The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. The ICER can be estimated as:
where and are the cost and effect in the intervention group and where and are the cost and effect in the control care group. [1] Costs are usually described in monetary units, while effects can be measured in terms of health status or another outcome of interest. A common application of the ICER is in cost-utility analysis, in which case the ICER is synonymous with the cost per quality-adjusted life year (QALY) gained.
The ICER can be used as a decision rule in resource allocation. If a decision-maker is able to establish a willingness-to-pay value for the outcome of interest, it is possible to adopt this value as a threshold. If for a given intervention the ICER is above this threshold it will be deemed too expensive and thus should not be funded, whereas if the ICER lies below the threshold the intervention can be judged cost-effective. This approach has to some extent been adopted in relation to QALYs; for example, the National Institute for Health and Care Excellence (NICE) adopts a nominal cost-per-QALY threshold of £20,000 to £30,000. [2] As such, the ICER facilitates comparison of interventions across various disease states and treatments. In 2009, NICE set the nominal cost-per-QALY threshold at £50,000 for end-of-life care because dying patients typically benefit from any treatment for a matter of months, making the treatment's QALYs small. [3] In 2016, NICE set the cost-per-QALY threshold at £100,000 for treatments for rare conditions because, otherwise, drugs for a small number of patients would not be profitable. [3] The use of ICERs therefore provides an opportunity to help contain health care costs while minimizing adverse health consequences. [4] Treatments for patients who are near death offer few QALYs simply because the typical patient has only months left to benefit from treatment. They also provide to policy makers information on where resources should be allocated when they are limited. [5] As health care costs have continued to rise, many new clinical trials are attempting to integrate ICER into results to provide more evidence of potential benefit. [6]
Many people feel that basing health care interventions on cost-effectiveness is a type of health care rationing and have expressed concern that using ICER will limit the amount or types of treatments and interventions available to patients. [5] Currently, the National Institute for Health and Care Excellence (NICE) of England's National Health Service (NHS) uses cost-effectiveness studies to determine if new treatments or therapies at the prices proposed by manufacturers provide better value relative to the treatment that is currently in use. With the number of cost-effectiveness studies rising, it is possible for a cost-effectiveness ratio threshold to be established in other countries for the acceptance of reimbursement or formulary listing at a given price.
Research by the University of York identified that the cost per quality adjusted life year for changes in existing NHS expenditure in 2008 was £12,936 leading to concerns new treatments approved by NICE at £30,000 per quality adjusted life year are less cost-effective than spend on existing treatments. This would mean that diverting NHS spend to new treatments would forgo more than 2 quality adjusted life years for every year gained from the new treatment. [7]
The concern that ICER may lead to rationing has affected policy makers in the United States. The Patient Protection and Affordable Care Act of 2010 provided for the creation of the independent Patient-Centered Outcomes Research Institute (PCORI). The Senate Finance Committee in writing PPACA forbade PCORI from using "dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual's disability) as a threshold to establish what type of health care is cost effective or recommended". [8]
Health care reform is for the most part governmental policy that affects health care delivery in a given place. Health care reform typically attempts to:
Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of different courses of action. Cost-effectiveness analysis is distinct from cost–benefit analysis, which assigns a monetary value to the measure of effect. Cost-effectiveness analysis is often used in the field of health services, where it may be inappropriate to monetize health effect. Typically the CEA is expressed in terms of a ratio where the denominator is a gain in health from a measure and the numerator is the cost associated with the health gain. The most commonly used outcome measure is quality-adjusted life years (QALY).
Health economics is a branch of economics concerned with issues related to efficiency, effectiveness, value and behavior in the production and consumption of health and healthcare. Health economics is important in determining how to improve health outcomes and lifestyle patterns through interactions between individuals, healthcare providers and clinical settings. In broad terms, health economists study the functioning of healthcare systems and health-affecting behaviors such as smoking, diabetes, and obesity.
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation of the country.
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care.
Preventive healthcare, or prophylaxis, is the application of healthcare measures to prevent diseases. Disease and disability are affected by environmental factors, genetic predisposition, disease agents, and lifestyle choices, and are dynamic processes that begin before individuals realize they are affected. Disease prevention relies on anticipatory actions that can be categorized as primal, primary, secondary, and tertiary prevention.
Cost–utility analysis (CUA) is a form of economic analysis used to guide procurement decisions. The most common and well-known application of this analysis is in pharmacoeconomics, especially health technology assessment (HTA).
The quality-adjusted life year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 to 0 (dead). QALYs can be used to inform health insurance coverage determinations, treatment decisions, to evaluate programs, and to set priorities for future programs.
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost and effects of a pharmaceutical product. Pharmacoeconomic studies serve to guide optimal healthcare resource allocation, in a standardized and scientifically grounded manner.
Criticism of the National Health Service (England) includes issues such as access, waiting lists, healthcare coverage, and various scandals. The National Health Service (NHS) is the publicly funded health care system of England, created under the National Health Service Act 1946 by the post-war Labour government of Clement Attlee. It has come under much criticism, especially during the early 2000s, due to outbreaks of antibiotic resistant infections such as MRSA and Clostridioides difficile infection, waiting lists, and medical scandals such as the Alder Hey organs scandal. However, the involvement of the NHS in scandals extends back many years, including over the provision of mental health care in the 1970s and 1980s (ultimately part of the reason for the Mental Health Act 1983), and overspends on hospital newbuilds, including Guy's Hospital Phase III in London in 1985, the cost of which shot up from £29 million to £152 million.
Unwarranted variation in health care service delivery refers to medical practice pattern variation that cannot be explained by illness, medical need, or the dictates of evidence-based medicine. It is one of the causes of low value care often ignored by health systems.
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making.
Health care rationing refers to mechanisms that are used for resource allocation in health care.
The Cancer Drugs Fund (CDF) was introduced in England in 2011. It was established in order to provide a means by which National Health Service (NHS) patients in England could receive cancer drugs that had been rejected by National Institute for Health and Care Excellence because they were not cost effective. Its establishment was confirmed by the UK government's coalition agreement in 2010, and by the White Paper, Equity and excellence – Liberating the NHS.
The Pharmaceutical Price Regulation Scheme (PPRS) is the mechanism used by the UK Department of Health to ensure that the NHS has access to good quality branded medicines at reasonable prices. It involves a non-contractual agreement between the UK Department of Health and The Association of the British Pharmaceutical Industry (ABPI). The scheme applies to all branded, licensed medicines available on the NHS. The purpose of the scheme is to achieve a balance between reasonable prices for the NHS and a fair return for the pharmaceutical industry.
Ariel Beresniak is a Swiss specialist in Public Health and Health Economics, author of reference books and scientific articles in modeling and decision-making analyses.
Professor Karl Claxton is a health economist at the University of York.
The Institute for Clinical and Economic Review (ICER) is a Boston-based independent nonprofit organization that seeks to place a value on medical care by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures.
ISPOR—The Professional Society for Health Economics and Outcomes Research, also known as ISPOR is a global, nonprofit 501(c)(3) public organization for educational and scientific purposes, as defined by the United States Internal Revenue Service.
The Equal Value of Life Years Gained or evLYG is a generic measure used to determine how much a medical treatment can extend the life of the patient. Unlike other healthcare metrics, the evLYG does not consider the quality of life for the patient; it exclusively considers the length of life. It is used in economic evaluation to determine the added time a treatment may give a patient. Critics argue the evLYG measurement is flawed because it values a medication based solely on the added years of life. A higher priced drug that both extends life and adds two years of life receives the same evLYG score as a lower priced drug that adds two years but does not improve life.