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      Cancer medicines: a private vice for public benefit?

      editorial
      Author(s):
      Publication date (Electronic):
      Journal: ecancermedicalscience
      Publisher: Cancer Intelligence
      Keywords: affordability, systemic anti cancer therapy, cancer medicines, pharmaceutical policy

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          Abstract

          Cancer medicines have become one of the most dominant global medical technologies. They generate huge profits for the biopharmaceutical industry as well as fuel the research and advocacy activities of public funders, patient organisations, clinical and scientific communities and entire federal political ecosystems. The mismatch between the price, affordability and value of many cancer medicines and global need has generated significant policy debate, yet we see little change in behaviours from any of the major actors from public research funders through to regulatory authorities. In this policy analysis we examine whether, considering the money and power inherent in this system, any rationale global consensus and policy can be achieved to deliver affordable and equitable cancer medicines that consistently deliver clinically meaningful benefit.

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          Diagnosing the decline in pharmaceutical R&D efficiency.

          Helen Boldon, Alex Blanckley, Brian Warrington … (2012)
          The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (RD). Yet the number of new drugs approved per billion US dollars spent on RD has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. There have been many proposed solutions to the problem of declining RD efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed. Here, we discuss four factors that we consider to be primary causes, which we call the 'better than the Beatles' problem; the 'cautious regulator' problem; the 'throw money at it' tendency; and the 'basic research-brute force' bias. Our aim is to provoke a more systematic analysis of the causes of the decline in RD efficiency.
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            Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

            Courtney Davis, Huseyin Naci, Evrim Gurpinar … (2017)
            Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.
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              Delivering affordable cancer care in high-income countries.

              Richard J Sullivan, Jeffrey Peppercorn, Karol Sikora … (2011)
              The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies. Copyright © 2011 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Ecancermedicalscience
                Journal ID (iso-abbrev): Ecancermedicalscience
                Journal ID (publisher-id): ecancermedicalscience
                Title: ecancermedicalscience
                Publisher: Cancer Intelligence
                ISSN (Electronic): 1754-6605
                Publication date Collection: 2024
                Publication date (Electronic): 30 January 2024
                Volume: 18
                Electronic Location Identifier: ed131
                Affiliations
                Institute of Cancer Policy, Centre for Cancer, Society & Public Health, King’s College London, London SW1 9RT, UK
                Author notes
                Correspondence to: Richard Sullivan Richard.sullivan@ 123456kcl.ac.uk
                Article
                Publisher ID: can-18-ed131
                DOI: 10.3332/ecancer.2024.ed131
                PMC ID: 10901629
                PubMed ID: 38425769
                SO-VID: 5d9e4f09-52bf-4698-ab36-02577f1f41f7
                Copyright © © the authors; licensee ecancermedicalscience.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 04 January 2024
                Categories
                Subject: Editorial

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: affordability,systemic anti cancer therapy,cancer medicines,pharmaceutical policy
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: affordability, systemic anti cancer therapy, cancer medicines, pharmaceutical policy

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