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Konference Onkológia na Slovensku

Tomáš Khorel | Head of CZ&SK Consulting

Bratislava, 30 May 2019

Copyright © 2019 IQVIA. All rights reserved. Selected global Oncology trends

1 A third of global value comes from five therapy areas and they contribute over 55% of global growth

Therapy area sales (2017) bn USD Share of global growth 2017

Oncologics 45% 22% 10% $110 bn 23%

36% of Antidiabetics 64% 9% 11% $82 bn 13% global Autoimmune 67% 15% $68 bn 19% value Pain 35% 15% 23% $48 bn -2%

Respiratory 59% 14% 10% $44 bn 4%

Antihypertensives 18% 16% 13% 26% $40 bn

Antibacterials 16% 11% 48% $39 bn

Anticoagulants 40% 20% $35 bn US EU5 Mental Health 49% 14% $32 bn Japan Pharmerging HIV Antivirals 67% 17% $30 bn RoW 3%

2 Onkologia na Slovensku The cancer treatment landscape has been majorly transformed since 2011 New Active Substance Launches from 2011 by Indication

• Irinotecan • liposome • • • • nivolumab • • • ado- emtansine Head & Pancreatic • Neck Renal • • Bladder Breast • • pembrolizumab • • • nivolumab Neuro- • • blastoma Melanoma • • T-vec • , • cabozantinib • • lenvatinib • ziv- Colorectal Thyroid • tipiracil/trifluridine cancer • (CML) • omacetaxine • romidepsin (PTCL, CTCL) • mepesuccinate (CML) • • radotinib (CML) (Hodgkin’s, ALCL) GIST • (CLL, FL) • pixantrone (NHL) • (CML, ALL) regorafenib • (NHL) • (ALL) • Idelalisib (CLL, FL, SLL) • (CLL) • (ATCL) • (CLL) • belinostat (PTCL) • (CLL) Castleman’s • ibrutinib (MCL, WM) siltuximab • bortezomib (MCL) • • pembrolizumab • chidamide (PTCL) • • • venetoclax (CLL) • • • nivolumab (Hodgkin’s) • • Lung Ovarian • • atezolizumab • olaparib • nivolumab • • rucaparib • mifamurtide • trabectedin Cervical • eribulin Sarcoma • • abiraterone Basal • bevacizumab acetate Prostate cell • enzalutamide carcinoma Multiple • ra 223 dichloride MPD myeloma Gastric • carfilzomib • • pomalidomide • • • lxazomib • panobinostat • ramucirumab • •

3 Onkologia na Slovensku Oncology is the innovation powerhouse of the pharmaceutical industry

Top Therapy Area – Global 2018 Sales (USD) % Contribution by NAS 2014-17 Total value of TA $ 25 Bn 84 Viral Hepatitis High Innovation Turn-over HIV Innovation Powerhouses 28 26 24 Oncologics 22 20 18 16 14 12 Multiple Sclerosis 10 Autoimmune Diseases Antidiabetics 8 6 RespiratoryAgents Mental Health 4 2 Low Innovation Turn-over Innovation Peaked Anticoagulants 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 % Contribution by NAS 2010-13

5 Source: IQVIA European Thought Leadership, MIDAS Padds MAT Q4 2018, Innovative Branded New Active Substances globally launched between 2010-2017. Onkologia na Slovensku IQVIA forecasts an average of 17 new oncology products per annum

FDA NCE average approvals 2014-2023

+63% 54

46 30% 24%

70% 76%

2014 – 2018 (a) 2019 – 2023 (f)

Oncology Non-oncology

7 Source: IQVIA Institute, Dec 2018; FDA CDER reports 2014 –2018; IQVIA Thought Onkologia na Slovensku Leadership analysis April 2019 Oncology is the #1 growth driver and the largest therapy area

Top-20 therapy area growth dynamics Top-5 therapy area ranking 20 Growth (PPG) Bubble size represents 2018 sales in US$ Oncologics 2016 - 2017 - # Therapy area 15 2017 2018

(%) Anticoagulants

PPG 1 Oncology 12% 16% 10 Autoimmune

18) 18) RespiratoryAgents - World PPG HIV = 5.2% Antidiabetics 2 Autoimmune 17% 14.5% (2017 5 Mental Health Antibacterials

growth 3 Anticoagulant 13% 14% 0

term Pain 4 Antidiabetics 9% 10% Antihypertensives

Short Short -5 World 5yr 5 HIV 9% 7% CAGR = 6.5% -10 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Long term growth (2013-18) CAGR (%)

Note: Chinese Medicines have been excluded; growth in 13 LCUS$, Rx only Source: IQVIA MIDAS MAT Q4 2018 Onkologia na Slovensku Many indications are becoming more and more complex and stratified through predictive biomarkers

% of Patients Tested by Biomarker and Cancer Once tested positive for that specific biomarker,the NSCLC majority of the patients receive a drug targetingit 80% 77% EGFR (+) PD-1 (+)* ALK (+) 75% 20% 15% 16% 70% 70% 68%

65% 80% 85% 84% EGFR Inhibitor PD-1 Inhibitor ALK Inhibitor 60% EGFR ALK PD-1

Melanoma PD-1 inhibitors 94% 100% used in 31% of all BRAF (+) PD-1 (+)* NSCLC patients 80%

60% 15% PD-1 inhibitors are 35% carving out their 40% 65% segment not 23% 85% necessarily driven 20% by the biomarker BRAF Inhibitor PD-1 Inhibitor 0% BRAF PD-1

16 Note: PD-1 Positive defined as >50% expression Onkologia na Slovensku Source: IMS Real World Data, Oncology dynamics, Patient Level Oncology Survey Data. MAT Q4 2018 Countries included in analysis: France, Germany, Italy, Spain, UK. NSCLC: (Projected = ~150,100), Melanoma: (Projected =~30,200) Immuno-oncology has become the major focus of growth Checkpoint inhibitors expected to reach ~$30 billion globally by 2022

Checkpoint inhibitor forecast Immuno-oncology development highlights (Sales US$ Bn, 2018-2022) $ 37 Bn $ 33 Bn >300 immuno-oncology therapies in $ 30 Bn development, phase 1 through pre-registration $ 26 Bn 60 immuno-oncology mechanisms investigated $ 22 Bn in early-stage pipeline vs. 4* in late-stage pipeline $ 18 Bn 1/3 of IO phase 1 & 2 trials accounted for by anti-PD-1/-L1 and CD19 modulators $ 10 Bn Immuno-oncology products have shown promise in a small number of haematological cancers 2017 2018 2019 2020 2021 2022 2023

Historic sales Forecast sales

18 ® 2018 IQVIA; Source: MAT Q4 2017 US$ Analytics link; Analyst Consensus; ARK Onkologia na Slovensku * PD-1/-L1, CTLA4, CD19, (INDO) R&D Intelligence CAR T-cells, RNAi and CRISPR gene editing are the new therapy approaches – small companies dominate discovery

RNAi Gene editing technologies, Number of pipeline in CAR T-cells cell and gene therapy by (RNA interference/silencing) including CRISPR Top 10 companies …are modified cells with engineered …is an efficient and stable process …are techniques which are more Phase II to Reg receptors, which graft an arbitrary in which RNA molecules inhibit gene powerful, rapid and less expensive specificity onto an immune expression or translation than any previously invented process Ionis 19 effector cell Guided Alnylam 9 RNAi new sequence J&J 8 Sangamo T-cell Therapeutics 6 modification Kite Pharma 5 DNA mRNA Protein New New DNA Celgene 3 2 5 mRNA Protein GSK 1 4 5 Key companies/partners Key companies/partners Key companies/partners Novartis 2 3 5 Novartis, Celgene, Merck, Amgen, Ionis, Alnylam, Sanofi Genzyme, Caribou Biosciences, CRISPR Pfizer, Servier, GSK, Gilea/Kite BMS, Quark Pharmaceuticals, Therap., Editas Medicine, Intelia Sanofi 5 Pharma, Juno, Cellectis, Celyad Sylentis Therap., Regeneron, Novartis, Vertex, Bayer, Juno AGTC 4 Key therapy areas Leukemia, cancer Key therapy areas Key therapy areas Cancer, hepatitis, ophthalmological Rare genetic diseases, cancer, HIV, Cell therapy Gene therapy disorder organ transplants

Onkologia na Slovensku Look in recent past – Slovakia in 2018

10 SUMMARY Oncology landscape in Slovakia has been benchmarked with several EU countries to help with assessment of its development Country benchmarking

Geographical coverage in the report1) Market Cancer Economic Quantitative Qualitative Country performance burden assessment onco analysis onco analysis Austria Role models ✓ ✓ ✓ ✓ France Role models ✓ ✓ ✓ Germany Role models ✓ ✓ ✓ ✓ Netherlands Role models ✓ ✓ ✓ ✓ Slovenia Role models ✓ ✓ ✓ ✓ Czechia Peers ✓ ✓ ✓ ✓ Hungary Peers ✓ ✓ ✓ ✓ Poland Peers ✓ ✓ ✓ ✓ Bulgaria EU28 ✓ ✓ ✓ Romania EU28 ✓ ✓ UK EU28 ✓ ✓ Role models Peers Slovakia EU28

1) Selection of the scope countries has been defined by the Patient Association – Nie Rakovine 11 Onkologia na Slovensku CANCER BURDEN IN SLOVAKIA

Cancer to become the top killing disease in Slovakia Causes of death – Slovakia

Rate of deaths by causes, 2016 [per 100k inhabitants]2) Years of life lost, 2016 [per Commentary 100k inhabitants] 2) • In Slovakia, and still 2010-2016 2016 globally, Cardiovascular trend diseases are top deadly Cardiovascular dieseases 497 45,4% 6.874 diseases, causing the most deaths • At the same time, the world is seeing fatality rates of CV Neoplasms (Cancer) 239 33,5% 5.079 fall, while Cancer rates grow, which will potentially bring Cancer related deaths Neurological disorders 52 4,1% 626 in Slovakia to the top • Cancer has already become top deadly disease in some Diabetes, urogenital, blood, and 34 3,9% 594 of the EU countries – endocrine diseases France (since 1998), UK, Italy, Spain and many Chronic respiratory diseases 20 2,2% 326 more1) • This report has been designed to assess, if Slovak healthcare system Other 56 9,4% 1.426 is ready for the challenge…

Source: 1) European Heart Journal, Volume 37, Issue 42 - Cardiovascular disease in Europe: epidemiological update 2016 2) Global Health Burden - http://ghdx.healthdata.org 12 Onkologia na Slovensku CANCER BURDEN IN SLOVAKIA …and while cardio is going down thanks to better access to innovative drugs, oncology threat is growing Cancer impact on society – Slovakia

Years of life lost (YLLs) index, 2010-2016 Commentary [2010 as a 100% index] • In Slovakia, we already see the change in CV and 104 Cancer Years of Life lost trend – clearly showing the 102 growth in cancer burden • Such development, shows 100 that Slovakia should also be expected to join the 98 Western Europe countries, that successfully dealt with 96 CV risks, but will need to be increasingly focused on 94 support and treatment of neoplasms affected patients 92 • This report has been 90 Cardiovascular diseases designed to assess, if Cancer Slovak healthcare 0 system is ready for the 2010 2011 2012 2013 2014 2015 2016 challenge…

Source: Global Health Burden - http://ghdx.healthdata.org 13 Onkologia na Slovensku CANCER BURDEN IN SLOVAKIA Slovakia with one of the lowest cancer incidence and mortality – numbers are however mainly influenced by level of diagnostics Cancer epidemiology – International

Cancer incidence and mortality per country, 2016 Cancer epidemiology dynamics, 2010-2016 [%] [per 100k inhabitants] Incidence Mortality +1.0% United Kingdom Slovakia 533 239 2007 +0.8% Slovenia Netherlands 761 287 +0.6% Romania Slovakia Germany 755 293 Austria +0.4% Germany United Kingdom 695 274 France +0.2% Poland France 616 271 Netherlands 0.0% Bulgaria Austria 589 241 -0.2% Hungary

Slovenia 575 281 CAGR 7Y Mortality -0.4% Czechia 649 262 -0.6% Hungary 602 338 Czechia -0.8% Bulgaria 498 246 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4 Romania 453 242 Incidence 7Y CAGR Poland 448 264 Role models EU28 Peers Slovakia

Source: Global Health Burden - http://ghdx.healthdata.org 14 Onkologia na Slovensku HEALTHCARE FINANCING Even though SK was catching up with role models in terms of GDP per capita, it did not follow with healthcare investments Healthcare financing

GDP per capita, 2017 [2010 PPP, USD ths, %] Total healthcare cost per capita1), 2015 [USD ths, %] CAGR CAGR 2010 – 2017 2010 – 2015 Germany 44 +1% 89% 6.0 +4%

Netherlands 47 +1% 89% 6.0 +3%

Austria 44 +1% 85% 6.1 +4%

France 38 +1% 94% 4.9 +3%

United Kingdom 39 +1% 87% 4.8 +7%

Czechia 32 +2% 87% 2.8 +5%

Slovenia 30 +1% 89% 3.1 Slovakia as only +3% country with HC expenditure close to Slovakia 30 +3% 84% 2.4 0% per annum – 0% resulting in below Hungary 26 +3% 77% 2.5 average spending on +4% all HC related Poland 26 services, including +3% 81% 2.1 cancer care +5%

Role models Peers Slovakia EU28 1) Includes public and private expenditure on services provided by healthcare system during the whole chain of care = total expenditure on health

Source: OECD (2018), Health spending (indicator). doi: 10.1787/8643de7e-en (Accessed on 11 June 2018), World Health Organization Global Health Expenditure and GDPA database (http://apps.who.int/nha/database) 15 Onkologia na Slovensku ONCOLOGY PERFORMANCE At the same time, onco market in SK almost did not grow in value suggesting potential innovation problems Onco market and growth; MAT 03/2018

Value [EUR m] Hospital share 3y CAGR Volume Hospital share 3y CAGR Commentary [%] [%] [SU m] [%] [%] • Growth in value in Germany 6,938 32.0% +14.2% 416.3 4.4% +2.0% Slovakia negligible compared with other France 5,828 60.5% +12.5% 379.7 5.9% +2.9% benchmark countries – peers Austria 1,005 51.9% +17.0% 46.0 4.64% +3.1% growing with CAGR ~3-17% Poland 646 83.6% +4.8% 152.4 10.3% +3.8% • Volume increase in SK lays also in the Hungary 390 58.8% +12.8% 46.3 8.3% +3.9% lowest quartile – lowest among the Romania 313 37.8% +2.6% 45.9 3.5% +4.0% peers (CZ, HU, PL) Bulgaria 226 88.7% +17.3% 19.9 21.7% +6.7% • Value dynamics in Slovakia, suggests Czechia 378 91.0% +8.8% 59.9 69.2% +4.0% limited access to newer, more Slovakia 216 53.8% +1.4% 22.5 57.3% +2.5% innovative SK recorded lowest treatments that are Netherlands 156 19.1% +12.4% 80.2volumes out of V4 countries3.6% +1.8% usually priced higher than the market Slovenia 117 0.0% +13.3% 11.9 0.0% +3.3% average

Role models Peers Slovakia EU28

Source: SUKL, NCZI, MIDAS, IQVIA 16 Onkológia na Slovensku ONCOLOGY PERFORMANCE Trend also visible in the oncology drug consumption – SK the only one with decrease in value and zero growth of volumes Consumption and growth per onco patient

Value MAT 03/2018 CAGR MAT 03/15 – Volume MAT 03/2018 CAGR MAT 03/15 – Commentary [EUR ths/patient] 03/18 [%] [SU/patient] 03/18 [%]

Germany 10.5 +10.8% 631.0 -1.1% • Overall, role model countries serve France 14.1 +10.9% 921.5 +1.4% higher volume per patient while also Austria 18.6 +14.0% 851.7 +0.4% paying more money for more advanced Poland 3.6 +2.9% 847.9 +2.0% therapies • Slovakia with no Hungary 6.5 +12.5% 773.7 +3.6% change in terms of oncology drugs Romania 3.5 +1.8% 516.2 +3.2% consumption suggests growing Bulgaria 6.1 +16.0% 541.1 +5.5% pressures on Czechia 5.4 +7.2% 849.2 +2.6% access to treatment for local patients – Slovakia 7.3 -1.0% 752.0 +0.1% especially since, epidemiology trends SK showed slowest growth Netherlands 1.1 +9.8% of all short583.5-listed countries -0.6% suggest stable increase in incidence Slovenia 9.6 +12.0% 976.4 +2.1%

Role models Peers Slovakia EU28

Source: SUKL, NCZI, MIDAS, IQVIA, values not discounted to real market prices 17 Onkologia na Slovensku ONCOLOGY PERFORMANCE Innovative immunology molecules are being sold in SK and the country is on the peers average, lagging behind role models Consumption and growth per onco patient – Immuno-oncology

Value 2017 CAGR 15-‘17 [%] Volume 2017 CAGR 15-‘17 [%] Commentary [EUR/patient] [SU/1000 patients]

Germany 571.7 99% 512.7 112% • Evaluating the adoption of most France 1,099.7 94% 1,014.0 104% innovative onco molecules, the role Austria 1,732.3 169% 1,124.2 147% models outperforms Poland 145.0 725% 114.7 652% dominantly all peers countries Hungary * 305.1 440% 280.0 399% • Looking on peers, Slovakia shows Romania** 74.7 311% 78.8 361% average numbers – PL, CZH and BG Bulgaria** 294.6 136% 176.7 158% with higher adoption, Czechia 201.4 479% 178.9 504% while RO and HUN

Slovakia 98.6 181% 77.0 225% SK is on par with RO, lags Netherlands behind Peers

Slovenia 435.5 484% 352.1 442%

Role models Peers Slovakia EU28 Note: Immunology market defined as Keytruda and Opdivo brands * Keytruda and Opdivo in HUN are in itemized reimbursement. Drugs ** CAGR done only for last 2 years due to null values in first year are procured centrally under the authority of MNHIF and all Source: SUKL, MIDAS, IQVIA consumption data is classified. Stated values are estimated by IQVIA 18 Onkologia na Slovensku ONCOLOGY PERFORMANCE Market dynamics positions Slovakia as a country with limited innovation and decreasing access to oncology treatments Onco market dynamics – MAT 03/2015-2018; [EUR m]

1 004.9 3Y value Commentary Price driven countries 86.9 CAGR [%] 290.9 Markets with growing access to more advanced • Austria 627.1 treatments • Germany 17.0% • Greatest growth of average list price (around • Slovenia 40%) in last 3y • France • Level of biosimilars rather low (around 10%) and their growth is relatively stable

210.6 216.5 Limited innovation and almost no change in usage of 4.6 10.5 oncology drugs – limiting the access for patients • List price decrease over last 3 years Slovakia • Share of biosimilars around 7% with annual 1.4% growth around 1 p.p, • Negligible growth of the market, driven by slight increase in volumes of low priced drugs

313.1 Volume driven countries 290.2 Markets with lower innovativeness of oncology, but 11.7 34.5 with increasing access to treatment • Stable average list price or slight decrease (RO) • Romania 2.6% • Price decrease however not driven by • Poland biosimilars which share remains rather flat • Czechia (around 15%)

2015 Price Volume 2018 Note: Slovakia for whole years 2015-2018, not MAT 03

Source: SUKL, NCZI, MIDAS, IQVIA 19 Onkologia na Slovensku In Slovakia, a number of SoC molecules is not categorized and thus much less likely to access Standard of Care – overview per indication & SK reimbursement status

Lung Breast Melanoma Prostate Multiple Myeloma CRC

Alecensa  Avastin ✓ Cotellic  Jevtana  Darzalex  Avastin ✓ Avastin ✓ Halaven  Keytruda  Xtandi ✓ Farydak  Cyramza  Giotrif ✓ Herceptin ✓ Mekinist  Zoladex ✓ Kyprolis  Erbitux ✓ Iressa ✓ Ibrance  Opdivo  Zytiga ✓ Ninlaro  Stivarga  Keytruda  Kadcyla  Tafinlar  Revlimid ✓ Vectibix ✓ Opdivo  Kisqali  Yervoy  Velcade ✓ Zaltrap ✓ Tagrisso  Perjeta  Zelboraf  Tarceva ✓ Tyverb ✓ Tecentriq  Xalkori  Zykadia 

Note: Status as of June 2018, Bolded products are present in more than one indication within this analysis ✓ Reimbursed in SK  Not reimbursed in SK PLEASE NOTE THAT EVEN PARTIAL REIMBURSEMENT CONSIDERED AS “REIMBURSED” FOR THE ANALISIS PURPOSES

Source: Nie Rakovine, IQVIA, SK MoH 20 Onkologia na Slovensku ONCOLOGY PERFORMANCE Slovakia with lowest rate of reimbursed drugs and patients waiting 4 years to get the treatment that is already available elsewhere Time to market for oncology drugs

Time to market – From EMA approval to 100% normalized sales Comments

Months 6 12 18 24 30 36 42 48 Reimbursed • Slovakia has the lowest ratio of molecules [%] reimbursed onco molecules Germany 7.2 2.5 100% • Molecules reimbursed in Slovakia show 11.8 1.7 the one of the biggest delay among UK 89% evaluated countries France 14.7 3.6 87% • When German patient gets the drug Czechia 34.3 2.5 52% average Slovakian patients needs to wait additional average 3 years and in 4 out of Bulgaria 34.8 7.3 44% 5 instances does not get it in the end

Poland 40.8 2.2 44% • Role model countries have significantly shorter time to market of innovative 41.0 7.3 Hungary 47% onco molecules while also substantially greater number of molecules is given Slovakia 43.5 2.8 23% the reimbursement Romania 46.2 2.0 42%

1 year 2 years 3 years 4 years

Time to reimbursement decision Prescription initiation Note: Analysis based on 62 onco molecules approved by EMA form Jan 2009 to Jan 2017, status as of June 2018; Calculation based on the period between EMA approval and receipt of reimbursement status, if the molecule is still not reimbursed – the time as period between EMA approval and Jun 2018 PLEASE NOTE THAT EVEN PARTIAL REIMBURSEMENT CONSIDERED AS “REIMBURSED” FOR THE ANALISIS PURPOSES Source: EMA, MIDAS, IQVIA 21 Onkologia na Slovensku ONCOLOGY PERFORMANCE At the same time, patients affected by other analyzed diseases received new treatments more often Onco reimbursement vs other TAs

Approved and reimbursed molecules across TAs [MAT 03/2011-2018] Commentary Reimburse- • Reimbursement ratio shows that ment ratio 32% 60% 47% 57% 14% oncology is the least prioritized [%] therapeutic area in terms of 72 categorization 34 22 63 • Only 14% of molecules approved by Absolute 10 18 7 15 EMA from 2011 being categorized in numbers 7 6 4 16 4 3 9 SK while this means also the highest Hepatitis Multiple sclerosis Diabetes Hyperlipidemia Oncology number in absolute perspective since oncology is one of the most innovative Year of EMA approval and reimbursement status as of June 2018 [# of molecules] treatment areas

13 14 • Number of approved molecules by 11 11 EMA is growing rapidly – between 8 62% 8 years 2011 and 2017 the number more 5 100% than doubled 75% 100% 100% 100% 2 60% 38% • No innovative onco molecules approved 40% 25% 100% 0% 0% 0% 0% Not reimbursed by EMA since 2015 got the 2011 2012 2013 2014 2015 2016 2017 2018* Reimbursed reimbursement

Note: Molecules analyzed are original meaning not generic molecules or biosimilars included in analysis, 2018 as of June 2018 PLEASE NOTE THAT EVEN PARTIAL REIMBURSEMENT CONSIDERED AS “REIMBURSED” FOR THE ANALISIS PURPOSES Source: EMA, SK MoH, MIDAS, IQVIA, 22 Onkologia na Slovensku ONCOLOGY REGULATIONS SETTING …moreover, when looking on QALY threshold the level is significantly lower compared to other countries Oncology setting comparison – Selected peers

Country Status QALY Funding and pricing Onco accessibility • No specifically dedicated budget for onco mols Screening system ✓ • Special temporary reimbursement status for highly Peers 46,404 EUR Czechia innovative mols (VILP) Systematic treatment landscape ✓ • Provision of best available treatment granted by law Outcomes data (registries) ✓ • Most of the onco mols in itemized list - medicines are Screening system ✓ procured under the payer authority (NEAK) Peers 71,644 EUR Systematic treatment landscape Hungary • Strict price control – blind bidding, preferred pricing ✓ • Possibility of compassionate use of medicine Outcomes data (registries) ✓ • No specifically dedicated budget for onco mols Screening system ✓ • Government initiatives to implement a centralized Peers n/a Systematic treatment landscape Bulgaria national tender procurement - maximum prices at ✓ which hospitals can finish their tenders Outcomes data (registries) ✓ • Onco mols funded mainly via drug programs Screening system ✓ • Price-volume agreements often used – outcomes- Peers 73,186 EUR Systematic treatment landscape Poland based schemes in discussion ✓ • Reimbursement resubmission required every 2 years Outcomes data (registries) ✓

• No special funding programs for onco mols Screening system ✓ • Hospital tenders from 2013 and payers considering 38,503 EUR Systematic treatment landscape Slovakia initiation of centralized procurement ✓ QALY threshold for • Compassionate use of medicine individually possible Outcomes data (registries) reimbursement lowest in ✓ Best ( )/ Worst ( ) oncology accessibility Slovakia and highly limiting Note: Oncology specifics not considered ( )/ fully considered( in ) in funding and pricing setting Element present and fully working Element present and not fully working or just planned access to new treatments for ✓ ✓ Slovak patients Source: Market Prognosis, P&R Guide, IQVIA 23 Onkologia na Slovensku ONCOLOGY REGULATIONS SETTING SK is almost the only country from the scope missing national screening for major cancer indications – roll out planned for 2019 Oncology accessibility – Screening

Nationwide screening programs – Timeline Slovakia Cancer Pioneer Last adopter Usual screening age No nationwide screening • MoH recently presented National Oncology Program Breast 1988 – United Kingdom 2015 – Romania 45+ SK, BG including the schedule for Cervical 1970 – Netherlands 2012 – Romania 25+ SK, BG national cancer screening Colorectal 1974 – Germany 2014 – Netherlands 50+ SK, BG, RO • Roll out is planned from beginning of 2019 • Public communication about the future national 1970 ‘71 ‘74 ‘88 ‘89‘91 ‘00 ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 ‘12 ‘14 2015 screening is planed from ? September 2018 • Screening program will cover UK NL HU CZ FR DE PL SI AT RO all 3 major cancers - Cervical and Colorectal in the first launching wave followed by Breast cancer screening NL DE UK FR HU PL CZ RO SI • National Oncology Institute will be responsible for screening outcomes DE CZ FR AT UK HU SI PL NL analysis Breast Cervical Colorectal

Countries in scope: Peers, Role models, SK

Source: SK MoH, Cancer Screening in the European Union (International Agency for Research on Cancer), IQVIA 24 Onkologia na Slovensku Where should Slovakia go?

25 General so-what comments

• Many more oncology medicines will become available in the EU

• Brand new treatment & diagnostics schemes will change the treatment landscape prolonging patients´ lives and their quality of life with the disease burden

• SK healthcare system should keep eye on these innovations and reshape regulatory environment to be ready for these challenges – mainly in via managed entry agreements financing and big data usage (e.g. Real world evidence)

26 Onkologia na Slovensku Thank you for your attention!

Tomáš Khorel | Head of Consulting in CZ&SK [email protected] +420 778 726 767