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PubMed1997

Pharmacoeconomics: state of the art in 1997.

Economic evaluation of pharmaceutical products, or pharmacoeconomics, is a rapidly growing area of research. Pharmacoeconomic evaluation is important in helping clinicians and managers make choices about new pharmaceutical products and in helping patients obtain access to new medications. Over the last few years, the scientific rigor of this field has increased greatly. At the same time, new types of analysis, based on prospective data collection, have been developed. This article reviews the basic concept of pharmacoeconomics, the types of data available for economic evaluation, and the "state of the art" in pharmacoeconomics as reported in the medical literature.

Cost-Benefit Analysis↗
PubMed2001

Assessment of health economics in Alzheimer's disease (AHEAD): galantamine treatment in Canada.

BACKGROUND: Given the high costs of caring for patients with AD in Canada, it is important to evaluate the costs of new therapies that halt or delay the advancement of AD, relative to the savings associated with delaying disease progression. METHODS: The Assessment of Health Economics in Alzheimer's Disease (AHEAD) model, which uses algorithms to predict the time until patients with AD require full-time care (FTC), was adapted to Canada to compare treatment with galantamine versus no pharmacologic treatment. Data from two clinical trials provided inputs into the algorithms, and forecasts were made for up to 10 years. Drug and health care costs were evaluated according to the stage of disease based on Quebec unit costs along with follow-up data from the Canadian Study of Health and Aging. RESULTS: Galantamine is predicted to reduce the duration of FTC by almost 10%. Approximately 5.6 patients with mild to moderate disease must be placed on treatment to avoid one year of FTC, resulting in savings averaging $788 CAD ($528 USD) per patient. For patients with moderate disease, 3.9 patients must be placed on treatment to avoid one year of FTC, with savings predicted at $3718 CAD ($2533 USD) per patient. CONCLUSION: Galantamine cannot only potentially increase the time before patients require FTC, but may also lead to overall savings because treatment costs are offset by reductions in other health care expenditures.

Aged↗
PubMed1996

The FDA and regulation of cost-effectiveness claims.

The Food and Drug Administration (FDA) has issued draft guidelines that would require more rigorous standards for making pharmacoeconomic claims. This paper critiques the guidelines and explores the objectives of market regulation for health-related cost and effectiveness information on pharmaceutical products. It argues that the FDA should proceed with caution and flexibility. In particular, regulations should recognize the potential usefulness of pharmacoeconomic information in helping health care decisionmakers make better-informed choices. They also should acknowledge the enhanced ability of those using the information to evaluate pharmacoeconomic studies and the degree to which the various players in the market can impose their own regulatory discipline.

Cost-Benefit Analysis↗
PubMed2004

Assessing the health and economic impact of galantamine treatment in patients with Alzheimer's disease in the health care systems of different countries.

INTRODUCTION: Cholinesterase inhibitors have been shown to improve cognitive function and improve or maintain global function. OBJECTIVE: To estimate the long-term economic impact of treating patients with Alzheimer's disease with galantamine in seven healthcare systems: Australia, Canada, Finland, New Zealand, Sweden, the Netherlands and the UK. METHODS: The time until patients require full-time care (FTC), defined as the consistent requirement for a significant amount of care giving and supervision each day, and the associated costs were evaluated using the 'Assessment of Health Economics in Alzheimer's Disease (AHEAD)' model. Efficacy data were obtained from three clinical trials comparing galantamine with placebo and local cost and resource use data were determined for each country. Forecast costs reported in Euros (2001 value), were made for up to 10 years in each healthcare system. All costs were determined from a perspective somewhat broader than that of a comprehensive payer, including social services. Both benefits and costs were discounted at 3%. RESULTS: Galantamine (16 mg/day) is predicted to delay the need for FTC by 6.8%, thus the cumulative cost of care over 10 years is expected to be reduced, and this offsets much or all of the cost of galantamine. Approximately five patients need to be treated to avoid 1 year of FTC. In each healthcare system, FTC was estimated to account for 61-92% of the cost. Savings were estimated for most of the countries. For those countries with an expected expense, there were reasonable costs per FTC month avoided (euro553, discounted) and costs per quality-adjusted life year gained (euro25,000). CONCLUSION: In addition to the clinical benefits associated with galantamine treatment, the savings predicted from delaying FTC may offset the treatment costs.

Alzheimer Disease↗
PubMed1998

The effect of changes in treatment patterns on drug expenditure.

This paper investigates the effects of changes in drug therapy on drug expenditure in Sweden between 1990 and 1995. Analyses have been carried out for both the aggregate drug expenditure and for drug expenditure according to the main groups of the Anatomical Therapeutic Chemical (ATC) classification system. Changes in expenditure can be divided into 3 components: the price of drugs, the quantity of drugs consumed and a residual. The size of the residual is a measure of the effect of changes in drug treatment patterns on drug expenditure. The aggregate real drug expenditure increased by 50% between 1990 and 1995. The relative retail price index of drugs decreased by 9% and the quantity index measured in terms of defined daily doses increased by 27%. The remaining residual increased by 30%. This implies that, if the residual had been unchanged during the study period, the aggregate expenditure would have increased by only 15%. The results also show that the size of the residual varies substantially across different ATC groups. The increase in the residual was largest for drugs that affect the nervous system (ATC group N); the residual increased by 86%. From the observed changes in residual values, it can be concluded that the underlying factor responsible for the increase in drug expenditure in Sweden is changes in drug therapy from less expensive to more expensive drugs.

Drug Costs↗
PubMed2004

Why did drug spending increase during the 1990s? A decomposition based on Swedish data.

OBJECTIVE: To decompose drug spending in Sweden between the years 1990 and 2000. This paper updates a previous study, which looked at the period 1990-1995, by providing an additional 5 years of data (1995-2000) and extending the previous analysis in a number of ways. METHODS: The paper builds on the earlier work that showed that changes in drug spending could be decomposed into three components: price, quantity and a residual. The size of the residual is a measure of the impact of changes in drug treatment patterns on drug spending. The data set used in this paper was collected from Apoteket AB (The National Corporation of Swedish Pharmacies) and was based on comprehensive information (inpatients as well as outpatients) on drug deliveries from wholesalers to pharmacies. Data were obtained for aggregate drug spending (from 1990-2000) and for spending according to anatomical therapeutic chemical (ATC) classification system group. RESULTS: Real drug spending increased by 119% during the study period. The residual rose by 67% indicating the switch from cheaper to more innovative and expensive drug therapies was a major cost driver. Real drug spending would have increased by about 31% if there had been no changes in treatment patterns. The second driver of drug spending was the quantity of drugs consumed, which increased by 41%. The main reason for the larger quantity sold appears to be increases in the intensity of medication in terms of defined daily doses per patient, rather than a larger number of patients starting drug treatment. Real prices decreased during the 10-year study period. We found large differences between ATC groups in terms of spending growth. The ATC groups that have contributed the most to the increase in spending are: drugs that affect the CNS (N), the alimentary tract and metabolism (A) and the cardiovascular system (C), which are also the three largest groups in terms of sales. For all three groups, it was the residual that mainly drove costs. CONCLUSION: This study indicates very clearly that the main driving force behind the increase in drug costs in Sweden between 1990 and 2000 was the change in drug therapy from old to new and more innovative and expensive drug therapies. This shows the importance of carrying out economic evaluations of new more costly drugs in order to make an assessment of the social benefits of a switch from a cheaper to a more expensive drug.

Drug Costs↗
PubMed2005

Role of pharmacoeconomic analysis in R&D decision making: when, where, how?

Pharmacoeconomics is vitally important to drug manufacturers in terms of communicating to external decision-makers (payers, prescribers, patients) the value of their products, achieving regulatory and reimbursement approval and contributing to commercial success. Since development of new drugs is long, costly and risky, and decisions must be made how to allocate considerable research and development (R&D) resources, pharmacoeconomics also has an essential role informing internal decision-making (within a company) during drug development. The use of pharmacoeconomics in early development phases is likely to enhance the efficiency of R&D resource use and also provide a solid foundation for communicating product value to external decision-makers further downstream, increasing the likelihood of regulatory (reimbursement) approval and commercial success. This paper puts the case for use of pharmacoeconomic analyses earlier in the development process and outlines five techniques (clinical trial simulation [CTS], option pricing [OP], investment appraisal [IA], threshold analysis [TA] and value of information [VOI] analysis) that can provide useful input into the design of clinical development programmes, portfolio management and optimal pricing strategy. CTS can estimate efficacy and tolerability profiles before clinical data are available. OP can show the value of different clinical programme designs, sequencing of studies and stop decisions. IA can compare expected net present value (NPV) of different product profiles or study designs. TA can be used to understand development drug profile requirements given partial data. VOI can assist risk management by quantifying uncertainty and assessing the economic viability of gathering further information on the development drug. No amount of pharmacoeconomic data can make a bad drug good; what it can do is enhance the drug developers understanding of the characteristics of that drug. Decision-making, in light of this information, is likely to be better than that without it, whether it leads to faster termination of uneconomic projects or the allocation of more appropriate resources to attractive projects.

Decision Making, Organizational↗
PubMed2005

The importance of socio-economic context for social marketing models for improving reproductive health: evidence from 555 years of program experience.

BACKGROUND: Over the past two decades, social marketing programs have become an important element of the national family planning and HIV prevention strategy in several developing countries. As yet, there has not been any comprehensive empirical assessment to determine which of several social marketing models is most effective for a given socio-economic context. Such an assessment is urgently needed to inform the design of future social marketing programs, and to avoid that programs are designed using an ineffective model. METHODS: This study addresses this issue using a database of annual statistics about reproductive health oriented social marketing programs in over 70 countries. In total, the database covers 555 years of program experience with social marketing programs that distribute and promote the use of oral contraceptives and condoms. Specifically, our analysis assesses to what extent the model used by different reproductive health social marketing programs has varied across different socio-economic contexts. We then use random effects regression to test in which socio-economic context each of the models is most successful at increasing use of socially marketed oral contraceptives and condoms. RESULTS: The results show that there has been a tendency to design reproductive health social marketing program with a management structure that matches the local context. However, the evidence also shows that this has not always been the case. While socio-economic context clearly influences the effectiveness of some of the social marketing models, program maturity and the size of the target population appear equally important. CONCLUSIONS: To maximize the effectiveness of future social marketing programs, it is essential that more effort is devoted to ensuring that such programs are designed using the model or approach that is most suitable for the local context.

Condoms↗
PubMed1999

Couple resilience to economic pressure.

Over 400 married couples participated in a 3-year prospective study of economic pressure and marital relations. The research (a) empirically evaluated the family stress model of economic stress influences on marital distress and (b) extended the model to include specific interactional characteristics of spouses hypothesized to protect against economic pressure. Findings provided support for the basic mediational model, which proposes that economic pressure increases risk for emotional distress, which, in turn, increases risk for marital conflict and subsequent marital distress. Regarding resilience to economic stress, high marital support reduced the association between economic pressure and emotional distress. In addition, effective couple problem solving reduced the adverse influence of marital conflict on marital distress. Overall, the findings provided substantial support for the extended family stress model.

Adaptation, Psychological↗