Role of centralized review processes for making reimbursement decisions on new health technologies in Europe

ClinicoEconomics and Outcomes Research

Volumn 3, Issue 1, 2011, Pages 117-186

  Stafinski, Tania ^a   Menon, Devidas ^b   Davis, Caroline ^a   McCabe, Christopher ^c  

^a Health Technology and Policy Unit   (Canada)

^b UNIVERSITY OF ALBERTA   (Canada)

^c UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

Centralized review; Europe; Health technologies; Reimbursement

Indexed keywords

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; COMPARATIVE EFFECTIVENESS; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; EUROPEAN UNION; EVIDENCE BASED MEDICINE; GOVERNMENT REGULATION; HEALTH CARE FINANCING; HEALTH CARE PLANNING; HEALTH CARE POLICY; HUMAN; INSTITUTIONAL REVIEW; INTEGRATED HEALTH CARE SYSTEM; MANDATORY PROGRAM; MEDICAL DECISION MAKING; MEDICAL TECHNOLOGY; PRACTICE GUIDELINE; PROSPECTIVE PRICING; QUALITY ADJUSTED LIFE YEAR; REIMBURSEMENT; RESOURCE MANAGEMENT; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW;

EID: 84855598266     PISSN: None     EISSN: 11786981     Source Type: Journal    
DOI: 10.2147/ceor.s14407     Document Type: Article

References (214)

1. Mitton C, Donaldson C. Health care priority setting: Principles, practice and challenges. Cost Eff Resour Alloc. 2004;2:3-8.
2. The health of Canadians: The federal role. Final report. Volume 6: Recommendations for reform. Ottawa, ON: Government of Canada, Standing Senate Committee on Social Affairs, 2002. Available from: http://www.parl.gc.ca/Content/SEN/Committee/372/soci/rep/repoct02 vol6-e.htm. Accessed July 22, 2011.
3. Wilking N, Jonsson B. A pan-European comparison regarding patient access to cancer drugs. Stockholm, Sweden: Karolinska Institutet, 2006. Available from: http://ki.se/content/1/c4/33/52/Cancer_Report.pdf. Accessed March 13, 2011.
4. Stafnski T, Menon D, Philippon DJ, McCabe C. Health technology funding decision-making processes around the world the same, yet different. Pharmacoeconomics. 2011;29:1-21.
5. Organization for Economic Cooperation and Development. Health Technologies and Decision Making. Paris, France: Organization for Economic Cooperation and Development; 2005.
6. von der Schulenburg J, Vauth C, Mittendorf T, Greiner W. Methods for determining cost-Benefit ratios for pharmaceuticals in Germany. Eur J Health Econ. 2007;8 Suppl 1:S5-S31.
7. Chalkidou K. Comparative effectiveness review within the UK's National Institute for Health and Clinical Excellence. Issue Brief (Commonw Fund). 2009. Available from: http://www.commonwealthfund.org//media/Files/Publications/Issue%20Brief/2009/Jul/ Chalkidou/1296_Chalkidou_UK_CER_issue_brief_717.pdf. Accessed July 18, 2011.
8. Institute for Quality and Effciency in Health Care. General methods. Cologne, Germany: Institute for Quality and Effciency in Health Care; 2008. Available from: http://www.iqwig.net/methods-procedures.926. en.html. Accessed July 15, 2011.
9. Van Wilder PB, Dupont AG. Reimbursement of medicines in Belgium: Role of evidence-based medicine. Acta Clin Belg. 2009;64: 120-128.
10. International Society for Pharmacoeconomics and Outcomes Research. Pharmacoeconomic guidelines around the world: Spain. Lawrenceville, NJ: International Society for Pharmaco-economics and Outcomes Research; 2010. Available from: http://www.ispor.org/PEguidelines/countrydet.asp?c=20&t=4. Accessed July 22, 2011.
11. Cleemput I, Van W P, Huybrechts M, Vrijens F. Belgian methodological guidelines for pharmacoeconomic evaluations: Toward standardization of drug reimbursement requests. Value Health. 2009;12:441-449.
12. Greiner W, Kuhlmann A, Schwarzbach C. An economic evaluation of the IQWiGs effcient frontier. Gesundheitsokonomie und Qualitatsmanagement. 2010;15:241-250. German.
13. Guide to the multiple technology appraisal process. London, UK: National Insitute for Health and Clinical Excellence; 2009. Available from: http://www.nice.org.uk/media/916/6B/Guide_to_the_MTA-proof_8-26-10-09.pdf. Accessed July 15, 2011.
14. Faulkner E, Matuszewski K, Niziol C. ISPOR global health care systems road map: Sweden. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/HTARoadMaps/Sweden.asp. Accessed July 15, 2011.
15. Guidelines for companies: The Swedish Pharmaceutical Benefits Board (LFN). Stockholm, Sweden: Swedish Pharmaceutical Benefits Board; 2008. Available from: http://www.tlv.se/Upload/English/Guidelines- for-Companies.pdf. Accessed July 15, 2011.
16. Le Pen C. Pricing and reimbursement policies in France: Current and future trends. In: Garau M, Mestre-Ferrandiz J, editors. European Medicines Pricing and Reimbursement. Milton Keynes, UK: Radcliffe Publishing; 2007. Available from: http://www.radcliffe-oxford.com/books/samplechapter/184X/ Garau_CHPT1-5e62f200rdz.pdf. Accessed July 22, 2011.
17. Cleemput I, van Wilder P V, Vrijens F, Huybrechts M, Ramaekers D. Guidelines for Pharmacoeconomic Evaluations in Belgium [KCE Reports 78C]. Brussels, Belgium: Belgian Health Care Knowledge Centre. 2008. Available from: www.kce.fgov.be/Download. aspx?ID=1081. Accessed July 15, 2011.
18. Nasser M, Sawicki P. Institute for quality and efficiency in health care: Germany. Issue Brief (Commonw Fund). 2009;57:1-12. Available from: http://www.commonwealthfund.org//media/Files/Publications/ Issue%20Brief/2009/Jul/Chalkidou/1294_Nasser_CER_Germany_ issue_brief_724.pdf. Accessed July 15, 2011.
19. The Federal Joint Committee: About us. Berlin, Germany: Gemeinsamer Bundesausschuss, Institut fur Qualitat und Wirtschaftlichkeit in Gesund-heitswesen; 2010. Available from: http://www.g-ba.de/downloads/17-98-2804/2010-01-01-Faltblatt-GBA_engl.pdf. Accessed July 15, 2011.
20. Rochaix L, Xerri B. National Authority for Health: France. Issue Brief (Commonw Fund). 2009;58. New York: The Commonwealth Fund; 2009. Available from: http://www.commonwealthfund.org/Content/ Publications/Issue-Briefs/2009/Jul/National-Authority-for-Health- France.aspx. Accessed July 15, 2011.
21. Habl C, Antony K, Arts D, et al. Surveying, assessing and analysing the pharmaceutical sector in the 25 EU member states: Country profles. Vienna: European Commission; Osterreichisches Bundesinstitut fur Gesundheitswesen; 2006. Available from: http://ec.europa.eu/competi tion/mergers/studies_reports/oebig.pdf. Accessed July 15, 2011.
22. Chicoye A, Levesque K. ISPOR global health care systems road map: France - Medical devices. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2010. Available from: http://www.ispor.org/htaroadmaps/FranceMD.asp. July 15, 2011.
23. Sermet C, Andrieu V, Godman B, Van GE, Haycox A, Reynier J P. Ongoing pharmaceutical reforms in France: Implications for key stakeholder groups. Appl Health Econ Health Policy. 2010;8:7-24.
24. General methods for the assessment of the relation of Benefits to costs. Version 1.0. Cologne, Germany: Institute for Quality and Effciency in Health Care; 2009. Available from: http://www.iqwig.de/download/General_Methods_for_the_Assessment_of_the_Relation_of_ Benefits_to_Costs.pdf. Accessed July 15, 2011.
25. Criteria for ranking therapeutic innovation of new drugs and elements for supplementing the dossier for admission to the reimbursement system. Rome, Italy: AIFA - Italian Medicines Agency. Working Group on Innovative Drugs; 2007. Available from: http://www.agenziafarmaco. gov.it/allegati/integral_document.pdf. Accessed July 15, 2011.
26. Sorenson C. Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison. Issue Brief (Commonw Fund). 2010;91. New York: The Commonwealth Fund; 2010. Available from: http://www.commonwealthfund.org//media/Files/Publications/Issue%20Brief/2010/Jul/1420_Sorenson_Comp_Effect_intl_ib_71.pdf. Accessed July 15, 2011.
27. Lo Scalzo A, Donatini A, Orzella L, Cicchetti A, Profli S, Maresso A. Italy: Health system review [Health Systems in Transition]. Copenhagen, Denmark: European Observatory on Health Care Systems, World Health Organization Regional Offce for Europe; 2009. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0006/87225/E93666. pdf. Accessed July 15, 2011.
28. All Wales Medicines Strategy Group. Vale of Glamorgan (Wales): Welsh Medicines Partnership; 2010. Available from: http://www.wales.nhs.uk/ sites3/home.cfm?orgid=371. Accessed July 15, 2011.
29. Guide to the single technology appraisal (STA) process. London, UK: National Insitute for Health and Clinical Excellence (NICE); 2009. Available from: http://www.nice.org.uk/media/913/06/Guide_to_the_ STA-proof_6-26-10-09.pdf. Accessed July 15, 2011.
30. Guidance to manufacturers for completion of new product assessment form (NPAF). Revised June 2010. Glasgow, Scotland: Scottish Medicines Consortium; 2010. Available from: http://www.scottishmedicines.org.uk/files/submissionprocess/New_Product_Assessment_Form_ NPAF_Guidance_Notes_updated_February_2011_Final.doc. Accessed July 22, 2011.
31. Zuidberg C, editor. Pharmaceutical Pricing and Reimbursement Information. The pharmaceutical system of the Netherlands. Vienna, Austria: 2010. Available from: http://ppri.oebig.at/Downloads/Publications/The%20pharmaceutical%20system%20of%20the%20Netherlands_FINAL.pdf. Accessed July 15, 2011.
32. Daniels N, Sabin JE. Last chance therapies and managed care. Pluralism, fair procedures, and legitimacy. Hastings Cent Rep. 1998;28:27-41.
33. Sjogren E. Deciding subsidy for pharmaceuticals based on ambiguous evidence. J Health Organ Manag. 2008;22:368-383.
34. Pharmaceutical pricing and reimbursement information: Norway. Vienna, Austria: Pharmaceutical Pricing and Reimbursement Information; 2008. Available from: http://ppri.oebig.at/Downloads/Results/ Norway_PPRI_2008.pdf. Accessed July 15, 2011.
35. Sorenson C, Drummond M, Kanavos P. Ensuring value for money in health care: the role of health technology assessment in the European Union [European Observatory on Health Systems and Policies. Observatory Studies Series No. 11]. Copenhagen, Denmark: World Health Organization Regional Office for Europe; 2008. Available from: http:// www.euro.who.int/__data/assets/pdf_file/0011/98291/E91271.pdf. Accessed July 15, 2011.
36. Teixeira I, Agostinho I. Pharmaceutical pricing and reimbursement information: Lisbon, Portugal: Pharmaceutical Pricing and Reimbursement Information; 2008. Available from: http://www.infarmed.pt/portal/page/portal/INFARMED/MONITORIZACAO_DO_MERCADO/OBSERVATORIO/Projectos_Internacionais/Portugal_PPRI_2008.pdf. Accessed July 15, 2011.
37. Appraising life-extending, end of life treatments. London, UK: National Institute for Health and Clinical Excellence (NICE); 2009. Available from: http://www.nice.org.uk/aboutnice/howwework/devnicetech/endofifetreatments.jsp. Accessed July 15, 2011.
38. Guidelines for application for general reimbursement of medicinal products. Copenhagen, Denmark: The Danish Medicines Agency; 2008. Available from: http://laegemiddelstyrelsen.dk//media/31C93DCD939A43FBB9E20070B5548337.ashx. Accessed July 22, 2011.
39. 2000/030 summary of the appeals process. London, UK: National Insitute for Health and Clinical Excellence (NICE); 2000. Available from: http://www.nice.org.uk/newsroom/pressreleases/pressrelease-archive/pressreleases2000/2000_030_summary_of_the_appeals_pro-cess.jsp. Accessed January 7, 2010.
40. Stafnski T, McCabe CJ, Menon D. Funding the unfundable: Mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconom-ics. 2010;28:113-142.
41. Adamski J, Godman B, Oferska-Sujkowska G, et al. Risk sharing arrangements for pharmaceuticals: Potential considerations and recommendations for European payers. BMC Health Serv Res. 2010;10:153. Available from: http://www.biomedcentral.com/1472-6963/10/153. Accessed July 15, 2011.
42. Garner S. How does NICE value innovation? Drug Dev Res. 2010;71:449-456.
43. Grandfls N. Drug price setting and regulation in France [Working paper no. 16]. Paris, France: Institut de recherche et documentation en economie de la sante (IRDES); 2008. Available from: http://www.irdes.fr/EspaceAnglais/Publications/WorkingPapers/DT16DrugPriceSet-tingRegulationFrance.pdf. Accessed July 15, 2011.
44. Barros P P, de Almeida Simoes J, Allin S, Mossialos E, editors. Portugal: Health system review [Health Systems in Transition 2007;9(5)]. Copenhagen, Denmark: World Health Organization Regional Offce for Europe. European Observatory on Health Systems and Policies; 2007. Available from: http://www.euro.who.int/data/assets/pdf_ fle/0004/107842/E90670.pdf. Accessed July 15, 2011.
45. Briggs A, Ritchie K, Fenwick E, Chalkidou K, Littlejohns P. Access with evidence development in the UK: Past experience, current initiatives and future potential. Pharmacoeconomics. 2010;28: 163-170.
46. The Danish Medicines Agency: Reimbursement. Copenhagen, Denmark: The Danish Medicines Agency; 2010. Available from: http://laegemiddelstyrelsen.dk/en/topics/statistics,-prices-and-reimbursement/ reimbursement-of-medicines. Accessed July 22, 2011.
47. Tonarelli L. Italy: Pioneering pay for performance in the age of austerity. InPharm News(InPharm com) 2011. Available from: http://www.inpharm.com/news/110104/italy-drug-price-cuts. Accessed July 22, 2011.
48. Towse A. Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong? Br J Clin Pharmacol. 2010;70:360-366.
49. Le Polain M, Franken M, Koopmanschap M, Cleemput I. Drug reimbursement systems: International comparison and policy recommendations. Brussels, Belgium: Belgian Health Care Knowledge Centre; 2010. Available from: http://www.kce.fgov.be/ index_en.aspx?SGREF=5211&CREF=18732. Accessed July 22, 2011.
50. Guidelines on procedure for reassessment of reimbursement status. Copenhagen, Denmark: Danish Medicines Agency; 2005. Available from: http://laegemiddelstyrelsen.dk/en/topics/statistics,-prices-and-reimbursement/reimbursement-of-medicines/general-reimbursement/reassessment-of-re-imbursement-status-for-l-products/guidelines/guidelines-on-procedure-for-reassessment-ent-status. Accessed July 22, 2011.
51. Welcome to TLV [the Dental and Pharmaceutical Benefits Agency]. Stockholm, Sweden: Dental and Pharmaceutical Benefits Agency; 2008. Available from: http://www.tlv.se/in-english-old/in-english/. Accessed July 22, 2011.
52. McLaughlin N. Of problems and solutions. Issues with variable-rate bonds, medical errors led our recent coverage. Mod Healthc. 2009;39:18.
53. McCabe CJ, Stafnski T, Edlin R, Menon D. Access with evidence development schemes: A framework for description and evaluation. Pharmacoeconomics. 2010;28:143-152.
54. Menon D, McCabe CJ, Stafnski T, Edlin R. Principles of design of access with evidence development approaches: A consensus statement from the Banff Summit. Pharmacoeconomics. 2010;28:109-111.
55. Buchholz P. ISPOR global health care systems road map: Austria - Pharmaceuticals. Lawrenceville, NJ: International Society for Pharmaco-economics and Outcomes Research; 2009. Available from: http://www. ispor.org/htaroadmaps/Austria.asp. Accessed July 23, 2011.
56. Godman B, Bucsics A, Burkhardt T, Haycox A, Seyfried H, Wieninger P. Insight into recent reforms and initiatives in Austria: Implications for key stakeholders. Expert Rev Pharmacoecon Outcomes Res. 2008;8:357-371.
57. Wild C. Austria: History of health technology assessment during the past 20 years. Int J Technol Assess Health Care. 2009;25 Suppl 1:74-81.
58. Pharmaceutical pricing and reimbursement information: Austria. [Pharmaceutical Pricing and Reimbursement Information]. Vienna, Austria: European Commission, Health and Consumer Protection Directorate-General and Austrian Ministry of Health, Family and Youth; 2008. Available from: http://ppri.oebig.at/Downloads/Results/ Austria_PPRI_2008_Englih_Version.pdf. Accessed July 23, 2011.
59. Hofmarcher MM, Rack HM, Rohrling G. Austria: Health system review [Health Systems in Transition]. Copenhagen, Denmark: European Observatory on Health Care Systems, World Health Organization Regional Offce for Europe; 2006. Available from: http://www.euro. who.int/__data/assets/pdf_fle/0009/96435/E89021.pdf. Accessed July 23, 2011.
60. Van Wilder PB, Dupont AG. Reimbursement of medicines in Belgium: Role of evidence-based medicine. Acta Clin Belg. 2009;64:120-128.
61. Cleemput I, van W P, Huybrechts M, Vrijens F. Belgian methodological guidelines for pharmacoeconomic evaluations: Toward standardization of drug reimbursement requests. Value Health. 2009;12: 441-449.
62. Belgium. In: Policies for rare diseases and orphan drugs [KCE reports 112C]. Brussels, Belgium: Belgian Health Care Knowledge Centre; 2009. Available from: http://www.kce.fgov.be/Download. aspx?ID=2161. Accessed July 23, 2011.
63. Arrete royal portant modifcation de l'arrete royal du 3 juillet 1996 portant execution de la loi relative a l'assurance obligatoire soins de sante et indemnites, coordonnee le 14 juillet 1994. [Brussels]: Ministere des Affaires Sociales de la Sante Publique et de l'Environnement; 2001. Available from: http://www.inami.fgov.be/drug/fr/drugs/reglementation/ legal-texts/pdf/arkb20011221.pdf. Accessed July 23, 2011.
64. Corens D. Belgium: Health system review [Health Systems in Transition 2007;9(2)]. Copenhagen, Denmark: World Health Organization Regional Offce for Europe. European Observatory on Health Care Systems; 2007. Available from: http://www.euro.who.int/__data/assets/ pdf_fle/0007/96442/E90059.pdf. Accessed July 23, 2011.
65. Prices and reimbursements of medicinal products and foods for special medical purposes. Prague, Czechoslovakia: State Institute for Drug Control; 2010. Available from: http://www.sukl.eu/sukl/prices-and-reimbursements-of-medicinal-products-and-foods. Accessed July 23, 2011.
66. Bryndova L, Pavlokova K, Roubal T, Rokosova M, Gaskins M. Czech Republic: Health system review [Health Systems in Transition 2009;11(1)]. Copenhagen, Denmark: World Health Organization. Regional Offce for Europe. European Observatory on Health Systems and Policies; 2009. Available from: http://www.euro.who.int/__data/assets/pdf_file/0010/97633/E92968.pdf. Accessed July 23, 2011.
67. Praznovcova L, Suchopar J, Wertheimer AI. Drug policy in the Czech Republic. In: Wertheimer AI, Smith MC, editors. International Drug Regulatory Mechanisms. Binghamton, NY: Haworth Press; 2003.
68. Pricing and reimbursement in Denmark. Copenhagen, Denmark: The Danish Association of the Pharmaceutical Industry; 2007. Available from: http://parno1.ipapercms.dk/LIF/Notater/Pricingandreimburse-mentinDenmark/. Accessed July 23, 2011.
69. Strandberg-Larsen M, Knudsen MS. ISPOR Global Health Care Systems Road Map: Denmark. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/htaroadmaps/Denmark.asp. Accessed July 23, 2011.
70. High quality care for all. NHS next stage review final report. London, UK: Department of Health; 2008. Available from: http://www.dh.gov. uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_085828.pdf. Accessed July 23, 2011.
71. Pedersen KM, Christiansen T, Bech M. The Danish health care system: Evolution - not revolution - in a decentralized system. Health Econ. 2005;14 Suppl 1:S41-S57.
72. Kanavos P, Vandoros S, Habicht J, de Joncheere K. Review of the Estonian pharmaceutical sector: towards the development of a national medicines policy. Copenhagen, Denmark: World Health Organization Regional Offce for Europe; 2009. Available from: http://www.euro.who. int/__data/assets/pdf_fle/0004/96448/E93049.pdf. Accessed July 15, 2011.
73. Decree of the Ministry of Social Affairs and Health on the priced services of the Pharmaceuticals Pricing Board. Helsinki, Finland: Finland Ministry of Social Affairs and Health; 2010. Available from: http://www.stm. f/c/document_library/get_fle?folderId=71837&name=DLFE-14601. pdf. Accessed July 23, 2011.
74. Decree of the Ministry of Social Affairs and Health on applications and price notifcations made to the Pharmaceuticals Pricing Board. Helsinki, Finland: Finland Ministry of Social Affairs and Health; 2009. Available from: http://www.ispor.org/PEguidelines/source/Guidelines-inFinland_EnglishVersion.pdf. Accessed July 23, 2011.
75. Pharmaceuticals Pricing Board: The expert group of the Pharmaceuticals Pricing Board. Helsinki, Finland: Ministry of Social Affairs and Health; 2010. Available from: http://www.stm.f/en/ministry/boards/ pharmaboard/expert. Accessed July 23, 2011.
76. Ministry of Social Affairs and Health, Finland. Decree of the Ministry of Social Affairs and Health on applications and price notifcations made to the Pharmaceuticals Pricing Board. Helsinki, Finland: Ministry of Social Affairs and Health, Finland; 2009. Available from: http://www.ispor.org/PEguidelines/source/GuidelinesinFinland_EnglishVersion.pdf. Accessed July 23, 2011.
77. Becker C. Few details on DRG revamp. The CMS may reveal portions of new system in April. Modern Healthc. 2006;11:12.
78. Falissard B, Izard V, Xerri B, Bouvenot G, Meyer F, Degos L. Relative effectiveness assessment of listed drugs (REAL): A new method for an early comparison of the effectiveness of approved health technologies. Int J Technol Assess Health Care. 2010;26:124-130.
79. Weill C, Banta D. Development of health technology assessment in France. Int J Technol Assess Health Care. 2009;25 Suppl 1:108-111.
80. Chicoye A, Chhabra A. ISPOR global health care systems road map: France - Pharmaceuticals. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research (ISPOR); 2009. Available from: http://www.ispor.org/htaroadmaps/France.asp. Accessed July 23, 2011.
81. Pharmaceutical pricing and reimbursement information: Germany. Vienna, Austria: Pharmaceutical Pricing and Reimbursement Information; 2008. Available from: http://ppri.oebig.at/Downloads/Results/ Germany_PPRI_2008.pdf. Accessed July 23, 2011.
82. Paris V, Docteur E. Pharmaceutical pricing and reimbursement policies in Germany [OECD Health Working Papers No. 39]. Paris, France: Organisation for Economic Co-operation and Development; 2008. Available from: http://www.oecd.org/dataoecd/6/57/41586814.pdf. Accessed July 23, 2011.
83. Fricke FU, Dauben H P. Health technology assessment: A perspective from Germany. Value Health. 2009;12 Suppl 2:S20-S27.
84. Sorenson C. The role of HTA in coverage and pricing decisions: A crosscountry comparison. Euro Observer: The Health Policy Bulletin of the European Observatory on Health Systems and Policies. 2009;11:1-12. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0019/80335/EuroOb-server_spring2009.pdf. Accessed July 23, 2011.
85. Pricing [Greece]. In: Surveying, assessing and analysing the pharmaceutical sector in the 25 EU member states. Luxembourg: Osterreichisches Bundesinstitut fur Gesundheitswesen for the European Commission; 2006. Available from: http://ec.europa.eu/competition/mergers/stud-ies_reports/oebig.pdf. Accessed July 23, 2011.
86. National Organization for Medicines. Athens, Greece: National Organization for Medicines; 2011. Available from: http://www.eof.gr/web/ guest/structure. Accessed July 23, 2011.
87. International Society for Pharmacoeconomics and Outcomes Research global health care systems road map: Greece. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2008. Available from: http://www.ispor.org/HTARoadMaps/Greece.asp. Accessed July 23, 2011.
88. Gaal P. Health care systems in transition: Hungary. Brussels, Belgium: European Observatory on Health Care Systems; 2004. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0008/80783/E84926.pdf. Accessed July 23, 2011.
89. Gulacsi L, David T, Dozsa C. Pricing and reimbursement of drugs and medical devices in Hungary. Eur J Health Econ. 2002;3:271-278.
90. Gulacsi L, Brodszky V, Pentek M, Varga S, Vas G, Boncz I. History of health technology assessment in Hungary. Int J Technol Assess Health Care. 2009;25 Suppl 1:120-126.
91. Tilson L, O'Leary A, Usher C, Barry M. Pharmacoeconomic evaluation in Ireland: A review of the process. Pharmacoeconomics. 2010;28:307-322.
92. Barry M. Economies in drug usage in the Irish healthcare setting. Dublin, Ireland: Department of Health and Children; 2009. Available from: http://www.dohc.ie/publications/pdf/economies_drug_usage.pdf?direct=1. Accessed July 23, 2011.
93. Coughlan JJ, Fortescue-Webb D, Heaney R, Judge G, Tilson L, Barry M. ISPOR global health care systems road map: Ireland - Pharmaceutical. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/HTARoadMaps/Ireland.asp. Accessed July 23, 2011.
94. Garattini L. Pricing and reimbursement policies in Italy: Current and future trends. In: Garau M, Mestre-Ferrandiz J, editors. European Medicines Pricing and Reimbursement. Milton Keynes, UK: Radcliffe Publishing; 2007. Available from: http://www.radcliffe-oxford.com/books/samplechapter/184X/Garau_CHPT4-65cf3e00rdz.pdf. Accessed July 23, 2011.
95. Folino-Gallo P, Montilla S, Bruzzone M, Martini N. Pricing and reimbursement of pharmaceuticals in Italy. Eur J Health Econ. 2008;9:305-310.
96. Impact of HTA on policy: Examples from INAHTA members. Stockholm, Sweden: International Network of Agencies for Health Technology Assessment; 2001. Available from: http://www.inahta.org/upload/About%20INAHTA/Survey_HTA_Policy_Oct2001.pdf. Accessed July 23, 2011.
97. Fattore G, Jommi C. The last decade of Italian pharmaceutical policy: Instability or consolidation? Pharmacoeconomics. 2008;26:5-15.
98. Johnsen JR. Health systems in transition: Norway. Copenhagen: World Health Organization Regional Offce for Europe on behalf of the European Observatory on Health Systems and Policies; 2006. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0005/95144/E88821.pdf. Accessed July 23, 2011.
99. Kuszewski K, Gericke C. Health systems in transition: Poland [Health Systems in Transition 2005;7(5)]. Brussels, Belgium: European Observatory on Health Care Systems; 2005. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0011/95159/E88670.pdf. Accessed July 23, 2011.
100. ISPOR global health care systems road map: Poland - reimbursement process. Lawrenceville, NJ: International Society for Pharmacoeco-nomics and Outcomes Research; 2008. Available from: http://www.ispor.org/HTARoadMaps/Poland.asp. Accessed July 23, 2011.
101. Alves da Silva E, Gouveia Pinto C, Sampaio C, Pereira JA, Drummond M, Trindade R. Guidelines for economic drug evaluation studies. Lisbon, Portugal: Autoridade Nacional do Medicamento e Produtos de Saude; 1998. Available from: http://www.infarmed.pt/portal/page/portal/INFARMED/ ENGLISH/PCAEC04_vering.pdf. Accessed July 23, 2011.
102. Mazag J, Segec A. Pharmaceutical pricing and reimbursement information: Slovakia [Pharmaceutical Pricing and Reimbursement Information]. Vienna, Austria. European Commission, Health and Consumer Protection Directorate-General; Austrian Ministry of Health, Family and Youth; 2007. Available from: http://ppri.oebig.at/Downloads/ Results/Slovakia_PPRI_2007.pdf. Accessed July 23, 2011.
103. Hall PS, McCabe C, Brown JM, Cameron DA. Health economics in drug development: Effcient research to inform healthcare funding decisions. Eur J Cancer. 2010;46:2674-2680.
104. Kohli H, Tannahill A. NICE guidance in the Scottish context. Scott Med J. 2009;54:35-38. Available from: http://www.smj.org.uk/0209/pdfs/Original%20Kohli%20and%20Tannahill.pdf. Accessed July 23, 2011.
105. Tomek D, Psenkova M, Hanzelova M. Reimbursement of innovative drugs in Slovakia - pharmacoeconomics of agomelatin in depression. Value Health. 2009;12:A364-A365.
106. Kalo Z, Docteur E, Moise P. Pharmaceutical pricing and reimbursement policies in Slovakia [OECD Health Working Paper No. 31]. Paris, France: Organisation for Economic Co-operation and Development; 2008. Available from: http://www.oecd.org/dataoecd/14/40/40177050.pdf. Accessed July 23, 2011.
107. Szalay T, Pazitny P, Szalayova A, et al. Slovakia: Health system review [Health Systems in Transition 2011;13(2)]. Copenhagen, Denmark: World Health Organisation Regional Offce for Europe. European Observatory on Health Systems and Policies.; 2011. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0004/140593/e94972.pdf. Accessed July 23, 2011.
108. Vogler S, Espin J, Habl C. Pharmaceutical pricing and reimbursement information (PPRI) - new PPRI analysis including Spain. Pharm Pol Law. 2009;11:213-234. Available from: http://ppri.oebig.at/Downloads/Publications/Article_PPRI_Spain_PharmaceuticalPolicyAndLaw_2009.pdf. Accessed July 23, 2011.
109. Persson U, Willis M, Odegaard K. A case study of ex ante, value-based price and reimbursement decision-making: TLV and rimonabant in Sweden. Eur J Health Econ. 2010;11:195-203.
110. Moise P, Docteur E. Pharmaceutical pricing and reimbursement policies in Sweden [OECD Health Working Papers, No. 28]. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2007. Available from: http://www.oecd.org/dataoecd/63/17/40699881.pdf. Accessed July 23, 2011.
111. Pharmaceutical Pricing and Reimbursement Information: Sweden. Vienna, Austria: PPRI - Pharmaceutical Pricing and Reimbursement Information; 2007. Available from: http://ppri.oebig.at/Downloads/Results/Sweden_PPRI_2007.pdf. Accessed July 23, 2011.
112. Erntoft S. ISPOR global health care systems road map: Sweden - pharmaceutical. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/HTARoadMaps/Sweden.asp. Accessed July 23, 2011.
113. Gress S, Niebuhr D, May W, Wasem J. Reform of prescription drug reimbursement and pricing in the German social health insurance market: A comparison of three scenarios. Pharmacoeconomics. 2007;25:443-454.
114. Paris V, Docteur E. Pharmaceutical pricing and reimbursement policies in Switzerland [OECD Health Working Papers, No. 27]. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2007. Available from: http://www.oecd.org/dataoecd/54/42/38868953.pdf. Accessed July 23, 2011.
115. European Observatory on Health Care Systems. Health care systems in transition: Switzerland. Brussels, Belgium: European Observatory on Health Care Systems; 2000. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0003/96411/E68670.pdf. Accessed July 23, 2011.
116. van der Meijden C, Grahlmann C. Dutch assessment procedures for the reimbursement of outpatient medicines. Diemen, The Netherlands: Ministry of Health, Welfare and Sport/College voor zorgverzek-eringen; 2010. Available from: http://www.cvz.nl/binaries/live/cvzinternet/hst_content/nl/documenten/rubriek+zorgpakket/cfh/assessment-outpatient-medicines.pdf. Accessed July 23, 2011.
117. Stolk EA, de Bont A, van Halteren AR, Bijlmer RJ, Poley MJ. Role of health technology assessment in shaping the Benefits package in The Netherlands. Expert Rev Pharmacoecon Outcomes Res. 2009;9:85-94.
118. ISPOR global health care systems road map: The Netherlands. Law-renceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2007. Available from: http://www.ispor.org/HTARoadMaps/Netherlands.asp. Accessed July 23, 2011.
119. Heemstra HE. Variations in access and use of orphan drugs among EU member states. EJHP Practice. 2010;16:25-27. Available from: http://www.eahp.eu/EJHP/EJHP-Practice/Issue-4-2010/Cover-Story/Variations-in-access-and-use-of-orphan-drugs-among-EU-Member-States. Accessed July 23, 2011.
120. ISPOR global health care systems road map: United Kingdom (England and Wales) - reimbursement process. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2008. Available from: http://www.ispor.org/htaroadmaps/UK.asp. Accessed July 23, 2011.
121. The Danish Health Act/legislation. Copenhagen, Denmark: Danish Medicines Agency; 2010. Available from: http://laegemiddelstyrelsen.dk/en/service-menu/legislation/the-danish-health-act. Accessed July 23, 2011.
122. Mossialos E, Srivastava D. Pharmaceutical policies in Finland: Challenges and opportunities [Observatory Studies Series No. 10]. Copenhagen, Denmark: World Health Organisation. Regional Offce for Europe on behalf of the European Observatory on Health Systems and Policies; 2008. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0020/80651/E91239.pdf. Accessed July 23, 2011.
123. Perleth M, Gibis B, Gohlen B. A short history of health technology assessment in Germany. Int J Technol Assess Health Care. 2009; 25 Suppl 1:112-119.
124. Holtorf A P, Matuszewski K, Nuijten M, Vauth C. ISPOR global health care systems road map: Germany. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/htaroadmaps/Germany.asp. Accessed July 23, 2011.
125. Tilson L, Barry M. Recent developments in pharmacoeconomic evaluation in Ireland. Expert Rev Pharmacoecon Outcomes Res. 2010;10:221-224.
126. Pricing and reimbursement. Rome, Italy: Agenzia Italiana del Farmaco; 2010. Available from: http://www.agenziafarmaco.it/en/content/pricing-and-reimbursement. Accessed July 23, 2011.
127. Agencja Oceny Technologii Medycznych. Warsaw, Poland: Agencja Oceny Technologii Medycznych; 2011. Available from: http://www. aotm.gov.pl/.Accessed July 23, 2011.
128. Scottish Medicines Consortium. Scottish Medicines Consortium; 2010. Available from: http://www.scottishmedicines.org.uk/smc/22.html. Accessed July 23, 2011.
129. Wilking N, Jonsson B. A pan-European comparison regarding patient access to cancer drugs. Stockholm, Sweden: Karolinska Institutet; 2006. Available from: http://ki.se/content/1/c4/33/52/Cancer_Report.pdf. Accessed July 23, 2011.
130. Informace k pravidelne revizi uhrad. Prague, Czechoslovakia: Statni Ustav pro Kontrolu Leciv (SUKL); 2009. Available from: http://www.sukl.cz/leciva/informace-k-pravidelne-revizi-uhrad. Accessed July 23, 2011.
131. Tomek D, Bielik J. Legislative aspects of health technology assessment in Slovakia. Value Health. 2009;12:A87.
132. ISPOR global health care systems road map: Spain - Pharmaceutical. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2009. Available from: http://www.ispor.org/HTARoadMaps/Spain.asp. Accessed July 23, 2011.
133. Pharmaceutical Pricing and Reimbursement Information: Sweden. Vienna, Austria: Pharmaceutical Pricing and Reimbursement Information; 2007. Available from: http://ppri.oebig.at/Downloads/Results/Sweden_PPRI_2007.pdf. Accessed July 23, 2011.
134. Working guidelines for the pharmaceutical reimbursement review. Stockholm, Sweden: Tandvards-Och Lakemedelsformansverket (TLV)/the Dental and Pharmaceutical Benefits Agency [formerly the Swedish Pharmaceutical Benefits Board]; 2008. Available from: http://www.tlv.se/Upload/Genomgangen/guidelines-pharmaceutical-reimbursement.pdf. Accessed July 23, 2011.
135. Reimbursement review. Stockholm, Sweden: Tandvards Och Lakemedelsformansverket (TLV) [The Swedish Pharmaceutical Benefits Board]; 2009. Available from: http://www.tlv.se/in-english/reimbursement-review/. Accessed July 23, 2011.
136. Glenngard AH, Hjalte F, Svensson M, Anell A, Bankauskaite V. Health systems in transition: Sweden. Copenhagen, Denmark: World Health Organisation Regional Offce for Europe on behalf of the European Observatory on Health Systems and Policies; 2005. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0010/96409/E88669.pdf. Accessed July 23, 2011.
137. Gress S, Niebuhr D, Rothgang H, Wasem J. Criteria and procedures for determining benefit packages in health care. A comparative perspective. Health Policy. 2005;73:78-91.
138. Dolezal T. Pricing and reimbursement in Czech Republicroad to HTA? Lawrenceville, NJ: International Society for Pharmacoeco-nomics and Outcomes Research; 2008. Available from: http://www.google.ca/url?sa=t&source=web&cd=2&ved=0CBwQFjAB&url=ht tp%3A%2F%2FError! Hyperlink reference notvalid.10%2F02.ppt&ei=QgTkTfnFDqvQiAL0l7WoBg&usg=AFQjCNEcRD0RWYovvKcnIEV-017m4bG0ow. Accessed July 23,2011.
139. Pharmacoeconomic analysis. Tallinn, Estonia: Estonian Health Insurance Fund; 2002. Available from: http://www.haigekassa.ee/eng/health-insurance-in-estonia/medicinal-products/pharmacoeconomic-analysis. Accessed July 23, 2011.
140. Aaviskoo A, Saluse J, Palm E. Scientifc community leads HTA development [Health Policy Monitor]. 2009. Available from: http://www.hpm.org/survey/ee/a14/2. Accessed July 23, 2011.
141. Daniels N, Sabin J. Limits to health care: Fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philos Public Aff. 1997;26:303-350.
142. Bekkering GE, Kleijnen J. Procedures and methods of Benefit assessments for medicines in Germany. Eur J Health Econ. 2008;9 Suppl 1: 5-29.
143. Martikainen J, Rajaniemi S. Drug reimbursement systems in EU member states, Iceland and Norway: France. In. 54. Helsinki: The Social Insurance Institution; 2002. Available from: http://www.kela.f/in/internet/english.nsf/NET/050303135141PN. Accessed July 23, 2011.
144. Paris V, Docteur E. Pharmaceutical pricing and reimbursement policies in Germany [OECD Health Working Papers, No. 39]. Paris: Organisation for Economic Co-operation and Development (OECD); 2008. Available from: http://www.oecd.org/dataoecd/6/57/41586814.pdf. Accessed July 23, 2011.
145. Yfantopoulos J. Pharmaceutical pricing and reimbursement reforms in Greece. Eur J Health Econ. 2008;9:87-97.
146. Irish healthcare technology assessment guidelines. version 1. Dublin, Ireland: National Centre for Pharmacoeconomics (NCPE) in Ireland; 2000. Available from: http://www.ncpe.ie/contact.php. Accessed July 23, 2011.
147. Guidelines for the economic evaluation of health technologies in Ireland. Dublin, Ireland: Health Information and Quality Authority; 2010. Available from: http://www.hiqa.ie/system/fles/HTA_Economic_Guidelines_2010.pdf. Accessed July 23, 2011.
148. Pharmacoeconomic guidelines around the world: Italy. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2010. Available from: http://www.ispor.org/PEguidelines/countrydet.asp?c=13&t=4. Accessed July 23, 2011.
149. Application standard for acceptance to the drug reimbursement scheme; pursuant to Article 9 of the regulation on reimbursement of crucial drug costs. [Oslo]: Statens legemiddelverk/Norwegian Medicines Agency; 2005. Available from: http://www.legemiddelverket.no/templates/InterPage_25665.aspx. Accessed July 23, 2011.
150. Norwegian guidelines for pharmacoeconomic analysis in connection with applications for reimbursement. Oslo, Norway: Statens legemid-delverk/Norwegian Medicines Agency; 2005. Available from: http://www.legemiddelverket.no/templates/InterPage_25644.aspx. Accessed July 23, 2011.
151. Polish guidelines for conducting pharmacoeconomic evaluations. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2010. Available from: http://www.ispor.org/PEguidelines/source/Polish-Guidelines-for-Conducting-Pharma coeconomic-Evaluations_2010.pdf. Accessed July 23, 2011.
152. Pharmacoeconomic guidelines around the world: Slovak Republic. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2011. Available from: http://www.ispor.org/peguidelines/countrydet.asp?c=35&t=1. Accessed July 23, 2011.
153. General guidelines for economic evaluations from the Pharmaceutical Benefits Board (LFNAR 2003:2). Stockholm, Sweden: Pharmaceutical Benefits Board; 2003. Available from: http://www.ispor.org/peguidelines/source/Guidelines_in_Sweden.pdf. Accessed July 23, 2011.
154. Vegter S, Rozenbaum MH, Postema R, Tolley K, Postma MJ. Review of regulatory recommendations for orphan drug submissions in The Netherlands and Scotland: Focus on the underlying pharmacoeconomic evaluations. Clin Ther. 2010;32:1651-1661.
155. Stolk EA, Poley MJ. Criteria for determining a basic health services package. Recent developments in The Netherlands. Eur J Health Econ. 2005;6:2-7.
156. Stolk EA, de BA, van Halteren AR, Bijlmer RJ, Poley MJ. Role of health technology assessment in shaping the Benefits package in The Netherlands. Expert Rev Pharmacoecon Outcomes Res 2009;9: 85-94.
157. Single technology appraisal (STA): Specifcation for manufacturer/ sponsor submission of evidence. London, UK: National Institute for Health and Clinical Excellence; 2009. Available from: http://www.nice.org.uk/media/59C/B3/SpecifcationForManufacturerSponsorSubmis-sionEvidenceJune2010.doc. Accessed July 23, 2011.
158. Lloyd A, Wild D, Gallop K, Cowell W. Reimbursement agency requirements for health related quality-of-life data: A case study. Expert Rev Pharmacoecon Outcomes Res. 2009;9: 527-537.
159. Niemietz KPMP. A healthy market? Health technology assessment in the UK and Germany [Stockholm Network Papers on Health Technology Assessment. Paper No. 2]. Stockholm, Sweden: Stockholm Network; 2007. Available from: http://www.stockholm-network.org/downloads/publications/HTA3_2.pdf. Accessed July 23, 2011.
160. Barros P P. Pharmaceutical policies in European countries. Adv Health Econ Health Serv Res. 2010;22:3-27.
161. Annex to the decree by the Ministry of Social Affairs and Health on applications for a reasonable wholesale price, on special reimbursement status for a medicinal product, and on the documentation to be attached to the application (1393/2003). Helsinki, Finland: Finland Ministry of Social Affairs and Health; 2003. Available from: http://www.stm.f/c/document_library/get_fle?folderId=71837&name=DLFE-7603.pdf. Accessed July 23, 2011.
162. Medical device assessment in France: Guidebook. Cedex, France: Haute Autorite de Sante; 2009. Available from: http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-03/guide_dm_gb_050310.pdf. Accessed July 23, 2011.
163. Offce of Health Technology Assessment of the National Institute for Strategic Health Research. Budapest, Hungary: National Institute for Strategic Health Research; 2011. Available from: http://www.eski.hu/new3/technologia_en/technologia_en.php. Accessed July 23, 2011.
164. Brodszky V, Orlewska E, Pentek M, Karpati K, Skoupa J, Gulacsi L. Challenges in economic evaluation of new drugs: Experience with rituximab in Hungary. Med Sci Monit. 2010;16:SR1-SR5.
165. Barry M, Tilson L. Recent developments in pricing and reimbursement of medicines in Ireland. Expert Rev Pharmacoecon Outcomes Res. 2007;7:605-611. Available from: http://www.expert-reviews.com/doi/pdf/10.1586/14737167.7.6.605. Accessed July 23, 2011.
166. Kozierkiewicz A, Trabka W, Romaszewski A, Gajda K, Gilewski D. Defnition of the "health Benefit basket" in Poland. Eur J Health Econ. 2005;6 Suppl 1:58-65. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1388086/?tool=pubmed. Accessed July 23, 2011.
167. Orlewska E, Mierzejewski P. Project of Polish guidelines for conducting pharmacoeconomic evaluations in comparison to international health economic guidelines. Eur J Health Econ. 2003;4:296-303.
168. Pharmacoeconomic guidelines around the world: Scotland. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2010. Available from: http://www.ispor.org/PEguidelines/countrydet.asp?c=19&t=2. Accessed July 15, 2011.
169. Visnansky M. HTA and health care decisions in Slovakia. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research; 2010. Available from: http://www.ispor.org/regional_chapters/Slovakia/documents/ISPOR_HTA_and_HC_Dcisions_in_SK_HTAC_112010.pdf. Accessed July 23, 2011.
170. Guideline: the Ministry of Health of the Slovak Republic no. 343/2008 Z. z. the details of pharmaco-economic analysis of drug. The Ministry of Health of the Slovak Republic no. 210/2008 Z. laws, which provides details on the medico-economic analysis of the medical device when the decree of the Ministry of Health of the Slovak Republic no. 149/2009 Z. z. the details of medico-economic analysis of dietary food for the implementation of pharmaco-economic analysis of drug; medico-econoic analysis of the medical device and medico-economic analysis of the dietary food. Bratislava, Slovakia: Ministerstva zdra-votnictva Slovenskej republiky; 2009. Available from: http://www2.health.gov.sk/redsys/rsi.nsf/0/4399FF0A33156D1CC1256FAF002B94DE?OpenDocument. Accessed July 23, 2011.
171. Duran A, Lara JL, van Waveren M. Spain: Health system review [Health Systems in Transition]. Copenhagen, Denmark: European Observatory on Health Care Systems, World Health Organization Regional Offce for Europe; 2006. Available from: http://www. euro.who.int/en/home/projects/observatory/publications/health-system-profles-hits/full-list-of-hits/spain-hit-2007. Accessed July 23, 2011.
172. Muller KR. ISPOR global health care systems road map: Switzerland - Pharmaceutical. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research (ISPOR); 2011. Available from: http://www.ispor.org/htaroadmaps/SwitzerlandPH.asp. Accessed July 23, 2011.
173. van Nooten F, van Agthoven M. Mandatory pharmacoeconomic studies in the Dutch reimbursement setting. Institute for Medical Technology Assessment newsletter. 2005;3:1-3. Available from: http://www.bmg.eur.nl/fleadmin/ASSETS/bmg/english/iMTA/Publications/Newsletter/imta_newsletter_3_1.pdf. Accessed July 23, 2011.
174. All Wales Medicines Strategy Group: Structure of appraisal. Vale of Glamorgan, Wales: All Wales Medicines Strategy Group; 2007. Available from: http://www.wales.nhs.uk/sites3/home.cfm?orgid=371. Accessed July 23, 2011.
175. INAMI - medicaments. Brussels, Belgium: I National Institute for Health and Disability Insurance; 2011. Available from: http://www.inami.fgov.be/drug/fr/drugs/index.htm#2. Accessed July 23, 2011.
176. Sandmann FG. Framework of decision making regarding the Benefit package in the Czech Republic. In: Decision making on the inclusion of new provisions in the Benefit package: A comparative study between the Netherlands and the Czech Republic (with a focus on the role of value for money considerations in pharmaceutical reimbursement decision making). Enschede, The Netherlands: University of Twente. School of Management and Governance; 2010. Available from: http://www.utwente.nl/mb/htsr/education/completed%20assignments/Sandmann.pdf. Accessed July 23, 2011.
177. Petrikova A, Dolezal T, Lamka J, Klimes J. Description of the pricing and reimbursement system in the Czech Republic. Prague, Czechoslovakia: Institute of Health Economics and Technology Assessment; 2010. Available from: http://www.iheta.org/ext/fles/27/Poster_ISPOR_PR_CZ.pdf. Accessed July 23, 2011.
178. Davidova J, Praznovcova L, Lundborg CS. Pricing and reimbursement of pharmaceuticals in the Czech Republic and Sweden. Pharm World Sci. 2008;30:57-64.
179. Davidova J, Ivanovic N, Praznovcova L. Participation in pharmaceutical costs and seniors' access to medicines in the Czech Republic. Cent Eur J Public Health. 2008;16:26-28. Available from: http://www1.szu.cz/svi/cejph/archiv/2008-1-06-full.pdf. Accessed July 23, 2011.
180. Spacilova L, Petrelli F, Grappasonni I, Scuri S. Health care system in the Czech Republic. Ann Ig. 2007;19:573-581.
181. Mossialos E, Srivastava D. Overview of the pharmaceutical system in Finland. In: Pharmaceutical policies in Finland: challenges and opportunities [Observatory Studies Series No. 10]. Copenhagen, Denmark: World Health Organization; European Observatory on Health Systems and Policies; Ministry of Social Affairs and Health Finland; 2008. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0020/80651/E91239.pdf. Accessed July 23, 2011.
182. Government decree on the Pharmaceuticals Pricing Board. Helsinki, Finland: Finland Ministry of Social Affairs and Health; 2008. Available from: http://www.stm.fi/c/document_library/get_fle?folderId=71837&name=DLFE-10036.pdf. Accessed July 23, 2011.
183. Strandberg-Larsen M, Nielsen MB, Vallgarda S, Krasnik A, Vrang-baek K. Denmark: Health system review [Health Systems in Transition 2007;9]. Copenhagen, Denmark: World Health Organisation Regional Offce for Europe. European Observatory on Health Care Systems; 2007. Available from: http://www.euro.who.int/__data/assets/pdf_fle/0004/80581/E91190.pdf. Accessed July 23, 2011.
184. Falissard B, Zylberman M, Cucherat M, et al. Real medical ben-eft assessed by indirect comparison. Therapie. 2009;64:225-232. French.
185. Haute Autorite de Sante. Cedex, France: Haute Autorite de Sante; 2010. Available from: http://www.has-sante.fr. Accessed July 23, 2011.
186. Yfantopoulos J. Pharmaceutical pricing and reimbursement reforms in Greece. Eur J Health Econ. 2008;9:87-97.
187. Rules of procedure of the social insurance inclusion of pharmaceuticals in Hungary. Budapest, Hungary: National Institute for Strategic Health Research. Offce of Health Technology Assessment; 2011. Available from: http://www.eski.hu/new3/technologia_en/technologia_en_pro-cedure.php. Accessed July 23, 2011.
188. ISPOR global health care systems road map: Italy - Pharmaceuticals. Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research (ISPOR); 2011. Available from: http://www.ispor.org/HTARoadMaps/Italy.asp. Accessed July 23, 2011.
189. Godman B, Sakshaug S, Berg C, Wettermark B, Haycox A. Combination of prescribing restrictions and policies to engineer low prices to reduce reimbursement costs. Expert Rev Pharmacoecon Outcomes Res. 2011; 11:121-129.
190. Nizankowski R, Wilk N. From idealistic rookies to a regional leader: The history of health technology assessment in Poland. Int J Technol Assess Health Care. 2009;25 Suppl 1:156-162.
191. Ministerio da Saude: Decreto-Lei no. 48-A/2010. Oeiras, Portugal: Associacao Portuguese de Medicamentos Genencos; 2010. Available from: http://www.apogen.pt/conteudos/uploads/Files/apogen/PacoteMedicamento_13Maiode2010.pdf. Accessed July 23, 2011.
192. Jansson S. Implementing accountability for reasonableness - the case of pharmaceutical reimbursement in Sweden. Health Econ Policy Law. 2007;2(Pt 2):153-171.
193. Guidelines for pharmacoeconomic research, updated version. Diemen, The Netherlands: College voor Zorgverzekeringen; 2006. Available from: http://www.ispor.org/peguidelines/source/HTAGuidelinesNLupdated2006.pdf. Accessed July 23, 2011.
194. Healy P, Pugatch M. Theory versus practice: Discussing the governance of health technology assessment systems. Stockholm, Sweden: Stockholm Network; 2009. Available from: http://www.stockholm-network.org/downloads/publications/Theory_versus_Practice.pdf. Accessed July 23, 2011.
195. Sculpher M. Single technology appraisal at the UK National Institute for Health and clinical excellence: A source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28:347-349.
196. Kennedy I. Appraising the value of innovation and other Benefits: A short study for NICE. London, UK: National Institute for Health and Clinical Excellence; 2009. Available from: http://www.nice.org.uk/media/98F/5C/KennedyStudyFinalReport.pdf. Accessed July 23, 2011.
197. Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and its value judgments. BMJ. 2004;329:224-227.
198. All Wales Medicines Strategy Group: Independent review process. Vale of Glamorgan, Wales: All Wales Medicines Strategy Group; 2007. Available from: http://www.wales.nhs.uk/sites3/Documents/371/Independent%20Review%20process%20_fna%20for%20website_.pdf. Accessed July 23, 2011.
199. General method for assessing health technologies. Paris, France: Haute Autorite de Sante, Department of Medical and Surgical Procedures Assessment; 2007. Available from: http://www.has-sante.fr/portail/upload/docs/application/pdf/general_method_eval_techno.pdf. Accessed July 23, 2011.
200. ISPOR global health care systems road map: Italy - Reimbursement process. Lawrenceville, NJ: International Society for Pharmacoeco-nomics and Outcomes Research; 2008. Available from: http://www.ispor.org/HTARoadMaps/Italy.asp. Accessed July 23, 2011.
201. Stolk EA, Rutten F F. The "health Benefit basket" in the Netherlands. Eur J Health Econ. 2005;Suppl:53-57.
202. Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors infuence its decisions? A binary choice analysis. Health Econ. 2004;13:437-452.
203. Pharmaceuticals Pricing Board: the Pharmaceuticals Pricing Board and the secretariat. Helsinki, Finland: Ministry of Social Affairs and Health/Social - Och Halsovardsministeriet; 2009. Available from: http://www.stm.fi/en/ministry/boards/pharmaboard/board. Accessed July 23, 2011.
204. Nasser M, Sawicki P. Institute for quality and effciency in health care: Germany. Issue Brief (Commonw Fund). 2009;57:1-12. Available from: http://www.commonwealthfund.org//media/Files/Publications/Issue%20Brief/2009/Jul/Chalkidou/1294_Nasser_CER_Germany_issue_brief_724.pdf. AccessedJuly 23, 2011.
205. Vandoros S, Kanavos P. Pricing, regulation, reimbursement and healthcare budgets. European Cancer Patient Coalition. 2009. Available from: http://www.ecpc-online.org/component/docman/doc_download/121-sotiri-vandoros-pricing-regulation-reimbursement-and-healthcare-budgets.html?ItemId=127. Accessed July 23, 2011.
206. Persson U, Willis M, Odegaard K. A case study of ex ante, value-based price and reimbursement decision-making: T LV and rimonabant in Sweden. Eur J Health Econ. 2010;11:195-203.
207. Moise P, Docteur E. Pharmaceutical pricing and reimbursement policies in Sweden [OECD Health Working Papers, No. 28]. Paris, France: Organisation for Economic Co-operation and Development (OECD); 2007. Available from: http://www.oecd.org/dataoecd/63/17/40699881.pdf. Accessed July 23, 2011.
208. Jansson S. Implementing accountability for reasonableness - the case of pharmaceutical reimbursement in Sweden. Health Econ Policy Law. 2007;2(Pt 2):153-171.
209. Willis M, Persson U, Zoellner Y, Gradl B. Reducing uncertainty in value-based pricing using evidence development agreements: The case of continuous intraduodenal infusion of levodopa/ carbidopa (DuodopaR) in Sweden. Appl Health Econ Health Policy. 2010;8:377-386.
210. Stolk P, Schneeweiss S, Leufkens HGM, Heerdink ER. Impact analysis of the discontinuation of reimbursement: The case of oral contraceptives. Contraception. 2008;78:399-404.
211. Schafer W, Kroneman M, Boerma W, et al. The Netherlands: Health system review [Health Systems in Transition]. Copenhagen, Denmark: European Observatory on Health Care Systems, World Health Organization Regional Offce for Europe; 2010. Available from: http://www.euro.who.int/en/home/projects/observatory/publications/health-system-profles-hits/full-list-of-hits/netherlands-hit-2010. Accessed July 23, 2011.
212. Webb DJ. Value-based medicine pricing: NICE work? Lancet. 2011; 377:1552-1553.
213. Kanavos P, Manning J, Taylor D, Schurer W, Checchi K. Implementing value-based pricing for pharmaceuticals in the UK. Final report. London, UK: 2020 Health; 2010. Available from: http://www.2020health.org/2020health/research/vbp-a.html. Accessed July 23, 2011.
214. A new value-based approach to the pricing of branded medicines: A consultation. London, UK: UK Department of Health. Medicines, Pharmacy and Industry Group; 2010. Available from: http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_122760. Accessed July 23, 2011.