The transferability of health technology assessment: the European perspective with focus on central and Eastern European countries

References

• Boncz I, Vajda R, Ágoston I, et al. Changes in the health status of the population of Central and Eastern European countries between 1990 and 2010. Eur J Health Econ. 2014 1;15(1):137–141.
   Google Scholar
• Marmot M, Allen J, Bell R, et al. WHO European review of social determinants of health and the health divide. Lancet. 2012 15;380(9846):1011–1029.
   PubMed Web of Science ®Google Scholar
• Mackenbach JP. Convergence and divergence of life expectancy in Europe: a centennial view. Eur J Epidemiol. 2013 1;28(3):229–240.
   PubMed Web of Science ®Google Scholar
• De Angelis R, Sant M, Coleman MP, et al. Cancer survival in Europe 1999–2007 by country and age: results of EUROCARE-5—a population-based study. Lancet Oncol. 2014 1;15(1):23–34.
   PubMed Web of Science ®Google Scholar
• Vrdoljak E, Bodoky G, Jassem J, et al. Cancer control in central and eastern Europe: current situation and recommendations for improvement. Oncologist. 2016 1;21(10):1183–1190.
   PubMed Web of Science ®Google Scholar
• Blachier M, Leleu H, Peck-Radosavljevic M, et al. The burden of liver disease in Europe: a review of available epidemiological data. J Hepatol. 2013 1;58(3):593–608.
   PubMed Web of Science ®Google Scholar
• Jakovljevic MB. Resource allocation strategies in Southeastern European health policy. Eur J Health Econ. 2013;14:153–159.
   PubMed Web of Science ®Google Scholar
• Kaló Z, Gheorghe A, Huic M, et al. HTA implementation roadmap in Central and Eastern European countries. Health Econ. 2016 Feb;25:179–192.
   PubMed Web of Science ®Google Scholar
• Vlădescu C, Baculea S, Chiriac ND. The burden of cancer and market access for new oncology drugs in European countries. Manag Health. 2009 10;13(2):25–30.
   Google Scholar
• Péntek M, Poór G, Wiland P, et al. Biological therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur J Health Econ. 2014 1;15(1):35–43.
   Google Scholar
• Pejcic AV, Iskrov G, Jakovljevic MM, et al. Access to orphan drugs–comparison across Balkan countries. Health Policy. 2018 1;122(6):583–589.
   PubMed Web of Science ®Google Scholar
• Jonsson E, Banta HD, Henshall C, et al. Summary report of the ECHTA/ECAHI project. Int J Technol Assess Health Care. 2002;18(2):218–237.
   PubMed Web of Science ®Google Scholar
• Schaefer R, Different Methods SM. Different Results? Comparing Health Technology Assessments in the United Kingdom and Germany. Value Health. 2016 1;19(7):A494.
   PubMed Web of Science ®Google Scholar
• Akehurst RL, Abadie E, Renaudin N, et al. Variation in health technology assessment and reimbursement processes in Europe. Value Health. 2017 1;20(1):67–76.
   PubMed Web of Science ®Google Scholar
• Lipska I, McAuslane N, Leufkens H, et al. A decade of health technology assessment in Poland. Int J Technol Assess Health Care. 2017;33(3):350–357.
   PubMed Web of Science ®Google Scholar
• Németh B, Csanádi M, Kaló Z. Overview on the current implementation of health technology assessment in the healthcare system in Hungary. Int J Technol Assess Health Care. 2017;33(3):333–338.
   PubMed Web of Science ®Google Scholar
• Huic M, Hacek RT, Svajger I. Health technology assessment in Central, Eastern, and South European countries: croatia. Int J Technol Assess Health Care. 2017;33(3):376–383.
   PubMed Web of Science ®Google Scholar
• Atanasijevic D, Zah V. Health Technology Assessment in Serbia. Int J Technol Assess Health Care. 2017;33(3):384–389.
   PubMed Web of Science ®Google Scholar
• Csanádi M, Inotai A, Oleshchuk O, et al. Health Technology Assessment Implementation in Ukraine: current Status and Future Perspectives. Int J Tech Assess Health Care. 2019;35(5):393–400.
   PubMed Web of Science ®Google Scholar
• Rais C, Kaló Z, Csanádi M, et al. Current and future perspectives for the implementation of health technology assessment in Romania. Health Policy Technol. 2020;9(1):45–52.
   Web of Science ®Google Scholar
• Chamova J Mapping of HTA national organisations, programmes and processes in EU and Norway. Directorate-General for Health and Food Safety, European Commission, Brussels. [Internet]. 2017. cited 2020 May 20. Available from: https://eceuropa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc_en. pdf
   Google Scholar
• Transparency International Corruption Perceptions Index. [Internet]. 2018 [cited 2019 Jul 26]. Available from: https://www.transparency.org/cpi2018/
   Google Scholar
• Löblová O. Three worlds of health technology assessment: explaining patterns of diffusion of HTA agencies in Europe. Health Econ Policy Law. 2016;11(3):253–273.
   PubMed Web of Science ®Google Scholar
• Csanádi M, Löblová O, Ozierański P, et al. When health technology assessment is confidential and experts have no power: the case of Hungary. Health Econ Policy Law. 2019;14(2):162–181.
   PubMed Web of Science ®Google Scholar
• Kaló Z, Bodrogi J, Boncz I, et al. Capacity building for HTA implementation in middle-income countries: the case of Hungary. Value Health Reg Issues. 2013 1;2(2):264–266.
   PubMedGoogle Scholar
• Gulácsi L, Rotar AM, Niewada M, et al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. Eur J Health Econ. 2014 1;15(1):13–25.
   Web of Science ®Google Scholar
• Löblová O. What has health technology assessment ever done for us? J Health Serv Res Policy. 2018;23(2):134–136..
   PubMed Web of Science ®Google Scholar
• Rusu A, Löblová O. Failure is an option: epistemic communities and the circulation of Health Technology Assessment. In: Baker T, Christopher W, editors. Public Policy Circulation: Areas, Agents and Actions. Cheltenham (United Kingdom): Edward Elgar Publishing; 2019. p. 103–121.
   Google Scholar
• Kristensen FB. Development of European HTA: from vision to EUnetHTA. Michael J. 2012;9:147–156.
   Google Scholar
• Hawlik K, Rummel P, Wild C. Analysis of duplication and timing of health technology assessments on medical devices in Europe. Int J Technol Assess Health Care. 2018;34(1):18–26.
   PubMed Web of Science ®Google Scholar
• Goeree R, He J, O’Reilly D, et al. Transferability of health technology assessments and economic evaluations: a systematic review of approaches for assessment and application. Clinicon Econ Outcomes Res. 2011;3:89.
   PubMedGoogle Scholar
• Makady A, Ten Ham R, de Boer A, et al. Policies for use of real-world data in health technology assessment (HTA): a comparative study of six HTA agencies. Value Health. 2017 1;20(4):520–532.
   PubMed Web of Science ®Google Scholar
• Kristensen FB, Husereau D, Huić M, et al. Identifying the need for good practices in health technology assessment: summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA. Value Health. 2019 1;22(1):13–20.
   PubMed Web of Science ®Google Scholar
• Kawalec P, Sagan A, Pilc A. The correlation between HTA recommendations and reimbursement status of orphan drugs in Europe. Orphanet J Rare Dis. 2016;11(1):122.
   PubMedGoogle Scholar
• Allen N, Liberti L, Walker SR, et al. A comparison of reimbursement recommendations by European HTA agencies: is there opportunity for further alignment? Front Pharmacol. 2017;30(8):384.
   Google Scholar
• Drummond M, Barbieri M, Cook J, et al. Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value Health. 2009 1;12(4):409–418.
   PubMed Web of Science ®Google Scholar
• Mandrik O, Knies S, Kalo Z, et al. Reviewing transferability in economic evaluations originating from Eastern Europe. Int J Technol Assess Health Care. 2015;31(6):434–441.
   PubMed Web of Science ®Google Scholar
• Danko D. Health technology assessment in middle-income countries: recommendations for a balanced assessment system. J Mark Access Health Policy. 2014 1;2(1):23181.
   PubMedGoogle Scholar
• Kristensen FB, Mäkelä M, Neikter SA, et al. European network for Health Technology Assessment, EUnetHTA: planning, development, and implementation of a sustainable European network for Health Technology Assessment. Int J Technol Assess Health Care. 2009;25(S2):107–116.
   PubMedGoogle Scholar
• EUnetHTA. [Internet]. [cited 2019 Jul 26]. Available from: https://www.eunethta.eu.
   Google Scholar
• Kristensen FB, Lampe K, Wild C, et al. The HTA Core Model®—10 years of developing an international framework to share multidimensional value assessment. Value Health. 2017 Feb 1;20(2):244–250.
   PubMed Web of Science ®Google Scholar
• Oyebode O, Garrett Z, George E, et al. Evidence requirements for reimbursement of pharmaceuticals across Europe. Int J Technol Assess Health Care. 2015;31(1–2):59–67.
   PubMed Web of Science ®Google Scholar
• Lampe K, Mäkelä M, Garrido MV, et al. The HTA core model: a novel method for producing and reporting health technology assessments. Int J Technol Assess Health Care. 2009 Dec;25(S2):9–20.
   PubMedGoogle Scholar
• EUnetHTA Core Model. [Internet]. [cited 2019 Jul 26]. Available from: https://www.eunethta.eu/hta-core-model/
   Google Scholar
• Chase D, Rosten C, Turner S, et al. Development of a toolkit and glossary to aid in the adaptation of HTA reports for use in different contexts. HTA Monogr. 2009;13(59).
   Google Scholar
• Turner S, Chase DL, Milne R, et al. The health technology assessment adaptation toolkit: description and use. Int J Technol Assess Health Care. 2009;25(S2):37–41.
   PubMed Web of Science ®Google Scholar
• Kleijnen S, Fathallah M, van der Linden MW, et al. Can a joint assessment provide relevant information for national/local relative effectiveness assessments? An in-depth comparison of pazopanib assessments. Value Health. 2015 1;18(5):663–672.
   PubMed Web of Science ®Google Scholar
• Welte R, Feenstra T, Jager H, et al. A decision chart for assessing and improving the transferability of economic evaluation results between countries. Pharmacoeconomics. 2004 1;22(13):857–876.
   PubMed Web of Science ®Google Scholar
• European Commission. Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU. [cited 2019 Jul 26]. Available from: https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/com2018_51final_en.pdf
   Google Scholar
• Vella Bonanno P, Bucsics A, Simoens S, et al. Proposal for a regulation on health technology assessment in Europe–opinions of policy makers, payers and academics from the field of HTA. Expert Rev Pharmacoecon Outcomes Res. 2019 4;19(3):251–261.
   PubMed Web of Science ®Google Scholar
• Dankó D Pragmatic value assessment system for Serbia – 5th SFUS Conference, 9 Oct 2015; Belgrade, Serbia. [cited 2019 Aug 12]. Available from: http://www.farmakoekonomija.org/files/presentations/vconf/20151009David%20Danko%20Novartis%20Serbia%20HTA%20system%20-%20Belgrade%20DankoD.pdf
   Google Scholar
• Dankó D, Molnár MP. Balanced assessment systems revisited. J Mark Access Health Policy. 2017 1;5(1):1355190.
   PubMedGoogle Scholar
• Lopert R, Ruiz F, Chalkidou K. Applying rapid ‘de-facto’ HTA in resource-limited settings: experience from Romania. Health Policy. 2013 1;112(3):202–208.
   PubMed Web of Science ®Google Scholar
• Lopert R, Lang DL, Hill SR, et al. Differential pricing of drugs: a role for cost-effectiveness analysis? Lancet. 2002 Jun 15;359(9323):2105–2107.
   PubMed Web of Science ®Google Scholar
• Lopert R Pharmaceutical expenditure in Serbia – scope for HTA. 4th International Conference EVIDENCE BASED DECISION MAKING IN CENTRAL EASTERN EUROPE HEALTH CARE 15-16 May 2014; Belgrade, Serbia. [cited 2019 Aug 12]. Available from: http://www.farmakoekonomija.org/presentations/ivconf/HTA%20in%20Serbia%20PPT%20-%20Lopert.pdf
   Google Scholar
• Radu CP, Pana BC, Furtunescu FL. Drug policy in Romania. Value Health Reg Issues. 2018;1(16):28–32.
   Google Scholar
• Radu CP, Chiriac ND, Pravat AM. The development of the Romanian scorecard HTA system. Value Health Reg Issues. 2016 1;10:41–47.
   PubMedGoogle Scholar
• Seiter A. A practical approach to pharmaceutical policy. Washington (DC), USA: World Bank Publications. 2010.
   Google Scholar
• Gyldmark M, Lampe K, Ruof J, et al. Is the EUnetHTA HTA Core Model® Fit for Purpose? Evaluation from an Industry Perspective. Int J Technol Assess Health Care. 2018;34(5):458–463.
   PubMed Web of Science ®Google Scholar
• Kleijnen S, Pasternack I, Van de Casteele M, et al. Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals. Int J Technol Assess Health Care. 2014;30(5):488–496.
   PubMed Web of Science ®Google Scholar
• EUnetHTA National Uptake and Case Studies. [Internet]. cited 2019 Jul 26. Available from: https://www.eunethta.eu/national-implementation/national-uptake-and-case-studies/
   Google Scholar
• Kristensen FB Mapping of HTA methodologies in EU and Norway. Directorate-General for Health and Food Safety, European Commission, Luxembourg. [Internet]. 2017 [cited 2020 May 20]. Available from: https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_methodologies_en.pdf. Accessed 10 August 2018
   Google Scholar
• Radaelli G, Lettieri E, Masella C, et al. Implementation of EUnetHTA core model® in Lombardia: the VTS framework. Int J Technol Assess Health Care. 2014;30(1):105–112.
   PubMed Web of Science ®Google Scholar
• Ducournau P, Irl C, Tatt I, et al. Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company. Int J Technol Assess Health Care. 2019;35(1):10–16.
   PubMed Web of Science ®Google Scholar
• Kõrge K, Berndt N, Hohmann J, et al. Evaluation of the HTA Core Model for national health technology assessment reports: comparative study and experiences from European countries. Int J Technol Assess Health Care. 2017;33(6):644–653.
   PubMed Web of Science ®Google Scholar
• Bilekova BK, Gavurova B, Rogalewicz V. Application of the HTA Core Model for complex evaluation of the effectiveness and quality of Radium-223 treatment in patients with metastatic castration resistant prostate cancer. Health Econ Rev. 2018;8(1):27.
   PubMedGoogle Scholar
• Inotai A, Németh B. Navigating Joint HTA, Procurement, and Fair Pricing: evidence-Based Insights and Practical Recommendations-A meeting report from ISPOR Regional Conference in Warsaw, 2019. Expert Rev Pharmacoecon Outcomes Res. 2019;19(4):379–381.
   PubMed Web of Science ®Google Scholar
• EUnetHTA. An analysis of HTA and reimbursement procedure in EUnetHTA partner countries: final report. [cited 2019 Jul 26]. Available from: https://www.eunethta.eu/wp-content/uploads/2018/02/WP7-Activity-1-Report.pdf
   Google Scholar
• Chiriac ND, Radu PC, Mazilu MA. Access gap to innovative treatments in Romania. Value Health. 2017;1(20):A690.
   Google Scholar
• Business Review. [Internet]. Bucharest, Romania: Bloc-Notes Media Network. 2016 [cited 2019 Jul 30]. Available from: http://business-review.eu/news/analysis-romanian-patients-facing-shortage-of-essential-drugs-products-missing-from-the-country-111707
   Google Scholar
• Balkan Insight. [Internet]. Belgrade, Serbia: Balkan Investigative Reporting Network; 2019 [cited 2019 Jul 30]. Available from: https://balkaninsight.com/2019/03/18/romania-faces-critical-shortage-of-childrens-cancer-drug/
   Google Scholar
• Tesar T, Obsitnik B, Kaló Z, et al. How Changes in Reimbursement Practices Influence the Financial Sustainability of Medicine Policy: lessons Learned from Slovakia. Front Pharmacol. 2019;10:664.
   PubMed Web of Science ®Google Scholar
• Löblová O, Csanádi M, Ozierański P, et al. Patterns of Alternative Access: unpacking the Slovak extraordinary drug reimbursement regime 2012-2016. Health Policy. 2019;123(8):713–720.
   PubMed Web of Science ®Google Scholar
• Kaló Z, Landa K, Doležal T, et al. Transferability of National Institute for Health and Clinical Excellence recommendations for pharmaceutical therapies in oncology to Central‐Eastern European countries. Eur J Cancer Care (Engl). 2012;21(4):442–449..
   PubMed Web of Science ®Google Scholar
• Inotai A, Petrova G, Vitezic D, et al. Benefits of investment into modern medicines in Central–Eastern European countries. Expert Rev Pharmacoecon Outcomes Res. 2014 1;14(1):71–79.
   PubMed Web of Science ®Google Scholar
• Csanádi M, Kaló Z, Prins CP, et al. The implications of external price referencing on pharmaceutical list prices in Europe. Health Policy Technol. 2018 1;7(3):243–250.
   Web of Science ®Google Scholar
• Klemp M, Frønsdal KB, Facey K. What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care. 2011;27(1):77–83.
   PubMed Web of Science ®Google Scholar
• Kanavos P, Ferrario A, Tafuri G, et al. Managing risk and uncertainty in health technology introduction: the role of managed entry agreements. Global Policy. 2017;8:84–92.
   Web of Science ®Google Scholar
• Vogler S, Zimmermann N, Leopold C, et al. Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev. 2011;4(2):69.
   PubMedGoogle Scholar
• Inotai A, Csanádi M, Vitezic D, et al. Policy practices to maximise social benefit from biosimilars. J Bioequivalence Bioavailability. 2017;9(4):467–472.
   Google Scholar
• Atanasijevic D Rare diseaes management in Serbia. ISPOR Europe Conference 2018. Barcelona, Spain. [cited 2019 Aug 12]. Available from: https://www.ispor.org/docs/default-source/presentations/93544pdf.pdf?sfvrsn=745ab712_0
   Google Scholar
• National Health Insurance Fund of Serbia. [Internet]. Financial Reports 2008-2019. [cited 2019 Aug 24]. Available from: https://www.rfzo.rs/index.php/finansije/finansijskiizvestaji
   Google Scholar
• Pauwels K, Huys I, Vogler S, et al. Managed entry agreements for oncology drugs: lessons from the European experience to inform the future. Front Pharmacol. 2017;4;8:171.
   Web of Science ®Google Scholar
• Németh B, Kaló Z. European cooperation in HTA implementation: the perspective of CEE countries. J Comp Effect Res. Published Online. 2020 Jun 5. Available from: https://www.futuremedicine.com/doi/abs/10.2217/cer-2020-0062?journalCode=cer
   Google Scholar
• Godman B, Bucsics A, Bonanno PV, et al. Barriers for access to new medicines: searching for the balance between rising costs and limited budgets. Front Public Health. 2018;6:328.
   PubMed Web of Science ®Google Scholar
• Smith N, Mitton C, Davidson A, et al. A politics of priority setting: ideas, interests and institutions in healthcare resource allocation. Pub Policy Adm. 2014;29(4):331–347.
   Web of Science ®Google Scholar
• Trowman R, Ollendorf DA, Sampietro-Colom L. Burning Issues in Health Technology Assessment and Policy Making: what’s Keeping Senior Health Technology Assessment Users and Producers up at Night? Int J Technol Assess Health Care. 2020 Mar;12:1–3.
   Google Scholar
• Löblová O, Trayanov T, Csanádi M, et al. The emerging social science literature on health technology assessment: a narrative review. Value Health. 2020 1;23(1):3–9.
   PubMed Web of Science ®Google Scholar