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The price of added value for new anti-cancer drugs in France 2004-17
PUBLIC POLICY 1629O PR
The price of added value for new anti-cancer drugs in France 2004-17
Background: The cost of new cancer medications is increasing prompting clinicians and policymakers to ask if newer therapies are worth their cost. We evaluated the relation between the price of new cancer drugs and their added therapeutic benefit measured by France’s High Authority of Health (HAS) and the European Society for Medical Oncology (ESMO). Methods: We studied drugs to treat solid tumors registered by the European Medicines Agency (EMA) from 2004 to 2017. Prices were obtained from the French Official Journal. Rating for added therapeutic value were obtained from the HAS Added Therapeutic Benefit ranking (ASMR 1 being the highest benefit, and 5 the lowest) and the v1.1 ESMO-Magnitude of Clinical Benefit Scale (MCBS, 5 being the highest and 2 being the lowest). We calculated monthly treatment costs for each new drug compared with existing treatment and the correlations between price increase and added therapeutic value using Spearman’s tests. Results: Thirty-six drugs were approved for 68 indications (with 35 first registration). The median ESMO-MCBS and ASMR scores were 4 (range 1-5) and 4 (range 2-5), respectively. Forty-eight percent and 70% of drugs had low added value according to ESMO-MCBS and ASMR, respectively. The mean monthly price for new drugs and comparators were 4,616 and 2,314 euros, respectively and increased during the observation period. For all indications there were significant but weak correlations between ESMO-MCBS and ASMR (jrhoj ¼ 0.28, p ¼ 0.019), ESMO-MCBS and price (jrhoj ¼ 0.33, p ¼ 0.005) and between ASMR and price (jrhoj ¼ 0.35, p ¼ 0.004). Correlation with price was higher when considering the first indication (ESMO-MCBS, jrhoj ¼ 0.48, p ¼ 0.004; ASMR, jrhoj ¼ 0.37, p ¼ 0.030). There was no correlation between price increases and ASMR or ESMO (jrhoj<0.2, p > 0.1). Conclusions: Most new drugs provided low added value. On average, new drug prices increased 2,525 euros over their comparator. Prices were weakly correlated with added value, but price increases were not. Legal entity responsible for the study: The authors. Funding: IMe´RA Institute. Disclosure: A. Gonc¸alves: Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen Pfizer; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Celgene. All other authors have declared no conflicts of interest.
v924 | Public policy
Clinical benefit and prices of cancer drugs in the US and Europe
K.N. T. Hwang2, A. Tibau3, T.J. Rosemann4, A.S. Kesselheim5 Academic Chair for Health Policy, Faculty of Law, Institute for Primary Care, University Hospital Zurich, Zurich, Switzerland, 2Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, 3Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 4Institute for Primary Care, University of Zurich/University Hospital of Zurich, Zurich, Switzerland, 5Program on Regulation, Therapeutics, and Law, Harvard Medical School, Boston, MA, USA 1
Background: Given rising cancer drug costs, US Medicare recently proposed to tie some drug prices to average prices paid by comparable countries. To understand the potential scope of this policy, we assessed differences in cancer drug prices in the US and European countries. We also evaluated the correlation between drug prices and their clinical benefit, as measured by two value frameworks: the American Society of Clinical Oncology Value Framework v2 (ASCO VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale v1.1 (ESMO-MCBS). Methods: We identified all new drugs for adult solid and hematologic cancers, approved by the FDA from 2009-2017 and that have also been approved by the EMA by December 31, 2018. US average sales prices (and if not available, wholesale acquisition costs) were extracted as of February 1, 2019, and compared to comparable currencyadjusted ex-factory drug costs in England, France, Germany, and Switzerland. ASCO VF and ESMO-MCBS scores were assessed for pivotal trials supporting solid tumor drugs; in case of multiple trials, we focused on the highest score. Consistent with the developers of the rating scales, “high benefit” was defined as scores of A-B (neo/adjuvant setting) and 4-5 (palliative setting) on the ESMO-MCBS scale and scores 45 on the ASCO VF. Linear regression models and non-parametric Kruskal-Wallis test and were used to assess the association between drug prices and benefit scores. Results: The study cohort included 63 drugs approved by the FDA and the EMA during the study period. 46 (73%) were approved for solid tumors, and 17 (27%) were approved for hematologic malignancies. Overall, median cancer drug prices in Europe were 52% (interquartile range: 37-72%) lower than US prices. There was no association between monthly treatment cost and ASCO-VF or ESMO-MCBS scores in any country. There was also no association between price differential between US and median European drug prices and either ASCO-VF (P ¼ 0.599) or ESMO-MBCS (P ¼ 0.321) scores. Conclusions: Drug prices of cancer drugs were not associated with clinical benefit in the US or in European countries. Cancer drug prices in the US were significantly higher than in the compared European countries. Legal entity responsible for the study: University of Zurich. Funding: Swiss Cancer League. Disclosure: All authors have declared no conflicts of interest.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz394.085/5578416 by guest on 14 October 2019
P. Marino1, A-C. Jalbert2, S. Duran2, J. Mancini3, A. Gonc¸alves4, M. Rodwin5 1 SESSTIM, Institut Paoli-Calmettes, Aix Marseille University, INSERM, IRD, Marseille, France, 2Pharmacy, Institut Paoli-Calmettes, Marseille, France, 3Medicine, Aix Marseille University, INSERM, IRD, SESSTIM, Marseille, France, 4Medical Oncology, Aix-Marseille Univ, Inserm U1068, CNRS UMR7258, Institut Paoli-Calmettes, Marseille, France, 5Law School, Suffolk University, Boston, MA, USA
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The price of added value for new anti-cancer drugs in France 2004-17
Background: The cost of new cancer medications is increasing prompting clinicians and policymakers to ask if newer therapies are worth their cost. We evaluated the relation between the price of new cancer drugs and their added therapeutic benefit measured by France’s High Authority of Health (HAS) and the European Society for Medical Oncology (ESMO). Methods: We studied drugs to treat solid tumors registered by the European Medicines Agency (EMA) from 2004 to 2017. Prices were obtained from the French Official Journal. Rating for added therapeutic value were obtained from the HAS Added Therapeutic Benefit ranking (ASMR 1 being the highest benefit, and 5 the lowest) and the v1.1 ESMO-Magnitude of Clinical Benefit Scale (MCBS, 5 being the highest and 2 being the lowest). We calculated monthly treatment costs for each new drug compared with existing treatment and the correlations between price increase and added therapeutic value using Spearman’s tests. Results: Thirty-six drugs were approved for 68 indications (with 35 first registration). The median ESMO-MCBS and ASMR scores were 4 (range 1-5) and 4 (range 2-5), respectively. Forty-eight percent and 70% of drugs had low added value according to ESMO-MCBS and ASMR, respectively. The mean monthly price for new drugs and comparators were 4,616 and 2,314 euros, respectively and increased during the observation period. For all indications there were significant but weak correlations between ESMO-MCBS and ASMR (jrhoj ¼ 0.28, p ¼ 0.019), ESMO-MCBS and price (jrhoj ¼ 0.33, p ¼ 0.005) and between ASMR and price (jrhoj ¼ 0.35, p ¼ 0.004). Correlation with price was higher when considering the first indication (ESMO-MCBS, jrhoj ¼ 0.48, p ¼ 0.004; ASMR, jrhoj ¼ 0.37, p ¼ 0.030). There was no correlation between price increases and ASMR or ESMO (jrhoj<0.2, p > 0.1). Conclusions: Most new drugs provided low added value. On average, new drug prices increased 2,525 euros over their comparator. Prices were weakly correlated with added value, but price increases were not. Legal entity responsible for the study: The authors. Funding: IMe´RA Institute. Disclosure: A. Gonc¸alves: Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen Pfizer; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Celgene. All other authors have declared no conflicts of interest.
v924 | Public policy
Clinical benefit and prices of cancer drugs in the US and Europe
K.N. T. Hwang2, A. Tibau3, T.J. Rosemann4, A.S. Kesselheim5 Academic Chair for Health Policy, Faculty of Law, Institute for Primary Care, University Hospital Zurich, Zurich, Switzerland, 2Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, 3Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 4Institute for Primary Care, University of Zurich/University Hospital of Zurich, Zurich, Switzerland, 5Program on Regulation, Therapeutics, and Law, Harvard Medical School, Boston, MA, USA 1
Background: Given rising cancer drug costs, US Medicare recently proposed to tie some drug prices to average prices paid by comparable countries. To understand the potential scope of this policy, we assessed differences in cancer drug prices in the US and European countries. We also evaluated the correlation between drug prices and their clinical benefit, as measured by two value frameworks: the American Society of Clinical Oncology Value Framework v2 (ASCO VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale v1.1 (ESMO-MCBS). Methods: We identified all new drugs for adult solid and hematologic cancers, approved by the FDA from 2009-2017 and that have also been approved by the EMA by December 31, 2018. US average sales prices (and if not available, wholesale acquisition costs) were extracted as of February 1, 2019, and compared to comparable currencyadjusted ex-factory drug costs in England, France, Germany, and Switzerland. ASCO VF and ESMO-MCBS scores were assessed for pivotal trials supporting solid tumor drugs; in case of multiple trials, we focused on the highest score. Consistent with the developers of the rating scales, “high benefit” was defined as scores of A-B (neo/adjuvant setting) and 4-5 (palliative setting) on the ESMO-MCBS scale and scores 45 on the ASCO VF. Linear regression models and non-parametric Kruskal-Wallis test and were used to assess the association between drug prices and benefit scores. Results: The study cohort included 63 drugs approved by the FDA and the EMA during the study period. 46 (73%) were approved for solid tumors, and 17 (27%) were approved for hematologic malignancies. Overall, median cancer drug prices in Europe were 52% (interquartile range: 37-72%) lower than US prices. There was no association between monthly treatment cost and ASCO-VF or ESMO-MCBS scores in any country. There was also no association between price differential between US and median European drug prices and either ASCO-VF (P ¼ 0.599) or ESMO-MBCS (P ¼ 0.321) scores. Conclusions: Drug prices of cancer drugs were not associated with clinical benefit in the US or in European countries. Cancer drug prices in the US were significantly higher than in the compared European countries. Legal entity responsible for the study: University of Zurich. Funding: Swiss Cancer League. Disclosure: All authors have declared no conflicts of interest.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz394.085/5578416 by guest on 14 October 2019
P. Marino1, A-C. Jalbert2, S. Duran2, J. Mancini3, A. Gonc¸alves4, M. Rodwin5 1 SESSTIM, Institut Paoli-Calmettes, Aix Marseille University, INSERM, IRD, Marseille, France, 2Pharmacy, Institut Paoli-Calmettes, Marseille, France, 3Medicine, Aix Marseille University, INSERM, IRD, SESSTIM, Marseille, France, 4Medical Oncology, Aix-Marseille Univ, Inserm U1068, CNRS UMR7258, Institut Paoli-Calmettes, Marseille, France, 5Law School, Suffolk University, Boston, MA, USA
163