Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry.

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration.

Supporting tough decisions in Norway: a healthcare system approach.

OBJECTIVES: We describe, in general, the principles used in priority setting and, in particular, policy processes and decision making in Norway. METHODS: A newly established council for setting priorities in health care is presented to illustrate how health technology assessments (HTAs) can support national advisors in complex priority-setting processes. RESULTS AND CONCLUSIONS: Setting priorities in health care is a complex task. Careful thinking is, therefore, required in determining the components of a system for priority-setting. Based on recent Norwegian experiences, we believe that the following generic parts may provide some of the solution: a common set of values; an organizational structure made up of key stakeholders; supporting mechanisms in the form of HTA organizations and documented best evidence; and loyalty to decisions by stakeholders responsible for implementing national policies.

Health technology assessment to optimize health technology utilization: using implementation initiatives and monitoring processes.

BACKGROUND: The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems. METHODS: In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members' experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting. RESULTS: Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA. CONCLUSIONS: Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.

The history of health technology assessment in Norway.

OBJECTIVES: The aim of this study was to describe the Norwegian contribution to the broad picture of our international health technology assessment (HTA) history. METHODS: A general examination of some pre-HTA activities, as consensus conferences, closer reading of all background papers to the establishment of an HTA agency in Norway, the ongoing activities of this agency, its evaluation, and its merge into a broader knowledge center for the health services were performed. All information and statements are the authors' own understandings, but also were reviewed by some of the people taken part in these processes. RESULTS: The Norwegian HTA activity was set up rather late compared to, for instance, Sweden, and our involvement in Nordic early warning activities. This may be related to Norwegian scientists being more involved in the Cochrane Collaboration. However, when established, the HTA agency was regarded as highly successful in involving clinical experts and responding to questions arising from the macro- as well as micro-levels of decision makers. International collaboration was essential in building the capacity to serve all levels. After 6 years, the agency was merged with some related health service knowledge activities, into a new center. CONCLUSIONS: During the 10 years' time, HTA has become a well-established activity in Norway.

Internal evaluation of the European network for health technology assessment project.

OBJECTIVES: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe. METHODS: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants' opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents. RESULTS: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support. CONCLUSIONS: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

European network for health technology assessment, EUnetHTA: planning, development, and implementation of a sustainable European network for health technology assessment.

OBJECTIVES: The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders. RESULTS: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration. CONCLUSIONS: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

Joint project of the International Network of Agencies for Health Technology Assessment--Part 2: Managing the diffusion of positron emission tomography with health technology assessment.

OBJECTIVES: Since 1997, members of the International Network of Agencies for Health Technology Assessment (INAHTA) have collaborated on a Joint Project to track the diffusion, evaluation, and clinical policy of positron emission tomography (PET). Part 2 of this updated Joint Project report summarizes HTA-based strategies for directing the clinical use of PET and a discussion on the value of HTA in managing the diffusion of high cost diagnostic technologies, which were presented at an INAHTA-sponsored workshop at the Health Technology Assessment International Annual Meeting in 2004 on strategies for managing high cost diagnostic technologies. METHODS: A summary of the workshop proceedings is presented. CONCLUSIONS: Sharing assessment work, universal agreement in assessment conclusions, stakeholder input, and modeling techniques help manage the uncertainty in the evidence base while targeting clinical use of PET toward the most promising indications. Emphasis on HTA findings, linkage between financing of clinical PET and outcome evaluation, and targeted dissemination of scientific findings empower providers to reduce unnecessary utilization and contain costs within a quality improvement framework. Above all, a trustworthy source of HTA information and a process that is conducive to using scientific evidence as the basis for decision making are essential for managing the diffusion of complex and costly diagnostic technologies in patient care.

Six years' experience with interdisciplinary review teams in health technology assessment in Norway.

OBJECTIVES: The aim of this study was to evaluate the use of interdisciplinary review teams that have been the main and central work form in making health technology assessments at the Norwegian Centre for Health Technology Assessment. METHODS: Evaluation questionnaires were sent to all 112 participants in the 17 review teams for the period of January 1998 to June 2003 after completion of the literature assessment. Questions were on the theme/mandate of the assessments, composition of the review team, organization of the work, the working method, and update of the report. RESULTS: The teams ranged from 4 to 14 persons regarded as opinion leaders in their field. The project periods lasted from 4 to 33 months. In all, fifty-five participants gave fifty-eight responses (51.8 percent) to the questionnaires. A total of 83 percent thought the theme was well argued, and 62 percent thought the mandate for the assessments was sufficiently clear. Approximately 80 percent were positive to the composition of the review team. In all, 22 percent expressed that the work method was too extensive and 43 percent wanted more tuition. General comments were that the working method gave competence in assessing medical literature, relevant professional training, and tuition in a working method that ensured the legitimacy of their work. CONCLUSIONS: The review team participants were satisfied with most aspects of the work. The Norwegian Centre for Health Technology Assessment will continue using interdisciplinary review teams in making health technology assessments.