歐洲的藥價與回本:參照價格和類似的配合措施適用於創新藥物成為製藥公司的一大挑戰 是由出版商GBI Research在2011年11月所出版的。
這份英文市場調查報告書包含Pages: 68 價格從美金3500起跳。
在EU及歐洲的大部分國家的醫療是利用公共資金營運，提供醫療保險制度。各國政府在國民的醫療提供上擔負著重要的作用。
本報告提供歐洲各國的醫療制度與藥價設定，回本制度的相關概述，各國趨勢與問題點，法律規範趨勢等，為您概述為以下內容。
第1章 目錄
第2章 簡介
第3章 歐洲的藥價與回本:概要
- GDP和互相相關的醫療費
- 醫療費用和GDP的關係
- 歐洲的醫療相關法規概要
- 談判
- 國際參照價格
- 國內參照價格
- 競標
- 學名藥的價格限制
- 處方集的使用
- 以價值為基礎的藥價設定和風險分擔模式
- 以證據為基礎的醫療和醫療技術評估
- 藥價，回本的藥物經濟學所扮演的角色
- EU單一價格:無數的問題尚未解決
- 歐洲的藥價，回本主要的變化
- 儘管有企業和專業人士的擔憂，英國還是預計從2014年開始引進取代PPRS的VBP
- 英國的VBP引進相關課題
- 法國由於整體的價格下降依照臨床療效減少報銷
- 利益評估的價格談判，價格凍結，強制降價是德國的特徵
- 義大利由降價和參考價格的變化所支配
- 西班牙則是專利保護藥品加上7.5％的回扣，實施學名藥的降價措施
- 捷克的藥品價格· 7％的報銷削減視2012年與2013年的VAT的變化
- 在波蘭實施NHF17%的固定醫藥品報銷
- 匈牙利的回本藥物銷售增加20%
第4章 歐洲主要5個國家的趨勢
- 英國
- 醫療制度
- 醫療費
- 藥價·回本流程
- 主要趨勢
- 主要課題
- 法國
- 德國
- 義大利
- 西班牙
第5章 東歐的藥價設定與回本
- 捷克
- 波蘭
- 羅馬尼亞
- 匈牙利
- 第6章 北歐各國
- 挪威
- 芬蘭
- 丹麥
第7章 附錄
圖表
Abstract
Summary
GBI Research, the leading business intelligence provider, has released its latest research “Pharmaceutical Pricing and Reimbursement in Europe - Reference Pricing and Similar Initiatives Being Applied to Innovative Drugs Pose Significant Challenge to Pharmaceutical Companies”. It provides a comprehensive overview of the healthcare system, and pricing and reimbursement process in 12 European nations with a detailed analysis of the different regulatory mechanisms used in these countries. The report closely scrutinizes the major changes in the pharmaceuticals related pricing and reimbursement in these European nations in the recent past and their impact in the near future. The countries analyzed in the report are the top five countries of Europe, Eastern European countries such as Czech Republic, Poland, Romania and Hungary as well as Scandinavian countries such as Norway, Finland and Denmark.
GBI Research's analysis describes healthcare across the 12 European nations, which is largely publicly financed and is provided by health insurance systems; hence, the European governments play a key role in providing healthcare for their citizens. Health is of high priority for Europe's citizens and pharmaceutical costs are the third most important component in the member states' healthcare budgets. Currently, the governments of the member countries face substantially rising costs for the provision of health care (average costs are rising at a faster rate than GDP) due to over-prescription of drugs, their irrational usage, and other key factors such as Europe's ageing population and increasing cost of new medical technologies. Consumer preference for branded drugs to generic drugs in cases where the patent for the drug has expired is also one of the reasons for increasing healthcare costs. Austerity packages announced by the countries are incorporating demand side and supply side policies to reduce the fiscal burden of which healthcare costs command a major proportion. The governmental demand side policies include measures that affect the reimbursements of drugs such as positive and negative lists, cost sharing, reference pricing, risk-sharing contracts, tenders, pay-back arrangements and other provisions aimed at a more rational use of pharmaceutical products and making demand more price sensitive. The most applied supply policy is price regulation which includes price control and price negotiation. The specific features of individual policies vary significantly across the member states. Single pricing mechanism is still an issue in the Europe.
Scope
- Detailed study of the healthcare systems and roles of the key players in the respective pharmaceutical systems of top five countries of Europe - the UK, France, Germany, Italy and Spain; Eastern European countries of Czech Republic, Poland, Hungary, and Romania; and Scandinavian countries of Norway, Denmark and Finland.
- Analysis of the major pricing and reimbursement mechanisms in each country.
- Key trends that follow from the recent changes brought about in the pricing and reimbursement mechanism.
- Build an understanding of the possible major challenges brought about by the enactment of changes in the pricing and reimbursement scene in the countries covered.
Reasons to buy
- Build understanding of the pharmaceuticals related key pricing and reimbursement mechanisms in the key markets of Europe.
- Optimize your investment through identification and understanding of the changes in the pharmaceuticals regulatory mechanism in the economies.
- Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in pricing and reimbursement scene for the countries covered.
Executive Summary
GBI Research, the leading business intelligence provider, has released its latest research “Pharmaceutical Pricing and Reimbursement in Europe - Reference Pricing and Similar Initiatives Being Applied to Innovative Drugs Pose Significant Challenge to Pharmaceutical Companies”. It provides a comprehensive overview of the healthcare systems as well as pricing and reimbursement processes in 12 European nations with a detailed analysis of the different regulatory mechanisms used in these countries. The report closely scrutinizes major changes in pricing and reimbursement for pharmaceuticals in these European nations in the recent past and their impact in the near future. The countries analyzed in the report are the top five European countries as well as Eastern European countries, namely the Czech Republic, Poland, Romania and Hungary in addition to the Scandinavian nations Norway, Finland and Denmark.
Pricing and Reimbursement in Europe
Healthcare across the European Union (EU) and majority of the European nations is largely publicly financed and is provided by health insurance systems; hence, the governments of European nations play a key role in providing healthcare for their citizens. Health is a high priority for Europe's citizens and pharmaceutical costs are the third most costly component in the member states' healthcare budgets. Hospital and ambulatory care spending account for the first two most important components in their health care budgets, according to a 2009 report by the European Commission. Currently, the governments of the member countries face substantially rising costs for the provision of health care (average costs are rising at a faster rate than Gross Domestic Product (GDP) due to factors such as over-prescription of drugs, their irrational usage, and other key factors such as Europe's ageing population and increasing cost of new medical technologies. Consumer preference for branded drugs to generic drugs in cases where drug patents have expired is also contributing to increasing healthcare costs.
Growing Healthcare Expenditure Fueled by an Ageing Population in Europe
It was estimated that in 2009, the average number of healthy life years by people in the EU (27 countries) was 73.3 years, with Sweden accounting for the highest number of healthy life years at 79.1 years. Governments across Europe are facing growing healthcare expenditure, primarily due to ageing populations. However, recent austerity measures implemented by countries such as Italy, France, Germany and the UK to tackle the economic crisis have resulted in tightening healthcare budgets, resulting in a downward pressure on pharmaceutical prices. This is bringing changes in the pricing and reimbursement scenario in countries across Europe. The specific features of individual policies vary significantly across the member nations.
Value-based pricing Replacing Pharmaceutical Price Regulation Scheme in the UK from 2014
After the current PPRS, the system of pricing medicines, launched in 2009 has run its course, a new value-based approach to the pricing of branded medicines, called value-based pricing (VBP) is expected to be introduced in the UK after the expiry of PPRS in 2013, despite concerns regarding the mechanism of the VBP system. The UK is among the few markets that allows drug companies to set their own prices; however, the National Institute of Health and Clinical Excellence (NICE), one of the main regulatory bodies, under the Conservative-Liberal Democrat coalition has decided to adopt VBP which will be determined by the maximum affordable cost per Quality Adjusted Life Years (QALY) generated by the use of new medicines. At the time of establishing the price of a new drug candidate, the drug manufacturer will be required to submit clinical trial evidence suggesting that their drug is more effective than existing drugs in the market. The new system will be applied to newly branded prescription drugs, but will not be applied to currently marketed drugs or generics. As this new system is introduced, the main focus of regulation is shifted towards profit rather than price controls.
Reimbursement Reduced for Drugs with Moderate and Low Clinical Benefit in France
The French government intends to cut its healthcare bill and a major reduction will be derived from limiting drug prices and enforcing price cuts including parallel imported drugs. The French government's pricing and reimbursement committee, Economic Committee on Health Products (CEPS) has instituted a change in reimbursement rate of drugs with moderate clinical benefit from 35% to 30% and to 15% from a previous 20% for drugs with low clinical benefit. The move was part of the 2011 Social Security Budget Bill. Moreover, for all medical procedures, the co-payment will be increased by half a percentage point. Also, the health ministry is creating a roadmap for changes in the laws on reimbursing drugs that will result in quicker termination of reimbursement for drugs given a minimal clinical benefit rating.
Benefit Assessment Led Price Negotiation, Price Freeze and Mandatory Discounts in Germany
Pharmaceutical prices in Germany have been among the highest in Europe. The Act on the Reform of the Market for Medicinal Products (AMNOG) that came into effect on January 2011 in Germany is expected to assist in the overall effort to curb in exploding costs for the country's public health insurance system. The new act will only allow the pharmaceutical manufacturers to set prices freely for the first year post the drug product's launch in the German market after which they are required to negotiate the prices with the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). A major cost containment measure relates to the in-patent drugs where pharmaceutical manufacturers are required to submit evidence of the added benefit rendered to patients when they launch a product with new active ingredients to market. Mandatory discounts for patented medicines offered to the statutory health system have been increased from 6% to 16%. Moreover, price freeze on medicines have been imposed until the end of 2013 at August 2009 levels. The objective behind the measure was an urgent and short term control on expenditure growth. It will also retain the old discount price contract system for generic drugs.
A Rebate of 7.5% for In-Patent Drugs and Price Cuts for Generics in Spain
Though price cuts are not imposed on reimbursed patented drugs in Spain, effective from June 2010 they have been imposed with rebates under the National Health System (NHS). The rebate is 7.5% of the sales to the NHS for all reimbursed medicines, whether for ambulatory or hospital use. Orphan medicines are also subject to a 4% rebate. An average 25% cut in generic prices has been implemented from July 2010 as a part of the austerity package in an effort to bring down the health care costs. Moreover, several regions in the country such as Navarra, Extremadura, Catalonia are attempting to shape prescribing pattern and encourage greater use of generics by instructing doctors to prescribe common medications by active pharmaceutical ingredient instead of branded products. Other initiatives expected to impact pricing of pharmaceuticals include regional tendering, and creating regional catalogues that prioritize reimbursed medicines though such catalogues exceed regional authority and the Supreme Court often overturn these regional initiatives. Table of Contents
1. Table of Contents
- 1.1 List of Tables
- 1.2 List of Figures
2. Pricing and Reimbursement in Europe - Introduction
- 2.1 GBI Research Report Guidance
3. Pricing and Reimbursement in Europe - Overview
- 3.1 Healthcare Expenditure Highly Correlated with GDP
- 3.2 Relation between Pharmaceutical Expenditure and GDP
- 3.3 Overview of Pharmaceutical Regulations in Europe
- 3.3.1 Negotiations
- 3.3.2 International Price Referencing
- 3.3.3 Internal Reference Pricing
- 3.3.4 Tendering
- 3.3.5 Price Capping of Generic Pharmaceuticals
- 3.3.6 Use of Positive and Negative Formulary
- 3.3.7 Value Based Pricing and Risk-Sharing Models
- 3.3.8 Increased Focus on Evidence-based Medicine and Health Technology Assessment (HTA)
- 3.3.9 Role of Pharmacoeconomics in Pricing and Reimbursement
- 3.3.10 EU Single Pricing - Still an Unresolved Issue
- 3.4 Recent Major Changes in Pricing and Reimbursement of Drugs in Europe
- 3.4.1 The UK to Adopt VBP Replacing PPRS from 2014 despite Concerns of Companies and Experts Alike
- 3.4.2 Major Challenge Regarding VBP Adoption in the UK
- 3.4.3 France Decreases Reimbursement for Drugs with Moderate Clinical Benefits Along With Overall Price Cuts
- 3.4.4 Benefit Assessment Led Price Negotiation, Price Freeze and Mandatory Discounts Key Features Of German P&R Changes
- 3.4.5 Italian P&R Scene Dominated By Price Cuts and Changes in Reference Price Level
- 3.4.6 Main Austerity Measures in Spain Include 7.5% Rebate for In-Patent Drugs and Price Cuts for Generics
- 3.4.7 Renewed P&R Cut Of 7% in Czech Republic and Proposed Changes in VAT for 2012 And 2013
- 3.4.8 Expenditure on Reimbursement of Medicines Fixed At 17% of the NHF in Poland
- 3.4.9 Levy on Sale of Reimbursed Drugs in Hungary to Go Up To 20%; Payment-By-Result another Major Move
4. Pricing and Reimbursement in Europe - The Top Five Countries of Europe
- 4.1 The UK
- 4.1.1 Healthcare System in the UK
- 4.1.2 Healthcare expenditure - Other Developed Countries More Prominent Healthcare Spenders
- 4.1.3 Pricing and Reimbursement Process in the UK
- 4.1.4 Key Trends
- 4.1.5 Major Challenges
- 4.2 France
- 4.2.1 Healthcare System in France
- 4.2.2 Pricing and Reimbursement Process in France
- 4.2.3 Key Trends
- 4.2.4 Major Challenges
- 4.3 Germany
- 4.3.1 Healthcare System in Germany
- 4.3.2 Pricing and Reimbursement Process in Germany
- 4.3.3 Key Trends
- 4.3.4 Major Challenges
- 4.4 Italy
- 4.4.1 Healthcare System in Italy
- 4.4.2 Pricing and Reimbursement Process in Italy
- 4.4.3 Key Trends
- 4.4.4 Major Challenges
- 4.5 Spain
- 4.5.1 Healthcare System in Spain
- 4.5.2 Pricing and Reimbursement Process in Spain
- 4.5.3 Key Trends
- 4.5.4 Major Challenges
5. Pricing and Reimbursement in Europe - Eastern Europe
- 5.1 Czech Republic
- 5.1.1 Healthcare System in Czech Republic
- 5.1.2 Pricing and Reimbursement Process in the Czech Republic
- 5.1.3 Key Trends
- 5.1.4 Major Challenges
- 5.2 Poland
- 5.2.1 Healthcare System in Poland
- 5.2.2 Pricing and Reimbursement Process in Poland
- 5.2.3 Key Trends
- 5.2.4 Major Challenges
- 5.3 Romania
- 5.3.1 Pricing and Reimbursement Process in Romania
- 5.3.2 Key Trends
- 5.3.3 Major Challenges
- 5.4 Hungary
- 5.4.1 Healthcare System in Hungary
- 5.4.2 Pricing and Reimbursement Process in Hungary
- 5.4.3 Key Trends
- 5.4.4 Major Challenges
6. Pricing and Reimbursement in Europe - Scandinavia
- 6.1 Norway
- 6.2 Finland
- 6.3 Denmark
7. Pricing and Reimbursement in Europe - Appendix
- 7.1 Market Definitions
- 7.2 Abbreviations
- 7.3 Research Methodology
- 7.3.1 Healthcare System
- 7.3.2 Pricing and Reimbursement Process
- 7.3.3 Key Trends
- 7.3.4 Major Challenges
- 7.4 Contact Us
- 7.5 Disclaimer
- 7.6 Sources
List of Tables
- Table 1: Pricing and Reimbursement in Europe, Supply-Side Pharmaceutical Regulations
- Table 2: Pricing and Reimbursement in Europe, Demand-Side Pharmaceutical Regulations
- Table 3: Pricing and Reimbursement in Europe, Regulatory Mechanisms in Top Five Countries of Europe
- Table 4: Pricing and Reimbursement in Europe, the UK, General Price Changes (%), 2009-2013
- Table 5: Pricing and Reimbursement in Europe, France, Types of Treatment and their Reimbursement levels
- Table 6: Pricing and Reimbursement in Europe, France, Social Security Deficit, €bn and $bn, 2009-2011
- Table 7: Pricing and Reimbursement in Europe, France, National Target for Expenditure in Public Healthcare/ ONDAM, €bn and $bn, 2010-2011
- Table 8: Pricing and Reimbursement in Europe, List of Innovative Drugs for Regions, AIFA, 2010
- Table 9: Pricing and Reimbursement in Europe, Regulatory Mechanisms in Eastern Europe
- Table 10: Pricing and Reimbursement in Europe, Regulatory Mechanisms in the Scandinavian Countries
List of Figures
- Figure 1: Pricing and Reimbursement in Europe, Estimated Costs Paid by the Patient and Health Insurance System in the Total Reimbursed Pharmacy Market Value at Retail Prices (%), 2008
- Figure 2: Pricing and Reimbursement in Europe, Healthy Life Years At 65 For Males And Females, 2009
- Figure 3: Pricing and Reimbursement in Europe, Health expenditure per capita With Respect To GDP per capita, $PPP, 2009
- Figure 4: Healthcare Expenditure in Europe and the US, Healthcare Expenditure as % of GDP, 1960-2008
- Figure 5: Pricing and Reimbursement in Europe, Pharmaceutical Expenditure Per Capita And GDP Per Capita ($PPP), 2009
- Figure 6: Pricing and Reimbursement in Europe, Value Based Pricing - Concept and Process
- Figure 7: Pricing and Reimbursement in Europe, ISPOR 33 Guidelines for Pharmacoeconomics Assessment
- Figure 8: Pricing and Reimbursement in Europe, Healthcare expenditure % of GDP, 2008
- Figure 9: Pricing and Reimbursement in Europe, the UK, NHS expenditure on medicines ($bn) Vs NHS Medicines Cost per capita ($), 2000-2009
- Figure 10: Pricing and Reimbursement in Europe, European Counties, the US, Japan, Total Healthcare Expenditure vs Out-of-Pocket Expenditure in European Countries, 2009
- Figure 11: Pricing and Reimbursement in Europe, Pharmaceutical Expenditure Per Capita Among the Highest in France, $PPP, 2007-2008
- Figure 12: Pricing and Reimbursement in Europe, LFSS 2011
- Figure 13: Pricing and Reimbursement in Europe, Germany, Healthcare Expenditure, $ per inhabitant, 2008
- Figure 14: Pricing and Reimbursement in Europe, Germany, Cost Containment Measures, 1980-2011
- Figure 15: Pricing and Reimbursement in Europe, Germany, Structural Reforms by AMNOG, 2011
- Figure 16: Pricing and Reimbursement in Europe, Romania, Key Aspects of New Pharmaceutical Regulations
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