Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies demonstrating that broader prescription drug insurance reduces use of other health care services and has a positive impact on patient outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the Affordable Care Act expansions in drug coverage to improve the health of low-income patients receiving state-based health insurance. (Am J Public Health. Published online ahead of print December 18, 2014: e1-e14. doi:10.2105/AJPH.2014.302240).
BACKGROUND: Growing expenditures on prescription medicines represent a major challenge to many health systems. Cap and co-payment policies are intended as an incentive to deter unnecessary or marginal utilisation, and to reduce third-party payer expenditures by shifting parts of the financial burden from insurers to patients, thus increasing their financial responsibility for prescription medicines. Direct patient payment policies include caps (maximum numbers of prescriptions or medicines that are reimbursed), fixed co-payments (patients pay a fixed amount per prescription or medicine), co-insurance (patients pay a percentage of the price), ceilings (patients pay the full price or part of the cost up to a ceiling, after which medicines are free or are available at reduced cost) and tier co-payments (differential co-payments usually assigned to generic and brand medicines). This is the first update of the original review.
OBJECTIVES: To determine the effects of cap and co-payment (cost-sharing) policies on use of medicines, healthcare utilisation, health outcomes and costs (expenditures).
SEARCH METHODS: For this update, we searched the following databases and websites: The Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Library; MEDLINE, Ovid; EMBASE, Ovid; IPSA, EBSCO; EconLit, ProQuest; Worldwide Political Science Abstracts, ProQuest; PAIS International, ProQuest; INRUD Bibliography; WHOLIS, WHO; LILACS), VHL; Global Health Library WHO; PubMed, NHL; SCOPUS; SciELO, BIREME; OpenGrey; JOLIS Library Network; OECD Library; World Bank e-Library; World Health Organization, WHO; World Bank Documents & Reports; International Clinical Trials Registry Platform (ICTRP), WHO; ClinicalTrials.gov, NIH. We searched all databases during January and February 2013, apart from SciELO, which we searched in January 2012, and ICTRP and ClinicalTrials.gov, which we searched in March 2014.
SELECTION CRITERIA: We defined policies in this review as laws, rules or financial or administrative orders made by governments, non-government organisations or private insurers. We included randomised controlled trials, non-randomised controlled trials, interrupted time series studies, repeated measures studies and controlled before-after studies of cap or co-payment policies for a large jurisdiction or system of care. To be included, a study had to include an objective measure of at least one of the following outcomes: medicine use, healthcare utilisation, health outcomes or costs (expenditures).
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study limitations. We reanalysed time series data for studies with sufficient data, if appropriate analyses were not reported.
MAIN RESULTS: We included 32 full-text articles (17 new) reporting evaluations of 39 different interventions (one study - Newhouse 1993 - comprises five papers). We excluded from this update eight controlled before-after studies included in the previous version of this review, because they included only one site in their intervention or control groups. Five papers evaluated caps, and six evaluated a cap with co-insurance and a ceiling. Six evaluated fixed co-payment, two evaluated tiered fixed co-payment, 10 evaluated a ceiling with fixed co-payment and 10 evaluated a ceiling with co-insurance. Only one evaluation was a randomised trial. The certainty of the evidence was found to be generally low to very low.Increasing the amount of money that people pay for medicines may reduce insurers' medicine expenditures and may reduce patients' medicine use. This may include reductions in the use of life-sustaining medicines as well as medicines that are important in treating chronic conditions and medicines for asymptomatic conditions. These types of interventions may lead to small decreases in or uncertain effects on healthcare utilisation. We found no studies that reliably reported the effects of these types of interventions on health outcomes.
AUTHORS' CONCLUSIONS: The diversity of interventions and outcomes addressed across studies and differences in settings, populations and comparisons made it difficult to summarise results across studies. Cap and co-payment polices may reduce the use of medicines and reduce medicine expenditures for health insurers. However, they may also reduce the use of life-sustaining medicines or medicines that are important in treating chronic, including symptomatic, conditions and, consequently, could increase the use of healthcare services. Fixed co-payment with a ceiling and tiered fixed co-payment may be less likely to reduce the use of essential medicines or to increase the use of healthcare services.
OBJECTIVES: To evaluate the effects of health insurance benefit designs that introduced or increased the price difference between prescription drugs representing potential clinical substitutes.
STUDY DESIGN: Systematic review of peer-reviewed articles.
METHODS: Using English-language articles listed in PubMed between 1980 and 2012, we identified articles meeting our inclusion criteria and minimum methodological standards. We compared findings regarding the immediate patient response, total spending, and health outcomes after implementing the price change.
RESULTS: Among the 31 articles identified, the mechanisms varied for creating the price differential between prescription drug substitutes, though they most frequently involved tiered formularies (19) or reference pricing (10). While nearly all studies (29 of 31) reported on patient responses to price changes, only 5 articles comprehensively assessed patient price responses, total spending, and health outcomes. Several studies found that some patients switched to cheaper drugs, but out-of-pocket spending increased on average, suggesting that other patients continued using the more expensive drug (ie, cost shifting to patients). Few studies examined the degree of heterogeneity in behavior responses, especially between patient cohorts for whom the substitute drugs had varying value. Some studies observed long-term effects, but most had limited post intervention observation periods.
CONCLUSIONS: Differential cost-sharing designs influence drug use behavior, but there is limited evidence on how these designs affect the overall value of received care. The existing literature provides limited guidance for policy makers or organizational leaders to design benefits. We offer suggestions for future studies to inform policy and practice.
Objective: To review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry. Method: Systematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients’ or providers’ behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented. Results: A total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as nonessential drugs, and without adequate exemptions they affect vulnerable groups disproportionately. The majority of studies relating to doctors evaluated the effects of educational approaches (78 studies), reimbursement restrictions (48 studies) and incentive systems (22 studies). Evidence on these policies is of mixed quality. It appears possible to influence prescribing modestly, through various means, but it is essential that messages to prescribers are based on good evidence of effectiveness and cost-effectiveness. Twenty-nine studies related to industry regulation, and they were of mixed quality. Evidence from studies of reference pricing suggests that this may result in cost savings. These are, however, achieved not by companies reducing or restraining prices, or by reductions in the overall volume of prescriptions, but by some shifts in use and shifting costs to patients, with consequent adverse effects on the equity of access to medicines. Other price and profit controls remain almost completely lacking in evaluative evidence. Conclusions: It may be that the undesirable consequences of policies influencing patients, particularly user charges, can outweigh the benefits. To influence demand for pharmaceuticals, it is more appropriate to influence prescribing doctors and although interventions to improve prescribing practice have been developed, they often achieve relatively modest benefits and sometimes at high cost. Good evaluative evidence related to industry regulation is scarce despite its policy importance.
BACKGROUND: There is extensive literature demonstrating that formulary restrictions reduce the pharmacy costs and utilization of restricted drugs. However, some research suggests that there may be unintended consequences of formulary restrictions on other patient outcomes. While several literature reviews have assessed the relationship between formulary restrictions and medication adherence, clinical outcomes, economic outcomes, or health care resource utilization, these reviews were either not systematic, were conducted more than 5 years ago, or did not assess the aggregate directional impact of the relationships.
OBJECTIVE: To conduct a systematic literature review assessing the direction (positive, negative, or neutral) of the relationship between managed care formulary restrictions (including step therapy, cost sharing, prior authorization, preferred drug lists, and quantity limits) on medication adherence, clinical outcomes, economic outcomes, and health care resource utilization.
METHODS: Articles published in 1993 or later were identified from PubMed using 2 lists of search terms. List A included 12 formulary restriction terms and List B included 12 patient outcomes terms, resulting in 144 unique search term combinations. Each article was evaluated by 2 investigators against the following exclusion criteria using a stepwise approach: (a) the article was a commentary or review article; (b) the article did not assess the impact of managed care formulary restrictions on outcomes; and (c) the study was conducted outside the United States. The total number of studies was reported by formulary restriction type. Next, the total number of outcomes reported in each study was summed to conduct an outcomes-level analysis. The outcomes were categorized by type of outcome (medication adherence, clinical, economic, or health care resource utilization) and direction of association (positive, negative, or neutral/not significant) based on the relationship reported in each study. The frequencies of each type of outcome were stratified by direction of association.
RESULTS: A total of 93 studies were included from 811 reviewed articles. Cost sharing was the most commonly assessed type of formulary restriction (60.2% of included articles), followed by prior authorization (21.5%). Of the 262 patient outcomes assessed, medication adherence was the most common (120 outcomes, 45.8%). Overall, formulary restrictions were most frequently negatively correlated with outcomes (130 outcomes, 49.6%). When outcome type was stratified by direction of association, 68.3% (82/120) of medication adherence outcomes were negative. The direction of association of economic outcomes (n = 59) with formulary restrictions was split between neutral (37.3%), positive (33.9%), and negative (28.8%). Health care resource utilization outcomes (n = 72) had no association with formulary restrictions in 50.0% of the outcomes assessed. There were 11 clinical outcomes identified in the literature review.
CONCLUSIONS: There is a strong evidence base demonstrating a negative correlation between formulary restrictions on medication adherence outcomes. Additional research on commonly used formulary restrictions, specifically prior authorization and step therapy, as well as on the association between formulary restrictions and clinical outcomes, is warranted.
This article reviews the quantitative evidence on the behavioural effects of copayment within the health area across a wide range of countries. The review distinguishes itself from previous similar reviews by having a high degree of transparency for the search strategy used to identify the studies included in the review as well as the criteria for inclusion and by including the most recent literature. Empirical studies were identified by performing searches in EconLit. The literature search identified a total of 47 studies of the behavioural effects of copayment. Considering the demand effects, the majority of the reviewed studies found that copayment reduces the use of prescription medicine, consultations with general practitioners and specialists, and ambulatory care, respectively. The literature found no significant effects of copayment on the prevalence of hospitalisations. The empirical evidence on whether copayment for some services, but not for others, causes substitution from the services that are subject to copayment to the 'free' services rather than lower total use is sparse and mixed. Likewise, the health effects of copayment have only been analysed empirically in a limited number of studies, of which half did not find any significant effects in the short term. Finally, the empirical evidence on the distributional consequences of copayment indicates that individuals with low income and in particular need of care generally reduce their use relatively more than the remaining population in consequence of copayment. Hence, it is clear that copayment involves some important economic and political trade-offs.
BACKGROUND: Out-of-pocket payments can have a large impact on the demand for healthcare. They can be essential not only to decrease unnecessary service use, but also to encourage the use of particular preventive services provided free of charge or at a lower price. Moreover, out-of-pocket payments may increase the costs of unhealthy behaviour and provide incentives for a healthier lifestyle.
METHOD: This study systematically reviews empirical evidence on the effects of out-of-pocket payments on the use of preventive services and health-related lifestyle. All possible combinations of three key words 'prevention', 'patient payment' and 'health-related behaviour' were searched in PUBMED, ECONLITH, ECONPAPER and EMBASE. In total, 47 relevant publications were identified.
RESULTS: The results suggest that out-of-pocket payments can create a financial barrier and can decrease the use of preventive services and the uptake of preventive medications. A few studies (with contradicting empirical evidence) address the impact of cost sharing and reduced insurance coverage on a healthier lifestyle.
CONCLUSION: Although the great diversity of study designs (various indicators of out-of-pocket payments and preventive/health-related behaviour) makes it difficult to offer robust policy recommendations, our findings support calls to reconsider how preventive services should be financed. More research is needed to explore the actual impact of cost sharing on different aspects of health-related lifestyles, as well as to explain the role of other relevant determinants that could impact this relationship.
BACKGROUND: Emergency department (ED) utilization has dramatically increased in developed countries over the last twenty years. Because it has been associated with adverse outcomes, increased costs, and an overload on the hospital organization, several policies have tried to curb this growing trend. The aim of this study is to systematically review the effectiveness of organizational interventions designed to reduce ED utilization.
METHODOLOGY/PRINCIPAL FINDINGS: We conducted electronic searches using free text and Medical Subject Headings on PubMed and The Cochrane Library to identify studies of ED visits, re-visits and mortality. We performed complementary searches of grey literature, manual searches and direct contacts with experts. We included studies that investigated the effectiveness of interventions designed to reduce ED visits and the following study designs: time series, cross-sectional, repeated cross-sectional, longitudinal, quasi-experimental studies, and randomized trial. We excluded studies on specific conditions, children and with no relevant outcomes (ED visits, re-visits or adverse events). From 2,348 potentially useful references, 48 satisfied the inclusion criteria. We classified the interventions in mutually exclusive categories: 1) Interventions addressing the supply and accessibility of services: 25 studies examined efforts to increase primary care physicians, centers, or hours of service; 2) Interventions addressing the demand for services: 6 studies examined educational interventions and 17 examined barrier interventions (gatekeeping or cost).
CONCLUSIONS/SIGNIFICANCE: The evidence suggests that interventions aimed at increasing primary care accessibility and ED cost-sharing are effective in reducing ED use. However, the rest of the interventions aimed at decreasing ED utilization showed contradictory results. Changes in health care policies require rigorous evaluation before being implemented since these can have a high impact on individual health and use of health care resources. Systematic review registration: http://www.crd.york.ac.uk/PROSPERO. Identifier: CRD420111253.
OBJECTIVE: We sought to assess the relationship between patient cost sharing; medication adherence; and clinical, utilization, and economic outcomes.
METHODOLOGY: We conducted a literature review of articles and abstracts published from January 1974 to May 2008. Articles were identified using PubMed, Ovid, medline, Web of Science, and Google Scholar databases. The following terms were used in the search: adherence, compliance, copay, cost sharing, costs, noncompliance, outcomes, hospitalization, utilization, economics, income, and persistence.
RESULTS: We identified and included 160 articles in the review. Although the types of interventions, measures, and populations studied varied widely, we were able to identify relatively clear relationships between cost sharing, adherence, and outcomes. Of the articles that evaluated the relationship between changes in cost sharing and adherence, 85% showed that an increasing patient share of medication costs was significantly associated with a decrease in adherence. For articles that investigated the relationship between adherence and outcomes, the majority noted that increased adherence was associated with a statistically significant improvement in outcomes.
CONCLUSION: Increasing patient cost sharing was associated with declines in medication adherence, which in turn was associated with poorer health outcomes.
Drug insurance schemes are systems that provide access to medicines on a prepaid basis and could potentially improve access to essential medicines and reduce out-of-pocket payments for vulnerable populations.
, OBJECTIVES:
To assess the effects on drug use, drug expenditure, healthcare utilisation and healthcare outcomes of alternative policies for regulating drug insurance schemes.
, SEARCH METHODS:
We searched CENTRAL, MEDLINE, Embase, nine other databases, and two trials registers between November 2014 and September 2020, including a citation search for included studies on 15 September 2021 using Web of Science. We screened reference lists of all the relevant reports that we retrieved and reports from the Background section. Authors of relevant papers, relevant organisations, and discussion lists were contacted to identify additional studies, including unpublished and ongoing studies.
, SELECTION CRITERIA:
We planned to include randomised trials, non-randomised trials, interrupted time-series studies (including controlled ITS [CITS] and repeated measures [RM] studies), and controlled before-after (CBA) studies. Two review authors independently assessed the search results and reference lists of relevant reports, retrieved the full text of potentially relevant references and independently applied the inclusion criteria to those studies. We resolved disagreements by discussion, and when necessary by including a third review author. We excluded studies of the following pharmaceutical policies covered in other Cochrane Reviews: those that determined how decisions were made about which conditions or drugs were covered; those that placed restrictions on reimbursement for drugs that were covered; and those that regulated out-of-pocket payments for drugs.
, DATA COLLECTION AND ANALYSIS:
Two review authors independently extracted data from the included studies and assessed risk of bias for each study, with disagreements being resolved by consensus. We used the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials and controlled before-after studies, we planned to report relative effects. For dichotomous outcomes, we reported the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For interrupted time series and controlled interrupted time-series studies, we computed changes along two dimensions: change in level; and change in slope. We undertook a structured synthesis following the EPOC guidance on this topic, describing the range of effects found in the studies for each category of outcomes.
, MAIN RESULTS:
We identified 58 studies that met the inclusion criteria (25 interrupted time-series studies and 33 controlled before-after studies). Most of the studies (54) assessed a single policy implemented in the United States (US) healthcare system: Medicare Part D. The other four assessed other drug insurance schemes from Canada and the US, but only one of them provided analysable data for inclusion in the quantitative synthesis. The introduction of drug insurance schemes may increase prescription drug use (low-certainty evidence). On the other hand, Medicare Part D may decrease drug expenditure measured as both out-of-pocket spending and total drug spending (low-certainty evidence). Regarding healthcare utilisation, drug insurance policies (such as Medicare Part D) may lead to a small increase in visits to the emergency department. However, it is uncertain whether this type of policy increases or decreases hospital admissions or outpatient visits by beneficiaries of the scheme because the certainty of the evidence was very low. Likewise, it is uncertain if the policy increases or reduces health outcomes such as mortality because the certainty of the evidence was very low.
