Achieving consensus in the EU is always slow but there has been steady progress on collaboration in the field of HTA since the European Commission and Council of Ministers targeted HTA as “a political priority” in 2004, recognising “…an urgent need for establishing a sustainable European network on HTA”.

This led to EUnetHTA, an organisation of 51 partners from 30 countries, in 2005. Its activities since then have been organised principally through three programmes: EUnetHTA Collaboration 2009, the EUnetHTA Joint Action 2010-2012 and EUnetHTA Joint Action 2 2012-2015. The objective of all three programmes is to support cross-border HTA collaboration.

Directive 2011/24/EU on the application of EU patients’ rights in cross-border healthcare committed the EU to support and facilitate cooperation between national authorities or bodies responsible for HTA designated by Member States by providing “objective, reliable, timely, transparent comparable and transferable information on the relative effectiveness…and avoiding duplication of assessments” (Art 15.2). The European Commission published an Implementing Decision in June 2013 (2013/329/EU) setting out the rules for the establishment, management and transparent functioning of the network of national authorities or bodies responsible for HTA. On the basis of this decision, EUnetHTA has been tasked with supporting scientific and technical cooperation until the end of Joint Action 2 2012-2015 (JA2). When JA2 is complete, at the end of 2015, the Commission will identify EUnetHTA or another appropriate mechanism for continued scientific and technical cooperation.

A recent paper confirms in more detail the direction of travel in the EU, a HTA update with a more collaborative approach to HTA. This paper sets the scene for how joint working will develop to make it easier for national and regional HTA bodies to reuse it in national activities. The HTA Network acknowledge that participation is voluntary and will respect differing levels of scientific and technical cooperation. The paper explicitly acknowledges that joint working does not interfere with individual Member States’ competence in deciding on whether and how to implement the conclusions of any HTA, will not harmonise any laws or regulations of individual Member States, and fully respects the responsibility of Member States for the organisation and delivery of health services and medical care (Art 15.7 of Directive 2011/24). In other words, harmonising the technical assessment piece of HTA does not imply harmonising the more subjective, local, more touchy-feely appraisal piece, in which the scientific findings on cost-effectiveness are placed in a local context – money, priorities, social concerns – as part of making a decision about offering a treatment to patients.

An important practical consequence of Joint Working for reimbursement is to raise the capacity of reimbursement authorities to use HTA. More assessments can be done. As a result we can expect a move towards some formal HTA process guarding the gateway to reimbursement.

The paper explicitly recognises that HTA applies to medical devices as well as other technologies. It suggests that because EU legislation on medical devices is currently being revised, concrete mechanisms of cooperation for specific activities may not be fully defined until the legislative process is complete. This is a tactical rather than a strategic issue: the HTA Network anticipates that HTA will work in broadly the same way for devices as for other healthcare technologies.

Joint Working includes rapid and full assessments of cost-effectiveness, tools (common templates and methodological standards), and support for “Evidence Generation initiatives appropriate for HTA purposes”. The last of these implicitly recognises the growing influence of ‘coverage with evidence development’ in reimbursement decisions involving technologies before there has been time to generate sufficiently long follow-up data.

Some practical steps include setting up databases to share information. EVIDENT³ is an evidence database on new technologies run by EUnetHTA. EVIDENT supports the “effective and sustainable collaboration” EUnetHTA was set up to foster collaboration across Europe, including knowledge sharing. At present, access to EVIDENT is currently restricted to EUnetHTA Partners and Associates who contribute to the EVIDENT database. by providing information on ADC and/or responding to queries and although at the moment it only has data on 23 projects from six EUnetHTA partners from five countries, it is expected that this will grow to become an important tool to help payers make more evidence-based decisions. Projects include drugs, devices, and procedures.

Using EUnetHTA’s Planned and Ongoing Projects (POP) database⁴ is intended to HTA bodies to share information with each other on planned and on-going projects conducted at the individual agency. The aim of the database is to reduce duplication and facilitate collaboration among HTA bodies. The database currently stores 1031 planned, ongoing and recently published projects from 43 EUnetHTA partners from 24 countries.

These initiatives are part of the EUnetHTA Joint Action on HTA (2010-2012) funded by the EU under its Health Programme. They point to a serious, medium-term, programme for making the application of HTA across a wider range of technologies a practical reality.

Another practical initiative, ADVANCE-HTA⁵, is funded by the EU’s Research Framework Programme (FP7) to “advance and strengthen the methodological tools and practices relating to the application and implementation of [HTA]”. The nine Work Packages cover a wide range of relevant features of an international HTA programme. Of particular interest is Work Package #5 (WP5) which considers HTA and medical devices. Core research objectives of WP5 are to:

• map the methodology and process of HTA and how it is used in appraising medical devices in EU Member States, clearly distinguishing between different categories of devices;
• advance the debate on the suitability of current HTA assessment tools across different categories of medical devices;
• identify how the current HTA assessment tools can be modified or adapted across different categories of medical devices with a view to producing robust HTA methods for medical devices.

During its first two years, WP5 has:

• developed a classification for medical devices, incorporating the elements of risk and role/functionality of device types, and whether it is diagnostic or therapeutic;
• reviewed the applicability of existing device categorizations for HTA purposes;
• reviewed whether and how assessment tools for devices should be modified according to the category;
• validated the classification by applying it to 740 HTA reports from 32 institutions evaluating 799 technologies.

WP5, co-ordinated by the University of Berlin is currently working on more detailed aspects of methodology and interviews across Europe to establish best practice. Recognising that the application of HTA to medical devices is at an early stage than pharmaceuticals, this is intended to produce a common classification which will help to identify the agreed common methodology which should apply, taking account of various characteristics of the device or test.

Another FP7 programme, MedtecHTA⁶, focuses specifically on research to improve HTA methodology when applied to medical devices. The stated purpose of the project, which has seven partners from five countries, is to help a wide range of key stakeholders (“policy makers, scientific community, HTA agencies, healthcare providers, medical device industry and patients”) make informed decisions about the cost-effectiveness and appropriate use of and patients’ access to medical devices. In other words, there may be differences between medical devices and pharmaceuticals, but there is no reason why the principles of HTA should not, and cannot, be applied to medical devices in the same way to make more cost-effective, perhaps less costly, safer, and more appropriate decisions.

Along with a collaborative policy framework, HTA implementation tools, and methodological initiatives, FP7 also funds AdHopHTA (Adopting Hospital based HTA in the EU)⁷. Hospitals are the main entry points for new technologies in health care but often lack the know-how and resources to evaluate them. AdHopHTA aims to facilitate the application of high-quality HTA in hospital settings to promote the adoption of technologies with proven value in hospitals. This project will also develop tools for formal coordination of existing hospital-based HTA initiatives, applying similar principles on ‘HTA users’ as described earlier for HTA ‘producers’. With 10 partners from nine countries, AdHopHTA will produce a handbook on best practices and a toolkit for the introduction of hospital-based HTA, make available a database of hospital-based HTA products to avoid duplication.

At a lower level of detail, another FP7 project, INTEGRATE-HTA⁸ is using palliative care as a case study to develop concepts and methods that enable a patient-centred, comprehensive assessment of complex health technologies.

The way in which HTA will increasingly be applied routinely to medical devices in the EU to inform reimbursement decisions is clear. There will be an EU-wide agreed definitions and methodology so that assessments carried out in one country are easy for other countries to use albeit. This will raise the capacity of Member States to carry out HTA by loosening the constraints of available expertise and budget. Using an EU-wide database holding copies of past work (an EU version of the Cochrane Collaboration Library), it will be easy to identify and access relevant work. This should save HTA bodies reinventing the wheel. This and an EU-wide database on work in progress and planned reviews will make it easier to coordinate their work programmes. This will increase the number of technologies that can be reviewed quickly enough to put obstacles in the way of early adopters: closing the stable door before the horse has bolted.

Since all EU health systems are under sustained budgetary pressure, HTA will be used more and more to approve reimbursement only of tests and devices which are considered to offer value for money. As donkeys eat grass, HTA agencies graze on evidence, preferably high-grade evidence. We will explore the implications for reimbursement strategies in EU.