#EAPM: More co-operation needed to make HTA truly effective

Health technology assessment (HTA) is described by the World Health Organization as the systematic evaluation of properties, effects, and/or impacts of health technology, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

It is a multidisciplinary process used to evaluate the social, economic, organizational and ethical issues and the main purpose of conducting an assessment is to inform a policy decision making.  It summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner.

Health technology, meanwhile, constitutes the application of organized knowledge and skills in the form of medicines, medical devices, vaccines, procedures and systems developed to solve a health problem and improve quality of life.

EUnetHTA is a network of government appointed organizations (from member states, EU-accession countries, plus EEA and EFTA countries) and a large number of relevant regional agencies and non-for-profit organizations that produce or contribute to HTA in Europe.  Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value.

The organization states that HTA has to firmly rely upon research and scientific methods, and examples include diagnostic and treatment methods, medical equipment, pharmaceuticals,
rehabilitation and prevention methods, plus organizational and supportive systems within which healthcare is provided.

However, when it comes to introducing innovative medicines and treatments, things could certainly improve. MEP António Correia De Campos, who is vice-president of the panel for the Assessment of Scientific and Technological Policy Options for the European Parliament, has said: “While health technology assessment is a valuable and necessary instrument for decision making, it is important that it does not represent an unnecessary burden for companies facing a diversity of national requirements for HTA and approval mechanisms.”

For its own part, EAPM has consistently pointed out that delayed decision making by HTA authorities and health-care-system chiefs does very little to help patient access to the treatments that they need (and have a right to expect) and, in fact, does a great deal of harm.

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There is probably not much that the Commission can do all by itself in respect to this, but silo mentalities within different disciplines need to be discarded as much more co-operation and collaboration needs to occur between member states, within those countries (ie regionally) and even between hospitals.

Improved dialogue is key. EMA came to the conclusion in the summer of this year that so valuable is early dialogue seen to be that it instituted a new form of partnering with the EUnetHTA.   This, explains EMA, aims to allow medicine developers to obtain feedback from regulators and HTA bodies on their evidence-generation plans to support decision-making on marketing authorization and reimbursement of new medicines at the same time.

The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies. This is a step ahead of the previous parallel scientific advice procedure operated by EMA and HTA bodies, which was more ponderous in that it required medicine developers to contact member states’ HTA bodies individually.

Interactions between medicines’ developers, regulators and HTA bodies or other possible stakeholders to discuss the development plan means that evidence can be generated to meet the needs of respective decision-makers as efficiently as possible.

“This facilitates patient access to important new medicines and hence benefits overall public health," said EMA, pointing to the benefits that more structured interaction brings in terms of incre-ased mutual understanding and problem-solving ability between itself and HTA bodies.

It is clear that delayed implementation for patients costs lives. But one improvement has been the EMA piloting adaptive/staggered licensing with the aim of reducing the time to market by getting HTA agencies involved throughout the development process.  HTA is, of course, a vital link in the chain of bringing health innovations to patients, but EAPM believes that it is  a long way away from achieving any effective European accord, despite the urgent need to establish some clearer understanding at EU level of the concept of value in health care.

In major disease categories such as diabetes, neurological disease and cancer, the EU member states continue to entertain distinct views on what is worth pursuing in terms of treatment, prevention, diagnosis and reimbursement.

More than 50 national and regional HTA bodies across Europe persist in conducting their assessments in their own way, and 15 years of well-meaning but ineffectual encouragements towards working together at EU level have barely altered that situation.   An earnest attempt at cooperation is underway to find some form of agreement before EU support runs out in 2020, but by mid-2017 the Commission had got no further than completing a consultation on options, with the promise of some as-yet undefined "further initiative".

The critical role of HTA in therapeutic innovation cannot be overlooked. It is essential that issues such as use in combination and sequencing and duration of use are given the attention they deserve. It is good that it is happening to some extent in the aforementioned discussions on new drugs between EMA and HTA bodies, but it does not go far enough.

When it comes to much-needed innovation in healthcare and its implementation, HTA can help decision-makers with the evidence-based selection of health technologies and services and the equally important task to improve their effectiveness and efficiency over time.

It acts as a supportive process that allows payers to seriously consider whether or not to fund one treatment over another and make it available to those patient groups that will be most likely to benefit from it. Increasingly, EAPM has stated, payers are severely restricting or even denying patient access to health technologies and services when there is no clear or exceptional value as they seek to cut costs and to increase the efficiency of the healthcare system.

This must be addressed, as there is clearly a long way to go when it comes to building a better system for the benefit of all patients across the EU.

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