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Jornadas #PatientInHTA · Iñaki Imaz

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Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017

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Jornadas #PatientInHTA · Iñaki Imaz

  1. 1. Zaragoza, 27-28 April 2017 European Network for Health Technology Assessment Iñaki Imaz Iglesia AETS-ISCIII Health Technology Assessment Agency Institute for Health “Carlos III”, Madrid, Spain PUBLIC HEALTH CONFERENCE 10th anniversary of the Spanish Network of Health Technology Assessment (HTA) Agencies: Insights for collaborative networking Towards Patient and public engagement in HTA
  2. 2. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Outline • HTA European Framework • Historical timeline • EUnetHTA Joint Action 3 • Joint Assessments • Future • Lessons learnt
  3. 3. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 3 29 countries, 81 partners consisting of national, regional and non-for-profit agencies that produce or contribute to HTA Project Coordinator: ZIN Dutch National Health Care Institute 20 million € (60% EU funded) EUnetHTA Joint Action 3 (2016-2020) Scientific and technical support to the HTA Network (Directive on patients’ rights in cross-border healthcare, 2011/24/EU)
  4. 4. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 4 European HTA landscape efficient? • Overlap in topics assessed (1) • Redundancies are problematic (2) – HTA is costly and resource-intensive • Thus, cross-border collaboration is needed 1. Huić, Nachtnebel, Zechmeister, Pasternak, & Wild, 2013 2. Böhm & Landwehr, 2014
  5. 5. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 5 What is HTA and why do we need it? Health technology assessment (HTA) ˗ Multidisciplinary research process on: ˗ medical, social, economic and ethical issues; ˗ related to the use of a health technology; ˗ in a systematic, transparent, unbiased, robust manner. Aims to inform (safe and effective) health policies ˗ E.g. needed in reimbursement decision-making ˗ Due to increasing healthcare expenditures ˗ Patient focused ˗ Achieve best value
  6. 6. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Health Technologies are PREVENTION: Vaccination PHARMACEUTICALS DEVICES: Cochlear implant DIAGNOSTIC TESTS: Computed Tomography SURGICAL PROCEDURES: Laparoscopic surgery
  7. 7. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 7
  8. 8. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 8 EUnetHTA European Network for Health Technology Assessment OUR AIMS ARE: • To support decision makers to ensure sustainability of health systems • To protect citizens against ineffective technologies • To improve access to high-value health technologies • To disseminate health information and knowledge.
  9. 9. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 9 EUnetHTA • Ascribes to the EU’s values for health systems – Universality, access to good quality care, equity and solidarity • Autonomy of Member States (MS) retained – EUnetHTA does not provide advice regarding price and reimbursement – Solely produce Relative Effectiveness information • MS can use this information for their own local HTA reports • MS able to consider their context in HTA process
  10. 10. European network for Health Technology Assessment | www.eunethta.eu 2013+ HTA Network The timeline of reaching a sustainable and permanent HTA network in Europe 10 2005 Call for project proposals 2009 Call for joint action 2011 Call for joint action 2006-2008 EUnetHTA Project 2009 EUnetHTA Collaboration 2011 Cross Border Healthcare Directive 2014-2020 Health Programme Call 2011 FP7-Health 2012-Innovation-1 New methodologies for HTA Legislation DG R&I Health Programme 2010-2012 EUnetHTA JA1 2016-2020 EUnetHTA JA3 Horizon 2020 Calls Health Care 2012-2015 EUnetHTA JA2 1994-1997 EUR-Assess Project 2000-2002 ECHTA- ECAHI Project EUnetHTA JA3 provides scientific and technical support to the HTA Network, set up by the Directive on patients’ rights in cross-border healthcare (2011/24/EU).
  11. 11. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 11
  12. 12. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu EUnetHTA in the life cycle of technologies Early Dialogues. Discussing requirements of studies Additional data collection Full HTA Useoftechnologyinhealthcare Time line of innovation Collecting evidence in development Submission files for EMA and HTA EUnetHTA Technology Producers Regulators Assessment for market authorization Rapid REA
  13. 13. European network for Health Technology Assessment | www.eunethta.eu 13
  14. 14. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu EUnetHTA Joint Action 3
  15. 15. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 15 29 countries, 81 partners consisting of national, regional and non-for-profit agencies that produce or contribute to HTA Project Coordinator: ZIN Dutch National Health Care Institute 20 million € (60% EU funded) EUnetHTA Joint Action 3 (2016-2020) Scientific and technical support to the HTA Network (Directive on patients’ rights in cross-border healthcare, 2011/24/EU)
  16. 16. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 16 Joint Action 3 Objectives Sharing knowledge Alignment of processes Increase re-use Building a Permanent HTA Cooperation post-2020
  17. 17. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 17 Organisational and governance structure DG SANTE and CHAFEA WP 2 Dissemination WP 3 Evaluation WP 4 Joint Production WP 5 Evidence Generation WP 6 Quality Management WP 7 National Implementation Lead: AETS-ISCIII Lead: TLV Lead: NIPHNO Co-lead: LBI ZIN Lead: HAS Co-lead: GBA Lead: IQWiG Co-lead: KCE Lead: NICE Co-lead: Agenas Work Package 1 Coordination – ZIN (Dutch Health Care Institute EUnetHTAAssembly ExecutiveBoard Spain Sweden Norway Austria Netherlands Germany United Kingdom Belgium Croatia Cyprus Czech Republic Denmark Finland France Greece Hungary Ireland Latvia Malta Poland Portugal Romania Slovakia Slovenia Italy Estonia Lithuania Bulgaria Switzerland
  18. 18. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Joint Assessments
  19. 19. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 19
  20. 20. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Available Joint Assessments (1 of 2) April 28, 2017 20 • JA3 Collaborative assessments on other technologies (2016-2020):  Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk  Repetitive transcranial magnetic stimulation for treatment-resistant major depression • JA2 Full/Comprehensive assessments (2012-2015):  Fecal Immunochemical Test (FIT) versus guaiac-based fecal occult blood test (FOBT for colorectal cancer screening. (Core HTA 1)  Use of Intravenous immunoglobulins for Alzeheimer's disease including Mild Cognitive Impairment. (Core HTA 2)  Structured telephone support (STS) for adult patients with chronic heart failure. (Core HTA 3) • JA2 Rapid REA of Pharmaceuticals (2012-2015):  Canagliflozin for the treatment of type 2 Diabetes Mellitus  Sorafenib for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/hürthle cell) Thyroid Carcinoma, refractory to radioactive Iodine  Rapid REA of new Pharmaceuticals for the treatment of Chronic Hepatitis C  Ramucirumab in combination with Paclitaxel as second-line treatment for adult patients with advanced gastric or gastro-oesophageal junction Adenocarcinoma  Vorapaxar for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI).  Zostavax for the prevention of Herpes Zoster and postherpetic Neuralgia
  21. 21. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Available Joint Assessments (2 of 2) April 28, 2017 21 • JA2 Rapid REA of Other Technologies (2012-2015):  Canagliflozin for the treatment of type 2 Diabetes Mellitus  Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction  Biodegradable stents for the treatment of refractory or recurrent benign Oesophageal Stenosis  Duodenal-jejunal bypass sleeve for the treatment of Obesity with or without type ii Diabetes Mellitus  Endovascular therapy using mechanical thrombectomy devices for acute ischaemic stroke  Renal denervation systems for treatment-resistant hypertension  Transcatheter implantable Devices for mitral valve repair in adults with Chronic Mitral Valve Regurgitation • JA1 Joint Assessments (2010-2012):  Abdominal Aorta Aneurysm Screening  Prognostic tests for breast cancer recurrence  Pazopanib • EUnetHTA Project (2006 - 2008):  Core HTA on MSCT Angiography  Core HTA on Drug Eluting Stents
  22. 22. European network for Health Technology Assessment | www.eunethta.eu 22 Activity Status Production Assessments on pharmaceutical technologies • 1st Joint Assessment Midostaurin for the treatment of Acute Myeloid Leukemia • Scoping phase/project plan • 2nd Joint Assessment Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment • Scoping phase - assessment team is built. EUnetHTA JA3 Specific Deliverable update
  23. 23. European network for Health Technology Assessment | www.eunethta.eu 23 Activity Status Production of Assessments on other technologies 2 published: • Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk • Repetitive transcranial magnetic stimulation for treatment- resistant major depressive disorder – Assessment phase (Co-author: OSTEBA) 4 ongoing: • Antibacterial-coated sutures versus non-antibacterial- coated sutures for the prevention of abdominal, superficial and deep, surgical site infection (SSI) – production of 3rd draft • Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT) – Scoping phase/ project plan (Lead author: Avalia-t) • MammaPrint for personalised management of adjuvant chemotherapy decisions in early breast cancer – Scoping phase • Cyanoacrylate-based adhesives for the treatment of varicose veins of the legs (Lead author: ISCIII) EUnetHTA JA3 Specific Deliverable update
  24. 24. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu After 2020
  25. 25. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu April 28, 2017 25 After 2020 • No more Joint Actions • Permanent structure of technical support to the HTA Network • Ongoing consultations (European Parliament, DG Santé, Research projects, JA3 WP7, …)
  26. 26. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu Discussion Lessons learnt
  27. 27. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu April 28, 2017 27 Values • Use of best available evidence • Common methodological standards • Transparency • Overcome barriers caused by language, variations in terminology, and culture. • Trust
  28. 28. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu April 28, 2017 28 Quality Consistency Timeliness Efficiency Key benefits of collaboration on HTA
  29. 29. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu Thank you Any Questions?
  30. 30. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 30 Relative Effectiveness Assessment • Relative effectiveness assessment (REA) (1) – The extent to which an intervention does more good than harm – compared to one or more intervention alternatives • for achieving the desired results – when provided under the usual circumstances of health care practice. 1. High Level Pharmaceutical Forum, 2008
  31. 31. European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu EUnetHTA HTA Core Model® HTA Core Model DOMAINS 1. Health problem and current use of technology 2. Description and technical characteristics 3. Safety 4. Clinical effectiveness 5. Costs and economic evaluation 6. Ethical analysis 7. Organisational aspects 8. Patient and social aspects 9. Legal aspects SCOPE RapidREA Comprehensive/FullHTA

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