TY - JOUR
T1 - Coverage with evidence development and managed entry in the funding of personalized medicine
T2 - practical and ethical challenges for oncology
AU - Lewis, Jan R R
AU - Kerridge, Ian
AU - Lipworth, Wendy
N1 - © 2015 by American Society of Clinical Oncology.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - Personalized medicines hold promise for many diseases. However, demonstrating the clinical efficacy and cost effectiveness of these medicines can be difficult. It is essential that decision-making processes for funding new medicines, including personalized medicines, are both robust and fit for purpose. We will argue that randomized trials of personalized medicines should be routinely supplemented with other research methods, such as observational research and single-arm studies, and that managed-entry funding programs, such as coverage with evidence development, may offer a means of providing early access to technologies where there is uncertainty about efficacy, safety, and cost effectiveness. These programs, however, raise a number of practical and ethical challenges that need to be worked through and resolved.
AB - Personalized medicines hold promise for many diseases. However, demonstrating the clinical efficacy and cost effectiveness of these medicines can be difficult. It is essential that decision-making processes for funding new medicines, including personalized medicines, are both robust and fit for purpose. We will argue that randomized trials of personalized medicines should be routinely supplemented with other research methods, such as observational research and single-arm studies, and that managed-entry funding programs, such as coverage with evidence development, may offer a means of providing early access to technologies where there is uncertainty about efficacy, safety, and cost effectiveness. These programs, however, raise a number of practical and ethical challenges that need to be worked through and resolved.
UR - http://www.scopus.com/inward/record.url?scp=84951743075&partnerID=8YFLogxK
U2 - 10.1200/JCO.2015.61.2838
DO - 10.1200/JCO.2015.61.2838
M3 - Article
C2 - 26460298
SN - 0732-183X
VL - 33
SP - 4112
EP - 4117
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 34
ER -