Effectiveness of National Pricing Policies for Patent-Protected Pharmaceuticals in the OECD: A Systematic Literature Review
- 299 Downloads
The aim of this review is to assess the current state of empirical research regarding the effectiveness of national pricing regulations of the patent-protected market for prescription pharmaceuticals. Effectiveness is understood to be the capacity of policies to have a desired impact on outcomes, such as health status, patient access, healthcare expenditure, and research investments, among others.
A systematic review of the published literature on pricing regulations in OECD countries was performed. The PubMed, MEDLINE, Scopus, Web of Science, Cochrane Library and the OECD iLibrary databases were searched in September 2016 and December 2017, with an update in August 2018. Interrupted time series studies and additional empirical studies were included, as well as systematic reviews if appropriate methods were applied. The risk of bias was assessed based on the recommendations of the BMJ guidelines, Cochrane EPOC criteria, QHES instrument, HTA good practice guidelines, CRD’s guidance and the CHEC criteria. The quality of evidence was evaluated using the suggestions from EPOC and GRADE.
Thirty-one publications met the inclusion criteria. Most of the assessed empirical research included therapeutic (TRP) and/or external reference pricing (ERP), with a clear majority focusing on TRP. The main outcomes that were analysed were drug prices, expenditures and drug use. For value-based pricing (VBP), only limited empirical data were found.
We found evidence that TRP may reduce pharmaceutical prices and expenditures in the short term. Furthermore, TRP may lead to substitution effects towards lower-priced pharmaceuticals. The effects of TRP on patient access, healthcare utilisation and R&D investments were found to be uncertain. No conclusions were drawn for ERP and VBP. No evidence was found for the effects on health outcomes for any of the analysed policies. There is a strong need for evidence generation regarding effective pricing policies, particularly for VBP, managed entry agreements and non-financial outcomes.
All of the authors (DJW and SB) fulfilled the authorship criteria and contributed to the design of the study, review of the search protocol, analysis and interpretation of the results, and writing and review of the manuscript. DJW prepared the search protocol, performed the database searches, screenings, categorisations, and assessments and prepared the draft of the manuscript. All of the authors are aware of the submission and are in agreement with the manuscript.
Compliance with Ethical Standards
No funding was received for the research performed or the writing of the manuscript.
Conflict of interest
DJW is an external PhD student at the University of Lucerne and was employed at the pharmaceutical company Takeda Pharma while performing this research. Neither the former employer of the first author nor any other private or public entity supported or influenced this research in any relevant way. SB has no conflicts of interest to declare. All of the authors submitted a signed Conflict of Interest disclosure form.
- 1.Belloni A, Morgan D, Paris V. Pharmaceutical expenditure and policies: past trends and future challenges. OECD Health Working Papers. 2016;(87):0_1–4,8–73.Google Scholar
- 6.Aitken M, Kleinrock M. Global oncology trend report: a review of 2015 and outlook to 2020. IMS Institute for Healthcare Informatics; 2016.Google Scholar
- 7.Aitken M, Kleinrock M, Simorellis A, Nass D. Global oncology trends 2018, innovation, expansion and disruption. IQVIA Institute for Human Data Science; 2018. https://www.iqvia.com/institute/reports/global-oncology-trends-2018.
- 12.Paris V, Belloni A. Value in pharmaceutical pricing. OECD Health Working Papers, No. 63. Paris: OECD Publishing; 2013. https://doi.org/10.1787/5k43jc9v6knx-en.
- 13.OECD. New health technologies: managing access, value and sustainability. Paris: OECD Publishing; 2017. https://doi.org/10.1787/9789264266438-en.
- 14.Expert Panel on effective ways of investing in Health (EXPH). Innovative payment models for high-cost innovative medicines. European Commission; 2018. https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/docsdir/opinion_innovative_medicines_en.pdf.
- 16.Lorenzoni L, Murtin F, Springare L-S, Auraaen A, Daniel F. Which policies increase value for money in health care? OECD Health Working Papers, No. 104. Paris: OECD Publishing. 2018. https://doi.org/10.1787/a46c5b1f-en.
- 17.Cole A, Towse A, Lorgelly P, Sullivan R. Economics of innovative payment models compared with single pricing of pharmaceuticals. OHE Research Paper 18/04, London: Office of Health Economics; 2018. https://www.ohe.org/publications/economics-innovative-payment-models-compared-single-pricing-pharmaceuticals#overlay-context=publications.
- 19.Espin J, Rovera J, de Labry AO. Working paper 1: external price referencing—review series on pharmaceutical pricing policies and interventions. Geneva: World Health Organization and Health Action International; 2011.Google Scholar
- 20.Acosta A, Ciapponi A, Aaserud M, et al. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database Syst Rev. 2014(10):CD005979.Google Scholar
- 21.Green CJ, Maclure M, Fortin PM, Ramsay CR, Aaserud M, Bardal S. Pharmaceutical policies: effects of restrictions on reimbursement. Cochrane Database Syst Rev. 2010(8):CD008654.Google Scholar
- 23.Vogler S, Zimmermann N. Glossary of pharmaceutical terms. In: WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, ed. WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies; 2016. http://whocc.goeg.at.
- 24.Verordnung über die Krankenversicherung (KVV). In: Bundesrat DS, ed. vol 832.102. Systematische Sammlung des Bundesrechts (SR). 1995.Google Scholar
- 26.Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. 2013. http://eprints.lse.ac.uk/50513/.
- 28.Garrison LP Jr, Towse A, Briggs A, et al. Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force. Value Health. 2013;16(5):703–19.PubMedCrossRefGoogle Scholar
- 31.Spezialitätenliste: Avastin. BAG; 2018. http://www.spezialitaetenliste.ch/. Accessed 1 Aug 2018.
- 33.PubMed. PubMed search. 2018; https://www.ncbi.nlm.nih.gov/pubmed/. Accessed 31 Aug 2018.
- 34.Cochrane Effective Practice and Organisation of Care (EPOC). What study designs should be included in an EPOC review? EPOC Resources for review authors. Oslo: Norwegian Knowledge Centre for the Health Services; 2016.Google Scholar
- 36.World Bank Country and Lending Groups. 2016. https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups. Accessed 31 Dec 2016.
- 37.Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ (Clinical research ed.). 2009;339:b2535.Google Scholar
- 38.Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ (Clinical research ed.). 1996;313(7052):275–83.Google Scholar
- 39.Drummond M, Sculpher M, Torrance G, O’Brien BJ, Stoddart G, editors. Methods for the economic evaluation of health care programmes. 3rd ed. Oxford: Oxford University Press; 2005.Google Scholar
- 40.Cochrane Effective Practice and Organisation of Care (EPOC). Suggested risk of bias criteria for EPOC reviews. EPOC Resources for review authors. Oslo: Norwegian Knowledge Centre for the Health Services; 2015.Google Scholar
- 43.Tacconelli E. Systematic reviews: CRD’s guidance for undertaking reviews in health care. Heslington, York: University of York NHS Centre for Reviews & Dissemination; 2009. ISBN 978-1-900640-47-3.Google Scholar
- 46.Cochrane Effective Practice and Organisation of Care (EPOC). Reporting the effects of an intervention in EPOC reviews. EPOC Resources for review authors. 2017:24. https://epoc.cochrane.org/resources/epoc-resources-review-authors. https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/how_to_report_the_effects_of_an_intervention.pdf.
- 73.Cochrane Effective Practice and Organisation of Care (EPOC). Interrupted time series (ITS) analyses. EPOC resources for review authors. 2013. https://epoc.cochrane.org/resources/epoc-resources-review-authors. https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/interrupted_time_series_analyses.docx.
- 84.EFPIA. EFPIA response to draft opinion on innovative payment models for high-cost innovative medicines. 2017. https://www.efpia.eu/media/288630/final_efpia-response-to-exph-draft-opinion-7_12_2017_wir.pdf.
- 85.European Parliament. European Parliament resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)). European Parliament; 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52017IP0061.
- 88.HABERMAS, Jürgen. Verwissenschaftlichte Politik und öffentliche Meinung. Rentsch, 1964. In: (PUBLISHER) Bretscher, Willy. (1964). Humanität und politische Verantwortung. Erlenbach-Zürich.Google Scholar
- 89.Jasanoff S. States of knowledge : the co-production of science and the social order. London: Routledge; 2005.Google Scholar