Showing papers in "Journal of managed care & specialty pharmacy in 2015"
TL;DR: Analysis of Medicaid patients receiving oral versus LAI antipsychotic medications in the 6 months after a schizophrenia-related hospitalization found that LAI initiators had lower odds of being nonadherent and of having continuous 60-day gaps than FGA and SGA users.
Abstract: BACKGROUND: Antipsychotic medications are a central component of effective treatment for schizophrenia, but nonadherence is a significant problem for the majority of patients. Long-acting injectable (LAI) antipsychotic medications are a recommended treatment option for nonadherent patients, but evidence regarding their potential advantages has been mixed. Observational data on newer, second-generation LAI antipsychotic medications have been limited given their more recent regulatory approval and availability. OBJECTIVE: To examine antipsychotic medication nonadherence, discontinuation, and rehospitalization outcomes in Medicaid patients receiving oral versus LAI antipsychotic medications in the 6 months after a schizophrenia-related hospitalization. METHODS: The 2010-2013 Truven Health Analytics MarketScan Medicaid research claims database was used to identify adult patients with a recent history of nonadherence (prior 6 months) who received an oral or LAI antipsychotic medication within 30 days after an ...
171 citations
TL;DR: Heterogeneity enabled a best evidence synthesis to elucidate effective components of pharmacist intervention and it was found that performing medication reconciliation alone is insufficient in reducing postdischarge clinical outcomes and should be combined with active patient counseling and a clinical medication review.
Abstract: BACKGROUND: A transition from one health care setting to another increases the risk of medication errors. Several strategies have been applied to improve care transitions and reduce adverse clinical outcomes. Pharmacist intervention during and after hospitalization has been frequently studied and show a variable effect on these outcomes. OBJECTIVE: To identify the components of pharmacist intervention that improve clinical outcomes during care transitions. METHODS: MEDLINE, EMBASE, International Pharmaceutical Abstracts, and Web of Science databases were searched for randomized controlled trials (RCTs) that studied pharmacist intervention with regard to hospitalization. Two reviewers independently screened all references published from inception to November 2014, extracted data, and assessed risk of bias. RESULTS: A total of 30 studies met the inclusion criteria. A model was created to categorize and cluster components of pharmacist intervention. The average number of components deployed, stages of hospitalization covered, and intervention targets were equally distributed between effective and ineffective studies. A best evidence synthesis of 15 studies revealed strong evidence for a clinical medication review in multifaceted programs (5 effective vs. 0 ineffective studies). Conflicting evidence was found for an isolated postdischarge intervention, admission medication reconciliation, combining postdischarge interventions with in-hospital interventions, and covering of multiple stages. Closely collaborating with other health care providers enhanced the effectiveness. CONCLUSIONS: Although there is a need for well-designed and well-reported RCTs, the study heterogeneity enabled a best evidence synthesis to elucidate effective components of pharmacist intervention. In isolated postdischarge intervention programs, evidence tends towards collaborating with nurses and tailoring to individual patient needs. In multifaceted intervention programs, performing medication reconciliation alone is insufficient in reducing postdischarge clinical outcomes and should be combined with active patient counseling and a clinical medication review. Furthermore, close collaboration between pharmacists and physicians is beneficial. Finally, it is important to secure continuity of care by integrating pharmacists in these multifaceted programs across health care settings. Ultimately, pharmacists need to know patient clinical background and previous hospital experience.
105 citations
TL;DR: Results suggest that in combination with MTX most of the available novel DMARDs have similar levels of efficacy in DMARD-IR patients, and tocilizumab displayed higher ACR responses than aTNF or tofacitinib.
Abstract: BACKGROUND: Given the availability of a number of alternative biologic treatment options and other novel disease-modifying antirheumatic drugs (DMARDs) for the treatment of patients with rheumatoid arthritis (RA), clinicians are faced with an increasingly challenging choice regarding optimal treatment. Biologics are usually combined with traditional DMARDs, primarily methotrexate (MTX), but some biologics and tofacitinib (together referred to in this article as novel DMARDs) have been shown to be efficacious as monotherapy as well. In real-world practice, approximately one-third of RA patients receiving biologics are on monotherapy, primarily because of intolerance of, or noncompliance with, MTX. Limited data, however, are available analyzing the effectiveness of monotherapy compared with combination therapy across novel DMARDs. OBJECTIVE: To compare American College of Rheumatology (ACR) responses to approved novel DMARDs used as monotherapy or as combination therapy with methotrexate (MTX) at 24 weeks i...
98 citations
TL;DR: While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen and the mean ICER per QALY gained suggests a favorable cost-effectiveness.
Abstract: BACKGROUND: Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. OBJECTIVE: To evaluate the economic cost and the incremental costeffectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. METHODS: A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. RESULTS: No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001).
68 citations
TL;DR: The risk of fall-related events over 365 days increased 2-fold among elderly patients with diabetes who experienced hypoglycemia, and Elevated risks were also seen for individual fall- related outcomes of fractures, head injuries, long-term care placement, and hospital admissions.
Abstract: BACKGROUND: Hypoglycemia is a major barrier to achieving optimal glycemic control and managing diabetes successfully in patients with diabetes. Falls are the most significant consequences caused by hypoglycemia episodes. Both hypoglycemia and falls lead to substantial economic burden on the health care system in the United States. OBJECTIVE: To examine the association of hypoglycemia with fall-related outcomes in elderly patients with type 2 diabetes mellitus (T2DM). METHODS: Records were obtained for T2DM patients (N=1,147,937) from January 1, 2008, to December 31, 2011. The nonhypoglycemia patients were randomly matched 1:1 by age and gender to the hypoglycemia patients. Fall-related events (composite of fall-related outcomes) were defined using ICD-9-CM codes. Conditional logistic regression models were used to compare the fall-related events within 30 days, 90 days, 180 days, and 365 days between the 2 cohorts. RESULTS: A total of 21,613 hypoglycemia patients were matched with 21,613 nonhypoglycemic p...
61 citations
TL;DR: Adherence to long-term controller medications was suboptimal among patients with asthma, and increased SABA use served as a predictor of increased OCS use, which indicates poor asthma control.
Abstract: BACKGROUND: Adherence to asthma long-term controller medications is one of the key drivers to improve asthma management among patients with persistent asthma. While suboptimal use of controller medications has been found to be associated with more frequent use of oral corticosteroids (OCS), few studies exist regarding the relationship between adherence to controller therapy and the use of short-acting beta2-agonists (SABAs). A better understanding of the association between adherence to asthma controller agents and use of reliever medications will help health care providers and decision makers enhance asthma management. OBJECTIVE: To determine if there is a relationship between asthma controller adherence, risk of exacerbation requiring OCS, and use of asthma rescue agents. METHODS: Texas Medicaid claims data from January 1, 2008, to August 31, 2011, were retrospectively analyzed. Continuously enrolled patients aged 5-63 years with a primary diagnosis of asthma (ICD-9-CM code 493) and with 4 or more presc...
61 citations
TL;DR: The utilization patterns and costs associated with the use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis were examined to examine the real-world cost of treatment.
Abstract: BACKGROUND: Dose escalations of biologic agents may be attempted in the management of moderate-to-severe psoriasis. This has implications for the real-world cost of treatment. OBJECTIVE: To examine the utilization patterns and costs associated with the use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: This was a retrospective cross-sectional study. Patients with 2 or more medical claims with a diagnosis of psoriasis (excluding psoriatic arthritis) who were enrolled in large employer-sponsored health plans (including a pharmacy benefit) in the United States from January 2007 to March 2012 were identified and extracted from the MarketScan Commercial Encounters Database. Patients aged at least 18 years were required to have 2 or more pharmacy claims for etanercept, adalimumab, or ustekinumab; the index date was the first biologic fill date. Demographics and comorbidities were identified during the 1-year pre-index period, and medication utilization and ...
58 citations
TL;DR: Compared with PsO- and PsA-free controls, moderate-to-severe PsO patients were more likely to have selected comorbidities and higher health care utilization and costs.
Abstract: BACKGROUND: Previous studies demonstrated substantial economic and comorbidity burden associated with psoriasis (PsO) before biologics were available. Biologics have changed PsO treatment paradigms and potentially improved patient outcomes. There is a need to reassess the economic and comorbidity burden of PsO in the biologic era. OBJECTIVE: To compare the prevalence of comorbidities, health care resource utilization, and costs between moderate-to-severe PsO patients and demographically matched controls. METHODS: Adults aged 18-64 years with at least 2 PsO diagnoses (ICD-9-CM code 696.1) were identified in the OptumHealth Reporting and Insights claims database from January 2007 to March 2012. Moderate-to-severe PsO patients were identified as those receiving ≥ 1 systemic therapy or phototherapy during the 12-month study period following the index date (randomly selected date after the first PsO diagnosis). Controls were free of PsO and psoriatic arthritis (PsA) and were matched 1:1 with PsO patients on ag...
49 citations
TL;DR: Tablets containing drugs with a wide therapeutic index and long half-life might be more suitable candidates for division and could be safer and easier when drug- and patient-specific criteria have been met.
Abstract: BACKGROUND: Tablet splitting is a well-established medical practice in clinical settings for multiple reasons, including cost savings and ease of swallowing. However, it does not necessarily result in weight-uniform half tablets. OBJECTIVES: To (a) investigate the effect of tablet characteristics on weight and content uniformity of half tablets, resulting from splitting 16 commonly used medications in the outpatient setting and (b) provide recommendations for safe tablet-splitting prescribing practices. METHODS: Ten random tablets from each of the selected medications were weighed and split by 5 volunteers (2 men and 3 women aged 25-44 years) using a knife. The selected medications were mirtazapine 30 mg, bromazepam 3 mg, oxcarbazepin 150 mg, sertraline 50 mg, carvedilol 25 mg, bisoprolol fumarate 10 mg, losartan 50 mg, digoxin 0.25 mg, amiodarone HCl 200 mg, metformin HCl 1,000 mg, glimepiride 4 mg, montelukast 10 mg, ibuprofen 600 mg, celecoxib 200 mg, meloxicam 15 mg, and sildenafil citrate 50 mg. The resulting half tablets were evaluated for weight and drug content uniformity in accordance with proxy United States Pharmacopeia (USP) specification (95%-105% for digoxin and 90%-110% for the other 15 drugs). Weight and drug content uniformity were assessed by comparing weight or drug content of the half tablets with one-half of the mean weight or drug content for all whole tablets in the sample. The percentages by which the weight and drug content of each whole tablet or half tablet differed from sample mean values were calculated. Other relevant physical characteristics of the 16 products were measured. RESULTS: A total of 52 of 320 half tablets (16.2%) and 48 of 320 half tablets (15.0%) fell outside of the proxy USP specification for weight and drug content, respectively. Bromazepam, carvedilol, bisoprolol, losartan, digoxin, and meloxicam half tablets failed the weight and content uniformity test; however, the half tablets for the rest of the medications passed the test. Mean percent weight loss after splitting was less than 1.5% for all drugs. Bromazepam, carvedilol, and digoxin showed the highest powdering loss during the tablet-splitting process. CONCLUSIONS: Tablet splitting could be safer and easier when drug- and patient-specific criteria have been met. Tablet size, shape, and hardness may also play a role in the decision to split a tablet or not. Tablets containing drugs with a wide therapeutic index and long half-life might be more suitable candidates for division. Dose variation exceeded a proxy USP specification for more than one-third of sampled half tablets of bromazepam, carvedilol, bisoprolol, and digoxin. Drug content variation in half tablets appeared to be attributed to weight variation due to fragment or powder loss during the splitting process.
47 citations
TL;DR: An ABMS program in a community pharmacy setting was associated with higher rates of adherence and persistence for patients who had been taking chronic medications for at least 6 months, and shows that ABMS programs can improve medication adherence and persistency for patientsWho are newly prescribed or currently taking Chronic medications.
Abstract: BACKGROUND: Appointment-based medication synchronization (ABMS) has been associated with greater patient adherence and persistence when patients begin taking chronic medications. It is not known wh...
45 citations
TL;DR: The VBF and copayment changes enabled pharmacy plan cost savings without negatively affecting utilization in key disease states and caused no significant decline in medication use or adherence for patients with diabetes, hypertension, or dyslipidemia.
Abstract: BACKGROUND: Value-based insurance design attempts to align drug copayment tier with value rather than cost. Previous implementations of value-based insurance design have lowered copayments for drugs indicated for select “high value” conditions and have found modest improvements in medication adherence. However, these implementations have generally not resulted in cost savings to the health plan, suggesting a need for increased copayments for “low value” drugs. Further, previous implementations have assigned equal copayment reductions to all drugs within a therapeutic area without assessing the value of individual drugs. Aligning the individual drug’s copayment to its specific value may yield greater clinical and economic benefits. In 2010, Premera Blue Cross, a large not-for-profit health plan in the Pacific Northwest, implemented a value-based drug formulary (VBF) that explicitly uses cost-effectiveness analyses after safety and efficacy reviews to estimate the value of each individual drug. Concurrently...
TL;DR: Hospital follow- up visits coordinated by the multidisciplinary team decreased 30-day hospital readmission rates compared with follow-up visits by a physician-only team.
Abstract: BACKGROUND: The Affordable Care Act of 2010 allows for the adjustment of reimbursement to health care centers based on 30-day readmission rates. High readmission rates may be explained by multiple events at discharge, including medication errors that occur during the transition of care from inpatient to outpatient. Pharmacist involvement at discharge has been shown to improve health outcomes in patients with chronic disease; however, there is limited knowledge regarding the benefits of a clinic appointment with a pharmacist postdischarge. OBJECTIVE: To compare hospital readmission rates and interventions in a multidisciplinary team visit coordinated by a clinical pharmacist practitioner with those conducted by a physician-only team within an internal medicine hospital follow-up program. METHODS: A retrospective observational study was completed. Patients seen between May 2012 and January 2013 in 1 of the 2 hospital followup program models (multidisciplinary team or physician-only team) were included. RESULTS: A total of 140 patient visits were included for 124 patients. Patients seen by the multidisciplinary team had a 30-day readmission rate of 14.3% compared with 34.3% by the physician-only team (P=0.010). Interventions completed during the visits, including addressing nonadherence, initiating a new medication, and discontinuing a medication were also statistically different between the groups, with the multidisciplinary team completing these interventions more frequently.
TL;DR: Persistence, indicated by continuous use of the index therapy without a gap of 60 days or more; medication coverage ratio (MCR), the proportion of days covered by the index Therapy; and compliance, defined as an MCR ≥ 0.80, were assessed during the 12-month follow-up.
Abstract: BACKGROUND: Prior research has shown that rates of persistence and compliance with osteoporosis therapies are associated with significantly fewer vertebral, nonvertebral, and hip fractures. A number of studies have examined medication-taking behavior with oral bisphosphonates and teriparatide, and these 1-year persistence rates have ranged from 39.9% to 56.7%. Limited real-world data are available regarding persistence and compliance rates with newer therapies such as denosumab, a RANK ligand inhibitor administered every 6 months as a subcutaneous injection. OBJECTIVE: To assess persistence and compliance rates over 1 year with newly initiated osteoporosis therapies, including denosumab, alendronate, ibandronate, risedronate, raloxifene, and teriparatide, within a cohort of commercially insured women. METHODS: Health insurance claims data derived from Truven Health Analytics MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases (2010-2013) were used t...
TL;DR: It is suggested that pazopanib is cost-effective compared with sunitinib as the first-line treatment of patients with mRCC in the United States.
Abstract: BACKGROUND: Current first-line treatments for metastatic renal cell carcinoma (mRCC) include the multityrosine kinase inhibitors pazopanib and sunitinib. Both agents had similar progression-free survival (PFS) and overall survival (OS) in the COMPARZ trial (Comparing the Efficacy, Safety and Tolerability of Pazopanib versus Sunitinib); however, the adverse event profiles of the 2 agents are different. In the PISCES trial (Patient Preference Study of Pazopanib versus Sunitinib in Advanced or Metastatic Kidney Cancer), patients and physicians preferred pazopanib primarily because it offered better health-related quality of life (HRQoL) and caused less fatigue. OBJECTIVE: To compare the cost-effectiveness of pazopanib versus sunitinib from a U.S. health care system perspective in the first-line treatment of patients with mRCC. METHODS: A partitioned-survival analysis model with 3 health states (preprogression, postprogression, and dead), data from 2 randomized controlled trials of pazopanib versus sunitinib ...
TL;DR: A pharmacist-led diabetes collaborative care management program in a patient-centered primary care setting was associated with significantly better follow-up glycemic control relative to comparison patients, which could translate into reduced costs and improved outcomes to managed care payers.
Abstract: BACKGROUND: Clinical pharmacy services (CPS) in the primary care setting have been shown to help patients attain treatment goals and improve outcomes. However, the availability of CPS in community-based primary care is not widespread. One reason is that current fee-for-service models offer limited reimbursement opportunities for CPS in the community setting. Furthermore, data demonstrating the value of CPS in this setting are limited, making it difficult for providers to determine the feasibility and sustainability of incorporating CPS into primary care practice. OBJECTIVES: To (a) evaluate the association between a pharmacist-led, diabetes collaborative drug therapy management program and patient outcomes, including glycemic control and health care costs, and (b) assess short-term economic outcomes in a primary care setting. METHODS: A retrospective cohort analysis was conducted using medical record data. This study was conducted using patients with uncontrolled type 2 diabetes (T2DM), defined as HbA1c ≥ 7.0%. Outcomes were compared between patients referred to a diabetes collaborative care management (DCCM) intervention from 2009-2012 and patients who did not participate in the DCCM program. To illustrate the difference in HbA1c between the 2 cohorts over the follow-up period, mean time adjusted HbA1c values were estimated using a panel-type random effects regression model, with results plotted at 90-day intervals from index date through the end of the study period. To help control for confounding by other factors, multivariate regression models were run. A difference-in-difference model was employed to estimate the effect of the program on resource utilization and all-cause charges. RESULTS: A total of 303 DCCM and 394 comparison patients were included. Mean (95% CI) age was 57.4 years (55.963, 58.902) versus 59.9 years (58.613, 61.276; P < 0.001) with 48% and 44% female for DCCM and comparison patients, respectively (P = 0.49). Mean baseline HbA1c was higher for DCCM (10.3%; 10.10, 10.53) than comparison patients (8.4%; 8.26, 8.61; P < 0.001). The greatest reduction in HbA1c was seen for both groups at 9 and 12 months post-index date. At these time points, the mean time adjusted difference in HbA1c between groups was no longer significant. Multivariate modeling identified that the DCCM program was associated with a -0.44% (-0.64, -0.25; P < 0.001) lower HbA1c at follow-up relative to the comparison group controlling for potential confounders, including baseline HbA1c. Change in resource utilization from pre- to post-index date did not differ between groups. However, in the difference-in-difference multivariate analysis the difference in mean all-cause charges from the 12-month pre- to post-index periods DCCM patients experienced a smaller average increase in charges ($250) than comparison patients ($1,341; coefficient = -0.423; 95% CI = -0.779, -0.068). CONCLUSIONS: A pharmacist-led diabetes collaborative care management program in a patient-centered primary care setting was associated with significantly better follow-up glycemic control relative to comparison R ESEAR C H
TL;DR: Nonadherence to dabigatran was common among patients with atrial fibrillation and future studies are needed to understand the reasons for nonadherence.
Abstract: BACKGROUND: Dabigatran is a direct thrombin inhibitor approved by the FDA in October 2010 for the treatment of nonvalvular atrial fibrillation. Little is known regarding patient adherence to this therapy. OBJECTIVE: To examine adherence and persistence to dabigatran among adults with atrial fibrillation. METHODS: We used IMS Health’s LifeLink Health Plan Claims Database from 2010 to 2012 to identify patients with atrial fibrillation who were new users of dabigatran. We derived adherence and persistence for continuously enrolled patients at 6 months, 9 months, and 12 months of follow-up. We measured adherence using the medication possession ratio (MPR), defined as individuals with MPRs of 0.80 or greater as adherent, and examined persistence by identifying individuals with gaps in drug possession of 60 days or greater. RESULTS: Of 5,951 adults with atrial fibrillation who were new users of dabigatran, 49% had prevalent atrial fibrillation and at least 6 months of continuous follow-up. Of these, 89% used da...
TL;DR: This retrospective analysis demonstrates that chemotherapy-related adverse events in patients with mBC have an impact on the delivery of chemotherapy regimens, demonstrating that severe adverse events have more impact on chemotherapy regimen.
Abstract: BACKGROUND: Stage IV breast cancer, also known as metastatic breast cancer (mBC), is not a curable condition. However, treatment can prolong life, delay the progression of the cancer, or improve quality of life. Currently, patients with mBC are often treated with chemotherapy. Patients often experience adverse events from chemotherapy during the treatment cycle, which leads to chemotherapy modifications such as dose delay, dose reduction, or discontinuation of chemotherapy. Previous studies have evaluated the rates of adverse events that occur from the use of chemotherapy; however, few studies have evaluated the clinical impact on the chemotherapy regimen once the adverse event occurs. This study evaluates the clinical impact on the chemotherapy regimen from chemotherapy-related adverse events in patients with mBC in an integrated health care delivery system. OBJECTIVES: To assess the adverse events in patients with mBC and evaluate the clinical impact on the chemotherapy regimen from these adverse events...
TL;DR: The incremental health care costs of specific AEs among patients with MM treated with paclitaxel, vemurafenib, ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, or interferon α, along with AEs known to be associated with dabrafenib and trametinib are estimated.
Abstract: BACKGROUND: There are currently many approved agents for the treatment of metastatic melanoma (MM), the most aggressive form of skin cancer. Treatments may include systemic therapies such as ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, interferon α, dacarbazine- or temozolomide-based combination chemotherapy/biochemotherapy, paclitaxel, paclitaxel/cisplatin, and paclitaxel/carboplatin, as well as the targeted therapies vemurafenib, dabrafenib, and trametinib for patients with BRAF V600 mutation. However, all treatment options are associated with different adverse events (AEs) and, in some instances, considerable toxicity. The occurrence of such treatment-related AEs can lead to higher health care resource utilization and increasing treatment and patient management costs. An understanding of the economic burden of these AEs will therefore enable better management of health care expenditures, not just for existing therapies, but also for new and novel treatments in development. OBJECTIVE: To estimate the incremental health care costs of specific AEs among patients with MM treated with paclitaxel, vemurafenib, ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, or interferon α, along with AEs known to be associated with dabrafenib and trametinib. METHODS: This cohort study employed a retrospective administrative claims-based analysis of MarketScan commercial and Medicare supplemental databases from July 1, 2004, to April 30, 2012. Patients included those aged ≥ 18 years who had diagnosed melanoma (ICD-9-CM code 172.xx) with ≥ 1 diagnosis of metastasis and ≥ 1 claim for any of the 7 study treatments. Health care encounters for AEs of interest were based on ICD-9-CM diagnosis/procedure codes. Incremental cost per AE was determined by comparing the 30-day expenditures in patients with the event to patients without the event based on a shadow event date. Multivariate generalized linear models (GLMs) with a log-link function and gamma distribution were utilized to control for baseline differences between groups. RESULTS: A total of 2,621 patients with MM were included. Mean age was 56.0 years (SD ± 13.0); 64% were male; and 24% had a diagnosis of primary or secondary brain cancer at the time of MM diagnosis. GLM-based estimate of 30-day incremental costs by AE category were metabolic, $9,135 (95% CI = $6,404-$12,392); hematologic/lymphatic, $8,450 (95% CI = $6,528-$10,633); cardiovascular, $6,476 (95% CI = $4,667-$8,541); gastrointestinal, $6,338 (95% CI = $4,740-$8,122); skin/subcutaneous, –$900 (95% CI = –$1,899-$237); central nervous system/psychiatric, $5,903 (95% CI = $3,842-$8,313); and pain, $5,078 (95% CI = $3,392$7,012). CONCLUSIONS: Incremental costs associated with many MM treatmentrelated AEs are substantial. New approaches to prevent and/or better manage these events may reduce overall health care costs.
TL;DR: The prevalence of LCGP users in a privately insured adult population is quantified to provide important insights into the potential impact LCGPs may have on exposure misclassification in claims data.
Abstract: BACKGROUND: Administrative claims data are used for a wide variety of research and quality assurance purposes. Despite their utility, they are prone to medication exposure misclassification if medications are purchased without utilizing an insurance benefit. Low-cost generic programs (LCGPs) offered at major chain pharmacies are a relatively new and sparsely investigated source of exposure misclassification. Since they were implemented in 2006, LCGPs are now available at 8 of the 10 largest pharmacy chains and include a wide variety of medication classes. LCGP medications are often purchased out of pocket; thus, a pharmacy claim may never be submitted and exposure may go unobserved in claims data. There are little data regarding the utilization of these programs, and estimates of their use can provide important insights into the potential impact LCGPs may have on exposure misclassification in claims data. OBJECTIVES: To (a) quantify the prevalence of LCGP users in a privately insured adult population, (b)...
TL;DR: Using a claims-based algorithm in a large commercial claims database, etanercept was the most effective and had the lowest biologic cost per effectively treated patient with RA.
Abstract: BACKGROUND: Administrative claims contain detailed medication, diagnosis, and procedure data, but the lack of clinical outcomes for rheumatoid arthritis (RA) historically has limited their use in comparative effectiveness research. A claims-based algorithm was developed and validated to estimate effectiveness for RA from data for adherence, dosing, and treatment modifications. OBJECTIVE: To implement the claims-based algorithm in a U.S. managed care database to estimate biologic cost per effectively treated patient. METHODS: The cohort included patients with RA aged 18-63 years in the Optum Research Database who initiated biologic treatment between January 2007 and December 2010 and were continuously enrolled 6 months before through 12 months after the first claim for the biologic (the index date). Patients were categorized as effectively treated by the claims-based algorithm if they met all of the following 6 criteria in the 12-month post-index period: (1) a medication possession ratio ≥80% for subcutane...
TL;DR: A retrospective cohort study on the rates and predictors of warfarin discontinuation/interruption in patients with nonvalvular AF in the usual clinical practice settings in the United States to determine demographic, clinical, and health care-related factors associated with discontinuation and interruption.
Abstract: BACKGROUND: Use of warfarin is standard of care for stroke prevention in patients with atrial fibrillation (AF). However, AF patients experience high rates of warfarin discontinuation/interruption, resulting in increased health risks and health care costs. As such, it is important to study the rates and predictors of warfarin discontinuation/interruption in this population. OBJECTIVES: To determine (a) rates of warfarin discontinuation and interruption and (b) demographic, clinical, and health care-related factors associated with discontinuation and interruption in patients with nonvalvular AF (NVAF) in the usual clinical practice settings in the United States. METHODS: This retrospective cohort study used the MarketScan Database and included patients (aged ≥ 18 years) with NVAF who were initiated on warfarin. The study period was January 1, 2008, to June 30, 2012. To be included, patients were required to have at least 2 claims with AF diagnosis separated by ≥ 30 days and ≤ 12 months and at least 1 outpa...
TL;DR: Health care costs were lower among patients with advanced RCC treated first-line with pazopanib versus sunitinib, and a post hoc economic analysis applied direct medical care and pharmacy unit costs, obtained from the Truven Health MarketScan Databases, to HCRU and AE rates.
Abstract: BACKGROUND: Pazopanib was noninferior to sunitinib in progression-free survival in a phase III, open-label, randomized clinical trial comparing the efficacy and safety of the 2 drugs for treatment of patients with advanced renal cell carcinoma (RCC). A secondary analysis of this trial conducted on patient-reported health care resource utilization (HCRU) endpoints revealed significantly fewer monthly telephone consultations and emergency department visits among patients treated with pazopanib over the first 6 months of treatment. OBJECTIVES: To (a) compare total costs of HCRU and adverse events (AEs) in patients with advanced RCC receiving first-line pazopanib or sunitinib from the phase III clinical trial and (b) perform a post hoc economic analysis that applied direct medical care and pharmacy unit costs, obtained from the Truven Health MarketScan Databases, to HCRU and AE rates. METHODS: Total HCRU costs included components for provider contacts, diagnostics, hospitalizations, procedures, and study/nons...
TL;DR: Important financial benefits may be realized through use of genotype-guided antiplatelet therapy to reserve prasugrel or ticagrelor use for patients with reduced CYP2C19 activity to avoid costs associated with adverse cardiac events.
Abstract: BACKGROUND: Dual antiplatelet therapy is an established standard of care for patients with acute coronary syndrome (ACS) to reduce thrombotic risk. Reduced CYP2C19 activity impairs clopidogrel bio-activation and increases risk of adverse clinical outcomes. Patients with poor and intermediate CYP2C19 metabolizers treated with clopidogrel incur higher cardiovascular event rates, including myocardial infarction, stroke, and stent thrombosis, following ACS than patients with normal CYP2C19 function. Tests are available to identify the CYP2C19 genotype and can be used to support individualization of antiplatelet therapy. OBJECTIVE: To estimate the financial impact of CYP2C19 genotyping in a theoretical cohort of 1,000 patients with ACS, who received percutaneous coronary intervention and coronary stent implantation and were treated with clopidogrel, prasugrel, or ticagrelor in a managed care setting. METHODS: Differences in overall and average cost per patient were estimated based on the rate of CYP2C19 genotyping in a theoretical cohort of 1,000 patients. Sensitivity analysis was carried out for varying costs, adherence, and the percentage of patients treated according to genotyping results. All clinical event costs were reported in terms of 2012 U.S. dollars. The budget impact analysis used published event rates from primary literature to estimate costs of events analysis for 3 different scenarios: Scenario A, no CYP2C19 genotyping; Scenario B, 50% of patients received CYP2C19 genotyping with appropriate treatment based on genotype; and Scenario C, 100% of patients received CYP2C19 genotyping with appropriate treatment based on genotype. RESULTS: According to this model, there was no change in the market share for the 3 antiplatelet agents in Scenario A. Initial market share for clopidogrel, prasugrel, and ticagrelor was 93%, 5%, and 2%, respectively; however, use of CYP2C19 genotyping is expected to shift market share from clopidogrel to either prasugrel or ticagrelor. In Scenario B, where 50% of the patients received genotyping, clopidogrel market share was reduced to 83%, while prasugrel increased to 12.1% and ticagrelor increased to 4.9%. In Scenario C, where all patients received genotyping, clopidogrel market share was reduced to 73%, prasugrel increased to 19.3%, and ticagrelor increased to 7.7%. Total estimated cost differences when all possible patients were genotyped included annual savings of roughly $444,852. CONCLUSIONS: Important financial benefits may be realized through use of genotype-guided antiplatelet therapy to reserve prasugrel or ticagrelor use for patients with reduced CYP2C19 activity to avoid costs associated with adverse cardiac events.
TL;DR: In a population of patients who had not picked up new prescriptions after 3 calls from the pharmacy, additional nurse-directed outreach did not improve primary medication adherence and re-engagement with the prescribing clinician may be needed to improve adherence.
Abstract: BACKGROUND: Primary medication nonadherence (PMN), defined as patients not picking up an initial prescription, can limit the effectiveness of therapy for chronic conditions. Effective interventions to reduce PMN have not been widely studied or implemented. OBJECTIVE: To evaluate the ability of an additional nurse-directed telephone intervention to reduce PMN in a cohort of patients with persistent nonadherence after repeated pharmacy-based outreach. METHODS: Patients in the Geisinger Health System receiving new (i.e., initially prescribed) prescriptions sent to CVS pharmacies for medications treating asthma, hypertension, diabetes, or hyperlipidemia were identified. As part of existing programs, all patients received 2 automated and 1 live call from CVS pharmacies encouraging them to pick up their prescriptions; those who had canceled their prescriptions or had not picked them up after the 3 pharmacy interventions were eligible for this study. Patients were then randomized, and the intervention group received telephone outreach from a nursing call center to assess reasons for PMN and encourage pickup of prescriptions, with up to 3 attempts to reach each patient. Medication pickup rates were compared across the intervention and control groups. RESULTS: Initial PMN rates in the overall population were 6%, lower than previously observed in other studies. A total of 290 patients had not picked up their prescriptions after 3 calls from the pharmacy and were enrolled in the study: 142 in the intervention group and 148 controls. The intervention did not change the rate at which patients picked up their prescriptions: 25% of intervention patients did so compared with 24% of control patients. Multivariate models adjusting for patient characteristics and medication classes did not change the results. CONCLUSIONS: In a population of patients who had not picked up new prescriptions after 3 calls from the pharmacy, additional nurse-directed outreach did not improve primary medication adherence. Re-engagement with the prescribing clinician may be needed to improve adherence in this patient population. The low rate of PMN in the overall population differed from prior studies in this setting and others and should be assessed in future research.
TL;DR: Infrequent exacerbators have an increased risk for future exacerbations compared with nonexacerbators and, on a total sample-level, incur greater costs compared with frequent exacerbators, demonstrating a significant economic burden.
Abstract: BACKGROUND: There is scarce information on chronic obstructive pulmonary disease (COPD) outcomes and costs for patients with differing levels of COPD exacerbations. OBJECTIVE: To examine COPD-related and all-cause health care resource use and costs in subsequent years for frequently and infrequently exacerbating COPD patients. METHODS: Patients with a diagnosis of COPD (ICD-9-CM codes 491.xx, 492.xx, and 496.xx) were identified (1 hospitalization or 1 emergency department visit or at least 2 outpatient visits) using administrative claims data in 2007. Patients were classified in 2008 as frequent (at least 2 exacerbations/year), infrequent (1 exacerbation/year) and nonexacerbators. Outcomes were computed during a subsequent 2-year period (2009 and 2010). Average per person estimates and total sample-level estimates were calculated. A logistic regression model estimated the predictors of having 2 or more exacerbations per year during the follow-up period. RESULTS: 61,750 COPD patients met the study criteria...
TL;DR: In this commentary, some of the challenges to the integration and delivery of PGx testing in MTM services are considered.
Abstract: Some have proposed the integration of pharmacogenetic (PGx) testing into medication therapy management (MTM) to enable further refinement of treatments to reduce risk of adverse responses and improve efficacy. PGx testing involves the analysis of genetic variants associated with therapeutic or adverse response and may be useful in enhancing the ability to identify ineffective and/or harmful drugs or drug combinations. This “enhanced” MTM might also reduce patient concerns about side effects and increase confidence that the medication is effective, addressing 2 key factors that impact patient adherence: concern and necessity. However, the feasibility and effectiveness of the integration of PGx testing into MTM in clinical practice has not yet been determined. In this commentary, we consider some of the challenges to the integration and delivery of PGx testing in MTM services.
TL;DR: Two main recommendations can be made to increase the knowledge and enhance the trust in cheaper equivalent medicines: highlighting the name of the active substance on the label of medicine packages can reduce confusion and avoid health risks, especially among older consumers.
Abstract: BACKGROUND:Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. OBJECTIVE: To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. METHODS: We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge...
TL;DR: Evaluating and addressing barriers to medication adherence may increase medication adherence and evaluate patient-level characteristics associated with reporting medication barriers.
Abstract: BACKGROUND: Many patients experience barriers that make it difficult to take cardiovascular disease (CVD)-related medications as prescribed. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) was a tailored behavioral pharmacist-administered and telephone-based intervention for reducing CVD risk. OBJECTIVES: To (a) describe patient-reported barriers to taking their medication as prescribed and (b) evaluate patient-level characteristics associated with reporting medication barriers. METHODS: We recruited patients receiving care at primary care clinics affiliated with Durham Veterans Affairs Medical Center. Eligible patients were diagnosed with hypertension and/or hyperlipidemia that were poorly controlled (blood pressure of greater than150/100 mmHg and/or low-density lipoprotein value greater than130 mg/dL). At the time of enrollment, patients completed an interview with 7 questions derived from a validated medication barriers measure. Patient characteristics and individual medic...
TL;DR: Febuxostat was found to be a cost-effective option compared with allopurinol based on a U.S. health care payer's perspective and one-way sensitivity analysis and probabilistic sensitivity analyses were performed to assess the robustness of the results.
Abstract: BACKGROUND: Gout is a chronic inflammatory condition associated with poor urate metabolism. Xanthine oxidase inhibitors such as allopurinol and febuxostat are recommended to reduce uric acid levels and to prevent gout attacks in adult patients. Under budget-driven constraints, health care payers are faced with the broader challenge of assessing the economic value of these agents for formulary placement. However, the economic value of allopurinol versus febuxostat has not be assessed in patients with gout over a 5-year time period in the United States. OBJECTIVE: To evaluate the cost-effectiveness of allopurinol versus febuxostat in adult patients with gout over a 5-year time period from a U.S. health care payer’s perspective. METHODS: A Markov model was developed to compare the total direct costs and success of serum uric acid (sUA) level reduction associated with allopurinol and febuxostat. Treatment success was defined as patient achievement of a sUA level less than 6 mg/dL (0.36 mmol/L) at 6 months. ...
TL;DR: High noncompliance rates in this population of older females using oral BIS treatment was associated with lower fracture rates, OP- and all-cause costs, and health care utilization and these findings highlight the financial implications and treatment outcomes of BIS medication noncompliance within a female osteoporotic population.
Abstract: BACKGROUND: Despite the favorable efficacy, safety, and cost-effectiveness profile of bisphosphonate (BIS) treatment for osteoporosis (OP), patient compliance remains suboptimal. A longer follow-up period could help to better characterize patient behavior as well as the predictors of noncompliance because of the extended durations of osteoporosis and time to a fracture. OBJECTIVE: To determine health care outcomes associated with compliance and noncompliance to BIS therapy in women diagnosed with OP. METHODS: This retrospective claims study focused on women with OP, who were aged 55 years and older and using oral BIS treatment. Patients were identified within the HealthCore Integrated Research Environment (HIRE) between January 1, 2007, through June 30, 2010. Patients were required to have ≥ 12 months of pre-index eligibility and ≥ 24 months of post-index health plan eligibility. Post-index eligibility was split into 2 periods: (1) the compliance time period (the first 12-month post-index period, in which compliance was determined) and (2) the cost and consequences time period (13- to 24-month post-index period during which time health care resource utilization, cost, and outcomes were assessed). Noncompliance was defined as medical possession ratio (MPR) 1 inpatient visits; 16% had > 1 emergency room visits; 94% had >1 outpatient visits; and 95% had > 1 office visits. Logistic regression results indicated that under aged 65 years (P = 0.012) predicted noncompliance. Relative to the compliant group, noncompliant patients had higher fracture rates at post-index second year, 3.3% vs. 2.4%, and combined second and third years, 6.0% vs. 4.8%, respectively. Compared with noncompliant patients, compliant patients had 9% (P = 0.007) lower OP-related costs, 3% lower all-cause costs during the second post-index year, and 11% (P = 0.016) lower OP-related costs. Mean 13- to 24-month post-index period all-cause costs were $7,237 for noncompliant patients versus $6,758 for compliant patients (P = 0.008). CONCLUSIONS: These results indicate high noncompliance rates in this population of older females. OP medication compliance was associated with lower fracture rates, OP- and all-cause costs, and health care utilization. These findings highlight the financial implications and treatment outcomes of BIS medication noncompliance within a female osteoporotic population.