Cardiovascular Clinical Research in an Era of DRGs. Paradise Lost?

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1 Cardiovascular Clinical Research in an Era of DRGs Paradise Lost? Thomas D. Szucs University of Basel Myths and Science Thus science must begin with myths, and with the criticism of myths; neither with the collection of observations, nor with the invention of experiments, but with critical discussion of myths, and of magical techniques and practices. - Conjectures and Refutations: The Growth of Scientific Knowledge (1963) Karl Raimund Popper ( ) 1

2 DO DRG S IMPEDE INNOVATION? If only there were no such prejudice 4 2

3 Impact of DRGs Total 81 studies 100% Positive conclusion Negative conclusion Neutral conclusion Brügger From uncontrolled dual financing to fix-dual financing Until now: - Only partially attributed costs in basic coverage - Guarantee of deficits of cantons - Incentivisation through longer length of stay New: service-based, dual-fix financing: Services are transparent for insurer Every service covered and payed using a set price 3

4 No or any delayed acces to innovation? New procedure Covered by existing tariff Not Covered by existing tariff Service qustionable Service unquestionable Tariff Short-Track-approach Normal procedure Mandatory service: Tarif approved Service in Evaluation No mandatory service, tariff not approved We have a coverage process in place SwissD 7 RG Forum 2010: Pius Gyger Establishing tariffs of new procedures Rules of tarif KVG applicable Negotiation hospital/ insurer Approval cantonal government New procedures need to be tariffed outside of Swiss DRG, if they are non questionable (anerkannt) Coverage only for a limited period, until tariff structure Swiss DRG is in place 8 4

5 Fazit Innovationen 1 Endlich werden die Leistungen transparent. Das schafft die Voraussetzung, gute von schlechten Innovationen zu unterscheiden. 2 Die Schweiz kennt bereits einen Zugangsprozess für Leistungen. Wir müssen ihn nicht neu erfinden. 3 Krankenversicherer tarifieren unbestrittene bzw. zugelassene Leistungen. 4 Leistungsorientierung: endlich werden die Spitalpreise an die Leistung geknüpft. Neue Leistung = neue Verhandlung. 9 Innovations and DRGs DRGs do not block innovations Accepting innovations is a question of financing rules and not a issue of the tariff system Today we have a financing of services, not anay more a reimbursement system We have a process for access to new procedures and services New pocedures can always be tariffed between contractual partners (hospital- insurer) Insurers are interested in innovations 10 5

6 HOW ARE PAYORS ADAPTING? Transformig the roles of health plans Old role: culture of denial Restrict patient choice of providers and treatment Micromanage provider processes and choices Minimize the cost of each service or treatment Engage in complex paperwork and administrative transactions with providers and subscribers to control costs and settle bills Compete on minimizing premium increases New role: enable value-based competition on results Enable informed patient and physician choice and patient management of health Measure and reward providers based on results Maximize the value of care over the full care cycle Minimize the need for administrative transactions and simplify billing Compete on subscriber health results Porter & Teisberg (2006) 12 6

7 New hospital financing Strategic options for payors Important drivers! DRGs increases competitive pressure! Quality requirements are increased! Client counselling efforts increased! Patients request more value from payors and providers Procurement Patient Guidance Partnerships Art 71a/b KVV Licensed Use within label Specialties List (SL) Listed Use within limitations Basic health insurance Obligation to pay Art. 71 a/b KVV Use within SL limitations out-oflimitations use unlisted use off-label use unlicensed use 7

8 WHAT IS THE ROLE OF ACADEMIC HEALTH CENTERS? Main benefits for firms to work with universities Access to new ideas, breakthroughs Access to a large intellectual pool of competencies or technologies Leveraging the research budget with public funding schemes Spotting an recruiting the brightest young talents Expanding pre-competitive research Access to specialized consultancy Georges Haour & Laurent Miéville: From Science to Business (2011) 16 8

9 Two Worlds Knowledge for Knowledge s Sake UNIVERSITY INDUSTRY Management of Knowledge for Profit Teaching Research Service Economic Development Commercialization of New and Useful Technologies Profits Product R&D Academic Freedom Open Discourse Confidentiality Limited Public Disclosure Ways in which firms engage with academia More institutional Collaborative Research, consulting Licensing and selling IP Spin-out Donations, endowments Joint laboratories Continuing education Support of generic tool Firms hire graduates Managers on boards/ Committees of universities Publications contacts/discussions/ conferences/forums Graduates work on companies premises Informal Education Contractual Generic Georges Haour & Laurent Miéville: From Science to Business (2011) 18 9

10 The 2 cultures Academia Industry Mission Education, discovery Driven by intellectual curiosity Mission Translational research, commercialisation, Profit making 19 Who does it better? Frye S et al. Nature Rev Drug Discovery

11 HOW CAN WE SUSTAIN THE FINANCING OF INNOVATION? Churchill emphasized the importance of seeing every crisis as an opportunity in disguise

12 New funding opportunities Research bonds Charities and foundations Private research organisations 23 Public-Private Collaborations across are required to Create new and more effective networks between pharmaceutical companies and their public partners (universities and hospitals) Mobilise knowledge and share previously unobtainable information Stimulate creativity by involving the entire biomedical R&D sector in Europe Achieve a critical mass required to solve the complex questions of biology Create innovation through partnerships Increase dialogue with regulators and drive rapid application of scientific findings Help change the public perception of pharmaceutical research in Europe

13 The Innovative Medicines Initiative (IMI): the largest PPP in life sciences R&D 25 Crowdfunding Sidesteps the limitations of traditional investment channels Harnesses the collective power of thousands of small-scale donations from the general public 26 13

14 Crowd funding 27 What is crowdfunding 28 14

15 CureLauncher CureLauncher is dedicated to crowdfunding earlystage clinical development as well as connecting patients and their families to the cutting edge of medical research. Aims to provide alternative funding for important research projects and clinical trials in the US through large numbers of small contributions, which could be used as primary funding or as bridge funding so projects can continue to develop their science while they wait for federal grants. Takes a small percentage of each pledge to make its profit

16 Impactree 31 The future? 16

17 And what about funding research by payors? In principle, by law, impossible However, there are options Health service research departments of insurers Innovationsfonds Trustee organisations of health insurers 33 Negotiating wisely is the name of the game 34 17

18 The Payor of the future / 2 Es ist nicht alles Gold was glänzt Not all what is gold sparkles»es ist nicht alles Gold, lieber Sohn, was glänzet, und ich habe manchen Stern vorn Himmel fallen und manchen Stab, auf den man sich verließ, brechen sehen.«matthias Claudius, An meinen Sohn Johannes, 1799 Nur die Besten zählen Only the best count Die besten Dinge im Leben sind nicht die, die man für Geld bekommt. Albert Einstein

19 3 / 4 Unverhofft kommt oft Unexpected comes often Vieles geschieht unverhofft - und doch ergab eins das andere. - Else Pannek, ( ), deutsche Lyrikerin Jenseits von Eden East of Edeb / 6 Wer sucht der findet He who searches finds Wer suchet, der findet - Anonym Das verflixte letzte Jahr The last year itch

20 7 / 8 Jedem das Seine (Suum cuique) To each his own Justinian ( ) Irrungen und Wirrungen Trials and trubulations Theodor Fontane ( ) / 10 Wissen ist Macht Knowledge is power Francis Bacon ( ) Eine Unze Prävention entspricht einem Pfund Therapie An ounce of prevention is a pound of cure Benjamin Franklin ( )

21 Summary Good news: DRGs are new and will allow for adaptation Bad news: The past has triggered much scepticism and frustration Ugly news: It might take longer than anticipated. So accept patience Thanks to Pius Gyger Matthias Früh Wolfram Strüwe 42 21

22 Thank you for your attention 43 Questions? 44 22

23 Contacts Thomas D. Szucs, MD MBA MPH LLM Director; Professor of Medicine Institute of Pharmaceutical Medicine European Center of Pharmaceutical Medicine Klingelbergstrasse 61 CH-4056 Basel T F E thomas.szucs@unibas.ch W References Books Georges Haour & Laurent Miéville. From Science to Business. How firms create value by partnering with universities. Palgrave McMillan, 2011 ISBN Gordon Binder and Philip Bashe. Science Lessons. What the Business of Biotech Taught Me About Management by Harvard Business Review Press, 2008 Papers Blumenthal D. Academic Industrial Relationships in the Life Sciences. N Engl J Med 2008; 349: 2452 Frye S et al. US academic drug discovery. Nat Rev Drug Disc 2011; 10: 409 Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Disc 2009; 8: 959 Kesselheim AS, Avorn J. University-Based Science and Biotechnology Products Defining the Boundaries of Intellectual Property. JAMA 2005;

24 In der Schweiz existiert ein Zugangsprozess für neue Leistungen. Wir müssen Ihn also nicht neu erfinden wie es die Deutschen mussten. Gibt es eine neue (Pflicht-)Leistung, die über den Tarif noch nicht gedeckt ist, kann es bis zu 4 Jahre dauern, bis die Behandlung im DRG-System integriert ist (SwissDRG). Bis zur Vollendung von (2) müssen neue Leistungen ausserhalb von SwissDRG tarifiert werden, wenn sie als Pflichtleistung vom Versicherer anerkannt ist. Die Versicherer sind dann sogar verpflichtet sie zu tarifieren (da ja Pflichtleistung). Sie könnte aber auch über das VVG vergütet werden. Wichtig ist, dass diese Sondervergütung zeitlich befristet wird, bis sie im Fallpauschalenkatalog enthalten ist. Es gäbe auch die Möglichkeit einen Aufschlag auf die Baserate zu verhandeln. Wie ein Versicherer das tarifiert, ist letztlich seine Sache (und natürlich via Verhandlungen des Spitals). Spitäler können ein Entschädigungsbegehren an die Versicherer stellen. Klinische Forschung war auch vor der DRG-Einführung und der neuen Spitalfinanzierung nicht Teil der OKP-Preise. Musste also dazumal schon anderweitig finanziert werden. Daran hat sich nichts geändert