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edited by AIFA’s Office of Osmed and HTA


Treatment with high-energy rays (such as x-rays) to kill or shrink cancer cells. The radiation may come from outside the body (external radiation) or from radioactive materials placed directly in the tumour (brachytherapy or internal radiation). Radiation therapy may be used to shrink the cancer before surgery, to destroy any remaining cancer cells after surgery, or as the main treatment. It may also be used as palliative treatment for advanced cancer. [Source: American Cancer Society. Glossary]
A measure of the frequency of occurrence of a phenomenon. In epidemiology, demography, and vital statistics, a rate is an expression of the frequency with which an event occurs in a defined population in a specified period of time. The use of rates rather than raw numbers is essential for comparison of experience between populations at different times, different places, or among different classes of persons. [Source: Last. A dictionary of epidemiology edited for the International Epidemiological Association]
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]
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)]
Process by which medications are removed from distribution channels and returned to the manufacturer due to safety concerns (such as inadvertent product contamination) or other product integrity concerns (including subpotency, inappropriate labelling, etc.). [Source: Global Conference on the Future of Hospital Pharmacy]
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]
The direction of people to an appropriate facility, institution or specialist in a health system, such as a health centre or a hospital, when health workers at a given level cannot diagnose or treat certain individuals by themselves, or face health or social problems they cannot solve by themselves. [Source: WHO. A Glossary of Terms for Community Health Care and Services for Older Persons]
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
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]
The reimbursement market is the sub-market in which a third party payer reimburses medicines.
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]
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]
The reimbursement system which covers the majority of residents in a country, in some countries also referred to as “general” reimbursement. [Source: PPRI Glossary]
The payment of a health care provider (individual or organisation) for the services provided. The services may be paid directly by the patient or by a third party payer.
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]
A risk management system is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions. The aim of a risk management system is to ensure that the benefits of a particular medicine (or a series of medicines) exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole. This can be done either by increasing the benefits or by reducing the risks and focuses on the risk reduction approach. Article 6 of Regulation (EC) No 726/2004 and Article 8 of Directive 2001/83/EC lay down the particulars and documents to be included in an application for the authorisation of a medicinal product for human use. The EU Risk Management Plan (EU-RMP) should be seen within the framework of the following provisions: 1. In the context of centrally authorised products Article 9 (4) of Regulation (EC) No 726/2004 which requires for a favourable opinion and that the following shall be attached to the Opinion: a. “details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including conditions under which the medicinal product may be made available to the patients, in accordance with the criteria in Title VI of Directive 2001/83/EC” b. “details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product” 2. In addition to Article 9 (4) (c) above, Article 127 a) of Directive 2001/83/EC, as amended states that “When a medicinal product is to be authorised in accordance with Regulation (EC) 726/2004 and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the medicinal product […], a decision addressed to the Member States shall be adopted in accordance with the procedure provided for in Article 33 and 34 of the Directive, for the implementation of those conditions or restrictions” The EU-RMP contains 2 parts: Part I which contains a safety specification and a pharmacovigilance plan and Part II which contains an evaluation of the need for risk minimisation activities. If there is a need for additional (ie non- routine) risk minimisation activities, a risk minimisation plan is also required.
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, 7:155-7.] See also: managed entry agreements
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]
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]
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