Please klick on a work package to receive more information.

WP1: Healthcare innovation system

Objectives

• To develop a working definition of “Healthcare innovation”
• To adopt the general notion of an innovation system for the healthcare sector
• To select participants for the indicators and dissemination workshops

Task 1.1          Overview of conceptual approaches of innovation in the healthcare sector
Based on literature and internet researches completed and ongoing European and Member States’ methodological concepts for innovation (i.e. new or emerging technologies) in the healthcare sector are collected and described systematically. About 15 telephone interviews will be carried out to retrieve additional information on the concepts and discuss the concepts with their authors where necessary. Gaps will be identified in the existing conceptual framework that will be closed during the project. An inventory of experts in the field is compiled as basis for the further steps.

Task 1.2          Working definition of “Healthcare innovation”
A working definition of what constitutes an innovation in the healthcare sector is elaborated within the project team. To this end existing definitions are reviewed from different technological fields (pharmaceuticals, medical technologies etc.). This will sharpen the focus of the project and lead to a clear common understanding of the scope of the project within the project team.
A workshop (Workshop 1 “Health innovation”, about month 4) will be organised by Fraunhofer ISI with about 15 representatives of the relevant research projects and experts in the field of early identification and assessment of emerging healthcare technologies. They will be selected to represent different technological fields (drugs, medical devices, biotechnology etc.). The group will help select the technologies that are to be analysed by the “Innovation-HTA” method and finalise the working definition of “Healthcare innovation”. These experts will further build the Inno-HTA Advisory Board and will be invited to participate in the consensus process (WP 4) as well and will be asked to comment on the major deliverables.

Task 1.3          Elaboration of the draft concept of the “Healthcare innovation system”
The general notion of a sectoral innovation system presented above will be the starting point of the development of a draft concept of the “Healthcare innovation system”. To this end, lists of the relevant stakeholder groups and their interactions will be collected on the basis of the theoretical model described above. Although a generic concept will be elaborated in the end, in the first step special attention will be paid to the differences in the regulations between regions and Member States that define the type and extent of interactions between stakeholder groups. The stakeholders in the health system are structured to build the draft concept of the “Healthcare innovation system”.

A first collection of indicators used in the reviewed studies is compiled for later use.

Expected results:
The working paper on conceptual approaches and working definition of “Healthcare innovation” will structure the further work and lead to a common understanding of the field (the “healthcare innovation system”) within the consortium. This will be discussed at the innovation indicators workshop in WP5 together with the draft concept of the “Healthcare innovation system”. The list of indicators will feed into WP3, the lists of experts and stakeholders will be used particularly in the consensus process in WP5.

Top of page

WP2: HTA methods for emerging healthcare technologies

Objectives

• To make best use of the internationally available knowledge base in HTA methodology for healthcare innovations by compiling and assessing relevant assessment schemes including international, EU as well as nationally funded and private initiatives
• To integrate all actually EU-funded and most important Member States’ projects into the research process
• To elaborate an overview of the methods actually used in HTAs for emerging healthcare technologies including their respective scope, strengths and weaknesses
• To identify experts for methodological questions to be included the further steps of the project

Task 2.1          Integration of existing projects
In order to exploit synergies between Inno-HTA and completed and ongoing European initiatives/projects in HTA methodology and in order to avoid any duplication of work, the first task aims at establishing an interface with these initiatives. Starting points will be the EUNetHTA project that is coordinated by partner DACEHTA and particularly its WP7 that is led by partner LBI@HTA as well as the other well-established professional contacts of the consortium. Workshop 1 “Health Innovation” (see task 1.2) will bring together representatives of the most relevant projects; the representatives are invited to assist the project within the Advisory board.
Gaps will be identified in the existing knowledge base that will be closed during task 2.2.

Task 2.2          Fact-finding
Open questions that emerge during Task 2.1 will be addressed by desk research and about 20 telephone interviews with international HTA experts where necessary. Interview partners will be selected to represent the European regions as well as different disciplines and fields of application.

Task 2.3          Overview of HTA methods for healthcare innovations
Based on the working definition of healthcare innovation developed in WP1 as well as published literature, an overview of methods that are actually used to assess emerging technologies is compiled. The methods are described in a structured way that includes their scope, aspects of internal and external validity etc. An inventory of the methods’ authors will be collected for further use in the expert panel, and a first list of healthcare innovation indicators will be compiled from the reviewed HTA approaches.

Expected results:
The main result of the workpackage will be an overview of the methods actually used in HTAs for emerging healthcare technologies including their respective scope, strengths and weaknesses, which will be used to identify and evaluate healthcare innovation indicators in WP3. The experts identified for methodological questions of HTA will be included in the further steps of the project, particularly in the consensus process in WP5.

Top of page

WP3: Indicators for healthcare innovations

Objectives

• To integrate the methodology of classical HTA for emerging technologies into the concept of a “Healthcare innovation system”
• To develop a draft set of reliable and valid indicators that allow describing the state and potential of healthcare innovations

Task 3.1          Integration of classical HTA into the “Healthcare innovation system”
On the basis of the results elaborated during WPs 1 and 2, we will analyse the commonalities of both fields with respect to targets and methods of measurement. The needs for a lean but comprehensive coverage of the health innovation system will be compared with the ‘best’ methods and criteria to work out a draft model for the assessment of the state and potentials of a healthcare innovation.

Based on a literature review focussing on methods of economic evaluation of emerging technologies in early phases of development (including clinical trial phase II), Participant 7 will establish a Working paper on the Contribution of economic evaluation to early phases of product development. The aim of this deliverable is to show the pathways by which health economic evaluation can contribute to the early phases of product development. Economic evaluations establish the cost-effectiveness of an intervention by dividing the additional cost it incurs (as compared to a defined alternative) by the additional health benefit achieved. In contrast to other potential approaches to support strategic decisions in early product development, health economic evaluation focuses on cost-effectiveness as a key criterion to determine access to the markets covered by social security systems and national health services, a criterion that has gained significantly in importance in a number of health systems. Innovators who are aiming at these markets have to consider the requirements set for the actual access of their products, and they have to integrate these considerations into the development of new products.

Task 3.2          Draft set of reliable and valid indicators
Based on the draft model and the analyses of methods of HTA in early phases of technological development, indicators will be selected that have been identified in the previous WPs as the most reliable and valid.

Gaps in the draft set of indicators will be identified by aspects of the “Healthcare innovation system” for which no candidate indicators have been found yet. These gaps will be closed by additional analyses of literature and about 10 telephone interviews with experts in the field.

Expected results:
The results of the work package will be a measurement model and first set of indicators as input for the case studies (WP4) and the consensus process (WP5).

Top of page

WP4: Validation of the indicators

Objectives

• To select six different emerging healthcare innovations for the validation of the set of indicators
• To test the first set of indicators for feasibility and validity in six case studies

Task 4.1          Selection of case studies
The case studies are selected according to medical need for the technology as well as to guarantee a large variety in the type and state of development of the respective technologies (e.g. tissue engineering, innovations in cancer research, personal health monitoring systems, body computing). They will build on assessments (“primary studies”) that the partners LBI@HTA (or its predecessor ITA) and Fraunhofer have carried out in the past and for which a research field has been analysed in sufficient comprehensiveness to apply most of the indicators.

Task 4.2          Evaluation of the first set of indicators for feasibility and validity
The draft model for the assessment of healthcare innovations (from WP3) will structure the case studies which will be carried out in the form of a secondary data analysis based on existing reports and literature. For each case study, if not already existing in the primary studies, qualitative and quantitative analyses of publications and patents are carried out to test these important innovation indicators, as well as analyses of economic indicators and databases on product development and product pipelines, in order to test the salience and fit of indicators from different fields within the theoretical framework of the “healthcare innovation system”. Indicators that turn out to be invalid, unreliable or for which in most or all case studies data were missing are earmarked as candidates for deletion from the model.

Expected results:
The results of the case studies will be used to modify the first set of indicators where necessary and will be fed into the consensus process in WP5.

Top of page

WP5: Consensus process

Objectives

• To finalise the measurement model and set of indicators for the assessment of healthcare innovations
• To establish a broad consensus on the criteria and indicators to assess healthcare innovations

Task 5.1          Delphi process on indicators
As for other methodological concepts within HTA and evaluation research, even after the indicators have been tested for validity and feasibility, a number of open questions will remain that cannot be solved based on the literature and case studies alone. In addition, the chances that the model will be used in future studies to generate better evidence on emerging health technologies can be increased if the model has been developed together with experts in the field and the potential users of the approach.

Therefore, a consensus process will be carried out using a Delphi panel with about 50 of the previously identified experts from all relevant stakeholder groups including the Advisory Board. The process will include at least two rounds with feedback of the interim results after each round. The experts will be selected from the lists identified in WPs 1 and 2, will be informed about the project and invited to participate in month 6, and will represent all relevant stakeholder groups and professional associations (e.g. HTAi; INAHTA etc.).

Task 5.2          Expert workshop 2 “Innovation indicators”
The workshop with about 30 experts from all stakeholder groups including the Advisory Board will be used to present and discuss the underlying concept of the healthcare innovation system, innovation in healthcare, draft set of indicators and results from the Delphi survey. Information material on the project as well as the working papers on the “Healthcare innovation system” and the draft model for the assessment of healthcare innovations will be sent to the participants in advance.

Draft recommendations on the implementation of the “Innovation-HTA” method are discussed.

Expected results:
The result of the workpackage will be the final model for the assessment of healthcare innovations and draft recommendations for the implementation from the experts’ perspective.

Top of page

WP6: Recommendations and dissemination

Objectives

• To inform all stakeholders about the European model for the assessment of healthcare innovations
• To develop information material targeted for different groups of stakeholders
• To make recommendations how to encourage stakeholders to implement the model within their field of responsibility and to mobilise resources

Task 6.1          Project internet site
An internet site that describes the project and its results will be established and made available online within the first three months of the project and updated at least every 6 months. It will be maintained after the end of the project.

Task 6.2          Targeted information
A project presentation will be produced within the first three months of the project and distributed via the internet site and other channels. General information on the project will also be presented on the Inno-HTA internet site.
On the basis of the interim results elaborated during WP5, e.g. the background documents for the experts (D5.3), we will develop specific information packages for the relevant stakeholder groups, particularly for

• HTA agencies,
• researchers in public and private institutes,
• companies that are or might be interested in commercially using the approach,
• policy-makers at the EU and Member States level,
• NGOs including patient organisations, and
• the general public.

The information will be pre-tested with a small sample from all target groups and will be modified according to their feedback.
The information packages will be distributed via e-mail to the actors in the field contained in the inventories, via the project’s Inno-HTA internet platform and distribution lists of related EU projects and initiatives in HTA. Moreover, they will be made available during the Dissemination event.

Task 6.3          Workshop 3 “Dissemination event”
The results of the project will be discussed at an international workshop with representatives from policy making, industry, HTA, science, and from health service providers and health insurance institutions, particularly under the perspective of the method’s contribution to the healthcare system. About 50-80 participants are expected.

Invited speakers (about two from the Commission, two keynote speakers from the HTA and innovation research community) will give an introduction into the field and focus on the European perspective. The results obtained will be presented and discussed.

On this basis, opportunities to implement the “Innovation-HTA” approach for the different stakeholder groups and in different fields of application will be discussed considering the different starting conditions and regulatory frameworks within the Member States. The specific goals will be formulated in an operational and measurable way for later evaluation. The presentations and discussions of the dissemination event will be documented and the documentation will be broadly disseminated via the routes outlined in Task 6.1.

Task 6.4          Recommendations for the implementation of the assessment approach
The draft recommendations discussed at the dissemination event as well as experiences from other EU projects on HTA method will be analysed. Besides the dissemination of the results, other measures might be helpful to support the application of the assessment approach with actual healthcare innovations, as e.g. checklists or software programmes. Such options will be analysed and respective recommendations for future projects will be made. These will be specifically targeted to the relevant stakeholder groups (EU and Member States’ policy-makers, HTA agencies, research bodies, companies, patient organisations).

Expected results:
The results of the work package will be the broad dissemination of the Inno-HTA methodology to all relevant players in the EU, and encouraging them to implement the model in their field of responsibility.

Top of page

WP7: Project management

Objectives

• To ensure the quality and timely submission of all deliverables
• To establish good communication channels within and outside the project including an internet site that describes the project and its results
• To promote ensure the quality of the research on the overall as well as on the workpackage and task level

Task 7.1          General quality management
The general quality management for the consortium is described in section 6. It is based on the rigorous following of the project plan laid down in its milestones and deliverables. The WP leaders as well as the coordinator have the responsibility to control, and a clear share of responsibilities for the quality of the deliverables checked by the WP leaders as well as by the coordinator.

Task 7.2          Internal meetings
All internal meetings of the consortium (kick-off and four interim meetings) are used to review the progress and discuss the next steps. The Commission is invited to participate in all meetings.

Task 7.3          Reporting
All regular reports (interim and final) are submitted to the European Commission according to the provisions of the Contract. Besides this, the Commission is kept up-to-date on all steps by frequent informal contacts with the coordinator.

Expected results:
The result of the workpackage will be the attainment of the project’s goals and the provision of the deliverables in due time and highest-possible quality.

Top of page

Startpage