Pharmaceutical Markets and Insurance Worldwide: Volume 22

Pedro Pita Barros reviews pharmaceutical policies adopted by health care systems in European (OECD) countries. He notes that cost-sharing for pharmaceuticals is higher than cost-sharing for other services. However, although pharmaceutical cost-sharing is pervasive across the European Union, concerns over equity have led most countries to adopt sliding fee schedules and even outright exemptions from copayments for vulnerable populations such as the elderly and low income households. The most common form of price regulation in these countries is reference pricing, either “external” (pegging pharmaceutical payments to lowest prices in a group of countries) or “internal” (pegging pharmaceutical prices to the lowest price within a therapeutic class), as well as outright administrative price controls. In his theoretical results, Barros shows that reference pricing lowers cost to consumers the most, followed by administrative price lists, while the pure coinsurance system yields the higher total cost. To foster innovation, Barros proposes adoption of innovative payment schemes based on supply-side risk sharing whereby payments to drug manufacturers are tied to treatment results and patient outcomes. Such schemes are akin to pay-for performance methods used to reimburse physicians in certain managed care settings in the United States.

Purpose – Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers.

Methodology – To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies.

Findings – Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a “silver bullet” to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Purpose – Although the US has lagged behind international developments in health technology assessment (HTA), renewed interest in HTA in the US has been fueled by the appropriation of $1.1 billion comparative effectiveness research (CER) in 2009 and the debate over health care reform.

Approach – To inform CER practices in the US, we present case studies of HTA from England/Wales and Germany: contrasting methods; relevance to the US; and impact on innovation.

Findings – The National Institute of Health and Clinical Excellence (NICE) was established in 1999 to inform trusts within the National Health Service of England and Wales. It uses cost-effectiveness analysis to guide the allocation resource across preventative and curative interventions. In Germany, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) was established in 2004 to inform reimbursement and pricing policies for the statutory sickness funds set by the Gemeinsamer Bundesausschuss (G-BA). IQWiG evaluates competing technologies within specific therapeutic areas, placing more weight on clinical evidence and the relative efficiency of competing therapies.

Practical implications – Although having deep political and cultural antecedents, differences between NICE and IQWiG can be explained by perspective: the former guiding resource allocation across an entire system (macro-evaluation), the latter focusing on efficiency within the bounds of a particular therapeutic area (micro-evaluation). Given the decentralized nature of the US health care system, and the relative powers of different medical specialties, the IQWiG model presents a more suitable case study to guided CER efforts in the US.

Purpose – To analyse the development of pharmaceutical policy in the Dutch market for outpatient prescription drugs since the early 1990s.

Methodology – A literature review and document analysis is performed to examine the effects of pharmaceutical policy on the performance of the Dutch market for outpatient prescription drugs since the early 1990s.

Findings – Government efforts to control prices of pharmaceuticals were effective in constraining prices of in-patent drugs, but had an opposite effect on the prices of generic drugs. The gradual transition towards managed competition – that particularly gained momentum after the introduction of the new universal health insurance scheme in 2006 – appears to be more effective in constraining prices of generic drugs than earlier government efforts to control these prices.

Originality – Comparative analysis of the impact of price regulation and managed competition on generic drug prices in the Netherlands.

Implications – Implications of the changing role of health insurers are discussed for the future market for prescription drugs and role of pharmacies in the Netherlands.

Purpose – There is a particular need for health policy evaluations in terms of achievement of goals, which may help inform policy-making not only locally but for the wider international policy community. In this chapter, we review the impact of pharmaceutical regulation and policies in Israel on a range of health system performance goals that, in the pharmaceutical context, are mainly related to ensuring the availability, accessibility and affordability of medicines.

Approach – We assess pharmaceutical policies and their impact, within the Israeli National Health Insurance (NHI) system enacted in 1995, on the degree to which the following main policy goals are being achieved: containment of drug expenditures; sustainability and equity of financing for pharmaceuticals; efficiency of expenditure in the pharmaceutical sector; and availability and accessibility of pharmaceuticals.

Findings – The findings point to a number of accomplishments as well as outstanding challenges. The main accomplishment is successful cost containment of (public) expenditure on medicines. Government price regulation operates as a mechanism responsible for sickness funds’ (SFs) savings, over which the state has no information or monitoring. Although the package of publicly financed drugs is comprehensive, delays in reimbursement decisions and high level of cost sharing mean that medicines have become increasingly unaffordable for many patients, especially for low-income persons with chronic diseases.

Implications – Regulation of the pharmaceutical sector should focus on two aspects: decreasing the information gap between the SFs and the regulator and reforming the cost-sharing policy to increase affordability and equity.

Purpose – This chapter examines how drug prescribing behavior in Taiwanese hospitals changed after the government changed reimbursement systems. In 2002, Taiwan instituted a system in which hospitals are reimbursed for drug expenditures at full price from a fixed global budget before the remaining budget is allocated to reimburse all other expenditures, often at discounted prices. Providers are thus given a financial incentive to increase prescriptions.

Methodology – We isolate the effect of this system from that of other confounding factors by estimating a difference-in-difference model to analyze monthly drug expenditures of hospital departments for outpatients during the years 1999–2006.

Findings – Our results suggest that hospital departments which use drugs more heavily as part of their regular medical care increased their drug prescription expenditures after the implementation of the global budget system. In addition, we find that the response was stronger among for-profit than not-for-profit and public hospitals.

Implications – Hospital doctors responded to the financial incentive created by the particular global budgeting system adopted in Taiwan by increasing expenditures on drug treatments for outpatients.

Purpose – As Medicare Part D enters its fifth year, we assess how the supply side of the market has evolved and what research has shown about how Medicare drug coverage has affected consumers.

Methods – We conduct descriptive data analyses to explore the varied nature of Medicare standalone prescription drug plans (in terms of both price and non-price features), examine features associated with high enrollment, and show trends over time in both plan design and enrollment patterns from 2006 to 2010. We also review existing evidence about Part D's effects on drug access for beneficiaries and conclude with a discussion of current policy concerns.

Findings – Medicare Part D has been successful in certain ways, but several areas of concern remain. Although it is a measure of success that 90% of Medicare beneficiaries now have drug coverage, efforts continue to reach the vulnerable populations who are not yet signed up. Use of medications (and relative use of generics) has increased under the program, while out of pocket costs have fallen. Policymakers continue to question government's role in areas such as negotiating prices directly with pharmaceutical manufacturers and limiting the number of plans offered. Results from data analysis indicate, among other things, high growth in premiums, whereas plans have become less generous by certain measures.

Originality – This chapter brings together data on all plans offered in Medicare Part D standalone drug coverage market and shows new evidence on the landscape's rapid evolution.

Purpose – To estimate the impact of diabetic drug adherence on hospitalizations, emergency room (ER) visits, and hospital costs.

Methods – It is often difficult to measure the impact of drug adherence on hospitalizations since both adherence and hospitalizations may be correlated with unobservable patient severity. We control for such unobservables using propensity score methods and instrumental variables for adherence such as drug coinsurance levels and direct-to-consumer advertising.

Findings – We find a significant bias due to unobservable severity in that patients with more severe health are more apt to comply with medications. Thus, the relationship between adherence and hospitalization will be underestimated if one does not control for unobservable severity. Overall, we find that increasing diabetic drug adherence from 50% to 100% reduces the hospitalization rate by 23.3% from 15% to 11.5%. ER visits reduce by 46.2% from 17.3% to 9.3%. Although such an increase in adherence increases diabetic drug spending by $776 a year per diabetic, the cost savings for averted hospitalizations and ER visits are $886 per diabetic, a cost offset of $1.14 per $1.00 spent on diabetic drugs.

Originality – Most of the drug cost-offset literature focuses only on the impact of cost-sharing and drug spending on cost-offsets, making it impossible to back-out the empirical impact of actual drug adherence on cost-offsets. In this chapter, we estimate the direct impact of adherence on hospitalizations and costs.

Purpose – The authors focus on understanding the relationship between costs and cost sharing on medication adherence for individuals who initiated a disease-modifying therapy (DMT) for the treatment of multiple sclerosis (MS). DMTs reduce the risk of relapse and are an essential component of MS treatment. Furthermore, the authors compare monthly payment levels for copayments versus coinsurance and estimate the effects on adherence.

Methods – Using the MarketScan Commercial Claims and Encounters database evidence from July 1 2005 to March 31 2008, the authors employ a multivariate two-stage least-squares model (2SLS) to examine the impact of copayments or coinsurance on the medication possession ratio (MPR).

Findings – Descriptive results show that the mean out-of-pocket (OOP) costs of DMT per month were higher for patients with coinsurance than for patients with copayments. For the cohort of patients with copayment there was little difference in monthly copayments across adherence thresholds. Regression analysis shows that an increase in cost sharing reduces adherence overall, but this effect was small and insignificant in the copayment cohort. In contrast, in the coinsurance cohort increased cost sharing was significantly associated with decreased adherence to DMT medication; with a 10% increase in cost sharing leading to an 8.6% decline in adherence.

Implications – Employers increasingly rely on coinsurance, despite evidence that reliance on coinsurance results in lower adherence. Our research findings suggest that coinsurance appears to be a greater obstacle to compliance, confirming predictions found in the theoretical literature.

Originality – This research converted counts of injectable treatments into a continuous adherence measure. Previous literature on cost sharing did not examine MS.

Purpose – The purpose of this study is to estimate the own- and cross-price elasticity of brand-name outpatient prescription drug cost-sharing for maintenance medications and to estimate the effects of changes in the price differential between generic and brand-name prescription drugs.

Methodology/approach – We first review the literature on the effects of an increase in brand-name drug patient cost-sharing. In addition, we analyze two examples of utilization patterns in filling behavior associated with an increase in brand-name cost-sharing for patients in employer-sponsored health plans with chronic illness.

Findings – We found that the own-price elasticity of demand for brand-name prescription drugs was inelastic. However, the cross-price elasticity was not consistent in sign, and utilization patterns for generic prescription fills did not always increase after a rise in brand-name cost-sharing.

Research limitations – The empirical examples are limited to the experience of patients with employer-sponsored health insurance.

Practical implications – The common practice of increasing brand-name prescription drug patient cost-sharing to increase consumption of generic drugs may not always result in higher generic medication use. Higher brand-name drug cost-sharing levels may result in discontinuation of chronic therapies, instead of therapeutic switching.

Originality/value of chapter – The value of this chapter is its singular focus on the effects of higher brand-name drug cost-sharing through a synthesis of the literature examining the own- and cross-price elasticity of demand for brand-name medications and two empirical examples of the effects of changes in brand-name cost-sharing.

Purpose – To examine how drug prices for specific diseases vary across payers in the United States and how insurer and patient out-of-pocket (OOP) costs vary by payer type.

Methodology – This study uses data from the Medical Expenditure Panel Survey (MEPS) from 1996 to 2006. We estimate multivariate price regressions for four major drug product classes (antihypertensive, antidepressant, antiasthma drugs, and non-steroidal anti-inflammatory drugs (NSAIDs)). Separate models are estimated for brand and generic drugs within each of these drug product classes. In addition to estimating overall transaction price equations for brands and generics, the study estimates patient OOP payments and insurer payments for drugs.

Findings – We find relatively modest differences among payers in terms of total prices (e.g., insurer plus OOP). The main difference is in terms of how prices were shared between insurers and patients. Medicaid paid significantly more than other payers for each drug class, while Medicaid beneficiaries paid significantly less.

Research implications – Our results shed light on how drug prices vary by different payers and how drug prices are shared by third party payers and patients. The relatively modest differences in total drug prices across payer type suggest that these payers do not differ greatly in terms of their ability to negotiate price concessions from their suppliers. Instead, larger differences emerge in terms of how total costs are shared among the payer and their patients. Understanding the reasons for these variations, and their implications for health outcomes, are important directions for further research.

Purpose – To examine the effects of health insurance types on the use of prescribed medication that treat patients with hypertension, diabetes, and asthma. The study distinguishes between individuals with private health maintenance organization (HMO) plans and private non-HMO plans. The study also distinguishes between people with health insurance and drug coverage and people with health insurance and no drug coverage.

Methods – Joint discrete factor models are estimated to control for endogeneity of each type of coverage.

Findings – The main findings suggest that the effect of health insurance varies across patients with different conditions. The strongest and most significant effect is evident among patients with hypertension while the weakest and least significant is among patients with asthma. These findings suggest that patients with asymptomatic conditions are more likely to exhibit moral hazard than patients with conditions that impose immediate impairment. Additional results suggest that, relative to the uninsured and people with health insurance but no drug coverage, patients with drug coverage are more likely to initiate drug therapy and to consume more medications.

Originality – The results of the study indicate that moral hazard of drug utilization is condition specific. The variation in “silence” of conditions’ symptoms could be a key reason for difference in insurance effects among patients with hypertension, diabetes, and asthma.

Using micro data on virtually all of the drugs and diseases of over 500,000 people enrolled in Puerto Rico's Medicaid program, the impact of the vintage (original FDA approval year) of drugs used to treat a patient on the patient's three-year probability of survival, controlling for demographic characteristics (age, sex, and region), utilization of medical services, and the nature and complexity of illness are examined. It is found that people using newer drugs during January–June, 2000, were less likely to die by the end of 2002, conditional on the covariates. The estimated mortality rates are strictly declining with respect to drug vintage. For pre-1970 drugs, the estimated mortality rate is 4.4%. The mortality rates for 1970s, 1980s, and 1990s drugs are 3.6%, 3.0%, and 2.5%, respectively. The actual mortality rate is about 16% (3.7% vs. 4.4%) lower than it would have been if all of the drugs utilized in 2000 had been pre-1970 drugs. Estimates for subgroups of people with specific diseases display the same general pattern.

Objective – To examine whether local area pharmacy market structure influences contract terms between prescription drug plans (PDPs) and pharmacies under Part D.

Data – Data were collected and compiled from four sources: a national mail survey to independent pharmacies, National Council for Prescription Drug Programs (NCPDP) Pharmacy database, 2000 U.S. Census data, and 2006 Economic Census data.

Results – Reimbursements varied substantially across pharmacies. Reimbursement for 20mg Lipitor (30 tablets) ranged from $62.40 to $154.80, and for 10mg Lisinopril (30 tablets), it ranged from $1.05 to $18. For brand-name drug Lipitor, local area pharmacy ownership concentration had a consistent positive effect on pharmacy bargaining power across model specifications (estimates between 0.084 and 0.097), while local area per capita income had a consistent negative effect on pharmacy bargaining power across specifications(−0.149 to −0.153). Few statistically significant relationships were found for generic drug Lisinopril.

Conclusion – Significant variation exists in PDP reimbursement and pharmacy bargaining power with PDPs. Pharmacy bargaining power is negatively related to the competition level and the income level in the area. These relationships are stronger for brand name than for generics. As contract offers tend to be non-negotiable, variation in reimbursements and pharmacy bargaining power reflect differences in initial insurer contract offerings. Such observations fit Rubinstein's subgame perfect equilibrium model.

Implication – Our results suggest pharmacies at the most risk of closing due to low reimbursements are in areas with many competing pharmacies. This implies that closures related to Part D changes will have limited effect on Medicare beneficiaries’ access to pharmacies.

Purpose – To evaluate the efficiency consequences of the Medicare Part D program.

Methods – We develop and empirically calibrate a simple theoretical model to examine the static and the dynamic welfare effects of Medicare Part D.

Findings – We show that Medicare Part D can simultaneously reduce static deadweight loss from monopoly pricing of drugs and improve incentives for innovation. We estimate that even after excluding the insurance value of the program, the welfare gain of Medicare Part D roughly equals its social costs. The program generates $5.11 billion of annual static deadweight loss reduction and at least $3.0 billion of annual value from extra innovation.

Implications – Medicare Part D and other public prescription drug programs can be welfare-improving, even for risk-neutral and purely self-interested consumers. Furthermore, negotiation for lower branded drug prices may further increase the social return to the program.

Originality – This study demonstrates that pure efficiency motives, which do not even surface in the policy debate over Medicare Part D, can nearly justify the program on their own merits.