Journal: The Lancet Oncology

Abbreviation

Lancet Oncol

Publisher

Elsevier

Journal Volumes

ISSN

1470-2045
1474-5488

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2003 - 200912020 - 20255
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Publications 1 - 6 of 6
  • New EU regulation on health technology assessment of cancer medicines
    Item type: Journal Article
    Hwang, Thomas J.; Vokinger, Kerstin Noëlle (2022)
    The Lancet Oncology
  • Molecular mechanisms of resistance to imatinib in Philadelphia-chromosome-positive leukaemias
    Item type: Journal Article
    Gambacorti-Passerini, Carlo B.; Gunby, Rosalind H.; Piazza, Rocco; et al. (2003)
    The Lancet Oncology
  • Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis
    Item type: Journal Article
    Vokinger, Kerstin Noëlle; Hwang, Thomas J.; Grischott, Thomas; et al. (2020)
    The Lancet Oncology
    Background Increasing cancer drug prices are a challenge for patients and health systems in the USA and Europe. By contrast with the USA, national authorities in European countries often directly negotiate drug prices with manufacturers. The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) developed frameworks to evaluate the clinical value of cancer therapies: the ASCO-Value Framework (ASCO-VF) and the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). We aimed to assess the association between the clinical benefit of approved cancer drugs based on these frameworks and their drug prices in the USA and four European countries (England, Switzerland, Germany, and France). Methods For this cost–benefit analysis, we identified all new drugs with initial indications for adult cancers that were approved by the US Food and Drug Administration between Jan 1, 2009, and Dec 31, 2017, and by the European Medicines Agency up until Sept 1, 2019. For drugs indicated for solid tumours, we assessed clinical benefit using ASCO-VF and ESMO-MCBS. We compared monthly drug treatment costs between benefit levels using hierarchical linear regression models, and calculated Spearman's correlation coefficients between costs and benefit levels for individual countries. Findings Our cohort included 65 drugs: 47 (72%) drugs were approved for solid tumours and 18 (28%) were approved for haematological malignancies. The monthly drug treatment costs in the USA were a median of 2·31 times (IQR 1·79–3·17) as high as in the assessed European countries. There were no significant associations between monthly treatment costs for solid tumours and clinical benefit in all assessed countries, using the ESMO-MCBS (p=0·16 for the USA, p=0·98 for England, p=0·54 for Switzerland, p=0·52 for Germany, and p=0·40 for France), and for all assessed countries except France using ASCO-VF (p=0·56 for the USA, p=0·47 for England, p=0·26 for Switzerland, p=0·23 for Germany, and p=0·037 for France). Interpretation Cancer drugs with low or uncertain clinical benefit might be prioritised for price negotiations. Value frameworks could help identify therapies providing high clinical benefit that should be made rapidly available across countries.
  • Shortages of essential cancer medicines: who is responsible and what are the possible solutions?
    Item type: Journal Article
    Vokinger, Kerstin Noëlle; Jenei, Kristina; Lythgoe, Mark P. (2024)
    The Lancet Oncology
  • Price changes and within-class competition of cancer drugs in the USA and Europe: a comparative analysis
    Item type: Journal Article
    Vokinger, Kerstin Noëlle; Hwang, Thomas J.; Carl, David L.; et al. (2022)
    The Lancet Oncology
    Background: Cancer drugs are a major component of pharmaceutical spending in the USA and Europe. The number of approved cancer drugs continues to increase. More new drugs with overlapping mechanisms of action and similar approved indications might be expected to decrease prices within drug classes. We compared patterns of price changes for cancer drugs within the same class in the USA and in two European countries (Germany and Switzerland) with national mechanisms for drug price negotiation. Methods: For this comparative analysis, we identified cancer drugs approved for the treatment of solid cancers in the USA and Europe (Germany and Switzerland) between Jan 1, 2009, and Dec 31, 2020, using the US Food and Drug Administration's Drugs@FDA database and the European Medicines Agency's publicly available database. We considered cancer drugs as within-class competitors if they were approved for the same indication and had the same biological mechanism. We calculated monthly treatment prices for each drug, median price changes at launch and over time, and differences within and across drug classes. European price data were converted to US dollars by applying the exchange rates on Dec 1, 2020, and prices were adjusted for inflation. Median changes in the drugs' monthly treatment prices at 2 and 4 years after market entry across and within drug classes were also assessed. For the USA, correlations in relative price changes between all pairs of drugs within and across drug classes were calculated with Spearman's rank correlation. Findings: Our study cohort comprised 12 drug classes covering nine indications. With the exception of one drug, increasing prices were observed within and across all drug classes in the USA (median 6·07% [range −3·60 to 33·83] 2 years after market entry, and 15·31% [–4·15 to 54·64] 4 years after market entry). By contrast, in Europe, prices generally decreased over time or did not increase more than inflation (2 years after market entry: −21·01% [range −50·72 to 12·71] in Germany and −1·48% [–26·81 to 1·69] in Switzerland; 4 years after market entry: −25·54% [–51·81 to 11·63] in Germany and −13·02% [–43·83 to 18·31] in Switzerland). In the USA, most prices changes within and across drug classes occurred at the end and beginning of the year (ie, from Dec 1 to Jan 31). In the USA, correlation for price changes was r=0·29 (SD 0·36) for within-class drugs and r=0·28 (0·36) for drugs across drug classes. Interpretation: Competition within classes of cancer drugs generally did not constrain rising prices in the USA. Price negotiations, as practised in Germany or Switzerland, could help address the high prices of cancer drugs in the USA. Funding: Swiss Cancer Research Foundation (Krebsforschung Schweiz), Swiss National Science Foundation, and Arnold Ventures.
  • The importance of high-quality evidence supporting cancer drug approvals
    Item type: Other Journal Item
    Vokinger, Kerstin N. (2025)
    The Lancet Oncology
Publications 1 - 6 of 6