Author Jaime Espín
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Analysis of differences and commonalities in pricing and reimbursement systems in Europe / Jaime Espín / Granada [Spain] : University of Granada (2007)
Analysis of differences and commonalities in pricing and reimbursement systems in Europe : Final Report [printed text] / Jaime Espín, Author ; Joan Rovira, Author . - Granada (Spain) : University of Granada : Brussels (Belgium) : European Commission, 2007 . - 217 p. ; A4. - (Andalusian School of Public Health) .
A study funded by DG Enterprise and Industry of the European Commission
Languages : English (eng)
W 100 Medical, Dental, and Pharmaceutical Service Plans -- General works
Europe ; Insurance, Health, Reimbursement
Abstract: Analysis of the pharmaceutical sectors performance is a complex task, due to the convergence of often conflicting social and health goals on the one hand and industrial goals on the other. While innovation and access are usually welcomed by all stakeholders, high prices and growing expenditure are perceived as bad news from the payers perspective (consumers and health insurers) but as good news for suppliers, since for them it translates into higher revenues and profits. A comprehensive pharmaceutical policy has to make trade-offs between these conflicting goals.
Building a coherent EU pharmaceutical policy is a difficult task because pharmaceutical budgets, as well as decisions regarding pricing and reimbursement, are responsibilities of individual Member States. EU Member States differ greatly in their priorities regarding pharmaceutical policy: providing incentives for innovation, supporting domestic (generics or innovative) industry and employment, ensuring and improving access to drugs, limiting public expenditures on drugs, etc. Although concern over limiting public expenditures is rather common and growing in most countries, differences in priorities persist. Differences are obviously related to the pharmaceutical sectors diverse characteristics and levels of development, to the general level of income, and to the varied characteristics of health policies and health systems, among other factors.
Many countries have established a number of practices to control costs while maintaining the balance between equitable access and industry goals. There are significant differences in these practices, particularly in the rules for pricing and reimbursement of medicines in the EU Member States. These differences can be found not only due to the presence or absence of certain practices (price control, cost sharing, reference pricing, etc.) but in differences within the very practices themselves. Policy practices also change rapidly in MS, as do the responses of economic agents, adapting to and often reducing a policys intended effects. This rapidly changing regulatory environment makes it difficult to assess the impact of policies on expected goals, or even to obtain an up-to-date picture of the EUs regulatory landscape. Nevertheless, because of rising concerns over cost containment and the need to strike a balance, Member States have an increased need to grasp the substance of different practices and their impact. Since parts of this understanding are available in other Member States, it is significantly valuable to promote the exchange of experiences, practices, and policies among the Member States.
The purpose of this study is, therefore, twofold. First, to obtain an updated, overall picture of the application of pharmaceutical policies and practices in European countries. Second, to build an in-depth understanding of certain selected practices as implemented in different countries, particularly regarding set-up, risks, success factors and impact on expenditure, reward for innovation and patient access. The methodology of this study is based on two main instruments: a review of the literature on the impact of policy practices and a survey with country representatives in the Working Group on Pricing of the Pharmaceutical Forum (which ran in parallel to this study).
The report is structured in four parts:
The first, Part A, is an introduction that lays down the studys objectives, justification and methods.
Part B, the overview, presents an overall picture of a variety of pricing and reimbursement practices, presenting a structured overview of those currently in use. It focuses on supply-side mechanisms, such as price controls, expenditure and industry profits, as well as demand-side mechanisms aimed at physicians, patients and pharmacists, and also includes practices focused on financing/reimbursement. The questionnaire revealed that, on the supply side, most countries focus on control of prices although several focused on control of expenditure. On the demand side, practices aimed at physicians usually consist of guidance, education and monitoring; those aimed towards patients focus on education and cost-sharing and for pharmacists (generic) substitution is the most common practice.
Part C, assessment or evaluation of impact, offers an in-depth assessment of 6 practices and policies, and looks for evidence on the establishment and impact of selected practices in different countries. Finally, part D highlights risk and success factors and looks for interactions between different practices within the framework of global pricing and reimbursement policies. The evidence gathered in Part C leads to a set of tentative conclusions: Direct product price regulation is losing ground in Europe, probably less the result of deliberate policy shifts than its decreased effectiveness within the new context of the Single European Market. Direct product price control can be difficult to implement in fair and efficient ways, and if it is effectively applied to lower the prices of innovative products beyond a certain level, is claimed to remove the incentives for innovation. Pricing based on a set of international prices in countries with similar characteristics looks quite reasonable for a small country that has no capacity to impose its own criteria and preferences. Cost-plus approaches to price control appear to be abandoned in favour of those based on international price-comparisons. Finally, pricing based on economic evaluation and profit control makes a lot of economic sense, but it is complex to organise and its impact is not well assessed.
Cost-sharing has been maintained in most countries. It would appear reasonable to assume that cost-sharing is likely to have a disproportionately higher effect on mostly low-income patients who frequently need/use expensive services. These negative effects are often overcome by implementing safeguarding criteria, such as excluding some patient groups from cost-sharing or through sophisticated monitoring of patients expenditures, as occurs in some Nordic countries.
According to responses obtained from the questionnaire, monitoring and follow-up of the effects of this practice in most countries has been limited, not going much beyond calculating the aggregate volume of payments by patients.
Reference Pricing is rapidly spreading across Europe. Most countries define the equivalent groups/clusters narrowly (active ingredient), but a few countries (Netherlands, Germany) have shifted to groups based on therapeutic equivalence . There are also broad differences in the way reimbursement prices are set and how exceptions are made. It is difficult to separate the effects of RP and generics policies, two policies which are often implemented together. Some in the industry claim that therapeutic RP reduces incentives for incremental innovation, which is assumed to pave the way step by step to major innovations over time. Some studies and experts have also concluded that RP does refrain price competition between generics. Savings were reported in the questionnaire by some countries (around 5%, Hungary and Italy). Changes in access are assumed to be limited, with some exceptions.
Payback is one of the most recent additions to pharmaceutical policies, and not much is known to date on how this practice is applied or what impact it might have. Some countries reported estimated savings between 10 and 800m EUR (between 0,3% and 7% of the pharmaceutical budget), depending on scope and set-up. Payback is not assumed to change access, given that patients are not affected. Impact on incentives for innovation differs, also depending on the specific exemptions taken into account or not for innovative medicines. Payback also offers an opportunity for low-price countries to accept higher prices, at the international level, while controlling final expenditures (taking also into account the difficulties in managing the money back). Providing incentives for more efficient prescribing does not reflect a single practice but rather a large set of heterogeneous practices. Most countries provide guidelines, information and education, but only a limited number go beyond this light approach to monitoring and providing feedback and personal advice to prescribers. Financial and other incentives are very rarely applied. Some of the existing incentives for more efficient prescribing especially, financial incentives - have a documented effectiveness, but most practices need to be considered as a group since they tend to reinforce each other.
Great variations are also found in generics policies, particularly regarding leading elements of such policies: selective/priority financing, prescription by generic name, reference pricing, substitution by pharmacist, etc. Also, generics policies are usually the result of a large combination of both demand and supply-side practices. The literature reveals a substantial number of studies on the impact of specific generics policy practices, such as generic substitution by the pharmacist. Generics policies haven been applied for a long time, accompanied by selective reimbursement, differential cost-sharing, patient and prescriber information and education. Recently, generics policies have been complemented by RP and stronger financial incentives to pharmacists and prescribers. Few countries provide data on the impact of generic policies, although Sweden provides evidence to have attained ~760mEUR accumulated savings between October 2002 and December 2005. Most respondents assume no negative impact on innovation. It has also been noted that the impact of generics policies cannot be evaluated independently from other related practices, particularly reference pricing.
Section D explains that each practice requires certain conditions for success, often depending on the applications scope and rigor, and that some carry potential risks, not only due to the way they impact on budgets but also how they effect patient access and reward innovation.
In conclusion, EU Member States share concerns for keeping several key issues in balance: controlling pharmaceutical expenditures, ensuring access for patients, rewarding industry for valuable innovations, and maintaining pharmaceutical production, which is associated with employment and income-generation. Most Member States employ a variety of practices as part of their national pharmaceutical policy and frequently introduce changes to counterbalance certain strategies adopted by the industry that might not necessarily coincide with Member States own priorities. To date, little evidence is available for key decision-makers on the impact of these different practices. This study summarizes some of the evidence obtained from the literature and has gathered and compared early findings from individual Member States. However, it is based on fragmented inputs and only reflects a situation that existed in one specific period, autumn 2006. It might, therefore, be interesting to consider adopting a more long-term approach, exchanging evidence on a greater number of practices among national authorities.
Contents note: A. Introduction.20 -- I. Scope and purpose of the study .. 20 -- II. Methodological issues in assessing the impact of policy practices . 21 -- III. Sources and methodology . 24 -- A. Literature 25 -- B. Questionnaire 25 -- B. Overview of pharmaceutical policy practices in EU MS ..27 -- I. A classification and definition of pharmaceutical policy practices 28 -- Supply side practices 28 -- Demand side practices. 30 -- II. Selection of 6 policy practices for detailed analysis 35 -- C. Selected practices .36 -- Price control..36 -- I. Introduction. 36 -- Description..36 -- Modalities 37 -- Purposes .37 -- Theory/rationale38 -- II. Application in Europe .. 38 -- Overview..38 -- Individual replies to the questionnaire.41 -- III. Impact. 51 -- Experiences reported by countries. .51 -- Literature .51 -- IV. Discussion.. 53 -- Key messages ..53 -- Risks..54 -- Key success factors 55 -- Cost-sharing..56 -- I. Introduction 56 -- Description..56 -- Modalities 56 -- Purposes .56 -- Theory/Rationale..57 -- II. Application in Europe .. 58 -- Overview..58 -- Individual replies by countries 59 -- III. Impact.. 69 -- Overall experiences reported by countries69 -- Individual replies by countries 70 -- Literature review79 -- IV. Discussion.. 81 -- Key messages ..81 -- Risks..81 -- Key success factors 82 -- Reference pricing 83 -- I. Introduction 83 -- Description..83 -- Modalities 83 -- Purposes .84 -- Theory/ Rationale.84 -- II. Application in Europe .. 85 -- Individual replies by countries 87 -- III. Impact. 93 -- Overall experiences reported by countries93 -- Individual replies by countries 94 -- Literature .. 100 -- IV. Discussion 103 -- Key messages 103 -- Risks 103 -- Key success factors .104 -- Payback.105 -- I. Introduction 105 -- Description 105 -- Purposes .. 105 -- Theory/rationale. 106 -- Modalities . 106 -- II. Application in Europe 107 -- Overview 107 -- Individual replies provided by MS, . 107 -- III. Impact. 111 -- Experiences reported by countries 111 -- Individual replies by countries . 111 -- Literature .. 113 -- IV. Discussion. 114 -- Key messages 114 -- Risks 114 -- Key success factors .115 -- Incentives for good prescribing practices .116 -- I. Introduction.. 116 -- Description 116 -- Modalities . 117 -- Purposes .. 117 -- Theory/Rationale117 -- II. Application in Europe 119 -- Overview 119 -- Individual replies by countries . 119 -- III. Impact.. 130 -- Overall experience reported by countries130 -- Individual replies by countries . 130 -- IV. Discussion 142 -- Key messages 142 -- Risks 142 -- Key success factors .142 -- Generics Policies ..143 -- I. Introduction. 143 -- Description 143 -- Modalities . 143 -- Purposes .. 144 -- Theory/Rationale144 -- II. Application in Europe 144 -- Overview 144 -- Individual Country Replies. 145 -- III. Impact of Generics policies 157 -- Overall experiences reported by countries.157 -- Individual replies by countries . 158 -- Literature review 167 -- IV. Discussion 170 -- Key messages 170 -- Risks 171 -- Key success factors .171 -- D. Global perspective on pricing and reimbursement policies 173 -- I. Similarities and dissimilarities in EU MS pharmaceutical policies -- .. 173 -- II. Evidence of impact . 174 -- III. Interactions/interdependence between practices .. 177 -- IV. Conditions for application.. 179 -- List of references .182 -- Link for e-copy: http://ec.europa.eu/enterprise/phabiocom/docs/study_pricing_2007/andalusian_scho [...] Format of e-copy: Record link:
Barcode Call number Media type Location Section Status No copyIncentives for market penetration of biosimilars in Belgium and in five European countries / Nathalie Swartenbroekx in Journal de Pharmacie de Belgique, 04(2014)Dec ([12/01/2014])
[article] Incentives for market penetration of biosimilars in Belgium and in five European countries [printed text] / Nathalie Swartenbroekx, Author ; Maria-Isabel Farfan-Portet, Author ; Jaime Espín, Author ; Sophie Gerkens, Author . - 2014 . - 36-46.
Languages : French (fre)
in Journal de Pharmacie de Belgique > 04(2014)Dec [12/01/2014] . - 36-46
W 1 Serials. Periodicals
2012-13 ; Belgium ; Biosimilar Pharmaceuticals ; Cost Savings ; Economics, Hospital ; Europe ; Journal Article ; Peer Review ; R199 ; Reimbursement Mechanisms
Abstract: Biosimilars are products similar to a biological already authorized and no longer protected by a patent. As the biological product, they contain a biological substance produced by or derived from a living organism. Alike with generics, biosimilars are potential tool to ensure savings for health systems. The current lack of market penetration of biosimilars may be seen by national authorities as a lost opportunity in terms of cost- containment. The objective of this paper is therefore to analyze the current situation in Belgium and to identify potential measures to stimulate biosimilar uptake in Belgium through an analysis of the experience in five European countries: France, Germany, The Netherlands, Spain and Sweden. This international comparison was performed using a two steps analysis: a structured review of the literature followed by a validation from experts in each country. Potential incentives and constraints were identified, i.e., prescription quotas/target, clinical guidelines, primary substitution, reference price system, fixed payment and public tendering. However, the literature reviewed provided little evaluation of the effectiveness of these policies in terms of biosimilar uptake or potential savings. The impact of these policies on biosimilar related savings is currently based on expectation and assumptions. Such kind of studies is therefore essential in the future. Record link: [article]