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European Network for Health Technology Assessment (EUnetHTA) - Joint Action 3 [EUnetHTA JA3] [724130] - Joint Actions
Project abstract

The general objective for EUnetHTA JA3 is to increase the use, quality and efficiency of joint HTA work at European level to support evidence-based, sustainable and equitable choices in healthcare and health technologies and ensure re-use in regional and national HTA reports and activities, in order notably to avoid duplication of assessments. An overarching objective is to develop a general strategy, principles and proposal for a scientific and technical mechanism of permanent sustainable European Collaboration on HTA in the light of the Directive on CBHC. During the JA3 the collaborative production of structured HTA core information, including rapid HTAs will be structurally implemented and the methodologies and production related information and communication technology infrastructure will be finalised as to stand alone from 2020 onwards. EUnetHTA JA3 will also aim to increase the alignment between HTA reports used for reimbursement decisions and clinical practice guidelines that are used by physicians in daily practice. Additionally, EUnetHTA JA3 will also support more alignment of different processes in the lifecycle of health technologies. For instance, processes on market authorization and HTA of pharmaceuticals could be organised in a more closely aligned fashion which may lead to a timelier and more efficient process promoting earlier patient access to products that have a real added value. EUnetHTA JA3 will also contribute to the discussion on the assessment of the effectiveness and safety of new medical devices as is currently taken place as part of the debate on new European legislation for medical devices. Finally, all these outcomes will contribute to the dissemination of health information and knowledge, thus improving policy-and decision-making in the health systems, which turns into protection of citizens against unsafe or ineffective technologies and improves access to high value health technologies. Ultimately this contributes to imTo be developed

Summary of context, overal objectives, strategic, relevance and contribution of the action

Health Technology Assessment (HTA) aims at responding to decision-makers’ information needs regarding the introduction, coverage, use or disinvestment of health technologies. Information needs often arise simultaneously across Member States (MS), and multiple HTA agencies address these needs concurrently. Despite concurrent need for HTA information to support decision makers, differences in decision making structures, timing, information requirements and level of HTA implementation vary across the MS. Without a sustainable mechanism for cross European collaboration in HTA to support timely and transparent transfer of information, frequent duplication of efforts in HTA can occur. A sustainable mechanism of cooperation within Europe in meeting these information needs would decrease the duplication of efforts and result in increased efficiency and support at national HTA agencies and across MS. This European collaboration is focused on the technical and scientific assessment; appraisal, the societal valuation of the assessment results, that supports national or regional decision-making on reimbursement of health technologies, will remain within the remit of the Member States. EUnetHTA has always been very explicit in stating that the evidence should be global (and therefore be assessed globally) while the decision making (appraisal) should be local.

Previous European projects have demonstrated that collaboration and information sharing is facilitated with an organisational structure and common tools for HTA production. The EUnetHTA Joint Action (JA1) 2010-2012 refined the collaboration structure and tools with attention to global developments in the field. EUnetHTA Joint Action 2 (2012-2015) extended this by strengthening the practical application of tools and approaches to cross-border HTA collaboration, further supporting and refining a system of collaboration in HTA. These experiences have proven the ability of national HTA organisations to work together and produce valuable products.

The Directive on cross-border healthcare (CBHC, 2013) requires the establishment of a permanent network on HTA in Europe. The Council of the European Union has pointed out the need to strengthen activities aiming at ensuring financial sustainability of health systems while ensuring universal, equitable access to quality care. HTA is under the same financial pressure as the health systems and thus itself is required to use its resources efficiently. The need to enhance the use of HTA has also been pointed out by the European Commission and the HTA-scientific community. Participation in collaborative projects in JA1 and JA2 has been shown to foster HTA in countries lacking an established HTA structure or capacity. JA3 will now proceed with the final step of establishing this permanent sustainable network on HTA in Europe.

The objective of EUnetHTA JA3 is to support voluntary cooperation at scientific and technical level between Health Technology Assessment Bodies to validate the model for joint work to be continued after EU funding under the Health Programme ends. The cooperation between national and regional HTA Bodies is essential to meet the provisions set out by Article 15 of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare and to create synergy with the strategic HTA Network set up under this Directive.

An overarching objective is to develop a general strategy, principles and proposal for a scientific and technical mechanism of permanent sustainable European Collaboration on HTA in the light of the Directive on CBHC, which states that a voluntary HTA network should support cooperation between national HTA institutions and support MS in the provision of objective, reliable, timely and comparable information. During the JA3 the collaborative production of structured HTA core information, including rapid HTAs will be decentralised and the methodologies and production related information and commun

Methods and means

The JA3 will have two interrelated streams of activity. The implementation stream (WP4, WP5 and WP7) and the structure and methodological consolidation stream to ensure scientific quality (WP6).

In the implementation stream HTA information for priority technologies will be produced collaboratively based on the methods and recommendations generated so far by EUnetHTA. This output will be then implemented on a national level (WP7), in a way also to closely relate to additional evidence needed for the decision making process in that country (WP5).

In the second stream the information and knowledge management tools developed during JA2 will be refined and finalised and additional methodologies, guidelines and models developed. Experiences from the implementation stream will be accounted for.

More fundamentally, the work builds on the scientific background of relevant international research. Joined assessments will be conducted in a collaborative manner based on the methodological developments and recommendations generated in the JA1 and JA2. These methodologies are firmly based on international methodology developed by Cochrane and GRADE. To ensure collaboration, all partners have committed to actively contribute to one of the implementation WPs. In later phases of this JA3 coordination of the joint assessment may be decentralized for some types of technologies, in order to create a stand-alone structure from 2020 onwards. For specific types of technologies, such as pharmaceuticals it may be more obvious to have a centralized approach because of the submission based form of assessment and the needed alignment with EMA procedures and timing.

In the structure and methodological consolidation stream the information and knowledge management tools which were developed in the JA2 will be refined and finalized, methodologies, guidelines and models new developed and further refined (WP6). Also, there will be maintenance, revision, and development of tools and methodologies and training according to needs. The governance structure and the approach to involve stakeholders will be continued, and even extended.

Work performed during the reporting period

The most important activities carried by each WP during the reporting period are presented below.

Work Package 1 - Coordination:
• EUnetHTA JA3 4-year work plan was developed together with WP Lead Partners and Co- Lead Partners, being updated for each project year;
• A joint work plan describing the collaborative activities between EMA and EUnetHTA was developed;
• A network infrastructure was created to provide partners a platform for collaboration and support in their project activities.

Work Package 2 - Dissemination:
• A leaflet was created and made available at main EUnetHTA JA3 events that were organised during the reporting period;
• A Training Strategy including training materials was developed;
• A Communication Strategy including dissemination actions, communication tools and communication channels was delivered.

Work Package 3 - Evaluation:
• Three evaluation reports, two bi-annual short reports and one yearly interim report were finalised.

Work Package 4 - Joint Production:
• Two joint assessments for pharmaceutical technologies and three collaborative assessments for other technologies were published.

Work Package 5 - Life cycle approach to improve Evidence Generation:
• Seven early dialogues were completed based on the organisational framework and procedure specially created;
• Two collaborative disease/registry specific PLEG pilots on drugs were launched.

Work Package 6 - Quality Management, Scientific Guidance and Tools:
• A quality management concept paper was developed which describes the fundamental aspects as well as EUnetHTA specific means of quality management in the context of joint work;
• Process flows for Rapid REA for pharmaceutical technologies and Rapid REA for other technologies were elaborated and required SOPs for each process step were defined. Initial quality management SOP was finalized;
• A prototype of the EUnetHTA Companion Guide was developed and presented to partners to ensure timely consideration of feedback from potential future users;
• A roadmap for the orientation of the development of the EUnetHTA scientific guidance and tools was created and delivered.

Work Package 7 - National implementation and impact:
• A report, presenting key implementation challenges in 59 agencies in 31 countries and how agencies could engage in HTA cooperation and use EUnetHTA assessments, was made available;
• Nine case studies were completed covering nine countries and involving 21 agencies;
• A metric tool to monitor uptake and implementation of joint products was developed in collaboration with WP3 and WP1 and incorporated into the feedback survey.

The main output achieved so far and their potential impact and use by target group (including benefits)

From the perspective of the specific objectives of EUnetHTA JA3, two joint assessments for pharmaceutical technologies and three collaborative assessments were produced. These assessments were produced based on a standardised methodology and process and by using tools that can be incorporated in the working processes of HTA national producers. Also, the collaboration between partners involved in the joint work was further strengthened.

As the produced assessments were recently published, it is too early to provide an accurate insight of the implementation at national, local or regional level of these assessments. According to the current surveys performed, 23 partners have worked or are working on the topic areas related to the finalised assessments and 13 partners expect to be working on the topic area in the future so more intake is expected. The first set of implementation data for these assessments will be published in May 2018.

Achieved outcomes compared to the expected outcomes

During the reporting period, two joint assessments for pharmaceutical technologies and three collaborative assessments were produced. According to the Grant Agreement, fifty joint products are expected to be produced per year by the end of JA3. Nevertheless, during the reporting period, the production of joint assessments encountered a series of challenges that are described in the first technical report. Corrective actions were taken or are planned to be taken to improve the production process and to determine the increase of joint products.

Dissemination and evaluation activities carried out so far and their major results

Two EUnetHTA JA3 Forums, organised during the reporting period, offered a platform for networking, scientific discussions and exchange of experience between EUnetHTA partners and HTA stakeholders. Also, several partners showed strong commitment by representing EUnetHTA JA3 in more than sixty conferences around Europe and promoting the EUnetHTA JA3 activities in fourteen published articles. As a result, part of this representation strengthened the collaboration with other scientific organisations that deal with HTA such as HTAi and ISPOR.

Three evaluation reports were finalised during the reporting period: two bi-annual short reports and one yearly interim report. The aim of these reports was to evaluate EUnetHTA JA3 activities in accordance with the Grant Agreement.