HTA in Hospital Management

European HTA: From Research to Policy Parallel Forum F3 4th-7th October, 2006 HTA in Hospital Management Prof. Americo Cicchetti Director of Research HTA Unit A. Gemelli University Hospital Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Agenda HTA s Map Decentralizing HTA Toward hospital based HTA Conclusion Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA s Map DURING BEFORE AFTER WHO Macro Meso Micro HTA? What WHEN DRUGS DEVICES PROCEDURES Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA s Map DURING BEFORE AFTER HTA AGENCY HTA Unit Hospitals, HCOs WHO Macro Meso Micro WHAT WHEN DRUGS DEVICES PROCEDURES Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Decentralizing HTA HTA Italian Network (25 partners) Ricciardi, Cicchetti, Marchetti, IJPH 3(2) 2005 HTA Swiss Network (SNHTA; 22 partners) Mini-HTA in Denmark Helers et al (2006), IJTAHC 22(3): 295-301 HTA Unit at McGill University Hospital (Montreal) Mc Gregor & Brobhy, IJTAHC 21(2) 2005 HMOs and Health Care organizations (US) Luce & Brown (1995), Int J Tech Ass Health Care, 11(1): 79-82 Es. Veterans Health Administration Technology Program HTA in Israeli Medical Centers Greenberg, Petersburg, Vekstein & Pliskin, IJATHC, 21 (2) 2005 Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Toward hospital based HTA Bringing HTA into practice Pressures to micro-economic efficiency Technology-organization interaction Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

JAMA, October 20, 1999-Vol 282, No. 15 Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Setting, delivering, monitoring standards National Institute for Clinical Excellence (NICE) National Service Frameworks (NSF) Clear standards of service Patient & public involvement Professional self-regulation Clinical governance Lifelong learning Dependable local delivery Commission for Health Improvement National Performance Framework National Patient and User Survey National Clinical Indicators Monitored standards Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA s Map DURING BEFORE AFTER HTA & NICE WHO Macro Meso Micro Clinical Governance Framework WHAT WHEN DRUGS DEVICES PROCEDURES Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

The ambassadors at SBU Ambassadors have to have high legitimacy and clear mandates Ambassadors have to have resources i.e. defined time A contract of what is to be achieved and how helps Road show to faculties and county councils is of value Both top down and bottom up necessary Nina Rehnqvist, Executive Director (Rome, June 21st 2005) Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA Units and Mini-HTAs Local participation in making analysis can be important to the implementation process Analyses of implementation processes show that the course of the decision making process affects implementation process Ehlers, L. et al. 2006. Intl. J. Tech Ass. Health Care, 22(3) Locally developed HTAs would have grater influence on health policy and decision making process McGregor & Bropghy 2005 Intl. J. Tech Ass. Health Care, 21(2) Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Toward hospital based HTA Bringing HTA into practice Pressures to micro-economic efficiency Technology-organization interaction Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Micro economic efficiency Hospitals operating under budget constraints payment mechanisms based on DRGs Internal markets Responsibility and autonomy at HCOs level - Financial equilibrium Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Decision Making Alternative Approaches Rational (Evidence Based Management Model based on HTA principles) Based on scientific evidence Granting distinctive competencies Coherent with corporate strategies (Mission, Goals) Shared with professionals (Involvement and commitment) Multi-dimensional (efficacy, cost-effectiveness, organizational impact, equity, appropriateness, safety, ethics ) Value of innovation Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Policlinico A. Gemelli Rome, Italy (HTA Unit: Estabilished in 2001) University Hospital and Network (5HCOs; Acute, Rehab, Hospice, Nursing Homes) 3.000 beds Budget: 400 million /Year 5.000 employed 2004-2006 New tech investment plan (30 million ) Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA Unit Aim To support top-management decision making Activities To produce in-house HTA reports (reports based on external HTAs and on local evidences); To manage a three-year technology investment plan Structure Professional staff (Multidisciplinary: MD, Eng, Health Econ) Clinical committee Other Research and training (Ulysse Project; LDL HTA Course Hospital-Industry collaborations on HTA Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Clinical Departments Mission (Effectiveness) (Balance) (Appropriateness) Proposals Guidelines for technology needs assessment Goal setting (Selection of strategic options) HTA-U Strategic Plan Feedback Investment Budget Implementation of plans Strategic Monitoring HTA framework in the Strategic planning process Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Toward hospital based HTA Bringing HTA into practice Pressures to micro-economic efficiency Technology-organization interaction Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Technology-Organization interaction Traditional approach in HTA Among health care organizations there is an equal distribution of: - Professional-technical skills - Management skills - Managerial capabilities to control organizational processes Impacts of health technologies use (eg. outcomes) is independent by other organizational factors A more reasonable approach Technology is one organizational factor and it is a medium for organizational performance Health technologies impact depends on resources and skills availability, organizational competencies managerial capabilities, personnel motivation, organizational climate It is reasonable to assess health technologies out of their organizational context? It seems impossible to solve the problem only designing multi-centric RCTs (the mean trap ) Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Conclusion (1) System level Efficacy Cost effectiveness Ethical issues Patient perspective (populations) Patient perspective (specific groups) Hospital budget impact Organizational impact Overlapping Hospital level Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

Conclusion (2) Increasing need for collaboration in HTA (more competencies, more resources) Horizontal specialization Division of labor (at national-regional levels) Vertical Specialization Distribution of competencies among different levels of the health care system Network as a coordinating mechanism Mutual trust and recognition Setting quality standards and procedures (shared among network members) Università Cattolica del Sacro Cuore A. Gemelli University Hospital and Network

HTA: a tool to improve patient access to innovation an industry perspective Gastein, 4 October 2006 Andrea Rappagliosi Chair, EuropaBio Healthcare Council Vice-President, Corporate Health Policy & Government Relations

Bringing healthcare to patients: the innovation race «Drug discovery and development are more like a marathon than a 400-meters dash; The innovative race is not an he wins I win race, but rather, an everybody wins race». Bringing innovation to patients is a challenge for all stakeholders: regulators, reimbursements, physicians, researchers, policy makers and the industry. Source: Scherer FM, 1996 Comment. In: Helms RB, ed. Competitive strategies in the Pharmaceutical Industry Washington, DC: American Enterprise Institute, 269-73 2

Controversies in innovation «Controversies appear when the distribution of expertise during the innovation process does not take into account some potentially interested actors. The controversies begin when some actors who claim the right to participate to the definition of risks, cost and benefit are not included in the management of innovation». Source: Senker, J et al (1999) - EC Targeted Socio-Economic Research (TSER) Project for the period 1998 2000 European Biotechnology Innovation System (EBIS) 3

Overcoming controversies In order for the necessary dialogue to occur there must be greater transparency (including international exchange of evaluations) and a cessation of emotive statements that do little more than polarise attitudes rather than develop partnerships. Lloyd Sansom Chair of PBAC Australia July 2006 4

Beyond semantics: what is «value» in healthcare? Most common misunderstandings: «value» = price Governments, reimbursement authorities, «value» = performance Patients, clinicians, industry,, 5

The first step to wisdom is getting things by their right name Chinese proverb Policy-makers face tremendous challenges when making recommendations for the adoption of new therapies. The perceived value of a therapy may differ depending on whether one is a payer, a patient, a family member, or a physician involved in the healthcare of a patient. Where healthcare allocation decisions are judgemental and values driven, the fullest possible transparency and stakeholder involvement are basic and necessary components. 6

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The 3 pillars of value Defining Measuring Rewarding Patients / Individual health System / Management of community health Economy / Science Patients = performance System = wider impact of new technologies Economic growth, scientific knowledge = parameters Pricing / ICER on patients Longterm benefits for community health management The contribution to economic growth and progress in medicine 8

The «value» of innovation should be a reasonable balance between: Interest of payers: Better management of budgets Interest of patients: Better access Interest of physicians: Better outcomes Where the innovative R&D and biotech industry = appropriate reward for innovation 9

«Coverage criteria sit aside the flow of money» Eddy, D. M. (1996). Benefit language: Criteria that will improve quality while reducing costs. JAMA, 275, 650-657. Ensuring timely access to and rationale use of medicines for all people is a difficult goal in itself; Changing relationship between the public and private sectors has become a critical success factor; Longterm strategic dialogue should be focused on building trust, understanding the mutual benefit and adding value to patient access; and Reliability, consistency and integrity from both sides are key but: Allocation of appropriate and adequate funding within the healthcare system is paramount 10

«Due to budgetary constraints, the light at the end of the tunnel will be turned off until further notice» Anonymous 11

HTA as input to reimbursement decisions EHFG AM 04.10.2006 Dr. Gottfried Endel HVB-EBM

HTA Role of HTA in Theory Impact of the health care system The Austrian experience Future developments HVB-EBM Dr. Gottfried Endel 2 12.10.2006

Role of HTA in Theory What is technology? John Kenneth Galbraith referred to it as the systematic application of scientific or other organized knowledge to practical tasks (Galbraith, John Kenneth. 1967. The new industrial state. Boston: Houghton Mifflin.) HVB-EBM Dr. Gottfried Endel 3 12.10.2006

Role of HTA in Theory PubMed search Search Most Recent Queries Result Time #2 Search "health technology assessment" Limits: Publication Date from 2006/01/01 12:13:03 95 #1 Search "health technology assessment" 12:11:42 690 HVB-EBM Dr. Gottfried Endel 4 12.10.2006

Role of HTA in Theory Information for technology related policy making Clarify the question Present the scientific evidence Recommend a decision Demonstrate the impact and outcome of different scenarios HVB-EBM Dr. Gottfried Endel 5 12.10.2006

Impact of the health care system Categories of healthcare systems decisions for purchasing or funding of procedures and different forms of treatment are made by official authorities (local or centralised) contracts between health professionals and official authorities (local or centralised) contracts between health professionals and health insurance companies contracts between patients and health insurance firms contracts between patients and health professionals HVB-EBM Dr. Gottfried Endel 6 12.10.2006

Impact of the health care system Influence of law and judicial system Decisions by official authorities voting decisions by courts case law depends on opinions of experts and judges HVB-EBM Dr. Gottfried Endel 7 12.10.2006

Impact of the health care system Conductive to HTA Tax funding utilitaristic use of financal resources decision by official authorities global decisions (not individual cases) completely described health system also in private health insurance! HVB-EBM Dr. Gottfried Endel 8 12.10.2006

Impact of the health care system SACHLEISTUNG benefit in kind VERSICHERTER insured person Leistungsgarantie, Krankenordnung performance guarantee,rules for insured persons Abrechnung, Antragstellung accounting, application Beiträge, Selbstverwaltung contribution, self administration Leistungen benefits Versicherungsnachweis evidence for insurance VERTRAGSPARTNER contracting party VERTRAG Contract SOZIALVERSICHERUNG social insurance HVB-EBM Zahlung, Kontroll payment, controle Dr. Gottfried Endel 9 12.10.2006 Use of HTA

Impact of the health care system SACHLEISTUNG benefit in kind VERSICHERTER insured person Leistungsgarantie, Krankenordnung performance guarantee,rules for insured persons Leistungen benefits Eintragung, Zuordnung Beiträge, Steuern contribution, taxes Leistungsdokumentation documentation of benefits VERTRAGSPARTNER contracting party VERTRAG, ANSTELLUNG contract, employment Leistungskatalog, Zahlung, Kontrolle cataloge of benefits, payment, control Nationales Gesundheitssystem NHS Use of HTA HVB-EBM Dr. Gottfried Endel 10 12.10.2006

The Austrian experience Fragmented healthcare system Hospital care (>11 regulations) Outpatient care (>12 regulations) Rehabilitation (> 4 authorities) Long term care (> 10 regulations) HVB-EBM Dr. Gottfried Endel 11 12.10.2006

The Austrian experience Different reimbursement systems Metahono Pos 1 Metahono Pos 2 Metahono Pos 3 Cataloge of procedures VSTR VSTR VSTR VSTR VSTR VSTR VSTR HVB-EBM Dr. Gottfried Endel 12 12.10.2006

The Austrian experience Use of HTA for Appraisal of new procedures Reimbursement of pharmaceuticals Regulated by law http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=11 0&p_menuid=61065&p_id=5 Population screening protocol http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=11 0&p_id=3&p_menuid=59337 HTA unit of the Main association of social insurance companies http://www.hauptverband.at/esvapps/page/page.jsp?p_pageid=219&p_ menuid=63044&p_id=5 HVB-EBM Dr. Gottfried Endel 13 12.10.2006

The Austrian experience HVB-EBM Dr. Gottfried Endel 14 12.10.2006

The Austrian experience HVB-EBM Dr. Gottfried Endel 15 12.10.2006

The Austrian experience HVB-EBM Dr. Gottfried Endel 16 12.10.2006

Future developments Standardisation Globalisation Adaption of work done internationally EUnetHTA http://www.eunethta.net/ Health evidence network http://www.euro.who.int/hen INAHTA http://www.inahta.org/inahta_web/index.asp HTAi http://www.htai.org/ HVB-EBM Dr. Gottfried Endel 17 12.10.2006

Future developments HVB-EBM Dr. Gottfried Endel 18 12.10.2006

Future developments HVB-EBM Dr. Gottfried Endel 19 12.10.2006

Future developments HVB-EBM Dr. Gottfried Endel 20 12.10.2006

Future developments HVB-EBM Dr. Gottfried Endel 21 12.10.2006

HTA THANK YOU FOR YOUR ATTENTION! VIELEN DANK FÜR IHRE AUFMERKSAMKEIT! HVB-EBM Dr. Gottfried Endel 22 12.10.2006