Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab
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 impo...
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| Autor*in: |
Pontes, Caridad [verfasserIn] Zara, Corinne [verfasserIn] Torrent-Farnell, Josep [verfasserIn] Obach, Merce [verfasserIn] Nadal, Cristina [verfasserIn] Vella-Bonanno, Patricia [verfasserIn] Ermisch, Michael [verfasserIn] Simoens, Steven [verfasserIn] Hauegen, Renata Curi [verfasserIn] Gulbinovic, Jolanta [verfasserIn] Timoney, Angela [verfasserIn] Martin, Antony P. [verfasserIn] Mueller, Tanja [verfasserIn] Nachtnebel, Anna [verfasserIn] Campbell, Stephen [verfasserIn] Selke, Gisbert [verfasserIn] Bochenek, Tomasz [verfasserIn] Rothe, Celia C. [verfasserIn] Mardare, Ileana [verfasserIn] Bennie, Marion [verfasserIn] Fürst, Jurij [verfasserIn] Malmstrom, Rickard E. [verfasserIn] Godman, Brian [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Übergeordnetes Werk: |
Enthalten in: Applied health economics and health policy - [S.l.] : Springer International, 2004, 18(2019), 1 vom: 07. Nov., Seite 5-16 |
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| Übergeordnetes Werk: |
volume:18 ; year:2019 ; number:1 ; day:07 ; month:11 ; pages:5-16 |
| Links: |
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| DOI / URN: |
10.1007/s40258-019-00527-x |
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| Katalog-ID: |
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| 245 | 1 | 0 | |a Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab |
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| 520 | |a 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. | ||
| 700 | 1 | |a Zara, Corinne |e verfasserin |4 aut | |
| 700 | 1 | |a Torrent-Farnell, Josep |e verfasserin |4 aut | |
| 700 | 1 | |a Obach, Merce |e verfasserin |4 aut | |
| 700 | 1 | |a Nadal, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Vella-Bonanno, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Ermisch, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Simoens, Steven |e verfasserin |4 aut | |
| 700 | 1 | |a Hauegen, Renata Curi |e verfasserin |4 aut | |
| 700 | 1 | |a Gulbinovic, Jolanta |e verfasserin |4 aut | |
| 700 | 1 | |a Timoney, Angela |e verfasserin |4 aut | |
| 700 | 1 | |a Martin, Antony P. |e verfasserin |4 aut | |
| 700 | 1 | |a Mueller, Tanja |e verfasserin |4 aut | |
| 700 | 1 | |a Nachtnebel, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Campbell, Stephen |e verfasserin |4 aut | |
| 700 | 1 | |a Selke, Gisbert |e verfasserin |4 aut | |
| 700 | 1 | |a Bochenek, Tomasz |e verfasserin |4 aut | |
| 700 | 1 | |a Rothe, Celia C. |e verfasserin |4 aut | |
| 700 | 1 | |a Mardare, Ileana |e verfasserin |4 aut | |
| 700 | 1 | |a Bennie, Marion |e verfasserin |4 aut | |
| 700 | 1 | |a Fürst, Jurij |e verfasserin |4 aut | |
| 700 | 1 | |a Malmstrom, Rickard E. |e verfasserin |4 aut | |
| 700 | 1 | |a Godman, Brian |e verfasserin |4 aut | |
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10.1007/s40258-019-00527-x doi (DE-627)SPR032976488 (SPR)s40258-019-00527-x-e DE-627 ger DE-627 rakwb eng 610 ASE Pontes, Caridad verfasserin aut Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Zara, Corinne verfasserin aut Torrent-Farnell, Josep verfasserin aut Obach, Merce verfasserin aut Nadal, Cristina verfasserin aut Vella-Bonanno, Patricia verfasserin aut Ermisch, Michael verfasserin aut Simoens, Steven verfasserin aut Hauegen, Renata Curi verfasserin aut Gulbinovic, Jolanta verfasserin aut Timoney, Angela verfasserin aut Martin, Antony P. verfasserin aut Mueller, Tanja verfasserin aut Nachtnebel, Anna verfasserin aut Campbell, Stephen verfasserin aut Selke, Gisbert verfasserin aut Bochenek, Tomasz verfasserin aut Rothe, Celia C. verfasserin aut Mardare, Ileana verfasserin aut Bennie, Marion verfasserin aut Fürst, Jurij verfasserin aut Malmstrom, Rickard E. verfasserin aut Godman, Brian verfasserin aut Enthalten in Applied health economics and health policy [S.l.] : Springer International, 2004 18(2019), 1 vom: 07. Nov., Seite 5-16 (DE-627)481906118 (DE-600)2180637-8 1179-1896 nnns volume:18 year:2019 number:1 day:07 month:11 pages:5-16 https://dx.doi.org/10.1007/s40258-019-00527-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2019 1 07 11 5-16 |
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10.1007/s40258-019-00527-x doi (DE-627)SPR032976488 (SPR)s40258-019-00527-x-e DE-627 ger DE-627 rakwb eng 610 ASE Pontes, Caridad verfasserin aut Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Zara, Corinne verfasserin aut Torrent-Farnell, Josep verfasserin aut Obach, Merce verfasserin aut Nadal, Cristina verfasserin aut Vella-Bonanno, Patricia verfasserin aut Ermisch, Michael verfasserin aut Simoens, Steven verfasserin aut Hauegen, Renata Curi verfasserin aut Gulbinovic, Jolanta verfasserin aut Timoney, Angela verfasserin aut Martin, Antony P. verfasserin aut Mueller, Tanja verfasserin aut Nachtnebel, Anna verfasserin aut Campbell, Stephen verfasserin aut Selke, Gisbert verfasserin aut Bochenek, Tomasz verfasserin aut Rothe, Celia C. verfasserin aut Mardare, Ileana verfasserin aut Bennie, Marion verfasserin aut Fürst, Jurij verfasserin aut Malmstrom, Rickard E. verfasserin aut Godman, Brian verfasserin aut Enthalten in Applied health economics and health policy [S.l.] : Springer International, 2004 18(2019), 1 vom: 07. Nov., Seite 5-16 (DE-627)481906118 (DE-600)2180637-8 1179-1896 nnns volume:18 year:2019 number:1 day:07 month:11 pages:5-16 https://dx.doi.org/10.1007/s40258-019-00527-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2019 1 07 11 5-16 |
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10.1007/s40258-019-00527-x doi (DE-627)SPR032976488 (SPR)s40258-019-00527-x-e DE-627 ger DE-627 rakwb eng 610 ASE Pontes, Caridad verfasserin aut Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Zara, Corinne verfasserin aut Torrent-Farnell, Josep verfasserin aut Obach, Merce verfasserin aut Nadal, Cristina verfasserin aut Vella-Bonanno, Patricia verfasserin aut Ermisch, Michael verfasserin aut Simoens, Steven verfasserin aut Hauegen, Renata Curi verfasserin aut Gulbinovic, Jolanta verfasserin aut Timoney, Angela verfasserin aut Martin, Antony P. verfasserin aut Mueller, Tanja verfasserin aut Nachtnebel, Anna verfasserin aut Campbell, Stephen verfasserin aut Selke, Gisbert verfasserin aut Bochenek, Tomasz verfasserin aut Rothe, Celia C. verfasserin aut Mardare, Ileana verfasserin aut Bennie, Marion verfasserin aut Fürst, Jurij verfasserin aut Malmstrom, Rickard E. verfasserin aut Godman, Brian verfasserin aut Enthalten in Applied health economics and health policy [S.l.] : Springer International, 2004 18(2019), 1 vom: 07. Nov., Seite 5-16 (DE-627)481906118 (DE-600)2180637-8 1179-1896 nnns volume:18 year:2019 number:1 day:07 month:11 pages:5-16 https://dx.doi.org/10.1007/s40258-019-00527-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2019 1 07 11 5-16 |
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10.1007/s40258-019-00527-x doi (DE-627)SPR032976488 (SPR)s40258-019-00527-x-e DE-627 ger DE-627 rakwb eng 610 ASE Pontes, Caridad verfasserin aut Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Zara, Corinne verfasserin aut Torrent-Farnell, Josep verfasserin aut Obach, Merce verfasserin aut Nadal, Cristina verfasserin aut Vella-Bonanno, Patricia verfasserin aut Ermisch, Michael verfasserin aut Simoens, Steven verfasserin aut Hauegen, Renata Curi verfasserin aut Gulbinovic, Jolanta verfasserin aut Timoney, Angela verfasserin aut Martin, Antony P. verfasserin aut Mueller, Tanja verfasserin aut Nachtnebel, Anna verfasserin aut Campbell, Stephen verfasserin aut Selke, Gisbert verfasserin aut Bochenek, Tomasz verfasserin aut Rothe, Celia C. verfasserin aut Mardare, Ileana verfasserin aut Bennie, Marion verfasserin aut Fürst, Jurij verfasserin aut Malmstrom, Rickard E. verfasserin aut Godman, Brian verfasserin aut Enthalten in Applied health economics and health policy [S.l.] : Springer International, 2004 18(2019), 1 vom: 07. Nov., Seite 5-16 (DE-627)481906118 (DE-600)2180637-8 1179-1896 nnns volume:18 year:2019 number:1 day:07 month:11 pages:5-16 https://dx.doi.org/10.1007/s40258-019-00527-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2019 1 07 11 5-16 |
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10.1007/s40258-019-00527-x doi (DE-627)SPR032976488 (SPR)s40258-019-00527-x-e DE-627 ger DE-627 rakwb eng 610 ASE Pontes, Caridad verfasserin aut Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Zara, Corinne verfasserin aut Torrent-Farnell, Josep verfasserin aut Obach, Merce verfasserin aut Nadal, Cristina verfasserin aut Vella-Bonanno, Patricia verfasserin aut Ermisch, Michael verfasserin aut Simoens, Steven verfasserin aut Hauegen, Renata Curi verfasserin aut Gulbinovic, Jolanta verfasserin aut Timoney, Angela verfasserin aut Martin, Antony P. verfasserin aut Mueller, Tanja verfasserin aut Nachtnebel, Anna verfasserin aut Campbell, Stephen verfasserin aut Selke, Gisbert verfasserin aut Bochenek, Tomasz verfasserin aut Rothe, Celia C. verfasserin aut Mardare, Ileana verfasserin aut Bennie, Marion verfasserin aut Fürst, Jurij verfasserin aut Malmstrom, Rickard E. verfasserin aut Godman, Brian verfasserin aut Enthalten in Applied health economics and health policy [S.l.] : Springer International, 2004 18(2019), 1 vom: 07. Nov., Seite 5-16 (DE-627)481906118 (DE-600)2180637-8 1179-1896 nnns volume:18 year:2019 number:1 day:07 month:11 pages:5-16 https://dx.doi.org/10.1007/s40258-019-00527-x lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2019 1 07 11 5-16 |
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Pontes, Caridad @@aut@@ Zara, Corinne @@aut@@ Torrent-Farnell, Josep @@aut@@ Obach, Merce @@aut@@ Nadal, Cristina @@aut@@ Vella-Bonanno, Patricia @@aut@@ Ermisch, Michael @@aut@@ Simoens, Steven @@aut@@ Hauegen, Renata Curi @@aut@@ Gulbinovic, Jolanta @@aut@@ Timoney, Angela @@aut@@ Martin, Antony P. @@aut@@ Mueller, Tanja @@aut@@ Nachtnebel, Anna @@aut@@ Campbell, Stephen @@aut@@ Selke, Gisbert @@aut@@ Bochenek, Tomasz @@aut@@ Rothe, Celia C. @@aut@@ Mardare, Ileana @@aut@@ Bennie, Marion @@aut@@ Fürst, Jurij @@aut@@ Malmstrom, Rickard E. @@aut@@ Godman, Brian @@aut@@ |
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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. 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Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab |
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Pontes, Caridad |
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Pontes, Caridad Zara, Corinne Torrent-Farnell, Josep Obach, Merce Nadal, Cristina Vella-Bonanno, Patricia Ermisch, Michael Simoens, Steven Hauegen, Renata Curi Gulbinovic, Jolanta Timoney, Angela Martin, Antony P. Mueller, Tanja Nachtnebel, Anna Campbell, Stephen Selke, Gisbert Bochenek, Tomasz Rothe, Celia C. Mardare, Ileana Bennie, Marion Fürst, Jurij Malmstrom, Rickard E. Godman, Brian |
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Pontes, Caridad |
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time to review authorisation and funding for new cancer medicines in europe? inferences from the case of olaratumab |
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Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab |
| abstract |
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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
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Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab |
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Zara, Corinne Torrent-Farnell, Josep Obach, Merce Nadal, Cristina Vella-Bonanno, Patricia Ermisch, Michael Simoens, Steven Hauegen, Renata Curi Gulbinovic, Jolanta Timoney, Angela Martin, Antony P. Mueller, Tanja Nachtnebel, Anna Campbell, Stephen Selke, Gisbert Bochenek, Tomasz Rothe, Celia C. Mardare, Ileana Bennie, Marion Fürst, Jurij Malmstrom, Rickard E. Godman, Brian |
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| score |
7.4009724 |