Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements
| Published date | 01 March 2017 |
| Author | Giovanni Tafuri,Panos Kanavos,Paolo Siviero,Alessandra Ferrario |
| DOI | http://doi.org/10.1111/1758-5899.12386 |
| Date | 01 March 2017 |
Managing Risk and Uncertainty in Health
Technology Introduction: The Role of Managed
Entry Agreements
Panos Kanavos and Alessandra Ferrario
Medical Technology Research Group –LSE Health, London School of Economics,
London, United Kingdom
Giovanni Tafuri
European Medicines Agency
Paolo Siviero
Principia SGR, Milan, Italy
Abstract
Managed entry agreements (MEAs) comprise a variety of instruments to reduce uncertainty arising from incomplete informa-
tion on budget impact, cost-effectiveness, use in real life, and access to new therapies. MEAs have a number of advantages
and limitations and are sometimes faced with scepticism among decision-makers. Their uptake and use –particularly financial
MEAs - has been fast in many European Union Member States and beyond. The use of MEAs highlights their significance as a
conduit for satisfying a number of policy imperatives while mitigating risk and the limitations of current approaches to cover-
age decisions, including health technology assessment (HTA), in securing reasonable prices and addressing uncertainties
around therapeutic effect in real life. Despite the large number of agreements implemented, little information is available on
their impact. The little amount of available information is hampering cross-country learning and the ability of patients to
engage in the process. Despite their proliferation, MEAs should not become a quick-fix solution to addressing the risk and
uncertainty arising from the introduction of new therapies; instead, they should be integrated into a process of managed
introduction of new therapies starting with horizon scanning and forecasting activities, proceeds to HTA assessment and con-
tinues with post-marketing studies and surveillance.
1. Background
The overall evidence base available at registration is often
insufficient to accurately estimate the clinical and cost-effec-
tiveness of a drug in clinical practice or its budget impact in
real life. Uncertainty, due to lack of information on effective-
ness and partly driven by concerns about the cost of new
therapies, may delay reimbursement decisions and patient
access.
Formal arrangements between payers and manufacturers
with the aim of sharing the financial risk due to uncertainty
surrounding the introduction of new technologies have
been developed and introduced in order to enable access
to new medicines and aid resource allocation. These agree-
ments can take different forms, including price-volume
agreements (PVAs), outcome guarantees, coverage with evi-
dence development (CED), and disease management pro-
grammes, among others. A variety of names have been
used to describe these schemes (e.g. risk-sharing agree-
ments (RSAs), performance-based agreements (PBAs), patient
access schemes (PAS), etc.), or managed entry agreements
(MEAs) (Klemp et al., 2011).
Despite the diversity in the different models of MEAs
these agreements are introduced in an attempt to address
one or more of three objectives: first, to limit the budget
impact and address uncertainty regarding expenditure on
new therapies; second, to address uncertainties regarding
clinical effectiveness and cost-effectiveness and/or in a
specific context (e.g. validate cost-effectiveness information
from another country with local data), and third to man-
age utilisation with a view to optimising performance.
Some of the instruments used by countries in their
attempt to achieve these objectives have application in
more than one area, for example, conditional treatment
continuation or limitation of reimbursement to specific
patient sub-groups contribute to both managing budget
impact (through reduced utilisation) and managing utilisa-
tion to optimise performance (by limiting reimbursement
to the patient sub-groups who are likely to benefit the
most).
©2017 University of Durham and John Wiley & Sons, Ltd. Global Policy (2017) 8:Suppl.2 doi: 10.1111/1758-5899.12386
Global Policy Volume 8 . Supplement 2 . March 2017
84
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