Innovation in European healthcare â what can Sweden learn? - LIF

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A long way to go from innovation to reimbursement. The difference between medical devices and drugs Medical Devices Drugs Medical Acts CLINICAL TRIALS Industry Industry Teaching hospitals and health professionals CE Marking AFSSAPSANSM Market surveillance MARKET AUTORISATION EMA Efficacy and Security AFSSAPSANSM Delivers Market Autorisation AMM HTA / EVALUATION OF THE MEDICAL BENEFIT CNEDiMTS Transparency Commission CEAP COVERAGE DECISION : PRICING CEPS after negotiations with manufacturers CEPS after negotiations with the pharmaceutical company UNCAM Tariff and Reimbursement Rate for Medical Acts Ministry of Health List of reimbursed medical devices UNCAM Reimbursement Rate REIMBURSEMENT BY THE STATUTORY PUBLIC HEALTH INSURANCE Ministry of Health List of reimbursed drugs LPPR 96 UNCAM List of reimbursed acts
The evaluation of new products by the HAS: the 2 types of Added Clinical Value • SMR: Non-comparative approach. The impacts of the innovative product on the pathology. – Is it in the public interest to reimburse this product? – Advantages provided by the new product to the patient: risk/benefit, efficiency… • ASMR : Comparative approach. – Advantages of the product compared to alternative treatments – Quantify the improvement of the medical service • This medical-economic evaluation will affect the reimbursement tariffs • Most drugs are covered at a rate of 65%, but this varies from 100% for non-substitutable or expensive drugs to 15% for drugs judged to have a low medical benefit. • Taking into account the respective weight of the different types of eligible drug consumed and the proportion of expenditure fully reimbursed (that is, without any contribution from the patient), the average rate of reimbursement for drugs is estimated to be 73%. 97 Drugs’ Added Clinical Value I II III Devices’ added clinical value IV V Major innovation Important innovation Moderated innovation Minor innovation No innovation Reimbursement Tariffs Irreplaceable drugs 100% Drugs with major medical benefit Drugs with moderated medical benefit Drugs with insufficient medical benefit 65% 30% 15%
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Innovation in European healthcare -
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Introduction If it was up to the NI
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GDP per capita 2011, thUSD Annual G
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Import Technology uptake Export End
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Venture capital flight away from li
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Issues in Sweden: clinical research
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Issues in Sweden: communication and
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Issues in Sweden: reimbursement for
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Summary - the innovation challenges
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InDex Pharmaceuticals InDex Pharmac
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Addressable Patient Population in E
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What conclusions can be drawn from
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Elekta has established a model for
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The five European countries 27
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German healthcare system • German
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Role of important Government and Of
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Role of important Government and Of
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Germany needs more healthcare for t
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37 DRG was developed in the US in t
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The base rate varied during the con
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There are public, private for profi
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Financing System of the German SHI
Page 45 and 46: Central Changes in the German healt
Page 47 and 48: Innovations in the German Health Ca
Page 49 and 50: Cost of Pharmaceuticals and Medical
Page 51 and 52: Three steps for Integration of New
Page 53 and 54: NUB Process in the German DRG Syste
Page 55 and 56: Innovative drugs in the outpatient
Page 57 and 58: Implementation and use of innovativ
Page 59 and 60: Innovations in the outpatient secto
Page 61 and 62: Implementation and use of innovatio
Page 67 and 68: New possibility of testing potentia
Page 69 and 70: Structural Innovations in the Inpat
Page 71 and 72: Structural Innovations in the Outpa
Page 73 and 74: During the last ten years two centr
Page 75 and 76: France The healthcare system in Fra
Page 77 and 78: Financing of the French health care
Page 79 and 80: The French medical device industry
Page 81 and 82: The French Medical Devices Market:
Page 83 and 84: The average time necessary to get a
Page 85 and 86: Shortening the reimbursement proces
Page 87 and 88: A successful solution to provide ad
Page 89 and 90: 2. Pharmaceuticals 89
Page 91 and 92: Hospitals carry out more and more o
Page 93 and 94: ATU System: Off label use Exemption
Page 95: 3. Financial incentives and reimbur
Page 99 and 100: Some particularly expensive drugs a
Page 101 and 102: In hospitals, expensive and innovat
Page 103 and 104: The impact of T2A on innovation Act
Page 105 and 106: The Support for Innovative and Cost
Page 107 and 108: Financing innovation through the Pu
Page 109 and 110: 8 clusters specialised in the healt
Page 111 and 112: Medical Devices’ Patenting: less
Page 113 and 114: The example of the SAAT Conectus Al
Page 115 and 116: The UK The healthcare in the UK is
Page 117 and 118: The NHS is underpinned by a set of
Page 119 and 120: Today the PCTs are the main purchas
Page 121 and 122: Prior to the Health and Social Care
Page 123 and 124: Primary Care Trusts (PCTs) have pla
Page 125 and 126: The new national level bodies overs
Page 127 and 128: The NHS, must deliver efficiency sa
Page 129 and 130: PbR was first introduced in 2005/06
Page 131 and 132: The design of HRG4 reflects a signi
Page 133 and 134: PbR is being incrementally reformed
Page 135 and 136: NHS-funded primary care is provided
Page 137 and 138: The Quality of Outcomes Framework (
Page 139 and 140: The Health and Social Care Act (201
Page 141 and 142: The United Kingdom is a major produ
Page 143 and 144: £m Healthcare industries are clust
Page 145 and 146: Several bodies aim to improve the k
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National Institute for Health and C
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Overview of key NICE assessment pro
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NHS National Technology Adoption Ce
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“Innovation” has central place
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Bodies to support innovation in hea
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The UK is a world-leader in life-sc
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There still exists large regional v
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UK rankings and usage as a percenta
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Multiple structural layers within N
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NHS lacks control mechanism for imp
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Short-term budget-cycles often are
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Actions described by respondents du
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Actions described by respondents du
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Actions deriving from the review
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The following measures were suggest
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The planned compliance regime is ge
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Actions to incentivise innovation t
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NICE’s HTA process: NICE’s stan
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The implementation of NICE guidelin
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Implementation: A recommended proce
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The NHS Technology Adoption Centre
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The Government has invested a recor
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The Government’s funding has also
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Case 2: AstraZeneca and NIHR Cancer
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The NIHR has also established Healt
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As part of the Government’s Life
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All applications for the Biomedical
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NOCRI has worked together with MRC
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Academic Health Science Centres (AH
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What can Sweden learn from the UK?
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Facts - the proportions of Danish h
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The Danish healthcare system is pri
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Public-private investments in R & D
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The Danish healthcare industry is a
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Public investments in the future st
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The public renewal fund is meant to
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With the responsibility for adminis
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Organisational chart - the capital
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The Innovation environments invest
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Overall the innovation environments
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Sara established a successful busin
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Infrastructure for Innovation - The
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The networks consist of 22 innovati
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The overall Danish Innovation infra
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The new market maturing-fund will h
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The new Danish Innovation strategy
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Subsidy for new outpatient medicame
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The evaluation and assessment of ne
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Cost reduction in expensive hospita
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The public procurement of Medtech -
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Innovative public procurement of Me
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What can Sweden learn from Denmark?
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The Netherlands are spending more o
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Health insurers are allowed to make
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Financial flows in the Dutch health
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Impact of the reform on providers
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Impact of the reform on patients/in
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Impact of the reform The Dutch heal
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Innovations in the Dutch healthcare
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The reimbursement system should all
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Summary and conclusions 277
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There is a correlation between a co
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Conclusions - what can Sweden learn
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Two general recommendations and one
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