For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs

The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. M...
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Autor*in:	Gyeongseon Shin [verfasserIn] Hye-Young Kwon [verfasserIn] SeungJin Bae [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	cancer drug oncology drug value expedited review economic evaluation

Übergeordnetes Werk:	In: International Journal of Environmental Research and Public Health - MDPI AG, 2005, 19(2022), 4204, p 4204
Übergeordnetes Werk:	volume:19 ; year:2022 ; number:4204, p 4204

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc Journal toc

DOI / URN:	10.3390/ijerph19074204

Katalog-ID:	DOAJ030367913

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allfields	10.3390/ijerph19074204 doi (DE-627)DOAJ030367913 (DE-599)DOAJe102cbded6f244638d9c38fa49c222ef DE-627 ger DE-627 rakwb eng Gyeongseon Shin verfasserin aut For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations. cancer drug oncology drug value expedited review economic evaluation Medicine R Hye-Young Kwon verfasserin aut SeungJin Bae verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 19(2022), 4204, p 4204 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:19 year:2022 number:4204, p 4204 https://doi.org/10.3390/ijerph19074204 kostenfrei https://doaj.org/article/e102cbded6f244638d9c38fa49c222ef kostenfrei https://www.mdpi.com/1660-4601/19/7/4204 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2022 4204, p 4204
spelling	10.3390/ijerph19074204 doi (DE-627)DOAJ030367913 (DE-599)DOAJe102cbded6f244638d9c38fa49c222ef DE-627 ger DE-627 rakwb eng Gyeongseon Shin verfasserin aut For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations. cancer drug oncology drug value expedited review economic evaluation Medicine R Hye-Young Kwon verfasserin aut SeungJin Bae verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 19(2022), 4204, p 4204 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:19 year:2022 number:4204, p 4204 https://doi.org/10.3390/ijerph19074204 kostenfrei https://doaj.org/article/e102cbded6f244638d9c38fa49c222ef kostenfrei https://www.mdpi.com/1660-4601/19/7/4204 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2022 4204, p 4204
allfields_unstemmed	10.3390/ijerph19074204 doi (DE-627)DOAJ030367913 (DE-599)DOAJe102cbded6f244638d9c38fa49c222ef DE-627 ger DE-627 rakwb eng Gyeongseon Shin verfasserin aut For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations. cancer drug oncology drug value expedited review economic evaluation Medicine R Hye-Young Kwon verfasserin aut SeungJin Bae verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 19(2022), 4204, p 4204 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:19 year:2022 number:4204, p 4204 https://doi.org/10.3390/ijerph19074204 kostenfrei https://doaj.org/article/e102cbded6f244638d9c38fa49c222ef kostenfrei https://www.mdpi.com/1660-4601/19/7/4204 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2022 4204, p 4204
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allfieldsSound	10.3390/ijerph19074204 doi (DE-627)DOAJ030367913 (DE-599)DOAJe102cbded6f244638d9c38fa49c222ef DE-627 ger DE-627 rakwb eng Gyeongseon Shin verfasserin aut For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations. cancer drug oncology drug value expedited review economic evaluation Medicine R Hye-Young Kwon verfasserin aut SeungJin Bae verfasserin aut In International Journal of Environmental Research and Public Health MDPI AG, 2005 19(2022), 4204, p 4204 (DE-627)477992463 (DE-600)2175195-X 16604601 nnns volume:19 year:2022 number:4204, p 4204 https://doi.org/10.3390/ijerph19074204 kostenfrei https://doaj.org/article/e102cbded6f244638d9c38fa49c222ef kostenfrei https://www.mdpi.com/1660-4601/19/7/4204 kostenfrei https://doaj.org/toc/1661-7827 Journal toc kostenfrei https://doaj.org/toc/1660-4601 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 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_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2022 4204, p 4204
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source	In International Journal of Environmental Research and Public Health 19(2022), 4204, p 4204 volume:19 year:2022 number:4204, p 4204
sourceStr	In International Journal of Environmental Research and Public Health 19(2022), 4204, p 4204 volume:19 year:2022 number:4204, p 4204
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topic_facet	cancer drug oncology drug value expedited review economic evaluation Medicine R
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authorswithroles_txt_mv	Gyeongseon Shin @@aut@@ Hye-Young Kwon @@aut@@ SeungJin Bae @@aut@@
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author	Gyeongseon Shin
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title	For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs
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title_auth	For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs
abstract	The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations.
abstractGer	The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations.
abstract_unstemmed	The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an overall survival gain in the confirmatory trial. Moreover, clinical data are often generated based on small, single-arm studies with surrogate outcomes, challenging economic evaluation. With their high price and uncertain (marginal) clinical value, cancer drugs are frequently rejected by health technology assessment (HTA) bodies. Therefore, agencies, including the UK’s National Institute for Health and Care Excellence (NICE), have adopted cancer drug funds (CDF) or risk-sharing schemes to provide extra access for expensive cancer drugs which fail to meet NICE’s cost effectiveness threshold. With rising pricing and fewer new cancer medications with novel mechanisms of action, it is unclear if newly marketed cancer therapies address unmet clinical needs or whether we are paying too much. Transparency, equity, innovativeness, and sustainability are all harmed by a “special” approach for cancer medications. If early access is allowed, confirmatory trials within a certain time frame and economic evaluation should be conducted, and label changes or disinvestment should be carried out based on those evaluations.
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title_short	For Whom the Price Escalates: High Price and Uncertain Value of Cancer Drugs
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