1. Combining access to innovation and financial sustainability
Roberto Musneci
FEBRUARY 2018

2. MEA’s and Electronic Registers Raising Awareness in CEE
CORE-Cineca & SMA Progress
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

3. 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

4. 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

5. 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

6. 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.

7. 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)

8. 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

9. 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

10. 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

11. ACCOUNT TEAM

12. 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