Systematic reviews included in this broad synthesis

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Primary study

Unclassified

Journal Annals of internal medicine
Year 2012
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BACKGROUND: Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope. OBJECTIVE: To determine the effect of the coverage gap on drugs used for asymptomatic (antihypertensive and lipid-lowering drugs) and symptomatic (pain relievers, acid suppressants, and antidepressants) conditions in elderly patients with hypertension and hyperlipidemia. DESIGN: Quasi-experimental study using pre-post design and contemporaneous control group. SETTING: Medicare claims files from 2005 and 2006 for 5% random sample of Medicare beneficiaries. PATIENTS: Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage, generic-only coverage, or both brand-name and generic coverage during the gap in 2006. Patients who were fully eligible for the low-income subsidy served as the control group. MEASUREMENTS: Monthly 30-day supply prescriptions available, medication adherence, and continuous medication gaps of 30 days or more for antihypertensive or lipid-lowering drugs; monthly 30-day supply prescriptions available for pain relievers, acid suppressants, or antidepressants before and after coverage gap entry. RESULTS: Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap. Nonadherence also increased in this group (antihypertensives: odds ratio [OR], 1.60 [95% CI, 1.50 to 1.71]; lipid-lowering drugs: OR, 1.59 [CI, 1.50 to 1.68]). The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3% (OR, 1.38 [CI, 1.29 to 1.46]) and 3.2% (OR, 1.35 [CI, 1.25 to 1.45]), respectively, because of the coverage gap. Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage. Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions. No measures changed in the brand-name and generic coverage groups. Results of sensitivity analyses were consistent with the main findings. LIMITATION: Because this study was nonrandomized, unobserved differences may still exist between study groups. CONCLUSION: The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage. The proposed phasing out of the gap by 2020 will benefit such patients; however, use of low-value medications may also increase. PRIMARY FUNDING SOURCE: Penn-Pfizer Alliance and American Heart Association.

Primary study

Unclassified

Authors Zhang Y , Donohue JM , Lave JR , Gellad WF
Journal Health services research
Year 2011
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OBJECTIVE: To evaluate Medicare Part D's impact on use of antihypertensive medications among seniors with hypertension. DATA SOURCES: Medicare-Advantage plan pharmacy data from January 1, 2004 to December 12, 2007 from three groups who before enrolling in Part D had no or limited drug benefits, and a comparison group with stable employer-based coverage. STUDY DESIGN: Pre-post intervention with a comparison group design was used to study likelihood of use, daily counts, and substitutions between angiotensin-converting enzyme inhibitors and angiotensin-II receptor blockers (ARBs). PRINCIPAL FINDINGS: Antihypertensive use increased most among those without prior drug coverage: likelihood of use increased (odds ratio = 1.40, 95 percent confidence interval [CI] 1.25-1.56), and daily counts increased 0.29 (95 percent CI 0.24-0.33). Proportion using ARBs increased from 40 to 46 percent. CONCLUSIONS: Part D was associated with increased antihypertensive use and use of ARBs over less expensive alternatives.

Primary study

Unclassified

Journal Medical care
Year 2010
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BACKGROUND: Little is known about how Medicare Part D affects the medication refill adherence for cardiovascular and diabetes medications, particularly among beneficiaries without prior drug coverage. OBJECTIVES: To evaluate Medicare Part D's effect on medication adherence among beneficiaries with hyperlipidemia, hypertension, and/or diabetes enrolled in Medicare Advantage products. RESEARCH DESIGN: We used a quasi-experimental pre-post design, with 3 treatment groups and a comparison group, to assess the effect of Part D on several measures of adherence to prescription medications. SUBJECTS: Adults aged 65 or older with hyperlipidemia, hypertension, and/or diabetes in 2003 continuously enrolled between 2004 and 2007 in a large Pennsylvania insurer's Medicare Advantage products. MEASURES: Medication possession ratios (MPR), good adherence with MPR >0.8, and intensity of treatment measured by average daily counts of pills per day of treatment. RESULTS: Part D improved MPRs in the group without prior drug coverage by 13.4 percentage points (95% CI, 10.1-16.8), 17.9 (95% CI, 13.7-22.1), and 13.5 (95% CI, 11.5-15.5) for those with hyperlipidemia, diabetes, and hypertension, respectively. Adherence improved less in the other 2 groups with limited prior drug benefits. Although the proportion of beneficiaries in the intervention groups who attained good adherence levels increased after Part D, less than 50%, 68%, and 78% of beneficiaries with hyperlipidemia, diabetes, and hypertension, respectively, attained good adherence. CONCLUSION: Part D increased adherence to medications that reduce the risk of cardiovascular events for patients with hypertension, diabetes, and hyperlipidemia. This should improve the health of the elderly people in the long run.

Primary study

Unclassified

Authors Doshi JA , Zhu J , Lee BY , Kimmel SE , Volpp KG
Journal Circulation
Year 2009
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BACKGROUND: In February 2002, the Department of Veterans Affairs (VA) increased copayments from $2 to $7 per 30-day drug supply of each medication for many veterans. We examined the impact of the copayment increase on lipid-lowering medication adherence. METHODS AND RESULTS: This quasiexperimental study used electronic records of 5604 veterans receiving care at the Philadelphia VA Medical Center from November 1999 to April 2004. The all copayment group included veterans subject to copayments for all drugs with no annual cap. Veterans subject to copayments for drugs only if indicated for a non-service-connected condition with an annual cap of $840 for out-of-pocket costs made up the some copayment group. Veterans who remained copayment exempt formed a natural control group (no copayment group). Patients were identified as adherent if the proportion of days covered with lipid-lowering medications was > or =80%. Patients were identified as having a continuous gap if they had at least 1 continuous episode with no lipid-lowering medications for > or =90 days. A difference-in-difference approach compared changes in lipid-lowering medication adherence during the 24 months before and after copayment increase among veterans subject to the copayment change with those who were not. Adherence declined in all 3 groups after the copayment increase. However, the percentage of patients who were adherent (proportion of days covered > or =80%) declined significantly more in the all copayment (-19.2%) and some copayment (-19.3%) groups relative to the exempt group (-11.9%). The incidence of a continuous gap increased significantly at twice the rate in both copayment groups (all copayment group, 24.6%; some copayment group, 24.1%) as the exempt group (11.7%). Compared with the exempt group, the odds of having a continuous gap in the after relative to the before period were significantly higher in both the all copayment group (odds ratio, 3.04; 95% confidence interval, 2.29 to 4.03) and the some copayment group (odds ratio, 1.85; 95% confidence interval, 1.43 to 2.40). Similar results were seen in subgroups of patients at high risk for coronary heart disease, high medication users, and elderly veterans. CONCLUSIONS: The copayment increase adversely affected lipid-lowering medication adherence among veterans, including those at high coronary heart disease risk.

Primary study

Unclassified

Journal The New England journal of medicine
Year 2009
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BACKGROUND: It is not known what effect the increased use of prescription drugs by enrollees in Medicare Part D has had on spending for other medical care. METHODS: We compared spending for prescription drugs and other medical care 2 years before the implementation of Part D in January 2006 with such expenditures 2 years after the program's implementation in four groups of elderly beneficiaries: Medicare Advantage enrollees with stable, uncapped, employer-based drug coverage throughout the study period (no-cap group), those who had no previous drug coverage, and those who had previous limited benefits (with either a $150 or a $350 quarterly cap) before they were covered by Part D in 2006. RESULTS: Between December 2005 and December 2007, as compared with the increase in the no-cap group, the increase in total monthly drug spending was $41 higher (95% confidence interval [CI], $33 to $50) (74%) among enrollees with no previous drug coverage, $27 higher (95% CI, $20 to $34) (27%) among those with a previous $150 quarterly cap, and $13 higher (95% CI, $8 to $18) (11%) among those with a previous $350 cap. The use of both lipid-lowering and antidiabetic medications rose in the groups with no or minimal previous drug coverage. As compared with expenditures in the no-cap group, monthly medical expenditures (excluding drugs) were $33 lower (95% CI, $29 to $37) in the group with no previous coverage and $46 lower (95% CI, $29 to $63) in the group with a previous $150 quarterly cap, whereas medical spending was $30 higher (95% CI, $25 to $36) in the group with a previous $350 cap. CONCLUSIONS: Enrollment in Medicare Part D was associated with increased spending on prescription drugs. Groups that had no or minimal drug coverage before the implementation of Part D had reductions in other medical spending that approximately offset the increased spending on drugs, but medical spending increased in the group that had more generous previous coverage.

Primary study

Unclassified

Journal The American journal of managed care
Year 2007
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OBJECTIVE: To evaluate the effects of patient copayment and coinsurance policies on adherence to therapy with beta-adrenergic blocking agents (beta-blockers) and on the rate of initiation of beta-blocker therapy after acute myocardial infarction (MI) in a population-based natural experiment. STUDY DESIGN: Three sequential cohorts included British Columbia residents age 66 years and older who initiated beta-blocker therapy during time intervals with full drug coverage (2001), a $10 or $25 copayment (2002), and 25% coinsurance (2003-2004). We used linked data on all prescription drug dispensings, physician services, and hospitalizations. Follow-up of each cohort was 9 months after the policy changes. METHODS: We measured the proportion of subjects in each cohort who were adherent to beta-blocker therapy over time, with adherence defined as having >80% of days covered. We also measured the proportion of patients initiating beta-blocker therapy after acute MI. Policy effects were evaluated using multivariable regression. RESULTS: Adherence to beta-blocker therapy was marginally reduced as a consequence of the copayment policy (-1.3 percentage points, 95% confidence interval [CI] = -2.5 , -0.04) or the coinsurance policy (-0.8 percentage points, 95% CI = -2.0, 0.3). The proportion of patients initiating beta-blockers after hospitalization for acute MI remained steady at about 61% during the study period, similar to that observed in a control population of elderly Pennsylvania residents with full drug coverage. CONCLUSIONS: Fixed patient copayment and coinsurance policies had little negative effect on adherence to relatively inexpensive beta-blocker therapy, or initiation of beta-blockers after acute MI.

Primary study

Unclassified

Journal Circulation
Year 2007
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BACKGROUND: As medication spending grows, Medicare Part D will need to adapt its coverage policies according to emerging evidence from a variety of insurance policies. We sought to evaluate the consequences of copayment and coinsurance policies on the initiation of statin therapy after acute myocardial infarction and adherence to therapy in statin initiators using a natural experiment of all British Columbia residents aged 66 years and older. METHODS AND RESULTS: Three consecutive cohorts that included all patients who began statin therapy during full drug coverage (2001), coverage with a $10 or $25 copay (2002), and coverage with a 25% coinsurance benefit (2003-2004) were followed up with linked healthcare utilization data (n=51,561). Follow-up of cohorts was 9 months after each policy change. Adherence to statin therapy was defined as > or = 80% of days covered. Relative to full-coverage policies, adherence to new statin therapy was significantly reduced, from 55.8% to 50.5%, under a fixed copayment policy (-5.4% points; 95% CI, -6.4% to -4.4%) and the subsequent coinsurance policy (-5.4% points; 95% CI, -6.3% to -4.4%). An uninterrupted increase in the proportion of patients initiating statin therapy after an acute myocardial infarction (1.7% points per quarter) was observed over the study period, similar to a Pennsylvania control population with full coverage. Sudden changes to full out-of-pocket spending, similar to Medicare's Part D "doughnut hole," almost doubled the risk of stopping statins (adjusted odds ratio, 1.94, 95% CI, 1.82 to 2.08). CONCLUSIONS: Fixed patient copayment and coinsurance policies have negative effects on adherence to statin lipid-lowering drug therapy but not on their initiation after myocardial infarction.

Primary study

Unclassified

Authors Liu SZ , Romeis JC
Journal Health policy (Amsterdam, Netherlands)
Year 2004
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This paper examines changes in drug utilization following Taiwan's newly implemented National Health Insurance (NHI) outpatient prescription drug cost-sharing program for persons over 65 years old. The study is a hospital outpatient prescription level analysis that adopts a pretest-posttest control group experiment design. Selected measures of outpatient prescription drug utilization are examined for cost-sharing and non cost-sharing groups in cost-sharing periods and pre cost-sharing periods. Additional analyses were conducted comparing older patients with and without chronic diseases and differences for essential and non-essential drugs. Patients over age 65 were drawn from 21 hospitals in the Taipei area using a stratified random sampling method. This paper yields several interesting findings. First, average prescription cost and prescription period increased for both the cost-sharing and non cost-sharing groups. However, the rate of increase was significantly less in the cost-sharing group when compared with the non cost-sharing group. Second, the elderly with non-chronic diseases were more sensitive (i.e., reducing drug utilization) to the drug cost-sharing program when compared with those with chronic diseases. Third, for the elderly with non-chronic diseases average drug cost per prescription experienced a smaller decrease in essential drugs but a moderate increase in non-essential drugs for the cost-sharing group. By contrast, for the non cost-sharing group, average drug cost per prescription increased sharply in non-essential drugs as well as essential drugs. Finally, there was a significant increase in the number of prescriptions as well as drug costs above the upper bound of the cost-sharing schedule. The outpatient drug cost-sharing program implemented by the NHI in Taiwan did not reverse the trend of prescription drug cost increases in hospitals. The significant increase in the number of prescriptions above the upper bound of the cost-sharing schedule implies that the NHI should increase the upper bound. Further analysis needs to evaluate any adverse clinical impact for older patients resulting from policy changes.

Primary study

Unclassified

Journal CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
Year 2002
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BACKGROUND: After a change in Quebec's policy on drug coverage in August 1996, elderly patients' copayments for prescription drugs increased. We assessed the impact of this drug policy reform on prescribing patterns for essential cardiac medications, utilization of medical care and related health outcomes after acute myocardial infarction. METHODS: Patients at least 65 years of age who experienced acute myocardial infarction between 1994 and 1998 were identified through the Quebec discharge summary database. Drug claims databases were analyzed to determine rates of prescription of essential cardiac medications for cohorts of patients admitted before and after the policy reform. The impact on readmissions for cardiac-related complications, outpatient visits to physicians and emergency departments, and mortality rate was also assessed. RESULTS: The proportion of patients who received prescriptions for beta-blockers, angiotensin-converting enzyme inhibitors and lipid-lowering drugs increased over time and, more specifically, did not appear to decline with the change in the drug policy. In addition, the policy reform did not appear to affect persistence of drug therapy (the proportion of time for which patients were covered by prescriptions over the year after discharge). There was no within-class shift from more to less expensive drugs. Use of cardiac procedures increased over time, but this increase was unrelated to the date of the policy reform. Finally, rates of readmission for complications, visits to individual physicians and to emergency departments, and mortality rate were unchanged. The findings did not vary with sex or socioeconomic status. INTERPRETATION: Prescriptions for essential cardiac medications and care related to acute myocardial infarction in elderly patients did not change with increases in out-of-pocket copayment, regardless of sex or socioeconomic status.

Primary study

Unclassified

Journal JAMA : the journal of the American Medical Association
Year 1985
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In a controlled trial of the effects of medical insurance on spending and health status, we previously reported lower average (0.8 mm Hg) diastolic blood pressures with free care than with cost-sharing plans. We show herein that for clinically defined hypertensives, blood pressures with free care were significantly lower (1.9 mm Hg) than with cost-sharing plans, with a larger difference for low-income hypertensives than for high-income hypertensives (3.5 vs 1.1 mm Hg), but similar differences for blacks and whites. The cause of the difference was the additional contact with physicians under free care; this led to better detection and treatment of hypertensives not under care at the start of the study. Free care also led to higher compliance by hypertensives with diet and smoking recommendations and higher use of medication by those who needed it.