Elsevier

Health Policy

Volume 105, Issues 2–3, May 2012, Pages 236-245
Health Policy

Stakeholders involvement by HTA Organisations: Why is so different?

https://doi.org/10.1016/j.healthpol.2012.01.012Get rights and content

Abstract

Objective

To investigate stakeholder involvement by Health Technology Assessment Organisations (HTAOs) in France, Spain, England and Wales, Germany, Sweden, and The Netherlands and to examine whether this involvement depends on (i) the administrative tradition and the relevant conception of the relationship between state and society (contractarian and corporative vs. organic), (ii) the general structure of the healthcare system (HCS) (Bismarckian vs. Beveridgian system), and (iii) the role of Health Technology Assessment (HTA) and HTAOs in the HCS.

Methods

Given the exploratory nature of the study, we considered interviews based on semi-structured questionnaires the most appropriate data-gathering technique. The interviews were administered to 16 key personnel in the HTAOs concerned. We have also carried out a literature review on HTAOs and stakeholders (1999–2011) using PubMed, Ebsco, JSTOR and Wiley Science.

Results

In contractarian and (to a lesser extent) Bismarckian models, stakeholders are more involved. The administrative tradition and the HCS appear less important when the HTA is binding and used for regulatory purposes. In such situations, stakeholders are more intensively involved because their participation provides an opportunity for HTAOs to achieve consensus and legitimacy in advance.

Conclusions

Despite the limitations of the research (we did not conduct multiple interviews for each HTAO, and key informants were not always available) and its exploratory nature, we can conclude that models of stakeholders involvement cannot easily be transferred from one country to another due to the importance of national administrative traditions and the characteristics of HCSs.

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

References (28)

  • J. Abelson et al.

    Bringing “the public” into health technology assessment and coverage policy decisions: from principles to practice

    Health Policy

    (2007)
  • F.P. Gauvin et al.

    “It all depends”: conceptualizing public involvement in the context of health technology assessment agencies

    Social Science & Medicine

    (2010)
  • M. Velasco-Garrido et al.

    Health systems, health policy and health technology assessment

  • M. Brans et al.

    Comparative observations in tensions between professional policy advice and political control in the low countries

    International Review of Administrative Sciences

    (2006)
  • C. Weiss

    Using social research in public policy-making

    (1977)
  • C.P. Nielsen et al.

    Policy processes and health technology assessment

  • Office of Technology Assessment

    Assessing the efficacy and safety of medical technologies

    (1978)
  • C.P. Nielsen et al.

    Involving stakeholders and developing a policy for stakeholder involvement in the European network for health technology assessment, EUnetHTA

    International Journal of Technology Assessment in Health Care

    (2009)
  • R.N. Battista et al.

    The “natural history” of health technology assessment

    International Journal of Technology Assessment in Health Care

    (2009)
  • R. Schwarzer et al.

    Methods, procedures, and contextual characteristics of health technology assessment and health policy decision-making: comparison of health technology assessment agencies in Germany, United Kingdom, France, and Sweden

    International Journal of Technology Assessment in Health Care

    (2009)
  • C. Sorenson et al.

    Ensuring value for money in healthcare. The role of health technology assessment in the European Union

    (2008)
  • F. Martelli et al.

    Health technology assessment agencies: an international overview of organisational aspects

    International Journal of Technology Assessment in Health Care

    (2007)
  • A. Zentner et al.

    Methods for the comparative evaluation of pharmaceuticals

    GMS Health Technology Assessment

    (2005)
  • M.P. Gagnon et al.

    Introducing patients’ and the public's perspectives to health technology assessment: a systematic review of international experiences

    International Journal of Technology Assessment in Health Care

    (2011)
  • Cited by (24)

    • Involvement of Patients and Medical Professionals in the Assessment of Relative Effectiveness: A Need for Closer Cooperation

      2022, Value in Health
      Citation Excerpt :

      The result of this analysis is one of the most important elements in reimbursement decisions.4-6 Besides scientific evidence, many HTA organizations involve the input from patients and medical experts in their work.7,8 HTA organizations differ in the degree of stakeholder involvement: ranging from informing stakeholders about process and outcome to active participation in the entire HTA process.7,9-11

    • Access to medicines - a systematic review of the literature

      2020, Research in Social and Administrative Pharmacy
      Citation Excerpt :

      These findings have consequences regarding the suitability of current policies of recommeding the orphan drugs at a very high threshhold, partcularly considering the rise in numbers of people with these diseases and the cost of orphan drugs.14 A study by Cavazza & Jommi64 investigating stakeholders' involvement by Health Technology Assessment Organizations in France, Spain, England and Wales, Germany, Sweden, and The Netherlands, indicates that the NICE involves all relevant stakeholders in an HTA process and in the subsequent decisions making process. Industry has a voting right in all appraisals in the UK.

    • New model for prioritised adoption and use of hospital medicine in Denmark since 2017: Challenges and perspectives

      2019, Health Policy
      Citation Excerpt :

      Aiming for greater allocative efficiency of healthcare resources, fast and uniform use of new effective medications, and a stronger basis for pharmaceutical procurement [4], the regional authorities in Denmark adopted a new model for the assessment of hospital medicines in 2016 (in force since 2017). In international comparison, the new model is ambitious in terms of stakeholder involvement [5,6] and it adopts many of the principles advocated in the literature on health technology assessment (HTA) and priority setting [7,8]. Still, new challenges have emerged.

    View all citing articles on Scopus
    View full text