{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T00:14:07Z","timestamp":1773965647036,"version":"3.50.1"},"reference-count":41,"publisher":"Universidad Nacional de Lanus","license":[{"start":{"date-parts":[[2019,3,10]],"date-time":"2019-03-10T00:00:00Z","timestamp":1552176000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SC"],"abstract":"<jats:p>En Argentina, los nuevos medicamentos pueden ser autorizados presentando el certificado de aprobaci\u00f3n en al menos uno de los 15 pa\u00edses considerados de alta vigilancia sanitaria, sin necesidad de realizar una evaluaci\u00f3n propia de eficacia, seguridad o valor terap\u00e9utico agregado por el nuevo producto. En este art\u00edculo, evaluamos los nuevos medicamentos comercializados en Argentina en el a\u00f1o 2016, utilizando diferentes enfoques: su aprobaci\u00f3n por otras agencias reguladoras, demostraci\u00f3n de eficacia en ensayos cl\u00ednicos aleatorizados, tipo de desenlaces estudiados, calificaci\u00f3n del valor terap\u00e9utico agregado por medio de dos escalas reconocidas y el precio de venta al p\u00fablico. Se concluye que, como reflejo de lo que ocurre en los pa\u00edses desarrollados, los nuevos medicamentos ingresan con precios exorbitantes, pero la mayor\u00eda no representa un avance terap\u00e9utico significativo. El resultado es un aumento de riesgos para los pacientes y una sobrecarga para los sistemas de financiaci\u00f3n p\u00fablicos y privados.<\/jats:p>","DOI":"10.18294\/sc.2019.1962","type":"journal-article","created":{"date-parts":[[2019,3,22]],"date-time":"2019-03-22T20:50:21Z","timestamp":1553287821000},"page":"e1962","source":"Crossref","is-referenced-by-count":6,"title":["Valor terap\u00e9utico y precio de los nuevos f\u00e1rmacos comercializados en Argentina: \u00bfvalen lo que cuestan?"],"prefix":"10.18294","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0500-5866","authenticated-orcid":false,"given":"Mart\u00edn","family":"Ca\u00f1\u00e1s","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8534-3608","authenticated-orcid":false,"given":"H\u00e9ctor Omar","family":"Buschiazzo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6018-8250","authenticated-orcid":false,"given":"Mart\u00edn Alejandro","family":"Urtasun","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7901","published-online":{"date-parts":[[2019,3,10]]},"reference":[{"issue":"7520","key":"ref0","doi-asserted-by":"publisher","first-page":"815","DOI":"10.1136\/bmj.38582.703866.AE","article-title":"\"Breakthrough\" drugs and growth in expenditure on prescription drugs in Canada","volume":"331","author":"Morgan","year":"2005","unstructured":"1. 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Analysis of new drugs registered in Brazil in view of the Unified Health System and the disease burden. Ci\u00eancia & Sa\u00fade Coletiva. 2018;23(1):215-228.","journal-title":"Ci\u00eancia & Sa\u00fade Coletiva"},{"key":"ref3","unstructured":"4. Editorial Staff. New products and new indications in 2016: a system that favours imitation over the pursuit of real progress. Prescrire International. 2017;26(182):136-139."},{"key":"ref4","doi-asserted-by":"publisher","unstructured":"5. Ward DJ, Slade A, Genus T, Martino OI, Stevens AJ. How innovative are new drugs launched in the UK?: A retrospective study of new drugs listed in the British National Formulary (BNF) 2001-2012. BMJ Open. 2014;4(10):e006235.","DOI":"10.1136\/bmjopen-2014-006235"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1186\/2052-3211-6-2","article-title":"Assessment of the therapeutic value of new medicines marketed in Australia","volume":"6","author":"Vitry","year":"2013","unstructured":"6. Vitry AI, Shin NH, Vitre P. Assessment of the therapeutic value of new medicines marketed in Australia. Journal of Pharmaceutical Policy and Practice. 2013;6:2.","journal-title":"Journal of Pharmaceutical Policy and Practice"},{"issue":"5","key":"ref6","doi-asserted-by":"publisher","first-page":"445","DOI":"10.1007\/s00228-010-0808-3","article-title":"Superior efficacy of new medicines","volume":"66","author":"van Luijn","year":"2010","unstructured":"7. van Luijn JCF, Gribnau FWJ, Leufkens HGM. Superior efficacy of new medicines? European Journal of Clinical Pharmacology. 2010;66(5):445-448.","journal-title":"European Journal of Clinical Pharmacology"},{"key":"ref7","unstructured":"8. Argentina, Poder Ejecutivo Nacional. Decreto 150\/92: Normas para el registro, elaboraci\u00f3n, fraccionamiento, prescripci\u00f3n, expendio, comercializaci\u00f3n, exportaci\u00f3n e importaci\u00f3n de medicamentos; Ambito de aplicaci\u00f3n; Disposiciones Generales [Internet]. 1992 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/y79tdvq8."},{"key":"ref8","unstructured":"9. Ahlqvist-Rastad J, Bardelay D, Beermann B, Mignot G. Judging the therapeutic value of drugs: A comparison between La revue Prescrire and Information fr\u00e5n L\u00e4kemedelsverket, the bulletin of the Swedish Medical Products Agency. The International Journal of Risk & Safety in Medicine. 2004;16(2):83-90."},{"key":"ref9","unstructured":"10. Prescrire. Prescrire's ratings system: new drugs and indications, at a glance [Internet]. c2018 [citado 6 mar 2018]. Disponible en: https:\/\/tinyurl.com\/ydx9muqn."},{"issue":"4","key":"ref10","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1038\/nrd3715","article-title":"Defining rewardable innovation in drug therapy","volume":"11","author":"Aronson","year":"2012","unstructured":"11. Aronson JK, Ferner RE, Hughes DA. Defining rewardable innovation in drug therapy. Nature Reviews Drug Discovery. 2012;11(4):253-254.","journal-title":"Nature Reviews Drug Discovery"},{"issue":"5","key":"ref11","doi-asserted-by":"publisher","first-page":"610","DOI":"10.1111\/j.1365-2125.2006.02700.x","article-title":"An update on the first decade of the European centralized procedure: how many innovative drugs","volume":"62","author":"Motola","year":"2006","unstructured":"12. Motola D, De Ponti F, Poluzzi E, Martini N, Rossi P, Silvani MC, Vaccheri A, Montanaro N. An update on the first decade of the European centralized procedure: how many innovative drugs? British Journal of Clinical Pharmacology. 2006;62(5):610-616.","journal-title":"British Journal of Clinical Pharmacology"},{"issue":"3","key":"ref12","doi-asserted-by":"publisher","first-page":"317","DOI":"10.18294\/sc.2016.1073","article-title":"Ensayos cl\u00ednicos en Am\u00e9rica Latina: implicancias para la sustentabilidad y seguridad de los mercados farmac\u00e9uticos y el bienestar de los sujetos","volume":"12","author":"Homedes","year":"2016","unstructured":"13. Homedes N, Ugalde A. Ensayos cl\u00ednicos en Am\u00e9rica Latina: implicancias para la sustentabilidad y seguridad de los mercados farmac\u00e9uticos y el bienestar de los sujetos. Salud Colectiva. 2016;12(3):317-345.","journal-title":"Salud Colectiva"},{"key":"ref13","unstructured":"14. Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica. Altas en el vadem\u00e9cum nacional de medicamentos [Internet]. c2018 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/y8rb5wog."},{"key":"ref14","unstructured":"15. WHO Collaborating Centre for Drug Statistics Methodology. ATC\/DDD Index 2018 [Internet]. c2017 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/yckuy4rt."},{"key":"ref15","unstructured":"16. Kairos. 2016;XXXVIII(448):1-210."},{"key":"ref16","unstructured":"17. Drugs@FDA: FDA Approved Drug Products [Internet]. c2018 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/l5mfqlh."},{"key":"ref17","unstructured":"18. Center for Drug Evaluation and Research. Manual of policies and procedures [Internet]. 2013 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/yamw8h6s."},{"key":"ref18","unstructured":"19. European Medicines Agency [Internet]. c1995-2018 [citado 1 mar 2018]. Disponible en: https:\/\/www.ema.europa.eu\/."},{"issue":"3","key":"ref19","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1111\/j.1365-2125.1983.tb02165.x","article-title":"Drug utilization studies: a tool for determining the effectiveness of drug use","volume":"16","author":"Laporte","year":"1983","unstructured":"20. Laporte JR, Porta M, Capella D. Drug utilization studies: a tool for determining the effectiveness of drug use. British Journal of Clinical Pharmacology. 1983;16(3):301-304.","journal-title":"British Journal of Clinical Pharmacology"},{"key":"ref20","unstructured":"21. United States, Food and Drug Administration. New drug, antibiotic, and biological drug product regulations: accelerated approval; Final rule. Federal Register. 1992;57(239):58942-58960."},{"key":"ref21","unstructured":"22. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. 2016 [citado 5 mar 2018]. Disponible en: https:\/\/tinyurl.com\/ydbcc2er."},{"issue":"2","key":"ref22","doi-asserted-by":"publisher","first-page":"47","DOI":"10.18773\/austprescr.2009.023","article-title":"Surrogate outcome markers in research and clinical practice","volume":"32","author":"Twaddell","year":"2009","unstructured":"23. Twaddell S. Surrogate outcome markers in research and clinical practice. Australian Prescriber. 2009;32(2):47-50.","journal-title":"Australian Prescriber"},{"issue":"12","key":"ref23","doi-asserted-by":"publisher","first-page":"1992","DOI":"10.1001\/jamainternmed.2015.5868","article-title":"Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US food and drug administration approvals","volume":"175","author":"Kim","year":"2015","unstructured":"24. Kim C, Prasad V. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US food and drug administration approvals. JAMA Internal Medicine. 2015;175(12):1992-1994.","journal-title":"JAMA Internal Medicine"},{"issue":"2","key":"ref24","doi-asserted-by":"publisher","first-page":"276","DOI":"10.1001\/jamainternmed.2016.7761","article-title":"Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints","volume":"177","author":"Rupp","year":"2017","unstructured":"25. Rupp T, Zuckerman D. Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints. JAMA Internal Medicine. 2017;177(2):276-277.","journal-title":"JAMA Internal Medicine"},{"key":"ref25","unstructured":"26. Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica. Disposici\u00f3n 8806\/16 [Internet]. 2016 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/y7gfs6kv."},{"key":"ref26","unstructured":"27. Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica. Disposici\u00f3n 0759\/16 [Internet]. 2016 [citado 1 mar 2018]. Disponible en: https:\/\/tinyurl.com\/y7u7ejug."},{"issue":"11","key":"ref27","doi-asserted-by":"publisher","first-page":"1829","DOI":"10.1007\/s11606-008-0783-x","article-title":"Predictors of mortality in patients with stable COPD","volume":"23","author":"Esteban","year":"2008","unstructured":"28. Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Espa\u00f1a PP, P\u00e9rez-Izquierdo J, Capelastegui A. Predictors of mortality in patients with stable COPD. Journal of General Internal Medicine. 2008;23(11):1829-1834.","journal-title":"Journal of General Internal Medicine"},{"key":"ref28","unstructured":"29. Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease: A 15-year follow-up study. The American Review Of Respiratory Disease. 1979;119(6):895-902."},{"issue":"4","key":"ref29","doi-asserted-by":"publisher","first-page":"1298","DOI":"10.1002\/hep.27880","article-title":"Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs","volume":"62","author":"Mishra","year":"2015","unstructured":"30. Mishra P, Murray J, Birnkrant D. Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs. Hepatology: Official Journal of the American Association for the Study of Liver Diseases. 2015;62(4):1298-1303.","journal-title":"Hepatology"},{"issue":"24","key":"ref30","doi-asserted-by":"publisher","first-page":"2584","DOI":"10.1001\/jama.2012.144878","article-title":"Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis","volume":"308","author":"van der Meer","year":"2012","unstructured":"31. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour J-F, Lammert F, Duarte-Rojo A, Heathcote EJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584-2593.","journal-title":"JAMA"},{"issue":"3","key":"ref31","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1161\/CIRCULATIONAHA.112.105890","article-title":"Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials","volume":"126","author":"Gabler","year":"2012","unstructured":"32. Gabler NB, French B, Strom BL, Palevsky HI, Taichman DB, Kawut SM, Halpern SD. Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials. Circulation. 2012;126(3):349-356.","journal-title":"Circulation"},{"issue":"6","key":"ref32","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1007\/s00228-018-2431-7","article-title":"A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs","volume":"74","author":"Zeukeng","year":"2018","unstructured":"33. Zeukeng MJ, Seoane-Vazquez E, Bonnabry P. A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs. European Journal of Clinical Pharmacology. 2018;74(6):811-818.","journal-title":"European Journal of Clinical Pharmacology"},{"issue":"9","key":"ref33","doi-asserted-by":"publisher","first-page":"1197","DOI":"10.1007\/s00228-018-2490-9","article-title":"The race for drug approvals: hasten slowly","volume":"74","author":"Braillon","year":"2018","unstructured":"34. Braillon A. The race for drug approvals: hasten slowly? European Journal of Clinical Pharmacology. 2018;74(9):1197-1198.","journal-title":"European Journal of Clinical Pharmacology"},{"issue":"8","key":"ref34","doi-asserted-by":"publisher","first-page":"1389","DOI":"10.1001\/jamainternmed.2015.2829","article-title":"The strength of association between surrogate end points and survival in oncology: A systematic review of trial-level meta-analyses","volume":"175","author":"Prasad","year":"2015","unstructured":"35. Prasad V, Kim C, Burotto M, Vandross A. The strength of association between surrogate end points and survival in oncology: A systematic review of trial-level meta-analyses. JAMA Internal Medicine. 2015;175(8):1389-1398.","journal-title":"JAMA Internal Medicine"},{"key":"ref35","doi-asserted-by":"publisher","unstructured":"36. Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ: British Medical Journal. 2017;357:j1680.","DOI":"10.1136\/bmj.j1680"},{"issue":"7","key":"ref36","doi-asserted-by":"publisher","first-page":"626","DOI":"10.1001\/jama.2017.9415","article-title":"Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the Us Food and Drug Administration","volume":"318","author":"Naci","year":"2017","unstructured":"37. Naci H, Smalley KR, Kesselheim AS. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the Us Food and Drug Administration. JAMA. 2017;318(7):626-636.","journal-title":"JAMA"},{"key":"ref37","doi-asserted-by":"publisher","unstructured":"38. Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ: British Medical Journal. 2016;355:i6286.","DOI":"10.1136\/bmj.i6286"},{"issue":"21","key":"ref38","doi-asserted-by":"publisher","first-page":"2001","DOI":"10.1056\/NEJMp1700446","article-title":"Accelerated approval and expensive drugs: A challenging combination","volume":"376","author":"WF","year":"2017","unstructured":"39. Gellad WF, Kesselheim AS. Accelerated approval and expensive drugs: A challenging combination. The New England Journal of Medicine. 2017;376(21):2001-2004.","journal-title":"The New England Journal of Medicine"},{"key":"ref39","doi-asserted-by":"publisher","unstructured":"40. Hawkes N. German body calls for pause in European plan for fast track drug approval. BMJ. 2016;354:i4479.","DOI":"10.1136\/bmj.i4479"},{"key":"ref40","unstructured":"41. Colombia, Ministerio de Salud. Decreto 433 de 2018 [Internet]. 2018 [citado 15 mar 2018]. 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