Access to medicines - time for a progressive model

Transcription

1 Access to medicines - time for a progressive model Richard Bergström, EFPIA Director General 1

2 A question of solidarity The sense of fairness and equity between Member States is being eroded. And without equity between Member States, how can there be equity between European citizens - State of the union, 11 Sept 2012, by Jose Manuel Barroso, President of the European Commission The decisive deal for Europe Strengthen social cohesion 2

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4 Growth Economic challenges have had a dramatic effect on the growth of healthcare expenditure 7% Average OECD health expenditure growth rates in real terms, 2000 to 2010, public and total 6% 5% 4% 3% 2% 1% 0% -1% Total expenditure on health, growth rates Public expenditure on health, growth rates SOURCE: OECD health accounts data. June

5 Council Conclusions June 2011: Towards modern, responsive and sustainable health systems 5

6 SALES PER 100,000 (m ) Seminal report from BE Presidency Sales of innovative products (launched ) per 100,000 inhabitants in 2009 per country 2,5 2,0 1,5 1,0 0,5 0,0 FR DK ES BE IE DE AT SE IT GR SK FI SI UK CZ LU NL HU RO EE PT PL BU LT LV SOURCE: IMS MIDAS; analysis for INAMI 6 6

7 What are the patterns of innovation uptake across Europe? An OECD study investigated reimbursement and pricing policies of 12 selected new drugs in 14 OECD countries This report expands on the OECD study by looking at differences in uptake of innovation across Europe The list of OECD molecules was refined based on amount of uptake history. The selection was expanded by identifying new molecules that are a part of the same innovative clusters INDICATION INNOVATIVE CHARACTERISTIC PRODUCT MOLECULE EMA APPROVAL JANUVIA Sitagliptin 03/2007 Delivery form mode of action: novel oral mediciation GALVUS Vildaiptin 09/2007 Mode of action: DPP 4 Inhibitor Type 2 diabetes ONLGYZA Saxagliptin 10/2009 Mode of action: GLP 1 Agonist BYETTA Exenatide 11/2006 VICTOZA Liraglutide 06/2009 Thromboembolic disorders Delivery form: novel PRADAXA Dabigtran Etexilate 03/2008 oral mediciation XARELTO Rivaroxban 09/2008 Wet form of age-related macular Therapeutic advancement: first treatment shown to improve LUCENTIS Ranibzumab 01/2007 degeneration (AMD) vision rather than slow vision loss MACUGEN Pegaptanib 01/2006 All products received EMA approval between Uptake was measured as DDD or MG per capita 7

8 Q12007 Q22007 Q32007 Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 Avg price (LC /DDD) Q12007 Q22007 Q32007 Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 DDD/100,000 people (thousands) It is not necessarily the first product to market in an innovative cluster which drives uptake 3,5 3,0 2,5 2,0 EU5: Quarterly uptake of GLP1 Agonists, Byetta and Victoza, (DDD/ 100,000 people) Byetta (Exenatide): 1st to market Victoza (Liraglutide): 2nd to market Byetta was the first in class of the GLP1 agonists to be launched in Europe for the treatment of diabetes 1,5 1,0 0,5 0,0 Two years later Victoza followed and proved to be clinically superior, as a result it was this second to market product which drove the uptake of this class within the EU5. 3,5 3 2,5 2 1,5 1 0,5 0 EU5: Avg Price (LC /DDD) Byetta (Exenatide) Victoza (Liraglutide) Uptake of Victoza was based on its superiority as an anti-diabetic rather than strategic pricing mechanisms. This example illustrates the need to use innovation clusters as opposed to single products to understand uptake Source: IMS Health MIDAS. June Population figures from Eurostat. Note as Victoza was only launched in 2009 only the EU5 were analysed to remove the influence of number of launch countries. In 2011, a controlled release form of Exenatide (Bydureon) was approved in the EU. To date it has been launched in Germany and the UK but is too recent a launch to be included in this analysis 8

9 Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 DDD/100,000 people (thousands) DDD/100,000 people (thousands) Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 DDD/100,000 people (thousands) Furthermore, product competition can impact uptake results Germany vs Denmark: combined quarterly uptake of Xarelto & Pradaxa GERMANY DENMARK At the individual product level, Xarelto outperformed in the German market. In contrast, in Denmark the uptake of Pradaxa was far superior to Xarelto Combing the uptake of both products, Denmark and Germany have similar uptake rates, illustrating the importance of using innovative clusters as opposed to individual products. Germany: quarterly uptake of Xarelto & Pradaxa Denmark: quarterly uptake of Xarelto & Pradaxa XARELTO PRADAXA XARELTO PRADAXA Source: IMS Health MIDAS Q EuroSTAT population statistics.

10 Uptake of innovation varies across countries and between innovative clusters MAT Q volume consumption DDD or MG*/100,000 people indexed to European Average LUXEMBOURG FINLAND FRANCE GREECE GERMANY PORTUGAL DENMARK UK BELGIUM IRELAND EUROPEAN SPAIN SWITZERLAND NORWAY SLOVENIA NETHERLANDS CZECH REPUBLIC SWEDEN SLOVAKIA AUSTRIA ITALY ESTONIA HUNGARY ROMANIA LITHUANIA LATVIA BULGARIA POLAND Innovative Anti-diabetics Innovative Anti-Coagulants Innovative wet AMD therapies 2,02 1,64 1,61 1,41 1,39 1,33 1,26 1,05 1,00 0,94 0,89 0,78 0,73 0,70 0,68 0,66 0,64 0,60 0,54 0,49 0,36 0,34 0,29 0,17 0,12 0,02 2,74 3,60 0,3 0,2 0,1 0,4 0,2 0,3 0,1 0,2 0,3 0,4 0,6 0,5 0,5 0,5 0,6 0,8 1,0 1,2 1,0 0,9 1,5 1,4 1,5 1,9 2,3 2,8 3,2 3,2 0,60 0,35 0,03 0,29 0,09 0,00 0,17 0,00 0,08 0,36 0,27 0,49 0,42 1,03 1,00 0,71 1,52 1,48 1,31 2,20 1,96 Source: IMS Health MIDAS. June Population figures from Eurostat. Anti-diabetics and Anti-coagulants were measured in DDD, wet AMD therapies in MG 2,63 3, ,90

11 POLAND BULGARIA LATVIA LITHUANIA ROMANIA HUNGARY ESTONIA ITALY AUSTRIA SLOVAKIA SWEDEN CZECH REPUBLIC NETHERLANDS SLOVENIA NORWAY SWITZERLAND SPAIN IRELAND BELGIUM UK DENMARK PORTUGAL GERMANY GREECE FRANCE FINLAND LUXEMBOURG DDD/ 100,000 people There are a number of factors which can impact uptake 450 Europe: Uptake of Innovative Anti-diabetics (DDD/100,000 people) MAT Q Many factors can affect uptake : - GDP per capita and the financial situation of the country - Regional decision makers - Price premium versus existing treatment - Stakeholder attitude to innovation - If innovation is funded by the public or private payer Source: IMS Health MIDAS. June Population figures from Eurostatfrom 11

12 Q12007 Q22007 Q32007 Q42007 Q12008 Q22008 Q32008 Q42008 Q12009 Q22009 Q32009 Q42009 Q12010 Q22010 Q32010 Q42010 Q12011 Q22011 Q32011 Q42011 Q12012 Q22012 DDD/100,000 people (thousands) Focussing on innovative anti-diabetics shows large country differences in rate of uptake Quarterly uptake of Innovative* Anti-diabetics over time (DDD/100,000 people) DENMARK LUXEMBOURG NORWAY SWITZERLAND AUSTRIA BELGIUM FINLAND FRANCE GERMANY IRELAND ITALY NETHERLANDS SPAIN SWEDEN UK BULGARIA CZECH REPUBLIC ESTONIA GREECE HUNGARY LATVIA LITHUANIA POLAND PORTUGAL ROMANIA SLOVAKIA SLOVENIA Source: IMS Health MIDAS Q EuroSTAT population statistics. 12

13 POLAND BULGARIA LATVIA LITHUANIA ROMANIA HUNGARY ESTONIA ITALY AUSTRIA SLOVAKIA SWEDEN CZECH REPUBLIC NETHERLANDS SLOVENIA NORWAY SWITZERLAND SPAIN IRELAND BELGIUM UK DENMARK PORTUGAL GERMANY GREECE FRANCE FINLAND LUXEMBOURG DDD/100,000 people (thousands) Treatment mix is highly variable between countries Europe: Uptake of Innovative* Anti-diabetics (DDD/100,000 people) MAT Q Innovation Modern Insulins Insulins Source: IMS Health MIDAS Q EuroSTAT population statistics. Modern Insulins includes (Apidra, Humalog, Humalog mix, Lantus, Levemir, Novomix, Novorapid) 13

14 POLAND BULGARIA LATVIA LITHUANIA ROMANIA HUNGARY ESTONIA ITALY AUSTRIA SLOVAKIA SWEDEN CZECH REPUBLIC NETHERLANDS SLOVENIA NORWAY SWITZERLAND SPAIN IRELAND BELGIUM UK DENMARK PORTUGAL GERMANY GREECE FRANCE FINLAND LUXEMBOURG DDD/100,000 people (thousands) Uptake of innovation is lower in poorer countries Europe: Uptake of Innovative Anti-diabetics (DDD/100,000 people) MAT Q In high and medium income countries we see variations in uptake of innovation. In countries where generics are commonly used as first line treatment uptake of innovation can be adversely impacted e.g Denmark, Norway and UK In low income countries we generally see low uptake of innovation (Greece and Portugal are an exception). While patients in these countries are able to access treatment they can not necessarily access the most effective treatment 0 Income Category GDP/Capita* High > $50,000 Middle : $30,000-$50,000 Low < $30,000 Source: IMS Health MIDAS. June Population figures from Eurostat. * OECD health accounts data. June

15 Jan-10 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12 May-12 Jul-12 DDD (thousands) Q12007 Q32007 Q12008 Q32008 Q12009 Q32009 Q12010 Q32010 Q12011 Q32011 Q12012 DDD/10,000 people (thousands) In low income markets it is not uncommon for innovation to be funded by the patient Quarterly uptake of Innovative* Anti-diabetics over time (DDD/100,000 people) Low Income countries Poland: Monthly uptake of Anti-diabetics (DDD) split by financing agent BULGARIA CZECH REP ESTONIA GREECE HUNGARY LATVIA LITHUANIA POLAND PORTUGAL ROMANIA SLOVAKIA SLOVENIA Private Public Poland has the lowest uptake of innovative anti-diabetics in Europe, furthermore, uptake of these products is almost fully based on private pay. These molecules are not included on the reimbursement list despite the issue being raised by the Polish Diabetes Association. In Romania the innovative anti-diabetics is publically funded where as the innovative anti-coagulant market is > 97% privately funded Product % Reimbursement* Pradaxa 3.76% Xarelto 1.13% Januvia 85.9% Byetta 91.4% Source: IMS Health MIDAS. June Polish data sources- public expenditure: NHF (National Health Found) report, 07/2012 (Retail market), IMS MIDAS sell in (hospital) private expenditure: IMS Pharmascope sell out (retail), Population figures from Eurostat.. Note: GR and PT could be impacted by parallel trade * Romanian reimbursement figures average of last 24 months available covering 3,500 retail pharmacies 15

16 DDD/100,000 people (thousnads) TRENTO - BASILICATA PUGLIA ABRUZZO PIEMONTE+ EMILIA LAZIO MARCHE LIGURIA MOLISE TOSCANA UMBRIA VENETO CALABRIA BOLZANO - FRIULI CAMPANIA SARDEGNA SICILIA LOMBARDIA DDD/100,000 people (thousands) GOTLANDS LÄN VÄSTERBOTTEN STOCKHOLMS ÖSTERGÖTLAN NORRBOTTENS VÄSTRA KALMAR LÄN KRONOBERGS SÖDERMANLAN HALLANDS LÄN ÖREBRO LÄN UPPSALA LÄN JÄMTLANDS LÄN VÄSTMANLANDS VÄSTERNORRLA JÖNKÖPINGS LÄN SKÅNE LÄN DALARNAS LÄN GÄVLEBORGS LÄN BLEKINGE LÄN VÄRMLANDS LÄN National reimbursement does not always ensure equal access within a country Sweden: Regional Uptake of Innovative* Anti-diabetics (DDD/100,000) MAT Q Italy: Regional Uptake of Innovative* Anti-diabetics (DDD/100,000) MAT Q Regions normally share common launch dates, technology assessments, prices, reimbursement, etc. Analysing uptake between healthcare regions within a country exposes differences in how innovation has been used Differences in uptake can be based on; the criteria applied by local drug committees, budget restrictions, information availability, medical judgements Source: IMS Health Swedish PrSellOut and Italian. Population statistics from SCB for Sweden and Istat for Italy. 16

17 Why differences Affordability Willingness to pay Delivery systems Education, health literacy Commercial behaviour 17

18 Referencing market International Reference Pricing (IRP) is used in some form in most European countries IRP Matrix COUNTRY Frequency of rereferencing IRP used? Formal/ Informal Calculation used Price referenced Drugs (months) No. of Reference Countries Austria Y F AVERAGE MNF Reimbursed - 25 Belgium Y I AVERAGE MNF All Bulgaria Y F LOWEST MNF POM 6 15 Cyprus Y F AVG. OF LOWEST 4 TRD Imported medicines 24 4 Czech Republic Y F AVERAGE MNF All 12 8 Denmark N Estonia Y F Not defined MNF Reimbursed 3 3 Finland Y I AVERAGE TRD Reimbursed France Y I/F AVERAGE MNF Innovative medicines 60 4 Germany Y I Not defined MNF Innovative medicines - 15 Greece Y F AVG. OF LOWEST 3 MNF All 6 22 Hungary Y F LOWEST TRD Reimbursed - 26 Ireland Y F AVERAGE MNF Innovative medicines 24 9 Italy Y I/F AVERAGE MNF Reimbursed Latvia Y F THIRD LOWEST MNF Reimbursed 6 25 Lithuania Y F AVERAGE MNF Reimbursed 12 8 Luxembourg Y I AVERAGE MNF All 18 Malta Y F AVERAGE MNF All - 12 Netherlands Y F AVERAGE TRD POM 12 4 Norway Y F AVG. OF LOWEST 3 TRD POM 12 9 Poland Y I LOWEST MNF Reimbursed - 26 Portugal Y F AVERAGE MNF POM 12 4 Romania Y F LOWEST MNF Reimbursed Slovakia Y F AVG. OF LOWEST 6 MNF Reimbursed 6 25 Slovenia Y F 95% OF AVG OF 3 MNF Reimbursed 24 3 Spain Y I LOWEST MNF Innovative medicines - 26 Sweden N UK N SOURCE: IMS HEALTH Pharmaquery Sept

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21 What factors do manufacturers now need to consider when launching in Europe? SHOULD I LAUNCH INTO A MARKET? Will I get reimbursement (for an acceptable price)? Is the market potential sufficient (to justify the launch cost)? IN WHAT SEQUENCE SHOULD I LAUNCH? Will the launch into a low price market directly impact the prices in rest of Europe? To what degree will parallel trade influence the attractiveness of the launch market? 21 21

22 Natural commercial response Launch sequencing Not launching (maybe to private market) What should be the public policy response? 22

23 Solutions Budget = price X volume = payer spend Targetted medicine, progressive approvals, conditional reimbursement, managed entry, stratified use, real-life assessment, pay for outcomes, differential pricing, appropriate budgets, framework stability agreements 23

24 What everyone avoids to discuss: Some people should pay more than others 24

25 EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0)