The twin forces of payors seeking fair pricing and the rising costs of developing new medicines has driven a closer relationship between pharmaceutical companies and diagnostics companies, because stratified medicines, guided by companion diagnostics, offer better commercial, as well as clinical, outcomes. Stratified medicines have created clinical success and provided rapid product approvals, particularly in oncology, and indeed have changed the dynamic between drug and diagnostic developers. The commercial payback for such partnerships offered by stratified medicines has been less well articulated, but this has shifted as the benefits in risk management, pricing and value creation for all stakeholders become clearer. In this larger healthcare setting, stratified medicine provides both physicians and patients with greater insight on the disease and provides rationale for providers to understand cost-effectiveness of treatment. This article considers how the economic value of stratified medicine relationships can be recognized and translated into better outcomes for all healthcare stakeholders.
References
[1]
Walker, I.; Newell, H. Do molecularly targeted agents in oncology have reduced attrition rates? Nat. Rev. Drug Discov. 2009, 8, 15–16, doi:10.1038/nrd2758.
[2]
Trusheim, M.R.; Berndt, E.R.; Douglas, F.L. Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers. Nat. Rev. Drug Discov. 2007, 6, 287–293.
[3]
Blair, E.D. Predictive tests and personalised medicine. Drug Discov. World (Autumn) 2009, 22, 27–31.
[4]
Gilham, I. Theranostics: An emerging tool in drug discovery and commercialisation. Drug Discov. World (Autumn) 2002, 6, 24–32.
[5]
Trusheim, M.R.; Burgess, B.; Hu, S.X.; Long, T.; Averbuch, S.D.; Flynn, A.A.; Lieftucht, A.; Mazumder, A.; Milloy, J.; Shaw, P.M.; et al. Quantifying factors for the success of stratified medicine. Nat. Rev. Drug Discov. 2011, 10, 817–833, doi:10.1038/nrd3557.
[6]
Agarwal, A. Overlooked Opportunities. Available online: http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=574630&pageID=1&sk=&date (accessed on 20 August 2012).
[7]
Blair, E.D. Assessing the value-adding impact of diagnostic-type tests on drug development and marketing. Mol. Diagn. Ther. 2008, 12, 331–337, doi:10.1007/BF03256298.
[8]
Hughes, B. The comparative effectiveness challenge. Nat. Rev. Drug Discov. 2009, 8, 261–263, doi:10.1038/nrd2866.
[9]
Hughes, B. Novel risk-sharing scheme puts the spotlight on biomarkers. Nat. Rev. Drug Discov. 2007, 6, 945.
[10]
Blair, E.D.; Blakemore, J.A. Drug-diagnostic co-development: How to harness the value. Drug Discov. Today 2011, 16, 902–905, doi:10.1016/j.drudis.2011.08.010.
[11]
Allen, D.; Alves, L.; Caruncho, G.; Chin, D.; Cohn, D.; Damle, B.; Dracos, B.; Friend, S.; Ha, J.; Kadar, A.; et al. The new science of personalized medicine. Available online: http://www.PWC.com (accessed on 20 August 2012).
[12]
Davis, J.C.; Furstenthal, L.; Desai, A.A.; Norris, T.; Sutaria, S.; Fleming, E.; Ma, P. The microeconomics of personalized medicine: Today’s challenge and tomorrow’s promise. Nat. Rev. Drug Discov. 2009, 8, 279–286.
[13]
Personalized Medicine Coalition. The Case for Personalized Medicine 3rd ed. Available online: http://www.personalizedmedicinecoalition.org/ (accessed on 20 August 2012).
[14]
Espicom Healthcare Intelligence. The World Pharmaceutical Markets Fact Book. 2011. Available online: http://www.marketresearch.com/Espicom-Healthcare-Intelligence-v1129/Pharmaceutical-Fact-Book-6485983/ (accessed on 20 August 2012).
[15]
EAC Diagnostics Industry Study. 2011. Available online: http://www.eacorp.com (accessed on 20 August 2012).
[16]
Blair, E.D. Molecular diagnostics and personalized medicine: Value-assessed opportunities for multiple stakeholders. Pers. Med. 2010, 7, 143–161, doi:10.2217/pme.10.1.
[17]
Pfizer invests in Monogram. Available online: http://www.fiercebiotech.com/story/pfizer-to-invest-25m-in-monogram-biosciences/2006-05-08 (accessed on 20 August 2012).
[18]
Mansfield, E.; Leptak, C. Draft Guidance for Industry and FDA Staff—In Vitro Companion Diagnostic Devices. Available online: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm (accessed on 20 August 2012).
[19]
Chapman, P.B.; Hauschild, A.; Robert, C.; Haanen, J.B.; Ascierto, P.; Larkin, J.; Dummer, R.; Garbe, C.; Testori, A.; Maio, M.; et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 2011, 364, 2507–2516.
[20]
Goodman, M. Xalkori and the Art of Modern Drug Development. In Vivo 2012. Article No. 2012800030.
[21]
Food and Drug Administration. FY2011 Innovative Drug Approvals. Available online: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm (accessed on 20 August 2012).
[22]
European Medicines Agency. Qualification of novel methodologies for medicine development: Guidance to applicants. Available online: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0 (accessed on 20 August 2012).
[23]
Stynen, D. Revision of Europe’s IVD Directive 98/79/EC—Lessons and results from the Public Consultation document. IVD Technology, 20, July, 2011.
[24]
Maverick, N.Y. My take on the Crizotinib / xalkori FDA approval. Available online: http://pharmastrategyblog.com/2011/08/my-take-on-the-crizotinibxalkori-fda-approval.html/ (accessed on 20 August 2012).
[25]
Herper, M. Gene Test for Pfizer Cancer Drug to Cost $1,500 per Patient. Available online: http://www.forbes.com/sites/matthewherper/2011/08/29/gene-test-for-pfizer-cancer-drug-to-cost-1500-per-patient/ (accessed on 20 August 2012).
[26]
Sauter, G.; Lee, J.A.; Slamon, D.J.; Press, M.F. Reply to V. Arena. et al. J. Clin. Oncol. 2010, 28, e85–e88, doi:10.1200/JCO.2009.25.3930.
[27]
Crino, L.; Kim, D.; Riely, G.J.; Janne, P.A.; Blackhall, F.H.; Camidge, D.R.; Hirsh, V.; Mok, T.; Solomon, B.J.; Park, K.; et al. Initial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005. J. Clin. Oncol. 2011, 29 (Suppl.). Abstract 7514.
[28]
Kwak, E.L.; Bang, Y.J.; Camidge, D.R.; Shaw, A.T.; Solomon, B.; Maki, R.G.; Ou, S.H.; Dezube, B.J.; J？nne, P.A.; Costa, D.B.; et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N. Engl. J. Med. 2010, 363, 1693–1703, doi:10.1056/NEJMoa1006448.
[29]
Camidge, D.R.; Bang, Y.; Kwak, E.L.; Shaw, A.T.; Iafrate, A.J.; Maki, R.G.; Solomon, B.J.; Ou, S.I.; Salgia, R.; Wilner, K.D.; et al. Progression-free survival (PFS) from a phase I study of crizotinib (PF 02341066) in patients with ALK-positive non-small cell lung cancer (NSCLC). J. Clin. Oncol. 2011, 29 (Suppl.). Abstract 2501.
[30]
Crystal, A.S.; Shaw, A.T. New Targets in Advanced NSCLC: EML4-ALK. Clin. Adv. Hematol. Oncol. 2011, 9, 313–331.
[31]
Jemal, A.; Siegel, R.; Xu, J.; Ward, E. Cancer statistics. Cancer J. Clin. 2010, 60, 277–300, doi:10.3322/caac.20073.
[32]
Taube, S.E.; Lively, T. Challenges in drug and biomarker co-development. Recent Results Cancer Res. 2012, 195, 229–239, doi:10.1007/978-3-642-28160-0_21.
[33]
Cheng, S.; Koch, W.H.; Wu, L. Co-development of a companion diagnostic for targeted cancer therapy. Biotechnology 2012, 29, 682–688.
[34]
COSMIC Database. Available online: http://www.sanger.ac.uk/genetics/CGP/cosmic/ (accessed on 20 August 2012).
[35]
Yervoy vs. Zelboraf: Melanoma Drugs Battle for Market Share. Available online: http://seekingalpha.com/article/744721-yervoy-vs-zelboraf-melanoma-drugs-battle-for-market-share (accessed on 20 August 2012).
[36]
Roche Half Year Results 2012. Available online: http://www.roche.com/investors/ir_agenda/halfyear-2012.htm (accessed on 20 August 2012).
[37]
Roche / Plexxikon: vemurafenib set to impact melanoma market. Available online: http://www.datamonitor.com/store/News/rocheplexxikon_vemurafenib_set_to_impact_melanoma_market?productid=9F516C6D-E974-47E4-8060-11C464770B05 (accessed on 20 August 2012).
[38]
Food and Drug Administration. FDA approves new treatment for a type of late-stage skin cancer. Available online: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm1193237.htm (accessed on 20 August 2012).
[39]
Uproar as NICE rejects B-MS skin cancer drug Yervoy. Available online: http://www.pharmatimes.com/article/11-10-14/Uproar_as_NICE_rejects_B-MS_skin_cancer_drug_Yervoy.aspx (accessed on 20 August 2012).
[40]
NICE consults on a new treatment for skin cancer. Available online: http://www.nice.org.uk/newsroom/pressreleases/VemurafenibForMelanomaACD.jsp (accessed on 20 August 2012).
[41]
Atherly, A.J.; Camidge, D.R. The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br. J. Cancer 2012, 106, 1100–1106, doi:10.1038/bjc.2012.60.
[42]
Miller, I.A.; Ashton-Chess, J.; Spolders, H.; Fert, V.; Ferrara, J.; Kroll, W.; Askaa, J.; Larcier, P.; Terry, P.F.; Bruinvels, A.; et al. Market access challenges in the EU for high medical value diagnostic tests. Pers. Med. 2011, 8, 137–148, doi:10.2217/pme.11.2.
[43]
Gesetz zur Neuordnung des Arzneimittelmarktes in der gesetzlichen Krankenversicherung (Arzneimittelmarktneuordnungsgesetz – AMNOG). Available online: http://www.bgbl.de/Xaver/start.xav?startbk=Bundesanzeiger_BGBl&bk=Bundesanzeiger_BGBl&start=//*[@attr_id=%27bgbl110s2262.pdf%27] (accessed on 20 August 2012).
