Added clinical benefit
A positive additional effect of a therapeutic intervention compared to other therapies (e.g. prolongation of life, reduction in pain, improvement in function, increased sense of well-being). 1
The institution/individual who is responsible to keep the costs and expenses within a special part of the total health care budget. For example, in the case of medicines, it is typically the manager of the pharma budget. For diagnostics, it may be the diagnostic or outpatient budget manager, and so on.
In medical terms, budget impact refers to the financial impact of a new health technology on the health care budget.2
Budget impact analysis
Budget impact analysis (BIA) is used to assess whether the adoption of a new health technology is affordable, given the resource and budget constraints of the context. BIAs are coming to be viewed as an important, if not essential, part of health technology assessment (HTA).2
In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial (e.g. survival, improvements in quality of life, relief of symptoms, disappearance of the tumour).3
One of the main approaches to health technology assessment (HTA): a comprehensive analysis which compares the clinical benefits of two or more health technologies. Decision-makers are generally focused on the added clinical benefit which determines allowable price or funding restrictions. Economic considerations are typically introduced during pricing negotiations (countries where comparative assessment is in use as an approach to HTA: France, Germany, Italy, Japan). 4
The comparator product is defined as a pharmaceutical product with which the evaluated product is intended to be interchangeable in clinical practice. The comparator has similar clinical benefits like the new health technology and is used to assess whether the adoption of the new health technology is affordable and clinically verified.5
A relatively small fixed or percentage fee that a health insurer requires the patient to pay upon incurring a medical expense (as for a routine office visit, surgical procedure, or prescription medicine) covered by the health insurer.6
Relationship between monetary inputs and the desired outcome, such as between the cost of a health technology and its health benefits. Usually used to indicate a favourable relationship.7
Cost-effectiveness analysis is used to identify the most cost-effective option for achieving a pre-set objective or criterion that is not measurable in monetary terms (e.g. some health outcomes). There are four types of cost-effectiveness analysis (the differences are in the measurement of the outcome unit).
- Cost-benefit analysis (CBA): CBA measures both the costs and outcomes in monetary unit, therefore it is not really used for the assessment of health technologies.
- Cost-effectiveness analysis (CEA): Costs are measured in monetary, but health benefits are measured in natural units (e.g. blood pressure, blood sugar level or disease-specific scores). It is a common type of cost-effectiveness analysis in case of assessment of health technologies.
- Cost-utility analysis (CUA): In this type, health benefits are converted into quality-adjusted life years (QUALY). It is also commonly used for the assessment of health technologies.
- Cost-minimization analysis (CMA): CMA compares only the costs of the two technologies. It is used only in some special cases when health outcomes can be assumed to be identical. For example, if a head-to-head study proves non-inferiority between two therapies.8
Diagnosis-related groups (DRG)
Outpatient care and inpatient care are often financed through standardized tariffs called ’diagnosis-related groups’ (DRG’s). In this model, it is not feasible for the health care provider to calculate and invoice the cost of each case individually to the payer. Condition-specific interventions are grouped into relatively homogeneous categories (’DRG groups’) which will receive the same amount of funding. Each DRG code is allocated a score which reflects its cost intensity. A base tariff is defined (and modified following inflation in health care services). Each intervention will be paid as the multiple of its score and the base tariff.9
A direct cost is a price that can be completely attributed to the production of specific goods or services. Direct medical costs are linked to medicines, medical devices, diagnostics, outpatient and inpatient care, other medical interventions. Direct non-medical costs can be patient transportation, costs associated with special diets, or other non-medical but patient-specific interventions.10
One of the main approaches to health technology assessment (HTA): decision-makers are focused on the budget impact and cost-effectiveness of the technology. Economic evaluation is the process of systematic identification, measurement and valuation of the inputs and outcomes (primarily monetary) of two alternative technologies/therapies etc., and the subsequent comparative analysis of these (countries where economic evaluation is in use as an approach to HTA: United Kingdom, South Korea, Thailand, Brazil, Turkey, Poland, Hungary, Slovakia).8
Formulary management is an integrated process in which the payer, physicians, pharmacists and other health care professionals work together to promote clinically sound, cost-effective medication therapy and positive therapeutic outcomes. Effective use of health care resources can minimize overall medical costs, improve patient access to more affordable care and provide an improved quality of life.11
This essentially means the reassessment of already funded technologies. Alternatively, HTA can be used for formulary reviews, too.
General practitioner (GP)
In the medical profession, a general practitioner (GP) is a medical doctor who treats acute and chronic illnesses and provides preventive care and health education to patients. GPs usually work in primary care, and they are the first contact and principal point of continuing care for patients within a healthcare system.
A follow-on pharmaceutical that contains the same active/key ingredient as an already registered (originator) medicinal product. Usually generic medicines are designed to correspond in dosage form, safety, strength, route of administration, quality, and performance characteristics to the originator medicine.12
Health care expenditure
The amounts spent by individuals, groups, nations, or private or public organizations for total health care and/or its various components.13
Health care system
The term usually is used to refer to the system or program by which health care is made available to the population and financed by government, private enterprise, or both. In a larger sense, the elements of a health care system embrace the following: (1) personal health care services for individuals and families, available at hospitals, clinics, and similar agencies, in physicians' offices, and in the clients' own homes; (2) the public health services needed to maintain a healthy environment, such as control of water and food supplies, regulation of medicines, and safety regulations intended to protect a given population; (3) teaching and research activities related to the prevention, detection, and treatment of disease; and (4) third party (health insurance) coverage of system services.14
Health outcomes are a change in the health status of an individual, group or population which is attributable to a planned intervention or series of interventions, regardless of whether such an intervention was intended to change health status.4
Health Technology Assessment (HTA)
The systematic evaluation of the clinical effectiveness and/or cost‐effectiveness and/or the social and ethical impact of a health technology on the lives of patients and the health care system. Its main purpose is to inform health care policy makers.
The process advises whether a health technology should be used, and if so, how it is best used and which patients will benefit most from it. Assessments vary, but most look at the health benefits and risks of using the technology. They also look at costs and any wider impacts that the technology might have on a population or on society.4
The number of new cases of a disease among a certain group of people during a specific period of time (usually 1 year).4
Incremental cost-effectiveness ratio (ICER)
A ratio that shows the extra cost of a more expensive test or treatment, compared with a cheaper treatment or no treatment, divided by the difference in health outcome. In economic evaluation, the value of the ICER is a crucial factor of the final decision of the reimbursement process.4
Costs that are not directly related to production of specific goods or services. Indirect costs are usually relevant from the societal perspective only. In medical terms, they can be all the goods, services and other resources that are used to provide a test or treatment, or in dealing with side effects or other current or future aspects linked to it. Some examples are loss of income or productivity, loss, additional burden on families or caretakers, sick leave payments or costs associated with early retirement.4
Innovative (originator) medicine
A new medicine that contains a new active substance classified as a new molecular entity by drug agencies. Usually it takes several (8+) years and significant financial investment before a new molecule becomes a medicine. The active substance of the innovative medicine has patent protection which may vary by country but it is usually 20 years. Until the expiration of the patent period, only the company that developed it has the right to manufacture the medicine.15
The care of patients whose condition requires admission to a hospital where the patients are hospitalized longer than 24 hours.
Life expectancy at birth
Life expectancy at birth is defined as how long, on average, a new-born can expect to live, if current death rates do not change. If rates are falling, actual life spans will be higher than life expectancy calculated using current death rates. Life expectancy at birth is one of the most frequently used health status indicators.16
Market access refers to the process by which a company gets a medicine to market so that it becomes available for patients. Access is defined as a patient's ability to obtain medical care.
The proportion of a population that dies within a particular timeframe, for example one year. The rate is often given as a certain number per 1000 people. The rate is often used to compare the outcomes of a particular disease in more countries.4
Multi-criteria assessment (balanced assessment)
One of the main approaches to health technology assessments (HTA): decision-makers are focused on both economic and non-economic factors of the technology. Economic value and clinical value can independently qualify a medicine for funding. Typically, these systems incorporate strong economic traditions but they also consider clinical, ethical or societal aspects. This is not considered by everyone as an approach on its own as it is essentially the combination of the economic evaluation and comparative assessment approaches (countries where multi-criteria assessment as an approach to HTA is in use: Canada, Australia, Netherlands, Sweden).
National health insurance (NHI)
National health insurance (NHI) – sometimes called statutory health insurance (SHI) – is a legally enforced scheme of health insurance that insures a national population against the costs of health care. It may be administered by the public sector, the private sector, or a combination of both. Funding mechanisms vary with the particular program and country. National or Statutory health insurance does not equate to government-run or government-financed health care, but is usually established by national legislation.
Net public pharmaceutical expenditure
Net public pharmaceutical expenditure covers the spending on prescription medicines adjusted for possible rebates payable by manufacturers, wholesalers or pharmacies. Pharmaceuticals consumed in hospitals and other health care settings are excluded, as well as the over-the-counter products. In other words, this is the money which governments effectively allocate to purchasing medicines for society.17
The medical care provided on an outpatient basis, including diagnosis, observation, consultation, treatment, intervention, and rehabilitation services. Outpatient care does not require hospitalization longer than 24 hours, but can include advanced medical technology. Also known as ambulatory care. In a broader interpretation, on-prescription pharmaceuticals and medical devices also belong to outpatient services.
Overall survival (OS)
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.18
Payer refers to entities other than the patient that finance or reimburse the cost of health services. In most cases, this term refers to insurance carriers, other third-party payers, or health plan sponsors (employers or unions).19
Pharmaceutical expenditure covers the spending on prescription medicines and over-the-counter products. In some countries, other medical non-durable goods are also included. Pharmaceuticals consumed in hospitals and other health care settings are excluded. Final expenditure on pharmaceuticals includes wholesale and retail margins and value-added tax.17
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces medicines (both innovative and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products.
It describes how common a disease or condition is within a population either at a point in time or over a given period (it includes new and existing cases).4
Primary care is the day-to-day healthcare given by a health care provider. Typically, this provider acts as the first contact and principal point of continuing care for patients within a healthcare system, and coordinates other specialist care that the patient may need. Patients commonly receive primary care from professionals such as a primary care physician (general practitioner or family physician) or a nurse practitioner. Primary care can be funded via various financing forms:
- Detailed service catalogues: GPs invoice the payer for each item of service they provide to patients.
- Fixed payments with adjustments: GPs receive fixed payment per period with individual adjustments to allow for experience, location, population size and other considerations.
- Capitation payments: GPs are remunerated based on the number of patients registered with them, with or without individual adjustments for experience or location
Performance pay: GPs are remunerated, at least in part, based on their performance as measured by some care quality indicators such as vaccination rates, patient complaints, participation in special programmes etc.20
Progression-free survival (PFS)
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.21
Public funding and public financing both refer to any funds used by public payers to purchase pharmaceuticals or reimburse them for patients.
Public health care expenditure
The amounts spent for total health care and/or its various components which are publicly funded.13
Quality-adjusted life years (QALY)
A measure of the state of health of a person or group of people in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. That is, a year of active normal life gained as the result of a treatment is rated higher than a year of living with reduced quality (such as being in extreme pain or being in hospital). It is often measured in terms of the level of a person’s ability to perform activities of daily living, their freedom from pain and mental disturbance.
Reimbursement and subsidies both refer to any funds provided to patients by public or private payers in order to covering the price of medicines in full or in part.
The sick fund refers to health care insurers. Sick funds can be funded by public and private source also.22
Systematic evaluation is the process of systematic identification, measurement and valuation of the inputs and outcomes of two alternative technologies/therapies etc., and the subsequent comparative analysis of these.8
A person, group or organization that has interest or concern in an organization. Stakeholders can affect or be affected by the organization's actions, objectives and policies.23
Unmet need means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised.
A measure of the desirability or worth of a particular health outcome or intervention.4
A list of people waiting for care or treatment, pending hospital resource availability. Separate lists are held by each specialty in hospital and are split according to the type of service planned (e.g., inpatient, day case, day patient and outpatients).24
- The Free Dictionary by Farlex. Available from: http://medical-dictionary.thefreedictionary.com/clinical+benefit.
- Leelahavarong P., Budget impact analysis. J Med Assoc Thai., 2014. 97(5): p. 65-71.
- NCI Dictionary. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=346519.
- Ann Single, et al., HTAi consumer and patient glossary - A beginner’s guide to words used in health technology assessment. Health Technology Assessment International, 2009.
- WHO Expert Committee on Specifications for Pharmaceutical Preparations, Annex 8 - Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products. Forty-ninth report: p. 185-189.
- Merriam-Webster dictionary. Available from: https://www.merriam-webster.com/dictionary/co-payment.
- Business Dictionary.
- Roy Brouwer and Stavros Georgiou, Economic evaluation - Chapter 12. World Health Organization, 2012: p. 429-459.
- Health lawyers. Diagnosis-related group (DRG). Available from: https://www.healthlawyers.org/hlresources/Health%20Law%20Wiki/Diagnosis-related%20group%20(DRG).aspx.
- Investopedia. Direct cost; Available from: http://www.investopedia.com/terms/d/directcost.asp.
- Academy of Managed Care Pharmacy. Formulary Management 2009; Available from: http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=9298.
- FDA. Generic Drug Facts. Available from: https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm.
- Definitions.net. Available from: http://www.definitions.net/definition/health%20expenditures.
- The Free Dictionary by Farlex. Health care system. Available from: http://medical-dictionary.thefreedictionary.com/health+care+system.
- European Medicines Agency, Innovative drug development approaches. 2007 (Final report).
- OECD. Life expectancy at birth. Available from: https://data.oecd.org/healthstat/life-expectancy-at-birth.htm.
- OECD. Pharmaceutical spending. Available from: https://data.oecd.org/healthres/pharmaceutical-spending.htm.
- National Cancer Institute Dictionary. Overall survival. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=655245.
- The Free Dictionary by Farlex. payer. Available from: http://medical-dictionary.thefreedictionary.com/payer.
- Oliver-Baxter J. et al, Primary health care funding models. PHCRIS Research Roundup, 2013(33).
- National Cancer Institute. Progression-free survival. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=44782.
- PNHP. Health Care Systems - Four Basic Models. Available from: http://www.pnhp.org/single_payer_resources/health_care_systems_four_basic_models.php.
- Dictionary, B. Stakeholder. Available from: http://www.businessdictionary.com/definition/stakeholder.html.
- The Free Dictionary by Farlex. Waiting list. Available from: http://medical-dictionary.thefreedictionary.com/waiting+list.