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Medicines Reimbursement Policies in Europe

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Medicines Reimbursement Policies in Europe MEDICINES REIMBURSEMENT POLICIES IN EUROPE MEDICINES REIMBURSEMENT POLICIES IN EUROPE Abstract This report reviews and analyses different reimbursement policies for medicines applied by countries in the WHO European region. The study used a mixed methods approach including primary data collection through a questionnaire addressing the competent authorities included in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, a literature review, qualitative interviews with authorities and researchers in selected case study countries, and a cross-country analysis of the actual financial burden for patients. The study found that while almost all countries provide full coverage for medicines in the inpatient sector, patients can be asked to co-pay for reimbursable medicines in the outpatient sector. As a commonly applied co-payment patients pay a defined share of the price of a medicine; in addition, prescription fees and/or deductibles are also in place in some countries. In the countries of the WHO European region, mechanisms have been established to protect defined population groups from excessive co-payments for medicines; key reasons for reductions of and exemptions from co-payments include low income, defined diseases or disabilities and age. The analysis of the actual financial burden suggested that co-payments may pose a substantial financial burden for patients, particularly in lower-income countries. The report identified several principles aiming to improve affordable access to medicines and protect people from excessive out-of-pocket co-payments. These include clear priority-setting processes, evidence- based decision-making, transparent processes, consideration of vulnerable population groups, making use of the efficiency of lower- priced medicines, regular evaluations and strategic design of policy measures. Keywords PHARMACEUTICAL POLICY INSURANCE, HEALTH, REIMBRUSEMENT ACCESS TO MEDICINES FEES, PHARMACEUTICALS EUROPE ISBN 9789289053365 Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office website (http://www.euro.who.int/ pubrequest). © World Health Organization 2018 All rights reserved. The Regional Office for Europe of the World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health Organization. The boundaries and names shown and the designations used on the maps in this report do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. iii Contents List of boxes, figures and tables ........................................................................................................ v Abbreviations..........................................................................................................................................vii Abbreviations of country names used in some figures ............................................................viii Executive summary .......................................................................................................................xi 1. Introduction ..........................................................................................................................1 2. Methods ................................................................................................................................3 2.1 Mixed methods .................................................................................................................3 2.2 Terminology ......................................................................................................................4 2.3 Survey of competent authorities ........................................................................................5 2.4 Qualitative interviews ........................................................................................................7 2.5 Literature review ...............................................................................................................7 2.6 Quantitative analysis of financial burden ............................................................................8 3. General policy context .......................................................................................................10 3.1 The global development context .....................................................................................10 3.2 The situation in the WHO European Region .....................................................................12 4. Reimbursement of medicines in the WHO European Region .........................................19 4.1 Eligibility for reimbursement coverage .............................................................................19 4.2 Reimbursement framework .............................................................................................22 4.3 Co-payments ..................................................................................................................45 4.4 Managing uptake for off-patent medicines......................................................................50 5. Country case studies ..........................................................................................................56 5.1 Azerbaijan .......................................................................................................................57 5.2 Finland ............................................................................................................................59 5.3 Greece ............................................................................................................................61 5.4 Kyrgyzstan ......................................................................................................................63 5.5 Republic of Moldova .......................................................................................................65 5.6 The Netherlands ..............................................................................................................68 5.7 Scotland, United Kingdom ..............................................................................................69 5.8 Spain ..............................................................................................................................70 5.9 Turkey .............................................................................................................................72 iv 6. Findings from the literature: analysis of reimbursement policies ..................................74 6.1 Impact on accessibility, affordability and health outcomes ................................................74 6.2 Vulnerability ....................................................................................................................76 7. Cross-country analysis of financial burden for patients .................................................77 7.1 Co-payment regulation and scenarios considered ............................................................77 7.2 Data availability ...............................................................................................................82 7.3 Cross-country analysis .....................................................................................................82 7.4 Limitations ......................................................................................................................92 8. Conclusions .........................................................................................................................93 8.1 Main findings ..................................................................................................................93
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