Hostname: page-component-cd9895bd7-7cvxr Total loading time: 0 Render date: 2024-12-27T06:38:10.642Z Has data issue: false hasContentIssue false

Paradigms in operation: explaining pharmaceutical benefit assessment outcomes in England and Germany

Published online by Cambridge University Press:  12 April 2019

Katharina Kieslich*
Affiliation:
Department of Political Science, University of Vienna, Universitätsstr. 7, 1010Vienna, Austria
*
*Correspondence to. Email: [email protected]

Abstract

Health technology assessments (HTAs) are used as a policy tool to appraise the clinical value, or cost effectiveness, of new medicines to inform reimbursement decisions in health care. As HTA organisations have been established in different countries, it has become clear that the outcomes of medicine appraisals can vary from country to country, even though the same scientific evidence in the form of randomised controlled trials is available. The extant literature explains such variations with reference to institutional variables and administrative rules. However, little research has been conducted to advance the theoretical understanding of how variations in HTA outcomes might be explained. This paper compares cases of HTA in England and Germany using insights from Kuhn (1962, The Structure of Scientific Revolutions, 2nd edn. Chicago: The University of Chicago Press) and Hall (1993, Policy paradigms, social learning, and the state: the case of economic policymaking in Britain. Comparative Politics 25, 275–296) to demonstrate how policy paradigms can explain the outcomes of HTA processes. The paper finds that HTA outcomes are influenced by a combination of logical issues that require reasoning within a paradigm, and institutional and political issues that speak to the interaction between ideational and interest-based variables. It sets out an approach that advances the theoretical explanation of divergent HTA outcomes, and offers an analytical basis on which to assess current and future policy changes in HTA.

Type
Articles
Copyright
Copyright © Cambridge University Press 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Abraham, J (2003) The science and politics of medicines control. Drug Safety 26, 135143.CrossRefGoogle ScholarPubMed
Abraham, J (2009) Partial progress: governing the pharmaceutical industry and the NHS, 1948–2008. Journal of Health Politics, Policy and Law 34, 931977.CrossRefGoogle ScholarPubMed
Béland, D (2005) Ideas and social policy. Social Policy and Administration 39, 118.CrossRefGoogle Scholar
Béland, D and Cox, RH (2013) The politics of policy paradigms. Governance 26, 193195.CrossRefGoogle Scholar
Biller-Andorno, N, Lie, R and Meulen, R (2002) Evidence-based medicine as an instrument for rational health policy. Health Care Analysis 10, 261275.CrossRefGoogle ScholarPubMed
Böhm, K, Landwehr, C and Steiner, N (2014) What explains ‘generosity’ in the public financing of high-tech drugs? An empirical investigation of 25 OECD countries and 11 controversial drugs. Journal of European Social Policy 24, 3955.CrossRefGoogle Scholar
Charlton, V, Littlejohns, P, Kieslich, K, Mitchell, P, Rumbold, B, Weale, A, Wilson, J and Rid, A (2017) Cost effective but unaffordable: an emerging challenge for health systems. British Medical Journal 356, j1402. doi: https://doi.org/10.1136/bmj.j1402CrossRefGoogle ScholarPubMed
Clark, S and Weale, A (2012) Social values in health priority setting: a conceptual framework. Journal of Health Organization and Management 26, 293316.CrossRefGoogle ScholarPubMed
Daniels, N and Sabin, J (1997) Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philosophy & Public Affairs 26, 303350.CrossRefGoogle ScholarPubMed
Della Porta, D. (2008) Comparative analysis: case-oriented versus variable-oriented research. In della Porta, D and Keating, M (eds), Approaches and Methodologies in the Social Sciences: A Pluralist Perspective. Cambridge: Cambridge University Press, pp. 198223.CrossRefGoogle Scholar
Fischer, KE (2012) A systematic review of coverage decision-making on health technologies – evidence from the real world. Health Policy 107, 218230.CrossRefGoogle ScholarPubMed
Fischer, KE, Heisser, T and Stargardt, T (2016) Health benefit assessment of pharmaceuticals: an international comparison of decisions from Germany, England, Scotland and Australia. Health Policy 120, 11151122.CrossRefGoogle ScholarPubMed
Freeman, R (2009) Pharmaceutical policy and politics in OECD countries. In Marmor, TR, Freeman, R and Okma, KGH (eds), Comparative Studies and the Politics of Modern Medical Care. New Haven: Yale University Press, pp. 244265.CrossRefGoogle Scholar
G-BA (Federal Joint Committee) (2012) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Fingolimod (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 a) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Abirateronacetat (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 b) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Apixaban (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 c) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Boceprevir (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 d) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Cabazitaxel (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 e) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Eribulin (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 f) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Ipilimumab (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 g) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Retigabin (Assessment). Berlin: G-BA.Google Scholar
G-BA (2012 h) Zusammenfassende Dokumentation über die Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V – Telaprevir (Assessment). Berlin: G-BA.Google Scholar
G-BA (2013) Verfahrensordnung des Gemeinsamen Bundesausschusses (Rules of Procedure). Berlin: G-BA.Google Scholar
George, AL and Bennett, A (2005) Case Studies and Theory Development in the Social Sciences. Cambridge: The MIT Press.Google Scholar
Gornall, J, Hoey, A and Ozieranski, P (2016) A pill too hard to swallow: how the NHS is limiting access to high priced drugs. British Medical Journal 354, i4117. doi: http://dx.doi.org/10.1136/bmj.i4117CrossRefGoogle ScholarPubMed
Haas, P (1992) Introduction: epistemic communities and international policy coordination. International Organization 46, 133.CrossRefGoogle Scholar
Hall, PA (ed) (1989) The Political Power of Economic Ideas: Keynesianism Across Nations. Princeton: Princeton University Press.Google Scholar
Hall, PA (1993) Policy paradigms, social learning, and the state: the case of economic policymaking in Britain. Comparative Politics 25, 275296.CrossRefGoogle Scholar
Immergut, EM (1992) Health Politics: Interests and Institutions in Western Europe. Cambridge: Cambridge University Press.Google Scholar
IQWiG (2011) Ticagrelor – Nutzenbewertung gemäß § 35a SGB V. Cologne: IQWiG.Google Scholar
IQWiG (2012) Fingolimod - Nutzenbewertung gemäß § 35a SGB V. Cologne: IQWiG.Google Scholar
IQWiG (2015) Allgemeine Methoden Version 4.2 vom 22.04.2015 (General Methods). Cologne: IQWiG.Google Scholar
Kanavos, P, Nicod, E, van den Aardweg, S and Pomedli, S (2010) The impact of health technology assessments: an international comparison. Euro Observer: The Health Policy Bulletin of the European Observatory on Health Systems and Policies 12, 17.Google Scholar
Kay, A (2007) Tense layering and synthetic policy paradigms: the politics of health insurance in Australia. Australian Journal of Political Science 42, 579591.CrossRefGoogle Scholar
Kenny, N and Joffres, C (2008) An ethical analysis of international health priority-setting. Health Care Analysis 16, 145160.CrossRefGoogle ScholarPubMed
Kieslich, K (2012) Social values and health priority setting in Germany. Journal of Health Organization and Management 26, 374383.CrossRefGoogle Scholar
Kieslich, K (2015) Paradigms in Operation: Pharmaceutical Benefit Assessments in England and Germany. (Doctoral dissertation). University College London, London.Google Scholar
Kieslich, K, Ahn, J, Badano, G, Chalkidou, K, Cubillos, L, Hauegen, RC, Henshall, C, Krubiner, C, Littlejohns, P, Lu, L, Pearson, S, Rid, A, Whitty, JA, Wilson, J (2016) Public participation in decision-making on the coverage of new antivirals for hepatitis C. Journal of Health Organization and Management 30, 769785.CrossRefGoogle ScholarPubMed
Kuhn, TS (1962) The Structure of Scientific Revolutions, 2nd edn.Chicago: The University of Chicago Press.Google Scholar
Löblova, O (2016) Three worlds of health technology assessment: explaining patterns of diffusion of HTA agencies in Europe. Health Economics, Policy and Law 11, 253273.CrossRefGoogle ScholarPubMed
Löblova, O (2018) When epistemic communities fail: exploring the mechanism of policy influence. The Policy Studies Journal 46, 160189.CrossRefGoogle Scholar
Majone, G. (1989) Evidence, Argument, & Persuasion in the Policy Process. New Haven and London: Yale University Press.Google Scholar
Menahem, G (2008) The transformation of higher education in Israel since the 1990s: the role of ideas and policy paradigms. Governance 21, 499526.CrossRefGoogle Scholar
NICE (2011 a) Retigabine for the Adjunctive Treatment of Partial Onset Seizures in Epilepsy. London: NICE.Google Scholar
NICE (2011 b) Ticagrelor for the Treatment of Acute Coronary Syndromes. London: NICE.Google Scholar
NICE (2012) Fingolimod for the Treatment of Highly Active Relapsing-Remitting Multiple Sclerosis. London: NICE.Google Scholar
NICE (2012 a) Abiraterone for Castration-Resistant Metastatic Prostate Cancer Previously Treated with a docetaxel-Containing Regimen. London: NICE.Google Scholar
NICE (2012 b) Apixaban for the Prevention of Venous Thromboembolism after Total Hip or Knee Replacement in Adults. London: NICE.Google Scholar
NICE (2012 c) Boceprevir for the Treatment of Genotype 1 Chronic Hepatitis C. London: NICE.Google Scholar
NICE (2012 d) Cabazitaxel for Hormone-Refractory Metastatic Prostate Cancer Previously Treated with A Docetaxel-Containing Regime. London: NICE.Google Scholar
NICE (2012 e) Eribulin for the Treatment of Locally Advanced or Metastatic Breast Cancer. London: NICE.Google Scholar
NICE (2012 f) Telaprevir for the Treatment of Genotype 1 Chronic Hepatitis C. London: NICE.Google Scholar
NICE (2012 g) Prostate Cancer (Metastatic, Castration Resistant) – Abiraterone (Following Cytotoxic Therapy): Appraisal Consultation. London: NICE.Google Scholar
NICE (2013) Guide to the Methods of Technology Appraisal 2013. London: NICE.Google Scholar
NICE (2014) Final Appraisal Determination: Ipilimumab for Previously Untreated Advanced (Unresectable or Metastatic) Melanoma. London: NICE.Google Scholar
Nicod, E (2017) Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four European countries. European Journal of Health Economics 18, 725730.CrossRefGoogle ScholarPubMed
Nicod, E and Kanavos, P (2012) Commonalities and differences in HTA outcomes: a comparative analysis of five countries and implications for coverage decisions. Health Policy 108, 167177.CrossRefGoogle ScholarPubMed
Norheim, O (2002) The role of evidence in health policy making: a normative perspective. Health Care Analysis 10, 309317.CrossRefGoogle ScholarPubMed
Perleth, M, Gibis, B and Göhlen, B (2009) A short history of health technology assessment in Germany. International Journal of Technology Assessment in Health Care 25, 112119.CrossRefGoogle Scholar
Poteete, AR (2003) Ideas, interests, and institutions: challenging the property rights paradigm in Botswana. Governance 16, 527557.CrossRefGoogle Scholar
Pujolras, LM and Cairns, J (2015) Why do some countries approve cancer drugs and others don't? Journal of Cancer Policy 4, 2125.CrossRefGoogle Scholar
Ragin, CC (1994) Constructing Social Research. Thousand Oaks: Pine Forge Press.Google Scholar
Sabatier, PA and Jenkins-Smith, HC (eds) (1993) Policy Change and Learning: An Advocacy Coalition Approach. Boulder: Westview Press.Google Scholar
Sorenson, C (2009) The role of HTA in coverage and pricing decisions: a cross-country comparison. Euro Observer: The Health Policy Bulletin of the European Observatory on Health Systems and Policies 11, 14.Google Scholar
Sorenson, C and Chalkidou, K (2012) Reflections on the evolution of HTA in Europe. Health Economics, Policy and Law 7, 2545.CrossRefGoogle ScholarPubMed
Van Der Wilt, GJ and Reuzel, R (1998) Assessment of health technologies. Which issues should be addressed? Evaluation 4, 351358.CrossRefGoogle Scholar
Weale, A (1992) The New Politics of Pollution. Manchester: Manchester University Press.Google Scholar
Weale, A, Kieslich, K, Littlejohns, P, Tugendhaft, A, Tumilty, E, Weerasuriya, K, and Whitty, JA (2016) Introduction: priority setting, equitable access and public involvement in health care. Journal of Health Organization and Management 30, 736750.CrossRefGoogle Scholar