Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study.

BACKGROUND: Improper medication adherence is associated with increased morbidity, healthcare costs, and fracture risk among patients with osteoporosis. The objective of this study was to evaluate the healthcare utilization patterns of Medicare Part D beneficiaries newly initiating teriparatide, and to assess the association of medication adherence and persistence with bone fracture. METHODS: This retrospective cohort study assessed medical and pharmacy claims of 761 Medicare members initiating teriparatide in 2008 and 2009. Baseline characteristics, healthcare use, and healthcare costs 12 and 24 months after teriparatide initiation, were summarized. Adherence, measured by Proportion of Days Covered (PDC), was categorized as high (PDC ≥ 80%), moderate (50% ≥ PDC < 80%), and low (PDC < 50%). Non-persistence was measured as refill gaps in subsequent claims longer than 60 days plus the days of supply from the previous claim. Multivariate logistic regression evaluated the association of adherence and persistence with fracture rates at 12 months. RESULTS: Within 12 months of teriparatide initiation, 21% of the cohort was highly-adherent. Low-adherent or non-persistent patients visited the ER more frequently than did their highly-adherent or persistent counterparts (χ2 = 5.01, p < 0.05 and χ2 = 5.84, p < 0.05), and had significantly lower mean pharmacy costs ($4,361 versus $13,472 and $4,757 versus $13,187, p < 0.0001). Furthermore, non-persistent patients had significantly lower total healthcare costs. The healthcare costs of highly-adherent patients were largely pharmacy-related. Similar patterns were observed in the 222 patients who had fractures at 12 months, among whom 89% of fracture-related costs were pharmacy-related. The regression models demonstrated no significant association of adherence or persistence with 12-month fractures. Six months before initiating teriparatide, 50.7% of the cohort had experienced at least 1 fracture episode. At 12 months, these patients were nearly 3 times more likely to have a fracture (OR = 2.9, 95% C.I. 2.1-4.1 p < 0.0001). CONCLUSIONS: Adherence to teriparatide therapy was suboptimal. Increased pharmacy costs seemed to drive greater costs among highly-adherent patients, whereas lower adherence correlated to greater ER utilization but not to greater costs. Having a fracture in the 6 months before teriparatide initiation increased fracture risk at follow-up.

Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.

BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. METHODS: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. RESULTS: A total of 15,615 people were observed to have at least one serology test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79-96%) compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings across datasets. PPA was highest in those with diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. CONCLUSION: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.

Real-world utilization of SARS-CoV-2 serological testing in RNA positive patients across the United States.

BACKGROUND: As diagnostic tests for COVID-19 were broadly deployed under Emergency Use Authorization, there emerged a need to understand the real-world utilization and performance of serological testing across the United States. METHODS: Six health systems contributed electronic health records and/or claims data, jointly developed a master protocol, and used it to execute the analysis in parallel. We used descriptive statistics to examine demographic, clinical, and geographic characteristics of serology testing among patients with RNA positive for SARS-CoV-2. RESULTS: Across datasets, we observed 930,669 individuals with positive RNA for SARS-CoV-2. Of these, 35,806 (4%) were serotested within 90 days; 15% of which occurred <14 days from the RNA positive test. The proportion of people with a history of cardiovascular disease, obesity, chronic lung, or kidney disease; or presenting with shortness of breath or pneumonia appeared higher among those serotested compared to those who were not. Even in a population of people with active infection, race/ethnicity data were largely missing (>30%) in some datasets-limiting our ability to examine differences in serological testing by race. In datasets where race/ethnicity information was available, we observed a greater distribution of White individuals among those serotested; however, the time between RNA and serology tests appeared shorter in Black compared to White individuals. Test manufacturer data was available in half of the datasets contributing to the analysis. CONCLUSION: Our results inform the underlying context of serotesting during the first year of the COVID-19 pandemic and differences observed between claims and EHR data sources-a critical first step to understanding the real-world accuracy of serological tests. Incomplete reporting of race/ethnicity data and a limited ability to link test manufacturer data, lab results, and clinical data challenge the ability to assess the real-world performance of SARS-CoV-2 tests in different contexts and the overall U.S. response to current and future disease pandemics.

Patient Preferences Regarding Rheumatoid Arthritis Therapies: A Conjoint Analysis.

BACKGROUND: Tofacitinib, an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA), provides patients with an alternative to subcutaneously or intravenously administered biologic disease-modifying antirheumatic drugs (DMARDs). Little is known about patient preference for novel RA treatments. OBJECTIVE: To investigate patient preferences for attributes associated with RA treatments. METHODS: A choice-based conjoint survey was mailed to 1400 randomly selected commercially insured patients (aged 21-80 years) diagnosed with RA, who were continuously enrolled from May 1, 2012, through April 30, 2013, and had ≥2 medical claims for International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 714.0 and no previous biologic DMARD use. Treatment attributes included route of administration; monthly out-of-pocket cost; frequency of administration; ability to reduce daily joint pain and swelling; likelihood of serious adverse events; improvement in the ability to perform daily tasks; and medication burden. Mean attribute importance scores were calculated after adjusting for patient demographics (eg, age, sex, years since diagnosis) using a hierarchical Bayes model. Patient preferences for each treatment attribute were ranked by the importance score. Part-worth utilities (ie, preference scores) were used to perform a conjoint market simulation. RESULTS: A total of 380 patients (response rate, 27.1%) returned the survey. Their mean age (± standard deviation) was 54.9 (± 9.3) years. Nonrespondents were 2 years younger (mean, 52.9 years; P = .002) but did not differ significantly from respondents in known clinical characteristics. After adjustment for demographic characteristics, mean patients' ranking of treatment attribute importance, in decreasing order, was route of administration, 34.1 (± 15.5); frequency of administration, 16.4 (± 6.8); serious adverse events, 12.0 (± 9.3); cost, 10.1 (± 6.2); medication burden, 9.8 (± 8.2); joint pain reduction, 8.9 (± 3.8); and daily tasks improvement, 8.8 (± 4.7). For the route of administration attribute, the part-worth utility was highest for the oral route. Conjoint simulation results showed that 56.4% of respondents would prefer an oral route of administration. CONCLUSION: Based on this survey completed by 380 patients with RA, commercially insured patients with RA consider the route of administration to be the most important attribute of their RA treatment. In this study, the majority (56.4%) of patients preferred the oral route of administration over other routes. Understanding patient preferences may help to inform provider and payer decisions in treatment selection that may enhance patient adherence to therapy.

Healthcare Utilization and Costs of Knee or Hip Replacements versus Pain-Relief Injections.

BACKGROUND: Given the dramatic increase in total knee and hip replacement procedures among the US population aged 45 years and older, there is a need to compare the downstream healthcare utilization and costs between patients who undergo joint replacement and those who receive intraarticular injections as a low-cost alternative. OBJECTIVE: To compare changes in osteoarthritis (OA)-related healthcare utilization and costs for Medicare members with OA who underwent knee or hip replacement versus those receiving steroid or viscosupplementation injections. METHODS: Medicare members aged ≥45 years diagnosed with OA were identified for this retrospective longitudinal study. Data were compared for patients who underwent primary knee or hip replacement surgery between July 1, 2007, and June 30, 2012, and those receiving injection of pain-relief medication during the same period. The date of joint replacement surgery was considered the index date. For the comparison cohort, the index date was 180 days postinjection of the first intraarticular injection. Medical and pharmacy claims were examined longitudinally in 90-day increments, from 180 days preindex until 360 days postindex. Difference-in-difference analyses were conducted to compare the change in OA-related healthcare costs, postindex versus preindex, between the study cohorts. Time-to-event analyses were used to measure rates of readmissions and venous thromboembolism (VTE). RESULTS: The mean age was 70.7 years for patients with knee replacement, 71.7 years for those with hip replacement, and 71.1 years for those receiving pain-relief injection (P <.0001). The RxRisk-V comorbidity index scores were 4.7, 4.4, and 4.8, respectively (P <.0001). Difference-in-difference analyses indicated that decreases in OA-related costs were greater for the joint replacement cohorts (coefficient for knee replacement*time: -0.603; hip replacement*time: -0.438; P <.001 for both) than for the comparison cohort. The VTE rates were 5.6% (knee) and 5.1% (hip) postsurgery versus 1.4% (knee) and 1.3% (hip) presurgery. CONCLUSION: The overall difference-in-difference results showed a greater decrease in healthcare utilization and costs for the members with joint replacement than for those receiving injection.

Out-of-pocket costs and prescription reversals with oral linezolid.

OBJECTIVE: To determine the relationship between benefit design, out-of-pocket costs, and prescription reversals, and the impact of reversals on rehospitalizations and total healthcare costs among Medicare members prescribed oral linezolid. STUDY DESIGN: Medicare members from a national health plan prescribed oral linezolid posthospitalization for skin and soft tissue infection (SSTI) or pneumonia were followed retrospectively. METHODS: Members were identified by an oral linezolid prescription between June 1, 2007, and April 30, 2011, where the index event was a prescription fill or reversal less than 2 days before or 10 days after discharge. Associations between out-of-pocket costs and reversal, and between reversal and rehospitalization 30 days postindex, were compared for prescription fills versus reversals. A generalized linear model calculated adjusted total healthcare costs per member controlling for age, sex, geographic region, and clinical characteristics. RESULTS: Reversal rates rose progressively from 2% for members with out-of-pocket costs of $0 to 27% for members with out-of-pocket costs higher than $100 (P < .0001). Infection-related rehospitalizations were 23% versus 9% for members with a prescription reversal versus a fill (P < .0001). While postdischarge prescription drug costs were $1228.78 lower (P <.0001), adjusted mean medical costs were $2061.69 higher (P = .0033) and total healthcare costs were $1280.93 higher (P = .0349) for reversal versus fill members. CONCLUSIONS: Higher out-of-pocket costs were associated with higher rates of reversal, and reversals were associated with higher rates of rehospitalization and adjusted total healthcare costs among Medicare members prescribed oral linezolid posthospitalization for SSTI or pneumonia.

Impact of certified CME in atrial fibrillation on administrative claims.

OBJECTIVE: To determine whether changes in physician behavior associated with a continuing medical education (CME) activity on atrial fibrillation (AF) can be measured using an administrative claims database. STUDY DESIGN: A retrospective, analytical review of physician practice changes and AF patient- related healthcare utilization and costs derived from an administrative claims database was performed on a cohort of Humana health system physicians. METHODS: The Humana physicians participated in a specified CME activity on the management of patients with AF. Treatment patterns of these providers and clinical outcomes of a cohort of established AF patients were compared 6 months before and 6 months after physician participation in the AF CME activity. RESULTS: Analysis of administrative claims data from Humana providers who participated in an AF CME activity and their patients demonstrated a significant reduction in AF-related healthcare costs and utilization, including decreased length of stay. Humana providers, in addition to the other CME activity participants, demonstrated significant gains in knowledge of evidence-based care strategies when presented with real-world scenarios of patients with AF. CONCLUSIONS: The use of administrative claims data is an innovative way of measuring the effectiveness of CME. These observations support the need for further investigation into the drivers of change in patient outcomes that may be associated with CME activities, as well as the utility of healthcare claims data as a possible valid measure of the impact of CME on physician performance and patient outcomes.

Impact of Celecoxib restrictions in medicare beneficiaries with arthritis.

OBJECTIVE: To compare the incidence of serious gastrointestinal (GI) complications and associated medical costs in a population with either osteoarthritis (OA) or rheumatoid arthritis (RA) enrolled in Medicare plans with celecoxib formulary restrictions versus plans without such restrictions. METHODS: This study was a retrospective cohort analysis of Medicare members in plans with and without celecoxib restrictions. Members diagnosed with OA or RA were identified and followed for 1 year. RESULTS: The restricted group had higher levels of nonselective nonsteroidal anti-inflammatory drug use (51% vs 40%, p <.001), and celecoxib use was double in the unrestricted group (16% vs 8%, p <.001). The incidence of a serious GI complication was slightly higher in the restricted group (5.4% vs 4.6%, P <.001). The adjusted mean serious GI complication-related cost for the restricted group was more than 15 times higher than that for the nonrestricted group ($1559 [95% confidence interval (CI) $1341-$1811] vs $101 [95% CI $87-$117]), adjusted mean arthritis-related medical costs were $5733 per year (95% CI $5097-$6448) for the restricted group and $3170 (95% CI $2816-$3569) for the unrestricted group. CONCLUSIONS: The restricted group had significantly less use of celecoxib, indicating that restriction was effective at reducing celecoxib utilization. Although limitations exist when comparing populations from different health plans, and the underlying causes of serious GI complications are multifactorial, the restricted group had a higher incidence of serious GI complications and higher costs related to serious GI complications and arthritis.