Masterclass NieuweZorg 3.0 De farmaceutische sector op Europees niveau. Author: Elizabeth Kuiper* Date: Maart 2016 * Presentation.

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1 Masterclass NieuweZorg 3.0 De farmaceutische sector op Europees niveau Author: Elizabeth Kuiper* Date: Maart 2016 * Presentation

2 About us Most businesses think that product is the most important thing, but without great leadership won't make a company successful Jane Doe The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. 2

3 Outline of EFPIA s Key Priorities Vision Shift the healthcare policy debate from a transactions focus to an outcomes focus Patient Access Innovation International Finance & Operations Develop EU and national competitiveness policies for the pharma industry, focusing on patient access for new products Modernise the research, development and regulatory model to restore Europe s competitiveness and speed up access to medicines Secure improved market access conditions, high regulatory and IP standards in international growth markets Implement best practice financial management and operations systems at EFPIA Governance & Processes 3

4 Improving outcomes is core to EFPIA's Health & Growth strategy Health & Growth Sustainable Financing Better Health Outcomes Priority: Improving health outcomes in chronic and noncommunicable diseases Ambition: Increase healthy life years and reduce hospitalisation rates in chronic disease by 10% by 2020 Thriving Eco-System Life Science Strategy Better Outcomes EFPIA's recommendations Standards of care grounded in evidence-based models Chronic disease management programmes through benchmarks and best-in-class patient pathways Development of health delivery infrastructure in line with best-practice standards Full industry support and expertise with new technologies, supporting multi-stakeholder initiatives (IMI) Source: EFPIA.eu, "A vision towards a life sciences strategy for Europe" (2014)

5 Pharmaceuticals and other medical non-durables represent 17% of total expenditure in Europe although variances exist between therapy areas Breakdown of total healthcare expenditure in Europe 2012* 16.9% 46.5% 36.6% Source: *EFPIA, the industry in figures, edition 2015 (OECD health data 2014, extracted in 2015, EFPIA calculations, non weighted average for 21 EU & EFTA countries). A.T. Kearney analysis (2012); Δ Schwarzkop et al. (2010); Damm el al. (2012). Inpatient care Outpatient care & others pharmaceuticals & other medical non durables 5

6 Outcomes maturity Health Systems move towards outcomes at different speeds Country Awareness/ interest Data Pay for outcomes The Ministry of Health and Social Affairs is putting outcome-based healthcare high on the agenda. Director of Swedish region Swedish registries have national coverage and collect data at a very granular level. County director - Sweden Reimbursement has an important role in creating right incentives. We don't need further evidence Chairman University hospital Politicians are the key drivers of outcome focus since the Torys came to power Senior manager, Department of Health There are few national registries, but with its national audits, the UK is one of the countries in the forefront of data collection and sharing. Former provider manager - UK Many initiatives on paying for performance in UK, but they need to be more linked to outcome metrics Academic & ex-provider manager Payers driving change by moving towards VBPs. Others follow first mover, which in many cases is CMS CMS manager [There are many initiatives of data collection] in the US, but we need a clear common vision of where we are going. Experienced HC consultant, US ~18% of total CMS payments are today linked to bundle or capitation models. In 3-4 years, we aim for ~50% CMS manager There are things going on. Everyone is talking about quality, even at the government level. Academic Germany Mandatory data collection done by AQUA institute, however, compared with registries, we need a more comprehensive view. Former provider CEO Germany Don't see the real interest of VBP in Germany. But it's the way we need to go Provider manager There is a lot of resistance from healthcare professionals to compare any outcomes between hospitals. Academic - France Data collection today is focused on structural and process measures. Academic - France I don't believe that financial incentives are the way to go to increase focus on outcomes Former senior manager, Health Ministry Source: Stakeholder interviews 6

7 Outcomes-focused health systems bring major opportunities for pharmaceutical companies Value improvement driven by structured work with transparent outcomes data will have several implications for the pharma industry: Reduction of "inefficiency" frees up resources to be invested in true innovation Providers will be willing to pay for innovations that help them succeed since superior outcomes are rewarded with price premium and/or volumegrowth We will see increased patient and provider compliance to effective treatments Pay-for-performance models for providers will enhance transformation and will stimulate closer collaboration with suppliers for joint development of solutions with measurable impact on value

8 Various challenges need to be overcome to move towards outcomes Lack of public and political awareness Low awareness of outcomes inequality, some of which are resulting from practice variation Suboptimal outcome transparency & Proof of Concepts Lack of a standard definitions, measurement and transparency of outcomes data As a result, lack of comprehensive examples demonstrating what can be achieved through an outcomes-focused system Health systems structural barriers Structural barriers in HC systems to move towards outcome-focused system 8

9 The "Innovative Medicines Initiative IMI" provides an attractive platform to accelerate outcomes focus in Europe IMI platform to speed up outcomes focus in HCSs Leverage in unique consortia involving top teams from industry, academia, SMEs, regulators, and others Multistakeholder effort required as proof of concept for scalable solutions and HC system changes of paradigm Benefit from the expertise, databases, and infrastructures of consortium partners Access to databases and best practices Credibility and visibility of IMI's projects in Europe and globally Enviable platform to promote change and best practices to healthcare systems across the world Companies contribute to projects with in-kind resources European Commission matches in-kind contributions with funds from the research framework programme EU funds go to applicants from the 'public' half of the consortium that are eligible for funding (e.g. HCS stakeholders, universities, SMEs, patient organisations, regulators, etc.) bn funds - cash bn 1 Partnership bn in-kind investments 1. Other life science industries may contribute 213M if they decide to join IMI 2 as members or as partners in individual projects

10 Big data for better outcomes Goal: Support the evolution towards outcomes-focused and sustainable healthcare systems, exploiting the opportunities offered by big and deep data sources COORDINATION AND SUPPORT ACTION (CSA) EUROPEAN DISTRIBUTED DATA NETWORK Design sets of standard outcomes and demonstrate value Increase access to high quality outcomes data Use data to improve value of HC delivery ROADS: ALZHEIMER'S DISEASE HEMATOLOGIC MALIGNANCIES MULTIPLE SCLEROSIS Increase patient engagement through digital solutions Launched: deadline for applications March 2016 CARDIOVASCULAR RARE CANCERS... ADDITIONAL TOPICS

11 Initiatives at EU level Stakeholder initiatives Eurordis/EPF call on payers Benelux pilot Patient Access Partnership PACT Parliament Interest Group on Access: focus on HC systems Riga Roadmap: action plan to create sustainable health systems WHO OECD European Parliament Healthcare community European Commission Member States & EU Presidencies Feedback loop Commission Communication on resilient healthcare systems Commission Expert Panel on Effective Ways of Investing in Health (EXPH) Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) Commission Expert Group on HSPA Focus on HSPA & Outcomes in Europe 2020 & European Semester Data Protection Regulation DSM: focus on e-health / Big Data, recognition of data as enabler for outcomes 16/10/15 11

12 EFPIA Brussels Office Leopold Plaza Building * Rue du Trône 108 B-1050 Brussels * Belgium Tel: + 32 (0) * info@efpia.eu