HTA Position Paper
The Global Medical Technology Alliance (GMTA) represents medical technology
associations whose members supply over 85 percent of the medical devices anddiagnostics purchased annually around the world. These members produce themedical devices, diagnostic products and health information systems that aretransforming health care through earlier disease detection, less invasive
procedures and more effective treatments and range in size from the largest to
the smallest medical technology innovators. They bring medical technology topatients around the world in every setting.
Health Technology Assessment (HTA) is playing an increasing role in determining
which medical technologies are available to patients throughout Europe and evenin emerging markets. HTA is becoming an active topic for the World HealthOrganization.
The International Network of Agencies for Health Technology Assessment(INAHTA) defines HTA as:“The systematic evaluation of properties, effects, and/or impacts of healthcaretechnology. It may address the direct, intended consequences of technologies aswell as their indirect, unintended consequences. Its main purpose is to inform
technology-related policymaking in healthcare. HTA is conducted byinterdisciplinary groups using explicit analytical frameworks drawing from a variety
of methods1.”
From a policy context, HTA is mainly applied by healthcare payers in decisions on
the appropriate use, coverage or reimbursement of new technologies at different
points of time of the MD life cycle. Formal assessment of technologies usuallyoccurs at a national level, although HTA is being increasingly applied at regional
and local levels, for example within individual hospitals. HTA is also used to help
inform best practice through the development of evidence based guidelines.

1

www.inahta.orgThe application of HTA to medical devices is challenging. HTA is a data driven
process and many HTA agencies adopt a strict adherence to the hierarchy ofevidence, demanding that technologies are supported by evidence from robust,
randomised controlled trials. For many medical technologies and surgicalinterventions, such evidence is often limited or unavailable at the time of launch.
Adopting a pharmaceutical paradigm, based on an expectation of multiple
randomised controlled trials being available at the time of launch, may lead torestrictions on access to many new medical technologies. A device specificassessment paradigm must be recognised.
The Purpose of HTA
Health technology assessment should be used to support patient access toinnovative technologies by promoting the use of technologies that are clinicallyand cost effective. Conversely, HTA should be used as a mechanism to support
disinvestment in current services and technologies which are cost ineffective, thus
creating ‘headroom’ for new technologies when they become available..
From a payer’s perspective, HTA is used to inform decisions on thereimbursement, coverage, adoption and uptake of healthcare technologies. HTA
should not be positioned as an additional barrier to regulatory approval. The focusof regulatory approval for CE marking (safety, quality and performance) and HTA(clinical and cost effectiveness) are fundamentally different and thus, requiredifferent data. Whilst the data required for regulatory approval are, to someextent, context free, data for HTA are largely context specific2. That is, theapplicability of the data will depend on local treatment practices, local funding
levels and socio-cultural factors.
Transparency & stakeholder involvement
HTA process should be transparent and encourage the involvement of relevant
stakeholders including healthcare practitioners, healthcare planners/payers,
patients and technology manufacturers at all stages of the process.
The process including the selection of topics, appraisal criteria, process timelines,
consideration of evidence, development of recommendations must be transparent
and supported by a clear audit trail. Analyses should be independent of policy
decision making and be conducted within a recognised process framework toensure transparency, quality and stakeholder involvement. Conflicts of interestshould be declared by all stakeholders including HTA assessors.

2For a full discussion of context-free and context-specific evidence, see Dobrow M et al. Social Science &Medicine 58:1, 2004.

2

Where this process is not followed, or the recommendations are found to beperverse in light of the evidence considered, then there must be an opportunity forany of the stakeholders involved to appeal against the recommendations. Appeals
should be considered by a body that is independent of the original assessment.
Perspective
HTA should adopt a broad perspective, capturing the impact of new technologies
on patients, care-givers, the health service and society as a whole. GMTA accepts
that healthcare decision makers are predominantly interested in the impact of newtechnologies on healthcare budgets. However, HTA bodies should be encouraged
to adopt a societal perspective considering the impact of technologies on broader
societal costs, such as productivity and social care costs.
Timing of HTA
From a healthcare decision maker’s perspective, undertaking HTA early in the lifecycle of a technology, prior to widespread dissemination is desirable. However,
HTA bodies need to balance the demands for early assessment with theavailability of data on new technologies. Discussion between the manufacturer and
HTA agency should seek to identify the optimal time to undertake HTA, taking into
account the need to inform decisions on adoption with the availability of evidence.
This is particularly important when considering devices intended for surgical use
which are often associated with a ‘learning curve’ effect whereby theireffectiveness can only be properly evaluated once healthcare professionals, haveadjusted their practice to incorporate the new technology3. A process of HTA must
be completed within a timeframe relevant to the pace of evolution of thetechnology in question.
HTA is an iterative process and should be revisited at relavant time-points in thelife-cycle of a technology to take into account important new evidence. As the
major providers of evidence, technology manufacturers should be consulted on theappropriate timing of a “lifecycle” HTA.
Evidence standards and patient access
HTA recommendations should be based on the best available evidence relevant tothe question under consideration. Whilst randomised controlled trials are the mostrobust means of assessing comparative efficacy, they still represent an artificial
setting and do not necessarily represent “real world” circumstances that are
essential for analyses of cost-effectiveness. HTA bodies should be pragmatic in
their consideration of other sources of evidence. Well-designed comparative and3

For a full discussion of the learning curve effect, see Ramsey et al, International Journal of Technology
Assessment in Healthcare, 16:4, 2000.

3

non-comparative observational studies inform clinical and cost-effectivenessassessments and should be considered, rather than being excluded on dogmaticgrounds.
There may be ethical and practical limitations associated with the design ofdouble-blinded randomised controlled trials, particularly in surgical indications.
This is the case when the most appropriate comparator to determine a treatment
effect would be a sham intervention. Furthermore, blinding may not be feasible.
The extent of these issues will depend on both the technology and the condition
under consideration.
HTA should not restrict access to new technologies that are proven to be safe andefficacious but have limited data on their effectiveness. Clinical and costeffectiveness (as differentiated from efficacy) data are frequently only available
after a technology has been in use for a period of time.
In order to support timely access to promising technologies that have limited but
positive effectiveness data to support their use at launch, alternative funding
mechanisms may need to be explored, such as coverage with evidence
development, which allows a technology to be covered for a period of time, during
which effectiveness evidence is generated4. Such approaches are associated withboth risks and benefits for manufacturers and payers and should be carefully
considered prior to implementation.
Implementation of HTA recommendations
HTA bodies, where relevant to remit, should put in place steps to support theimplementation of HTA recommendations to ensure the funding follows positivedecisions.
Implementation of both negative and positive HTA recommendations should betimely and effectively resourced and incentivised. Implementing positive HTA
recommendations presents healthcare planners with challenges where thisrequires investments mid-way through the budgetary cycle, however this must be
factored into implementation plans.
HTA impact on innovation
Policy makers should consider the implications of HTA on the environment needed
to foster innovation of medical devices. If HTA introduces significant newchallenges to market entry then there is a potential that this may impact on the4

Hutton J, Trueman P, Henshall C. Coverage with Evidence Development: an examination of conceptual andpolicy issues. International Journal of Technology Assessment in Healthcare 23:4, 2007.

4

rate of innovation of the device sector which already faces a number ofchallenges. Intellectual property associated with medical devices is less well
protected than patents on new medical compounds. In addition to this, medical
device development is characterised by iterative improvement of technologies
resulting in a more rapid life-cycle and increased competition.
Harmonisation of HTA
There is considerable interest in the international harmonisation of HTA. Whilst
there are potential efficiencies to be gained in reducing the duplication of HTA
activities across countries and reducing the requirement for manufacturers tosubmit to multiple HTA bodies, the potential for harmonisation remains limited.
Harmonisation of approaches to HTA and evidence requirements is at least
partially possible (systematic evidence review, alignment on key principles ofprocess and methods) and there is already a significant degree of consensus
between HTA bodies.
However, harmonisation of the application of HTA and the decision making
processes remains a distant prospect. The decision outcomes and application ofa HTA should remain at a national/regional level due to differences in levels of
healthcare funding, healthcare priorities and treatment pathways.
Summary
Medical devices impact on all aspects of the operation of the health service andthe availability of innovative device technologies is imperative to improving patient
outcomes. EUCOMED supports a transparent and collaborative partnership on thedevelopment of HTA processes and methodologies for medical technologies. The
GMTA is committed to working with HTA agencies throughout to ensure that HTA
is applied appropriately to medical devices. This fosters rapid patient access toeffective, reliable and safe technologies. The principles presented above areintended to ensure that the application of HTA encourages the efficient allocationof healthcare resources whilst also acknowledging the value of medical devices
innovation in Europe.
January 1, 20115