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The preponderance of journals with dubious publishing practices has resulted in a new term in academic publishing: predatory journals. Although there is no standard definition, predatory journals generally subvert the traditional peer-reviewed system for financial gain. Common practices of predatory journals include publishing almost all submissions, a lack of transparency about publication fees, aggressive solicitation of contributors irrespective of relevant expertise and credentials, and even closely mimicking names of reputable journals-effectively acting as a decoy to attract authors and readers. Left unchecked, these journals have the potential to threaten the evidence base relied on by managed care pharmacists. Given the importance of peer-reviewed literature to managed care pharmacy practice, how is one to discern between a predatory journal and a reputable one? There are 5 key practices that distinguish reputable journals. First, reputable journals rely on peer reviewers who are experts in their respective fields to carefully review submitted manuscripts for suitability to publish. Second, reputable journals have a board of experts in relevant areas that serve in an advisory capacity to the editorial staff. Third, reputable journals follow recognized publishing standards to guide their policies, which range from determining authorship, to journal management, to handling allegations of misconduct. Fourth, reputable journals are transparent and fair about their levied fees, avoiding any real or perceived conflict of interest. Finally, reputable journals are indexed in searchable databases that have quality selection criteria for inclusion. These 5 criteria should be used by managed care authors and researchers when determining where to publish their papers and whether to serve as an editorial board member or peer reviewer when requested. Studies published in journals meeting these criteria can be deemed as reputable and suitable for review by managed care and health policymakers. It is essential that everyone involved in producing and using peer-reviewed literature is informed about the threat of predatory publishing and avoids engaging in any activities with these journals. DISCLOSURES: No funding was received for the writing of this article. The author is editor-in-chief of the Journal of Managed Care & Specialty Pharmacy and has nothing to disclose.

Managed care pharmacists apply real-world evidence (RWE) to support activities such as pipeline forecasting, clinical policy development, and contracting for pharmaceutical products. Managed care pharmacy researchers strive to produce studies that can be applied in practice. While asking the right research question is necessary, it is not sufficient. As with all studies, consumers of RWE look for internal and external validity, as well as sources of bias, to determine how the study findings can be applied in their work. To date, however, some of the safeguards that exist for clinical trials-such as public registration of study protocols-are lacking for RWE. Several leading professional organizations have initiatives dedicated to improving the credibility and reliability of such research. One component common to these initiatives is enhanced transparency and completeness of methodologic reporting. Graphical representations of study designs can improve the reporting and design of research conducted in health care databases, specifically by enhancing the transparency and clarity of often complex studies. As such, Schneeweiss et al. (2019) proposed a graphical framework for longitudinal study designs in health care databases. Herein, we apply this framework to 2 studies published in the Journal of Managed Care & Specialty Pharmacy that represent common research designs and report how application of the framework revealed deficiencies in reporting. We advocate for adoption of this framework in the effort to increase the usability of RWE studies using health care databases by managed care pharmacy. DISCLOSURES: No funding was provided for this work. Gatwood has received research funding from Merck & Co., AstraZeneca, and GlaxoSmithKline, unrelated to this work. Schneeweiss is a consultant to Aetion, of which he also owns equity. He is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, Boehringer Ingelheim, and Vertex. Wang reports support from investigator-initiated grants from Novartis, Boehringer Ingelheim, and Johnson & Johnson to Brigham and Women's Hospital, unrelated to this work. Happe and Brown have nothing to disclose.

Introduction Primary care provider encounters are associated with health and well-being; however, limited evidence guides optimal primary care provider rate of visit, referred to as encounter cadence. This study measures associations between primary care provider encounter cadence and diabetes outcomes among individuals newly diagnosed with type 2 diabetes mellitus. Methods In this retrospective cohort study, 7,106 people enrolled in Medicare Advantage and newly diagnosed with type 2 diabetes mellitus between July 1, 2012 and June 30, 2013 were identified and followed for 36 months. Two methods measured primary care provider encounter cadence: total primary care provider encounters (frequency) and quarters with primary care provider encounter (regularity). Logistic regression measured relationships between primary care provider encounter cadence and non-insulin diabetes medication adherence, HbA1c control, emergency department visits, and inpatient admissions. Non-insulin diabetes medication adherence was defined according to the National Committee for Quality Assurance, Healthcare Effectiveness Data and Information Set specifications and measured using healthcare claims data. Post-hoc models examined adherence and diabetes control among those nonadherent (n=5,212) and with noncontrolled HbA1c (n=326) during the encounter/cadence period. Data were extracted and analyzed in 2017. Results Adjusted models indicated that both frequency (AOR=1.08, 95% CI=1.06, 1.10) and regularity (AOR=1.18, 95% CI=1.13, 1.22) of primary care provider encounters were associated with increased odds of adherence. Post-hoc analyses indicated that more frequent (AOR=1.12, 95% CI=1.10, 1.15) and regular (AOR=1.27, 95% CI=1.22, 1.33) primary care provider encounters were associated significantly with adherence and were associated directionally with HbA1c control. Conclusions More frequent and regular primary care provider encounters are associated with an increased likelihood of non-insulin diabetes medication adherence. These findings contribute to data needed to establish evidence-based guidelines for primary care provider encounter cadence for those newly diagnosed with type 2 diabetes mellitus.

DISCLOSURES: No funding contributed to the writing of this commentary. The authors have nothing to disclose.

Patients undergoing general surgical procedures are at increased risk for venous thromboembolism (VTE). Compliance rates with established guidelines for VTE thromboprophylaxis in patients at moderate-to-high risk are notably low. Recent literature has demonstrated that fondaparinux is associated with lower costs and fewer VTEs than enoxaparin in patients undergoing major orthopedic surgery (MOS), but data are limited in patients undergoing general surgery. This study was conducted to evaluate the cost implications and relative real-world effectiveness of fondaparinux vs. enoxaparin in general surgery patients.Data were obtained from inpatient billing records from over 500 hospitals using Premier's Perspective Comparative Database. Patients hospitalized for general surgery between July 1, 2003 and January 31, 2006 were eligible for inclusion. Eligible patients were included if they received fondaparinux or enoxaparin after their general surgery date. Patients were excluded if they received both anticoagulants on their first day of therapy, were18 years of age on the surgery date, or did not have data 6 months prior and 1 month post hospitalization. Included patients were stratified into two cohorts based on their first anticoagulant, fondaparinux or enoxaparin. Patients were matched in each group on 1:1 case-control matching based on propensity scores.A total of 5364 patients were included (n = 2682 for each cohort) from 326 unique hospitals. Average total costs per patient for the fondaparinux group were significantly lower than the enoxaparin group ($15 156 vs. 17 741, p0.0001). Patients receiving fondaparinux were significantly less likely to experience a VTE (2.80 vs. 3.77%, p = 0.046, a 35% relative risk reduction). No significant differences in bleeding events between the cohorts were observed (p = 0.6047), and no significant differences in all-cause inpatient death were noted (p = 0.3673).Fondaparinux was associated with significantly lower costs and fewer VTEs compared to enoxaparin without an increase in bleed rates or all-cause inpatient mortality. The findings from this study are limited by the retrospective study design and should only be generalized to a similar patient population.

In 2013, the Centers for Medicare and Medicaid Services reversed their coverage policy that limited bariatric operations to Centers of Excellence (COE). Data from Centers for Medicare and Medicaid Services may not be generalizable to younger, healthier populations; additional data are needed to inform coverage policies for other plans. This retrospective cohort study used the 2010 to 2011 administrative claims data from the TRICARE military healthcare program to evaluate readmission rates, readmission length of stay, and postoperative healthcare costs among patients who had bariatric surgery at a COE versus non-designated centers. Outcomes were reported at 30, 60, and 90 days, and compared using logistic and linear regression models while controlling for age, gender, and military status. A total of 3027 patients underwent bariatric operations (mean age 44.16, 84.11% female). At 30 days, there were no significant differences between patients in COEs (n = 2413) and non-designated centers (n = 614), in readmission rates (4.77%, 4.40%, P = 0.70), mean length of stay (5.5 days, 6.7 days, P = 0.41), or mean postoperative healthcare costs ($754, $962, P = 0.398). There were no significant differences in any outcomes at 60 or 90 days. Combined with concerns related to COE patient access barriers, these findings strengthen the evidence that reject the requirement for bariatric surgeries to be performed at COEs.

Value-based payments are rapidly replacing fee-for-service arrangements, necessitating advancements in physician practice capabilities and functions. The objective of this study was to examine potential differences among family physicians who are owners versus employed with respect to their readiness for value-based payment models. The authors surveyed more than 550 family physicians from the American Academy of Family Physician's membership; nearly 75% had made changes to participate in value-based payments. However, owners were significantly more likely to report that their practices had made no changes in value-based payment capabilities than employed physicians (owners 35.2% vs. employed 18.1%, P

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.

Objective: To examine the outcomes of a Medicare population who participated in a program combining digital health with human coaching for diabetes risk reduction. Method: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months. Results: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% ( SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = −0.14%, p = .001) and total cholesterol decreased (−7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved ( p < .0001). Discussion: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.

Introduction: Regular PCP encounters are associated with wellbeing; there is limited evidence to support the ideal PCP encounter cadence to optimize patient outcomes. The aim of this study was to measure the association between PCP encounter cadence and medication adherence and diabetes control, among those newly diagnosed with T2DM. Methods: A cohort of 7,106 persons enrolled in a Medicare Advantage health plan and newly diagnosed with T2DM between 7/1/12-6/30/13, was identified and followed for 36 months. Two methods measured PCP encounter cadence: total PCP encounters (frequency) and quarters with PCP encounter (regularity). Proportion of days covered (PDC) assessed noninsulin diabetes medication (NIDM) adherence (PDC ≥80.0%). Diabetes control was defined as A1c ≤ 8.0%. Logistic regression was used to measure the relationship between PCP encounter cadence and outcomes (NIDM adherence, diabetes control). Covariates included patient demographics, Charlson Comorbidity Index score, chronic conditions, healthcare utilization, insulin use, and prior NIDM adherence and diabetes control. Results: Overall, 5,212 and 326 people met inclusion criteria for the NIDM adherence and diabetes control analyses, respectively. Adjusted models indicated that each additional PCP encounter was associated with a 12.3% increase in the likelihood of NIDM adherence (95% CI 1.10, 1.15), and each additional quarter with a PCP encounter was associated with a 27.4% increase in the likelihood of NIDM adherence (95% CI 1.22, 1.33). PCP encounters (OR 1.06; 95% CI 1.00, 1.12) and quarters with a PCP encounter (OR 1.13; 95% CI 0.98, 1.30) were directionally associated with diabetes control. Conclusion: Our findings suggest that frequency and regularity of PCP encounters were associated with medication adherence. This study contributes to the data needed to establish evidence-based guidelines for PCP encounter cadence, for those newly diagnosed with T2DM. Disclosure S.E. Wixson: None. J. Dobbins: Employee; Self; Humana Inc. T.A. Cordier: Employee; Self; Humana Inc.. Stock/Shareholder; Self; Humana Inc.. G. Haugh: None. A. Renda: None. L.E. Happe: Employee; Self; Humana. Other Relationship; Self; Journal of Managed Care Pharmacy. A. Turchin: Research Support; Self; Sanofi-Aventis. Advisory Panel; Self; Merck Sharp & Dohme Corp., Monarch Medical Technologies. Stock/Shareholder; Self; Brio Systems. Research Support; Self; Eli Lilly and Company.

**Background:** Research has shown that treatment interruptions are associated with worse failure-free survival in chronic myeloid leukemia (CML); however they are commonly used in clinical trials to manage adverse events. **Objectives:** This study assessed the comparative rates of treatment interruption and regimen change between patients initiating first-line therapy with a first-generation tyrosine kinase inhibitor (1GTKI) imatinib versus second-generation TKI (2GTKI), dasatinib or nilotinib, for the treatment of CML in clinical practice. **Methods:** This was a retrospective cohort study using the Humana Research Database. Patients with CML who were between the ages of 18 and 89 and newly initiated 1GTKI or 2GTKI therapy between June 1, 2010 and December 31, 2011 were included. Treatment interruption and regimen change were compared using multivariable Cox proportional hazard regression models. Treatment interruption was defined as a gap in any TKI pharmacy claim that was longer than an allowable refill gap plus days’ supply from the previous TKI medication claim. Regimen change was defined as 1) a prescription claim for a different TKI therapy, or 2) increase in dose for the same medication. **Results:** 368 patients met the inclusion criteria: 1GTKI n=237, 2GTKI n=131. Patients initiating therapy with a 2GTKI had a 48% higher risk of treatment interruption versus patients initiating therapy with a 1GTKI (hazard ratio=1.48, 95% confidence interval 1.08-2.02). The time to treatment interruption was significantly longer in patients initiating therapy with a 1GTKI. Approximately 19% of patients had a regimen change, but there were no differences in rates of regimen changes between the two generations. **Conclusions:** In this study from a large single health plan population, treatment interruptions were more common among patients initiating therapy with a 2GTKI, yet regimen change rates did not vary by generation of TKI. Future research should assess reasons for treatment interruption and investigate these associations in other populations.

In this cohort of nearly 15000 11-year-old girls with insurance (commercial or Medicaid), the human papillomavirus vaccine was administered at only 1 in 4 well-adolescent visits and approximately one-third of vaccine-related visits, which suggests a substantial number of missed opportunities., Background This study assessed the initiation of HPV vaccination in insured adolescent females in relation to physician visits and receipt of other vaccines routinely given at the same age. Methods January 1, 2010, and September 31, 2015. Vaccination administration was determined by using Current Procedural Terminology codes. A missed opportunity was defined as the absence of an HPV vaccine at the following encounter types: visits with a 4-valent meningococcal conjugate vaccine (MenACWY) or tetanus, diphtheria, and acellular pertussis (Tdap) vaccine claim; well adolescent visits; or any encounter with a primary care provider (PCP). Missed opportunities were stratified by type of provider (pediatrician or nonpediatrician). Results Among 14588 adolescent girls, only 6098 (41.8%) initiated the HPV vaccine series. HPV vaccine was given at 37.1% of visits when a Tdap or MenACWY vaccine was administered, 26.0% of well adolescent visits and 41.8% of PCP visits. Pediatricians had fewer missed opportunities than nonpediatricians to administer HPV (50.7% vs 60.8%), as well as Tdap, although the difference was larger for Tdap (7.0% vs 29.6%). Conclusions These data indicate that pediatricians and nonpediatricians alike are missing opportunities to administer the HPV vaccine when other adolescent vaccines are given. Efforts should be focused on converting these missed vaccination opportunities into cancer-prevention visits.

BACKGROUND: Fingolimod, an oral immunomodulatory therapy approved to treat multiple sclerosis (MS) is contraindicated in patients with certain cardiac conditions, yet the frequency of these conditions in patients with MS is not known. This study assessed the frequency and economic impact of cardiac conditions among hospitalizations of patients with MS. OBJECTIVE: To determine the frequency and economic impact of selected comorbid cardiac conditions among hospitalizations of patients with a diagnosis of MS. METHODS: This was a retrospective, discharge-level cohort study of hospital discharge data from 2006-2010. The frequencies of cardiac conditions of interest (based on contraindications to fingolimod in the prescribing information) were reported among all discharges with a diagnosis of MS. Two cohorts were defined: (1) MS with cardiac condition of interest and (2) MS with no cardiac condition of interest. The mean adjusted cost per discharge and incremental cost per hospital day were reported. RESULTS: Among 136,542 discharges with a diagnosis of MS, 9.2% (n = 12,504) had a comorbid cardiac condition of interest based on contraindications to fingolimod in the prescribing information. Heart failure (59.4%), myocardial infarction (17.2%), and occlusion of cerebral arteries (12.4%) were the most common cardiac conditions. The mean adjusted cost per discharge was significantly higher for the MS with cardiac condition cohort compared with the MS with no cardiac condition cohort ($17,623 vs. $11,663, P < 0.0001). The incremental cost per hospital day was $6,479 for the MS with cardiac condition cohort. CONCLUSIONS: The presence of comorbid cardiac conditions among hospital discharges in patients with MS is substantial and associated with higher hospitalization costs. Health plans should give consideration to the overlapping presence of these diseases when determining coverage criteria for immunomodulatory therapies and designing clinical programs for MS.

There is extensive literature demonstrating that formulary restrictions reduce the pharmacy costs and utilization of restricted drugs. However, some research suggests that there may be unintended consequences of formulary restrictions on other patient outcomes. While several literature reviews have assessed the relationship between formulary restrictions and medication adherence, clinical outcomes, economic outcomes, or health care resource utilization, these reviews were either not systematic, were conducted more than 5 years ago, or did not assess the aggregate directional impact of the relationships.To conduct a systematic literature review assessing the direction (positive, negative, or neutral) of the relationship between managed care formulary restrictions (including step therapy, cost sharing, prior authorization, preferred drug lists, and quantity limits) on medication adherence, clinical outcomes, economic outcomes, and health care resource utilization. Articles published in 1993 or later were identified from PubMed using 2 lists of search terms. List A included 12 formulary restriction terms and List B included 12 patient outcomes terms, resulting in 144 unique search term combinations. Each article was evaluated by 2 investigators against the following exclusion criteria using a stepwise approach: (a) the article was a commentary or review article; (b) the article did not assess the impact of managed care formulary restrictions on outcomes; and (c) the study was conducted outside the United States. The total number of studies was reported by formulary restriction type. Next, the total number of outcomes reported in each study was summed to conduct an outcomes-level analysis. The outcomes were categorized by type of outcome (medication adherence, clinical, economic, or health care resource utilization) and direction of association (positive, negative, or neutral/not significant) based on the relationship reported in each study. The frequencies of each type of outcome were stratified by direction of association. A total of 93 studies were included from 811 reviewed articles. Cost sharing was the most commonly assessed type of formulary restriction (60.2% of included articles), followed by prior authorization (21.5%). Of the 262 patient outcomes assessed, medication adherence was the most common (120 outcomes, 45.8%). Overall, formulary restrictions were most frequently negatively correlated with outcomes (130 outcomes, 49.6%). When outcome type was stratified by direction of association, 68.3% (82/120) of medication adherence outcomes were negative. The direction of association of economic outcomes (n = 59) with formulary restrictions was split between neutral (37.3%), positive (33.9%), and negative (28.8%). Health care resource utilization outcomes (n = 72) had no association with formulary restrictions in 50.0% of the outcomes assessed. There were 11 clinical outcomes identified in the literature review.There is a strong evidence base demonstrating a negative correlation between formulary restrictions on medication adherence outcomes. Additional research on commonly used formulary restrictions, specifically prior authorization and step therapy, as well as on the association between formulary restrictions and clinical outcomes, is warranted.

Background As Medicare expands the use of computed tomography (CT) for diagnosing lung cancer, there is increased opportunity to diagnose lung cancer in asymptomatic patients. This descriptive study characterizes the disease-specific diagnostic and treatment services that patients with a positive diagnosis following CT received, stratified by presentation at CT. Methods Patients who were diagnosed with lung cancer following CT in 2013, had no history of lung cancer, survived at least 1 year, were aged 55–80 years, and had Medicare Advantage insurance were included. Patients were grouped based upon presentation at CT: morbidities unrelated to lung cancer, classic lung cancer symptoms, and cancer syndromes. Patients with none of these factors were categorized into a no diagnoses/symptoms group. The type and intensity of services used in the year following the CT was reported for each group. Results 1,261 patients were included. Early treatment services were most common in the group with morbidities unrelated to lung cancer (13.7%) and least common in the cancer syndromes group (6.6%). Advanced treatment services were used by 47.3% of the cancer syndromes group versus 23.5% of the no diagnoses/symptoms group. Conclusions The intensity of disease-specific diagnostic and treatment services varied by presentation at CT. Patients with no symptoms or morbidities at the time of CT less frequently received advanced interventions. Learning about the utilization patterns of others with a similar presentation at CT may help patients with positive lung cancer diagnoses engage in shared decision making and in norming their experiences against those of other similarly-situated patients.

Decades of practice under a system that set the financial interests of physicians and insurers at odds, has resulted in physician distrust of insurers being cited a key obstacle to value-based arrangements. Insurers must work to shift the insurer-provider relationship from one that's transactional to a partnership built on trust. Even when physicians and insurers agree philosophically on quality over quantity, there are practical challenges. Insurers can provide the data, systems and analytical insights that help inform the physician's care strategy. Implementing value-based payments requires the two groups to build trust and work together to change long-established systems.

Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011) and after (2013) the payment method introduction using relative risks (RR). After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p

To evaluate the burden of major bleed in patients with non-ST segment elevation acute coronary syndromes (NSTE ACS) receiving injectable anticoagulation from the hospital perspective.Retrospective analysis of inpatient medical and pharmacy data from the Premier Perspective Comparative Database between 1/1/2003 and 3/31/2006. Hospitalized patients agedor=18 years with a diagnosis of UA or NSTEMI who received an injectable anticoagulant agent during the same hospital stay were stratified into two cohorts: those who experienced a major bleed during hospitalization and those who did not, defined by the presence ofor=1 pre-specified ICD-9 codes. Length of hospital stay (LOS), inpatient mortality, 30-day readmissions, and hospitalization costs over 30 days were assessed between the cohorts using statistical models to control for covariates which may have impacted the outcomes.Patients with a major bleed had significantly longer length of stay (13.8 days vs 5.6 days), higher readmission rates (31.3% vs 14.7%), and increased all-cause mortality (15.0% vs 4.5%) compared with patients who did not bleed. After controlling for covariates, major bleeding was significantly associated with increased length of stay, readmission rate, and mortality. Adjusted costs were $13,856 higher on average for patients with a major bleed (95% CI: $13,828-$18,884; p0.0001). Subanalyses conducted on patients agedor=65 years and those undergoing invasive procedures demonstrated higher occurrence of bleed than the general population and a similar impact on outcomes assessed.In conclusion, the study showed that patients with UA or NSTEMI who experience a major bleed have significantly longer hospital stays, higher readmission rates, increased costs, and increased mortality than those without a major bleed. These data emphasize the importance of considering the safety profile in context of the efficacy of the recommended agents. The findings from this study are limited by the retrospective study design and certain endpoints, such as readmissions, may have been underreported.

The use of outpatient anticoagulation after major orthopedic surgery with oral or injectable anticoagulants is recommended by national guidelines. A retrospective analysis of medical and pharmacy claims data using the PharMetrics Patient-Centric Database Inc, Watertown, Mass, was conducted. After adjusting for covariates, patients receiving warfarin were approximately 30% more likely to experience a venous thromboembolism than those receiving an injectable anticoagulant (6.3% vs 4.8%; adjusted odds ratio, 1.3; 95% confidence interval, 1.1-1.5) by 30 days. The data at 90 days showed similar results. No significant differences in the incidence of major bleeding events between the cohorts were observed (incidence of major bleed

Background Multiple clinical studies have shown postdischarge anticoagulation to bo beneficial following major orthopedic surgery (MOS); however, outpatient prophylaxis is not widely practiced. Objective To quantify, from a third-party payer perspective, real-world clinical and economic outcomes tor patients receiving injectable or oral anticoagulation as prophylaxis for venous thromboembolism (VTE) following discharge after MOS. Methods A retrospective database analysis was conducted using outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002, to March 31, 2006). Patients greater than 18 years of age with 9 months of continuous eligibility who received an anticoagulant in the outpatient setting following MOS were eligible. Patients were stratified into 2 cohorts; injectable (dalteparin, enoxaparin, fondaparinux) and oral (warfarin), and were matched 1:1 on demographic and clinical characteristics. Results: A total of 12,724 patients were included (injectable, 6362; oral, 6362). At 90 days, patients receiving oral anticoagulation were 20% more likely to experience a VTE than were those receiving an injectable agent (7.4% vs 6.3%; p = 0.02, OR 1.18; 95% CI 1.03 to 1.36). No significant differences in bleeding were observed (Conclusions: This study demonstrates that the risk of VTE extends to the outpatient setting following MOS, even with postdischarge anticoagulation. Injectable agents used in the outpatient setting may result in fewer clinical VTEs without increasing the risk for major bleeding. These findings support 1he data from controlled clinical studies and expand the evidence to the real-world setting. Despite higher pharmacy acquisition costs for injectable anticoagulants, injectable agents may offer significant per patient savings to third party payers.

Purpose. The cost, effectiveness, and safety of injectable anticoagulants used for thromboprophylaxis after orthopedic surgery were compared. Methods. This retrospective, observational, cross-sectional, cohort analysis of inpatient billing data was conducted from the institutional perspective. Patients who received dalteparin, enoxaparin, fondaparinux, or unfractionated heparin after orthopedic surgery were included in the analysis. The primary outcome measure was the mean aggregated cost per patient treated with each injectable anticoagulant. Secondary outcomes included the percentages of patients in each treatment group who had a venous thromboembolism (VTE) or major bleeding episode. Results. Mean total adjusted costs were significantly lower for fondaparinux ($18,019) compared with other anticoagulants, with unfractionated heparin being the most costly ($20,835). Relative adjusted cost differences were 1.4% ( p = 0.0127), 1.8% ( p = 0.0105), and 14.6% ( p < 0.0001) higher for enoxaparin, dalteparin, and unfractionated heparin, respectively, compared with fondaparinux. Significantly fewer fondaparinux-treated patients had a VTE event compared with the other treatment groups. The use of dalteparin was associated with fewer major bleeding events, and no significant differences in the rate of major bleeding events were observed among groups treated with fondaparinux, enoxaparin, or unfractionated heparin. Conclusion. A retrospective analysis of inpatient billing data showed that, among orthopedic surgery patients, fondaparinux was associated with lower institutional cost and a lower frequency of VTE than were dalteparin, enoxaparin, and unfractionated heparin. Dalteparin was associated with a lower rate of major bleeding events than was fondaparinux, but there were no significant differences in such events among fondaparinux, enoxaparin, and unfractionated heparin.

Background: The number of shots represented by the routine childhood immunization schedule poses a logistical challenge for providers and a potential deterrent for parents. By reducing the number of injections, use of combination vaccines could lead to fewer deferred doses and improved coverage rates. Objective: To determine the effect of combination vaccines on coverage rates. Methods: This was a retrospective study of administrative claims data from the Georgia Department of Community Health Medicaid program conducted from January through September of 2003. Coverage rates were compared between children who received at least 1 dose of HepB/Hib (COMVAX) or DTaP/HepB/IPV (PEDIARIX) (the combination cohort) and children who received no doses of either combination (the reference cohort). Infants with fewer than 4 vaccination visits were excluded from the analysis. Multivariate logistic regression was performed on the whole study population to assess the effect of combination vaccines while controlling for potential confounders. Hepatitis B and pneumococcal conjugate vaccine coverage rates were not included as outcomes. Results: The study population consisted of 18,821 infants, 16,007 in the combination cohort and 2814 in the reference cohort. Unadjusted coverage rates for DTaP, IPV and the 4 DTaP:3 IPV:1 MMR, 4 DTaP: 3 IPV: 1 MMR: 3 Hib: 1 varicella, and 3 DTaP:3 IPV: 3 Hib series were higher in the combination cohort. Receipt of at least 1 dose of a combination vaccine was independently associated with increased coverage for each of these vaccines and vaccine series when controlling for gender, birth quarter, race, rural versus urban residence and historical provider immunization quality. Conclusions: Use of combination vaccines in this Medicaid population was associated with improved coverage rates. Additional studies are warranted, including those examining private sector populations and outcomes such as timeliness and cost.

Chronic myeloid leukemia (CML) treatment guidelines recommend first-line therapy with either first- or second-generation tyrosine kinase inhibitors (1GTKI, 2GTKI), but do not specify which generation should be used first.To examine the association between initiation of 2GTKI versus 1GTKI and medication adherence, health services utilization, and healthcare costs.This was a retrospective cohort study utilizing administrative claims data from a single health plan within the US of commercial and Medicare patients newly initiating 1GTKI or 2GTKI therapy for CML between June 2010 and December 2011. Multivariate logistic regression was used to investigate the association between TKI therapy and adherence, defined as proportion of days covered ≥0.85. Multivariate logistic regression and generalized linear models examined the association between TKI and health services utilization and direct healthcare costs (plan and patient paid) during the 12 month follow-up period.Among the 368 patients included, there was no difference in adherence between patients initiating a 2GTKI compared to a 1GTKI (odds ratio = 0.88, 95% confidence interval [CI] 0.55-1.40). Initiating a 2GTKI was associated with increased outpatient visits (incidence rate ratio [IRR] = 1.12, 95% CI 1.06-1.20); however, there were no statistically significant differences in emergency room visits or inpatient visits between the treatment groups. Total costs were 1.3 times higher for 2GTKI initiators versus 1GTKI initiators ($86,509 versus $66,443; p = 0.001), with a significant difference in TKI pharmacy costs.Although there were no differences in adherence, hospitalizations, or emergency room visits among patients initiating a second- versus first-generation TKI, total all-cause costs and outpatient visits were higher for 2GTKI initiators. With the impending release of generic imatinib, these comparative data will become germane in the selection of a first-line TKI therapy. Because this study used claims from a single health plan, it may not be generalizable to the general population.

Comparative effectiveness research (CER) has emerged as a priority for outlining the advantages and disadvantages of disease-modifying therapies (DMTs) for multiple sclerosis (MS). CER can provide physicians with valuable information to assist them in selecting the most appropriate therapeutics for their patients with MS. For payers, data from CER could inform decisions regarding the level of coverage for current and developing MS therapeutics, and drive the use of the most effective treatments for patients with MS. The base of CER data for DMTs has been expanding, and findings from a number of CER studies for currently available DMTs have been published, while further CER studies are planned to evaluate currently available and new DMTs or DMTs in development. While CER can be used to guide DMT selection for physicians and payers, the safety and tolerability of these treatments must be considered as well. Other emerging factors (eg, biomarkers and patient-specific factors) may also serve as important determinants of DMT choice in the future.

Objectives. To assess the impact of using “grey literature” (information internally produced in print or electronic format by agencies such as hospitals, government, businesses, etc) rather than a textbook in a course on healthcare delivery systems on students’ perception of the relevance of healthcare delivery system topics and their ability to identify credible sources of this information. Design. A reading from the grey literature was identified and assigned to the students for each topic in the course. Assessment. Pre- and post-course survey instruments were used for the assessment. Students reported healthcare delivery systems topics to be moderately relevant to the profession of pharmacy on both the pre- and post-course survey instruments. Students’ knowledge of current and credible sources of information on healthcare delivery system topics significantly improved based on self-reports and scores on objective assessments (p

BACKGROUND: Multiple sclerosis (MS) is a chronic, disabling, and costly disease with several treatment options available; however, there is variability in evidence-based clinical guidelines. Therefore, payers are at a disadvantage when making management decisions without the benefit of definitive guidance from treatment guidelines. OBJECTIVE: To outline approaches for the management of agents used to treat MS, as determined from a group of U.S. managed care pharmacists and physicians. METHODS: A modified Delphi process was used to develop consensus statements regarding MS management approaches. The panel was composed of experts in managed care and included 8 pharmacy directors and 6 medical directors presently or previously involved in formulary decision making from 12 health plans, 1 specialty pharmacy, and 1 consulting company. These decision makers, who have experience designing health care benefits that include MS treatments, provided anonymous feedback through 2 rounds of web-based surveys and participated in 1 live panel meeting held in December 2010. Consensus was defined as a mean response of at least 3.3 or 100% of responses either “agree” or “strongly agree” (i.e., no panelist answered “disagree” or “strongly disagree”) on a 4-item Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). RESULTS: After 3 phases, these managed care representatives reached consensus on 25 statements for management of patients with MS. Consistent with managed care principles, this group of managed care experts found that health plans should consider efficacy, effectiveness, and safety, as well as patient preference, when evaluating MS therapies for formulary placement. Cost and contracting should be considered if efficacy and safety are judged to be comparable between agents. CONCLUSION: The consensus statements developed by a panel of managed care representatives provide some insight into decision making in formulary and utilization management of MS therapies.

Background: Use of combination vaccines has been associated with improved coverage rates, but their effect on timeliness remains to be explored. This study assessed the effect of diphtheria-tetanus-acellular pertussis/hepatitis B/inactivated polio vaccine (DTaP/HepB/IPV) on the timeliness of vaccine administration. Methods: This retrospective cohort study used administrative claims data from the Georgia Medicaid program. Children with 24 months of continuous enrollment and at least 4 vaccine-related office visits were stratified into 2 cohorts: those with at least 3 DTaP/HepB/IPV doses (DTaP/HepB/IPV cohort) and those with at least 3 doses of DTaP but no doses of DTaP/HepB/ IPV (reference cohort). Children who received any dose of HepB/Hib were excluded to isolate the effect of the study vaccine. Timeliness was measured as the percentage of children who received their vaccines on time and the cumulative days undervaccinated. Results: There were 2880 children in the DTaP/HepB/IPV cohort and 2672 in the reference cohort. After controlling for covariates, receipt of DTaP/ HepB/IPV was associated with significantly improved timeliness for 3 doses of DTaP (on-time rates: 66.3% vs. 60.8%, P < 0.0001; cumulative days undervaccinated: 29.5 vs. 70.4 days, P < 0.0001). Significantly improved timeliness was also observed in the DTaP/HepB/IPV cohort for IPV, HepB, Hib, 4 DTaPs, and the combination series assessed (P < 0.001 for all comparisons). Conclusions: Use of DTaP/HepB/IPV in this Medicaid population was associated with improved on-time vaccination and fewer undervaccinated days. These findings, along with previous research associating combination vaccines with improved coverage rates, provide quantitative data to support the ACIP, AAP, and AAFP preference for combination vaccines.

Clinical trials have shown differences in efficacy among anticoagulants used for venous thromboembolism (VTE) prophylaxis after hip fracture surgery, but the applicability of their results is limited by constraints of the clinical trial setting. We conducted this retrospective cohort study to assess VTE after hip fracture surgery in patients who received prophylaxis with dalteparin, enoxaparin, fondaparinux, or unfractionated heparin in a hospital setting. After adjustments were made for demographic differences, risk for VTE was significantly higher for dalteparin (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.99-1.92), enoxaparin (OR, 1.4; 95% CI, 1.05-1.86), and unfractionated heparin (OR, 1.9; 95% CI, 1.39-2.58) compared with fondaparinux. These findings confirm the results of clinical trials in a real-world setting.

Background Venous thromboembolism (VTE) is a known complication of major orthopedic surgery (MOS) with important clinical and economic consequences. Recently published orthopedic guidelines have focused on prevention of pulmonary embolism as a primary outcome, but deep vein thrombosis (DVT) occurrence should not be readily dismissed. Objective To describe the burden of DVT following hospital discharge for MOS by assessing the impact of DVT on costs and resource utilization from the Third-party payer perspective. Methods Retrospective analysis used outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002–March 31. 2006). Patients 18 years of age or older with a record of MOS were eligible for inclusion. Included patients were stratified based on the presence of a DVT during the first month after hospital discharge. Characteristics of the samples were described. The impact of DVT on total 6–month costs and resource utilization (readmissions, outpatient, emergency department visits) was assessed through statistical models. Results: Of the 32,899 patients in the analysis, 1221 (3.71%) had a record of DVT during the first month following discharge for MOS. Compared with patients who did not develop DVT, patients who developed DVT postdischarge were slightly older (56.5 vs 55.8 y; p = 0.0127), had a higher occurrence of prior VTE (26.2% vs 3.4%; p < 0.0001), and had undergone recent surgical procedures other than MOS (73.0% vs 69.6%; p = 0.0116). After controlling for potential confounders, DVT was associated with a 22% and 74% increase in the average number of expected outpatient and emergency department visits, respectively, during the 6-month postdischarge period but did not significantly impact the number of readmissions. Furthermore, total 6-month costs were significantly higher for patients who developed DVT with an incremental increase of over $2000. Conclusions: The burden of DVT following hospital discharge for MOS is substantial. Specifically, DVT increases total costs and outpatient and emergency department visits.

To evaluate the impact of a pentavalent combination vaccine on childhood immunization coverage rates and timeliness within a managed care organization.Retrospective matched-cohort analysis of encounter data from administrative claims and a state immunization registry.Children were stratified into 2 demographically matched cohorts (combination and reference), based on receipt of the DTaP/HepB/IPV combination vaccine. Children were followed until 24 months of age, and coverage rates and on-time rates were assessed. Outcomes were measured for the HEDIS Combination 2 vaccine series (4 doses of diphtheria/tetanus/pertussis, 3 doses of polio, 1 dose of measles/mumps/rubella, 3 doses of Haemophilus influenzae type b, 3 doses of hepatitis B, and 1 dose of varicella) and each vaccine series individually.Children in the combination cohort were significantly more likely to be fully vaccinated for the HEDIS Combination 2 series by 2 years of age and to be vaccinated within the recommended age ranges. In the combination cohort 86.9% (752/865) of patients were fully covered compared with only 74.1% (641/865) of the reference cohort (P.001). In the combination cohort 45.2% (391/865) of patients received vaccinations on time versus 37.5% (324/865) of the reference cohort, P = .001.Receipt of DTaP/HepB/IPV was associated with improved coverage and age-appropriate immunization in a managed care population.

Background Many factors impact the choice of anticoagulant used for venous thromboembolism prophylaxis following orthopaedic surgery. Thrombocytopenia (TCP) is an important factor from both clinical and economic perspectives, warranting assessment between the available agents. Thus, a retrospective cohort analysis was conducted to: (1) report the occurrence of TCP in a treatment and no treatment group, (2) evaluate the impact of anticoagulant choice on TCP within the treatment group, and (3) assess the clinical and economic implications of TCP in the treatment group. Methods Administrative claims from a hospital database were used to identify patients with hip replacement, knee replacement, or hip fracture surgery. The treatment group (n = 144,806) included patients receiving one of the following injectable anticoagulants post-operatively: dalteparin (n = 16,109); enoxaparin (n = 97,827); fondaparinux (n = 12,532); or unfractionated heparin (UFH) (n = 18,338). The no treatment group consisted of patients who did not receive one of the four injectable anticoagulants (n = 112,574) post-operatively. Outcomes were assessed for the hospitalization period plus 2 months post-discharge while controlling for relevant demographic and clinical characteristics. Results The occurrence of TCP was 1.0% in the no treatment group and 1.7% in the treatment group. Within the treatment group, patients who received dalteparin, enoxaparin, and UFH were significantly more likely to experience coded thrombocytopenia than those in the no treatment group. The risk of TCP among patients who received fondaparinux was not significantly different from the no treatment cohort (odds ratio [OR] = 1.15, 95% CI: 0.96–1.37, P = 0.13). Patients in the treatment group with coded TCP had 22% higher adjusted mean total healthcare costs (relative cost difference) compared to those without ($19,134 vs. $15,400, respectively, P

Venous thromboembolism (VTE) is an important cause of morbidity and mortality following major orthopedic surgeries. In clinical trials, fondaparinux and low molecular weight heparins have been shown to be more effective than unfractionated heparin (UFH) in preventing VTE. We retrospectively analyzed a large hospital discharge database to assess the occurrence of clinically detected VTE as a function of the injectable antithrombotic agent used for VTE prophylaxis in orthopedic surgery.The Premier's Perspective database, representing over 500 hospitals across the US, was utilized to identify patients receiving dalteparin, enoxaparin, fondaparinux, or UFH following hip or knee replacement or hip fracture surgery between January 2003 and March 2005. The primary outcome was the proportion of patients in each cohort with a VTE, while secondary outcomes included VTE occurrence during index hospitalization, and proportion of patients with a VTE-associated hospital readmission.A total of 144,806 patients were included in the study. Significantly fewer fondaparinux patients experienced a VTE event (1.5%) compared to enoxaparin (2.3%), dalteparin (2.1%), and UFH (4.2%). After controlling for baseline covariates, the odds of experiencing a VTE was significantly higher for other treatments when compared to fondaparinux (odds ratios: dalteparin=1.22 [95% CI: 1.01 to 1.46] p=0.0370; enoxaparin=1.39 [1.19 to 1.62], p0.0001; UFH=1.98 [1.67 to 2.34], p0.0001). Significantly fewer fondaparinux-treated patients experienced an event during the index hospitalization or were readmitted for a VTE compared to other treatments.Similar to clinical trial findings, patients receiving fondaparinux in this study experienced fewer VTE events following orthopedic surgeries.