References
- Sorenson C Drummond M Kanavos P Ensuring Value for Money in Health Care Bodmin European Observatory on Health Systems and Policies 2008
- Oortwijn W Mathijssen J Banta D The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries Health Policy 2010 95 174 184 20074829
- Banta D Health technology assessment in Latin America and the Caribbean Int J Technol Assess Health Care 2009 25 suppl 1 253 254 19527544
- Franken M Le Polain M Cleemput I Koopmanschap M Similarities and differences between five European drug reimbursement systems Int J Technol Assess Health Care 2012 28 349 357 22989410
- Banta D Oortwijn W Health technology assessment and health care in the European Union Int J Technol Assess Health Care 2000 16 626 635 10932427
- Oortwijn W Broos P Vondeling H Banta D Todorova L Mapping of health technology assessment in selected countries Int J Technol Assess Health Care 2013 29 424 434 24290336
- Kristensen F EUnetHTA and health policy-making in Europe Eurohealth (Lond) 2006 12 36 38
- Drummond MF Schwartz JS Jönsson B Key principles for the improved conduct of health technology assessments for resource allocation decisions Int J Technol Assess Health Care 2008 24 244 258 18601792
- Ciani O Tarricone R Torbica A Diffusion and use of health technology assessment in policy making: what lessons for decentralised healthcare systems? Health Policy 2012 108 194 202 23093020
- van Nooten F Holmstrom S Green J Wiklund I Odeyemi IA Wilcox TK Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research Drug Discov Today 2012 17 615 622 22366662
- Luce BR Drummond M Jönsson B EBM, HTA, and CER: clearing the confusion Milbank Q 2010 88 256 276 20579285
- National Institute for Health and Care Excellence Guide to the Methods of Technology Appraisal 2013 National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance Accessed June 30, 2014
- Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework Clin Pharmacol Ther 2001 69 89 95 11240971
- Velasco Garrido M Mangiapane S Surrogate outcomes in health technology assessment: an international comparison Int J Technol Assess Health Care 2009 25 315 322 19619350
- Backhouse ME Wonder M Hornby E Kilburg A Drummond M Mayer FK Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study Value Health 2011 14 608 615 21669387
- Taylor RS Drummond MF Salkeld G Sullivan SD Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle BMJ 2004 329 972 975 15499118
- Rogowski WH Hartz SC John JH Clearing up the hazy road from bench to bedside: a framework for integrating the fourth hurdle into translational medicine BMC Health Serv Res 2008 8 194 18816378
- WHO Institutionalization of Health Technology Assessment: Report on a WHO Meeting, Bonn; 2001. June 30–July 1, 2000 Copenhagen World Health Organization Regional Office for Europe
- About NICE [homepage on the Internet] National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.nice.org.uk/aboutnice/about_nice.jsp Accessed June 30, 2014
- Agenzia Italiana del Farmaco. [homepage on the Internet] Agenzia Italiana del Farmaco [updated 2014]. Available from: http://www.agenziafarmaco.com/en Accessed June 30, 2014
- Fattore G Jommi C The last decade of Italian pharmaceutical policy: instability or consolidation? Pharmacoeconomics 2008 26 5 15 18088155
- Velasco-Garrido M Busse R Health Technology Assessment. An Introduction to Objectives, Role of Evidence, and Structure in Europe Brussels European Observatory on Health Systems and Policies 2005
- Horizon Scanning Centre [homepage on the Internet] Birmingham NIHR Horizon Scanning Centre [updated 2014]. Available from: http://www.hsc.nihr.ac.uk/about-us/ Accessed June 30, 2014
- Joppi R Dematte L Menti AM Pase D Poggiani C Mezzalira L The Italian Horizon Scanning Project Eur J Clin Pharmacol 2009 65 775 781 19495735
- Murphy K Packer C Stevens A Simpson S Effective early warning systems for new and emerging health technologies: developing an evaluation framework and an assessment of current systems Int J Technol Assess Health Care 2007 23 324 330 17579934
- EuroScan International Network [homepage on the Internet] NIHR Horizon Scanning Centre [updated 2014]. Available from: http://euroscan.org.uk/ Accessed June 30, 2014
- Storz P Kolpatzik K Perleth M Klein S Haussler B Future relevance of genetic testing: a systematic horizon scanning analysis Int J Technol Assess Health Care 2007 23 495 504 17937839
- Retel VP Hummel MJ van Harten WH Review on early technology assessments of nanotechnologies in oncology Mol Oncol 2009 3 394 401 19540817
- O’Malley SP Jordan E Horizon scanning of new and emerging medical technology in Australia: its relevance to Medical Services Advisory Committee health technology assessments and public funding Int J Technol Assess Health Care 2009 25 374 382 19619357
- Ijzerman MJ Steuten LM Early assessment of medical technologies to inform product development and market access: a review of methods and applications Appl Health Econ Health Policy 2011 9 331 347 21875163
- Pietzsch JB Pate-Cornell ME Early technology assessment of new medical devices Int J Technol Assess Health Care 2008 24 36 44 18218167
- Markiewicz K van Til JA MJ IJ Medical devices early assessment methods: systematic literature review Int J Technol Assess Health Care 2014 30 137 146 24805836
- About NICE Scientific Advice National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.nice.org.uk/about/What-we-do/Scientific-advice Accessed June 30, 2014
- What advice can be requested? National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.nice.org.uk/About/What-we-do/Scientific-advice/Find-out-what-advice-can-be-requested Accessed June 30, 2014
- Briefing Book Guidance for Company 2014 National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.nice.org.uk/Media/Default/About/what-we-do/Scientific-advice/Scientific-Advice-BB-Guidance.pdf Accessed June 30, 2014
- Osipenko L NICE scientific advice: an HTA agency perspective ISPOR 16th Annual European Congress Dublin 2013
- Scientific Advice Agenzia Italiana del Farmaco [updated 2014]. Available from: http://www.agenziafarmaco.gov.it/it/content/scientific-advice Accessed June 30, 2014
- Siviero P Le applicazioni in Italia ai farmaci oncologici: quali prospettive in futuro Economia del Farmaco e delle Tecnologie Sanitarie 6 23 2014 Novara, Italy Italian
- EMA EMA-HTA workshop: bringing together stakeholders for early dialogue in medicines development November 26, 2013 London, UK
- Regnstrom J HTAs and EMA working together: 23 parallel scientific advice procedures later – what have we learned? DIA 26th EuroMeeting 2014 Vienna, Austria
- Pavlovic M Early engagement between manufacturers, HTA assessors and regulators. Learning from the past to guide the future. A EUnetHTA perspective ISPOR 16th Annual European Congress November 3–6, 2013 Dublin, Ireland
- Wonder M Backhouse ME Hornby E Early scientific advice obtained simultaneously from regulators and payers: findings from a pilot study in Australia Value Health 2013 16 1067 1073 24041357
- Industry Perspective on Advice Models Where are we now, and where should we go? Results of the EFPIA Industry Survey [updated 2013]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/11/WC500155674.pdf Accessed June 30, 2014
- Patarnello F Recchia G Ricerca post-autorizzativa, registri e sviluppo del farmaco. [Post-authorization research, registries, and drug development] Recenti Prog Med 2013 104 275 279 Italian 23801233
- Morel T Arickx F Befrits G Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries Orphanet J Rare Dis 2013 8 198 24365263
- Carlson JJ Sullivan SD Garrison LP Neumann PJ Veenstra DL Linking payment to health outcomes: a taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers Health Policy 2010 96 179 190 20226559
- Garrison LPJr Towse A Briggs A Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force Value Health 2013 16 703 719 23947963
- Adamski J Godman B Ofierska-Sujkowska G Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers BMC Health Serv Res 2010 10 153 20529296
- Raftery J Multiple sclerosis risk sharing scheme: a costly failure BMJ 2010 340 c1672 20522654
- National Institute for Health and Care Excellence List of Technologies with Approved Patient Access Schemes National Institute for Health and Care Excellence [updated 2014]. Available from: https://www.nice.org.uk/About/What-we-do/Patient-access-schemes-liaison-unit/List-of-technologies-with-approved-Patient-Access-Schemes Accessed June 30, 2014
- National Institute for Health and Care Excellence Appraising Life-Extending, End of Life Treatments National Institute for Health and Care Excellence [updated 2009]. Available from: http://www.nice.org.uk/guidance/gid-tag387/resources/appraising-life-extending-end-of-life-treatments-paper2 Accessed June 30, 2014
- National Cancer Drugs Fund List National Institute for Health and Care Excellence [updated 2014]. Available from: http://www.england.nhs.uk/wp-content/uploads/2014/02/ncdf-list-feb-14-fin.pdf Accessed June 30, 2014
- Agenzia Italiana del Farmaco Registri Farmaci sottoposti a monitoraggio 2014 Agenzia Italiana del Farmaco [updated 2014]. Available from: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottoposti-monitoraggio Accessed June 30, 2014 Italian
- Henshall C Mardhani-Bayne L Fronsdal KB Klemp M Interactions between health technology assessment, coverage, and regulatory processes: emerging issues, goals, and opportunities Int J Technol Assess Health Care 2011 27 253 260 21756413
- Douma KF Karsenberg K Hummel MJ Bueno-de-Mesquita JM van Harten WH Methodology of constructive technology assessment in health care Int J Technol Assess Health Care 2007 23 162 168 17493301
- Poulin P Austen L Scott CM Introduction of new technologies and decision making processes: a framework to adapt a Local Health Technology Decision Support Program for other local settings Med Devices (Auckl) 2013 6 185 193 24273415
- Grueger J Scientific advice from regulators and HTA: industry perspective ISPOR 16th Annual European Congress November 3–6, 2013 Dublin, Ireland
- Jommi C Otto M Armeni P De Luca C Market access management by pharmaceutical companies in a complex environment: the Italian case study J Med Markting 2012 12 10