Interview with: Finn Boerlum Kristensen, M.D., Ph.D., Chairman of the Executive Committee of the European Network for Health Technology Assessment (EUnetHTA) and Director of its Coordinating Secretariat, Danish Health and Medicines Authority, Denmark, a speaker at the marcus evans Evolution Summit 2013, on improving HTA processes.

1. Interview with: Finn Boerlum
Kristensen, M.D., Ph.D., Chairman of
the Executive Committee of the
European Network for Health
Technology Assessment (EUnetHTA)
and Director of its Coordinating
Secretariat, Danish Health and
Medicines Authority, Denmark
“Drug developers need to come to
grips with the role of Health Technology
Assessment (HTA) and start considering
how they can provide the information
required for better decision-making,”
advises Finn Boerlum Kristensen, M.D.,
Ph.D., Chairman of the Executive
Committee of the European Network
for Health Technology Assessment
(EUnetHTA) and Director of its
Coordinating Secretariat hosted by the
Danish Health and Medicines Authority,
Denmark. Companies must keep their
focus on value and create internal HTA
systems that do not place additional
burden on everyone, he adds.
As a speaker at the marcus evans
Evolution Summit 2013 in Monte
Carlo, Monaco, 21 - 23 October,
Kristensen puts the focus on HTA,
clinical development and what Chief
Medical Officers (CMOs) need to take
into account.
In your opinion, what is the role of
HTA?
The role of HTA is to bridge between
evidence and decision-making. Its role
varies between countries - some have
formalized systems, particularly in
relation to pricing and reimbursement,
while others do not. It is increasingly
used as a tool in the process from
evidence to problem clarification of
policy issues, followed by clarification of
the decisions to be made and the input
to provide.
How will HTA help the industry
deliver value to all stakeholders?
HTA is all about value. If the HTA
focuses on the wider scope of
identifying value, that process is of
interest to the sponsor who wants to get
a drug to market, not only through
marketing authorization or approval,
which is given by regulators, but to
actually see market take-up.
HTA has opened up several domains of
value. Value on the clinical level is key,
but a drug may also make a
contribution to how patient care is
organized and handled. For example, if
a medication can be provided orally
instead of by drip both the health
system and patients would see the
value.
How HTA could benefit sponsors of
technologies has to be discussed more
concretely.
How does the process need to
improve?
The industry needs to start thinking
about how it can provide information in
certain domains that could actually be
useful for decision-making. What data
would HTAs like to have further down
the pipeline? This must be considered
during the early development phase of a
drug, as it may go beyond traditional
pre-clinical development programs to
include concomitant studies of the
organization of care for the relevant
patient group or studies of patient
preferences or perceptions.
HTA must go beyond the clinical
aspects, to organizational and
economical aspects, even wider patient,
legal and ethical aspects. This is a
different approach from marketing. It is
more about the decision structures that
lie behind reimbursement decisions,
when traditionally marketing has
focused on the actual prescriber of the
drug. The scope is broader here and the
recipient is the prescriber as well as the
payer or health insurer.
Any final comments?
Firstly, CMOs must focus on meeting
regulators’ requirements. That is the
goal of marketing authorization. In
parallel, they should discuss with their
peers and colleagues, who may be
experiencing similar issues on what data
collections and studies would be good to
have for HTA.
The regulatory goal is to produce or
bring to market drugs that are of a high
quality, safe and proved to have some
kind of efficacy. That focus could not be
lost by the CMO.
At the same time, bringing in HTA
should throw light on value and not stir
up everything in relation to regulatory
needs or burden everyone with more
work.
How HTA
could benefit
sponsors of
technologies
has to be
discussed
more
concretely
Making Healthcare Technology Assessment Achieve its Goal

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