Glossary of Terms
Glossary of Terms
Below is a list of terms which appear on this website or which are often part of discussions about market access or reimbursement.
Access: The patient’s ability to obtain medical care, including medicines, and a measure of the proportion of a population that reaches appropriate health services, including medication. The ease of access is determined by components such as the availability of medical services and their acceptability to the patient, the location of health care facilities, and cost of care. Barriers to access can be financial, geographic (distance to providers such as centres of excellence), organisational (lack of available providers) and sociological (e.g., discrimination). Efforts to improve access often focus on providing/improving health coverage. [Source: adapted from WHO. Glossary of Pharmaceutical Terms]
Burden of Disease: a measurement of the gap between a population’s current health and the optimal state where all people attain full life expectancy without suffering major ill-health. Burden of disease analysis enables decision makers to identify the most serious health problems facing a population. Loss of health in populations is measured in disability-adjusted life years (DALYs), which is the sum of years of life lost due to premature death and years lived with disability. [Source: WHO. Health Promotion Glossary: new terms]
Chronic Condition (Chronic Disease): A disease which has one or more of the following characteristics: is permanent; leaves residual disability; is caused by no reversible pathological alteration; requires special training of the patient for rehabilitation; or may be expected to require a long period of supervision, observation or care. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
Clinical benefit: A positive effect of a therapeutic intervention. Examples of clinical benefits include prolongation of life, reduction in pain, improvement in function, increased sense of well-being.
Conditional marketing authorisation: The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs of patients. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines. [Source: The European Medicines Agency]
Cost-effectiveness: the desire to achieve a predetermined objective at least cost to maximise the benefit to the population of patients served from a limited amount of resources. To achieve this aim tools of economic evaluation are used to select the most cost-effective options from a range of healthcare alternatives. Cost-effectiveness compares the costs and health effects of an intervention to assess the extent to which it can be regarded as providing value for money. This informs decision makers who have to determine where to allocate limited healthcare resources.
Efficacy: the extent to which an intervention does more good than harm under ideal circumstances.
European Medicines Agency (EMA): The European Union (EU) agency responsible for the evaluation and supervision of medicinal products for both humans and animals.
External Price Referencing (International Price Comparison): The practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country. [Source: adapted from PPRI Glossary]
Health economics: The branch of economics concerned with issues related to efficiency, effectiveness, value and behaviour in the production and consumption of health and healthcare. Health economists weigh up the technical ability to provide healthcare versus the ability of a healthcare system to afford all such technologies.
Health Products Regulatory Authority (HPRA): The authority which is charged with protecting and enhancing public and animal health in Ireland by regulating medicines, medical devices and other health products. The HPRA provides national marketing authorisation for medicines in Ireland. Formerly called the Irish Medicines Board (IMB).
Health Technology Assessment (HTA): A multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology/medicine in a systematic manner. The NCPE conducts HTAs of pharmaceutical products for the Health Service Executive (HSE) in Ireland. In the case of oncology (cancer) medicines, the National Cancer Control Programme is also involved. [Source: Adapted from EUnetHTA]
Incremental cost effectiveness ratio (ICER): Otherwise known as the cost per QALY. The ICER is calculated as the difference in the expected cost of two interventions divided by the difference in the expected QALYs produced by the two interventions.
Irish Pharmaceutical Healthcare Association (IPHA): Irish Pharmaceutical Healthcare Association represents the international research-based pharmaceutical industry in Ireland. Members include both manufacturers of prescription medicines and non-prescription or consumer health care medicines.
List price: The manufacturer’s suggested retail price. National health services such as the HSE often receive discounts.
Market access system: Decision-making process on the reimbursement status and price of a medicine. In Ireland, this process involves the National Centre for Pharmacoeconomics (NCPE), the Health Service Executive (HSE) and, on occasion, the Department of Health. The outcome of the process is the decision whether or not the medicine will be included reimbursed, or made publically available to patients through the HSE, and at which cost to the State.
Market access: a process that ensures all appropriate patients have rapid and continued access to a medicine or other medical treatment at the right price at the right time.
Marketing authorisation: All medicines must be authorised before they can be marketed and made available to patients. In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route. The centralised marketing authorisation is provided by the European Commission (EC). The national marketing authorisation in Ireland is provided by the Health Products Regulatory Authority (HPRA).
Performance-Linked Reimbursement Schemes: where the reimbursement level for covered products is tied to the measure of clinical outcomes in the real world.
Price Negotiation: A pricing procedure, where medicine prices are discussed/negotiated (e.g. between a manufacturer and a third party payer such as the HSE). [Source: Adapted from PPRI Glossary]
Public expenditure: health expenditure incurred by public funds (state, regional and local government bodies and social security schemes).
Quality-adjusted Life Years (QALYS): A measure of health outcome which looks at both length of life and quality of life. QALYS are calculated by estimating the years of life remaining for a patient following a particular care pathway and weighting each year with a quality of life score (on a zero to one scale). One QALY is equal to one year of life in perfect health, or two years at 50% health, and so on. [Source: NICE Glossary]
Reimbursement Process: See market access system.
Reimbursement: A reimbursed medicine is one whose cost will be covered for patients by a third party, for example the HSE.
Sustainability: The capacity to meet the needs of the present without compromising the ability to meet future needs. [Source: WHO Regional Office for Europe. Terminology – A glossary of technical terms on the economics and finance of health services. 1998]
The National Centre for Pharmacoeconomics (NCPE): Activities of the NCPE include economic evaluation of pharmaceutical products and the development of cost effective prescribing. In addition, the research of the NCPE focuses predominantly on the economic analysis of high cost areas e.g. HIV therapy and heart failure. It is funded by the Department of Health.
3 National Centre for Pharmacoeconomics http://www.ncpe.ie
4 EFPIA W.A.I.T Indicator 2016, http://www.ipha.ie/getattachment/Publications-Submissions/IPHA-publications/New-medicines-for-patients-as-fast-as-in-Europe.pdf.aspx, pg 8.
6 QuintilesIMS, MIDAS Mar 2017; the measure is recorded sales; GR and LU retail only; % represent the number of New Active Substances launched. http://www.ipha.ie/getattachment/Publications-Submissions/IPHA-publications/New-medicines-for-patients-as-fast-as-in-Europe.pdf.aspx