Istituti di Health Technology Assessment e portatori di interesse

Abstract

Background

The involvement of stakeholders (internal — third party payers, health care organisations and research centres, external — industry and patients, and clinicians) by HTA Organisations is hugely debated. On the one hand their participation may provide important information for the assessment process and could promote consensus over recommendations. On the other hand stakeholders’ involvement increases complexity in the decision-making process. The actual role of stakeholders and reasons for their different involvement in HTA organisations have not been deeply scrutinised so far. The aim of this paper is to investigate these two issues in six European countries, with a focus on those HTA organisations that assess medical devices (France, Germany, England, the Netherlands, Spain, and Sweden).

Methods

We carried out a literature review (1999–2009), using PubMed, Ebsco, JStore and Wiley Science. In addition, 16 semi-structured interviews were conducted with key personnel in the organisations concerned, consistently with the explorative nature of the study.

Results

We found huge differences across countries and these differences seem to be due to the administrative tradition, the way the health care system is organised and (even if more doubtful) the role of HTA organisations. External stakeholders are much more involved when the national administrative system is contract-based (e.g. England), whereas an organic conception (e.g. Spain) is more closed to stakeholders’ participation. Internal stakeholders (expecially third party payers) participate more, when the health care system is modeled as social insurance. The impact of administrative tradition and the health care system seem to be less important when recommendations based on HTA are binding and used for policy purposes (reimbursement and, possibly, prices), thus providing for an organisation-specific (and not only country-specific) source of difference.

Conclusions

It may be concluded that stakeholders’ involvement may be strongly influenced by the general context where the HTA organisations operate. As a consequence, a stakeholders’ involvement model cannot be easily transferred from one country to another. Despite of this, it can be stated that external stakeholders’ involvement was generally increasing, expecially when recommendations are binding: this could provide an opportunity for HTA organisations to achieve consensus in advance, thereby facilitating the implementation of any recommendations made.