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Background: Quantifying the value of pharmacy services is imperative for the profession as it works to establish an expanded role within evolving health care systems. The literature documents the work that many have contributed toward meeting this goal. To date, however, the preponderance of evidence evaluates the value of pharmacist services to third-party payers; few published studies address the value that consumers place on these services., Objectives: In 1999, a review of studies that used the contingent valuation method to value pharmacy services was published. The objective of this manuscript is to provide an update of that review., Methods: Relevant studies published in the English language were identified searching MEDLINE, ECONLIT and International Pharmaceutical Abstracts databases from January 1999 to November 2017. Only studies that specifically elicited willingness to pay for a community pharmacist provided service from actual or potential consumers were included., Results: Thirty-one studies using the contingent valuation method to value pharmacy services were identified using the search strategy outlined. These studies included surveys in different demographic and geographic populations and valuing various pharmacy services., Conclusions: Improving the quality of studies using contingent valuation to value pharmacy services will aid the profession in marketing pharmacy services to consumers, and may assist practitioners who wish to implement various pharmacy services in their practice settings. A limited number of studies have been conducted, but the quality of contingent valuation studies valuing pharmacist services is improving. Understanding the pharmacy services that consumers value, and understanding the level of their monetary willingness to pay for those services will be crucial as the profession continues to work toward establishing a sustainable and economically viable role within the evolving health care systems., (Copyright © 2018. Published by Elsevier Inc.)

Background: Filgrastim-sndz, a granulocyte-colony stimulating factor (G-CSF), was introduced as a biosimilar to filgrastim in 2015, but real-world comparative effectiveness for filgrastim versus filgrastim-sndz has not been reported to date., Objectives: To (a) compare the incidence of febrile neutropenia for patients taking filgrastim versus those taking filgrastim-sndz and (b) compare the incidence of a potential serious adverse event for filgrastim versus filgrastim-sndz., Methods: This retrospective cohort study identified patients receiving a G-CSF following chemotherapy, using administrative claims from the Humana Research Database. Patients enrolled in a Medicare Advantage Prescription Drug plan with a claim for a G-CSF from October 1, 2015, through September 30, 2016, were identified. G-CSF use had to occur within 6 days of exposure to chemotherapy and without any subsequent chemotherapy within 14 days after G-CSF use. Febrile neutropenia requiring hospitalization was defined as hospitalization within 14 days after G-CSF use with (a) diagnosis of infection and/or neutropenia (broad definition) or (b) infection and neutropenia diagnoses (narrow definition). Serious adverse drug events (spleen rupture, acute respiratory syndrome, serious allergic reactions, capillary leak syndrome, thrombocytopenia, leukocytosis, cutaneous vasculitis, or bones and muscle ache) were also identified within 14 days after G-CSF use. An incidence difference of < 1% with 90% CI crossing zero qualified as support for noninferiority. Two-tailed chi-square tests were also used to investigate differences., Results: A total of 88 filgrastim and 101 filgrastim-sndz patients were identified. Filgrastim and filgrastim-sndz met the criteria for noninferiority based on an incidence difference of -0.6% (90% CI = -5.1%-4.0%; P = 0.84) for the broad definition of febrile neutropenia and a difference of -0.8% (90% CI = -3.8%-2.1%; P = 0.64) for the narrow definition. For the analysis of serious adverse events, an incidence difference of -2.5% (90% CI = -7.5%-2.5%; P = 0.42) for filgrastim compared with filgrastim-sndz was not sufficient to establish noninferiority., Conclusions: This study is one of the first analyses of real-world evidence regarding the noninferiority of filgrastim and filgrastim-sndz. The study results support noninferiority of filgrastim and filgrastim-sndz for prevention of febrile neutropenia requiring hospitalization. While noninferiority for serious adverse events was not supported, there was also no statistically significant difference between filgrastim and filgrastim-sndz. The study's small sample size could have limited the analysis of the relatively rare outcomes of febrile neutropenia requiring hospitalization and serious adverse events. A study including a larger numbers of patients taking filgrastim or filgrastim-sndz could provide additional insights., Disclosures: This study received no outside funding. Douglas, Kennedy, and Slabaugh were employees of Humana Pharmacy Solutions at the time the study was conducted. Bowe, Schwab, and Lane were employees of Comprehensive Health Insights, a wholly owned subsidiary of Humana, at the time the study was conducted. Study concept and design were contributed by Douglas, Kennedy, Schwab, and Lane, along with Slabaugh and Bowe. Bowe took the lead in data collection, assisted by Schwab, and data interpretation was performed by Schwab, along with the other authors. The manuscript was written by Schwab, Lane, and Douglas and revised by Kennedy, Slabaugh, and Bowe, along with Schwab, Lane, and Douglas.

Objectives: To investigate whether self-reported unhealthy days are related to 6 chronic conditions and other health indicators by using administrative claims., Study Design: Cross-sectional study using Healthy Days survey data linked to administrative claims., Methods: Survey respondents 65 years or older with Medicare Advantage coverage in November or December 2014 and 12 months continuous presurvey enrollment were identified. Mean physically and mentally unhealthy days were reported by chronic condition subgroups. Mean incremental unhealthy days were calculated for individuals in chronic condition subgroups and those exhibiting noncompliance with 2014 quality measures after adjusting for age, gender, provider/insurer contractual relationship, dual Medicaid/Medicare eligibility, and sum of chronic conditions. The relationship between the unhealthy days category and adjusted mean resource utilization (inpatient and outpatient visits) and total healthcare costs for the year prior to the survey was also described., Results: The population averages for physically and mentally unhealthy days were 7.24 and 4.05, respectively. After adjustment, all 6 chronic conditions were associated with significantly more physically unhealthy days, and chronic obstructive pulmonary disease, depression, and diabetes were associated with significantly more mentally unhealthy days (P <.001 vs not having the condition). After adjustment, quality measure noncompliance was generally associated with incremental increases in unhealthy days. Utilization and cost generally increased with increasing unhealthy days., Conclusions: This is the first study to use administrative claims to demonstrate a relationship between Healthy Days and chronic conditions, related healthcare quality measures, utilization, and costs. Our findings underscore the validity of using Healthy Days to supplement traditional health measures in assessing health status in this population.

Introduction: Arthritis is related to poor health-related quality of life (HRQoL) in adults aged 18 years or older. We sought to determine whether this relationship persisted in an older population using claims-based arthritis diagnoses and whether people who also had arthritis and at least 1 of 5 other chronic conditions had lower HRQoL., Methods: We identified adults aged 65 years or older with Medicare Advantage coverage in November or December 2014 who responded to an HRQoL survey (Healthy Days). For respondents with and without arthritis, we used linear regression to compare mean physically, mentally, and total unhealthy days, overall and in 5 comorbidity subgroups (coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, diabetes, and hypertension), accounting for age, sex, dual Medicaid/Medicare eligibility, rural/urban commuting area, and Charlson Comorbidity Index., Results: Of the 58,975 survey respondents, 44% had arthritis diagnosed through claims. Respondents with arthritis reported significantly more adjusted mean physically, mentally, and total unhealthy days than those without arthritis (P < .001). Older adults with arthritis and either congestive heart failure, chronic obstructive pulmonary disease, diabetes, or hypertension reported significantly more adjusted physically, mentally, and total unhealthy days than older adults without arthritis but with the same chronic conditions., Conclusions: In older adults, having arthritis is associated with lower HRQoL and even lower HRQoL among those with at least 1 of 5 other common chronic conditions. Because arthritis is so common among older adults, improving HRQoL depends on managing both underlying chronic conditions and any accompanying arthritis.

Measuring population health with morbidity and mortality data, often collected at the site of care, fails to capture the individual's perspective on health and well-being. Because health happens outside the walls of medical facilities, a holistic and singular measure of health that can easily be captured for an entire population could aid in understanding the well-being of communities. This paper postulates that Healthy Days, a health-related quality of life measure developed and validated by the Centers for Disease Control and Prevention, is an ideal survey instrument to advance population health. A systematic literature review was conducted and revealed a strong evidence base using Healthy Days with significant correlations to chronic disease conditions. Building on the literature base and experience, methods for analyzing Healthy Days data are discussed, including stratified sampling techniques, statistical measures to account for variance, and modeling techniques for skewed distributions. Using such analytic techniques, Healthy Days has been used extensively in national health surveillance. As the health care system faces increasing costs and constrained resources, the Healthy Days survey instrument can be used to inform public policies and allocate health service resources. Because Healthy Days captures broad dimensions of health from the individual's perspective, it is a simple way to holistically measure the health and well-being of a population and its trend over time. Expanded use of Healthy Days can aid population health managers and contribute to the understanding of the broader determinants of the nation's and individual community's health and aid in evaluating progress toward health goals., Competing Interests: Author Disclosure Statement The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Drs. Davidson, Happe, Miao, Prewitt, and Slabaugh, Mr. Cordier and Mr. Havens are employees of Humana Inc. Drs. Happe and Slabaugh own Humana stock. No external financial support was provided to Humana for this research. Dr. Jia received compensation from Humana for his contributions. Drs. Shah and Zack report no conflict of interest. The investigators retained full independence in the conduct of this research. The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Introduction: Previous studies have found higher rates of adherence in patients with type 2 diabetes mellitus (T2DM) using insulin pens compared to vial and syringe administration; however, little evidence is available to support this observation in elderly patients., Methods: This was a retrospective claims database analysis of a predominantly elderly Medicare Advantage with Prescription Drug (MAPD) insurance population consisting of 3172 insulin-naïve patients with T2DM who initiated basal insulin using pre-filled pens or vial and syringe ('vial'). The index date was defined by the first pharmacy claim for basal insulin. Adherence, measured as proportion of days covered (PDC) and medication possession ratio (MPR), and persistence were evaluated in a 12-month follow-up period using an adjusted days' supply. Multivariate regression analyses and a Cox proportional hazards model were used to identify characteristics associated with adherence and non-persistence, respectively, and compare findings between the pen and vial groups., Results: The pen cohort was slightly younger than the vial cohort (69.4 vs. 70.1 years, respectively; P = 0.0338). Similar proportions of male patients (53.3% vs. 56.8%; P = 0.0529) occurred in both cohorts, and lower Deyo-Charlson Comorbidity Index (4.4 vs. 5.0; P < 0.0001) was found for the pen cohort. Adjusted mean PDC was significantly higher in the pen cohort than the vial cohort (0.67 vs. 0.50; P < 0.001), as was mean MPR (0.75 vs. 0.57; P < 0.0001). Adjusted odds for adherence (PDC ≥ 80%) showed a positive association with use of an insulin pen (odds ratio = 2.19, 95% CI: 1.86-2.59). The adjusted risk of non-persistence (discontinuation) was significantly lower (58%) in the pen cohort relative to the vial cohort (hazard ratio = 0.42, 95% CI: 0.38-0.45). Key limitations include assumptions related to accuracy and comprehensiveness of claims data, and specifically days' supply data used to measure insulin adherence., Conclusion: These findings suggest that pen devices improved insulin therapy adherence in a primarily elderly MAPD population with T2DM., Funding: Novo Nordisk Pharmaceuticals, Inc.

Aim: The objective of this study was to apply quantile regression (QR) methodology to a population from a large representative health insurance plan with known skewed healthcare utilization attributes, co-morbidities, and costs in order to identify predictors of increased healthcare costs. Further, this study provides comparison of the results to those obtained using ordinary least squares (OLS) regression methodology., Methods: Members diagnosed with Type 2 Diabetes and with 24 months of continuous enrollment were included. Baseline patient demographic, clinical, consumer/behavioural, and cost characteristics were quantified. Quantile regression was used to model the relationship between the baseline characteristics and total healthcare costs during the follow-up 12 month period., Results: The sample included 83,705 patients (mean age = 70.6 years, 48% male) residing primarily in the southern US (78.1%); 81.2% of subjects were on oral-only anti-diabetic therapy. Co-morbid conditions included nephropathy (43.5%), peripheral artery disease (26.4%), and retinopathy (18.0%). Variables with the strongest relationship with costs during the follow-up period included outpatient visits, ER visits, inpatient visits, and Diabetes Complications Severity Index score during the baseline period. In the top cost quantiles, each additional glycohemoglobin (HbA1c) test was associated with cost savings ($1400 in the 98th percentile). Stage 4 and Stage 5 chronic kidney disease were associated with an incremental cost increase of $33,131 and $106,975 relative to Stage 1 or no CKD in the 98th percentile ($US)., Conclusions: These results demonstrate that QR provides additional insight compared to traditional OLS regression modeling, and may be more useful for informing resource allocation to patients most likely to benefit from interventions. This study highlights that the impact of clinical and demographic characteristics on the economic burden of the disease vary across the continuum of healthcare costs. Understanding factors that drive costs on an individual patient level provide important insights that will help in ameliorating the clinical, humanistic, and economic burden of diabetes.

Background: Published guidelines for treatment of type 2 diabetes mellitus (T2DM) agree on initial pharmacotherapy. However, few specific recommendations on second-line agents are provided., Objective: The objective of this study was to describe antidiabetic treatment patterns in Medicare Advantage patients with T2DM within 6 months of measurement of the glycosylated hemoglobin (HbA1c) level., Research Design: This retrospective cross-sectional study utilized medical, pharmacy, and laboratory claims from a large Medicare Advantage with Prescription Drug (MAPD) coverage payer. MAPD members between 65 and 89 years old identified as having T2DM between 2009 and 2011 were eligible for inclusion. A 12-month baseline period before the first HbA1c value (index date) was evaluated for demographic and clinical differences. Antidiabetic therapy was evaluated for 6 months post-index. The study population was stratified into three cohorts based on index HbA1c value: controlled (<8%, 64 mmoL/mol), uncontrolled (≥ 8%, 64 mmoL/mol and <10%, 86 mmoL/mol), and severely uncontrolled (≥ 10%, 86 mmoL/mol)., Results: Despite elevated HbA1c values (≥ 8%, 64 mmoL/mol), 7-8% of patients did not receive antidiabetic therapy during the post-index period. Metformin and sulfonylureas were the oral antidiabetics (OADs) most frequently used as monotherapy. The majority of patients on combination therapy were on two or more OADs and higher injectable use was observed in the severely uncontrolled cohort. Metformin was included in >60% of the combination regimens with metformin + sulfonylurea being the most common., Conclusion: This study suggests suboptimal treatment of those not in glycemic control (HbA1c ≥ 8%, 64 mmoL/mol). Many patients classified as severely uncontrolled based on HbA1c received only monotherapy. Opportunities exist for treatment modification within this population to achieve tighter glycemic control.

Background: Three distinct shortages of the generic drug leucovorin, a reduced form of folic acid used in several chemotherapy regimens, were reported by the US Food and Drug Administration (FDA) between 2008 and 2014. Levoleucovorin, an alternative therapy to leucovorin, failed to demonstrate superiority over leucovorin in clinical trials and is substantially more expensive., Objective: To calculate the impact of the leucovorin shortages on primary treatment costs to patients and a health plan, and to present strategies for health plans to deal with future drug shortages., Methods: This retrospective descriptive study was conducted using Humana's Medicare Advantage prescription drug plan administrative claims database between January 1, 2009, and December 31, 2012. A total of 1542 patients with at least 1 medical or pharmacy claim for either leucovorin or levoleucovorin during the first 3 months of the respective plan year (between 2009 and 2012) who had continuous enrollment for the entirety of the same plan year, were included in this study. Trends in primary treatment costs-defined as the drug cost of leucovorin or levoleucovorin-over the 4-year evaluation period were assessed. The mean annual patient out-of-pocket (OOP) costs and the mean plan-paid per member per month (PMPM) costs were also calculated., Results: The percentage of patients receiving leucovorin decreased annually, with a 15.8% drop from 2010 to 2011. This reduction was accompanied by a 6.6% increase in patients receiving levoleucovorin. The mean annual patient OOP costs were $167 to $714 higher for levoleucovorin than for leucovorin. Similarly, the mean plan-paid PMPM costs were higher (up to $1667 PMPM) for levoleucovorin than for leucovorin. The aggregate costs for the 2 drugs increased steadily, including the patient OOP costs and the plan-paid PMPM costs. The most prominent cost increase occurred between 2010 and 2011, with a 3.8-fold increase in patient OOP costs and a 5-fold increase in the plan-paid PMPM costs. This corresponded to the timing of the second leucovorin shortage announcement by the FDA in June 2010., Conclusions: Health plans can play an important role in minimizing the impact of drug shortages by identifying the affected patient population, identifying therapeutic alternatives, assisting providers with alternative sourcing strategies when possible, adjusting approval processes, and implementing quality management or pathway programs.

Background: Polypharmacy, the simultaneous taking of many medications, has been well documented and is a topic of much concern for those looking to improve the quality of care for the elderly. Elderly patients often develop complicated and multifactorial health states that require extensive pharmacotherapy, leaving this population at risk for exposure to drug-drug interactions and other adverse events. Previous literature supports an association between an increase in the rate of adverse events as the number of drugs taken by a patient increases., Objective: We sought to evaluate the prevalence of polypharmacy, and to determine patient characteristics that are predictive of exposure to polypharmacy, in the elderly population of the Emilia-Romagna region in Italy., Methods: We conducted a retrospective cohort study of the 2007 Emilia-Romagna outpatient pharmacy database linked with patient information available from a demographic file of approximately 1 million Emilia-Romagna residents aged ≥65 years. The cohort comprised 887,165 elderly subjects who had at least one prescription filled during the study year. Using the WHO's defined daily dose (DDD) to determine the duration of treatment for a given drug, we defined a polypharmacy episode as overlapping treatment with five or more medications occurring for at least 1 day. The prevalence of polypharmacy was measured together with subject characteristics found to be predictive of polypharmacy exposure., Results: A total of 349,689 elderly people in the population (39.4%) were exposed to at least one episode of polypharmacy during the study period. The prevalence of polypharmacy substantially increased with age and with a higher number of chronic conditions. Over 35% of those exposed to polypharmacy were exposed for 101 or more days of the year. The top three classes of medications involved in polypharmacy were antithrombotics, peptic ulcer disease and gastro-oesophageal reflux disease agents, and ACE inhibitors. The odds of exposure to polypharmacy were higher for older subjects, males and subjects living in urban areas., Conclusions: This study provides evidence that the prevalence of polypharmacy in the elderly in Emilia-Romagna is substantial. Educational programmes should be developed to inform clinicians about the magnitude of the polypharmacy phenomenon and the patient characteristics associated with polypharmacy. Raising physicians' awareness of polypharmacy may help to ensure safe, effective and appropriate use of medication in the elderly.