One-year post-discharge resource utilization and treatment patterns of patients with acute coronary syndrome managed with percutaneous coronary intervention and treated with ticagrelor or prasugrel.

OBJECTIVE: Our objective was to compare 1-year real-world healthcare resource utilization (HRU), associated charges, and antiplatelet treatment patterns among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with ticagrelor or prasugrel. METHODS: Using the ProMetis-Lx database, adult ACS-PCI patients treated with ticagrelor or prasugrel post-discharge were identified between 1 August 2011 and 31 May 2013 and propensity matched to adjust for baseline differences. RESULTS: Before matching, ticagrelor-treated patients (n = 2991) were older with increased baseline ischemic and bleeding risks compared with prasugrel-treated patients (n = 12,797). After matching, ticagrelor patients had higher all-cause HRU (2.5 vs. 2.4 per patient per month; P = 0.012) and cardiovascular (CV) HRU (0.4 vs. 0.3 per patient per month; P = 0.026), with the difference in CV rehospitalizations (17.7 vs. 15.7 %; P = 0.011) primarily driven by congestive heart failure (CHF) (4.9 vs. 3.8 %; P = 0.02). All-cause charges within 1 year did not significantly differ between groups ($US5456 vs. 4844 per patient per month; P = 0.37), but dyspnea-related total charges were significantly higher with ticagrelor ($US139 vs. 95 per patient per month; P = 0.005). Although infrequent, switching was slightly higher with ticagrelor (8.3 vs. 6.0 %; P < 0.001) at 1 year, and mean persistence was slightly longer with prasugrel (150 vs. 159 days; P = 0.002), with no significant difference in mean adherence (61 vs. 63 %; P = 0.17). CONCLUSION: Overall monthly HRU was slightly lower with prasugrel than with ticagrelor, with no significant difference in bleeding HRU. Prasugrel was associated with slightly higher pharmacy charges, but lower dyspnea charges, resulting in no significant difference in total charges. Patients receiving prasugrel tended to use it for longer than those receiving ticagrelor as less switching occurred. These findings may aid decision making, but must be tempered due to inherent study limitations.

Comparison of healthcare resource utilization and costs in patients hospitalized for acute coronary syndrome managed with percutaneous coronary intervention and receiving prasugrel or ticagrelor.

OBJECTIVE: To compare healthcare resource utilization (HCRU) and healthcare costs in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with prasugrel or ticagrelor. METHODS: Hospital charge master data were used to identify ACS-PCI patients aged ≥ 18 years with ≥ 1 in-hospital claim for prasugrel or ticagrelor between August 1, 2011-April 30, 2013. Treatment groups were propensity matched for baseline and index hospitalization characteristics. HCRU and costs were assessed through 90-days post-discharge. Costs were determined based on hospital-specific cost-to-charge ratios and adjusted to 2013 US dollars. RESULTS: Before matching, ticagrelor patients were older, more-often female, and had increased cardiovascular (CV) and bleeding risks compared with prasugrel patients. Propensity-matched length of index hospital stay (4.7 vs 4.9 days, p = 0.23) and risk for all-cause [30-day: relative risk (RR) = 0.86; 95% CI = 0.73-1.0; 90-day: RR = 0.90; 95% CI = 0.80-1.0, and CV-related (30-day: RR = 0.77; 95% CI = 0.59-1.0; 90-day: RR = 0.89; 95% CI = 0.73-1.1) re-hospitalizations did not significantly differ between prasugrel and ticagrelor, respectively. Compared to ticagrelor, the propensity-matched risk of re-hospitalization for myocardial infarction (MI) (30-day: RR = 0.39; 95% CI = 0.21-0.75; 90-day: RR = 0.53; 95% CI = 0.34-0.81) and an outpatient medical encounter for dyspnea (30-day: RR = 0.49; 95% CI = 0.33-0.74; 90-day: RR = 0.60; 95% CI = 0.46-0.80) were significantly lower for prasugrel patients, with no significant differences in bleeding encounters between groups (30-day: RR = 0.87; 95% CI = 0.54-1.40; 90-day: RR = 1.0; 95% CI = 0.71-1.50). Matched total healthcare costs were not significantly different between groups during the index hospitalization ($36,011 vs $37,247, p = 0.21), 30-days post-discharge ($2007 vs $2522, p = 0.48), 90-days post-discharge ($4564 vs $5242, p = 0.49), and aggregate of the index hospitalization through 90-day follow-up ($40,576 vs $42,494, p = 0.09) timeframes. CONCLUSIONS: Re-hospitalization for MI and outpatient encounters for dyspnea were lower in prasugrel treated than in ticagrelor treated ACS-PCI patients up to 90-days post-index hospitalization discharge, with no difference in bleeding encounters or healthcare costs between the two populations. This data supports the utility of prasugrel in routine clinical practice. These findings should be considered within limitations of observational research.

A medication adherence and persistence comparison of hypertensive patients treated with single-, double- and triple-pill combination therapy.

OBJECTIVE: Fixed-dose combination therapy reduces pill burden and may, therefore, improve medication adherence and health outcomes. This study compared adherence to and persistence with single-, double-, and triple-pill treatment regimens among hypertensive patients in a US clinical practice setting. METHODS: Adults with hypertension treated with three anti-hypertensive medications were identified. Index date was the first occurrence of a single-, double-, or triple-pill regimen with olmesartan or valsartan plus amlodipine and hydrochlorothiazide from July 2010 to September 2011. Patients were followed for 12 months to assess adherence (proportion of days covered [PDC] ≥ 80%) and time to discontinuation (medication gap ≥ 60 days) of the index regimen. Multivariate regression models were used to compare adjusted outcomes. RESULTS: The number of prescribed pills in the index regimen was monotonically related to adherence with 55.3%, 40.4% and 32.6% of patients having PDC ≥ 80% in the single-, double- and triple-pill cohorts, respectively. In adjusted analysis, patients in the double- (odds ratio [OR]: 0.45; 95% confidence interval [CI]: 0.42-0.48) and triple-pill (OR: 0.26; 95% CI: 0.22-0.30) cohorts were less likely to be adherent to their index regimens than those in the single-pill cohort. Double-pill (hazard ratio [HR]: 1.89; 95% CI: 1.74-2.06) and triple-pill patients (HR: 2.49; 95% CI: 2.14-2.88) were more likely to discontinue treatment than single-pill patients. CONCLUSIONS: Greater pill burden was directly and significantly associated with decreased adherence and persistence with antihypertensive therapies in real-practice settings. Use of fixed-dose combinations that reduce pill burden could help patients to continue treatment and may result in improved clinical outcomes. Typical of observational studies, the potential for residual confounding of adherence estimates remains due to lack of randomization of treatment groups.

The COSEHC™ Global Vascular Risk Management quality improvement program: first follow-up report.

The Global Vascular Risk Management (GVRM) Study is a 5-year prospective observational study of 87,863 patients (61% females) with hypertension and associated cardiovascular risk factors began January 1, 2010. Data are gathered electronically and cardiovascular risk is evaluated using the Consortium for Southeastern Hypertension Control™ (COSEHC™)-11 risk score. Here, we report the results obtained at the completion of 33 months since study initiation. De-identified electronic medical records of enrolled patients were used to compare clinical indicators, antihypertensive medication usage, and COSEHC™ risk scores across sex and diabetic status subgroups. The results from each subgroup, assessed at baseline and at regular follow-up periods, are reported since the project initiation. Inference testing was performed to look for statistically significant differences between goal attainments rates between sexes. At-goal rates for systolic blood pressure (SBP) were improved during the 33 months of the study, with females achieving higher goal rates when compared to males. On the other hand, at-goal control rates for total and low-density lipoprotein (LDL) cholesterol (chol) were better in males compared to females. Diabetic patients had lower at-goal rates for SBP and triglycerides but higher rates for LDL-chol. The LDL-chol at-goal rates were higher for males, while high-density lipoprotein (HDL)-chol rates were higher for females. Utilization of antihypertensive medications was similar during and after the baseline period for both men and women. Patients taking two or more antihypertensive medications had higher mean COSEHC™-11 scores compared to those on monotherapy. With treatment, hypertensive patients can reach SBP and cholesterol goals; however, population-wide improvement in treatment goal adherence continues to be a challenge for physicians. The COSEHC™ GVRM Study shows, however, that continuous monitoring and feedback to physicians of accurate longitudinal data is an effective tool in achieving better control rates of cardiovascular risk factors.

Costs and outcomes associated with clopidogrel discontinuation in Medicare beneficiaries with acute coronary syndrome in the coverage gap.

BACKGROUND: Current guidelines for acute coronary syndrome recommend clopidogrel for an optimal period of 12 months in order to reduce the risk of reinfarction and mortality. Premature clopidogrel discontinuation has been associated with higher rates of rehospitalization, coronary stent thrombosis, and mortality. No data exist regarding the effect of the Medicare Part D coverage gap on medical costs and outcomes in Medicare beneficiaries who discontinue their clopidogrel upon entering the coverage gap. METHODS: Beneficiaries with a Medicare Advantage plan in 2009 who had a diagnosis of acute coronary syndrome were taking clopidogrel 75 mg daily, and reached the gap in the same year representing the study sample. From this cohort, those who filled at least two prescriptions for clopidogrel (continued) versus those that did not (discontinued) while in the gap were compared with regard to outcomes related to acute coronary syndrome and expenditure 30 days after the last prescription was filled and during any time while in the gap. Descriptive and multivariate analyses were used to compare these differences. RESULTS: A total of 1365 beneficiaries with acute coronary syndrome met the inclusion criteria, of which 705 beneficiaries entered into the coverage gap, wherein 103 (14.6%) and 602 (85.4%) of beneficiaries discontinued and continued clopidogrel, respectively. Compared with those who continued clopidogrel during the gap, beneficiaries who discontinued clopidogrel showed a higher trend in the number of hospitalizations related to acute coronary syndrome and emergency room visits, albeit not statistically significant. Those who discontinued clopidogrel showed a higher mean adjusted cost per member per month in hospitalizations ($3604) related to acute coronary syndrome and outpatient visits ($1144) related to acute coronary syndrome and total medical costs ($5614), albeit not statistically significant. CONCLUSION: Medicare beneficiaries who face large out-of-pocket costs for clopidogrel while in the coverage gap and discontinue therapy may experience adverse events related to acute coronary syndrome.

Burden of illness for an employed population with chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) affects approximately 7% of Americans. COPD impacts productivity and forces 1 in 5 employees ages 45-65 years old to retire prematurely. Our objective was to quantify the direct and indirect costs of COPD in an employed population in the United States. A retrospective analysis using Thomson Reuters MarketScan commercial claims and Health and Productivity (HPM) databases (2000-2007) identified employees (ages 18-65 years) with ≥ 1 COPD medical claim, ≥ 6 month insurance eligibility pre and ≥ 12 months post diagnosis, and ≥ 12 months HPM data post diagnosis. COPD subjects were matched to non-COPD subjects using propensity scores to create a comparison group with similar characteristics. Differences in medical and pharmacy utilization and productivity (absence and short-term disability [STD] days) were examined using negative binomial regression, and cost differences using Heckman selection models. A total of 27,612 COPD patients were matched in a 1:1 ratio to 825,884 non-COPD patients; 80% were ages 36-65 years, and 59% were male. COPD employees had about twice the rate of emergency department visits and hospitalizations compared to non-COPD employees (P<0.0001). The rate of absence and STD days was approximately 1.5 times higher (P<0.0001) compared to non-COPD employees. Yearly direct and indirect expenditures were higher ($3609 and $909, respectively; P<0.0001) for COPD versus non-COPD employees. Excess utilization and associated costs of COPD to employers was quantified. By understanding these costs, employers may evaluate disease management programs and treatment to improve outcomes for employees with COPD. Improved treatment options may reduce the direct and indirect costs of COPD.

A value-based insurance design program at a large company boosted medication adherence for employees with chronic illnesses.

This paper contributes to a small but growing body of evidence regarding the efficacy of value-based insurance design. In a retrospective, observational study of employees of a large global pharmaceutical firm, we evaluated how reduced patient cost sharing for prescription drugs for asthma, hypertension, and diabetes affected the use of these drugs and related medical services. We estimate that prescription medication use rose 5 percent per enrollee across the entire enrolled population. Increased use was most evident for patients taking cardiovascular medication. By the third year, adherence to cardiovascular medications was 9.4 percent higher, and patients realized cost savings over time. Overall, the program was mostly cost-neutral to the company, and there was no aggregate change in spending. However, we raise the prospect that this program may have saved the company money by reducing other medical costs.

Comparing pre-gap and gap behaviors for Medicare beneficiaries in a Medicare managed care plan.

OBJECTIVE: To examine the impact of the coverage gap on pharmacy use, expenditures, and out-of-pocket costs for Medicare managed care beneficiaries before and after reaching the gap. STUDY DESIGN: A longitudinal comparison of behaviors for beneficiaries with non-gap coverage before and after reaching the gap. METHODS: Prescription drug use and expenditures were assessed for Medicare beneficiaries who reached the gap, including subsets with one of four chronic disorders (congestive heart failure (CHF), diabetes, dyslipidemia, or hypertension). Differences in pre- and post-prescription use were calculated using generalized estimating equations. Time until the end and start of the gap was estimated using a Cox proportional hazards model. Expenditure data were estimated using bootstrap methods. RESULTS: Roughly a quarter (27.1 percent) of patients reached the gap in 2006, of whom 3.6 percent passed through the gap. The most prevalent disease state was hypertension (58.5 percent). Beneficiaries took an average of 8.1 months to reach the gap. Patients <65 years (HR = 1.42, 95% CI = 1.29 - 1.56) and those with diabetes (HR = 1.19, 95% CI = 1.12 - 1.27) were more likely to reach the gap sooner as compared to older beneficiaries (aged 65 to 74) and those without diabetes. These individuals were more likely to pass through the gap as well. Beneficiaries faced a 60.7 percent increase in out-of-pocket expenditures in the gap phase. Brand-name medication use decreased by 9.3 percent, while generic medication use increased by 7.4 percent. For chronic conditions, however, over 90 percent of individuals continued brand-name medication use in the gap. CONCLUSIONS: Our findings suggest that, in general, beneficiaries take lower-cost generics while in the gap. However, taking brand-name medications is the predominant behavior for beneficiaries with chronic diseases. Health care reform provisions that close the gap over the next ten years may facilitate continuity of medication use while in the gap.

Improved blood pressure control among school bus drivers with hypertension.

The impact of a hypertension awareness and educational program, BP DownShift, was evaluated among school bus drivers in a southern US state. At baseline (August 2007), blood pressure (BP) measurements, self-reported demographics, and hypertension awareness and management practices were collected from drivers who consented to participate in the study. Interventions included 4 educational mailings, installation of BP machines at all bus terminals, and access to free dietitian consultations and gym memberships. BP was evaluated using Department of Transportation guidelines. BP was remeasured and a survey was administered at follow-up (May 2008). At baseline, 208 drivers consented to the BP screening; 120 (58%) returned for a follow-up assessment. Most participants completing the study were female (73%) and African American (72%). Mean age was 50 years and mean body mass index was 32 kg/m(2); 52% of participants were obese. In all, 58% of participants reported a prior diagnosis of hypertension by a physician, and 63% reported taking antihypertensive medication. Both systolic and diastolic BP (SBP and DBP) were lower at follow-up (135/82 mmHg vs. 145/87 mmHg at baseline; P < 0.001, both comparisons); 42% had a reduction in SBP > 10 mmHg, and 44% had a reduction in DBP > 5 mmHg. At follow-up, 58% were controlled to BP < 140/90, compared to 38% at baseline (P < 0.001). At follow-up, an increased proportion of previously diagnosed drivers reported home BP monitoring, healthy diet, and regular exercise as components of hypertension self-management. The implementation of our hypertension education, self-management, and awareness program was associated with an improvement in BP control, which may positively impact commercial driver's license recertification as well as improve employee health.

Predictors of compliance with antihypertensive therapy in a high-risk medicaid population.

OBJECTIVE: To identify predictors of compliance with antihypertensive combination therapy in a Medicaid population. METHODS: Retrospective medical and pharmacy claims data for Maryland Medicaid patients receiving angiotensin converting enzyme inhibitors (ACEls)/hydrochlorothiazides (HCTZs) or ACEl/calcium channel blockers as fixed-dose combinations or separate agents during the period of January 1, 2002 to December 31, 2004, were analyzed. INCLUSION: Continuously enrolled patients 18 years and older and at least one year of follow-up. Exclusion: Use of fixed-dose combination antihypertensives between January 1, 2002 and June 30, 2002 (to identify incident cohort). Compliance was defined as medication possession ratio greater than or equal to 80%. Multivariate logistic regression was used to predict compliance as a function of age, gender, race, comorbidities (Charlson Comorbidity Index [CCI]), and use of either fixed-dose combination or separate agents. RESULTS: There were 568 patients, 63.73% female, 68.83% African American, median age 52 years, 35.56% on fixed-dose combinations, 72.89% started on ACEI/HCTZ, and 24.82% complied with therapy. Patients younger than 40 years (OR, 0.38; p = .01; 95% CI, 0.18-0.81) and African American (OR, 0.45; p = .0004; 95% CI, 0.29-0.70) were less likely to be compliant than patients older than 60 years and Caucasian, respectively, Patients with a CCI of 1 (OR, 2.11; p = .05; 95% CI, 1.01-4.40) and those on fixed-dose combinations (OR, 1.60; p = .02, 95% CI, 1.06-2.40) were more likely to be compliant than those with higher CCIs and on separate agents, respectively. CONCLUSION: Age, race, comorbidities, and simplified antihypertensive regimens were significant predictors of compliance. Higher compliance rates may enhance cardiovascular disease management outcomes.

Blood pressure control and pharmacotherapy patterns in the United States before and after the release of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guidelines.

OBJECTIVES: Despite recommendations from the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7), only 36.8% of patients were at target blood pressure (BP) in 2003 and 2004. The objective of this study was to assess improvements in BP control and treatment patterns before and after the publication of JNC 7. METHODS: This was a retrospective, time series analysis of 27 provider groups and managed care organizations from 1998 through 2006. Patients with hypertension were identified from more than 4000 physicians. Medical charts were collected and clinical data were evaluated using prevailing JNC criteria during the time period before and after JNC 7. RESULTS: A total of 19,258 patients were identified with hypertension: 15,258 included in the before-JNC 7 cohort and 4,000 in the after-JNC 7 cohort. BP control in the before-JNC 7 cohort was 40.8% compared with 49.3% in the after-JNC 7 cohort (P < .0001). After controlling for demographic and clinical covariates, patients in the before-JNC 7 cohort were 45% less likely to achieve BP control compared with the after-JNC 7 cohort (odds ratio, 0.551; P < .0001). CONCLUSION: Although findings indicate BP control is improving, a significant need for further improvement remains.

Blood pressure control among diabetes patients within a managed care setting.

Blood pressure (BP) control is a key component of diabetes management. BP control in patients with diabetes was assessed across 4 Colorado health plans. BP was obtained through retrospective chart reviews, and BP control was defined as <130/80 mm Hg. The study included 1,445 diabetic patients in 2004 and 1,423 diabetic patients in 2005. BP control did not improve significantly from 2004 to 2005; in 2004, 33.1% had controlled BP, compared with 35.2% in 2005. Women were more likely to have controlled BP than men, and younger patients were more likely to have controlled BP than older patients. Two of the 4 plans showed significant improvement in BP control, whereas the proportion of patients with BP controlled declined in 2 health plans. More aggressive disease management and pharmacologic treatment of blood pressure is needed to improve the cardiovascular health of patients with diabetes.

Predictors of fixed-dose combination antihypertensive drug therapy in a Medicaid population.

Physicians may prescribe hypertension combination therapy, either with fixed-dose combination therapy or with dual-agent component-based therapy. This study evaluated the predictors of hypertensive patients receiving either type of combination therapy. Our study was based on claims data from the Maryland Medicaid Managed Care Organizations. Patients had exclusively used either fixed-dose combination therapy or dual-agent component-based therapy. We used multivariate logistic regression to estimate the impact of age, gender, race, comorbidities, and specific managed care organizations on the likelihood of receiving dual-agent component-based therapy vs. fixed-dose combination therapy. Of a total 2,483 study subjects, 1,270 received dual-agent component-based therapy and 1,213 received fixed-dose combination therapy. Compared with the reference group (Americaid Community Care), Maryland Physicians Care was three times more likely to prescribe dual-agent component-based therapy for its enrollees (odds ratio [OR], 3.01; 95% confidence interval [CI], 2.24 - 4.05). United Healthcare and other managed care organizations were 37% and 57% more likely to have dual-agent component-based therapy than the reference group, respectively (OR, 1.37; 95% CI, 1.08 - 1.74 and OR, 1.57; 95% CI, 1.16 - 2.14). In conclusion, significant prescribing variations exist across managed care organizations. Sickly male patients were more likely to receive the dual-agent component-based therapy. This information can assist future plans in medication therapy management.

New-user persistence with antihypertensives and prescription drug cost-sharing.

This study employed a new-user design to assess predictors of persistence with antihypertensive therapy, with emphasis on prescription drug cost-sharing. This retrospective longitudinal analysis used 2001-2002 claims data from 45 large health plans. The sample consisted of 23,047 individuals with hypertension, aged 41 to 65 years and receiving new antihypertensive treatment of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, calcium channel blockers, or diuretics. Prescription drug cost-sharing was measured as generosity ratio of actual to expected copayment. Other measures included demographics, Charlson comorbidity, type of health plan, and health care spending. Multivariate models showed that generous drug coverage was associated with an 11% to 19% increase in persistence (P<.05) in 4 of 5 antihypertensive drug classes compared with less generous drug coverage, controlling for the other measures. Less generous drug coverage is a risk factor for poor persistence among most new antihypertensive users.

Effects of initial antihypertensive drug class on patient persistence and compliance in a usual-care setting in the United States.

Antihypertensive treatment regimen persistence and compliance were measured using a retrospective cohort study of pharmacy claims data. Newly treated patients receiving monotherapy with angiotensin II receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), beta-blockers (BBs), or diuretics were followed for 1 year (N=242,882). A higher proportion of ARB patients (51.9%) were persistent in taking prescribed medication compared with those in the ACEI (48.0%), BB (40.3%), CCB (38.3%), and diuretic groups (29.9%). Compared with patients receiving diuretics, those receiving ARBs (hazard ratio [HR], 0.593; P<.0001), ACEIs (HR, 0.640; P<.0001), CCBs (HR, 0.859; P<.0001), and BBs (HR, 0.819; P<.0001) were all less likely to discontinue therapy. Compliance was similar in ACEI and ARB patients, but patients receiving ARBs and ACEIs had better compliance than those receiving BBs, CCBs, or diuretics. The lesser degree of compliance and persistence observed in patients receiving diuretics compared with other antihypertensive medications may have public health as well as cost implications.

Ethnic/racial variations in blood pressure awareness, treatment, and control.

Understanding the impact of patient factors on blood pressure (BP) management is an important step to developing interventions to improve cardiovascular health. The National Health and Nutrition Examination Survey (NHANES) 1999-2002 was used to identify predictors of hypertension awareness, treatment, and control. An estimated 63.3 million (31.0%) US adults currently have BP exceeding 140/90 mm Hg, and prevalence is higher for blacks than for other racial/ethnic subgroups. Among antihypertensive medication-treated patients, 51.3% are controlled. Treated blacks and Mexican Americans have the lowest rates of BP control. Mexican Americans are 0.62 times as likely to be aware and 0.61 times as likely to be treated as white persons with hypertension. Compared with whites, treated Mexican Americans are 0.71 times as likely and treated blacks 0.59 times as likely to achieve BP control. Hypertension treatment and BP control in the United States remain suboptimal, and significant racial/ethnic disparities persist. Effective interventions targeting Mexican Americans and blacks as well as whites are essential to improving hypertension management.

Valsartan versus lisinopril or extended-release metoprolol in preventing cardiovascular and renal events in patients with hypertension.

PURPOSE: The objective of this study was to compare cardiovascular and renal events in patients with hypertension receiving the angiotensin II-receptor blocker valsartan versus those receiving the angiotensin-converting-enzyme lisinopril or the beta-blocker metoprolol succinate in an extended-release formulation. METHODS: A retrospective study was conducted using a health insurance claims database spanning the period from January 1997 through December 2003 and representing approximately 40 million members enrolled in over 70 health plans across the United States. Study subjects included all persons in the database with two or more outpatient prescriptions for valsartan, lisinopril, or extended-release metoprolol and two or more prior claims with a diagnosis of hypertension. Those with a history of major cardiovascular or renal events (diagnosis of myocardial infarction, stroke, heart failure, ventricular arrhythmias, or cardiac arrest; coronary revascularization procedure; diagnosis of renal failure; or dialysis or kidney transplantation) or using other antihypertensive medications except diuretics during the 12 months before treatment with valsartan, lisinopril, or extended-release metoprolol were excluded. Risks of major cardiovascular or renal event during follow-up were analyzed using Cox proportional hazards regression. RESULTS: A total of 29,357 antihypertensive patients were identified who initiated therapy with valsartan (n = 6,645), lisinopril (n = 17,320), or extended-release metoprolol (n = 5,392). In multivariate analyses, therapy with valsartan was associated with a significantly lower risk of a major cardiovascular or renal event versus extended-release metoprolol (heart rate [HR], 0.70; 95% confidence interval [CI], 0.56-0.87; p = 0.0015). Patients receiving valsartan had a nominally lower risk of a major cardiovascular or renal event than those receiving lisinopril, although this difference was not statistically significant (HR, 0.89; 95% CI, 0.74-1.07; p = 0.1987). CONCLUSION: Results of this observational study suggest that the use of valsartan may reduce the risk of major cardiovascular and renal events compared with extended-release metoprolol.

Effects of a step-therapy program for angiotensin receptor blockers on antihypertensive medication utilization patterns and cost of drug therapy.

BACKGROUND: Step therapy for angiotensin receptor blockers (ARBs) requiring prior use of angiotensin-converting enzyme inhibitors (ACEIs) is a common cost-containment intervention in managed care. OBJECTIVE: This study was designed to assess the effectiveness of the step-therapy intervention for ARBs, including ARB/hydrochlorthiazide (HCTZ) combinations, as measured by prescription use patterns and antihypertensive drug ingredient costs. METHODS: Rejected and paid pharmacy claims data were evaluated from 3 health plans with a total membership of approximately 1 million. These plans had implemented a step-therapy intervention for ARBs from May 1, 2001, through February 28, 2003. Patients in the intervention group who had experienced a claim rejection for an ARB within the first 6 months of program implementation (i.e., had had no ACEI [or ACEI/HCTZ combination] or ARB [or ARB/HCTZ] claim in the preceding 3 months) were followed for 1 year after the ARB claim rejection. The rate of initiation of ARB versus ACEI and other outcomes was compared with similar data from a health plan with approximately 2 million members that did not have a step-therapy intervention for ARBs (comparison group). Mean and median total antihypertensive drug ingredient costs per patient and per day of therapy over 12 months were analyzed for the intervention and comparison groups. One pharmacy benefit manager administered the pharmacy benefits for the intervention and comparison health plans during the entire study period from May 1, 2001, through February 28, 2004, and the drug formulary was similar for all health plans. RESULTS: In the step-therapy health plans, before the criterion for 15 months of continuous eligibility was applied, there were 8,904 patients (approximately 0.9% of health plan members) who either attempted and were rejected for an ARB or who newly started ACEI therapy, compared with 44,788 patients (approximately 2.2% of members in the comparison health plan) who newly started ARB or ACEI therapy without the step-therapy intervention. After the eligibility criterion was applied, there were 6,758 intervention health plan members (0.7% of members) and 33,709 comparison health plan members (1.7% of members) in the 2 study groups. In addition to the smaller proportion of total members affected by the intervention in the ARB step-therapy health plans, a smaller proportion of ARB/ACEI patients attempted to obtain an ARB (1,296/6,758 or 19.2%) compared with the health plan without step therapy (8,697/33,709 or 25.8%, P <0.001). Of the 1,296 patients who attempted to obtain an ARB and were rejected in the step-therapy group, 578 patients (44.6%) went through the prior-authorization process and received an ARB as initial therapy, 632 patients (48.8%) received other antihypertensive therapy, and 86 patients (6.6%) did not receive any antihypertensive therapy within the 12-month follow-up period. In the 12 months of follow-up, 51.1% (323/632) of patients in the intervention group who received other antihypertensives as index therapy switched to or added an ARB, and 1,234 of total ACE/ARB patients (n = 6,758, 18.3%) received ARB therapy in the health plan with step therapy compared with 10,498 of 33,709 total ACEI/ARB patients (31.1%) who received ARB therapy in the health plan without step therapy. The mean antihypertensive drug cost per patient was lower in the intervention group ($370.00) than in the comparison group ($445.12; P <0.001), and the average cost per day of antihypertensive drug therapy was 12.8% lower in the step-therapy group ($0.82) than in the comparison group ($0.94). Unadjusted annual cost savings were $75.12 per patient, and ordinary least squares regression analysis showed that the ARB step-therapy intervention was associated with $43.91 in antihypertensive drug cost savings per patient over 12 months. CONCLUSIONS: Within 12 months of follow-up, a step-therapy intervention for ARBs was associated with an 18% ratio of ARB users to total ACEI/ARB users compared with a 31% ratio in a comparison health plan without the ARB step-therapy intervention. Approximately 45% of patients who did not receive an ARB as a result of the step-therapy intervention had either switched to or added an ARB within 12 months of the intervention, and almost 7% of patients did not receive any antihypertensive therapy. Antihypertensive drug cost was about 13% lower for the ACEI/ARB patients in the intervention group, creating approximately $368,000 in savings in 1 year or $0.03 per member per month across the 1 million health plan members.

Copayment level and compliance with antihypertensive medication: analysis and policy implications for managed care.

OBJECTIVE: To measure the impact of medication copayment level and other predictors on compliance with antihypertensive medications, as measured by the medication possession ratio. STUDY DESIGN: Retrospective observational analysis. METHODS: We used claims data from a large managed care organization. The identification of subjects was based on a diagnosis of hypertension and a filled prescription for antihypertensive medication between January 1999 and June 2004. Multivariate logistic regression models were used to evaluate copayment level and patient characteristics as predictors of medication compliance. RESULTS: Analysis of data for 114,232 patients filling prescriptions for antihypertensive medications revealed that compliance was lower for drugs in less preferred tiers. Relative to medications with a 5 dollars copayment, the odds ratio (95% confidence interval) for compliance with drugs having a 20 dollars copayment was 0.76 (0.75, 0.78); for drugs requiring a 20 dollars to 165 dollars copayment, the odds ratio for compliance was 0.48 (0.47, 0.49). Medication compliance also differed by patient age, morbidity level, and ethnicity, as well as by medication therapeutic class--with the best compliance observed for angiotensin receptor blockers, followed by calcium channel blockers, beta-adrenergic receptor antagonists (beta-blockers), angiotensin-converting enzyme inhibitors, and last, thiazide diuretics. CONCLUSIONS: Copayment level, independent of other determinants, was found to be a strong predictor of compliance with antihypertensive medications, with greater compliance seen among patients filing pharmacy claims for drugs that required lower copayments. This finding suggests that patient use is sensitive to price. The potential impact on compliance should be considered when making pricing and policy decisions.

Relationship of blood pressure control to adherence with antihypertensive monotherapy in 13 managed care organizations.

OBJECTIVE: This study was conducted to evaluate the relationship between medication compliance and blood pressure (BP) control among members of 13 managed care organizations with essential hypertension (HTN) who received antihypertensive monotherapy for at least 3 pharmacy claims prior to the blood pressure measurement. METHODS: This was a retrospective review of medical and pharmacy claims over a 4-year period (1999-2002) from 13 U.S. health plans. Data were collected by trained health professionals from randomly selected patient medical records per Health Plan Employer Data and Information Set (HEDIS) technical specifications. Patients were selected if they (1) had received monotherapy or fixed-dose combination therapy (administered in one tablet or capsule) during the time BP was measured (thus those with no BP drug therapy were excluded); (2) had received 3 or more antihypertensive pharmacy claims for the antihypertensive drug therapy prior to BP measurement; and (3) had one or more antihypertensive pharmacy claims after BP was measured. Control of BP was defined according to guidelines of the Sixth Report of the Joint National Committee (JNC 6) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (<140/90 mm Hg, or <130/85 mm Hg for patients with diabetes). Medication adherence was measured using the medication possession ratio (MPR), and MPR was used to classify patients into 3 adherence levels: high (80%-100%), medium (50%-79%), and low (<50%). The relationship between medication adherence and BP control was assessed using a logistic regression model. RESULTS: There were 1,017,181 patients with a diagnosis of HTN in medical claims data from which 10,734 (10.6%) were randomly selected for chart review. There were 1,032 patients (9.6%) in the sample who had a diagnosis of HTN but who were excluded because they had no HTN drug therapy. Of the total 9,894 patients (92.2%) who were excluded from the sample, 3,029 patients (28.2%) met all other inclusion criteria but were receiving more than one HTN drug. Of the 840 patients on HTN monotherapy, the mean age was 59 12.2 years; 422 (50%) were women, 16% had diabetes, and 43% had dyslipidemia. The monotherapy HTN drug was an angiotensin-converting enzyme inhibitor (27% of patients), calcium channel blocker (22%), beta-blocker (20%), or diuretic (11%). Of the 840 patients, 629 (74.8%) were determined to have high medication adherence, 165 (19.6%) had medium adherence, and 46 (5.5%) had low adherence. Approximately 270 (43%) of high adherence patients achieved BP control compared with 56 (34%) and 15 (33%) patients with medium and low adherence, respectively. High-adherence patients were 45% more likely to achieve BP control than those with medium or low compliance after controlling for age, gender, and comorbidities (odds ratio=1.45; P =0.026). CONCLUSION: These results demonstrate that 75% of these health plan members with a diagnosis of essential HTN who were selected for receipt of at least 4 pharmacy claims for HTN monotherapy exhibited high medication adherence. However, only 43% of high-adherence patients attained their target (JNC 6) blood pressure goal compared with 33% to 34% of patients with medium or low adherence to antihypertensive monotherapy.