Stakeholders involvement by HTA Organisations: Why is so different?
Introduction
The introduction of new technologies into a healthcare system is regulated by policy makers [1], who are expected to promote allocative efficiency and to control costs. Health Technology Assessment (HTA) provides policy makers with the technical support required for their regulatory action [2]. Policy makers might not manage HTAs on their own and could depend on the support of HTA organisations (HTAOs) [3], [4]. Furthermore, the implementation of a HTA is a complex and multidimensional process [5]. Hence, unless HTAOs hold all the required competences and information internally, they require the technical support, information and expertise provided by stakeholders. The involvement of stakeholders could also guarantee the legitimacy of the final assessment and help prevent conflict after the technologies have entered the market [6], [7].
The literature on HTAOs demonstrates (i) significant similarities among the HTAOs in the way they formally organise the assessment process and in the technical issues of decision making (e.g., the parameters used for setting priorities) and (ii) important differences among HTAOs in how the decision-making process is actually implemented [8], [9], [10], [11], [12]. Some recent contributions have investigated the identity of stakeholders involved in the assessment process, how they are engaged and for what purposes [6], [7], [13], [14].
Our survey of the literature, however, has identified two gaps in understanding of the relationships between HTAOs and stakeholders. The first is the actual role played by all categories of stakeholders. The second implicates reasons for their different levels of involvement, i.e., whether the reasons are country-dependent or HTAO-dependent. Should the different engagements of stakeholders be country-dependent, the transferability of one model of relationships between HTAO and stakeholders from one country to another would be limited.
This research attempts to answer these two research questions. Section 2 analyses the theoretical framework used to compare the HTAOs. Section 3 describes the methodology used in this study. Section 4 describes the results, and Section 5 discusses policy implications and limits of the analysis.
Section snippets
Theoretical framework
As Nielsen et al. (2009) note, HTAOs usually do not hold decision-making power because they are not political or regulatory bodies, even though their status is very close to that of a political institution; they are often public bodies that are financed by taxes and engaged in an activity aimed at improving the healthcare system.
Referring to the literature on New Public Management [15], [16], HTAOs can be defined as Quasi-autonomous nongovernmental organisations (Quangos). A Quango is an
Methods
We conducted a literature review on the decision-making process of stakeholders in HTAOs for the years 1999–2011 using PubMed, Ebscom, JSTOR and Wiley Science and utilised the following key words: HTA, HTA organisation, HTA governance, HTA system, HTA and stakeholders, as well as using all these key words together with the name of a country (see below for the countries selected). Both peer-reviewed and “grey” literature were included in the review. As noted above, the literature has important
Results
Table 1 shows in detail the evidence that we collected for each of the HTAOs considered herein.
HTA in England and Wales is characterised by a purely contractarian, Beveridge model, with the involvement of numerous Quangos (including NICE) contracted by the Department of Health [26]. The roles of these bodies are (i) to collect technical information and knowledge required by the decision-makers and (ii) to allow scope for internal and external stakeholders to discuss recommendations. Table 1
Discussion and policy implication
The evidence we have collected shows that the institutional framework in which HTA is conducted may importantly influence the decision-making process and stakeholder involvement by HTAOs. However, we cannot make any conclusive statement due to the exploratory nature of the study. In addition, this research has focused on the institutional framework, whereas the literature has also stressed the importance of other forces (e.g., social pressure) that may influence the decision-making process of
Acknowledgements
We do thank responders to interviews: J.M. Amate Blanco (AETS), T. Cerdà Mota (Avalia-T), O. Solà-Morales (CAHTA), I. Gutiérrez Ibarluzea (OSTEBA), J.A. Blasco (UETS), A.F. Fay (CEDIT), S. Garner (NICE), C. Packer (NHSC), M. Westmore and P. Davidson (HTA Programme – NIHR), H. Dahlgren (SBU), C. Bergh (HTA Centrum), M. Perleth (G-BA), H.P. Dauben (Dahta@Dimdi), E. Steenland (ZonMw), A. Schuurman (CVZ), K. Groeneveld (Health Council of the Netherlands).
The authors thank also Amelia Compagni and
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