Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe

被引:12
作者
Akhmetov, Ildar [1 ]
Ramaswamy, Rakshambikai [1 ]
Akhmetov, Illias [2 ]
Thimmaraju, Phani Kishore [1 ]
机构
[1] Phamax Analyt Resources Pvt Ltd, 19,KMJ Ascend 1st Cross,17th C Main 5th Block, Koramangala Bangalore 560095, India
[2] Unicorn, UA-10020 Zhytomyr, Ukraine
关键词
Stratified medicine; companion diagnostics; market access; cost-effectiveness; value addition;
D O I
10.3390/jpm5020213
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.
引用
收藏
页码:213 / 228
页数:16
相关论文
共 30 条
  • [11] Biomarkers and Receptor Targeted Therapies Reduce Clinical Trial Risk in Non-Small-Cell Lung Cancer
    Falconi, Adam
    Lopes, Gilberto
    Parker, Jayson L.
    [J]. JOURNAL OF THORACIC ONCOLOGY, 2014, 9 (02) : 163 - 169
  • [12] Challenges in the Development and Reimbursement of Personalized Medicine-Payer and Manufacturer Perspectives and Implications for Health Economics and Outcomes Research: A Report of the ISPOR Personalized Medicine Special Interest Group
    Faulkner, Eric
    Annemans, Leven
    Garrison, Lou
    Helfand, Mark
    Holtorf, Anke-Peggy
    Hornberger, John
    Hughes, Dyfrig
    Li, Tracy
    Malone, Daniel
    Payne, Katherine
    Siebert, Uwe
    Towse, Adrian
    Veenstra, David
    Watkins, John
    [J]. VALUE IN HEALTH, 2012, 15 (08) : 1162 - 1171
  • [13] FDA, LIST CLEAR APPR COMP
  • [14] Garfield S., ADV ACCESS PERSONALI
  • [15] Groves E., BIOMARKERS DIAGNOSTI
  • [16] Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy
    Higashi, MK
    Veenstra, DL
    Kondo, LML
    Wittkowsky, AK
    Srinouanprachanh, SL
    Farin, FM
    Rettie, AE
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2002, 287 (13): : 1690 - 1698
  • [17] Kanavos P, MANAGED ENTRY AGREEM
  • [18] Kievits T., PERSONALISED MED CLI
  • [19] Markus B., PERSONALISED MED EUR
  • [20] Market access challenges in the EU for high medical value diagnostic tests
    Miller, Iain
    Ashton-Chess, Joanna
    Spolders, Herman
    Fert, Vincent
    Ferrara, Joseph
    Kroll, Werner
    Askaa, Jon
    Larcier, Patrick
    Terry, Patrick F.
    Bruinvels, Anne
    Huriez, Alain
    [J]. PERSONALIZED MEDICINE, 2011, 8 (02) : 137 - 148