Pharmaceuticals: Access, Cost, Pricing, and Directions for the Future. 13th Annual Herbert Lourie Memorial Lecture on Health Policy

Prescription drug expenditures make up less than 10 percent of total personal health care expenditures in the United States, but over the last decade the amount that Americans spend on prescription drugs has grown much faster than any other component of personal health care. For example, between 1999 and 2000, hospital care costs rose about 5 percent, physicians and clinical services 6 percent, while prescription drug expenditures climbed more than 17 percent. In dollar amounts, prescription drug expenditures doubled, from $61 billion to$122 billion, between 1995 and 2000. Is this an unwarranted expense that needs to be controlled, or does it represent increased value, as pharmaceuticals substitute for older, most costly treatments? What is the prevalence of health insurance coverage for prescription drugs, and how does this affect specific populations who have limited or no drug benefits? What are the components of drug prices? And what do we need to consider when we design health care policy? Stephen Soumerai and Patricia Danzon look at several aspects of pharmaceutical drug usage and pricing in the United States, illustrating their observations with their published research findings. They then briefly review recent legislative proposals to broaden public insurance coverage for prescription drugs and make their own policy recommendations.

History bias, study design, and the unfulfilled promise of pay-for-performance policies in health care

Recently, PCD published a longer, related article, “How Do You Know Which Health Care Effectiveness Research You Can Trust? A Guide for the Perplexed,” that was translational in nature. The article used simple graphs and easy-to-understand text—in five case studies—to illustrate how powerful biases, combined with weak study designs that cannot control for them, can yield untrustworthy research on several widespread interventions: influenza vaccination policy, health information technology, drug safety, prevention of childhood obesity and hospital safety (“mortality reduction”) programs. Since this was not a formal methods paper, the target audiences were policy makers, journalists, trainees, and the public. The primary goal was to understand how weak or strong study designs are likely to fail or succeed in controlling for these pervasive biases. At the start of that article, we promised to add to these case examples of common biases and research designs to show why “caution is needed in understanding and accepting the results of research that may have profound and long-lasting effects on health policy and clinical practice.” In this sixth case study, the authors revisit one of the most common and virulent biases, threats of history. Studies can mislead policymakers and clinicians because they fail to control for history, which represents pre-existing or co-occurring changes in study outcomes that were happening with or without the intervention. The policy in this case, pay-for-performance (PfP, see below), is extremely sensitive to this powerful bias because medical practice is always changing as a result of factors unrelated to a policy, such as widespread media or national guidelines supporting a life-saving treatment, e.g., beta blockers for acute MI (1). Without investigating and visualizing outcomes over time before and after a policy or intervention, it is likely that the investigators will attribute such ongoing changes to “effects” of the quality improvement policy, resulting in millions of dollars of waste implementing ineffective PfP policies worldwide

Pharmaceuticals: Access, Cost, Pricing, and Directions for the Future

Prescription drug expenditures make up less than 10 percent of total personal health care expenditures in the United States, but over the last decade the amount that Americans spend on prescription drugs has grown much faster than any other component of personal health care. For example, between 1999 and 2000, hospital care costs rose about 5 percent, physicians and clinical services 6 percent, while prescription drug expenditures climbed more than 17 percent. In dollar amounts, prescription drug expenditures doubled, from $61 billion to$122 billion, between 1995 and 2000. Is this an unwarranted expense that needs to be controlled, or does it represent increased value, as pharmaceuticals substitute for older, most costly treatments? What is the prevalence of health insurance coverage for prescription drugs, and how does this affect specific populations who have limited or no drug benefits? What are the components of drug prices? And what do we need to consider when we design health care policy? Stephen Soumerai and Patricia Danzon look at several aspects of pharmaceutical drug usage and pricing in the United States, illustrating their observations with their published research findings. They then briefly review recent legislative proposals to broaden public insurance coverage for prescription drugs and make their own policy recommendations

Effect of illicit direct to consumer advertising on use of etanercept, mometasone, and tegaserod in Canada: controlled longitudinal study

Objective To assess the impact of direct to consumer advertising of prescription drugs in the United States on Canadian prescribing rates for three heavily marketed drugs—etanercept, mometasone, and tegaserod

Principles of Educational Outreach ('Academic Detailing') to Improve Clinical Decision Making

With the efficacy and costs of medications rising rapidly, it is increasingly important to ensure that drugs be prescribed as rationally as possible. Yet, physicians' choices of drugs frequently fall short of the ideal of precise and cost-effective decision making. Evidence indicates that such decisions can be improved in a variety of ways. A number of theories and principles of communication and behavior change can be found that underlie the success of pharmaceutical manufacturers in influencing prescribing practices. Based on this behavioral science and several field trials, it is possible to define the theory and practice of methods to improve physicians' clinical decision making to enhance the quality and cost-effectiveness of care. Some of the most important techniques of such "academic detailing" include (1) conducting interviews to investigate baseline knowledge and motivations for current prescribing patterns, (2) focusing programs on specific categories of physicians as well as on their opinion leaders, (3) defining clear educational and behavioral objectives, (4) establishing credibility through a respected organizational identity, referencing authoritative and unbiased sources of information, and presenting both sides of controversial issues, (5) stimulating active physician participation in educational interactions, (6) using concise graphic educational materials, (7) highlighting and repeating the essential messages, and (8) providing positive reinforcement of improved practices in follow-up visits. Used by the nonprofit sector, the above techniques have been shown to reduce inappropriate prescribing as well as unnecessary health care expenditures

Health care payments in the asia pacific: validation of five survey measures of economic burden

Introduction: Many low and middle-income countries rely on out-of-pocket payments to help finance health care. These payments can pose financial hardships for households; valid measurement of this type of economic burden is therefore critical. This study examines the validity of five survey measures of economic burden caused by health care payments. Methods: We analyzed 2002/03 World Health Survey household-level data from four Asia Pacific countries to assess the construct validity of five measures of economic burden due to health care payments: any health expenditure, health expenditure amount, catastrophic health expenditure, indebtedness, and impoverishment. We used generalized linear models to assess the correlations between these measures and other constructs with which they have expected associations, such as health care need, wealth, and risk protection. Results: Measures of impoverishment and indebtedness most often correlated with health care need, wealth, and risk protection as expected. Having any health expenditure, a large health expenditure, or even a catastrophic health expenditure did not consistently predict degree of economic burden. Conclusions: Studies that examine economic burden attributable to health care payments should include measures of impoverishment and indebtedness

Measuring access to effective care among elderly medicare enrollees in managed and fee-for-service care: a retrospective cohort study

BACKGROUND: Our aim was to compare access to effective care among elderly Medicare patients in a Staff Model and Group Model HMO and in Fee-for-Service (FFS) care. METHODS: We used a retrospective cohort study design, using claims and automated medical record data to compare achievement on quality indicators for elderly Medicare recipients. Secondary data were collected from 1) HMO data sets and 2) Medicare claims files for the time period 1994–95. All subjects were Medicare enrollees in a defined area of New England: those enrolled in two divisions of a managed care plan with different physician payment arrangements: a staff model, and a group model; and the Medicare FFS population. We abstracted information on indicators covering several domains: preventive, diagnosis-specific, and chronic disease care. RESULTS: On the indicators we created and tested, access in the single managed care plan under study was comparable to or better than FFS care in the same geographic region. Percent of Medicare recipients with breast cancer screening was 36 percentage points higher in the staff model versus FFS (95% confidence interval 34–38 percentage points). Follow up after hospitalization for myocardial infarction was 20 percentage points higher in the group model than in FFS (95% confidence interval 14–26 percentage points). CONCLUSION: According to indicators developed for use in both claims and automated medical record data, access to care for elderly Medicare beneficiaries in one large managed care organization was as good as or better than that in FFS care in the same geographic area

Examining Product Risk in Context. Market Withdrawal of Zomepirac as a Case Study

Objective. —To examine changes in the prescribing of analgesics after the market entry and subsequent withdrawal of zomepirac sodium, a nonsteroidal anti-inflammatory drug (NSAID), following repeated reports of zomepirac-related deaths. Design. —To evaluate this natural quasi experiment, we conducted time-series analyses to compare prescribing in two cohorts of primary care physicians from July 1980 through September 1983. Setting. —Study physicians provided outpatient pharmaceutical care to patients enrolled in the New Jersey Medicaid program. Participants. —We identified 260 primary care physicians who provided 10 or more prescriptions for zomepirac (zomepirac prescribers) and 308 who provided 10 or more prescriptions for NSAIDs other than zomepirac (other-NSAID prescribers) in Medicaid during the study period. Main Outcome Measures. —Monthly rates of prescribing for zomepirac and several categories of substitute analgesics among Medicaid patients seen by study physicians. Main Results. —Zomepirac accounted for a stable 11.0% of analgesic prescribing among the zomepirac-prescriber cohort; label changes and manufacturer product-risk warnings 11 months before the product's withdrawal from the market had no impact on use. After market entry, zomepirac prescribers reduced use of other NSAIDs and propoxyphene (hydrochloride or napsylate) in comparison with other-NSAID prescribers (-8.1% and -2.8% of total analgesic prescribing, respectively; P<.001). After the product's withdrawal from the market, zomepirac prescribers showed significant increases in relative prescribing of other NSAIDs (+6.8%; P<.001), propoxyphene (+2.1%; P<.05), and analgesics containing barbiturates (+2.7%; P<.001). Conclusions. —The sudden withdrawal of zomepirac from the market resulted in substitutions not only of other NSAIDs, but also of alternative analgesics that carry risks of habituation and adverse effects. Apparent gains in patient safety resulting from market withdrawal of medications must be evaluated in comparison with risks of medications likely to be substituted.(JAMA. 1993;270:1937-1942

Barriers to self-monitoring of blood glucose among adults with diabetes in an HMO: A cross sectional study

BACKGROUND: Recent studies suggest that patients at greatest risk for diabetes complications are least likely to self-monitor blood glucose. However, these studies rely on self-reports of monitoring, an unreliable measure of actual behavior. The purpose of the current study was to examine the relationship between patient characteristics and self-monitoring in a large health maintenance organization (HMO) using test strips as objective measures of self-monitoring practice. METHODS: This cross-sectional study included 4,565 continuously enrolled adult managed care patients in eastern Massachusetts with diabetes. Any self-monitoring was defined as filling at least one prescription for self-monitoring test strips during the study period (10/1/92–9/30/93). Regular SMBG among test strip users was defined as testing an average of once per day for those using insulin and every other day for those using oral sulfonylureas only. Measures of health status, demographic data, and neighborhood socioeconomic status were obtained from automated medical records and 1990 census tract data. RESULTS: In multivariate analyses, lower neighborhood socioeconomic status, older age, fewer HbA1c tests, and fewer physician visits were associated with lower rates of self-monitoring. Obesity and fewer comorbidities were also associated with lower rates of self-monitoring among insulin-managed patients, while black race and high glycemic level (HbA1c>10) were associated with less frequent monitoring. For patients taking oral sulfonylureas, higher dose of diabetes medications was associated with initiation of self-monitoring and HbA1c lab testing was associated with more frequent testing. CONCLUSIONS: Managed care organizations may face the greatest challenges in changing the self-monitoring behavior of patients at greatest risk for poor health outcomes (i.e., the elderly, minorities, and people living in low socioeconomic status neighborhoods)