Abstract
The clinical utility and medico–economic value of several personalized diagnostic tests has been well described in the literature. Development of such tests, including generation of the necessary supportive clinical validation data, is a complex and expensive endeavor. In general, sponsors of such tests lack sufficient clarity on appropriate reimbursement and regulatory pathways to provide the clear development framework necessary to incentivize the required level of investment. In the USA, an imperfect reimbursement paradigm has evolved to accommodate a small number of ‘value-priced’ laboratory-developed tests, although major structural barriers remain to broader implementation. In Europe, by contrast, there is virtually no precedent for value-based public sector pricing, and even such procedurally based pricing as currently exists is administered by a complex network of largely decentralized bodies. As a consequence, patient access is limited and health–economic savings are not realized. This article explores some of the European market entry barriers, with a focus on reimbursement challenges, and highlights some collaborative proposals to address such.
Bibliography
- 1 Cowen & Co: Therapeutic Categories Outlook, 2008–2012 estimate. Cowen Group, NY, USA (2008).
- 2 Shankaran V, Luu TH, Nonzee N et al.: Cost–effectiveness of a healthcare provider-directed intervention to promote colorectal cancer screening. J. Clin. Oncol.27(15S), (2009) (Abstract 6583).
- 3 William Blair & Company: Equity research report. William Blair & Company, IL, USA (2010).
- 4 Hornberger J, Cosler LE, Lyman GH: Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. Am. J. Manag. Care11(5),313–324 (2005).
- 5 Reimbursement workshop jointly organized by European Device Manufacturers association (EDMA) and International Association of Clinical Chemistry and Laboratory Medicine (IFCC). Brussels, Belgium, 26 November 2010.
- 6 Spear BB, Heath-Chiozzi M, Huff J: Clinical Application of Pharmacogenetics. Trends Mol. Med.7(5),201–204 (2001).
- 7 Ernst FR, Grizzle AJ: Drug-related morbidity and mortality: updating the cost-of-illness model. J. Am. Pharm. Assoc.41,192–199 (2001).
- 8 Market Access for Personalised Medicine in Europe. European Personalized Medicine Coalition webinar, 15 September 2010.
- 9 Poithier K, Gustavsen G: In Vivo Business and Medicine Report. F-D-C Reports, Inc. and Windhover Information; Elsevier Business Intelligence, NJ, USA (2009).
- 101 McWilliam A, Lutter R, Nardinelli C: Health care savings from personalized medicine using genetic testing: the case of warfarin. Working Paper 0623 http://reg-markets.org/admin/authorpdfs/redirect-safely.php?fname=../pdffiles/WP06-23_topost.pdf
- 102 NICE diagnostic assessment program www.nice.org.uk/media/09E/D5/DiagnosticsAssessmentProgrammeInterimMethodsStatement.pdf
- 103 House of Lords: Science and Technology committee: genomic medicine volume 1 www.publications.parliament.uk/pa/ld200809/ldselect/ldsctech/107/107i.pdf
- 104 NHS UK genetic testing network www.ukgtn.nhs.uk/gtn/home
- 105 Technology strategy board www.innovateuk.org
- 106 Nordic immunohistochemistry quality control www.nordiqc.org/
- 107 UK National External Quality Assessment Service www.ukneqas.org.uk/
- 108 European Personalized Medicine Coalition: Personalised Medicine: in France and in Europe: a major health economics challenge for the next decades www.epemed.org/articles/uk_conference_agenda.pdf
- 109 EUnetHTA Joint Action www.eunethta.eu
- 110 European Personalized Medicine Coalition: Personalised Medicine www.epemed.org
- 111 EDMA: The European In Vitro Diagnostic (IVD) Market in 2009 www.edma-ivd.be/index.php?id=476&no_cache=1&tx_ttnews[tt_news]=117&tx_ttnews[backPid]=106