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The economic pressures for biosimilar drug use in cancer medicine

By Paul Cornes


The main rationale for using biosimilar drugs is for cost saving. The market development for biosimilar drugs will therefore depend on the degree to which cost saving measures are required by nations, medical insurers and individuals and the absolute savings that could be gained by switching from original drugs. This paper is designed to discover the degree to which financial constraints will drive future health spending and to discover if legal or safety issues could impact on any trend. A structured literature search was performed for papers and documents to 27 August 2011. Where multiple sources of data were available on a topic, data from papers and reports by multinational or national bodies were used in preference to data from regions or individual hospitals. Almost all health systems face current significant cost pressures. The twin driver of increasing cancer prevalence as populations age and cancer medicine costs rising faster than inflation places oncology as the most significant single cost problem. For some countries, this is predicted to make medicine unaffordable within a decade. Most developed countries have planned to embrace biosimilar use as a cost-control measure. Biosimilar introduction into the EU has already forced prices down, both the price of biosimilar drugs and competitive price reductions in originator drugs. Compound annual growth rates of use have been predicted at 65.8% per year. Most developed countries have planned to embrace biosimilar use as a major cost-control measure. Only legal blocks and safety concerns are likely to act against this trend. For centralised healthcare systems, and those with a strong tradition of generic medicine use, biosimilar use will clearly rise with predictions of more than 80% of prescriptions of some biologic drugs within 1 year of market entry in the USA. Delaying the implementation of such programmes however risks a real crisis in healthcare delivery for many countries and hospitals that few can now afford

Topics: Perspectives
Publisher: Springer-Verlag
OAI identifier: oai:pubmedcentral.nih.gov:3291824
Provided by: PubMed Central
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    1. (2011). A pan- European comparison regarding patient access to cancer drugs. Available at http://ki.se/ content/1/c4/33/16/Cancer_Report.pdf.
    2. (2011). Acceptable changes in quality attributes of glycosylated biopharmaceuticals.
    3. Acharya A et al (2000) Development of WHO guidelines on generalized cost-effectiveness analysis.
    4. (2011). Advisory Commission: report to the Congress: MedicarePaymentPolicy,(3,2010)(Washington,DC).Availableat http://www.medpac.gov/documents/Mar10_EntireReport.pdf.
    5. (2009). Annual Survey, Kaiser Family Foundation and Health Research Educational Trust
    6. (2008). Association of insurance with cancer care utilization and outcomes.
    7. (2007). Basic facts about biosimilars.
    8. Bertuccio P et al (2011) European cancer mortality predictions for the year 2011. Ann Oncol (first published online).
    9. (2007). Biologics in perspective: expanded clinical options amid greater cost scrutiny.
    10. (2010). Biosimilar epoetins and other “follow-on” biologics: update on the European experiences.
    11. (2004). Biosimilar epoetins: how similar are they?
    12. (2011). Biosimilar erosion of branded esa market share will be more rapid
    13. (2010). Biosimilars advisory service: physicianperspectivesonerythropoietinstimulatingagents,insulin, and human growth hormone.
    14. (2007). Biosimilars in the United States: a brief look at where we are and the road ahead.
    15. (2011). Biosimilars: a marathon, not a sprint. Industry Brief 12/16/09.
    16. (2011). Cancer Institute website for cancer prevalence and cost of care projection data. Available at http://costprojections. cancer.gov/graph.php.
    17. (2008). Cancer to be world’s top killer by
    18. (2011). Containing the high cost of cancer care. Four experts examine the issue and offer solutions.
    19. (2000). Cost effectiveness of early discharge after uncomplicated acute myocardial infarction.
    20. (2008). Cost-effectiveness of treating cancer anaemia. In: Nowrousian MR (ed) Recombinant human erythropoietin (rhEPO) in Clinical Oncology—Scientific and clinical aspects of anemia in cancer. 2nd Edition, Springer-Verlag,
    21. (2008). Criteria for deciding costeffectiveness for expensive new anticancer agents.
    22. (2008). Current and future cancer burden in Saudi Arabia: meeting the challenge.
    23. Data from the European Generic Medicines Association.
    24. (2007). Do generics offer significant savings to the UK National Health Service?
    25. (2006). Do oncologists believe new cancer drugs offer good value?
    26. (1999). Drug price divergence in Europe: regulatory aspects.
    27. Dueck A et al (2006) Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2+ breast cancer.
    28. (1997). Dying too soon: how costeffectiveness analysis can save lives.
    29. (2009). Efficacy does not necessarily translate to cost effectiveness: a case study in the challenges associated with 21st-century cancer drug pricing.
    30. (2007). EMEA Guidelines on biosimilars and their clinical implications.
    31. (2007). Entry and competition in generic biologics.
    32. (2006). Estimating the cost of new drug development:isitreally802milliondollars?HealthAff(Millwood)
    33. (2011). EU mAb biosimilars path.
    34. (2006). Evidence-based medicine is affordable: the cost-effectiveness of current compared with optimal treatment in rheumatoid and osteoarthritis.
    35. (2009). Expensive cancer drugs: a comparison between the United States and the United Kingdom. Milbank Quarterly 87:789–819.
    36. (2002). Experiences with generics.
    37. (2008). Fifteen countries had banned automatic substitution of biosimilars – EGA. APM Health Europe.
    38. (2009). Finance Committee Roundtable Proceedings on Healthcare Delivery System Reform,
    39. (2010). Forecasting the potential of the biosimilars market. Sep 27, http://social.eyeforpharma.com/story/forecastingpotentialbiosimilars-market.
    40. (2008). Generic antiepileptic drugs: current controversies and future directions.
    41. (2011). Generic drugs in USA’s Medicare Part D saved beneficiaries and program $33 billion
    42. (2001). Global cancer statistics in the year
    43. Google “related sites” programme. Available at http://www. google.com/help/features.htmlwebportal
    44. Headings (MeSH) portal of the USA National Library of Congress PubMed database. Available at http://www. ncbi.nlm.nih.gov/mesh
    45. (2011). Health haves and have- nots. The true cost of spiraling medical inflation.
    46. (2008). Health spending projections through 2017: the baby-boom generation is coming to medicare. Health Aff March 27: w145–w55; published ahead of print February 26. doi:10.1377/hlthaff.27.2.w145.
    47. (2009). How drug industry lobbyists won on health-care.
    48. (2009). How health care costs contribute to income disparity in the United States. McKinsey Quarterly
    49. (2009). How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question.
    50. (2009). How providers can lower costs and improve patient care using evidence-based medicine. An oracle white paper
    51. (2011). How similar are biosimilars in India? A blind comparative study.
    52. (2010). http:// progressreport.cancer.gov.
    53. (2009). Increased spending on health care: longterm implications for the Nation.
    54. (2006). Is the price of cancer treatment falling?” Paper presented at the annual meeting of the economics of population health:
    55. (2009). Limits on medicare’s ability to control rising spending on cancer drugs.
    56. (2009). Medical bankruptcy in the United States,
    57. (2007). Medical oncologists’ views on communicating with patients about chemotherapy costs: a pilot survey.
    58. (2011). Medicare unable to control rising costs of cancer care. Medscape Medical News. Available at http://www.medscape.
    59. (2010). Mirror, mirror on the wall: how the performance of the US Health Care System Compares Internationally,MPP Commonwealth fund,
    60. (2004). National Institute for clinical excellence and its value judgments. BMJ 329:224. doi:10.1136/ bmj.329.7459.224,
    61. (2009). NICE and the challenge of cancer drugs.
    62. (2011). NIH study predicts the cost of cancer care will increase 27% by 2020. Cancer Network,
    63. (2007). No-name heroes can save Europe billions. Cancerworld March–April: 24–28. Available at http://www.
    64. (2010). Of value: a discussion of cost, communication, and evidence to improve cancer care.
    65. (2009). Oncologists: Cost-Effectiveness Policy Necessary Despite Quality of Care Warnings.
    66. (2008). Presentation by Andrew Dillon, the head of the National Institute for Clinical Excellence (NICE), the UK’s technology assessment agency
    67. (2010). Projected costs of chronic diseases. Health Care Cost Monitor.
    68. (2011). Responsible spending in cancer care: the steps that really matter.
    69. (2008). Safety-related regulatory actions for biologicals approved in the United States and the European Union.
    70. (2010). Steenhoek A
    71. (2009). The “Win-Win” initiative: a global, scientifically based approach to resource sparing treatment for S66 Targ Oncol (2012) 7 (Suppl 1):S57–S67systemic breast cancer therapy.
    72. (2010). The biosimilars market today and tomorrow.
    73. (2008). The challenge of biosimilars.
    74. (2010). The cost of a QALY.
    75. (2006). The costs of caring: Who pays? Who profits? Who panders?
    76. (2015). The future of biosimilars—Market forecasts to
    77. (2011). The future of pharmaceuticals: generic medicines enhancing pharmaceutical competition and ensuring healthcare sustainability. Available at http://www.egagenerics.com/doc/ega_FuturePharmaceuticals. pdf.
    78. (2006). The market for follow-on biologics: how will it evolve? Follow-on biologics.
    79. (2008). The NICE costeffectiveness threshold: what it is and what that means.
    80. (2011). The relative effect of demographics and increased unit treatment costs on the spending on Medicare, Medicaid and Social Security as a% of USA GDP. Office of management and budget.
    81. (2010). The Rising Cost of Cancer Care: Who Takes Responsibility? J Multidisciplinary Cancer Care.
    82. (2000). The World Health Report
    83. (2010). Therapeutic decision making in oncology.
    84. (2009). Time to consider cost in evaluating cancer drugs in United States?
    85. TJ et al (2009) American Society of Clinical Oncology guidance statement: the cost of cancer care.
    86. (2009). To tell or not to tell: the community wants to know about expensive anticancer drugs as a potential treatment option.
    87. Towse A (eds) (2010) Biosimilars: How much entry and price competition will result? Office of Health Economics (OHE),
    88. (2005). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.
    89. (1980). US News and World Report Magazine.
    90. WHO—Spectre of ageing population worries economistsBulletin of the World Health Organization 88(3). Available at http://www.
    91. (2010). Wrestling with the high price of cancer care: should we control costs by individuals’ ability to pay or society’s willingness to pay?

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