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edited by AIFA’s Office of Osmed and HTA

Glossary

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CANCER
A group of over a hundred diseases that occur when malignant forms of abnormal cell growth develop in one or more body organs. Cancer arises after a series of genetic mutations remove the normal checks on cell growth. These cancer cells continue to divide and grow to produce tumours. Cancer cells can invade adjacent structures and spread via the lymph or blood to distant organs. It is estimated that about 80 percent of cancers are due to environment or lifestyle, and therefore are potentially preventable. The risk factors for some cancers have been clearly identified, but for others further research is needed. The cancer treatment that a patient receives is determined by the stage of cancer at diagnosis, the type and location of the cancer, the standard medical practices in the patient’s country, and the ability of the patient to pay for treatment (through national or private insurance or otherwise). Cancer treatment is a challenge to the sustainability of health care system. [Source: WHO. Priority medicines for Europe and the world]
CAPITATION
Strictly speaking, the term "capitation'' refers only to a payment mechanism - paying a provider a specific sum of money for the ongoing care of a person or group of people for a particular period of time. The sum is set in advance of the actual period of service, and it therefore represents a prediction, or at least an agreed-on estimate, of the amount of money that will be required to provide that care. Technically, a contract based on capitation can include or exclude almost any medical service. One can provide payment on a capitated basis, for example, for only primary care visits, for primary care visits and associated laboratory tests, or for only referrals to specialists. Mental health care can be covered. So can specialty services or surgery, whether or not primary care is included. The rate may be adjusted for the age, gender and other health characteristics of the population, based on actuarial projections of medical utilisation (Risk-adjusted capitation). [Source: adapted from: Berwick, D.M. Payment by Capitation and the Quality of Care. Part Five of Six. NEJM 1996]
CARRIAGE AND INSURANCE PACKAGING (CIP)
A type of price quotation, indicating the delivery of goods including cargo insurance to the named place of destination at seller's expense. In an export the quotation indicates the place of destination (discharge) after the acronym CIP, for example CIP Athens. [Source: PPRI Glossary]
CASE-MIX
A measure of the mix of cases being treated by a particular health care provider that is intended to reflect the patients' different needs for resources. Case-mix is generally established by estimating the relative frequency of various types of patients seen by the provider in during a given time period, and may be measured by factors such as diagnosis, severity of illness, utilisation of services, and provider characteristics. [Source: Office of Technology Assessment. Compilation of Abbreviations and Terms]
CATCHMENT AREA
A geographic area defined and served by a health program or institution such as a hospital or community mental health centre, which is delineated on the basis of such factors as population distribution, natural geographic boundaries, and transportation accessibility. By definition all residents of the area needing the services of the program are usually eligible for them, although eligibility may also depend on additional criteria. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
CHRONIC CARE
The ongoing provision of medical, functional, psychological, social, environmental and spiritual care services that enable people with serious and persistent health and/or mental conditions to optimise their functional independence and well-being, from the time of condition onset until problem resolution or death. Chronic care conditions are multidimensional, interdependent, complex and ongoing. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
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]
CLAW-BACK
A system allowing third party payers to recoup (part of the) discounts/rebates granted in a reimbursement system between various stakeholders, e.g. wholesalers and pharmacists. [Source: PPRI Glossary]
CLINICAL ENDPOINT
A characteristic or variable that reflects how a patient feels, functions, or survives. Clinical endpoints are distinct measurements or analyses of disease characteristics observed in a study or a clinical trial that reflect the effect of a therapeutic intervention. Clinical endpoints are the most credible characteristics used in the assessment of the benefits and risks of a therapeutic intervention in randomised clinical trials. [Source: Biomarkers Definitions Working Group]
CLINICAL PATHS (HOSPITAL PATHWAYS)
A clinical path is a key tool for managing treatment processes. It is a network of multidisciplinary diagnostic treatment measures founded on evidence-based clinical practice guidelines, which takes patient expectations, quality and cost-effectiveness into consideration and creates process-related lists of all services and resources used during a patient’s hospital stay from admission to discharge.
CLINICAL PHARMACOLOGY
The study of the effects of the pharmaceuticals in humans. [Source: Strom, Kimmel. Textbook of pharmacoepidemiology]
CLINICAL TRIAL (CLINICAL STUDY)
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. [Source: ICH Guideline for Good Clinical Practice] Clinical trials are generally divided into Phases I-IV. It is not possible to draw clear distinctions between these phases, and different opinions about details and methodology do exist. However, the individual phases, based on their purposes as related to the clinical development of pharmaceutical products, can be briefly defined as follows: Phase I. These are the first trials of a new active ingredient or new formulations in humans, often carried out in healthy volunteers. Their purpose is to make a preliminary evaluation of safety, and an initial pharmacokinetic/ pharmacodynamic profile of the active ingredient. Phase II. The purpose of these therapeutic pilot studies is to determine activity and to assess the short-term safety of the active ingredient in patients suffering from a disease or condition for which it is intended. The trials are preformed in a limited number of subjects and are often, at a later stage, of a comparative (e.g. placebo-controlled) design. This phase is also concerned with the determination of appropriate dose ranges/ regimens and (if possible) the clarification of dose-response relationships in order to provide an optimal background for the design of extensive therapeutic trials. Phase III. This phase involves trials in large (and possibly varied) patient groups for the purpose of determining the short- and long-term safety-efficacy balance of formulation(s) of the active ingredient, and assessing its overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated, and special features of the product must be explored (e.g. clinically relevant drug interactions, factors leading to differences in effect, such as age). The trials should preferably be randomized double-blind, but other designs may be acceptable, e.g. long-term safety studies. In general, the conditionsunder which the trials are conducted should be as close as possible to the normal conditionsof use. Phase IV. In this phase studies are performed after the pharmaceutical product has been marketed. They are based on the product characteristics on which the marketing authorization was granted and normally take the form of post-marketing surveillance, and assessment of therapeutic value or treatment strategies. Although methods may differ, the same scientific and ethical standards should apply to Phase IV studies as are applied in premarketing studies. After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc., are normally regarded as trials of new pharmaceutical products.
CO-MORBID CONDITION (CO-MORBIDITY)
Conditions that exist at the same time as the primary condition in the same patient (e.g. hypertension is a co-morbidity of many conditions, such as diabetes, ischemic heart disease, end-stage renal disease, etc.). Two or more conditions may interact in such a way as to prolong a stay in hospital or hinder successful rehabilitation. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
CO-PAYMENT
Insured patient’s contribution towards the cost of a medical service covered by the insurer. Can be expressed as a percentage of the total cost of the service or as a fixed amount. [Source: OECD – Pharmaceutical Pricing Policies in a Global Market ] See also: out-of pocket payments
COMBINATION PRODUCT
A medicine that contains more than one active ingredient. [Source: PPRI Glossary]
COMMUNITY CARE
Services and support to help people with care needs to live as independently as possible in their communities. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
COMMUNITY PHARMACY
Health care facility dispensing medicines (POM and OTC, reimbursable and non-reimbursable medicines) to out-patients. Pharmacies are subject to pharmacy legislation (e.g. national legislation regarding establishment and ownership of pharmacies). In many countries, community pharmacies are private facilities, but public pharmacies (i.e. in public ownership) also exist. Pharmaceutical provision for inpatients is provided for by hospital pharmacies or pharmaceutical depots; in some cases hospital pharmacies also act as community pharmacies. [Source: adapted from PPRI Glossary] See also: hospital pharmacy
COMPLICATION
A medical condition that arises during a course of treatment and is expected to increase the length of stay by at least one day for most patients.
COMPULSORY HEALTH INSURANCE
Health Insurance under an obligatory scheme basing on a legal act, usually with income-related contributions. [Source: PPRI Glossary] See also: social health insurance and voluntary health insurance.
CONDITIONAL APPROVAL
The legal basis for the conditional marketing authorisation is stated in article 11 of the Commission Regulation (EC) No 507/2006. The scope of the conditional marketing authorisation is defined in Article 2 of Commission Regulation (EC) No507/2006 which states that the product must fall within Article 3(1) and (2) of the Regulation (EC) No 726/2004 and belong to treatment, prevention or diagnosis of seriously debilitating disease or life-threatening disease, used in an emergency situation in response to a public health treatment and for products designated orphan medicinal products in accordance with Article 3 of the regulation (EC) No141/2000. An opinion on the conditional approval of a marketing authorisation application (MAA) is granted by the Committee for Medicinal Products for Human Use (CHMP) based on less complete clinical data package than would normally be required for a normal MAA and is subject to specific obligations. The CHMP may grant a conditional marketing authorisation if the following requirements are met: the risk-benefit balance is positive, the applicant is in a position to provide the additional data at a later stage, there is an unmet medical need which will be fulfilled and the benefit to public health of making the product available on the market outweighs the risk inherently associated with the additional data still required. The MAA is valid for one year only and renewable on a yearly basis or can be extended to a full marketing authorisation. Further information on conditional marketing authorisation can be found in the following links: Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9). http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2006_507/reg_2006_507_en.pdf Guideline on the scientific application and the practical arrangements necessary to implement commission regulation (EC) no 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of regulation (EC) no 726/2004 can be found at: http://www.emea.europa.eu/pdfs/human/regaffair/50995106en.pdf [Source: Commission Regulation No 507/2006 of 29 March 2006]
CONDITIONAL COVERAGE
Schemes where coverage is granted conditional on the initiation of a program of data collection. [Source: Carlson JJ , Sullivan SD, Garrison LP, Neumann PJ, Veenstra DL. Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy. 2010 Aug. 96(3):179-90.] See also: managed entry agreements
CONDITIONAL MARKETING AUTHORISATION
A conditional marketing authorisation may be granted where, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met: (a) the risk-benefit balance of the medicinal product is positive; (b) it is likely that the applicant will be in a position to provide the comprehensive clinical data; (c) unmet medical needs will be fulfilled; (d) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required. In emergency situations, a conditional marketing authorisation may be granted, also where comprehensive pre-clinical or pharmaceutical data have not been supplied. In the context of conditional marketing authorisation ‘unmet medical needs’ means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Community or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected. By way of specific obligations, the holder of a conditional marketing authorisation shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data. The specific obligations referred and the timeframe for their completion shall be clearly specified in the conditional marketing authorisation and made publicly available. After its period of validity of one year the conditional marketing authorisation may be renewed annually. The application for renewal shall be submitted to the Agency at least six months before the expiry of the conditional marketing authorisation, together with an interim report on the fulfilment of the specific obligations to which it is subject. The Committee shall assess the application for a renewal, on the basis that the risk-benefit balance is to be confirmed, taking into account the specific obligations contained in the authorisation and the timeframe for their fulfilment, and shall formulate an opinion as to whether the specific obligations or their timeframes need to be retained or modified. The Agency shall ensure that the opinion of the Committee is given within 90 days following receipt of a valid renewal application. That opinion shall be made publicly available. Once a renewal application has been submitted in accordance with paragraph 2, the conditional marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 10 of Regulation (EC) No 726/2004. [Source: Commission Regulation No 507/2006 of 29 March 2006] See also: marketing authorisation
CONDITIONAL TREATMENT CONTINUATION (CTC)
Continuation of coverage for individual patients is conditioned upon meeting short-term treatment goals. [Source: Carlson JJ , Sullivan SD, Garrison LP, Neumann PJ, Veenstra DL. Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy. 2010 Aug. 96(3):179-90.] See also: managed entry agreements
CONSIGNMENT (DELIVERY)
The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch. [Source: WHO. Good distribution practices (GDP) for pharmaceutical products]
CONSUMPTION (UTILISATION)
Use of services and supplies. Consumption in health care is commonly examined in terms of pattern of use of a single service (e.g. number of visits to a doctor per person per year) or type of care (e.g. admissions to the hospital per 1,000 persons in total or over age 65 per year). Consumption of medicines can be measured either in packages (or other units) or in DDD (Defined Daily Doses) within a given time period.
CONSUMPTION-BASED REIMBURSEMENT
The level of reimbursement depends on the expenses for medicines of a patient within a certain period of time (increasing reimbursement with rising consumption). [Source: PPRI Glossary]
CONTAINER
The material employed in the packaging of a pharmaceutical product. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. [Source: WHO. Good distribution practices (GDP) for pharmaceutical products]
COST, INSURANCE AND FREIGHT (CIF)
The cargo insurance and delivery of goods to the named port of destination (discharge) at the seller's expense. Buyer is responsible for the import customs clearance and other costs and risks. In the export quotation, indicate the port of destination (discharge) after the acronym CIF, for example CIF Athens. [Source: PPRI Glossary]
COST-BENEFIT ANALYSIS
Compares the cost of a medicinal intervention to its benefit. Both costs and benefits must be measured in the same monetary units (e.g. euro, dollars) [Source: Strom, Kimmel. Textbook of pharmacoepidemiology]
COST-CONTAINMENT
Measures taken to reduce expenditure or the growth rate of expenditure, or the unit cost of services. Cost-containment measures may be targeted to control inefficiencies in consumption, allocation, or production of health care services that contribute to higher than necessary costs. Cost-containment is a word used freely in health care to describe most cost reduction activities by providers. This includes a broad range of cost control mechanisms e.g. limiting budgets, cost-sharing, regulation of supply of services and staff, patients' waiting lists, exclusion of certain groups from entitlement to services, privatisation, and managed competition. Regarding medicines, it may concern the framework of the pricing and reimbursement systems (e.g. price control, reimbursement lists) and subsequent changes (e.g. price freeze/cuts, de-listings). [Source: adapted from PPRI Glossary]
COST-EFFECTIVENESS
Value for money. A specific health care treatment is said to be “cost-effective” if it gives a greater health gain than could be achieved by using the resources in other ways. [Source: NICE Glossary]
COST-EFFECTIVENESS ANALYSIS (CEA)
Cost-effectiveness analysis (CEA) is an economic analysis that assesses both the costs and the effects of a health intervention. Costs are measured in monetary units. Effects are measured in units of outcomes experienced such as life year gained (LYG), quality adjusted life of years (QALY) or cases of disease prevented. Whether the outcome of an analysis is cost-effective depends on the cost-effectiveness threshold value. CEA can identify the alternative that, for a given output level, minimises the actual value of costs, or, alternatively, for a given cost, maximises the outcome level.
COST-FREE MEDICINES
Cost free medicines are products which are given to hospitals/hospital pharmacies in the course of the delivery without need for payment (e.g. from wholesaler to hospitals/hospital pharmacies or pharmaceutical company to hospitals/hospital pharmacies).
COST-PLUS PRICING
Pricing procedure which calculates a “reasonable” price for a product based on the production costs, promotional expenses, research and development, administration costs, overheads and profit [Source:adapted from PPRI Glossary]
COST-SHARING
A provision of health insurance or third party payment that requires the individual who is covered to pay part of the cost of health care received. This is distinct from the payment of a health insurance premium, contribution or tax which is paid whether health care is received or not. [Source: OECD – A System of Health Accounts] See also: out-of pocket payments
COUNTERFEIT MEDICAL PRODUCT
The term counterfeit medical product describes a product with a false representation of its identity and/or Source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorised for marketing in a given country but authorised elsewhere are not considered counterfeit. Substandard batches of or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting. [Source: WHO. International Medical Products Anti-Counterfeiting Taskforce — IMPACT]
COVERAGE
A measure of the extent to which the services rendered cover the potential need for those services in the community. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
A binary coverage decision is conditioned upon the collection of additional population level evidence to support continues, expanded, or withdrawal of coverage. [Source: Carlson JJ , Sullivan SD, Garrison LP, Neumann PJ, Veenstra DL. Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy. 2010 Aug. 96(3):179-90.] See also: managed entry agreements
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