earlier Versus Later Diagnosis of Probable Alzheimer's Disease.

BACKGROUND: Effectiveness of Alzheimer's disease (AD) treatments may depend critically on the timeliness of intervention. OBJECTIVE: To compare characteristics and outcomes of patients diagnosed with probable AD (prAD) based on time elapsed from first onset of cognitive decline. METHODS: Patients with ≥1 prAD diagnosis and ≥1 follow-up visit were selected from the National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS; 9/2005-6/2015) and stratified based on the time between the perceived onset of cognitive decline at baseline and first prAD diagnosis (i.e., earlier versus later diagnosis). Characteristics at baseline and prAD diagnosis, clinically meaningful progression, and medication use following prAD diagnosis were compared. RESULTS: Median time from perceived onset of cognitive decline to prAD diagnosis was 4.5 years (earlier diagnosis: ≤3.46; later diagnosis: >5.71). Earlier-diagnosed patients (n = 1,476) were younger at baseline (74.3 versus 76.3 years) and had better cognitive and functional scores than later-diagnosed patients (n = 1,474). At first prAD diagnosis, earlier-diagnosed patients had lower mean global Clinical Dementia Rating (CDR) score (0.8 versus 1.1), higher mean Mini-Mental State Examination (MMSE) (22.6 versus 20.0), and lower mean Functional Activities Questionnaire (11.6 versus 17.3). Earlier- and later-diagnosed patients experienced similar time to a decrease of ≥3 points in MMSE (median 23.2 versus 23.1 months, p = 0.83), but earlier-diagnosed patients had longer time to a CDR score of ≥2 points, and longer times to initiation of AD medication and antipsychotic agents (all p < 0.01). CONCLUSION: Earlier prAD diagnosis in NACC data is associated with higher cognitive function and lower functional impairment at diagnosis.

Drivers of excess costs of opioid abuse among a commercially insured population.

OBJECTIVES: To replicate and extend a recently published analysis of the drivers of excess costs of opioid abuse. STUDY DESIGN: Retrospective data analysis using de-identified claims data from the Truven MarketScan Commercial Claims and Encounter database. METHODS: Medical and prescription drug claims from beneficiaries covered by large self-insured US companies were used to select patients with incident diagnoses of opioid abuse between 2012 and 2015. Two cohorts, abusers and nonabusers, were matched using propensity score methods. Excess healthcare costs were estimated over a 6-month baseline period and 12-month follow-up period. Cost drivers were assessed by diagnosis (3-digit International Classification of Diseases, Ninth Revision, Clinical Modification groupings) and place of service. RESULTS: The analysis included 73,714 matched pairs of abusers and nonabusers. Relative to nonabusers, abusers had considerably higher annual healthcare costs of $10,989 per patient, or $1.98 per member per month. Excess costs were similar, yet lower, than the previous analysis using another commercial claims database. In both analyses, a ramp-up in excess costs was observed prior to the incident abuse diagnosis, followed by a decline post diagnosis, although not to baseline levels. Key drivers of excess costs in the 2 studies included opioid use disorders, nonopioid substance misuse, and painful and mental health conditions. From 2010 to 2014, the prevalence of diagnosed opioid abuse doubled, with incidence rates exhibiting an increasing, though flatter, trend than earlier in the period. CONCLUSIONS: Opioid abuse imposes a considerable economic burden on payers. Many abusers have complex healthcare needs and may require care beyond that which is required to treat opioid abuse. These results are robust and consistent across different data sources.

Basal insulin initiation use and experience among people with type 2 diabetes mellitus with different patterns of persistence: results from a multi-national survey.

BACKGROUND AND OBJECTIVE: People with type 2 diabetes mellitus (T2DM) often interrupt basal insulin treatment soon after initiation. This study aimed to describe the experiences during and after basal insulin initiation among people with T2DM with different persistence patterns. METHODS: Adults with T2DM from France, Germany, Spain, UK, US, Brazil, and Japan were identified from consumer panels for an online survey. Respondents who initiated basal insulin 3-24 months prior to survey date were categorized as continuers (no gaps of ≥7 days in insulin treatment); interrupters (first gap ≥7 days within 6 months of initiation and restarted insulin); and discontinuers (stopped insulin for ≥7 days within 6 months of initiation without restarting). RESULTS: Among 942 participants, continuers were older than interrupters and discontinuers (46, 37, and 38 years, respectively, p < .01). Continuers reported having fewer concerns before and after insulin initiation than interrupters and discontinuers, while interrupters had the most concerns. Continuers also reported fewer challenges during the first week of insulin use. Continuers were more likely to respond that insulin use had a positive impact on specific aspects of life than interrupters and discontinuers, for example on glycemic control (73.0%, 63.0%, and 61.8%, respectively; p < .01 vs. continuers). CONCLUSION: Among people with T2DM with different persistence patterns after basal insulin initiation there were significant differences in patient characteristics and experience during and after insulin initiation. Interrupters and discontinuers more frequently reported having concerns and challenges during the initiation process, negative impacts after initiation, and less improvement in glycemic control than continuers.

The Economic Burden of Opioid Abuse: Updated Findings.

BACKGROUND: Opioid pain relievers can be highly effective in providing relief for patients suffering from pain. At the same time, prescription opioid abuse, dependence, overdose, and poisoning (hereinafter "abuse") have become a national public health concern. Opioid abuse is also costly: previous estimates of the annual excess costs of opioid abuse to payers range from approximately $10,000 to $20,000 per patient. OBJECTIVES: To (a) provide a comprehensive, current estimate of the economic burden of opioid abuse to commercial payers and (b) explore the drivers of these excess costs of abuse. METHODS: Administrative claims from beneficiaries covered by large self-insured companies throughout the United States were used to identify patients diagnosed with opioid abuse, dependence, and overdose/poisoning ("abuse") between 2012 and 2015. Sample selection criteria identified patients most likely to be misusing opioids. Abusers and nonabuser controls were matched using propensity scores. Excess health care costs were assessed over the 18-month study period. Drivers of excess costs were then evaluated by place of service and medical condition (identified as 3-digit ICD-9-CM groupings). RESULTS: 9,342 matched abuser/nonabuser pairs were analyzed. Relative to nonabusers, abusers had significantly higher annual health care resource utilization, leading to $14,810 in per-patient incremental annual health care costs. Excess costs began accumulating 5 months before the formal, incident diagnosis of abuse, driven by alcohol and nonopioid substance abuse. Major drivers of excess costs of abuse included opioid and other substance abuse disorders, mental health conditions, and painful conditions. Many patients had diagnoses for other substance abuse that predated their opioid abuse diagnoses. CONCLUSIONS: Opioid abuse imposes a substantial economic burden on payers and often occurs in the context of other substance abuse. Poly-substance abuse often precedes the diagnosis of opioid abuse. DISCLOSURES: This study was funded by Purdue Pharma. Mayne is an employee of Purdue Pharma. Kirson, Scarpati, and Birnbaum are employees of Analysis Group, which received funding from Purdue Pharma to conduct this study. Enloe and Dincer were employees of Analysis Group at the time this research was conducted. Study concept and design were contributed by Kirson, Birnbaum, Mayne, and Scarpati, along with Enloe and Dincer. Enloe and Dincer took the lead in data collection, along with Birnbaum and assisted by Kirson and Scarpati. Data interpretation was performed by all the authors. The manuscript was written and revised by Kirson and Scarpati, along with Mayne and Birnbaum.

Functional limitations and health care resource utilization for individuals with cognitive impairment without dementia: Findings from a United States population-based survey.

INTRODUCTION: Little is known about functional limitations and health care resource utilization of people with cognitive impairment with no dementia (CIND). METHODS: Respondents with stable or progressive cognitive impairment (CI) after the first (index) indication of CIND in 2000-2010 were identified from the Health and Retirement Study (HRS). Respondents never exhibiting CI were identified as potential controls. Propensity score-based optimal matching was used to adjust for differences in demographics and history of stroke. Differences between cohorts were assessed accounting for HRS survey design. RESULTS: After matching, CIND respondents had more functional limitations (difficulty with ≥1 activities of daily living: 24% vs. 15%; ≥1 instrumental activities of daily living: 20% vs. 11%) and hospital stays (37% vs. 27%) than respondents with no CI (all P < .001). Seventy five percent of CIND respondents developed dementia in the observable follow-up (median time: ∼6 years). DISCUSSION: Even before dementia onset, CI is associated with increased likelihood of functional limitations and greater health care resource use.

Basal Insulin Persistence, Associated Factors, and Outcomes After Treatment Initiation: A Retrospective Database Study Among People with Type 2 Diabetes Mellitus in Japan.

INTRODUCTION: The objective of this study was to assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in Japan. METHODS: People aged at least 18 years with T2DM with first claim for basal insulin between May 2006 and April 2013 (index date), no insulin use before index date, and continuous insurance coverage for 6 months before (baseline) and 12 months after index date were selected from the Japan Medical Center Database. On the basis of whether there were at least 30-day gaps in basal insulin treatment, patients were classified as continuers (no gap), interrupters (at least one prescription after gap), and discontinuers (no prescription after gap). A multinomial logistic regression model identified factors associated with persistence. Annual healthcare resource use and costs in the year after initiation were compared between continuers and interrupters and between continuers and discontinuers using propensity score-based inverse probability weighting to adjust for baseline differences. RESULTS: Of the 827 people included (mean age 50 years, ca. 71% male), 36% continued, 42% interrupted, and 22% discontinued basal insulin therapy in the year after initiation. Having at least one inpatient visit and using fewer classes of non-insulin antihyperglycemic medications during baseline were associated with lower likelihoods of continuing therapy. Relative to interrupters and discontinuers, continuers had lower hospitalization rates [continuers, 12.7%; interrupters, 25.4% (p < 0.001); discontinuers, 28.4% (p < 0.001)] and lower inpatient costs [continuers, ¥132,013; interrupters, ¥225,745 (p = 0.054); discontinuers, ¥320,582 (p = 0.036)], but higher pharmacy costs [continuers, ¥158,403; interrupters, ¥134,301 (p = 0.039); discontinuers, ¥121,593 (p = 0.002)] in the year after insulin initiation. Total healthcare costs were similar for the three cohorts. CONCLUSIONS: Substantial proportions of people with T2DM in Japan interrupt or discontinue basal insulin within the year after initiation, and they have higher rates and costs of hospitalizations than patients who continue with their insulin therapy. Further research is needed to understand reasons behind basal insulin persistence and the implications thereof to help clinicians manage T2DM more effectively. FUNDING: Eli Lilly and Company, Boehringer Ingelheim.

Real-World Treatment Patterns among Patients with Advanced Gastric Cancer in South Korea.

PURPOSE: The purpose of this study was to understand patient treatment patterns, outcomes, and healthcare resource use in cases of metastatic and/or locally recurrent, unresectable gastric cancer (MGC) in South Korea. MATERIALS AND METHODS: Thirty physicians reviewed charts of eligible patients to collect de-identified data. Patients must have received platinum/fluoropyrimidine first-line therapy followed by second-line therapy or best supportive care, had no other primary cancer, and not participated in a clinical trial following MGC diagnosis. Data were summarized using descriptive statistics. Kaplan-Meier analysis was used to describe survival. RESULTS: Of 198 patients, 73.7% were male, 78.3% were diagnosed with MGC after age 55 (mean, 61.3 years), and 47.0% were current or former smokers. The majority of tumorswere located in the antrum/pylorus (51.5%). Metastatic sites most often occurred in the peritoneum (53.5%), lymph nodes (47.5%), and liver (38.9%). At diagnosis, the mean Charlson comorbidity indexwas 0.4 (standard deviation, 0.6). The most common comorbidities were chronic gastritis (22.7%) and cardiovascular disease (18.7%). Most patients (80.3%) received second-line treatment. Single-agent fluoropyrimidine was reported for 22.0% of patients, while 19.5% were treated with irinotecan and a fluoropyrimidine or platinum agent. The most common physician-reported symptoms during second-line treatment were nausea/vomiting (44.7%) and pain (11.3%), with antiemetics (44.7%), analgesics (36.5%), and nutritional support (11.3%) most often used as supportive care. Two-thirds of inpatient hospitalizations were for chemotherapy infusion. Outpatient hospitalization (31.6%) and visits to the oncologist (58.8%) were common among second-line patients. CONCLUSION: Most patients received second-line treatment, although regimens varied. Understanding MGC patient characteristics and treatment patterns in South Korea will help address unmet needs.

Assessing the economic burden of Alzheimer's disease patients first diagnosed by specialists.

BACKGROUND: It is not known if there is a differential impact on Alzheimer's disease (AD) diagnosis and outcomes if/when patients are diagnosed with cognitive decline by specialists versus non-specialists. This study examined the cost trajectories of Medicare beneficiaries initially diagnosed by specialists compared to similar patients who received their diagnosis in primary care settings. METHODS: Patients with ≥2 claims for AD were selected from de-identified administrative claims data for US Medicare beneficiaries (5 % random sample). The earliest observed diagnosis of cognitive decline served as the index date. Patients were required to have continuous Medicare coverage for ≥12 months pre-index (baseline) and ≥12 months following the first AD diagnosis, allowing for up to 3 years from index to AD diagnosis. Time from index date to AD diagnosis was compared between those diagnosed by specialists (i.e., neurologist, psychiatrist, or geriatrician) versus non-specialists using Kaplan-Meier analyses with log-rank tests. Patient demographics, Charlson Comorbidity Index (CCI) during baseline, and annual all-cause medical costs (reimbursed by Medicare) in baseline and follow-up periods were compared across propensity-score matched cohorts. RESULTS: Patients first diagnosed with cognitive decline by specialists (n = 2593) were younger (78.8 versus 80.8 years old), more likely to be male (40 % versus 34 %), and had higher CCI scores and higher medical costs at baseline than those diagnosed by non-specialists (n = 13,961). However, patients diagnosed by specialists had a significantly shorter time to AD diagnosis, both before and after matching (mean [after matching]: 3.5 versus 4.6 months, p < 0.0001). In addition, patients diagnosed by specialists had significantly lower average total all-cause medical costs in the first 12 months after their index date, a finding that persisted after matching ($19,824 versus $25,863, p < 0.0001). Total per-patient annual medical costs were similar for the two groups starting in the second year post-index. CONCLUSIONS: Before and after matching, patients diagnosed by a specialist had a shorter time to AD diagnosis and incurred lower costs in the year following the initial cognitive decline diagnosis. Differences in costs converged during subsequent years. This suggests that seeking care from specialists may yield more timely diagnosis, appropriate care and reduced costs among those with cognitive decline.

Excess Costs Associated with Possible Misdiagnosis of Alzheimer's Disease Among Patients with Vascular Dementia in a UK CPRD Population.

BACKGROUND: Prior diagnosis of Alzheimer's disease (AD) among patients later diagnosed with vascular dementia (VaD) has been associated with excess costs, suggesting potential benefits of earlier rule-out of AD diagnosis. OBJECTIVE: To investigate whether prior diagnosis with AD among patients with VaD is associated with excess costs in the UK. METHODS: Patients with a final VaD diagnosis, continuous data visibility for≥6 months prior to index date, and linkage to Hospital Episode Statistics data were retrospectively selected from de-identified Clinical Practice Research Datalink data. Patients with AD diagnosis before a final VaD diagnosis were matched to similar patients with no prior AD diagnosis using propensity score methods. Annual excess healthcare costs were calculated for 5 years post-index, stratified by time to final diagnosis. RESULTS: Of 9,311 patients with VaD, 508 (6%) had prior AD diagnosis with a median time to VaD diagnosis exceeding 2 years from index date. Over the entire follow-up period, patients with prior AD diagnosis had accumulated healthcare costs that were approximately GBP2,000 higher than those for matched counterparts (mostly due to higher hospitalization costs). Cost differentials peaked particularly in the period including the final VaD diagnosis, with excess costs quickly declining thereafter. CONCLUSION: Potential misdiagnosis of AD among UK patients with VaD resulted in substantial excess costs. The decline in excess costs following a final VaD diagnosis suggests potential benefits from earlier rule-out of AD.

Basal insulin persistence, associated factors, and outcomes after treatment initiation among people with type 2 diabetes mellitus in the US.

OBJECTIVE: To assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in the US. RESEARCH DESIGN AND METHODS: People aged ≥18 years diagnosed with T2DM initiating basal insulin between April 2006 and March 2012 (index date), no prior insulin use, and continuous insurance coverage for 6 months before (baseline) and 24 months after index date (follow-up period) were selected using de-identified administrative claims data in the US. Based on whether there were ≥30 day gaps in basal insulin use in the first year post-index, patients were classified as continuers (no gap), interrupters (≥1 prescription after gap), and discontinuers (no prescription after gap). MAIN OUTCOME MEASURES: Factors associated with persistence - assessed using multinomial logistic regression model; annual healthcare resource use and costs during follow-up period - compared separately between continuers and interrupters, and continuers and discontinuers. RESULTS: Of the 19,110 people included in the sample (mean age: 59 years, ∼60% male), 20% continued to use basal insulin, 62% had ≥1 interruption, and 18% discontinued therapy in the year after initiation. Older age, multiple antihyperglycemic drug use, and injectable antihyperglycemic use during baseline were associated with significantly higher likelihoods of continuing basal insulin. Relative to interrupters and discontinuers, continuers had fewer emergency department visits, shorter hospital stays, and lower medical costs (continuers: $10,890, interrupters: $13,674, discontinuers: $13,021), but higher pharmacy costs (continuers: $7449, interrupters: $5239, discontinuers: $4857) in the first year post-index (p < 0.05 for all comparisons). Total healthcare costs were similar across the three cohorts. Findings for the second year post-index were similar. CONCLUSIONS: The majority of people in this study interrupted or discontinued basal insulin treatment in the year after initiation; and incurred higher medical resource use and costs than continuers. The findings are limited to the commercially insured population in the US. In addition, persistence patterns were assessed using administrative claims as opposed to actual medication-taking behavior and did not account for measures of glycemic control. Further research is needed to understand the reasons behind basal insulin persistence and the implications thereof, to help clinicians manage care for T2DM more effectively.

Impact of a Telehealth and Care Management Program on All-Cause Mortality and Healthcare Utilization in Patients with Heart Failure.

BACKGROUND: Telehealth has the potential to improve chronic disease management and outcomes, but data regarding direct benefit of telehealth in patients with heart failure (HF) have been mixed. The objective of this study was to determine whether the Health Buddy Program (HBP) (Bosch Healthcare, Palo Alto, CA), a content-driven telehealth system coupled with care management, is associated with improved outcomes in Medicare beneficiaries with HF. MATERIALS AND METHODS: This was a retrospective cohort study of 623 Medicare beneficiaries with HF offered HBP enrollment compared with a propensity score-matched control group of Medicare beneficiaries with HF from the Medicare 5% sample. Associations between availability of the HBP and all-cause mortality, hospitalization, hospital days, and emergency department visits were evaluated. RESULTS: Beneficiaries offered enrollment in the HBP had 24.9% lower risk-adjusted all-cause mortality over 3 years of follow-up (hazard ratio [HR] = 0.75; 95% confidence interval [CI], 0.63-0.89; p = 0.001). Patients who used the HBP at least once (36.9%) had 57.2% lower mortality compared with matched controls (HR = 0.43; 95% CI, 0.31-0.60; p < 0.001), whereas patients who did not use the HBP had no significant difference in survival (HR = 0.96; 95% CI, 0.78-1.19; p = 0.69). Patients offered the HBP also had fewer hospital admissions following enrollment (Δ = -0.05 admissions/quarter; p = 0.011), which was primarily observed in patients who used the HBP at least once (Δ = -0.10 admissions/quarter; p < 0.001). CONCLUSIONS: The HBP, a content-driven telehealth system coupled with care management, was associated with significantly better survival and reduced hospitalization in Medicare beneficiaries with HF. Prospective study is warranted to determine the mechanism of this association and opportunities for optimization.

Budget impact model of a 5-grass sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis.

OBJECTIVE: Allergic rhinitis (AR) is a chronic disease with a substantial clinical and economic burden. This study estimated the potential budget impact (BI) associated with market entry of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use ('5-grass SLIT tablet') for patients aged 10-65 with grass pollen-induced AR. METHODS: A budget impact model was constructed to estimate the potential BI from a US payer perspective. The model calculated pharmacy, medical, and total (pharmacy + medical) costs per-member-per-month (PMPM) with and without market entry of the 5-grass SLIT tablet, considering a 3-year time horizon. The target population was determined using an epidemiological approach and existing literature. The treatment market shares without 5-grass SLIT tablet entry were derived from an analysis of de-identified insurance claims data. Pharmacy costs and medical utilization rates and costs were obtained from the claims data analysis and existing literature. One-way sensitivities were conducted for key model inputs. RESULTS: Using an illustrative example of a hypothetical health plan with one million members, the estimated target population of AR patients aged 10-65 was 26,320. On a PMPM basis, pharmacy costs increased by $0.36, $0.44, and $0.51, while total costs (after medical cost offsets) increased by $0.15, $0.18, and $0.22 in the first, second, and third years following entry of the 5-grass SLIT tablet, respectively. Results were most sensitive to changes in the compliance rate, treatment duration, and price. The BI will vary from the base case example when alternative, payer-specific inputs are used. CONCLUSIONS: Using base case inputs, use of the 5-grass SLIT tablet to treat grass pollen-induced AR increased the pharmacy budget for a hypothetical third-party payer. Higher pharmacy costs were partially offset by lower medical budget due to reduced resource use compared with existing treatments.

Estimating the health care burden of prescription opioid abuse in five European countries.

BACKGROUND: Opioid abuse, including abuse of prescription opioids ("RxOs") and illicit substances like heroin, is a serious public health issue in Europe. Currently, there is limited data on the magnitude of RxO abuse in Europe, despite increasing public and scientific interest in the issue. The purpose of this study was to use the best-available data to derive comparable estimates of the health care burden of RxO abuse in France, Germany, Italy, Spain, and the United Kingdom (EU5). METHODS: Published data on the prevalence of problem opioid use and the share of opioid abuse patients reporting misuse of non-heroin opioids were used to estimate the prevalence of RxO abuse in the EU5 countries. The costs of RxO abuse were calculated by applying published estimates of the incremental health care costs of opioid abuse to country-specific estimates of the costs of chronic pain conditions. These estimates were input into an economic model that quantified the health care burden of RxO abuse in each of the EU5 countries. Sensitivity analyses examined key assumptions. RESULTS: Based on best-available current data, prevalence estimates of RxO abuse ranged from 0.7 to 13.7 per 10,000 individuals across the EU5 countries. Estimates of the incremental health care costs of RxO abuse ranged from €900 to €2,551 per patient per year. The annual health care cost burden of RxO abuse ranged from €6,264 to €279,927 per 100,000 individuals across the EU5 countries. CONCLUSION: This study suggests that RxO abuse imposes a cost burden on health systems in the five largest European countries. The extent of RxO abuse in Europe should be monitored given the potential for change over time. Continued efforts should be made to collect reliable data on the prevalence and costs of RxO abuse in Europe to facilitate an accurate characterization of the extent of this potentially growing problem.

Characteristics of High-Cost Patients Diagnosed with Opioid Abuse.

BACKGROUND: Prescription opioid abuse is associated with substantial economic burden, with estimates of incremental annual per-patient health care costs of diagnosed opioid abuse exceeding $10,000 in prior literature. A subset of patients diagnosed with opioid abuse has disproportionately high health care costs, but little is known about the characteristics of these patients.  OBJECTIVE: To describe the characteristics of a subset of patients diagnosed with opioid abuse with disproportionately high health care costs to assist physicians and managed care organizations in targeting interventions at the costliest patients. METHODS: This retrospective claims data analysis identified patients aged 12 to 64 years diagnosed with opioid abuse/dependence in the OptumHealth Reporting and Insights medical and pharmacy claims database, Quarter 1 (Q1) 1999-Q1 2012. Inclusion criteria required that patients had a diagnosis of opioid abuse during or after Q1 2006, no prior diagnoses of opioid abuse, and continuous non-HMO coverage over an 18-month study period. The study period comprised a 12-month observation period centered on the date of the first opioid abuse diagnosis (index date) and a 6-month baseline period immediately preceding the observation period. Patients in the top 20% of total health care costs in the observation period were classified as "high-cost patients," and the remaining patients were classified as "lower-cost patients." Patient characteristics, comorbidities, health care resource use, and health care costs were compared between high-cost patients and lower-cost patients using chi-square tests for dichotomous variables and Wilcoxon rank-sum tests for continuous variables. In addition, multivariate regression was used to assess the relationship between patient characteristics in the baseline period and total health care costs in the observation period among all patients diagnosed with opioid abuse.  RESULTS: 9,291 patients diagnosed with opioid abuse met the inclusion criteria. The 20% of patients classified as high-cost patients accounted for approximately two thirds of the total health care costs of patients diagnosed with opioid abuse. Compared with lower-cost patients, high-cost patients were older (42.5 vs. 36.1; P less than 0.001) and more likely to be female (55.9% vs. 42.9%; P less than 0.001). They had a higher comorbidity burden at baseline, as reflected in the Charlson Comorbidity Index (0.8 vs. 0.2; P less than 0.001), and rates of conditions such as chronic pulmonary disease (12.9% vs. 5.6%; P less than 0.001) and mild/moderate diabetes (8.4% vs. 3.4%; P less than 0.001). High-cost patients also had higher rates of nonopioid substance abuse diagnoses (12.4% vs. 8.9%; P less than 0.001) and psychotic disorders (26.5% vs. 13.6%; P less than 0.001). In the observation period, high-cost patients continued to have higher rates of nonopioid substance abuse diagnoses (53.0% vs. 47.2%; P less than 0.001) and psychotic disorders (67.1% vs. 47.5%; P less than 0.001). In addition, they had greater medical resource use across all places of service (i.e., inpatient, emergency department, outpatient, drug/alcohol rehabilitation facility, and other) compared with lower-cost patients. The mean observation period health care costs of high-cost patients was $89,177 compared with $11,653 for lower-cost patients (P less than 0.001). High-cost patients had higher medical costs linked to claims with an opioid abuse diagnosis in absolute terms, but the share of total medical costs attributed to such claims was lower among high-cost patients than among lower-cost patients. While many baseline characteristics were found to have a statistically significant (P less than 0.05) association with observation period health care costs, only 27.3% of the variation in observation period health care costs was explained by patient characteristics in the baseline period. CONCLUSIONS: This study found that the costliest patients diagnosed with opioid abuse had high rates of preexisting and concurrent chronic comorbidities and mental health conditions, suggesting potential indicators for targeted intervention and a need for greater awareness and screening of comorbid conditions. Opioid abuse may exacerbate existing conditions and make it difficult for patients to adhere to treatment plans for those underlying conditions. Baseline patient characteristics explained only a small share of the variation in observation period health care costs, however. Future research should explore the degree to which other factors not captured in administrative claims data (e.g., severity of abuse) can explain the wide variation in health care costs among opioid abusers.

Medical costs of Alzheimer's disease misdiagnosis among US Medicare beneficiaries.

INTRODUCTION: Recent developments in diagnostic technology can support earlier, more accurate diagnosis of non-Alzheimer's disease (AD) dementias. METHODS: To evaluate potential economic benefits of early rule-out of AD, annual medical resource use and costs for Medicare beneficiaries potentially misdiagnosed with AD prior to their diagnosis of vascular dementia (VD) or Parkinson's disease (PD) were compared with that of similar patients never diagnosed with AD. RESULTS: Patients with prior AD diagnosis used substantially more medical services every year until their VD/PD diagnosis, resulting in incremental annual medical costs of approximately $9,500-$14,000. However, following their corrected diagnosis, medical costs converged with those of patients never diagnosed with AD. DISCUSSION: The observed correlation between timing of correct diagnosis and subsequent reversal in excess costs is strongly suggestive of the role of misdiagnosis of AD - rather than AD comorbidity - in this patient population. Our findings suggest potential benefits from earlier, accurate diagnosis.

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals.

OBJECTIVES: Estimate the prevalence and healthcare costs of undiagnosed opioid abuse among commercially insured individuals. STUDY DESIGN: Retrospective analysis of de-identified pharmacy and medical claims data and publicly-available survey data (no IRB approval required). METHODS: This study focused on commercially insured individuals. Rates of prescription pain-reliever abuse/dependence ("abuse") among individuals ages ≥12 were calculated using National Survey on Drug Use and Health (NSDUH) public-use data for 2006-2011 and assumed to capture both diagnosed and undiagnosed opioid abuse. Rates of undiagnosed opioid abuse were calculated as the difference between NSDUH rates and published rates of diagnosed opioid abuse. OptumHealth Reporting and Insights claims data were used to estimate the healthcare costs of undiagnosed abuse. Diagnosed abusers ages 12-64 were identified using ICD-9-CM diagnosis codes for opioid abuse/dependence. Pre-diagnosis costs were assumed to be a proxy for undiagnosed opioid abuse costs. The ratio of undiagnosed to diagnosed abuse costs was calculated as the ratio of annual per-patient healthcare costs between pre-diagnosis and post-diagnosis periods. RESULTS: While rates of diagnosed opioid abuse among commercially insured individuals increased from 0.07% in 2006 to 0.19% in 2011, rates of undiagnosed abuse decreased from 0.42% to 0.38% over the same time period. Annual per-patient healthcare costs of undiagnosed abusers were 69.2% of those of diagnosed abusers. CONCLUSIONS: Per-patient healthcare costs of undiagnosed abusers among the commercially insured are estimated to be lower than those of diagnosed abusers. However, the higher prevalence of undiagnosed opioid abuse implies that undiagnosed abuse represents a substantial burden to commercial payers.

Positive subjective measures in abuse liability studies and real-world nonmedical use: Potential impact of abuse-deterrent opioids on rates of nonmedical use and associated healthcare costs.

OBJECTIVE: To quantify the potential impact of reductions in positive subjective measures from human abuse liability studies on real-world rates of nonmedical use of prescription drugs and associated healthcare resource utilization and costs. DESIGN: Positive subjective endpoints "overall drug liking," in-the-moment "drug liking," and "drug high" Emaxs (peak effects) were recorded from published studies. Nonmedical use data were obtained from the 2010 National Survey on Drug Use and Health (NSDUH) and Drug Abuse Warning Network surveys. Multivariate regressions evaluated the association between the positive subjective endpoints and nonmedical use rates, controlling for prescription volume, whether the drug is an opioid, and controlled substance schedule. A published budget-impact model was used to assess healthcare resource utilization and cost impacts of abuse-deterrent opioid formulations. RESULTS: A five-point reduction in overall drug liking/drug liking/drug high Emax was associated with a 0.25/0.10/0.05 (standard errors: 0.11/0.12/0.07) percentage point decrease in the NSDUH lifetime nonmedical use rates. Those decreases yielded a 11.3/4.2/2.1 percent reduction compared to the samples' lifetime nonmedical use rates of 2.21/2.38/2.36 percent. On the basis of a number of assumptions, these reductions were associated with private payer cost reductions for a morphine and oxycodone abuse-deterrent formulation in the ranges of $147.9-324.1 million and $230.7-958.7 million, respectively. CONCLUSIONS: Reductions in overall drug liking were significantly associated with reduced real-world nonmedical use, healthcare utilization, and costs. Associations using drug high and drug liking were directionally consistent with this finding though not statistically significant. A reduction in positive subjective measures associated with an abuse-deterrent formulation has potential to reduce abuse and associated healthcare utilization and costs.

Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers.

OBJECTIVE: To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC). METHODS: DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an 'intent-to-treat' design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., ≥1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006-2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples. RESULTS: Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (-27.6% BLCC, -22.2% HFDS), fewer days hospitalized (-33.3% BLCC, -42.4% HFDS), and fewer emergency department visits (-32.3% BLCC, -25.7% HFDS) among BLCC/HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (-$5253 BLCC, -$6991 HFDS). LIMITATIONS: Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation. CONCLUSION: These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.