Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States.

BACKGROUND: Galcanezumab (GMB) improved quality-of-life and reduced disability of patients with episodic (EM) and chronic migraine (CM) in Phase 3 trials. AIM: To estimate indirect cost savings associated with GMB treatment in patients with migraine in the United States (US). METHODS: We analyzed data of patients from the US from three randomized, Phase 3, double-blind, placebo (PBO)-controlled GMB studies: EVOLVE-1 and EVOLVE-2 (EM patients), REGAIN (CM patients). Annual indirect costs were calculated using items of the Migraine Disability Assessment (MIDAS) questionnaire: lost time/productivity at work/school, household work, and leisure time. All costs were annualized and expressed in 2019 US dollars. While the main analysis considered lost time/productivity at work/school and household work as a full day, a sensitivity analysis was performed by discounting them by half. For EM, annual indirect costs savings were estimated using mixed model repeated measures analysis. For CM, ANCOVA models were used to estimate annual indirect costs savings as change from baseline. RESULTS: The analysis included 805 patients with EM (mean age = 41.4 years; PBO = 534; GMB = 271) and 423 patients with CM (mean age = 38.9 years; PBO = 279; GMB = 144). Compared to PBO, GMB significantly reduced annual indirect costs among patients with EM at 3 months (least square mean [95% confidence interval] work/school = $1,883.6 [603.64-3,163.65], p = .0040, household work = $628.9 [352.95-904.88], p <.0001, and leisure activity = $499.17 [42.36-955.98], p = .0323) and 6 months (work/school = $2,382.29 [1,065.48-3,699.10], p = .0004, household work = $559.45 [268.99-849.90], p = .0002, and leisure activity = $753.81 [334.35-1,173.27], p = .0004), whereas a significant difference was not observed among patients with CM. Sensitivity analysis results were similar to primary analysis results. CONCLUSIONS: GMB treatment versus PBO resulted in significantly greater indirect cost savings in patients with EM through improved productivity at work/school, household work, and leisure days. Patients with CM receiving GMB versus PBO attained greater cost savings, although not statistically significant, through reduced lost productivity at work/school.

Migraine causes missed time or reduced productivity at home and work, which further imposes an economic burden on patients, referred to as indirect costs. In this study, we evaluated the indirect cost savings in patients with episodic or chronic migraine taking either galcanezumab or placebo for treatment. We collected data using a questionnaire called the Migraine Disability Assessment (MIDAS) that was completed by patients enrolled in three clinical studies in the United States (US), namely EVOLVE-1, EVOVLE-2 (episodic migraine patients), and REGAIN (chronic migraine patients). The MIDAS questionnaire evaluated time lost/reduced productivity at work/school, household work, and leisure activity in patients with episodic or chronic migraine. Using scores of the MIDAS questionnaire and standard annual wages for the US population, we calculated indirect costs in patients. A total of 805 patients with episodic migraine and 423 patients with chronic migraine were included in this study. In galcanezumab-treated patients with episodic migraine, a significant indirect cost saving was observed through decrease in time lost/reduced productivity at work/school, household work, and leisure activity compared with patients who received placebo. In galcanezumab-treated patients with chronic migraine, indirect cost saving observed through decrease in time lost/reduced productivity at work/school were not statistically different from placebo-treated patients. The relatively lower cost savings observed in patients with chronic migraine may be due to greater disease burden compared to patients with episodic migraine. Results of this study suggest that patients with migraine receiving galcanezumab may obtain indirect cost savings.

Annual indirect cost savings in patients with episodic or chronic migraine: post-hoc analyses from multiple galcanezumab clinical trials.

AIM: This post-hoc analysis estimated annual indirect cost savings with galcanezumab (GMB) treatment in patients with episodic migraine (EM) or chronic migraine (CM). METHODS: Data from 4 randomized, Phase 3, double-blind (DB), placebo (PBO)-controlled studies of GMB were analyzed: EVOLVE-1 and EVOLVE-2 (EM, 6-months DB), REGAIN (CM, 3-months DB), and CONQUER (previous failure of 2-4 migraine preventive medication categories, 3-months DB). Indirect costs were calculated at baseline and Month 3 using the first 2 items in Migraine Disability Assessment (MIDAS): (A + B)/60*country specific annual wage (A = days of missed work/school; B = days of reduced productivity at work/school; assuming 60 working days in 3 months). All costs were annualized and expressed in international dollars (Int$) in 2018. ANCOVA models estimated the indirect cost savings as a change from baseline. Secondary analyses determined cost savings by employment and responder status. RESULTS: Patients (>80% females) from EVOLVE-1 and -2 (n = 1,201; mean age 41.9 years), REGAIN (n = 759; mean age 41.3 years), and CONQUER (n = 453; mean age ∼46.0 years) were analyzed. GMB showed significant indirect cost savings for EM (Int$6256, p < .0001) and CM (Int$7129, p = .0002), with substantial savings for patients with previous failure of 2-4 migraine preventive medication categories (EM: Int$5664, p = .0030; CM: Int$5181, p = .1300). Compared with PBO, GMB showed significantly greater indirect cost savings for EM (p = .0156) and patients with previous failure of 2-4 migraine preventive medication categories (p = .0340). Employed patients with CM (p = .0018) and with previous failure of 2-4 migraine preventive medication categories (p < .0001) had significant cost savings after GMB treatment. GMB showed significant indirect cost savings in patients with a reduction in migraine headache days. CONCLUSION: GMB treatment resulted in annual indirect cost savings in patients with EM, CM, and with previous failure of 2-4 migraine preventive medication categories, with similar observations in the sensitivity analyses.

Antiplatelet patterns and outcomes in patients with atrial fibrillation not prescribed an anticoagulant after stroke.

BACKGROUND: To determine association of discharge antiplatelet therapy prescription with 1-year outcomes among patients with AF admitted with acute ischemic stroke and discharged without oral anticoagulation. METHODS: In a retrospective cohort study from the Get With The Guidelines-Stroke registry, we identified all Medicare fee-for-service beneficiaries 65 years or older with AF or atrial flutter admitted with acute ischemic stroke and discharged without oral anticoagulation from April 2003 through December 2014, and we determined association of discharge antiplatelet therapy prescription with 1-year outcomes using Medicare claims data. Primary outcomes were 1-year mortality and composite endpoint of major adverse cardiovascular/neurologic/bleeding events (MACNBE). RESULTS: Of 64,228 subjects (median [interquartile range] age, 84 [78-89] years; 62.5% female), 54,621 (85.0%) were discharged with antiplatelet therapy, and 9607 (15.0%) were discharged with no antithrombotic therapy. The unadjusted rates of 1-year mortality were lower among patients receiving antiplatelet therapy (37.3%) than among those receiving no antithrombotic therapy (48.1%); unadjusted rates of MACNBE were lower for those receiving antiplatelet therapy (45.5%) compared with those receiving no antithrombotic therapy (55.2%). After adjusting for potential confounders, antiplatelet therapy prescription was associated with reduced 1-year mortality (adjusted hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.62-0.66, P < .001) and MACNBE (adjusted HR 0.69, 95% CI 0.67-0.71, P < .001). CONCLUSIONS: Among Medicare beneficiaries with AF admitted for acute ischemic stroke but not discharged on oral anticoagulant therapy, antiplatelet therapy, compared with no antithrombotic therapy, was associated with reduced 1-year mortality and MACNBE.

Health Status Disparities by Sex, Race/Ethnicity, and Socioeconomic Status in Outpatients With Heart Failure.

OBJECTIVES: This study sought to describe the health status of outpatients with heart failure and reduced ejection fraction (HFrEF) by sex, race/ethnicity, and socioeconomic status (SES). BACKGROUND: Although a primary goal in treating patients with HFrEF is to optimize health status, whether disparities by sex, race/ethnicity, and SES exist is unknown. METHODS: In the CHAMP-HF (Change the Management of Patients with Heart Failure) registry, the associations among sex, race, and SES and health status, as measured by the Kansas City Cardiomyopathy Questionnaire-overall summary (KCCQ-os) score (range 0 to 100; higher scores indicate better health status) was compared among 3,494 patients from 140 U.S. clinics. SES was categorized by total household income. Hierarchical multivariate linear regression estimated differences in KCCQ-os score after adjusting for 31 patient characteristics and 10 medications. RESULTS: Overall mean KCCQ-os scores were 64.2 ± 24.0 but lower for women (29% of sample; 60.3 ± 24.0 vs. 65.9 ± 24.0, respectively; p < 0.001), for blacks (60.5 ± 25.0 vs. 64.9 ± 23.0, respectively; p < 0.001), for Hispanics (59.1 ± 21.0 vs. 64.9 ± 23.0, respectively; p < 0.001), and for those with the lowest income (<$25,000; mean: 57.1 vs. 63.1 to 74.7 for other income categories; p < 0.001). Fully adjusted KCCQ-os scores were 2.2 points lower for women (95% confidence interval [CI]: -3.8 to -0.6; p = 0.007), no different for blacks (p = 0.74), 4.0 points lower for Hispanics (95% CI: -6.6 to -1.3; p = 0.003), and lowest in the poorest patients (4.7 points lower than those with the highest income (95% CI: 0.1 to 9.2; p = 0.045; p for trend = 0.003). CONCLUSIONS: Among outpatients with HFrEF, women, blacks, Hispanics, and poorer patients had worse health status, which remained significant for women, Hispanics, and poorer patients in fully adjusted analyses. This suggests an opportunity to further optimize treatment to reduce these observed disparities.

Statin Use and Adverse Effects Among Adults >75 Years of Age: Insights From the Patient and Provider Assessment of Lipid Management (PALM) Registry.

BACKGROUND: Current statin use and symptoms among older adults in routine community practice have not been well characterized since the release of the 2013 American College of Cardiology/American Heart Association guideline. METHODS AND RESULTS: We compared statin use and dosing between adults >75 and ≤75 years old who were eligible for primary or secondary prevention statin use without considering guideline-recommended age criteria. The patients were treated at 138 US practices in the Patient and Provider Assessment of Lipid Management (PALM) registry in 2015. Patient surveys also evaluated reported symptoms while taking statins. Multivariable logistic regression models examined the association between older age and statin use and dosing. Among 6717 people enrolled, 1704 (25%) were >75 years old. For primary prevention, use of any statin or high-dose statin did not vary by age group: any statin, 62.6% in those >75 years old versus 63.1% in those ≤75 years old (P=0.83); high-dose statin, 10.2% versus 12.3% in the same groups (P=0.14). For secondary prevention, older patients were slightly less likely to receive any statin (80.1% versus 84.2% [P=0.003]; adjusted odds ratio, 0.81; 95% confidence interval, 0.66-1.01 [P=0.06]), but were much less likely to receive a high-intensity statin (23.5% versus 36.2% [P<0.0001]; adjusted odds ratio, 0.54; 95% confidence interval, 0.45-0.65 [P=0.0001]). Among current statin users, older patients were slightly less likely to report any symptoms (41.3% versus 46.6%; P=0.003) or myalgias (27.3% versus 33.3%; P<0.001). CONCLUSIONS: Overall use of statins was similar for primary prevention in those aged >75 years versus younger patients, yet older patients were less likely to receive high-intensity statins for secondary prevention. Statins appear to be similarly tolerated in older and younger adults.

Health Status Variation Across Practices in Outpatients With Heart Failure: Insights From the CHAMP-HF (Change the Management of Patients With Heart Failure) Registry.

BACKGROUND: Although a key treatment goal for patients with heart failure with reduced ejection fraction is to optimize their health status (their symptoms, function, and quality of life), the variability across outpatient practices in achieving this goal is unknown. METHODS AND RESULTS: In the CHAMP-HF (Change the Management of Patients With Heart Failure) registry, associations between baseline practice characteristics and Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) and Symptom Frequency (SF) scores were assessed in 3494 patients across 140 US practices using hierarchical regression after accounting for 23 patient and 11 treatment characteristics. We then calculated an adjusted median odds ratio to quantify the average difference in likelihood that a patient would have excellent (KCCQ-OS, ≥75) health status or minimal (monthly or fewer) symptoms (KCCQ-SF, ≥75) when treated at one practice versus another, at random. The mean (±SD) KCCQ-OS and KCCQ-SF were 64.2±24 and 68.9±25.6, with 40% (n=1380) and 50% (n=1760) having KCCQ scores ≥75, respectively. The adjusted median odds ratio across practices, for KCCQ-OS ≥75, was 1.70 (95% confidence interval, 1.54-1.99; P<0.001) indicating a median 70% higher odds of a patient having good-to-excellent health status when treated at one random practice versus another. In regard to KCCQ-SF, the adjusted median odds ratio for KCCQ-SF ≥75 was 1.54 (95% confidence interval, 1.41-1.76; P=0.001). CONCLUSIONS: In a large, contemporary registry of outpatients with chronic heart failure with reduced ejection fraction, we observed significant practice-level variability in patients' health status. Quantifying patients' health status as a measure of quality should be explored as a foundation for improving care. CLINICAL TRIAL REGISTRATION: URL: https://www.centerwatch.com. Unique identifier: TX144901.

Overtreatment and Deintensification of Diabetic Therapy among Medicare Beneficiaries.

BACKGROUND: Deintensification of diabetic therapy is often clinically appropriate for older adults, because the benefit of aggressive diabetes treatment declines with age, while the risks increase. OBJECTIVE: We examined rates of overtreatment and deintensification of therapy for older adults with diabetes, and whether these rates differed by medical, demographic, and socioeconomic characteristics. DESIGN, SUBJECTS, AND MAIN MEASURES: We analyzed Medicare claims data from 10 states, linked to outpatient laboratory values to identify patients potentially overtreated for diabetes (HbA1c < 6.5% with fills for any diabetes medications beyond metformin, 1/1/2011-6/30/2011). We examined characteristics associated with deintensification for potentially overtreated diabetic patients. We used multinomial logistic regression to examine whether patient characteristics associated with overtreatment of diabetes differed from those associated with undertreatment (i.e. HbA1c > 9.0%). KEY RESULTS: Of 78,792 Medicare recipients with diabetes, 8560 (10.9%) were potentially overtreated. Overtreatment of diabetes was more common among those who were over 75 years of age and enrolled in Medicaid (p < 0.001), and was less common among Hispanics (p = 0.009). Therapy was deintensified for 14% of overtreated diabetics. Appropriate deintensification of diabetic therapy was more common for patients with six or more chronic conditions, more outpatient visits, or living in urban areas; deintensification was less common for those over age 75. Only 6.9% of Medicare recipients with diabetes were potentially undertreated. Variables associated with overtreatment of diabetes differed from those associated with undertreatment. CONCLUSIONS: Medicare recipients are more frequently overtreated than undertreated for diabetes. Medicare recipients who are overtreated for diabetes rarely have their regimens deintensified.

Outcomes Associated With Extraction Versus Capping and Abandoning Pacing and Defibrillator Leads.

BACKGROUND: Lead management is an increasingly important aspect of care in patients with cardiac implantable electronic devices; however, relatively little is known about long-term outcomes after capping and abandoning leads. METHODS: Using the 5% Medicare sample, we identified patients with de novo cardiac implantable electronic device implantations between January 1, 2000, and December 31, 2013, and with a subsequent lead addition or extraction ≥12 months after the de novo implantation. Patients who underwent extraction for infection were excluded. Using multivariable Cox proportional hazards models, we compared cumulative incidence of all-cause mortality, device-related infection, device revision, and lead extraction at 1 and 5 years for the extraction versus the cap and abandon group. RESULTS: Among 6859 patients, 1113 (16.2%) underwent extraction, whereas 5746 (83.8%) underwent capping and abandonment. Extraction patients tended to be younger (median, 78 versus 79 years; P<0.0001), were less likely to be male (65% versus 68%; P=0.05), and had shorter lead dwell time (median, 3.0 versus 4.0 years; P<0.0001) and fewer comorbidities. Over a median follow-up of 2.4 years (25th, 75th percentiles, 1.0, 4.3 years), the overall 1-year and 5-year cumulative incidence of mortality was 13.5% (95% confidence interval [CI], 12.7-14.4) and 54.3% (95% CI, 52.8-55.8), respectively. Extraction was associated with a lower risk of device infection at 5 years relative to capping (adjusted hazard ratio, 0.78; 95% CI, 0.62-0.97; P=0.027). There was no association between extraction and mortality, lead revision, or lead extraction at 5 years. CONCLUSIONS: Elective lead extraction for noninfectious indications had similar long-term survival to that for capping and abandoning leads in a Medicare population. However, extraction was associated with lower risk of device infections at 5 years.

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

OBJECTIVES: Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. BACKGROUND: Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. METHODS: Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. RESULTS: A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p < 0.001), major lower extremity amputation (10.1% vs. 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs. 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs. 26.9% vs. 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. CONCLUSIONS: Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice.

Use of Antiarrhythmic Medications in Medicare Part D Patients With an Implantable Cardioverter-Defibrillator and Ventricular Tachycardia.

Ventricular tachycardia (VT) is common in cardiomyopathy patients with an implantable cardioverter-defibrillator. This analysis evaluated antiarrhythmic medication use and change in use over time in patients with VT and structural heart disease. Query of Medicare claims identified patients with an implantable cardioverter-defibrillator and VT. Patients with atrial fibrillation or supraventricular tachycardia were excluded. Two cohorts were created of patients enrolled in Medicare Part D for the 12 months before 2007 and 2012. Patients were identified through a search for antiarrhythmic medication fills with a supply covering January 1 of the cohort year. Adjusted logistic regression modeling evaluated the association between patient characteristics and antiarrhythmic medication use. The 2007 (n = 2,334) and 2012 (n = 3,892) Medicare Part D cohorts had similar demographics: median age 76 years, 64%-67% male, and 87%-89% white. Of the 2007 cohort, 1,380 (59%) patients were on a beta blocker, and 484 (20.7%) were on an antiarrhythmic medication (70% amiodarone and 20% sotalol). Between 2007 and 2012, there was a statistically significant higher use of any antiarrhythmic medication (p = 0.014), beta blockers (p <0.0001), mexiletine (p = 0.005), and ranolazine (p <0.0001), while amiodarone use remained unchanged (p = 0.53). After multivariable adjustment, male gender and renal disease were associated with higher antiarrhythmic medication use. In conclusion, although antiarrhythmic medication and beta blocker use in patients with VT increased over time, <1 in 4 patients were on an antiarrhythmic medication and only 65% of the patients were on a beta blocker.

Management of newly treated diabetes in Medicare beneficiaries with and without heart failure.

BACKGROUND: Several diabetes mellitus (DM) therapies are associated with worse heart failure (HF) outcomes, yet limited data exist characterizing routine DM management based on HF status. HYPOTHESIS: DM medications prescribed for patients with HF will differ in meaningful ways from patients without HF, and co-morbidities will impact the choice of medications prescribed. METHODS: Using Medicare fee-for-service claims data, we identified patients with newly treated DM between 2008 and 2011 and used multivariable logistic regression to assess associations between baseline HF status and DM medication use. We used the cumulative incidence function to describe outcomes at 1 year by HF status and DM medication use. RESULTS: Of 35 603 patients with newly treated DM, 8965 (25.2%) had HF at baseline. Patients with HF had greater comorbidity, including renal dysfunction. After adjustment for baseline covariates, patients with HF had higher odds of initiation on insulin monotherapy (odds ratio: 1.72, 95% confidence interval: 1.59-1.87, P < 0.001) and lower odds of initiation on metformin (odds ratio: 0.66, 95% confidence interval: 0.62-0.71, P < 0.001) compared with patients without HF. Cumulative incidence of 1-year mortality was higher among patients with HF than among those without (22.4% vs 6.4%) and highest among those prescribed insulin. CONCLUSIONS: Patients with HF were more likely to be initiated on insulin monotherapy than were patients without HF, who were more likely to be initiated on metformin. Studies of comparative effectiveness and safety are needed for DM treatment options in patients with comorbid HF.

Few Disparities in Baseline Laboratory Testing After the Diuretic or Digoxin Initiation by Medicare Fee-For-Service Beneficiaries.

BACKGROUND: Despite the persistence of significant disparities, few evaluations examine disparities in laboratory testing by race/ethnicity, age, sex, Medicaid eligibility, and number of chronic conditions for Medicare fee-for-service beneficiaries' newly prescribed medications. In Medicare beneficiaries initiating diuretics or digoxin, this study examined disparities in guideline-appropriate baseline laboratory testing and abnormal laboratory values. METHODS AND RESULTS: To evaluate guideline-concordant testing for serum creatinine and serum potassium within 180 days before or 14 days after the index prescription fill date, we constructed retrospective cohorts from 10 states of 99 711 beneficiaries who had heart failure or hypertension initiating diuretic in 2011 and 8683 beneficiaries who had heart failure or atrial fibrillation initiating digoxin. Beneficiaries initiating diuretics were less likely to have testing if they were non-Hispanic Black (relative risk [RR], 0.99; 95% confidence interval [CI], 0.98-0.99) than non-Hispanic White. Beneficiaries initiating diuretics and beneficiaries initiating digoxin were more likely to have testing if they had multiple chronic conditions relative to 0 to 1 conditions. Beneficiaries initiating diuretics with laboratory values were more likely to have an abnormal serum creatinine value at baseline if they were non-Hispanic Black (RR, 2.57; 95% CI, 1.91-3.44), other race (RR, 2.11; 95% CI, 1.08-4.10), or male (RR, 2.75; 95% CI, 2.14-3.52) or an abnormal serum potassium value if they were aged ≥76 years (RR, 1.29; 95% CI, 1.09-1.51) or male (RR, 1.17; 95% CI, 1.03-1.33). CONCLUSIONS: Testing rates were consistently high, so there were negligible disparities in guideline-concordant testing of creatinine and potassium after the initiation of digoxin or diuretics by Medicare beneficiaries.

Significant variation in P2Y12 inhibitor use after peripheral vascular intervention in Medicare beneficiaries.

UNLABELLED: There is no consensus regarding whether to use antithrombotic medications in patients with peripheral artery disease after lower-extremity peripheral vascular intervention. OBJECTIVES: The main hypothesis is that significant variation exists regarding use of antithrombotic medications after lower-extremity peripheral vascular intervention. We sought to examine the patterns of postprocedural antithrombotic medication use and associated factors in Medicare patients. METHODS: We measured rates of P2Y12 inhibitor use after peripheral vascular intervention in a 100% national sample of Medicare beneficiaries with Part D prescription drug coverage. We used logistic regression modeling to examine associations between patient and clinical factors and P2Y12 inhibitor use. RESULTS: Between 2010 and 2012, a total of 85,830 patients underwent peripheral vascular intervention and had prescription drug claims. Overall, 18.3% of patients were treated with an oral anticoagulant, 19.1% received no P2Y12 inhibitor, 30.8% received a P2Y12 inhibitor before and after the procedure, 6.2% received a P2Y12 inhibitor for up to 30 days after the procedure, and 25.6% received a P2Y12 inhibitor for more than 30 days after the procedure. After adjustment, factors associated with P2Y12 inhibitor use included male sex; black race; history of renal disease, dementia, or heart failure; physician specialty; and clinical setting of the procedure. We observed a strong interaction effect between clinical setting and physician specialty (P < .001). CONCLUSIONS: One-fifth of patients who underwent lower-extremity peripheral vascular intervention did not fill a prescription for a P2Y12 inhibitor. Patients whose operators were surgeons or radiologists had lower odds of P2Y12 inhibitor use. More research to determine the optimal use and duration of antithrombotic medications after the procedure is warranted.

Frequency of Disparities in Laboratory Testing After Statin Initiation in Subjects ≥65 Years.

Laboratory testing is important for the safety of older adults initiating statins, but there has been little examination of laboratory testing disparities by race/ethnicity, age, gender, Medicaid eligibility, and multimorbidity. The study's purpose was to examine disparities in guideline-concordant baseline laboratory testing and abnormal laboratory values among a retrospective cohort of 76,868 Medicare fee-for-service beneficiaries from 10 states in the eastern United States who had dyslipidemia and initiated a statin from July 1 to November 30, 2011. Guideline-concordant assessment of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was defined as evidence of an outpatient claim for either test within 180 days before or 14 days after the date of the index statin fill. In 2011, baseline laboratory testing rates were 89.3% for ALT and 88.8% for AST. Older adults were somewhat more likely to have ALT and AST testing if they were dually enrolled in Medicaid (relative risk 1.01, 95% confidence interval [CI] 1.00 to 1.02) or had multiple chronic conditions (relative risk 1.03, 95% CI 1.00 to 1.06 for 2 to 3 conditions; odds ratio [OR] 1.08, 95% CI 1.05 to 1.11 for 4 to 5 conditions; OR 1.14, 95% CI 1.11 to 1.17 for 6+ conditions), compared with 0 to 1 conditions. Non-Hispanic blacks were less likely to receive baseline testing (OR 0.97, 95% CI 0.96 to 0.98) than non-Hispanic Whites, and male beneficiaries were somewhat less likely to receive testing than female beneficiaries (OR 0.99, 95% CI 0.98 to 0.99). Abnormal values were rare. In conclusion, ALT and AST assessment after statin initiation was commonly done as recommended, and there were negligible disparities in testing rates for beneficiaries.

Use of the landmark method to address immortal person-time bias in comparative effectiveness research: a simulation study.

Observational comparative effectiveness and safety studies are often subject to immortal person-time, a period of follow-up during which outcomes cannot occur because of the treatment definition. Common approaches, like excluding immortal time from the analysis or naïvely including immortal time in the analysis, are known to result in biased estimates of treatment effect. Other approaches, such as the Mantel-Byar and landmark methods, have been proposed to handle immortal time. Little is known about the performance of the landmark method in different scenarios. We conducted extensive Monte Carlo simulations to assess the performance of the landmark method compared with other methods in settings that reflect realistic scenarios. We considered four landmark times for the landmark method. We found that the Mantel-Byar method provided unbiased estimates in all scenarios, whereas the exclusion and naïve methods resulted in substantial bias when the hazard of the event was constant or decreased over time. The landmark method performed well in correcting immortal person-time bias in all scenarios when the treatment effect was small, and provided unbiased estimates when there was no treatment effect. The bias associated with the landmark method tended to be small when the treatment rate was higher in the early follow-up period than it was later. These findings were confirmed in a case study of chronic obstructive pulmonary disease. Copyright © 2016 John Wiley & Sons, Ltd.

Early and Long-term Outcomes of Older Adults after Acute Care Encounters for Chronic Obstructive Pulmonary Disease Exacerbation.

RATIONALE: Older patients are at high risk of death and rehospitalization after hospitalizations for acute exacerbations of chronic obstructive pulmonary disease (AE-COPD). Emergency department visits comprise a substantial portion of acute care encounters in this patient population. The risks of mortality and repeat acute care encounters, including both hospital readmission and repeat emergency department visits, after AE-COPD among older adults are not well understood. OBJECTIVES: To examine early and long-term rates of death and repeat acute care encounters after hospitalization or emergency department visit for AE-COPD in Medicare fee-for-service beneficiaries and to identify patient characteristics, including medical comorbid conditions, associated with these outcomes. METHODS: A retrospective analysis was conducted using a nationally representative 5% sample of Medicare fee-for-service claims data from the U.S. Centers for Medicare and Medicaid Services to identify Medicare beneficiaries 65 years or older who had an acute care episode for an AE-COPD between January 1, 2006, and December 31, 2010 (n = 52,741). Outcomes of interest were all-cause mortality, repeat acute care encounters for any cause, and repeat acute care encounters for AE-COPD at 30 days, 1 year, and 3 years. MEASUREMENTS AND MAIN RESULTS: Acute care encounters, including hospitalizations and emergency department visits for AE-COPD, were associated with substantial subsequent mortality risk, with 4.6, 24.4, and 48.2% dying by 30 days, 1 year, and 3 years, respectively. The risk of repeat hospitalization or emergency department visit was similarly high, with 1 in 4 patients having a repeat acute care encounter within 30 days of discharge, increasing to 9 in 10 in the next 3 years. Several comorbid conditions and other patient factors, including heart failure, malnutrition, dual eligibility for Medicare and Medicaid, and prior supplemental oxygen use, were independently associated with increased risk of repeat acute care encounter. CONCLUSIONS: Repeat hospitalizations and emergency department visits and death are common in older fee-for-service Medicare beneficiaries seen in acute care for AE-COPD. Our results suggest that addressing important comorbid conditions, such as heart failure or malnutrition, and targeting resources to oxygen-dependent or dual Medicare- and Medicaid-eligible patients may help modify these outcomes.

Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009.

IMPORTANCE: Guidelines recommend consideration of chemotherapy for most patients with early-stage, estrogen receptor-positive, invasive breast cancer in the absence of additional prognostic information. The 21-gene recurrence score (RS) assay has been shown in limited academic settings to reduce physician recommendations for adjuvant chemotherapy. Associations between the adoption of the assay and receipt of chemotherapy in the general population have not been examined. OBJECTIVE: To examine whether adoption of the RS assay in a nationally representative sample of patients with early-stage breast cancer was associated with use of chemotherapy. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of Medicare beneficiaries who received a diagnosis of incident breast cancer between 2005 and 2009 using Surveillance, Epidemiology, and End Results data set with linked Medicare claims. MAIN OUTCOMES AND MEASURES: Receipt of chemotherapy within 12 months after diagnosis. RESULTS: A total of 44,044 patients had low-risk (24.0%), intermediate-risk (51.3%), or high-risk disease (24.6%, lymph node positive) as defined by National Comprehensive Cancer Network (NCCN) guidelines and met the study criteria. We observed no overall association between receipt of the RS assay and chemotherapy (odds ratio [OR], 1.03 [99% CI, 0.88-1.19]). In multivariable analysis, there was a significant interaction between NCCN risk and use of the RS assay, with assay use associated with lower chemotherapy use in high-risk patients (OR, 0.36 [99% CI, 0.26-0.50]) and greater chemotherapy use in low-risk patients (OR, 3.71 [99% CI, 2.30-5.98]), compared with no receipt of the assay (P=.006 for the overall interaction). Results were similar in prespecified subgroup analyses of patients 70 years and younger, with the exception of a shift toward lower chemotherapy use during 2008 (OR, 0.90 [99% CI, 0.77-.1.05]; P=.09) and 2009 (OR, 0.81 [99% CI, 0.66-0.99]; P=.007). In unadjusted analyses, overall chemotherapy use decreased over time in patients 70 years or younger with high-risk disease and those receiving the assay. CONCLUSIONS AND RELEVANCE: The impact of the adoption of the RS assay on receipt of chemotherapy was strongly population dependent and was associated with relatively lower chemotherapy use in groups with high-risk disease and relatively higher chemotherapy use in patients with low-risk disease. Overall use of chemotherapy decreased during the study period in patients who were most likely to receive chemotherapy.

Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009.

IMPORTANCE: In 2006, the Centers for Medicare & Medicaid Services approved coverage for the use of the 21-gene recurrence score (RS) assay in women with early-stage, estrogen receptor-positive, node-negative breast cancers to help guide recommendations for adjuvant chemotherapy. Use of the assay in community settings has not been previously examined in a nationally representative sample of patients. OBJECTIVE: To examine trends in the use of the RS assay in routine clinical practice in a nationally representative sample of women with breast cancer. DESIGN, SETTING, AND PARTICIPANTS: Retrospective observational study of Medicare beneficiaries diagnosed with incident breast cancer between 2005 and 2009, as recorded in a Surveillance, Epidemiology, and End Results data set with linked Medicare claims through 2010. MAIN OUTCOMES AND MEASURES: Demographic and clinical variables associated with the use of the assay. RESULTS: A total of 70,802 patients met the study criteria. Use of the RS assay increased from 1.1% in 2005 to 10.1% in 2009 (P < .001). The majority of tests (60.9%) occurred in patients with National Comprehensive Cancer Network-defined intermediate-risk disease (ie, estrogen receptor-positive, node-negative tumors >1 cm). Most patients with other than intermediate-risk disease had borderline indications for testing, including T1b (47.5%) or N1 (26.8%) disease. Testing was associated with younger age, fewer comorbid conditions, higher-grade disease, and being married. Among patients younger than 70 years with intermediate-risk disease, testing rates increased from 7.7% in 2005 to 38.8% in 2009 (P < .001). In multivariable analysis, testing was modestly higher in Northeast than in Western registries (odds ratio, 1.83; 95% CI, 1.49-2.26) but was otherwise not associated with region, local census tract demographic characteristics, black race, location in an urban area, or tumor histologic characteristics. CONCLUSIONS AND RELEVANCE: The RS assay was adopted quickly in clinical practice after the Medicare coverage decision in 2006, and use appears to be consistent with guidelines and equitable across geographic and racial groups. Factors influencing adoption of the assay and its impact on adjuvant chemotherapy use in clinical practice remain important areas of study.

Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system.

BACKGROUND: Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to encourage more efficient outpatient use of PVI in the United States. OBJECTIVES: The purpose of this study was to evaluate trends in the use and clinical settings of PVI and the effect of changes in reimbursement. METHODS: Using a 5% national sample of Medicare fee-for-service beneficiaries from 2006 to 2011, we examined age- and sex-adjusted rates of PVI by year, type of procedure, clinical setting, and physician specialty. RESULTS: A total of 39,339 Medicare beneficiaries underwent revascularization for PAD between 2006 and 2011. The annual rate of PVI increased slightly from 401.4 to 419.6 per 100,000 Medicare beneficiaries (p = 0.17), but the clinical setting shifted. The rate of PVI declined in inpatient settings from 209.7 to 151.6 (p < 0.001), whereas the rate expanded in outpatient hospitals (184.7 to 228.5; p = 0.01) and office-based clinics (6.0 to 37.8; p = 0.008). The use of atherectomy increased 2-fold in outpatient hospital settings and 50-fold in office-based clinics during the study period. Mean costs of inpatient procedures were similar across all types of PVI, whereas mean costs of atherectomy procedures in outpatient and office-based clinics exceeded those of stenting and angioplasty procedures. CONCLUSIONS: From 2006 to 2011, overall rates of PVI increased minimally. However, after changes in reimbursement, PVI and atherectomy in outpatient facilities and office-based clinics increased dramatically, neutralizing cost savings to Medicare and highlighting the possible unintended consequences of coverage decisions.