Cardiovascular Burden of Narcolepsy Disease (CV-BOND): a real-world evidence study.

Study Objectives: Narcolepsy is associated with cardiovascular risk factors; however, the risk of new-onset cardiovascular events in this population is unknown. This real-world study evaluated the excess risk of new-onset cardiovascular events in U.S.

Transferability of real-world data across borders for regulatory and health technology assessment decision-making.

Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in identifying high-quality and relevant RWD sources, researchers and regulatory/HTA bodies may turn to RWD generated in locales outside of the locale of interest (referred to as "transferring RWD"). We therefore performed a review of stakeholder guidance as well as selected case studies to identify themes for researchers to consider when transferring RWD from one jurisdiction to another.

Resource utilization and charges of patients with and without diagnosed venous thromboembolism during primary hospitalization and after elective inpatient surgery: a retrospective study.

Aims: To assess incremental charges of patients experiencing venous thromboembolisms (VTE) across various types of elective inpatient surgical procedures with administration of general anesthesia in the US.

Methods: The authors performed a retrospective study utilizing data from a nationwide hospital operational records database from July 2014 through June 2015 to compare a group of inpatients experiencing a VTE event post-operatively to a propensity score matched group of inpatients who did not experience a VTE. Patients included in the analysis had a hospital admission for an elective inpatient surgical procedure with the use of general anesthesia.

Use of the SF-36v2 Health Survey as a Screen for Risk of Major Depressive Disorder in a US Population-based Sample and Subgroup With Chronic Pain.

Study Objectives: To assess the feasibility of using the SF-36v2 mental health (MH) and mental component summary (MCS) scores for classification of risk for major depressive disorder (MDD), and to determine cut-off scores based on the sensitivity and specificity in a general US representative sample, and a chronic pain subpopulation.

Methods: Data were analyzed from the 2013 US National Health and Wellness Survey (adults 18 y old and above; N=75,000), and among a chronic pain subpopulation (n=6679). Risk of MDD was a score ≥10 on the Patient Health Questionnaire (PHQ-9).

Opioid Treatment Patterns Following Prescription of Immediate-Release Hydrocodone.

Background: Immediate-release (IR) hydrocodone is the most widely prescribed opioid in the United States; however, little is known about the utilization patterns and duration of opioid use among patients prescribed IR hydrocodone. A better understanding of the use of IR hydrocodone would result in more appropriate prescribing patterns of extended-release opioids.

Objective: To assess downstream length of opioid therapy and utilization patterns of extended-release/long-acting (ER/LA) opioids among patients on IR hydrocodone to provide a better understanding of how IR and ER/LA opioids are used to manage pain.

Characterizing downstream healthcare resource utilization and costs based on prior utilization patterns of immediate-release hydrocodone.

Objective: To assess downstream healthcare resource utilization (HRU) and costs among immediate release (IR) hydrocodone patients by days' supply and average doses/month in the prior 6 months.

Methods: Retrospective analysis using healthcare claims from Truven MarketScan commercial, Medicare supplemental, and Medicaid multistate databases was performed. Patients prescribed IR hydrocodone during the 6-month baseline (July-December 2011), and with continuous enrollment during baseline and the 12-month follow-up (2012) were selected.

Characteristics of High-Cost Patients Diagnosed with Opioid Abuse.

Background: Prescription opioid abuse is associated with substantial economic burden, with estimates of incremental annual per-patient health care costs of diagnosed opioid abuse exceeding $10,000 in prior literature. A subset of patients diagnosed with opioid abuse has disproportionately high health care costs, but little is known about the characteristics of these patients. 

Objective: To describe the characteristics of a subset of patients diagnosed with opioid abuse with disproportionately high health care costs to assist physicians and managed care organizations in targeting interventions at the costliest patients.

The Burden of Undiagnosed Opioid Abuse Among Commercially Insured Individuals.

Objectives: Estimate the prevalence and healthcare costs of undiagnosed opioid abuse among commercially insured individuals.

Study Design: Retrospective analysis of de-identified pharmacy and medical claims data and publicly-available survey data (no IRB approval required).

Methods: This study focused on commercially insured individuals.

Sources of prescription opioids among diagnosed opioid abusers.

Objective: Diversion and abuse of prescription opioids are important public health concerns in the US. This study examined possible sources of prescription opioids among patients diagnosed with opioid abuse.

Methods: Commercially insured patients aged 12-64 diagnosed with opioid abuse/dependence ('abuse') were identified in OptumHealth Reporting and Insights medical and pharmacy claims data, 2006-2012, and required to have continuous eligibility over an 18 month study period surrounding the first abuse diagnosis.

Medical resource use and costs among pain patients with potential opioid-tolerability issues.

Objective: To estimate excess medical resource use and costs associated with prescription opioid (RxO) tolerability issues.

Design: This was an observational, retrospective analysis of deidentified administrative claims data.

Setting: The study included commercially insured patients treated in different healthcare settings captured in the Truven MarketScan claims database.

The economic burden of diagnosed opioid abuse among commercially insured individuals.

The abuse of prescription opioids imposes a substantial public health and economic burden. Recent research using administrative claims data has substantiated the prevalence and cost of opioid abuse among commercially insured individuals. Although administrative claims data are readily available and have been used to effectively answer research questions about the burden of illness for many different conditions, an important issue is the reliability, replicability, and generalizability of estimates derived from different databases.

Impact of middle-of-the-night awakenings on health status, activity impairment, and costs.

Study Objectives: Middle-of-the-night (MOTN) awakenings with difficulty returning to sleep are among the most common symptoms of insomnia. Despite the epidemiological studies that have been conducted, there is a lack of data on the impact of MOTN awakenings on health status and socioeconomic indicators in comparison with other insomnia symptoms.

Methods: Data were analyzed from the 2011 US National Health and Wellness Survey (adults ≥18 years old; N=60,783), which asked respondents whether they had experienced specific symptoms of insomnia (ie, MOTN awakenings, difficulty falling asleep, waking several times, waking up too early, or poor quality of sleep).

Estimating the costs of opioid abuse and dependence from an employer perspective: a retrospective analysis using administrative claims data.

Background: Opioid abuse and dependence is problematic across many age groups, including the working-age population and their dependents. Little is known, however, about the economic costs of opioid abuse/dependence imposed on employers, who pay for a substantial portion of healthcare costs through their contributions to employer-sponsored health insurance and are also affected by indirect costs such as those due to disability and workplace absenteeism.

Objective: To provide a comprehensive, current estimate of the economic burden of prescription opioid abuse/dependence to employers.

Consequences of patient access restrictions to branded oxycodone hydrochloride extended-release tablets on healthcare utilization and costs in US health plans.

Objective: To evaluate the impact of increased access restrictions to branded oxycodone hydrochloride extended-release tablets (oxycodone HCl ER), on healthcare utilization and costs in patients using extended-release and long-acting opioids (ER/LA opioids) from the health plan perspective during the period from 1/1/2009 to 6/30/2012.

Methods: This retrospective cohort study analyzed claims data for adult patients from US plans that increased oxycodone HCl ER access restrictions. Study groups were segmented into commercial and Medicare payers, and by prior authorization (PA) and tier change (TC) restrictions.

Use of prescription opioids with abuse-deterrent technology to address opioid abuse.

Objective: The development of new formulations of extended-release (ER) opioids with abuse-deterrent technology attempts to deter prescription opioid abuse while maintaining appropriate access to care for pain patients. This study examined the degree to which some patients may avoid switching to reformulated ER opioids with abuse-deterrent technology and the extent to which those patients are more likely to be abusers.

Research Design And Methods: We analyzed Truven MarketScan pharmacy and medical claims data following the introduction of two reformulated ER opioids with abuse-deterrent technology.

US practitioner prescribing practices and patient characteristics of those newly treated with a buprenorphine transdermal patch system.

Objectives: Medication prescribing information provides guidance to healthcare providers on how to prescribe a drug properly. Oftentimes patient factors in addition to the prescribing information are considered when selecting medications. Utilizing real-world pharmacy and medical claims data, this study assessed US practitioner prescribing practices of US approved transdermal buprenorphine system (BTDS) in relation to BTDS's full prescribing information (FPI) as well as the relationship between patient factors and initial BTDS dose.

A perspective on the epidemiology of acetaminophen exposure and toxicity in the United States.

Acetaminophen is a commonly-used analgesic in the US and, at doses of more than 4 g/day, can lead to serious hepatotoxicity. Recent FDA and CMS decisions serve to limit and monitor exposure to high-dose acetaminophen. This literature review aims to describe the exposure to and consequences of high-dose acetaminophen among chronic pain patients in the US.

Medical cost savings associated with an extended-release opioid with abuse-deterrent technology in the US.

Objectives: In the US, prescription opioids with technology designed to deter abuse have been introduced to deter drug abuse without hindering appropriate access for pain patients. The objective of this study was to estimate changes in medical costs following the introduction of a new formulation of extended-release (ER) oxycodone HCl (oxycodone) with abuse-deterrent technology in the US.

Methods: Health insurance claims data were used to estimate changes in rates of diagnosed opioid abuse among continuous users of extended-release opioids (EROs) following the introduction of reformulated ER oxycodone in August 2010.

Predicting medication persistence to buprenorphine transdermal system.

Objectives: Persistence, the duration a patient remains on therapy, in chronic, symptomatic conditions plays an important role in therapy effectiveness. Understanding the duration and patient factors associated with prescribed medication persistence is, therefore, an important step toward better treatment and health outcomes for patients. In the following study, an analysis of such factors associated with buprenorphine transdermal system (BTDS) persistence was conducted utilizing a large US private practitioner and pharmacy claims database and is herein reported.

Predicting waist circumference from body mass index.

Background: Being overweight or obese increases risk for cardiometabolic disorders. Although both body mass index (BMI) and waist circumference (WC) measure the level of overweight and obesity, WC may be more important because of its closer relationship to total body fat. Because WC is typically not assessed in clinical practice, this study sought to develop and verify a model to predict WC from BMI and demographic data, and to use the predicted WC to assess cardiometabolic risk.

Daily average consumption of 2 long-acting opioids: an interrupted time series analysis.

Background: Oxycodone controlled release (CR) and oxymorphone extended release (ER) are frequently prescribed long-acting opioids, which are approved for twice-daily dosing. The US Food and Drug Administration approved a reformulated crush-resistant version of oxycodone CR in April 2010.

Objective: To compare the daily average consumption (DACON) for oxycodone CR and for oxymorphone ER before and after the introduction of the reformulated, crush-resistant version of oxycodone CR.

Direct and indirect costs of patients treated with extended-release oxymorphone HCl or controlled-release oxycodone HCl.

Objective: Compare direct and indirect costs of oxymorphone extended-release ('oxymorphone') and oxycodone controlled-release ('oxycodone') users.

Methods: Patients, aged 18+, with ≥1 claim for oxymorphone/oxycodone, Q2:2006-Q4:2009, were selected from a de-identified private payer claims database and observed from the first such claim ('index date') until the earliest of: use of comparator drug; end of continuous eligibility; 12 months ('study period'). Patients with claims for any formulation of the comparator drug during the first 30 days of the study period were excluded.

Economic impact of potential drug-drug interactions among osteoarthritis patients taking opioids.

Patients with osteoarthritis (OA) taking at least one CYP450-metabolized opioid concurrently with another CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk of a pharmacokinetic drug-drug interaction (PK DDI). This study compared patients with and without such an incident DDE to determine healthcare utilization and associated payments. Using a retrospective database analysis, the impact of DDEs was evaluated in terms of associated clinical events, healthcare services utilization (office visits, outpatient visits, ED visits, hospitalization), and payments in patient populations based on age (those under age 65 and those 65 years of age and older), during the 6 months after exposure.