Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies

Tay-Teo, Kiu; Ilbawi, André; Hill, Suzanne

doi:10.1001/jamanetworkopen.2018.6875

Cited by 68 publications

(52 citation statements)

References 32 publications

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“…Because developing new cancer medicines is risky, revenues should also cover costs for drugs that do not reach the market successfully. However, by the end of 2017, average income (in US dollars) from 99 cancer medicines for the originator companies was $14.50 (range, $3.30‐$55.10) for every dollar spent on risk‐adjusted research and development . Production costs of some cancer medicines are also relatively small in relation to their prices.…”

Section: Spiraling Cancer Medicine Pricesmentioning

confidence: 99%

“…However, by the end of 2017, average income (in US dollars) from 99 cancer medicines for the originator companies was $14.50 (range, $3.30-$55.10) for every dollar spent on risk-adjusted research and development. 31 Production costs of some cancer medicines are also relatively small in relation to their prices. The estimated generic production costs of 4 tyrosine kinase inhibitors was from 0.2% to 2.9% of their prices on the US market.…”

Section: Spiraling Cancer Medicine Pricesmentioning

confidence: 99%

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Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

145

108

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Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

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Section: Spiraling Cancer Medicine Pricesmentioning

confidence: 99%

Section: Spiraling Cancer Medicine Pricesmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

145

108

View full text Add to dashboard Cite

show abstract

“…Because the Medicare is not allowed to negotiate prices with companies, despite being mandated to cover for every US Food and Drug Administration (FDA)-approved drug, various experts have argued that this is the reason for high drug prices in the USA. Indeed, cancer drug prices far exceed the costs of their development12; such negotiations might help to lower the prices of cancer drugs as evidenced by lower cost of cancer drugs in other developed countries compared with the USA.…”

Section: Introductionmentioning

confidence: 99%

Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy

Trotta¹,

Mayer

Barone-Adesi

et al. 2019

BMJ Open

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ObjectiveTo investigate whether the prices of new anticancer drugs correlated with their relative benefit despite negotiation.DesignRetrospective cross-sectional study correlating new anticancer drugs prices with clinical outcomes.SettingWe did a retrospective cross-sectional study including all new anticancer drugs approved by the European Medicines Agency (EMA) (2010–2016) and reimbursed in Italy.Main outcome(s) and measure(s)Information on clinical outcomes—in terms of median overall survival (OS), median progression-free survival (PFS) and objective response rate (ORR)—was extracted from pivotal trials as reported in the European Public Assessment Reports available on the EMA website. Cost of a full course treatment was estimated on negotiated official and discounted prices. Regression coefficients β, their levels of significance p and the coefficients of determination R2 were estimated adjusting by tumour type.ResultsOverall, 30 new anticancer drugs (with 35 indications) were available for analysis. Where data on OS were available, we observed no correlation between the improvement in median OS (in weeks) and negotiated price (R2=0.067, n=16 drugs for 17 indications). When the clinical outcomes were expressed as improvements in the median PFS or ORR, 25 drugs (29 indications) were available for the analysis, and again, there was no correlation with prices (R2=0.004 and 0.006, respectively).Conclusions and relevanceOur results suggest that the prices of anticancer drugs in Italy do not reflect their therapeutic benefit. Drug price negotiations, which is mandatory by law in Italy, do not seem to ensure that prices correlate with clinical benefits provided by the cancer drugs. These results call for further efforts to establish the standard determinants of drug prices available at the time of negotiation. These findings need to be confirmed in other countries where price negotiations are in place. Moreover, further investigations may verify whether outcome data obtained after drug marketing would improve the correlation between prices and therapeutic benefit.

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“…Ce secteur est en effet particulièrement performant à cet égard, ses marges bénéficiaires excédant celles de la plupart des autres secteurs du monde économique (données de la New York university Stern school of business) [17]. En fait, le retour sur investissement des grandes entreprises pharmaceutiques dépasse de 3 % par an celui des autres secteurs économiques [18,19]. Ainsi, un euro investi en 1990 a rapporté en moyenne 44 € en 2015 pour l'ensemble des secteurs économiques mais 114 € pour le seul secteur pharmaceutique.…”

Section: Comment En Est-on Arrivé Là ?unclassified

L’innovation thérapeutique, à quel prix ?

Fischer

Dewatripont

2020

Med Sci (Paris)

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Comment préserver l’accessibilité aux nouveaux médicaments pour tous les patients qui en ont besoin ? La question se pose à la lumière des prix exorbitants auxquels les thérapies géniques, mais aussi les biothérapies et de nouvelles molécules chimiques, sont commercialisées. L’analyse montre qu’à court/moyen terme, l’arrivée sur le marché d’un nombre croissant de nouveaux traitements à haute valeur ajoutée mais à des prix très élevés deviendra insoutenable pour les organismes payeurs qui sous-tendent notre système de santé. Les arguments de rentabilité invoqués par les sociétés pharmaceutiques pour justifier les prix proposés sont à tout le moins contestables, d’autant plus qu’ils ne sont pas documentés de façon transparente et que cette industrie jouit déjà de marges bénéficiaires considérables, en comparaison de celles d’autres secteurs du monde économique. Quant aux promesses de guérison définitive assurée par certains traitements, il faudra encore attendre quelques années pour en vérifier le fondement. À l’aube d’une réforme qui apparaît incontournable, nous formulons plusieurs propositions pour faire avancer le débat, en particulier : (1) mettre en œuvre la résolution avancée par plusieurs états membres de l’Organisation mondiale de la santé (OMS) pour assurer la transparence des coûts de développement des nouveaux médicaments ; (2) imposer une clause de prix raisonnable dans les accords qui régissent le transfert de technologies entre les institutions académiques soutenues par des fonds publics et les entreprises privées ; (3) instituer une instance européenne commune de négociation des prix des médicaments adaptée aux conditions socioéconomiques de chaque pays ; (4) conditionner le remboursement des traitements innovants à leur commercialisation par des entreprises - ou des filiales de celles-ci - répondant à des normes certifiant leur responsabilité sociétale et (5) développer en Europe des partenariats public-privé à but non lucratif, pour la création de quelques unités de production de biothérapies et thérapies géniques. L’objectif général de ces mesures serait de fixer un cadre qui permette de définir des prix qui garantissent un juste retour de l’investissement public vers le système de santé tout en assurant pour les entreprises un profit d’un niveau conforme au marché et une incitation suffisante à investir dans les domaines prioritaires pour la santé publique.

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Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies

Cited by 68 publications

References 32 publications

Enhancing global access to cancer medicines

Enhancing global access to cancer medicines

Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy

L’innovation thérapeutique, à quel prix ?

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