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Prostate Cancer in Europe: Screening, Treatment and Control

Submitted by on 07 Oct 2011 – 13:15

SANOFI

SANOFI’s View

Prostate cancer is on the rise

The incidence of prostate cancer has been increasing over the past decades. Although organ-confined prostate cancer can be effectively treated and in most cases even cured by surgery and/or radiation therapy, metastatic prostate cancer remains incurable. Androgen ablation has been recognized as an efficacious treatment option in this setting; however, tumours invariably progress over time. Despite recent significant advances in the treatment of metastatic androgen-independent prostate cancer with novel chemo-, immuno-, and hormonal therapies, treatment outcomes remains poor, which presents significant challenges to physicians, patients, caregivers, and the society at large.

Increasing need for efficacious treatments through pharmaceutical innovation

The ever increasing burden of cancer and the exponentially growing number of potential treatment options for a particular indication combined with limited health-system access force drug manufacturers to develop break-through therapies that would maximize the economic and clinical value of their compounds by addressing what various stakeholders (payers, providers, patients) value most. Development of break-through therapies requires innovation. Pharmaceutical innovation is a multi-faceted concept covering a wide range of scientific, medical, economic and social issues. At Sanofi Oncology, we define pharmaceutical innovation as “the development and application of a new product, process, or service. It assumes novelty in the device, the application, or both. Thus, innovation can include the use of an existing type of product in a new application or the development of a new device for an existing application. Innovation encompasses many activities, including scientific, technical, and market research; product, process, or service development; and manufacturing and marketing to the extent they support dissemination and application of the invention” [1]. Innovation is therefore a continuum from initial innovation (break-through technologies) to incremental innovation (secondary applications, new indications, product modifications, and next-generation compounds, etc).

Initial and incremental innovation delivers significant value to society

Pharmaceutical innovation and innovative medicines have added tremendous value to patients, the economy and society at large at only a small percentage of overall health care spend. It transformed treatment outcomes, resulting in longer, healthier and more productive lives (it added more than one year of life to patients diagnosed with cancer in 1995 and accounted for ca. 30% of the decline in cancer mortality rate between 1995 and 2003). Pharmaceutical innovation has driven real financial gains to society, more outpatient care, quicker recovery and fewer lost workdays (as low as 1% reduction in cancer mortality would be worth USD 500bn saving). Innovative medicines provide long-term benefits to society, far outlasting patent protection [2-6].

The value of innovation is not fully recognized

Whilst certain aspects of pharmaceutical innovation has been traditionally recognized (e.g., its impact on patient life expectancy, on direct healthcare cost offsets, on some elements of patient quality of life, as well as its value assuming price at a point in time, or its value estimated at product launch in initial indication), important aspects of its value have been ignored (e.g., its value to society/employer, overall economic productivity, comprehensive assessment of impact on quality of life, its value to the caregiver and physician, its value that extends beyond patent expiry, and its value that is demonstrated over time in initial and future indications). Therefore, a broader definition of “value” is required to recognize the benefits of innovation appropriately. Such new definition should cover traditional value (i.e., efficacy and safety), incremental value (i.e., quality of life, patient adherence and compliance, tolerability, productivity), and new value (i.e., potential future indications, level of innovation, unmet patient needs). Comprehensive assessment of the “true” clinical and economic value of innovative compounds should be made through engagement of all stakeholders including patients, caregivers, health care providers, society, employers, etc.

Potential remedies to ensure the recognition of the value of initial and incremental innovation

  1. To develop a comprehensive approach to the assessment of the value of innovation. Criteria to assess new medicines should capture the broadest definition and all elements of value. Total benefits and costs of a medicine must be assessed over time, by segment/population and in a real-life context. A pragmatic processes for evaluating and rewarding the potential value of emerging data and clinical impact over time should be created.
  2. Price flexibility to reflect different value should be allowed for. To maintain the incentive to innovation, preferential pricing of generics or biosimilars should be matched by an increased focus on price setting during the patented period of parent/innovator compounds.
  3. Need to ensure that patients get timely access to innovative medicines. ‘Fast track’ approval should be implemented for products that offer significant therapeutic benefits. Establish conditional approval and pricing/reimbursement to enable prompt access for medicines while real-life data are collected and analysed. The regulatory process should be streamlined and regulatory authorities should focus on the provision of scientific advice and support to industry more effectively.
  4. Improve public private partnerships through effective collaboration.

 

 

  1. US Congress Office of Technology Assessment: Innovation and Commercialization of Emerging Technology. OTA-BP-ITC-165. Washington DC, US Government Printing Office, 1995.
  2. Gelijns AC, Rosenberg N, Moskowitz AJ. Capturing the unexpected benefits of medical research. N Engl J Med 1998;339:693-698.
  3. Lichtenberg F. “The Expanding Pharmaceutical Arsenal in the War on Cancer” National Bureau of Economic Research, 26 January 2004. Cited in: Wilking N, Jonsson B. A pan-European comparison regarding patient access to cancer drugs. Stockholm: Karolinska Institutet, 2005.
  4. Hay J. “Where’s the Value in Health Care?” Value Health 2006;9:141-143.
  5. Murphy KM, Topel RH. “The Economic Value of Medical Research” Chicago: University of Chicago, 1999. See also: Chapter 2 in Murphy KM, Topel RH. Measuring the Gains from Medical Research: An Economic Approach. Chicago: University of Chicago Press, 2003
  6. Hargrave G, Hiatt D (2005), “The EAP Treatment for Depressed Employees: Implications for Return on Investment” Employee Assistance Quarterly, Vol: 19 Issue: 4, 7/11/2005