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

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Improved access to innovative drugs: from hospitals’ to private pharmacies • Innovative medications which are exclusively reserved for in-hospital use have become more accessible to outpatients – Development of home hospitalisation to cut hospitals’ costs – Financial agreement between the hospital’s pharmacy and pharmaceutical companies: order drugs at discounted price • Some drugs are still available only in hospitals’s pharmacies (anti-cancer treatments, immunosuppressive agents) because of special storage conditions – Geographic inequalities – But becoming increasingly accessible in private local pharmacies since 2005 • Hospitals’ pharmacies can order specific innovative drugs for outpatients if no alternative treatments are available 92
ATU System: Off label use Exemptions of market authorisation to place innovative medicinal products placed on the market • A major challenge for regulatory agencies is balancing the need for rapid access to drugs for new indications against the limited information on their benefit–risk ratio for those uses. • Temporary Authorizations for Use (ATU) are issued under the following conditions: – Innovative products intended to treat, prevent or diagnose serious or rare diseases. – There is no appropriate alternative treatment – Their effectiveness and security are alleged by existing scientific knowledge Objective is to treat, not to investigate (it is not a clinical trial) • 2 types of temporary authorization: nominative ATU (for one patient) and cohort ATU (for a group of patients). – Since 1994, thousands of patients with serious disease conditions benefited from innovative treatments which received their market authorisation months after. • Availability 10-12 months on average before MA • In 2010, more than 240 drugs have been made available by the ANSM through this procedure and about 15,000 patients were treated under nominative ATU. • In 2011, the ANSM delivered more than 25,000 nominative ATU for 18,000 patients (30% children). 460 refusals. • In 2011, 15 of the available drugs in ATU obtained the market authorisation. • In 2011, 18 cohort ATU were submitted: major therapeutic innovations have been made available months before receiving the market authorisation (tritherapy of hepatitis C, targeted therapy of the metastatic melanoma.) • Cancer : – In 2011, 31 products were authorised for 3000 patients with nominative ATU • Rare diseases : – 70% of the authorised products were available through ATU beforehand • It was the case for all new AIDS medicines 93
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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
Page 41 and 42: There are public, private for profi
Page 43 and 44: 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: Hospitals carry out more and more o
Page 95 and 96: 3. Financial incentives and reimbur
Page 97 and 98: The evaluation of new products by t
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
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£m Healthcare industries are clust
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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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www.vascoadvisers.com Supported by
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