{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:06:08Z","timestamp":1786982768707,"version":"build-2736575974"},"reference-count":43,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T00:00:00Z","timestamp":1630713600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T00:00:00Z","timestamp":1630713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100009032","name":"Pfizer UK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009032","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["PharmacoEconomics"],"published-print":{"date-parts":[[2022,1]]},"DOI":"10.1007\/s40273-021-01070-1","type":"journal-article","created":{"date-parts":[[2021,9,3]],"date-time":"2021-09-03T22:12:23Z","timestamp":1630707143000},"page":"13-29","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["The Challenges of Outcomes-Based Contract Implementation for Medicines in Europe"],"prefix":"10.1007","volume":"40","author":[{"given":"Natalie","family":"Bohm","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Bermingham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2766-5347","authenticated-orcid":false,"given":"Frank","family":"Grimsey Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela C.","family":"Gon\u00e7alves-Bradley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Diamantopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica R.","family":"Burton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamish","family":"Laing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,9,4]]},"reference":[{"issue":"9","key":"1070_CR1","doi-asserted-by":"publisher","first-page":"901","DOI":"10.1007\/s40273-020-00918-2","volume":"38","author":"P Catchpole","year":"2020","unstructured":"Catchpole P, Barrett V. Keeping pace with pharmaceutical innovation: the importance of the NICE methods review. Pharmacoeconomics. 2020;38(9):901\u20133.","journal-title":"Pharmacoeconomics"},{"issue":"11","key":"1070_CR2","doi-asserted-by":"publisher","first-page":"1165","DOI":"10.1007\/s40273-020-00943-1","volume":"38","author":"C Zampirolli Dias","year":"2020","unstructured":"Zampirolli Dias C, et al. Integrative review of managed entry agreements: chances and limitations. Pharmacoeconomics. 2020;38(11):1165\u201385.","journal-title":"Pharmacoeconomics"},{"issue":"12","key":"1070_CR3","doi-asserted-by":"publisher","first-page":"1469","DOI":"10.1007\/s40273-019-00838-w","volume":"37","author":"F Antonanzas","year":"2019","unstructured":"Antonanzas F, et al. The use of risk-sharing contracts in healthcare: theoretical and empirical assessments. Pharmacoeconomics. 2019;37(12):1469\u201383.","journal-title":"Pharmacoeconomics"},{"issue":"6","key":"1070_CR4","doi-asserted-by":"publisher","first-page":"743","DOI":"10.1080\/14737167.2019.1587296","volume":"19","author":"J Darb\u00e0","year":"2019","unstructured":"Darb\u00e0 J, Ascanio M. The current performance-linked and risk sharing agreement scene in the Spanish region of Catalonia. Expert Rev Pharmacoecon Outcomes Res. 2019;19(6):743\u20138.","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"issue":"2","key":"1070_CR5","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1017\/S0266462311000079","volume":"27","author":"L Garattini","year":"2011","unstructured":"Garattini L, Casadei G. Risk sharing agreements: what lessons from Italy? Int J Technol Assess Health Care. 2011;27(2):169\u201372.","journal-title":"Int J Technol Assess Health Care"},{"issue":"35","key":"1070_CR6","doi-asserted-by":"publisher","first-page":"1063","DOI":"10.1007\/s40273-017-0535-z","volume":"10","author":"JJ Carlson","year":"2017","unstructured":"Carlson JJ, Chen S, Garrison LP. Performance-based risk-sharing arrangements: an updated international review. Pharmacoeconomics. 2017;10(35):1063\u201372.","journal-title":"Pharmacoeconomics"},{"issue":"1","key":"1070_CR7","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1080\/1364557032000119616","volume":"8","author":"H Arksey","year":"2005","unstructured":"Arksey H, O\u2019Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. 2005;8(1):19\u201332.","journal-title":"Int J Soc Res Methodol"},{"key":"1070_CR8","doi-asserted-by":"publisher","unstructured":"Cole A, et al. Making Outcome-Based Payment a Reality in the NHS. 2019. https:\/\/doi.org\/10.1007\/s40271-020-00430-x.","DOI":"10.1007\/s40271-020-00430-x"},{"issue":"1","key":"1070_CR9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/13696998.2016.1215991","volume":"20","author":"A Clopes","year":"2017","unstructured":"Clopes A, et al. Financial consequences of a payment-by-results scheme in Catalonia: gefitinib in advanced EGFR-mutation positive non-small-cell lung cancer. J Med Econ. 2017;20(1):1\u20137.","journal-title":"J Med Econ"},{"issue":"5","key":"1070_CR10","doi-asserted-by":"publisher","first-page":"703","DOI":"10.1016\/j.jval.2013.04.011","volume":"16","author":"LP Garrison Jr","year":"2013","unstructured":"Garrison LP Jr, 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\u201319.","journal-title":"Value Health"},{"issue":"12","key":"1070_CR11","doi-asserted-by":"publisher","first-page":"2329","DOI":"10.1377\/hlthaff.2010.1147","volume":"30","author":"PJ Neumann","year":"2011","unstructured":"Neumann PJ, et al. Risk-sharing arrangements that link payment for drugs to health outcomes are proving hard to implement. Health Aff. 2011;30(12):2329\u201337.","journal-title":"Health Aff"},{"key":"1070_CR12","unstructured":"Wenzl M, Chapman S. Performance-based managed entry agreements for new medicines in OECD countries and EU member states: how they work and possible improvements going forward, in Health Working Papers OECD. 2019."},{"issue":"22","key":"1070_CR13","doi-asserted-by":"publisher","first-page":"8309","DOI":"10.3390\/ijerph17228309","volume":"17","author":"RA Vreman","year":"2020","unstructured":"Vreman RA, et al. Application of managed entry agreements for innovative therapies in different settings and combinations: a feasibility analysis. Int J Environ Res Public Health. 2020;17(22):8309.","journal-title":"Int J Environ Res Public Health"},{"issue":"11","key":"1070_CR14","first-page":"5","volume":"2020","author":"S Michelsen","year":"1914","unstructured":"Michelsen S, et al. Barriers and opportunities for implementation of outcome-based spread payments for high-cost, one-shot curative therapies. Front Pharmacol. 1914;2020(11):5.","journal-title":"Front Pharmacol"},{"key":"1070_CR15","doi-asserted-by":"publisher","first-page":"280","DOI":"10.3389\/fphar.2018.00280","volume":"9","author":"JC Bouvy","year":"2018","unstructured":"Bouvy JC, Sapede C, Garner S. Managed entry agreements for pharmaceuticals in the context of adaptive pathways in Europe. Front Pharmacol. 2018;9:280.","journal-title":"Front Pharmacol"},{"key":"1070_CR16","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1186\/1472-6963-10-153","volume":"10","author":"J Adamski","year":"2010","unstructured":"Adamski J, et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010;10:153\u2013153.","journal-title":"BMC Health Serv Res"},{"issue":"4","key":"1070_CR17","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1016\/j.jval.2019.12.008","volume":"23","author":"M Dabbous","year":"2020","unstructured":"Dabbous M, et al. Managed entry agreements: policy analysis from the European perspective. Value Health. 2020;23(4):425\u201333.","journal-title":"Value Health"},{"issue":"1","key":"1070_CR18","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1016\/j.jval.2014.09.007","volume":"18","author":"A Navarria","year":"2015","unstructured":"Navarria A, et al. Do the current performance-based schemes in Italy really work? \u201cSuccess fee\u201d: a novel measure for cost-containment of drug expenditure. Value Health. 2015;18(1):131\u20136.","journal-title":"Value Health"},{"issue":"6","key":"1070_CR19","doi-asserted-by":"publisher","first-page":"377","DOI":"10.2165\/11531160-000000000-00000","volume":"8","author":"M Willis","year":"2010","unstructured":"Willis M, et al. Reducing uncertainty in value-based pricing using evidence development agreements. Appl Health Econ Health Policy. 2010;8(6):377\u201386.","journal-title":"Appl Health Econ Health Policy"},{"issue":"1","key":"1070_CR20","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1186\/s13561-019-0242-x","volume":"9","author":"R Lorente","year":"2019","unstructured":"Lorente R, Antonanzas F, Rodriguez-Ibeas R. Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists. Heal Econ Rev. 2019;9(1):25.","journal-title":"Heal Econ Rev"},{"issue":"3","key":"1070_CR21","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1016\/j.healthpol.2020.11.009","volume":"125","author":"CG Garc\u00eda-Collado","year":"2021","unstructured":"Garc\u00eda-Collado CG, et al. Impact of a risk-sharing agreement in rheumatoid arthritis in Spain. Health Policy. 2021;125(3):335\u201340.","journal-title":"Health Policy"},{"issue":"1","key":"1070_CR22","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1186\/1472-6963-11-259","volume":"11","author":"S Jaros\u0142awski","year":"2011","unstructured":"Jaros\u0142awski S, Toumi M. Market access agreements for pharmaceuticals in Europe: diversity of approaches and underlying concepts. BMC Health Serv Res. 2011;11(1):259.","journal-title":"BMC Health Serv Res"},{"issue":"3","key":"1070_CR23","doi-asserted-by":"publisher","first-page":"267","DOI":"10.1016\/j.healthpol.2018.09.016","volume":"123","author":"A Makady","year":"2019","unstructured":"Makady A, et al. Implementing managed entry agreements in practice: the Dutch reality check. Health Policy. 2019;123(3):267\u201374.","journal-title":"Health Policy"},{"key":"1070_CR24","unstructured":"US Food & Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. Accessed 2020."},{"key":"1070_CR25","unstructured":"Pollack A. Pricing pills by the results. New York Times. 2007. https:\/\/www.nytimes.com\/2007\/07\/14\/business\/14drugprice.html. Accessed 14 Jul 2007."},{"key":"1070_CR26","unstructured":"Department of Health & Social Care. Code of conduct for data-driven health and care technology. 2019. https:\/\/www.gov.uk\/government\/publications\/code-of-conduct-for-data-driven-health-and-care-technology\/initial-code-of-conduct-for-data-driven-health-and-care-technology. Accessed 2020."},{"issue":"1","key":"1070_CR27","first-page":"10","volume":"44","author":"MD Edo-Solsona","year":"2020","unstructured":"Edo-Solsona MD, Vitoria-Minana I, Poveda-Andres JL. Implementation and results of a risk-sharing scheme for enzyme replacement therapy in lysosomal storage diseases. Farm Hosp. 2020;44(1):10\u20135.","journal-title":"Farm Hosp"},{"issue":"4","key":"1070_CR28","doi-asserted-by":"publisher","first-page":"137","DOI":"10.4103\/2229-3485.86879","volume":"2","author":"PR Deshpande","year":"2011","unstructured":"Deshpande PR, et al. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res. 2011;2(4):137\u201344.","journal-title":"Perspect Clin Res"},{"key":"1070_CR29","unstructured":"The European Patients' Academy on Therapeutic Innovation (EUPATI). Patient-reported outcomes (PROs) assessment. 2020. https:\/\/toolbox.eupati.eu\/resources\/patient-reported-outcomes-pros-assessment\/. Accessed 2020."},{"key":"1070_CR30","unstructured":"National Insitute for Health and Care Excellence (NICE). Shared decision making. 2021. https:\/\/www.nice.org.uk\/about\/what-we-do\/our-programmes\/nice-guidance\/nice-guidelines\/shared-decision-making. Accessed 2021."},{"issue":"30","key":"1070_CR31","doi-asserted-by":"publisher","first-page":"4249","DOI":"10.1200\/JCO.2012.42.5967","volume":"34","author":"E Basch","year":"2012","unstructured":"Basch E, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol. 2012;34(30):4249\u201355.","journal-title":"J Clin Oncol"},{"issue":"1","key":"1070_CR32","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/1478-7547-10-9","volume":"10","author":"LA Guindo","year":"2012","unstructured":"Guindo LA, et al. From efficacy to equity: Literature review of decision criteria for resource allocation and healthcare decisionmaking. Cost Effective Resourc Alloc. 2012;10(1):9.","journal-title":"Cost Effective Resourc Alloc"},{"key":"1070_CR33","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1136\/bmj.f167","volume":"346","author":"N Black","year":"2013","unstructured":"Black N. Patient reported outcome measures could help transform healthcare. Br Med J. 2013;346:167.","journal-title":"Br Med J"},{"issue":"1","key":"1070_CR34","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1016\/j.jval.2017.07.009","volume":"21","author":"JD Brown","year":"2018","unstructured":"Brown JD, et al. Payer and pharmaceutical manufacturer considerations for outcomes-based agreements in the United States. Value Health. 2018;21(1):33\u201340.","journal-title":"Value Health"},{"key":"1070_CR35","unstructured":"Seeley E, Kesselheim AS. Outcomes-based pharmaceutical contracts: an answer to high US Drug Spending? 2017. https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2017\/sep\/outcomes-based-pharmaceutical-contracts-answer-high-us-drug. Accessed 2021."},{"key":"1070_CR36","unstructured":"Mytelka D, et al. Managing uncertainty in drug value: outcomes-based contracting supports value-based pricing. Health Affairs Blog. 2020. https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20200128.542919\/full\/. Accessed 30 Jan 2020."},{"key":"1070_CR37","unstructured":"Mulligan K, et al. Health technology assessment for the US Healthcare system. 2020. https:\/\/healthpolicy.usc.edu\/wp-content\/uploads\/2020\/02\/Health-Technology-Assessment-for-the-U.S.-Healthcare-System_White-Paper.pdf."},{"key":"1070_CR38","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1007\/s40273-020-00981-9","volume":"39","author":"S Kent","year":"2021","unstructured":"Kent S, et al. Common problems, common data model solutions: evidence generation for health technology assessment. Pharmacoeconomics. 2021;39:275\u201385.","journal-title":"Pharmacoeconomics"},{"key":"1070_CR39","unstructured":"Heppolette W, Rouse J. Pharmaceutical industry memorandum of understanding. 2017. https:\/\/www.gmhsc.org.uk\/wp-content\/uploads\/2018\/04\/05-Pharma-Industry-MoU-Cover-Sheet-FINAL.pdf."},{"issue":"12","key":"1070_CR40","doi-asserted-by":"publisher","first-page":"1107","DOI":"10.1007\/s40261-020-00972-w","volume":"40","author":"AE Kim","year":"2020","unstructured":"Kim AE, et al. Performance-Based risk-sharing arrangements (PBRSA): is it a solution to increase bang for the buck for pharmaceutical reimbursement strategy for our nation and around the world? Clin Drug Investig. 2020;40(12):1107\u201313.","journal-title":"Clin Drug Investig"},{"issue":"2","key":"1070_CR41","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1007\/s10198-009-0166-1","volume":"11","author":"U Persson","year":"2010","unstructured":"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(2):195\u2013203.","journal-title":"Eur J Health Econ"},{"key":"1070_CR42","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1471-2377-9-1","volume":"9","author":"M Pickin","year":"2009","unstructured":"Pickin M, et al. The multiple sclerosis risk sharing scheme monitoring study\u2013early results and lessons for the future. BMC Neurol. 2009;9:1\u20131.","journal-title":"BMC Neurol"},{"issue":"1","key":"1070_CR43","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1186\/s40545-021-00311-0","volume":"14","author":"V Ronco","year":"2021","unstructured":"Ronco V, et al. Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations? J Pharmaceut Policy Pract. 2021;14(1):30.","journal-title":"J Pharmaceut Policy Pract"}],"container-title":["PharmacoEconomics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40273-021-01070-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40273-021-01070-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40273-021-01070-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,1,6]],"date-time":"2022-01-06T16:44:57Z","timestamp":1641487497000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40273-021-01070-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,4]]},"references-count":43,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["1070"],"URL":"https:\/\/doi.org\/10.1007\/s40273-021-01070-1","relation":{},"ISSN":["1170-7690","1179-2027"],"issn-type":[{"value":"1170-7690","type":"print"},{"value":"1179-2027","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,4]]},"assertion":[{"value":"18 July 2021","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 September 2021","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"SB, FGJ and AD led the development of the thematic analysis, by identifying relevant topics and subtopics. NB, JRB and HL contributed with comments to the thematic analysis. SB, FGJ, DGB and AD were involved in the literature review and data extraction. All authors contributed to the writing of this article and reviewed and approved the manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}},{"value":"This study was partially funded by Pfizer Limited.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"NB and JRB are employees of Pfizer Limited. HL is employed by Swansea University, which has received funding from Pfizer Limited. SB, FGJ, DGB and AD are employees of Symmetron Limited, who received funding from Pfizer Limited to complete this work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Data available on request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}