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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 (1902-1994)

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DO DRG‘S IMPEDE INNOVATION?

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If only there were no such prejudice

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Impact of DRGs

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Total 81 studies 100%

Positive conclusion 31 38

Negative conclusion 25 30

Neutral conclusion 26 32

Brügger 2010

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“

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SwissDRG

Forum 2010: Pius Gyger

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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

Service„in Evaluation“

Mandatory service: Tarif approved

No mandatory service, tariff not approved

We have a coverage process in place

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Establishing tariffs of new procedures

•  Rules of tarif KVG applicable

•  Negotiation hospital/ insurer

•  Approval cantonal government

Coverage only for a limited period, until tariff structure Swiss DRG is in place

New procedures need to be tariffed outside of Swiss DRG, if they are non questionable (anerkannt)

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Fazit Innovationen

Endlich werden die Leistungen transparent. Das schafft die Vor-aussetzung, gute von schlechten Innovationen zu unterscheiden.

Die Schweiz kennt bereits einen Zugangsprozess für Leistungen. Wir müssen ihn nicht neu erfinden. 2

Krankenversicherer tarifieren unbestrittene bzw. zugelassene Leistungen. 3

Leistungsorientierung: endlich werden die Spitalpreise an die Leistung geknüpft. Neue Leistung = neue Verhandlung.

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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

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HOW ARE PAYORS ADAPTING ?

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Transformig the roles of health plans

Porter & Teisberg (2006)

Old role: culture of denial New role: enable value-based competition on results

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

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

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!  DRGs increases competitive pressure

!  Quality requirements are increased

!  Client counselling efforts increased

!  Patients request more value from payors and providers

Important drivers

New hospital financing– Strategic options for payors

Patient Guidance

Partner- ships

Procurement

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Specialties List (SL)

Basic health insurance

Use within limitations

+

+

within SL limitations

+

-

“unlisted use”

Obligation to pay + -

-

-

off-label use

-

Licensed

Use within label

Listed

+ + +

+ - -

+

+

“out-of-limitations

use”

-

+

-

-

-

unlicensed use

-

-

-

Art. 71 a/b KVV

Use

Art 71a/b KVV

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WHAT IS THE ROLE OF ACADEMIC HEALTH CENTERS?

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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)

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Two Worlds

UNIVERSITY INDUSTRY

Commercialization of New and Useful

Technologies

Teaching

Research

Service

Economic Development

Profits

Product R&D

Knowledge for Knowledge’s

Sake

Academic Freedom

Open Discourse

Management of Knowledge for

Profit

Confidentiality Limited Public

Disclosure

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Ways in which firms engage with academia

contacts/discussions/ conferences/forums

Graduates work on companies

premises

Managers on boards/ Committees of universities

Firms hire graduates

Continuing education

Licensing and selling IP Spin-out

Collaborative Research, consulting

Donations, endowments

Joint laboratories

More institutional

Publications

Support of generic tool

Informal Education Contractual Generic

Georges Haour & Laurent Miéville: From Science to Business (2011)

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The 2 cultures

Academia Industry

Mission Education, discovery Driven by

intellectual curiosity

Mission Translational

research, commer-

cialisation, Profit making

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Who does it better?

Frye S et al. Nature Rev Drug Discovery 2011

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HOW CAN WE SUSTAIN THE FINANCING OF INNOVATION?

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Churchill emphasized the importance of seeing every crisis as an opportunity in disguise

.

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New funding opportunities

•  Research bonds •  Charities and foundations •  Private research organisations

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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.

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The Innovative Medicines Initiative (IMI): the largest PPP in life sciences R&D

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Crowdfunding

•  Sidesteps the limitations of traditional investment channels

•  Harnesses the collective power of thousands of small-scale donations from the general public

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Crowd funding

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What is crowdfunding

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CureLauncher

•  CureLauncher is dedicated to crowdfunding early-stage 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.

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Impactree

The future?

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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

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Negotiating wisely is the name of the game

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The Payor of the future

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Es ist nicht alles Gold was glänzt Not all what is gold sparkles Nur die Besten zählen Only the best count

»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

„Die besten Dinge im Leben sind nicht die, die man für Geld bekommt.“ Albert Einstein

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Unverhofft kommt oft Unexpected comes often Jenseits von Eden East of Edeb

Vieles geschieht unverhofft - und doch ergab eins das andere. - Else Pannek, (1932 - 2010), deutsche Lyrikerin

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Wer sucht der findet He who searches finds Das verflixte letzte Jahr The last year itch

Wer suchet, der findet - Anonym

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Jedem das Seine (Suum cuique) To each his own Irrungen und Wirrungen Trials and trubulations

Justinian (482-565)

Theodor Fontane (1819-1898)

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Wissen ist Macht Knowledge is power

Eine Unze Prävention entspricht einem Pfund Therapie An ounce of prevention is a pound of cure

Francis Bacon (1561–1626)

Benjamin Franklin (1706-1790)

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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

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Thank you for your attention

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Questions?

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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 +41 61 265 76 50 F +41 61 261 76 55 E thomas.szucs@unibas.ch W www.ecpm.ch; www.szucs.ch

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References

Books •  Georges Haour & Laurent Miéville. From Science to Business. How

firms create value by partnering with universities. Palgrave McMillan, 2011 ISBN 978-0-230-23651-6

•  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; 293 850

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•  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.

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