{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T13:00:47Z","timestamp":1784120447129,"version":"3.55.0"},"reference-count":49,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T00:00:00Z","timestamp":1698105600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005622","name":"Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005622","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Even using well-established technology assessment processes, the basis of the decisions on drug price and reimbursement are sometimes perceived as poorly informed and sometimes may be seen as disconnected from value. The literature remains inconclusive about how Health Technology Assessment Bodies (HTAb) should report the determinants of their decisions. This study evaluates the relationship between oncology and hematology drug list prices and structured value parameters at the time of reimbursement decision in Spain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The study includes all new onco-hematological products (22), with a first indication authorized between January 2017 and December 2019 in Spain and pricing decisions published up until October 2022. For each product, 56 contextual and non-contextual indicators reflecting the structured multiple criteria decision analysis (MCDA) \u2013 Evidence-based Decision-Making (EVIDEM) framework were measured. The relationship between prices and the MCDA-EVIDEM framework was explored using univariate statistical analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Higher prices were observed when the standard of care included for combinations, if there were references to long-lasting responses, for fixed-duration treatment compared to treatment until progression and treatment with lower frequencies of administration; lower prices were observed for oral administration compared to other routes of administration. Statistically significant associations were observed between prices and the median duration of treatment, the impact on patient autonomy, the ease of use of the drug, and the recommendations of experts.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The study suggests that indicators related to the type of standard of care, references to long-lasting responders, the convenience of the use of the drug, and the impact of treatment on patient autonomy, as well as contextual indicators such as the existence of previous clinical consensus, are factors in setting oncology drug prices in Spain. The implementation of MCDA-EVIDEM methodologies may be useful to capture the influence on pricing decisions of additional factors not included in legislation or consolidated assessment frameworks such as the European Network for Health Technology Assessment (EunetHTA) core model. It may be opportune to consider this in the upcoming revision of the Spanish regulation for health technology assessments and pricing and reimbursement procedures.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2023.1265323","type":"journal-article","created":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T13:31:00Z","timestamp":1698154260000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Reporting reimbursement price decisions for onco-hematology drugs in Spain"],"prefix":"10.3389","volume":"11","author":[{"given":"David","family":"Elvira","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferran","family":"Torres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roser","family":"Vives","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gemma","family":"Puig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merc\u00e8","family":"Obach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Gay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Var\u00f3n","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thais","family":"de Pando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josep","family":"Tabernero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caridad","family":"Pontes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,10,24]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"527","DOI":"10.1080\/14737167.1884546","article-title":"Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications","volume":"21","author":"Godman","year":"2021","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1016\/j.ejca.2020.01.011","article-title":"The cost of cancer in Europe 2018","volume":"129","author":"Hofmarcher","year":"2020","journal-title":"Eur J Cancer"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"j4530","DOI":"10.1136\/bmj.j4530","article-title":"Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European medicines agency: retrospective cohort study of drug approvals 2009-13","volume":"359","author":"Davis","year":"2017","journal-title":"BMJ (Clinical Res Ed)"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"889","DOI":"10.3390\/cancers14040889","article-title":"Oncologic drugs approval in Europe for solid tumors: overview of the last 6 years","volume":"14","author":"Falcone","year":"2022","journal-title":"Cancers (Basel)"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1007\/s40258-019-00527-x","article-title":"Time to review authorisation and funding for new Cancer medicines in Europe? Inferences from the case of Olaratumab","volume":"18","author":"Pontes","year":"2019","journal-title":"Appl Health Econ Health Policy"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1586\/17512433.2015.990380","article-title":"Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?","volume":"8","author":"Godman","year":"2015","journal-title":"Expert Rev Clin Pharmacol"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"171","DOI":"10.3389\/fphar.2017.00171","article-title":"Managed entry agreements for oncology drugs: lessons from the European experience to inform the future","volume":"8","author":"Pauwels","year":"2017","journal-title":"Front Pharmacol"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1007\/s41669-017-0044-1","article-title":"Risk-sharing agreements in the EU: a systematic review of major trends","volume":"2","author":"Piatkiewicz","year":"2018","journal-title":"Pharmacoecon Open"},{"key":"ref9","volume-title":"Technical report: Pricing of cancer medicines and its impacts","year":"2018"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1038\/s41571-018-0027-x","article-title":"Sustainability and affordability of cancer drugs: a novel pricing model","volume":"15","author":"Uyl-de Groot","year":"2018","journal-title":"Nat Rev Clin Oncol"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"2069","DOI":"10.1001\/jama.2016.4915","article-title":"Utility of cancer value frameworks for patients, payers, and physicians","volume":"315","author":"Chandra","year":"2016","journal-title":"JAMA"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"761","DOI":"10.1007\/s40258-019-00495-2","article-title":"A framework to prioritise Health Research proposals for funding: integrating value for money","volume":"17","author":"Tuffaha","year":"2019","journal-title":"Appl Health Econ Health Policy"},{"key":"ref13","article-title":"Assessing the value of biopharmaceitical innovation in key therapy areas in middle-income countries","author":"Wilsdon","year":"2013"},{"key":"ref14","article-title":"Evaluaci\u00f3n, financiaci\u00f3n y regulaci\u00f3n de los medicamentos innovadores en los pa\u00edses desarrollados","author":"Hidalgo-Vega","year":"2018"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"j4543","DOI":"10.1136\/bmj.j4543","article-title":"Cancer drugs: high price, uncertain value","volume":"359","author":"Cohen","year":"2017","journal-title":"BMJ"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1016\/S1470-2045(20)30139-X","article-title":"Prices and clinical benefit of cancer drugs in the USA and Europe: a cost\u2013benefit analysis","volume":"21","author":"Vokinger","year":"2020","journal-title":"Lancet Oncol"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"1273","DOI":"10.1016\/j.jval.2021.04.1278","article-title":"Drug prices and value of oncology drugs in Italy","volume":"24","author":"Russo","year":"2021","journal-title":"Value Health"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"113042","DOI":"10.1016\/j.socscimed.2020.113042","article-title":"Relationship between costs and clinical benefits of new cancer medicines in Australia, France, the UK, and the US","volume":"258","author":"Salas-Vega","year":"2020","journal-title":"Soc Sci Med"},{"key":"ref19","volume-title":"Ensuring access to medicines: How to redesign pricing, reimbursement, and procurement?","author":"Vogler","year":"2018"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1017\/S0266462321000039","article-title":"Determinants of managed entry agreements in the context of health echnology assessment: a comparative analysis of oncology therapies in four countries","volume":"37","author":"Efthymiadou","year":"2021","journal-title":"Int J Technol Assess Health Care"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"814","DOI":"10.1186\/s12913-021-06784-8","article-title":"Description of the use of multicriteria to support pricing and reimbursement decisions by European health technology assessment bodies","volume":"21","author":"Elvira","year":"2021","journal-title":"BMC Health Serv Res"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"599","DOI":"10.1007\/s40271-020-00430-x","article-title":"Outcome-based payment schemes: what outcomes do patients with Cancer value?","volume":"13","author":"Lorgelly","year":"2020","journal-title":"Patient-Cent Outcomes Res"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"6132","DOI":"10.1002\/cam4.3191","article-title":"Therapy preferences in melanoma treatment\u2014willingness to pay and preference of quality versus length of life of patients, physicians, healthy individuals, and physicians with oncological disease","volume":"9","author":"Weiss","year":"2020","journal-title":"Cancer Med"},{"key":"ref24","year":"2021"},{"key":"ref25","first-page":"1","volume-title":"Plan para la consolidaci\u00f3n de los informes de posicionamiento terap\u00e9utico (IPT) de los medicamentos en el sistema nacional de salud (SNS)","year":"2020"},{"key":"ref26","author":"de Espana","year":"2022"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"e48","DOI":"10.1017\/S0266462322000332","article-title":"Feasibility study to characterize price and reimbursement decision-making criteria for the inclusion of new drugs in the Spanish National Health System: the cefiderocol example","volume":"38","author":"Calleja","year":"2022","journal-title":"Int J Technol Assess Health Care"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1016\/j.gaceta.2019.02.009","article-title":"Evaluation of new medicines in Spain and comparison with other European countries","volume":"34","author":"Epstein","year":"2020","journal-title":"Gac Sanit"},{"key":"ref29","author":"de Espana","year":"2015"},{"key":"ref30","year":"2022"},{"key":"ref31","year":"2022"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"112595","DOI":"10.1016\/j.socscimed.2019.112595","article-title":"Multiple criteria decision analysis for HTA across four EU member states: piloting the advance value framework","volume":"246","author":"Angelis","year":"2020","journal-title":"Soc Sci Med"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1186\/s12911-017-0524-3.2017","article-title":"Multiple criteria decision analysis in the context of health technology assessment: a simulation exercise on metastatic colorectal cancer with multiple stakeholders in the English setting","volume":"17","author":"Angelis","year":"2017","journal-title":"BMC Med Inform Decis Mak"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"e0225938","DOI":"10.1371\/journal.pone.0225938","article-title":"Comprehensive value assessment of drugs using a multi-criteria decision analysis: an example of targeted therapies for metastatic colorectal cancer treatment","volume":"14","author":"Hsu","year":"2019","journal-title":"PloS One"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"e033728","DOI":"10.1136\/bmjopen-2019-033728","article-title":"Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy","volume":"9","author":"Trotta","year":"2019","journal-title":"BMJ Open"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"1215","DOI":"10.1007\/s12325-018-0745-6","article-title":"Applying reflective multicriteria decision analysis (MCDA) to patient\u2013clinician shared decision-making on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) in the Spanish context","volume":"35","author":"Wagner","year":"2018","journal-title":"Adv Ther"},{"key":"ref37","year":"2022"},{"key":"ref38","year":"2022"},{"key":"ref39","year":"2022"},{"key":"ref40","doi-asserted-by":"publisher","first-page":"270","DOI":"10.1186\/1472-6963-8-270","article-title":"Evidence and value: impact on DEcisionMaking - the EVIDEM framework and potential applications","volume":"8","author":"Goetghebeur","year":"2008","journal-title":"BMC Health Serv Res"},{"key":"ref41","year":"2022"},{"key":"ref42","doi-asserted-by":"publisher","first-page":"1559","DOI":"10.1016\/j.jval.2022.04.1733","article-title":"The role of perceived utility of full health in age weighting","volume":"25","author":"Attema","year":"2022","journal-title":"Value Health"},{"key":"ref43","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1016\/j.socscimed.2005.11.046","article-title":"The pervasiveness of pharmaceutical expenditure inertia in the OECD countries","volume":"63","author":"Okunade","year":"2006","journal-title":"Soc Sci Med"},{"key":"ref44","doi-asserted-by":"publisher","first-page":"1768","DOI":"10.1093\/annonc\/mdw233","article-title":"Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries","volume":"27","author":"Kleijnen","year":"2006","journal-title":"Ann Oncol"},{"key":"ref45","doi-asserted-by":"publisher","first-page":"1049","DOI":"10.1007\/s10198-020-01201-z","article-title":"Predictors of negotiated prices for new drugs in Germany","volume":"21","author":"Gandjour","year":"2020","journal-title":"Eur J Health Econ"},{"key":"ref46","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1111\/bcp.14138","article-title":"Using GRADE methodology to assess innovation of new medicinal products in Italy","volume":"86","author":"Fortinguerra","year":"2020","journal-title":"Br J Clin Pharmacol"},{"key":"ref47","year":"2023"},{"key":"ref48","year":"2019"},{"key":"ref49","year":""}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2023.1265323\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T13:31:06Z","timestamp":1698154266000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2023.1265323\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,24]]},"references-count":49,"alternative-id":["10.3389\/fpubh.2023.1265323"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2023.1265323","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,24]]},"article-number":"1265323"}}