Глоссарий терминов

 

В этом разделе вы найдете глоссарий терминов, используемых в информационных материалах Кампании по обеспечению доступности EURORDIS Access Campaign.


Access (accessibility)
Access with Evidence Development
Affordability
Brand name
Budget impact
Budget impact analysis
Claw-back
Co-payment
Community pharmacy
Conditional coverage
Cost-benefit analysis
Cost-containment
Cost-effectiveness
Cost-effectiveness analysis (CEA)
Cost-free medicines
Cost-plus pricing
Cost-sharing
Coverage
Coverage with evidence development (CED)
E-listing
Discount
Disease-specific reimbursement
Dispensing fee
Effectiveness
Efficacy
Efficiency
End users of pharmaceuticals (end users)
Essential medicines
Ex-factory price
External price referencing (international price comparison)
Fixed co-payments
Generic substitution
Gross domestic product (GDP)
Group purchasing
Health expenditure (HE, total heath expenditure, THE)
Health technology
Health technology assessment (HTA)
High-cost patient
Hospital pharmacy
Hospital price (average selling price to hospitals)
Hospital-only medicines (HOM)
Informal payments
Internal price referencing
List price
Managed entry agreements
Margin (distributed margin)
Maximum price
Negative list
Order entry
Out-of pocket maximum (annual ceiling)
Out-of pocket payments (OPP)
Over prescribing
Over-the-counter (OTC) medicine (over-the-counter product)
Parallel trade
Patient access scheme (PAS)
Pay-back
Percentage co-payment
Performance based agreement
Performance based health outcome reimbursement schemes
Performance-linked reimbursement
Pharmaceutical budget
Pharmaceutical expenditure (PE, total pharmaceutical expenditure, TPE)
Pharmacy purchasing price
Pharmacy retail price
Pharmacy tax
Population-group-specific reimbursement
Positive list (formulary)
Prescription only medicines
Price cap (price ceiling)
Price control
Price cut
Price freeze
Price negotiation
Price notification
Price type
Price volume agreements
Procurement
Purchaser’s price
Purchasing power parities (PPP)
Rational use of medicines
Rebate
Reference price system
Reimbursement
Reimbursement category (reimbursement group)
Reimbursement market
Reimbursement price
Reimbursement rate
Reimbursement scheme
Retailer (dispensary)
Risk sharing schemes
Risk-benefit balance
Risk-sharing agreement
Sickness fund (social insurance institution)
Social health insurance (SHI)
Statutory pricing
Tender
Therapeutic benefit (therapeutic value)
Therapeutic referencing
Third party payer (payer, insurer, purchaser)
Transparency directive
Value added tax (VAT)
Volume control
Voluntary health insurance (VHI)
Wholesale



Access (Accessibility)

    The patient's ability to obtain medical care and a measure of the proportion of a population that reaches appropriate health services. The ease of access is determined by such components as the availability of medical services and their acceptability to the patient, the location of health care facilities, transportation, hours of operation and cost of care. Barriers to access can be financial (insufficient monetary resources), geographic (distance to providers), organisational (lack of available providers) and sociological (e.g., discrimination, language barriers). Efforts to improve access often focus on providing/improving health coverage. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]

Access with Evidence Development (AED)

    Initiative in which a payer provides temporary or interim funding for a particular technology or service to facilitate the collection of information needed to reduce specific uncertainties around a coverage decision. [Source: Stafinski T, McCabe C, Menon D: Funding the unfundable – mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconomics 2010; 28:113-42.] See also: managed entry agreements

Affordability

    The extent to which medicines and further health care products are available to the people who need them at a price they / their health system can pay. [Source: adapted from WHO. A model quality assurance system for procurement agencies]

Brand name (innovator`s name, proprietary product name, medicine speciality product name, medicinal speciality product name)

    Name given for marketing purposes to any ready-prepared medicine placed on the market under a special name and in a special pack. A brand name may be a protected trademark.

Budget impact

    A budget is an estimate of revenue and expenditure for a specified period. Budget impact refers to the total costs that pharmaceutical reimbursement and use entail with respect to one part of the health care system, pharmaceutical care, or to the entire health care system, taking into account the possible reallocation of resources across budgets or sectors of the health care system.

Budget impact analysis (BIA)

    Budget Impact Analysis is an essential part of a comprehensive economic assessment of a health care technology and is increasingly required, along with cost-effectiveness analysis (CEA), prior to formulary approval or reimbursement. The purpose of a BIA is to estimate the financial consequences of adoption and diffusion of a new health care intervention within a specific health care setting or system context given inevitable resource constraints. In particular, a BIA predicts how a change in the mix of medicines and other therapies used to treat a particular health condition will impact the trajectory of spending on that condition. Users of BIA include those who manage and plan for health care budgets such as administrators of national or regional health care programs, administrators of private insurance plans, administrators of health care delivery organisations and employers who pay for employee health benefits. BIA should be viewed as complementary to cost-effectiveness analysis (CEA), not as a variant or replacement. Whereas, CEA evaluates the costs and outcomes of alternative technologies over a specified time horizon to estimate their economic efficiency, BIA addresses the financial stream of consequences related to the uptake and diffusion of technologies to assess their affordability. [Source: Report of the ISPOR Task Force on Good Research Practices – Budget Impact Analysis]

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]

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

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

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

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 pharmaco-epidemiology]

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

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

Discount

    A price reduction granted to specified purchasers of a pharmaceutical product under specific conditions. [Source: OECD. Pharmaceutical Pricing Policies in a Global Market]

Disease-specific reimbursement

    Eligibility for reimbursement is linked to the underlying disease which shall be treated. [Source: PPRI Glossary]

Dispensing fee

    Normally a fixed fee that pharmacies are allowed to charge per prescribed item instead of, or in addition to, a percentage mark-up. The fee more accurately reflects the work involved in dispensing a prescription; a percentage mark-up makes profit dependent on the sale of expensive medicines.

E-listing

    Exclusion of a medicine from a medicine list (e.g. positive list), often resulting in exclusion from reimbursement [Source: PPRI Glossary]

Effectiveness

    Effectiveness is the extent to which an intervention does more good than harm when provided under the usual circumstances of health care practice. Relative effectiveness can be defined as the extent to which an intervention does more good than harm compared to one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of health care practice. [Source: European Union Pharmaceutical Forum. Core principles on relative effectiveness]

Efficacy

    Efficacy is the extent to which an intervention does more good than harm under ideal circumstances. Relative efficacy: can be defined as the extent to which an intervention does more good than harm, under ideal circumstances, compared to one or more alternative interventions. [Source: European Union Pharmaceutical Forum. Core principles on relative effectiveness]

Efficiency

    An ability to perform well or achieve a result without wasted energy, resources, effort, time or money thus the extent to which objectives are achieved by minimising the use of resources (i.e. obtaining the best possible value for the resources used). Greater efficiency is achieved where the same amount and standard of services are produced for a lower cost, if a more useful activity is substituted for a less useful one at the same cost or if needless activities are eliminated. Efficiency can be measured in physical terms (technical efficiency) or terms of cost (economic efficiency). Technical efficiency means producing the maximum possible sustained output from a given set of inputs. Allocative efficiency is when resources are allocated in such a way that any change to the amounts or types of outputs currently being produced (which might make someone better off) would make someone worse off. [Source: World Bank]

End users of pharmaceutical (end users)

    End users can be patients, consumers, or professional who directly use the pharmaceutical product on patients/consumers. [Source: WHO. IMPACT. Principles and elements for national legislation against counterfeit medical product]

Essential medicines

    Essential medicines are those that satisfy the priority health care needs of the population. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. The concept of essential medicines is forward-looking. It incorporates the need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure medicine quality; and the need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns. [Source: WHO. Essential medicines]

Ex-factory price

    The manufacturer’s posted price. Discounts or other incentives offered by manufacturers result in an effective price that is lower than the ex-factory price. [Source: OECD. Pharmaceutical Pricing Policies in a Global Market]

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]

Fixed co-payment

    An out-of-pocket payment in the form of a fixed amount (like for example a prescription fee) to be paid for a service, a medicine or a medical device. [Source: PPRI Glossary] See also: deductible and percentage co-payment.

Generic substitution

    Practice of substituting a pharmaceutical, whether marketed under a trade name or generic name (branded or unbranded generic), by a pharmaceutical, often a cheaper one, containing the same active ingredient(s) [Source WHO A model quality assurance system for procurement agencies]

Gross domestic product (GDP)

    The gross domestic product (GDP) is defined as the gross expenditure on the final uses of the domestic supply of goods and services valued at purchasers values less imports of goods and services. Comparisons of gross domestic products are arguably best based on purchasing power parities (PPP) and not on market exchange rates. [Source: OECD. Society at a glance, 2001]

Group purchasing

    Formation of an alliance of several purchasers to negotiate product price based on increased volume. This includes bulk procurement through a tender system, at a national or regional level. [Source: Global Conference on the Future of Hospital Pharmacy]

Health expenditure (HE, total health expenditure, THE)

    Health expenditure is defined as the sum of expenditure on activities that – through application of medical, paramedical, and nursing knowledge and technology – has the goals of: Promoting health and preventing disease; Curing illness and reducing premature mortality; Caring for persons affected by chronic illness who require nursing care; Caring for persons with health-related impairments, disability, and handicaps who require nursing care;  Assisting patients to die with dignity; Providing and administering public health; Providing and administering health programmes, health insurance and other funding arrangements. Health expenditure includes expenditure on: Personal health (curative care, rehabilitative care, long term nursing care, ancillary services to health care, medical goods dispensed to out-patients) and expenditure on Collective health (prevention and public health, administration and insurance). Health expenditure can be separated in: Public expenditure: health expenditure incurred by public funds (state, regional and local government bodies and social security schemes). Private expenditure: privately funded part of total health expenditure. Private sources of funds include out-of-pocket payments (both over-the-counter and cost-sharing), private insurance programmes, charities and occupational health care. [Source: OECD. A System of Health Accounts]

Health technology

    Health technologies include medicines, medical devices such as artificial hip joints, diagnostic techniques, surgical procedures, health promotion activities (e.g. the role of diet versus medicines in disease management) and other therapeutic interventions. [Source: NICE Glossary]

Health technology assessment (HTA)

    Health technology is the application of scientific knowledge in health care and prevention. Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe and  effective  health policies that are patient focused and seek to achieve best value. [Source: EUnetHTA]

High-cost patient

    A patient whose condition requires large financial expenditures or significant human and technological resources.

Hospital pharmacy

    Hospital pharmacy is the health care service, which comprises the art, practice, and profession of choosing, preparing, storing, compounding, and dispensing pharmaceuticals and medical devices, advising health care professionals and patients on their safe, effective and efficient use. Hospital pharmacy is a specialised field of pharmacy which forms an integrated part of patient health care in a health facility. Hospital pharmacy is the profession that strives to continuously maintain and improve the medication management and pharmaceutical care of patients to the highest standards in a hospital setting. [Source: European Association of Hospital Pharmacists]

Hospital price (average selling price to hospitals)

    The price or amount paid by a hospital (or hospital pharmacy) in order to take delivery of certain unit of medicines. Often the hospital price corresponds to the pharmacy purchasing price. It may or may not include VAT.

Hospital-only medicines (HOM)

    Medicines that may only be administered in hospitals [Source: PPRI Glossary]

Informal payments

    Informal payments are payments to health care professionals in cash or in kind made outside official remuneration for these services by third party payers. They are usually provided by patients.

Internal price referencing

    The practice of using the price(s) of identical medicines (ATC 5 level) or similar products (ATC 4 level) or even with therapeutic equivalent treatment (not necessarily a medicine) in a country in order to derive a benchmark or reference price for the purposes of setting or negotiating the price or reimbursement of the product in a given country. [Source: adapted from PPRI Glossary]

List price

    The prices that purchasers display as the prices at which they are prepared to sell their products and/or regulated by legislation. The prices of products as quoted in the purchaser’s price list, catalogue, internet site, advertisements, in a national price list/formulary etc. They are not necessarily actual transaction prices. Depending on the country and/or the product, they may or may not include delivery and installation costs, VAT and other indirect taxes on products, discounts, surcharges and rebates, invoiced service charges and voluntary gratuities. Certain pharmaceutical transactions, such as setting payment rates to pharmacies, may be based on list prices [Source: EUROSTAT-OECD. Methodological manual on purchasing power parities (PPPs)]

Managed entry agreements

    An arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximize their effective use, or limit their budget impact. [Source: Klemp, M Frønsdal KB, Facey K. What principles should govern the use of Managed Entry Agreements? International Journal of Technology Assessment in Health Care. 2011 Jan;27(1):77-83.] Types of managed entry agreements: • Access with evidence development (AED) • Conditional coverage • Coverage with evidence development (CED) • Patient access scheme (PAS) • Performance based agreement • Performance based health outcome reimbursement schemes • Performance-linked reimbursement • Price volume agreements • Risk sharing schemes.

Margin (distribution margin)

    The percentage margin is the percentage of the selling price that is profit. The wholesale margin is the gross profit of wholesalers, expressed as a percentage of the wholesale price. The pharmacy margin is the gross profit of pharmacies expressed as a percentage of the pharmacy retail price. [Source: adapted from PPRI Glossary]

Maximum price

    This term is used in a different way in different countries: e.g. in some countries it is the maximum amount which is reimbursed (cf. reference price system), in others it is the maximum share that is refunded by third party payers expressed as percentage of the reimbursement basis. [Source: PPRI Glossary]

Negative list

    List of medicines which cannot be prescribed at the expense of the third party payer [Source: PPRI Glossary]

Order entry

    Process by which a medication order is reviewed and processed in preparation for dispensing; may include manual or electronic processes. [Source: Global Conference on the Future of Hospital Pharmacy]

Out-of pocket maximum (annual ceiling)

    The maximum amount (e.g. a certain percentage of income) that an insured person has to pay for all covered health care services for a defined period (often a year). [Source: PPRI Glossary]

Out-of pocket payments (OPP)

    Payments made by a health care consumer that are not reimbursed by a third party payer. They include cost-sharing and informal payments to health care providers. 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. Cost-sharing can be in the form of deductibles, co-insurance or co-payments: Deductibles: Amounts required to be paid by the insured under a health insurance contract, before any payment of benefits can take place. Usually expressed in terms of an "annual" amount. Once the deductible is reached, the insurers then pays up to 100% of approved amounts for covered services provided during the remainder of that benefit year. Co-payment: cost-sharing in the form of a fixed amount to be paid for a service. Co-insurance: cost-sharing in the form of a set proportion of the cost of a service. [Source: OECD. A System of Health Accounts]

Over prescribing

    If a physician prescribes more medicines than comparable physicians (e.g. with similar patient groups or in the same region). The measurement of over prescribing is of particular importance if the doctor has been approved a pharmaceutical budget. [Source: PPRI Glossary]

Over-the-counter (OTC) medicine (over-the-counter product)

    Medicines which may be dispensed without a prescription and which are in some countries available via self-service in pharmacies a/o other retail outlets (e.g. drug stores). Selected OTC products may be reimbursed for certain indications in some countries. [Source: PPRI Glossary]

Parallel trade

    Parallel trade in medicines within the EU is a form of arbitrage in which medicinal products are purchased in one Member State, typically where income levels are relatively low, and sold into other Member States, where income levels and hence prices are higher (although there are exceptions to this, when high prices are being charged in lower income Member States). About 100 parallel trade enterprises are involved, between them employing about 12,000 people (5,000 in the UK), some on a part-time or casual basis. The major companies are represented at EU level by the trade association European Association of Euro-Pharmaceutical Companies (EAEPC), but there are a relatively large number of others holding licences about whom less is known. [Source: Europe Economics. Safe Medicines Through Parallel Trade Contribution to an Impact Assessment]

Patient access scheme (PAS)

    Patient access schemes are special ways Pharmaceutical companies can propose to enable patients to gain access to high costs drugs medicines. They are proposed by a pharmaceutical company and agreed between the Department of Health and the pharmaceutical company. [Source: Patient Access Scheme Liaison Unit at NICE, adapted] See also: managed entry agreements

Pay-back

    A cost-containment measure; a financial mechanism that requires manufacturers to refund a part of their revenue to a payer (i.e. third party payer) if sales exceed a previously determined or agreed target-budget. [Source: PPRI Glossary]

Percentage co-payment

    Cost-sharing in the form of a set proportion of the cost of a service or product. The patient pays a certain fixed proportion of the cost of a service or product, with the third party payer paying the remaining proportion. [Source: PPRI Glossary]

Performance based agreement

    Agreement between a payer and a pharmaceutical, device or diagnostic manufacturer where the price level and/or revenue received is related to the future performance of the product in either a research or a real world environment. [Source: Towse A, Garrison L. Can't get no satisfaction? Will pay for performance help? Toward an economic framework for understanding performance-based risk sharing agreements for innovative medical products. Pharmacoeconomics 2010, 28:93-102.] See also: managed entry agreements

Performance based health outcome reimbursement schemes

    Schemes between healthcare payers and medical product manufacturers in which the price, level, or nature of reimbursement are tied to future measures of clinical or intermediate endpoints ultimately related to patient quality or quantity of life, appear to have arisen out of a desire to provide patients with access to novel and potentially beneficial healthcare technologies under conditions of significant uncertainty and cost pressures. [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

Performance-linked reimbursement

    Schemes where the reimbursement level for covered products is tied to the measure of clinical outcomes in the real world. [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

Pharmaceutical budget

    Pharmaceutical budgets are a cost-containment measure of third party payers. The maximum amount of money to be spent on medicines in a specific region or period of time is fixed ex-ante. [Source: PPRI Glossary]

Pharmaceutical expenditure (PE, total pharmaceutical expenditure, TPE)

    It is defined as total expenditure on pharmaceutical and other medical nondurables. This comprises medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives. Other medical nondurables comprise wide range of medical nondurables such as bandages, elastic stockings, incontinence articles, condoms and other mechanical contraceptive devices

Pharmacy purchasing price

    The price charged by wholesalers to the retailers (usually pharmacies). It includes any wholesale mark-up. [Source: OECD. A System of Health Accounts]

Pharmacy retail price (prp)

    The price charged by retail pharmacist to the general public. It includes any pharmacy mark-up or dispensing fee. It can be a Gross PRP (including VAT) or a Net PRP (excluding VAT). [Source: adapted from PPRI Glossary]

Pharmacy tax

    A tax - other than VAT - levied by a state or city on the pharmacy retail price of an item, collected by the retailer. [Source: PPRI Glossary]

Population-group-specific reimbursement

    Specific population groups (e.g. children, old-age pensioners) are eligible for medicines, while others are not. [Source: PPRI Glossary]

Positive list (formulary)

    List of medicines that may be prescribed at the expense of the third party payer. [Source: PPRI Glossary]

Prescription only medicines

    Products that can be dispensed only on a health professional prescription. Products are subject to medical prescription where they: are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision; are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation; are normally prescribed by a doctor to be administered parenterally; the medicinal product is intended for out-patients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use]

Price cap (price ceiling)

    A cost-containment measure which fixes ex-ante the maximum price of medicine, e.g. taking into consideration inflation rates and production cost. Companies are allowed to choose any price below this threshold and in exchange authorities refrain from further control of company data (profit margins, sales etc.). [Source: PPRI Glossary]

Price control

    Pricing policies where government authorities set the price of a medicine and/or indirectly influence it (e.g. statutory pricing, price negotiations, public procurement). Contrary to free pricing. The bases on which regulated prices are set vary. These may be on costs, return on investment, mark-ups, etc. [Source: PPRI Glossary and OECD. Glossary of statistical terms]

Price cut

    A cost-containment measure where the set price of a medicine is reduced by the authorities.

Price freeze

    A common cost-containment method. The price of a medicine is fixed at a given level, mostly for a predetermined period of time. Price freezes are sometimes based on agreements between pharmaceutical industry and authorities but in most cases it is done by law. [Source: PPRI Glossary]

Price negotiation

    A form of pricing procedure, where medicine prices are discussed/negotiated (e.g. between manufacturer and third party payer). [Source: PPRI Glossary]

Price notification

    A form of pricing procedure where pharmaceutical companies officially inform the authorities about the price of the medicine.

Price type

    The level at which the price of a medicine is set. The following price types exist: ex-factory price, pharmacy purchasing price, pharmacy retail price.

Price volume agreements

    Agreements which focus on controlling financial expenditure with pharmaceutical companies refunding over budget situations. [Source: Adamski J. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Services Research 2010, 10:153.] See also: managed entry agreements

Price-volume agreement

    Like a framework agreement, a volume control tool. The price of a medicine is agreed between public authorities and a manufacturer on the basis of a forecast volume of sales. If the actual sales volume exceeds the forecast, the price of the medicine is usually reviewed downwards. [Source: PPRI Glossary]

Procurement

    The act of purchasing a pharmaceutical by a public authority. [Source: OECD. A System of Health Accounts] Pharmaceutical procurement is a complex process that involves many steps and many stakeholders. It is also conducted within national and institutional policies, rules, regulations, and structures that may hinder or support the overall efficiency of the procurement process. An effective procurement process at any level must ensure that four strategic objectives are achieved: the procurement of the most cost effective medicines in the right qualities; the selection of reliable suppliers of high-quality products; procurement and distribution systems that ensure timely and undisturbed deliveries; processes that ensure the lowest possible total costs. [Source: WHO. Operational principles for good pharmaceutical procurement]

Purchaser’s price

    The amount paid by the purchaser in order to take delivery of a unit of a good or service at the time and place required by the purchaser. It excludes any VAT (or similar deductible tax on products) which the purchaser can deduct from his own VAT liability in respect of VAT invoiced to his customers. It includes supplier’s retail and wholesale margins, separately invoiced transport and insurance charges and any VAT (or similar deductible tax on products) which the purchaser cannot deduct from his own VAT liability. In the case of equipment goods it will also include installation costs if applicable. Purchasers’ prices are the prices most relevant for decision-making by buyers. [Source: EUROSTAT-OECD. Methodological manual on purchasing power parities (PPPs)] See also: list price

Purchasing power parities (PPP)

    Spatial deflators and currency converters, which eliminate the effects of the differences in price levels between countries, thus allowing volume comparisons of Gross Domestic Product (GDP) components and comparisons of price levels. PPPs are calculated in three stages: first for individual products, then for groups of products or basic headings and, finally, for groups of basic headings or aggregates. The PPPs for basic headings are unweight averages of the PPPs for individual products. The PPPs for aggregates are weighted averages of the PPPs for basic headings. The weights used are the expenditure on the basic headings. PPPs at all stages are price relatives. They show how many units of currency A need to be spent in country A to obtain the same volume of a product or a basic heading or an aggregate that X units of currency B purchases in country B. In the case of a single product, the “same volume” means “identical volume”. But in the case of the complex assortment of goods and services that make up an aggregate such as GDP, the “same volume” does not mean an “identical basket of goods and services”. The composition of the basket will vary between countries according to their economic, social and cultural differences, but each basket will provide equivalent satisfaction or utility. Also referred to as “parity” or “parities”. [Source: EUROSTAT-OECD. Methodological manual on purchasing power parities (PPPs)]

Rational use of medicines

    Rational use of medicines requires that “patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.” Such a definition covers the good-quality (i.e. proper and appropriate) use of pharmaceuticals by providers and consumers, including adherence to treatment. [Source: WHO. The rational use of medicines]

Rebate

    A discount paid to the purchaser after the transaction has occurred. Pharmacies may receive a bulk refund from a wholesaler, based on sales of a particular product or total purchases from that wholesaler over a particular period of time. It does not affect the price the patient pays, but the retailer’s profits will be higher. [Source: EUROSTAT-OECD. Methodological manual on purchasing power parities (PPPs)]

Reference price system

    The third party payer determines a maximum price (=reference price) to be reimbursed for certain medicines. On buying a medicine for which a fixed price / amount (the so-called reimbursement price) has been determined, the insured person must pay the difference between the fixed price / amount and the actual pharmacy retail price of the medicine in question, in addition to any fixed co-payment or percentage co-payment rates. Usually the reference price is the same for all medicines in a given ATC 4 level and/or ATC 5 level group. [Source: PPRI Glossary]

Reimbursement

    Reimbursement is the percentage of the reimbursement price (for a service or a medicine) which a third party payer pays. So 100% reimbursement means that the third party payer covers 100% of the reimbursement price / amount of a medicine or service except a possible prescription fee

Reimbursement category (reimbursement group)

    Medicines eligible for reimbursement are often grouped according to selected characteristics, e.g. route of administration (oral, etc.), main indication (oncology, paediatric, etc.), ATC level, classification (hospital-only, etc.). In many countries different reimbursement rates are determined for different reimbursement categories. [Source: PPRI Glossary]

Reimbursement market

    The reimbursement market is the sub-market in which a third party payer reimburses medicines.

Reimbursement price

    This price is the basis for reimbursement of medicines in a health care system, i.e. the maximum amount paid for by a third party payer. The reimbursed amount can either be the full reimbursement price (like e.g. Austria) or a percentage share of the reimbursement price (e.g. in Denmark). In a reference price system the reimbursement price is lower than the full price of the medicine, leaving the patient to pay the difference privately (or through complementary voluntary health insurance). [Source: PPRI Glossary]

Reimbursement rate

    The percentage share of the price of a medicine or medicinal service, which is reimbursed/subsidised by a third party payer. The difference to the full price of the medicine or medicinal service is paid by the patients. [Source: PPRI Glossary]

Reimbursement scheme

    The reimbursement system which covers the majority of residents in a country, in some countries also referred to as “general” reimbursement. [Source: PPRI Glossary]

Retailer (dispensary)

    A company that sells goods to consumers. In the pharmaceutical sector, the retailer is the pharmacy or any other dispensary of medicines. Umbrella term for facilities that dispense/sell medicines (POM and OTC) to out-patients, e.g. community pharmacies, POM dispensaries, dispensing doctors, hospital pharmacies, pharmacy outlets, medicine chests, drugstores, supermarkets etc. In most countries the dispensation of medicines is regulated by law, e.g. stating that supermarkets or drug stores may only sell a limited range of OTC. [Source: WHO and HAI. Measuring medicine prices, availability, affordability and price components and PPRI Glossary]

Risk sharing schemes

    Agreements concluded by payers and pharmaceutical companies to diminish the impact on the payer's budget of new and existing medicines brought about by either the uncertainty of the value of the medicine and/or the need to work within finite budgets. [Source: Adamski J. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Services Research 2010, 10:153.] See also: managed entry agreements A contract between two parties who agree to engage in a transaction in which there are uncertainties regardless concerning its final value. Nevertheless, one party, the company, has sufficient confidence in its claims of either effectiveness or efficiency that it is ready to accept a reward or a penalty depending on the observed performance of its product. [Source: de Pourville G.Risk-sharing arrangements for innovative drugs. A new solution to old problems. Eur J Health Econ 2006, 7:155-Z

Risk-benefit balance

    An evaluation of the positive therapeutic effects of the medicinal product in relation to its risks (any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health and any risk of undesirable effects on the environment). [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use]

Risk-sharing agreement

    An agreement between public authorities and one manufacturer which links the price of a medicine to a defined risk. The risk can be a risk of inappropriate use (over prescribing compared to targeted population or prescription of inappropriate dosages) or can be related to the cost-effectiveness claimed by the manufacturer. [Source: PPRI Glossary]

Sickness fund (social insurance institution)

    A single social health insurance institution. In some countries there are several sickness funds operating (Austria) or even competing each other (Germany). Some sickness funds are operating on a regional basis whereas others are limited to specific professional groups like farmers or self-employed persons. [Source: PPRI Glossary]

Social health insurance (SHI)

    Social health insurance is a type of health care provision, often funded through insurance contributions by employers and employees as well as state subsidies. In many countries there are obligatory schemes for (employed) persons whose income does not exceed a certain amount/limit (= insurance obligation) in place. Social health insurance is often organised in different sickness funds - in some countries allowing the patient to select a sickness fund (Germany) whereas in others the membership is determined mandatory, e.g. depending on the type of occupation (e.g. Poland, Austria). In some social health insurance countries persons with higher income as well as self-employed persons may opt for substitutive private health insurance. In addition to social health insurance in some countries voluntary health insurance, covering e.g. out-of pocket payments or allowing for free choice of doctors, is very popular. [Source: PPRI Glossary]

Statutory pricing

    Pricing system, where medicine prices are set on a regulatory basis (e.g. law, enactment, decree). [Source: PPRI Glossary]

Tender

    Any formal and competitive procurement procedure through which tenders/offers are requested, received and evaluated for the procurement of goods, works or services, and as a consequence of which an award is made to the tenderer whose tender/offer is the most advantageous. [Source: African Development Bank Group – Glossary of procurement terms] See also: procurement methods

Therapeutic benefit (therapeutic value)

    The effect conveyed on a patient following administration of a pharmaceutical which restores, corrects or modifies a physiological function(s) for that patient. [Source: PPRI Glossary]

Therapeutic referencing

    The practice of using the price(s) of similar products (ATC 4 level) or with therapeutic equivalent treatment (not necessarily a medicine) in a country in order to derive a benchmark or reference price for the purposes of setting or negotiating the price or reimbursement of the product in a given country. [Source: adapted from PPRI Glossary]

Third party payer (payer, insurer, purchaser)

    Public or private organisation that pay or insure health or medical expenses on behalf of beneficiaries or recipients. Recipients pay a premium for this coverage in all private and some public programs of social insurance, while the system is supported by general taxation in the National Health Services. The payer then pays bills on behalf of covered individuals, which are called third party payments. They are distinguished by the separation among the individual receiving the service (the first party), the individual or institution providing it (the second party), and the organisation paying for it (third party).

Transparency directive

    Directive 89/105/EEC (of 21 December 1988) relates to the transparency of measures regulating the pricing of medicines for human use and their inclusion in the scope of national third party payers. [Source: PPRI Glossary]

Value added tax (VAT)

    A sales-tax on products collected in stages by enterprises. It is a wide-ranging tax usually designed to cover most or all goods and services, including pharmaceutical products. The VAT rate of pharmaceuticals in the EU is often lower than the standard VAT rate. Deductible VAT is the value added tax payable on purchases of goods and services intended for intermediate consumption, gross fixed capital formation or for resale which producers are permitted to deduct from their own VAT liability to the government in respect of VAT invoiced to their customers. Non-deductible VAT is the value added tax payable by purchasers that is not deductible from their own VAT liability, if any. [Source: adapted from EUROSTAT-OECD. Methodological manual on purchasing power parities (PPPs)]

Volume control

    Measures applied by authorities (e.g. state, third party payers) or actors (e.g. hospitals) in order to affect and limit the amount of medicines prescribed and/or dispensed (e.g. pharmaceutical budgets).

Voluntary health insurance (VHI)

    Health insurance that is taken up and paid for at the discretion of individuals or employers on behalf of individuals. VHI can be offered by public or quasi-public bodies and by for-profit (commercial) and non-profit private organisations. In the European context, VHI can be classified in three different ways: Substitutive Private Health Insurance provides cover that would otherwise be available provided by state. In a social health insurance system people who have no insurance obligation (in some countries e.g. self-employed) may opt for substitutive private health Insurance. Complementary VHI provides cover for services excluded or not fully covered by the state (e.g. dental care), including cover for co-payments imposed by the statutory health care system. Supplementary VHI provides cover for faster access and increased consumer choice. [Source: PPRI Glossary]

Wholesale

    All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in the Member State concerned. Wholesalers have a “public service obligation”: the obligation to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question. [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use] Full-liner: The activity of pharmaceutical full-line wholesaling consists of the purchase and sale, warehousing, order preparation and delivery / distribution of the full assortment of medicines (in range and depth) on a defined market) Short-liner: The activity of pharmaceutical short-line wholesaling consists of the delivery and distribution of a selected assortment of medicines on a defined market. [Source: adapted from GIRP website]

 
 

 

Page created: 06/05/2016
Page last updated: 22/06/2016
 
 
Голос пациентов с редкими заболеваниями в Европе The voice of rare disease patients in EuropeEURORDIS Сеть организаций, представляющих интересы пациентов с редкими заболеваниями их разных стран мираRare Disease International Социальная сеть RareConnect предоставляет пациентам, их семьям и специалистам многоязычную платформу для обмена информацией и опытом RareConnect Программа Rare Barometer — это инициатива EURORDIS, направленная на проведение исследований по преобразованию опыта пациентов с редкими заболеваниями в цифры и факты, которыми можно поделиться с ответственными руководителями. Rare Barometer День больных редкими заболеваниями – международная кампания по привлечению внимания к проблеме редких заболеваний, которая по инициативе EURORDIS ежегодно проводится в последний день февраляRare Disease Day Приняв участие в Европейской конференции по редким заболеваниям и орфанным препаратам (EUCERD), которая по инициативе EURORDIS проводится каждые два года, вы получите возможность побывать на самом представительном европейском форуме по проблемам редких заболеваний.European Conference on Rare Diseases