Combining access to innovation and financial sustainability Roberto Musneci FEBRUARY 2018

MEA’s and Electronic Registers Raising Awareness in CEE CORE-Cineca & SMA Progress 2016-2018 MAIN RESULTS ROMANIA - AWARENESS OF OPPORTUNITY POLAND - AWARENESS OF OBSTACLES BULGARIA - AWARENESS OF SUPPORT AVAILABLE SLOVENIA / CROATIA - LEGISLATIVE CHANGES - MOU’s RUSSIA CZECH / SLOVAKIA Confidential Draft for Internal Planning Purposes Only

COMPLEXITY & CHALLENGES FOR FUTURE ONCOLOGY MARKET ACCESS New model for the future MA - Multiple indications - mABs Combo - Combo therapy for different mutations Real World Evidence Registries & MEAs Drug Value Assesment Post - MA Principle Model

Key indicators for CEE countries 2016 Italy Romania Poland CZ Republic Slovakia Hungary Population 60, 665, 000 19,623,748 38,133,679 10,622,203 5,448,000 9,703,156 GDP per capita (EUR), thousand 27, 514 7, 773 10, 142 15, 099 14, 515 10, 463 Pharma market size, bil. EUR 21,3 2, 8 7, 57 1, 93 1, 25 2, 62 Healthcare expenditure/ capita 3, 391 816  1, 798 2, 544 2, 150 2, 101 % HC expenditure from GDP 11, 3 4, 54 6, 4 10, 6 8, 9 6, 7 Drug expenditure (out of pocket)/capita 228,7 -   1, 464 2, 077 1, 756 1, 716 Source: Organization for Economic Co-operation and Development (OECD) data

Status of MEAs Implementation in CEE Country Year of implementation Bulgaria 2015 Czech Republic 2013 Estonia 2014 Hungary 2006 Latvia Lithuania 2008 Poland 2012 Romania Slovenia 2005

MEAs in CEE countries Types of MEAs concluded Romania Poland CZ republic Hungary Bulgaria No of MEAs implemented as of March 2017  6 Confidential  159 367 Discounts implemented   √ Price Volume/ financial agreements  √ √  Free doses Payback Bundle agreements & others Payment by result Source: Study „MEAs in CEE countries”, A. Ferrario et al.

Number of products associated with one or more MEAs by therapeutic group in CEE countries in 2015/ 2016 Antineoplastic & immunomodulating agents (ATC - L) Bulgaria Estonia Hungary Lithuania Latvia Serbia Romania 96 5 32 22 10 4 Alimentary tract & metabolism (ATC - A) 42 3 Nervous system (ATC - N) 51 18 9 Anti – infectives for systemic use (ATC - J) 35 1 8 6 7 Cardiovascular system (ATC - C) 36 Blood & blood forming organs (ATC - B) 24 2 Respiratory system (ATC - R) 11 Sensory organs (ATC - S) 19 Genitourinary system &sex hormones (ATC - G) 13 Systemic hormonal preparations, excl. insulines & sex hormones 14 Musculoskeletal system (ATC -M) Various (ATC - V)

Electronic registers in CEE countries How many electronic patient registers are available? Poland CZ Rep. Slovakia Hungary Romania Latvia Estonia* Lithuania 4 1   Drug registers 5 7 Disease registers 3 20 16 6 Others (epidemiologic e.g.) 1  Are they used for access negotiations? Yes/ No Yes Is there a legislation on patient registries? If yes, for what type of registry and please specify the legislation (national law, ministerial decree etc.) Yes/ No Yes. All types of medical registries, national law, ministerial regulation * Estonia shares with Finland patient data as of 2017 – namely digital prescriptions & medical history  Source: SMA Research

Exportability of Italian experience towards CEE countries Exportability of Italian experience towards CEE countries. Case for change Specific Assets: Polish Case Functional legislative framework Privacy regulations & Data security is strong Issues to be addressed: Romanian case Weak legislative framework Political & admin culture resulting in resistance to change amongst medical staff & decision- makers Italian good practices’ experience: Criteria in assessing health innovation Therapeutic need & Added Therapeutic Value Quality of evidence brought

Exportability of Italian experience. THE PROCESS How electronic registries will be applied in Romania Local Needs Stakeholders acceptance for changing the current system Sharing process Training process Design an offer for transfer Implementation Follow-up and maintenance AIFA National workshop for sharing experience AIFA initiative to share the MEA experience Pharma Companies

ACCOUNT TEAM

About SMA SMA is built around a core team of senior professionals with solid track record in communication strategy, media relations, image audit and crisis communication. For over 14 years we have been providing intelligent, integrated consultancy and communication solutions to businesses and individuals who share our passion for sustainable success. We are therefore well placed to support you in develop Amgen projects. SMA has certification on ISO- 9001/2008 Quality management. SMA became affiliated with APCO Worldwide in 2012 – one of the world leaders in global communication, stakeholder engagement and business strategy, thus gaining the opportunity to approach EU institutional forums in a more powerful and complex manner. SMA is member of TRACE International Inc, a globally recognized anti-bribery business organization, also an active member of important business associations: AmCham - American Chamber of Commerce, AHK - The German-Australian Chamber of Industry, NRCC -The Netherlands Romanian Chamber of Commerce, The Romanian Lobbying Registry Association. Create awareness for the initiative and the problem of stroke care among EU and national policy makers in order to support investment in the infrastructure of stroke care .......