DOCSLIB.ORG

Joint Clinical Assessment and HTA 1

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Joint Clinical Assessment and HTA 1 Regulamento sobre Avaliação das Tecnologias de Saúde e Grupo La Valetta Heitor Costa, Director Executivo da APIFARMA 1 Cross-Country collaborations • Historical ties (except Valetta) ⚑ Iceland BeneluxA • Countries move… Finland Valetta Declaration ⚑ IE and LT belong to 2 CCC’s Norway ▼ Iberia partnership Sweden Estonia Visegrad+ • Not part of any CCC: Latvia Denmark⚑ FR, UK, DE and… BU, CH Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands • North vs South/East Nordic Tendering pilot ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia FINOSE Austria Hungary Slovenia Romania Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 2 Cross-Country collaborations Nordic collaborations ⚑ Nordic tendering pilot (Denmark, Norway, Iceland) led by AMGROS ⚑ • September 2018: call for 2 off-patent Iceland products BeneluxA • Innovative medicines as a second iteration Finland not excluded Valetta Declaration ⚑ Norway • Combination of strong political will and ▼ Iberia partnership Sweden expertise Estonia Visegrad+ • Industry has been very active already Latvia locally (engagement, legal analysis…) Denmark⚑ Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands Nordic Tendering pilot ⚑ Belgium Czech ● FINOSE (Finland, Norway, Sweden) led by AMGROS Luxembourg Republic Slovakia FINOSE • Collaboration on HTA/REA Austria Hungary Slovenia Romania • High-level meeting on 27 March 2018 Italy Croatia • Evaluation of the initiative planned late 2020 ▼ ▼ • Actively reaching out to companies Portugal Spain Greece Cyprus Malta 4 Cross-Country collaborations ⚑ Iceland BeneluxA Finland Visegrad (V4+) Valetta Declaration ⚑ Norway • 2 March 2018 Bratislava meeting ▼ Iberia partnership Sweden • 2 competing companies invited, Estonia Visegrad+ originally to negotiate prices of their Latvia products Denmark⚑ Baltic Partnership Lithuania • Hungarian cabinet still committed; no Ireland Poland high-level political impetus yet since last Nordic Council Netherlands political reshuffle in April 2018 Nordic Tendering pilot • Legal framework reportedly competed ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia (June 2018) FINOSE nd Austria Hungary • Next round of discussion 2 half of Slovenia Romania September Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 5 Cross-Country collaborations BeneluxA-I ⚑ • Ireland joined (22 June 2018) Iceland BeneluxA • Horizon Scanning • Call for tender announced (Sept. Finland Valetta Declaration ⚑ 2018) Norway • EFPIA-Pharma.be outreach (July ▼ Iberia partnership Sweden Estonia 2018) Visegrad+ • First positive reimbursement decision Latvia Denmark⚑ following joint price negotiation with Baltic Partnership Lithuania Ireland Belgium and Netherlands (11 July 2018) Poland • Other pilot joint-negotiations on-going Nordic Council Netherlands (expensive medicines) Nordic Tendering pilot ⚑ Belgium Czech • Reaching out to companies for joint led by AMGROS Luxembourg Republic Slovakia assessment FINOSE Austria Hungary Slovenia Romania Italy Croatia • www.beneluxa.org updated ▼ ▼ Portugal Spain Greece Cyprus Malta 6 Beneluxa-I First pricing & reimbursement negotiation concluded Common reimbursement conditions in Netherlands and Belgium announced on 12 July 2018 Joint HTA assessment Joint pricing negotiation Agreement concluded until end-2020 Manufacturer to collect Real World Evidence and carry out further research Question for other BeneluxA-I members, where the product is NOT reimbursed? 7 Cross-Country collaborations European Snapshot Nordic Tendering (Led by AMGROS) ⚑ • Pilot for joint tendering (Denmark, Norway, Iceland) to materialise in September 2018 – off-patent products • Innovative medicines as a second iteration not excluded ⚑ Baltic Partnership Iceland • Currently limited to joint tendering of vaccines BeneluxA Finland Valetta Declaration ⚑ V4+ Norway • No known development since 2 March 2018 Bratislava ▼ Iberia partnership Sweden meeting Estonia • Hungarian cabinet still committed; no high-level political Visegrad+ impetus yet since last political reshuffle in April 2018 Latvia Denmark⚑ Baltic Partnership Lithuania Valetta Declaration Ireland • 3-4 May 2018 meeting in Lisbon – Croatia now a Poland member Nordic Council Netherlands • 11 July 2018 meeting in Athens (November meeting in Nordic Tendering pilot Bucharest) ⚑ Belgium Czech led by AMGROS Luxembourg Republic • 2 products reportedly under consideration Slovakia • Methodological issues under resolution FINOSE Austria Hungary Slovenia Romania BeneluxA Italy Croatia • Ireland joined - 22 June 2018 • Horizon Scanning: Call for tender announced Sept. 2018 ▼ ▼ • Reaching out to companies for joint assessment Portugal Spain Greece • First successful joint pricing negotiations BE-NL July 2018 Cyprus • www.beneluxa.org updated Malta 8 Cross-Country collaborations ⚑ Iceland BeneluxA Valetta Declaration • 3-4 May 2018 meeting in Lisbon Finland Valetta Declaration ⚑ • Croatia now a member Norway ▼ Iberia partnership Sweden • 11 July 2018 meeting in Athens Estonia • November meeting in Bucharest Visegrad+ • 2 products reportedly under consideration ⚑ Latvia Denmark • Methodological issues under resolution – Baltic Partnership Lithuania Ireland (legal framework) Poland Nordic Council Netherlands • Internal divergences among membership Nordic Tendering pilot ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia FINOSE Austria Hungary Slovenia Romania Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 9 Valetta Declaration 5th Meeting 10-11 July 2018, Athens ✱ Attendance • Ministers from Portugal, Romania, Greece, Cyprus, Malta + a secretary of state from Italy • Valetta Technical Committee met in parallel ✱ MoH Xanthos reportedly made a proposal intending to address most gaps • International Convention • Roadmap ✱ Bilateral cooperation between Cyprus and Greece considered (pricing) ✱ Non-alignment between members reported informally following the meeting ✱ Next meeting in Bucharest, Romania (November 2018) 10 Valetta Declaration Greece MoH Xanthos’ proposed next steps ✱ “International convention” to set a regulatory framework to "armour" the procedure in legal terms as well as the result of the negotiation; proposed • Clear process for horizon scanning and negotiations • Clear rules for transposition of decisions at national level • Impartiality and confidentiality ✱ Overcome companies' "unwillingness”, e.g. no parallel procedure ✱ Reinforce technical workstream (VTechnicalCommittee) ; better exchange of information (clinical trials, epidemiological data, target populations, comparable clinical evaluations etc.) ✱ Roadmap with ultimate target of common negotiation to overcome internal divergences and technical issues, e.g. maximum or minimum price, prices range or fixed price, ability or not to conduct negotiations at a national level after the conclusion of the procedure within the "Valletta"). 11 VALETTA DEclaration Greek MoH Xanthos’ quote “ We are forced to break the limits. "Valletta" can and must constitute the successful "example" of voluntary co-operation that will affect the present negative correlations in Europe in a catalytic manner (mainly to the opposition of Germany and the other countries, to any idea of common policies for Health and Medicinal products). We have nothing to lose, we do not have the luxury of the "loner course" against "coalitions of interests" with a huge financial and political influence, we are obligated to maintain a climate of high – and not least – expectations for the citizens of our countries. “ 12 VALETTA Declaration Declarations following 5th Meeting 10-11 July 2018, Athens Romania • Interest in access to innovative medicines, common mechanisms for MoH Sorina Pintea HTA and common negotiations. and State Secretary • Agreed on the need of having more relevant and tangible solutions, Octavian supported the Greek proposal Alexandrescu. • Availablity is a key RO EU presidency topic (from January 2018) Malta “It is in our interest to collaborate since we face common problems, we face the same needs and therefore we can find common solutions through collaborating with the pharma industry – gaining a lot. The Greek proposal is important since it allows for processes acceleration.” 13 External Industry Public Policy Principles (July 2018) Key principles ✱ Depending on circumstances, there might be instances where cross-country initiatives could improve patient access to medicines and others where the optimal outcome may be reached through national procedure; ✱ Industry would support the option that is bringing the optimal result in terms of timely and effective access to innovative treatments. Positioning based on 5 key principles on: ✱ Horizon Scanning EFPIA/Industry 5 principles for collaboration (Dec. 2016) ✱ Joint Clinical Assessment and HTA 1. Broader & accelerated patient access ✱ Information Sharing and Price negotiations 2. No extra process burden (replace equivalent steps in countries) 3. For similar/close countries (economic/health/geographic) ✱ Public Procurement 4. Voluntary 5. Guaranted confidentiality 14 Overall Assessment Summary European Commission Competition Commissioner Margrethe Vestager made a declaration supportive of joint negotiations at a WHO meeting on 20 August 2018. The EC organized with OECD support a ‘Workshop on Building Capacity for Pharmaceutical Negotiations in the EU’ on 19 October 2018. BeneluxA-I The International Horizon Scanning Initiative (IHSI) is moving forward with 16 countries interested, and is to be granted legal personality under the form
Load more

Recommended publications
  • Annex 2 Case Studies
    EUnetHTA WP7 research and analysis activity 1: Annex 2 Case studies An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: Annex 2 Case studies Disclaimer: EUnetHTA is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the information contained therein. 1 of 43 EUnetHTA WP7 research and analysis activity 1: Annex 2 Case studies Contents Contents ..................................................................................................................... 2 Case study 1: Collaborative HTA by the Spanish Network of HTA agencies, Spain .. 4 Context ................................................................................................................... 4 The Spanish Network .......................................................................................... 4 Working Practices ................................................................................................... 5 Coordination functions ........................................................................................ 5 Topic selection .................................................................................................... 6 Allocation of work ................................................................................................ 6 Production of Assessments ................................................................................
    [Show full text]
  • Current Status of Health Intervention and Technology Assessment in the Balkan Region
    CURRENT STATUS OF HEALTH INTERVENTION AND TECHNOLOGY ASSESSMENT IN THE BALKAN REGION CURRENT STATUS OF HEALTH INTERVENTION AND TECHNOLOGY ASSESSMENT IN THE BALKAN REGION Abstract This report outlines the status of health technology assessment (HTA) in the Balkan region, including facilitators and barriers. It is based on the discussions during a WHO workshop on health intervention and technology assessment in support of universal health coverage held in Ljubljana, Slovenia, in February 2020, as well as a survey and a desktop review of relevant literature. Participants from public institutions working in the field of HTA from eight Balkan countries and areas attended the workshop, along with international technical experts and staff from WHO and WHO partners. The developmental status of HTA varies across countries. Facilitators of HTA identified include political will, networks, structured health systems, legal frameworks and relevant examples of gain. Barriers include political instability, small economies and human resources. Recommendations for future action include mapping needs and options, strengthening collaborative initiatives, involving stakeholders and develop roadmaps towards transparent and sustainable HTA frameworks. All participants recognized the need for increased transparency. Keywords HEALTH TECHNOLOGY ASSESSMENT HEALTHCARE DECISION MAKING HEALTH POLICY TRANSPARENCY COST-EFFECTIVENESS ANALYSIS Document number: WHO/EURO:2020-1303-41053-55733 © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below.
    [Show full text]
  • Presentation
    Patient registries in the BeNeLuxA member countries – A mapping exercise Background • Orientation Meeting on Patient Registries on 28 November 2017 • Policy makers and national patient registry experts from BeNeLuxA countries, Hungary and the United Kingdom met in Vienna on 28 November 2017 to explore a possible collaboration in the field of patient registries in order to increase efficiency, and enhance evidence generation and information sharing. • Mapping of patient registries • As a supportive exercise, a preliminary mapping of patient registries in the member countries of the BeNeLuxA collaboration was done and shared. Patient Registries 2 Disclaimer and citation policy • The mapping exercise was conducted for internal BeNeLuxA purposes, • however, the BeNeLuxA is pleased to make findings publically available. • Precautions have been taken to verify the information • but the mapping exercise does not pretend to be comprehensive. • Interested researchers and experts are allowed to use information compiled in the mapping exercise, • however, the BeNeLuxA collaboration shall be acknowledged as author. • Cite as follows: • BeNeLuxA Collaboration. Patient registries in the BeNeLuxA member countries – A mapping exercise. Available from: http://www.beneluxa.org Patient Registries 3 Purpose of registries • Research and evidence • Scientific publication • Statistics • Surveillance • Quality assurance and quality improvement • Overview and recruit patients for clinical trials • Cost containment • Looking for donors • Monitoring • Other (funding,
    [Show full text]
  • Intentions on Collaboration on Pharmaceutical Policy Between The
    Intentions on collaboration on pharmaceutical policy between the Kingdom of Belgium, the Kingdom of the Netherlands, the Grand Duchy of Luxembourg, the Republic of Austria and the Republic of Ireland (The Beneluxa Initiative on Pharmaceutical Policy) Shared views on the benefits of voluntary collaboration There are imbalances in the current pharmaceutical market which have been caused, to some extent, by the limitations of national policies on pricing, reimbursement and on the use of pharmaceuticals. At the same time, disproportionate stress is put on capabilities of individual authorities. Both elements could ultimately hamper timely access to medicines for patients. Joining forces and taking action on a voluntary basis to face common challenges resulting from these imbalances should support participating countries in fostering the sustainability of national healthcare systems and the affordability of medicinal products challenged by high prices, adverse consequences of incentives and the unfulfilled leverage potential of individual countries in negotiations with industry. The countries co‐signing this document agree that policies on pricing and reimbursement of pharmaceuticals benefit from collaboration between those countries. Objectives of the collaboration initiative Based on the current Beneluxa collaboration, four areas for potential collaboration were defined: 1. Horizon Scanning; 2. Health Technology Assessment; 3. Information sharing and policy exchange; 4. Joint price negotiations. The initiative aims to further investigate how collaboration on these topics can be formalized, to determine the possible extent of cooperation and to define the desired outcomes, with due respect to current confidentiality agreements. Pilot projects are conducted in order to test and optimize collaboration methods. Jointly composed Terms of Reference serve as a basis for execution and development of the current ongoing collaboration initiative, as well as for expansion to other countries.
    [Show full text]
  • Joint HTA and Drug Pricing Collaborations in EU: by Whom and When to Be Pursued? Eline Middelburg, Rachel Rowbottom, Dr
    Joint HTA and Drug Pricing Collaborations in EU: By whom and when to be pursued? Eline Middelburg, Rachel Rowbottom, Dr. Marc Matar | 1 Plough Place, EC4A 1DE, London, UK INTRODUCTION OBJECTIVES METHODS Over the past years, several cross-country joint Health Tech- This topic will remain relevant in the future, as new The purpose of this research is to: We conducted a qualitative in-depth nology Assessments (HTA) and drug pricing collabora- initiatives are introduced, and the existing bodies evolve analysis of publicly available information to Gain an understanding of pricing and market access im- tions have been developed in the EU with the aim of: analyze the P&MA implications for pharma- For example, a recent proposal was made for steps plications of existing joint HTA and drug price collaborations ceutical companies of joint HTA and drug Improving efficiency of evaluations, and avoiding towards allowing confidential net prices to be shared Identify and share Simon-Kucher’s future outlook on joint pricing collaborations duplication of decisions between members of the Valetta Declaration group HTA and drug price collaborations Based on these insights, we defined the Accelerating patient access Cross-country collaboration remains politically Share Simon-Kucher’s view on next steps pharmaceutical expected future outlook for joint HTA and Making use of combined payer negotiation power attractive, as an indicator of actions to address time to companies should consider when evaluating whether to drug price collaborations, assessing
    [Show full text]
  • Presentation
    Making the case for Horizon Scanning Facing the challenges: Equity, Sustainability and Access Aldo Golja, Beneluxa Coordinator Ministry of Health, The Netherlands 1 Introduction Samuel Becket bridge, Dublin 2 A question to payers How well do we know the impact of Spinraza (nusinersen)? Targeted population Expert opinions Impact on care pathway Expected price & budget-impact Competitors expected to enter the market Facing the challenges: Equity, Sustainability & Access - Lisbon, November 28-29, 2018 3 2 Horizon Scanning defined Graslei, Gent (B) Horizon Scanning •A HSS aims at identifying, filtering, and prioritising new and emerging health technologies with a considerable predicted impact on health, costs, society and the health care system in order to inform policymakers, purchasers, and health care providers or facilitate early access” (KCE report 2017) •Performed in some countries e.g. UK, Italy, Denmark, Sweden, Austria and the Netherlands •Universal need for predictive data: potential to enhance data collection internationally Facing the challenges: Equity, Sustainability & Access - Lisbon, November 28-29, 2018 5 The potential of Horizon Scanning •Improvement of Access Prioritisation (policies & capacity planning) Earlier planning for guidelines and registries Efficiency gains streamlining procedures from MA -> Prescription (e.g. early access schemes) •Potential for savings Budget planning Creating a level playing field – negotiations •Early identification – enables collaboration Facing the challenges: Equity, Sustainability
    [Show full text]
  • Patient Access to Innovative Medicines in Europe a Collaborative and Value Based Approach January 2019 Contents
    Patient access to innovative medicines in Europe A collaborative and value based approach January 2019 Contents Foreword 01 Executive summary 02 Infographic 04 Part 1. Payer challenges to pharma innovation 06 Part 2. Innovating in a more challenging environment 11 Part 3. New approaches to access and pricing 16 Part 4. Succeeding in the new value-based environment 23 Part 5. Next generation market access 31 Abbreviations 36 Appendix 37 Endnotes 38 Contacts 41 The Deloitte Centre for Health Solutions is the research arm of Deloitte LLP’s Life Sciences and Health Care practices. Our goal is to identify emerging trends, challenges, opportunities and examples of good practice, based on primary and secondary research and rigorous analysis. The UK Centre’s team of researchers seeks to be a trusted source of relevant, timely and reliable insights that encourage collaboration across the health value chain, connecting the public and private sectors, health providers and purchasers, patients and suppliers. Our aim is to bring you unique perspectives to support you in the role you play in driving better health outcomes, sustaining a strong health economy and enhancing the reputation of our industry. In this publication, references to Deloitte are references to Deloitte LLP, the UK affiliate of Deloitte NWE LLP, a member firm of Deloitte Touche Tohmatsu Limited. Patient access to innovative medicines in Europe | A collaborative and value based approach Foreword The European environment for pharmaceutical (pharma) market access and pricing is changing rapidly. European payers are struggling to meet the health demands of their populations. Consequently, health care providers are looking for ways to optimise their expenditure on health care services, and pharma products represent a clearly visible cost payers can attempt to control.
    [Show full text]
  • BENELUXA Et Al.: the BEST IS YET to COME
    UNIVERSAL ACCESS AND AFFORDABLE MEDICINES BENELUXA et al.: THE BEST IS YET TO COME ANALYSIS About EPHA EPHA is a change agent – Europe’s leading NGO alliance advocating for better health. We are a dynamic member-led organisation, made up of public health civil society, patient groups, health professionals, and disease groups working together to improve health and strengthen the voice of public health in Europe. About EPHA’s Universal Access and Affordable Medicines advocacy EPHA’s Universal Access and Affordable Medicines advocacy promotes transparency, accountability and the public interest in the field of pharmaceuticals in line with the priorities of our members most active in this field. We aim to guarantee better and affordable medicines for Europe by questioning and calling for reforms to the current pharmaceutical business model to ensure better access to medicines for all. See more at https://epha.org/universal-access-and-affordable-medicines/ BY Yannis Natsis • Policy Manager, Universal Access and Affordable Medicines Co-funded by Health Programme of The European Union The European Public Health Alliance has received funding under anoperating grant from the European Union’s Health Programme (2014-2020). The content of this document represents the views of the authoronly and is his/her sole responsibility; it cannot be considered to relectthe views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of theEuropean Union. The European Commission and the Agency do notaccept any responsibility for use that may be made of the informationit contains. Transparency Register Number: 18941013532-08 UNIVERSAL ACCESS AND AFFORDABLE MEDICINES | EPHA Contents Executive Summary 5 Preface 7 1.
    [Show full text]
  • First Results of Multi-Country Cooperation on Medicine Price Negotiations
    BENELUXA: First results of multi-country cooperation on medicine price negotiations Reflection Paper September 2017 The European Public Health Alliance (AISBL) has received funding from the European Union, in the framework of the Health Programme. Sole responsibility for the content displayed within this document lies with EPHA and the Executive Agency is not responsible for any use that may be made of the information contained therein. Transparency Register Number: 18941013532-08 By Yannis Natsis, Policy Manager for Universal Access and Afordable Medicines UNIVERSAL ACCESS AND AFFORDABLE MEDICINES | EPHA 1 BENELUXA: FIRST RESULTS OF MULTI-COUNTRY COOPERATION ON MEDICINE PRICE NEGOTIATIONS Executive summary In 2015, the Dutch and Belgian Ministers of Health signed a historic declaration of intent to jointly negotiate with the pharmaceutical sector on the price and reimbursement of some medicines. Since then, the cooperation has been joined by Luxembourg and Austria, with several more governments expressing an interest. This intergovernmental cooperation on medicines is unprecedented in Europe. Until now, each national government negotiated with pharmaceutical companies on a bilateral basis. The European Public Health Alliance (EPHA) has followed this development with great interest. The information asymmetry between the pharmaceutical industry as the vendor and national governments as buyers is assumed to have contributed to the rise in medicine prices to today’s unsustainable levels. As a consequence, access to medicines is no longer only an issue for developing countries. High prices are now also a barrier to accessing medicines for patients and health systems in some of the richest countries in the world. Could the new cooperations between national governments - not only “Beneluxa” but also the Valletta Declaration and other country groupings - go some way to redressing the balance? This paper tells the story so far of this innovative cooperation and summarises the irst results announced by the participating governments.
    [Show full text]
  • Beneluxa Pilots on Joint
    BeNeLuxA Pilots on joint HTA (Health Technology Assessment) and joint negotiations 1 Pilot requirements Bread house, Brussels Pilot requirements – HTA and negotiatons • A joint pilot is entered on a voluntary basis by all parties; • A joint pilot can include two or more BeNeLuxA partners; • In general, Luxembourg does not actively participate in any joint HTA & negotiations pilot. Luxembourg can act as an observer and will receive the joint HTA report. • A pilot will start with a joint HTA and if applicable, a joint negotiation can follow; • Joint price negotiation without a joint HTA will not be possible, as the joint negotiation will be based on a joint view on the (added) value of the pharmaceutical. • In a joint procedure all the steps will be handled as one by the participating countries; • At this moment, no formal joint ‘BeNeLuxA’ reimbursement regulation is put in place; • All formal separate national reimbursement procedures according to national legislation will run in parallel; • One of the participating countries will be designated as the primary contact for the company in the pilot. • Separate formal reimbursement decisions will be made in each participating country. BeNeLuxA guidance joint assessment & joint negotiations 3 2 Selection and eligibility of products Keizersgracht, Amsterdam Eligibility for a joint procedure • Selection of pilots case-by-case. • Focus on pharmaceuticals with (high) unmet medical need, expected added value and satisfactory degree of evidence. • A candidate for a pilot must comply with national legislations, for example: • in the Netherlands only hospital pharmaceuticals that enter the “lock procedure” • in Belgium only pharmaceuticals submitted as Class 1 or orphan application • in Austria only pharmaceuticals that are classified as outpatient products in the Austrian health system • A pilot candidate is only eligible if a reimbursement procedure has not yet started in any of the participating countries.
    [Show full text]
  • CROSS-COUNTRY COLLABORATIONS to Improve Access to Medicines and Vaccines in the WHO European Region
    CROSS-COUNTRY COLLABORATIONS to improve access to medicines and vaccines in the WHO European Region CROSS-COUNTRY COLLABORATIONS to improve access to medicines and vaccines in the WHO European Region ABSTRACT This report assesses five government-led, voluntary cross-country collaborations in the WHO European Region that aim to improve access to essential medicines through joint activities: the Baltic Procurement Initiative, Beneluxa Initiative, Fair and Affordable Pricing, Nordic Pharmaceutical Forum and Valletta Declaration. These cover activities including information sharing, health technology assessment, horizon scanning, joint pricing/reimbursement negotiations and joint procurement of medicines. The research shows that tangible results are only seen after months or years of cooperation. Challenges include the resources required, different languages of participants, dissimilar organizational and legal frameworks, the reluctance of industry to engage in negotiations with a collaboration and pressure to produce results. Nevertheless, interviewees considered the collaborations beneficial. Facilitating factors identified include political support, trust within the collaboration, commitment of the technical experts involved, similarities between health care systems and leadership of a dedicated person. The report concludes with a checklist of prerequisites for successful cross-country collaborations. Keywords PHARMACEUTICAL POLICY, INTERNATIONAL COLLABORATION, HEALTH, ACCESS TO MEDICINES, PHARMACEUTICALS, PRICING, REIMBURSEMENT, PROCUREMENT, EUROPE 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). ISBN 978 92 890 55031 © World Health Organization 2020 Some rights reserved.
    [Show full text]
  • Health Technology Assessment from an Eu Perspective*
    HEALTH TECHNOLOGY ASSESSMENT FROM AN EU PERSPECTIVE* ABA Section of International Law Life Sciences Conference 2018 11 June 2018 1 * With thanks to Koosje van Lessen Kloeke (Leijnse Artz) who drafted a part of this slide deck Key themes international discussions › Ensuring patients’ access to medicines › Lack of price transparency, access to medicines endangered by very high and unsustainable price levels › Bottom-up approach, commonly felt need to address the situation jointly › Potential areas for voluntary structured cooperation, i.a.: › Joint horizon scanning › Information-sharing › Health Technology Assessment (HTA) cooperation › Voluntary price negotiations › Systematic evaluation of properties, effects and/or impacts of health technology; multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology › Two aspects (but can be limited to one): › clinical assessment: What is How well does a new technology work compared with existing alternative health technologies? For which HTA? population group does it work best? etc. › economic assessment: What costs are entailed for the health system? › Main purpose: to inform policy decision making, ensuring accessibility, quality and sustainability of healthcare › EU: Directive 2011/24/EU – application of patients’ rights in cross-border healthcare, i.a. cooperation on HTA (EUnetHTA): › create effective and sustainable network for HTA across Europe › develop reliable, timely, transparent and transferable information
    [Show full text]