TY - JOUR
T1 - Enabling Equal Access to Molecular Diagnostics: What Are the Implications for Policy and Health Technology Assessment?
AU - Plun-Favreau, Juliette
AU - Immonen-Charalambous, Kaisa
AU - Steuten, Lotte
AU - Strootker, Anja
AU - Rouzier, Roman
AU - Horgan, Denis
AU - Lawler, Mark
N1 - © 2016 S. Karger AG, Basel.
PY - 2016/6/1
Y1 - 2016/6/1
N2 - Molecular diagnostics can offer important benefits to patients and are a key enabler of the integration of personalised medicine into health care systems. However, despite their promise, few molecular diagnostics are embedded into clinical practice (especially in Europe) and access to these technologies remains unequal across countries and sometimes even within individual countries. If research translation and the regulatory environments have proven to be more challenging than expected, reimbursement and value assessment remain the main barriers to providing patients with equal access to molecular diagnostics. Unclear or non-existent reimbursement pathways, together with the lack of clear evidence requirements, have led to significant delays in the assessment of molecular diagnostics technologies in certain countries. Additionally, the lack of dedicated diagnostics budgets and the siloed nature of resource allocation within certain health care systems have significantly delayed diagnostics commissioning. This article will consider the perspectives of different stakeholders (patients, health care payers, health care professionals, and manufacturers) on the provision of a research-enabled, patient-focused molecular diagnostics platform that supports optimal patient care. Through the discussion of specific case studies, and building on the experience from countries that have successfully integrated molecular diagnostics into clinical practice, this article will discuss the necessary evolutions in policy and health technology assessment to ensure that patients can have equal access to appropriate molecular diagnostics.
AB - Molecular diagnostics can offer important benefits to patients and are a key enabler of the integration of personalised medicine into health care systems. However, despite their promise, few molecular diagnostics are embedded into clinical practice (especially in Europe) and access to these technologies remains unequal across countries and sometimes even within individual countries. If research translation and the regulatory environments have proven to be more challenging than expected, reimbursement and value assessment remain the main barriers to providing patients with equal access to molecular diagnostics. Unclear or non-existent reimbursement pathways, together with the lack of clear evidence requirements, have led to significant delays in the assessment of molecular diagnostics technologies in certain countries. Additionally, the lack of dedicated diagnostics budgets and the siloed nature of resource allocation within certain health care systems have significantly delayed diagnostics commissioning. This article will consider the perspectives of different stakeholders (patients, health care payers, health care professionals, and manufacturers) on the provision of a research-enabled, patient-focused molecular diagnostics platform that supports optimal patient care. Through the discussion of specific case studies, and building on the experience from countries that have successfully integrated molecular diagnostics into clinical practice, this article will discuss the necessary evolutions in policy and health technology assessment to ensure that patients can have equal access to appropriate molecular diagnostics.
KW - Delivery of Health Care
KW - Europe
KW - Health Policy
KW - Health Services Accessibility
KW - Humans
KW - Pathology, Molecular
KW - Precision Medicine
KW - Technology Assessment, Biomedical
KW - Journal Article
U2 - 10.1159/000446532
DO - 10.1159/000446532
M3 - Article
C2 - 27237607
SN - 1662-4246
VL - 19
SP - 144
EP - 152
JO - Public health genomics
JF - Public health genomics
IS - 3
ER -