Seo Hyon Baik

Risk of Bleeding With Dabigatran in Atrial Fibrillation

IMPORTANCE It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. OBJECTIVE To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. DESIGN, SETTING, AND PARTICIPANTS In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. EXPOSURES Dabigatran users (n = 1302) and warfarin users (n = 8102). MAIN OUTCOMES AND MEASURES We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. RESULTS Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. CONCLUSIONS AND RELEVANCE Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.

Comparing local and regional variation in health care spending.

BACKGROUND Wide geographic variation in health care spending has generated both concern about inefficiency and policy debate about geographic-based payment reform. Evidence regarding variation has focused on hospital referral regions (HRRs), which incorporate numerous local hospital service areas (HSAs). If there is substantial variation across local areas within HRRs, then policies focusing on HRRs may be poorly targeted. METHODS Using prescription drug and medical claims data from a 5% random sample of Medicare beneficiaries from 2006 through 2009, we compared variation in health care spending and utilization among 306 HRRs and 3436 HSAs. We adjusted for beneficiary-level demographic characteristics, insurance status, and clinical characteristics. RESULTS There was substantial local variation in health care (drug and nondrug) utilization and spending. Furthermore, many of the low-spending HSAs were located in high-spending HRRs, and many of the high-spending HSAs were in low-spending HRRs. For drug spending, only 50.7% of the HSAs located within the borders of the highest-spending quintile of HRRs were in the highest-spending quintile of HSAs; conversely, only 51.5% of the highest-spending HSAs were located within the borders of the highest-spending HRRs. Similar patterns were observed for nondrug spending. CONCLUSIONS The effectiveness of payment reforms in reducing overutilization while maintaining access to high-quality care depends on the effectiveness of targeting. Our analysis suggests that HRR-based policies may be too crudely targeted to promote the best use of health care resources. (Funded by the Institute of Medicine and others.).

Disability, race/ethnicity, and medication adherence among Medicare myocardial infarction survivors

BACKGROUND Long-term medication therapy for patients with post-myocardial infarction (MI) can prolong life. However, recent data on long-term adherence are limited, particularly among some subpopulations. We compared medication adherence among Medicare MI survivors by disability status, race/ethnicity, and income. METHODS We examined 100% of Medicare fee-for-service beneficiaries discharged post-MI in 2008. The outcomes were adherence to β-blockers, statins, and angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, for 1-year and 6-month postdischarge. Adherence was defined as having prescriptions in possession for ≥75% of days. RESULTS Among aged beneficiaries who survived 1-year adherence to β-blockers were 68%, 66%, 61%, 58%, and 57% for whites, Asians, Hispanics, Native Americans, and blacks, respectively; among persons with disability, 1-year adherence was worse for each group: 59%, 54%, 52%, 47%, and 43%, respectively. The racial/ethnic difference persisted after adjustment for age, gender, income, drug coverage, location, and health status. Patterns of adherence to statins and angiotensin-converting enzymes/angiotensin II receptor blockers were similar. Among beneficiaries with close-to-full drug coverage, minorities were still less likely to adhere relative to whites: odds ratio 0.70 (95% CI 0.65-0.75) for blacks and odds ratio 0.70 (95% CI 0.55-0.90) for Native Americans. CONCLUSIONS Although β-blockers at discharge has improved since the National Committee for Quality Assurance implemented quality measures, long-term adherence remains problematic, especially among persons with disability and minority beneficiaries. Quality measures for long-term adherence should be created to improve outcomes in patients with post-MI. Even among those with close-to-full drug coverage, racial differences remain, suggesting that policies simply relying on cost reduction cannot eliminate racial differences.

Evaluating the Initiation of Novel Oral Anticoagulants in Medicare Beneficiaries

BACKGROUND As alternatives to warfarin, 2 novel oral anticoagulants (NOACs), dabigatran and rivaroxaban, were approved in 2010 and 2011 to prevent stroke and other thromboembolic events in patients with atrial fibrillation. It is unclear how patient characteristics are associated with the initiation of anticoagulants. OBJECTIVE To evaluate how patient demographics, clinical characteristics, types of insurance, and patient out-of-pocket spending affect the initiation of warfarin and 2 NOACs--dabigatran and rivaroxaban. METHODS We used pharmacy claims data from a 5% random sample of Medicare beneficiaries to identify patients who were newly diagnosed with atrial fibrillation between October 1, 2010, and October 31, 2012, and who were prescribed an oral anticoagulant within 60 days of diagnosis. We identified key predictors of initiation of NOACs using a multinomial logistic regression model with generalized logit link. RESULTS Patients who were black and who had a history of acute myocardial infarction, stroke or transient ischemic attack, chronic kidney disease, or congestive heart failure were significantly associated with lower odds of receiving NOACs compared with warfarin. Age greater than 65 years, a history of hypertension, and use of nonsteroidal anti-inflammatory drugs were positively associated with the initiation of NOACs. Rivaroxaban was most likely to be initiated among women, followed by warfarin and dabigatran. Individuals receiving a low-income subsidy were more likely to initiate warfarin than NOACs, even though they paid little copayment. Individuals with supplemental Part D drug coverage, such as national Programs for All-Inclusive Care for the Elderly or employer-sponsored plans, were more likely to initiate NOACs compared with warfarin. CONCLUSIONS We found that race, sex, type of Part D plans, and some clinical conditions were associated with the initiation of NOACs relative to warfarin. But patient demographic and clinical characteristics did not appear to affect which particular NOAC patients initiated.

Effects of Medicare Part D Coverage Gap on Medication and Medical Treatment Among Elderly Beneficiaries With Depression

CONTEXT Maintenance antidepressant pharmacotherapy in late life prevents recurrent episodes of major depression. The coverage gap in Medicare Part D could increase the likelihood of reducing appropriate use of antidepressants, thereby exposing older adults to an increased risk for relapse of depressive episodes. OBJECTIVES To determine whether (1) beneficiaries reduce antidepressant use in the gap, (2) the reduction in antidepressant use is similar to the reduction in heart failure medications and antidiabetics, (3) the provision of generic coverage reduces the risk of reduction of medication use, and (4) medical spending increases in the gap. DESIGN Observational before-after study with a comparison group design. SETTING AND PATIENTS A 5% random sample of US Medicare beneficiaries 65 years or older with depression (n = 65,223) enrolled in stand-alone Part D plans in 2007. MAIN OUTCOME MEASURES Antidepressant pharmacotherapy, physician, outpatient, and inpatient spending. RESULTS Being in the gap was associated with comparable reductions in the use of antidepressants, heart failure medications, and antidiabetics. Relative to the comparison group (those who had full coverage in the gap because of Medicare coverage or low-income subsidies), the no-coverage group reduced their monthly antidepressant prescriptions by 12.1% (95% CI, 9.9%-14.3%) from the pregap level, whereas they reduced use of heart failure drugs and antidiabetics by 12.9% and 13.4%, respectively. Those with generic drug coverage in the gap reduced their monthly antidepressant prescriptions by 6.9% (95% CI, 4.8%-9.1%); this decrease was entirely attributable to the reduction in the use of brand-name antidepressants. Medicare spending on medical care did not increase for either group relative to the comparison group. CONCLUSIONS The Medicare Part D coverage gap was associated with modest reductions in the use of antidepressants. Those with generic coverage reduced their use of brand-name drugs and did not switch from brand-name to generic drugs. The reduction in antidepressant use was not associated with an increase in nondrug medical spending.

Trends in Off-Label Use of Second-Generation Antipsychotics in the Medicare Population From 2006 to 2012

OBJECTIVE The study evaluated trends in the off-label use of second-generation antipsychotics in the Medicare population, a practice that has been identified as lacking adequate supporting evidence for many indications. METHODS Medicare claims data from 2006 to 2012 were used to identify beneficiaries who filled at least one prescription for any second-generation antipsychotic. Any use that was not associated with a medical claim for an approved indication in a given year was classified as off-label use. Rates of off-label use and of diagnoses associated with off-label use were compared over time. Fill counts standardized for 30-day supply and costs were compared by type of use. RESULTS On the basis of a sample of 490,314 patient-years, the rate of off-label use among beneficiaries prescribed a second-generation antipsychotic declined from 51% to 45%. Fill counts were 16% lower for off-label users compared with on-label users. Off-label users had higher out-of-pocket costs but lower total costs for second-generation antipsychotics. Off-label users most commonly had claims related to dementia, minor depression, anxiety disorders, and other psychosis. The proportion of off-label users without any claims for the most common off-label uses of second-generation antipsychotics declined from 45% in 2006 to 30% in 2012. CONCLUSIONS Off-label use of second-generation antipsychotics has declined, especially among persons without any of the common off-label conditions. The diagnoses accompanying off-label use did not systematically reflect changes in the evidence base for the use of these drugs, suggesting a mismatch between evidence supporting the use of off-label second-generation antipsychotics and prescribing practices.

A Simple Change To The Medicare Part D Low-Income Subsidy Program Could Save

Medicare Part D provides a subsidy to beneficiaries with incomes below 150 percent of the federal poverty level. Enrollees with the low-income subsidy accounted for 75 percent of the

5 Billion

60 billion in total federal Part D spending in 2013. The government randomly assigns any new beneficiary who automatically qualifies for the subsidy, or who successfully applies for it without indicating a preferred plan, to a stand-alone Part D plan whose premium is equal to or below the average premium for the basic Part D benefit in the region. We used an intelligent reassignment algorithm and 2008-09 Part D drug use and spending data to match enrollees to available plans according to their medication needs. We found that such a reassignment approach could have saved the federal government over

Explaining Improved Use of High-Risk Medications in Medicare Between 2007 and 2011.

5 billion in 2009, for mean government savings of

Race/Ethnicity, Disability, and Medication Adherence Among Medicare Beneficiaries with Heart Failure

710 (median: