Availability and quality of data on drug policy and management  of access to reimbursed medicinal products in the United Kingdom, Denmark, Germany, Italy and Poland

Tomasz Hermanowski,

Sylwia I. Szafraniec-Buryło,

Aleksandra N. Krancberg,

Dominika Dulęba,

Urszula Cegłowska


Objectives: To perform a systematic review, and to verify and define deficiencies in literature data on drug policy and management of access to reimbursed medicinal products in the United Kingdom, Denmark, Germany, Italy and Poland as a source of information intended to be used by government authorities in the decision-making process.
Methods: A systematic review was conducted through database search of Medline, SCOPUS, Embase and Cochrane Library, supplemented by nonsystematic review. The quality of the identified literature was critically appraised.
Results: Information necessary to develop a knowledge base was outline from 121 papers identified through database search. 0.83% of all publications were rated high in all of the assessed categories, i.e. were identified to represent high levels of consistency, coherence, strength and methodological quality.
Conclusions: In the policy decision-making process, concise recommendations based on validated data are more than needed. It is vital to rely on scientific evidence and avoid reports based on simple exchange of information or presenting single-source or unconfirmed data, including expert’s opinion.

Słowa kluczowe: dostępność danych, jakość, ocena metodologii, proces decyzyjny

Olejaz M., Juul Nielsen A., Rudkjøbing A., Okkels Birk H., Krasnik A., Hernández-Quevedo C., Denmark: Health system review, “Health Systems in Transition” 2012; 14, 2: 1–192.

Busse R., Riesberg A., Health care systems in transition: Germany, Copenhagen, WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies, 2004; 6, 9: 1–234.

Boyle S., United Kingdom (England): Health system re- view, “Health Systems in Transition” 2011; 13, 1: 1–486.

Lo Scalzo A., Donatini A., Orzella L., Cicchetti A., Profi li S., Maresso A., Italy: Health system review, “Health Systems in Transition” 2009; 11, 6: 1–216.

Sagan A., Panteli D., Borkowski W., Dmowski M., Domański F., Czyżewski M., Goryński P., Karpacka D., Kiersztyn E., Kowalska I., Księżak M., Kuszewski K., Leśniewska A., Lipska I., Maciąg R., Madowicz J., Mądra A., Marek M., Mokrzycka A., Poznański D., Sobczak A., Sowada C., Świderek M., Terka A., Trzeciak P., Wiktor- zak K., Włodarczyk C., Wojtyniak B., Wrześniewska-Wal I., Zelwiańska D., Busse R., Poland: Health system re- view, “Health Systems in Transition” 2011; 13, 8: 1–193.

West S., King V., Carey T.S., Lohr K.N., McKoy N., Sut- ton S.F., Lux L., Systems to Rate the Strength Of Scientific Evidence, “Evidence Report/Technology Assessment”, North Carolina 2002, March, Number 47, AHRQ Publi- cation No. 02-E016.

Liberati A., Altman D.G., Tetzlaff J. et al., The PRISMA statement for reporting systematic reviews and meta- analyses of studies that evaluate healthcare interventions: explanation and elaboration, “BMJ” 2009; 339: b2700, http://www.bmj.com/content/339/bmj.b2700; dostęp: 12.05.2013.

Stroup D.F., Berlin J.A., Morton S.C. et al., Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group, “JAMA” 2000; 283, 15: 2008–2012.

MOOSE checklist, Modified from Stroup D.F., Berlin J.A., Morton S.C., Olkin I., Williamson G.D., Rennie D. et al., Meta-analysis of observational studies in epi- demiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. “JAMA” 2000; 283: 2008–2012.

Vandenbroucke J.P. et al., Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Ex- planation and Elaboration, “Epidemiology” 2007; 18, 6: 805–835.

Adamski J. et al., Risk sharing arrangements for pharma- ceuticals: potential considerations and recommendations for European payers, “BMC Health Services Research” 2010; 10: 153.

Altenstetter Ch., EU and member state medical devices regulation, “International Journal of Technology Assessment in Health Care” 2003; 19, 1, 228–248.

Antos J.R., Ensuring Access to Affordable Drug Coverage in Medicare, “Health Care Financing Review” 2005/2006; 27, 2: 103–112.

Cohen J. et al., Patient access to pharmaceuticals: an in- ternational comparison, “Eur. J. Health Econ.” 2007; 8: 253–266.

Domenighetti G. et al., Ability to pay and equity in access to Italian and British National Health Services, “Euro- pean Journal of Public Health” 2010; 20, 5: 500–503.

Kennedy J. et al., Drug Affordability and Prescription Noncompliance in the United States: 1997–2002, “Clin. Ther.” 2004; 26(4): 607–614.

Krobot K.J. et al., The Disparity in Access to New Medication by Type of Health Insurance Lessons From Ger- many, “Medical Care” 2004; 42, 5.

Lasser K.E. et al., Access to Care, Health Status, and Health Disparities in the United States and Canada: Results of a Cross National Population-Based Survey, “American Journal of Public Health” 2006; 96, 7.

Lee P.P. et al., Access to Care, Eye Care Provider Work- force Considerations in 2020, “Socioeconomic and health services” 2007; 15: 406–410.

Lee P.P. et al., Access to Eye Care Response of the American Academy of Ophthalmology and Its Members to Societal Needs Now and in the Future, “Socioeconomic and health services” 2007; 15: 403–405.

Lluch M., Kanavos P., Impact of regulation of Commu- nity Pharmacies on efficiency, access and equity. Evidence from the UK and Spain, “Health Policy” 2010; 95: 245–254.

Lopert R., Rosenbaum S., What Is Fair? Choice, Fair- ness, and Transparency in Access to Prescription Medi- cines in the United States and Australia, “Global Health Law, Ethics, and Policy” 2007; 35(4): 643–656.

Lurie N., Dubowitz T., Health Disparities and Access to Health, “JAMA” 2007; 297, 10: 1118–1121.

Mackenbach J.P., Bakker M.J., Tackling socioeconomic inequalities in health: analysis of European experiences, “Lancet” 2003; 362: 1409–1414.

Morris S. et al., Inequity and inequality in the use of health care in England: an empirical investigation, “Social Science & Medicine” 2005; 60: 1251–1266.

Motl S. et al., Programs established by FDA to expedite patient access to medications, “Am. J. Health-Syst. Pharm.” 2003; 60: 339–345.

Orlewska E. et al., Access to biologic treatment for rheu- matoid arthritis in Central and Eastern European (CEE) countries, “Med. Sci. Monit.” 2011; 17 (4): SR1–13.

Pfefferle S.G., Pediatrician Perspectives on Children’s Access to Mental Health Services: Consequences and Potential Solutions, “Adm. Policy Ment. Health” 2007; 34: 425–434.

Reschovsky, Felland L.E., Access to Prescription Drugs for Medicare Beneficiaries, Center for Studying Health System Change, Washington 2009.

Shi L. et al., Access to Medical Care, Dental Care, and Prescription Drugs: The Roles of Race/Ethnicity, Health Insurance, and Income, “Southern Medical Journal” 2010; 103, 6: 509–516.

Simon F., Market Access For Biopharmaceuticals: New Challenges, “Health Affairs” 2006; 25, 5: 1363–1370

Szczepura A., Access to health care for ethnic minority populations, “Postgrad. Med. J.” 2005; 81: 141–147.

Urmie J.M., Effect of Medicare Part D and Insurance Type on Medicare Beneficiary Access to Prescription Medication and use of Prescription Cost-saving Meas- ures, “J. Am. Pharm. Assoc.” (2003) 2011; 51(1): 72–81.

Wilson A., Cohen J., Patient Access to New Cancer Drugs in the United States and Australia, “Value in Health” 2011; 14: 944–952.

Wyke S. et al., Should general practitioners purchase health care for their patients? The total purchasing experiment in Britain, “Health Policy” 2003; 65: 243–259.

Walker S. et al., Coverage with Evidence Develop- ment, Only in Research, Risk Sharing, or Patient Access Scheme? A Framework for Coverage Decisions, “Value in Health” 2012; 15: 570–579.

Sabik L., The Effect of Community Uninsurance Rates on Access to Health Care, “Health Services Research” 2012; 47, 3, Part I: 897–918.

Derose K.P. et al., Understanding disparities in health care access-and reducing them-through a focus on public health, “Health Aff.” 2011; 30 (10): 1844–1851.

Geyman J. et al., Cost-Sharing under Consumer-Driven Health Care Will Not Reform U.S. Health Care, “J. Law Med. Ethics” 2012; 40(3): 574–581.

Moreno-Serra R., Does progress towards universal health coverage improve population health?, “Lancet” 2012; 380 (9845): 917–923.

Aaserud et al., Pharmaceutical policies: effects of refer- ence pricing, other pricing, and purchasing policies (Re- view), “The Cochrane Library” 2009; 3.

Austvoll-Dahlgren et al., Pharmaceutical policies: effects of cap and co-payment on rational drug use (Review), “The Cochrane Library” 2008; 1.

Dewa C.S., Fixed and flexible formularies as cost-control mechanisms, “Expert Review Pharmacoeconomics Out- comes Research” 2003; 3 (3): 303–315.

Eaddy et al., How Patient Cost-Sharing Trends Affect Adherence and Outcomes, A literature Review, “P&T: A Peer-Reviewed Journal For Formulary Management” 2012; 37 (1): 45–55.

Encinosa W.E., Value-Based Insurance Design in Medi- care, “Applied Health Economics and Health Policy” 2009; 7 (3): 149–154.

Folino-Gallo et al., Pricing and reimbursement of phar- maceuticals in Italy, “European Journal of Health Economics” 2008; 9: 305–310.

Gibson et al., The Effects of Prescription Drug Cost Sharing: A Review of the Evidance, “The American Journal of Managed Care” 2005; 11: 730–740.

Greiner W., von der Schulenburg, HTA in Germany: very special and specific, “Eur. J. Health Econ.” 2010; 11: 13.

Herr et al., Pharmaceutical Prices under Regulation: Tiered Co-payments and Reference Pricing in Germany, Düsseldorf Institute for Competition Economics, Düsseldorf, April 2012.

Łanda et al., Pricing, Prices of reimbursed drugs, nego- tiations and risk sharing, Central and Eastern Society of Technology Assessment in Health Care, Kraków–Warszawa 2009.

Møller Pedersen K., Pricing and reimbursement of drugs in Denmark, “European Journal of Health Economics” 2003; 4(1): 60–65.

Morgan et al., Comparison of tiered formularies and reference pricing policies: a systematic review, “Open Medi- cine” 2009; 3(3): 131–139.

Mossialos et al., An overview of pharmaceutical policy in four countries: France, Germany, the Netherlands and the United Kingdom, “Int. J. Health Plann. Mgmt” 2005; 20: 291–306.

Olson B.M., Approaches to Pharmacy Benefit Manage- ment and the Impact of Consumer Cost Sharing, “Clinical Therapeutics” 2003; 25(1): 250–272.

Paris V., Docteur E., Pharmaceutical pricing and reimbursement policies in Germany, OECD Health Working Paper No. 39, October 2008, OECD, Paris 2008.

Polinski et al., Medicare Part D’s Effect on the Under- and Overuse of Medications: A systematic Review, “Journal of American Geriatrics Society” 2011; 59: 1922–1933.

The Danish Association of the Pharmaceutical Industry, Pricing and Reimbursement in Denmark, 2007, http://whocc.goeg.at/Publications/CountryReports; accessed: 10.05.2013.

Vogler et al., Comparing pharmaceutical pricing and reimbursement policies in Croatia to the European Union Member States, “Croatian Medical Journal” 2011; 52(2): 183–197.

Gemmill M.C., What impact do prescription drugs charges have on efficiency and equity? Evidence from high-income country, “International Journal for Equity in Health” 2008; 7: 12.

Choudhry N.K., Assessing the evidence for value-based insurance design, “Health Affairs” 2010; 29, 11.

Chernaw M.E., Evidence that value-based insurance can be effective, “Health Affairs” 2010;  29, 3.

Fairman K.A. Curtiss F.R., How do seniors respond to 100% cost-sharing for prescription drugs? Quality of the Evidance Underlying Opinions about Medicare Part D Coverage Gap, “J. Manag. Care Pharm.” 2011; 17(5): 382–392.

Hsu J. et al., Unintended Consequences of Caps on Medicare Drug Benefits, “N. Engl. J. Med.” 2006; 354: 2349–2359.

Vogler S. et al., Discounts and rebates granted to public payers for medicines in European countries, “Southern Med. Review” 2012; 5, 1: 38–46.

Fairman K., VBID, the PPACA, and FREEE Medications: Did Politics Trump the Evidence About Cost Sharing?, “JMCP” 2012; 18, 2.

Drummond M. et al., Is it time to reconsider the role of patient co-payments for pharmaceuticals in Europe?, “Eur. J. Health Econ.” 2012; 13: 1–5.

Jarosławski Sz. et al., Market access agreements for pharmaceuticals in Europe: diversity of approaches and underlying concepts, “BMC Health Services Research” 2011; 11: 259.

Costa J.F. et al., Does cost sharing really reduce inappropriate prescriptions among the elderly?, “Health Policy” 2011; 101: 195–208.

Sorenson C., Use of Comparative Effectiveness Research in Drug Coverage and Pricing Decisions: A Six-Country Comparison, 14. Issue brief , 2010; 91: 1–14.

Thomson S. et al., Primary Care and Prescription Drugs: Coverage, Cost-Sharing, and Financial Protection in Six European Countries, 19. Issue brief, 2010; 82: 1–14.

Rice T. et al., The impact of cost-sharing on appropriate utilization and health status: A review of the literature on seniors, “Medical Care Research and Review” 2004; 61, 4: 415–452.

Nair K.V. et al., Impact of three-tier pharmacy benefit structures on consumer attitudes, pharmacy, medical utili- zation and costs: A critical review, “Disease Management and Health Outcomes” 2004; 12, 2: 81–92.

Lexchin J. et al., Effects of prescription drug user fees on drug and health services use and on health status in vul- nerable populations: A systematic review of the evidence, “International Journal of Health Services” 2004; 34 (1): 101–122.

Fendrick M.A., A benefit-based copay for prescription drugs: Patient contribution based on total benefits, not drug acquisition cost, “American Journal of Managed Care” 2001; 7 (9): 861–867.

Fendrick M.A., A commentary on the potential of Value- Based Insurance Design (VBID) to contain costs and preserve quality, “Journal of Managed Care Pharmacy” 2008; 14 (supl. 6): S11–S15.

Parente S.T. et al., Evolution and early evidence of the impact of consumer-driven health plans: From e-commerce venture to health savings accounts, “Expert Review of Pharmacoeconomics and Outcomes Research” 2008; 8 (4): 343–348.

Lo Sasso A.T. et al., Health savings accounts and health care spending, “Health Services Research” 2010; 45 (4): 1041–1060.

Greenapple R., Emerging trends in cancer care: Health plans’ and pharmacy benefit managers’ perspectives on changing care models, “American Health and Drug Benefits” 2012; 5, 4.

Fronstin P., Health savings accounts and health reim- bursement arrangements: assets, account balances, and rollovers, 2006–2010, EBRI issue brief, Issue 353, January 2011: 1–27.

Charlton M.E. et al., Effects of health savings account- eligible plans on utilization and expenditures, “American Journal of Managed Care” 2011; 17(1): 79–86.

Buntin M.B. et al., Healthcare spending and preventive care in high-deductible and consumer-directed health plans, “American Journal of Managed Care” 2011; 17 (3): 222–230.

Brennan T. et al., Value-based insurance design and the next generation of consumer-driven health care, “Health Affairs” 2007; 26 (2): w204–w207.

Borah B.J. et al., Assessing the impact of high deduct- ible health plans on health-care utilization and cost: A changes-in-changes approach, “Health Economics” 2011; 20(9): 1025–1042.

Parente S.T. et al., Effects of a consumer driven health plan on pharmaceutical spending and utilization, “Health Services Research” 2008; 43 (5 P1): 1542–1556.

Ali O., Mantrala M., Pharma rebates, pharmacy benefit managers and employer outcomes, “Health Care Manag. Sci.”, 2010, 13: 281–293

Bassi L., Bertele V., Garattini S., European regulatory policies on medicines and public health needs, “European Journal Of Public Health” 2003; 13: 246–251.

Dorn S., United States Health Care Reform in 2009: A Primer for Gastroenterologists, “Clinical Gastroenter- ology and Hepatology” 2009; 7, 11: 1168–1173.

Fiscella K., Health Care Reform and Equity: Promise, Pitfalls, and Prescriptions, “Annals Of Family Medicine” January/February 2011; 9(1).

Fox P., Prescription Drug Benefits: Cost Management Issues for Medicare, “Health Care Financing Review” 2003; 25(2): 7–21.

Golec J., Vernon J., Financial Effects of Pharmaceutical Price Regulation on R&D Spending by EU versus US Firms, “Pharmacoeconomics” 2010; 28 (8): 615–628.

Kanavos P., Reinhardt U., Reference Pricing For Drugs: Is It Compatible With U.S. Health Care?, “Health Affairs” 2003; 22, 3: 16–30.

Kemp A., Preen D., Glover J., Semmens J., Ed D., Roug- head E., How much do we spend on prescription medicines? Out-of-pocket costs for patients in Australia and other OECD countries, “Australian Health Review” 2011; 35: 341–349.

Mackintosh M., Chaudhuri S., Mujinja P., Can NGOs reg- ulate medicines markets? Social enterprise in wholesal- ing, and access to essential medicines, “Globalization and Health” 2011; 7: 4, http://www.globalizationandhealth. com/content/17/1/4; accessed: 26.05.2013.

McDonald R., Roland M., Pay for Performance in Pri- mary Care in England and California: Comparison of Unintended Consequences, “Ann. Fam. Med.” 2009; 7(2): 121–127.

Morel Ch., McGuire A., Mossialos E., The Level Of In- come Appears To Have No Consistent Bearing On Phar- maceutical Prices Across Countries, “Health Affairs” 2011; 30, 8: 1515–1552.

Robone S., Rice N., Smith P., Health Systems’ Respon- siveness and Its Characteristics: A Cross-Country Com- parative Analysis, “HSR: Health Services Research” 2011; 46: 6, Part II.

Sampat B., Drummond M., Another Special Relationship? Interactions between Health Technology Policies and Health Care Systems in the United States and the United Kingdom, “Journal of Health Politics, Policy and Law” 2011; 36(I).

Tomar S., DMD, Cohen L., Attributes of an ideal oral health care system, “Journal of Public Health Dentistry” 2010; 70: S6–S14.

Wagner J., McCarthy E., International differences in drug prices, “Annu. Rev. Public Health” 2004; 25: 475–495.

Weaver L., Can the United States Learn from Other Countries?,  http://www.minnesotamedicine.com/Health-CareReformDiscussions/CommentaryApril2010.aspx; accessed: 15.05.2013.

Baeza C., Packard T., Beyond Survival: Protecting House- holds Against the Impoverishing Effects of Health Shocks, World Bank, Stanford University Press, Washington 2006.

Bennett S., Quick J.D., Velasquez G., Public-private roles in the pharmaceutical sector – implications for equitable access and rational drug use, WHO, Geneva 1997.

CBI Market Survey, The Pharmaceutical Products Market in Denmark, 2010, http://www.cbi.eu/marketinfo; accessed: 10.05.2013.

Department of Health, The Pharmaceutical Price Regulation Scheme 2009, http://www.dh.gov.uk/prod_con- sum_dh/groups/dh_digitalassets/documents/digitalasset/ dh_098498.pdf; accessed: 15.05.2013.

Ecorys Research and consulting, Competitiveness of the EU Market and Industry for Pharmaceuticals Volume II: Markets, Innovation & Regulation, Rotterdam 2009.

Habl C., Vogler S., Leopold C., Schmickl B., Fröschl B., Reference price systems in Europe. Analysis and prerequisites for an implementation in Austria [in German]. Vienna: ÖBIG Forschungs-und PlanungsgesellschaftmbH; 2008.

Institute of Medicine, Insuring America’s health: principles and recommendations. National Academies Press, Washington, DC 2004.

Institute of Medicine, Public policy options for better dental health: report of a study. National Academy Press, Washington, DC 1980.

Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century, National Academies Press, Washington, DC 2001.

Janiszewski R., Bondary K., Pharmaceutical pricing and reimbursement information (PPRI) profile Poland. PPRI/ Austrian Health Institute, Vienna 2007.

Koenig P., MacGarvie M., Regulatory policy and the location of bio-pharmaceutical foreign direct investment in Europe, “J. Health Econ.” 2011; 30(5): 950–965; doi:10.1016/j.jhealeco.2011.07.005. Epub 2011 Jul 30.

Law of 27 August 2004 on health care services financed from public funds (Official Journal 04.210.2135 with later amendments).

Morgan S., Kennedy J., Boothe K., McMahon M., Toward an Understanding of High Performance Pharmaceutical Policy Systems: A “Triple-A” Framework and Example Analysis, “The Open Health Services and Policy Journal” 2009; 2: 1–9.

OECD (2011), Health at a Glance 2011: OECD Indica- tors, OECD Publishing. http://dx.doi.org/10.1787/health_ glance-2011-en; accessed: 15.05.2013.

OECD. Generic Pharmaceuticals 2009. DAF/COMP(2009) 39. 5 October 2010, www.oecd.org/daf/competition/abuse/46138891.pdf; accessed: 12.05.2013.

Ognyanova D. et al., Pharmaceutical reform 2010 in Ger- many, “Eurohealth” 2011; 17(1): 11–13.

Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharma- ceutical Sector in the 25 EU Member States. European Communities, Luxembourg, July 2006.

Permanand G., Altenstetter C., The politics of pharmaceuticals in the European Union, w: Mossialos E., Mrazek M., Walley T. (red.), Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality, Open University Press, Maidenhead 2004.

Roemer M.I., National Health Systems of the World, Oxford: Oxford University Press 1993; 2.

Simoens S., De Coster S., Sustaining generic medicines markets in Europe, “Journal of Generic Medicines” 2006; 3: 257–268.

Squires D., The U.S. Health System in Perspective: A Comparison of Twelve Industrialized Nations, “Issues Brief (Commonw. Fund.)” 2011; 16: 1–14.

The Act on Reimbursement of Medicines, Food for Particular Nutritional Uses and Medical Devices, Dziennik Urzędowy Ministerstwa Zdrowia, Warszawa, dnia 25 kwietnia 2012, poz. 19.

The World Health Report (2000), Health Systems: Im- proving Performance, World Health Organization, Geneva, Switzerland, 2000.

Vogler S., The impact of pharmaceutical pricing and re- imbursement policies on generics uptake: implementation of policy options on generics in 29 European countries – an overview, “Generics and Biosimilars Initiative Journal (GaBI Journal)” 2012; 1(2): 93–100.