| Author | Pontes, Caridad | |
| Author | Zara, Corinne | |
| Author | Torrent-Farnell, Josep | |
| Author | Obach, Merce | |
| Author | Nadal, Cristina | |
| Author | Vella-Bonanno, Patricia | |
| Author | Ermisch, Michael | |
| Author | Simoens, Steven | |
| Author | Hauegen, Renata Curi | |
| Author | Gulbinovic, Jolanta | |
| Author | Timoney, Angela | |
| Author | Martin, Antony P. | |
| Author | Mueller, Tanja | |
| Author | Nachtnebel, Anna | |
| Author | Campbell, Stephen | |
| Author | Selke, Gisbert | |
| Author | Bochenek, Tomasz | |
| Author | Rothe, Celia C. | |
| Author | Mardare, Ileana | |
| Author | Bennie, Marion | |
| Author | Fürst, Jurij | |
| Author | Malmstrom, Rickard E. | |
| Author | Godman, Brian | |
| Access date | 2019-01-11T23:36:42Z | |
| Available date | 2019-01-11T23:36:42Z | |
| Document date | 2020 | |
| Citation | PONTES, Caridad et al. Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab. Applied Health Economics and Health Policy, New Zealand, v. 18, n. 1, p. 1-21, Feb. 2020. | |
| ISSN | 1175-5652 | |
| URI | https://www.arca.fiocruz.br/handle/icict/31008 | |
| Language | eng | en_US |
| Publisher | Open Mind Journals Ltd | |
| Later version | https://www.arca.fiocruz.br/handle/icict/59634 | |
| Rights | restricted access | |
| Title | Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab | en_US |
| Type | Preprint | |
| DOI | 10.1007/S40258-019-00527-X | |
| Abstract | The potential benefits of early patient access to new medicines in areas of high unmet medical need are recognised, but uncertainties concerning effectiveness, safety and added value when new medicines are authorised, and subsequently funded based on initial preliminary data only, have important implications. In 2016 olaratumab received accelerated conditional approval from both the European Medicines Agency and the US Food and Drug Administration for the treatment of soft-tissue sarcoma, based on the claims of a substantial reduction in the risk of death with an 11.8-month improvement in median overall survival in a phase II trial in combination with doxorubicin vs. doxorubicin alone. The failure to confirm these benefits in the post-authorisation pivotal trial has highlighted key concerns regarding early access and conditional approvals for new medicines. Concerns include potentially considerable clinical and economic costs, so that patients may have received suboptimal treatment and any money spent has foregone the opportunity to improve access to effective treatments. As a result, it seems reasonable to reconsider current marketing authorisation models and approaches. Potential pathways forward include closer collaboration between regulators, pharmaceutical companies and payers to enhance the generation of rapid and comparative confirmatory trials in a safe and fair manner, with minimal patient exposure as required to achieve robust evidence. Additionally, it may be time to review early access systems, and to explore new avenues regarding who should pay or part pay for new treatments whilst information is being collected as part of any obligations for conditional marketing authorisation. Greater co-operation between countries regarding the collection of data in routine clinical care, and further research on post-marketing data analysis and interpretation, may also contribute to improved appraisal and continued access to new innovative cancer treatments. | en_US |
| Affilliation | Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde. Glasgow, United Kingdom. | |
| Affilliation | Hauptverband der Österreichischen Sozialversicherungsträger. Vienna, Austria. | |
| Affilliation | Centre for Primary Care. Division of Population Health. Health Services Research and Primary Care. University of Manchester. Manchester, United Kingdom / NIHR Greater Manchester Patient Safety Translational Research Centre. School of Health Sciences. University of Manchester. Manchester, United Kingdom. | |
| Affilliation | Wissenschaftliches Institut der AOK (WidO). Berlin, Germany. | |
| Affilliation | Department of Drug Management. Faculty of Health Sciences. Jagiellonian University Medical College. Kraków, Poland. | |
| Affilliation | Department of Drug Management. Faculty of Health Sciences. Jagiellonian University Medical College. Kraków, Poland. | |
| Affilliation | Department of Public Health and Management. Faculty of Medicine. “Carol Davila” University of Medicine and Pharmacy. Bucharest, Romania. | |
| Affilliation | Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde. Glasgow, United Kingdom. | |
| Affilliation | Health Insurance Institute. Ljubljana, Slovenia. | |
| Affilliation | Department of Medicine Solna. Karolinska Institute. Karolinska University Hospital Solna. Stockholm, Sweden. | |
| Affilliation | Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde. Glasgow, United Kingdom / Health Economics Centre. University of Liverpool Management School. Liverpool, United Kingdom / Division of Clinical Pharmacology. Karolinska Institute. Karolinska University Hospital Huddinge. Stockholm, Sweden / School of Pharmacy. Sefako Makgatho Health Sciences University. Ga-Rankuwa, South Africa. | |
| Affilliation | Drug Area, Catalan Health Service. Barcelona, Spain / Department of Pharmacology. Therapeutics and Toxicology. Universitat Autònoma de Barcelona. Barcelona, Spain. | |
| Affilliation | Drug Area, Catalan Health Service. Barcelona, Spain. | |
| Affilliation | Drug Area, Catalan Health Service. Barcelona, Spain / Department of Pharmacology. Therapeutics and Toxicology. Universitat Autònoma de Barcelona. Barcelona, Spain. | |
| Affilliation | Drug Area. Catalan Health Service. Barcelona, Spain. | |
| Affilliation | Catalan Health Service. Barcelona, Spain. | |
| Affilliation | Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde. Glasgow, United Kingdom. | |
| Affilliation | Pharmaceutical Department. National Association of Statutory Health Insurance Funds. Berlin, Germany. | |
| Affilliation | Department of Pharmaceutical and Pharmacological Sciences. KU Leuven. Leuven, Belgium. | |
| Affilliation | Oswaldo Cruz Foundation. Center for Technological Development in Health. National Institute of Science and Technology for Innovation on Diseases of Neglected Populations. Rio de Janeiro, RJ, Brazil. | |
| Affilliation | Department of Pathology. Forensic Medicine and Pharmacology. Institute of Biomedical Sciences. Faculty of Medicine. Vilnius University. Vilnius, Lithuania. | |
| Affilliation | Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde. Glasgow, United Kingdom / NHS Lothian. Edinburgh, UK | |
| Affilliation | Health Economics Centre. University of Liverpool Management School. Liverpool, United Kingdom. | |
| Subject | New Cancer Medicines | en_US |
| Subject | Case of Olaratumab | en_US |
| Subject | Review Authorisation and Funding | en_US |
| Subject | Managed entry agreements | en_US |
| Subject | Health technology assessment | en_US |
| e-ISSN | 1179-1896 | |
| Embargo date | 2030-12-31 | |
