Clara MONLEON BONET

Doctorante du Laboratoire Parcours de Santé Systémique EA 4129 - Ecole Doctorale EDISS, Université Claude Bernard Lyon 1.

Activité professionnelle actuelle : Employée de Takeda.

Ma thématique de recherche au sein du P2S: Identification et évaluation des facteurs implicites influant dans les décisions finales de remboursement des médicaments en Europe et Canada.

Thèse en cours sujet résumé:Global healthcare expenditures have been rising sharply and drug costs are a major factor. High prices of innovative medicines entering into the market are challenging increasingly the public health care systems, its sustainability and patients´ affordability. To ensure that the access of innovative health technologies and medicines to the healthcare system is made without endangering the system sustainability, a multidisciplinary and standardized process is set to do recommendations in an objective and transparent way.  Here is where the Health Technologies Assessment (HTA) comes into action, informing policy and clinical decision making around the introduction of health technologies. The HTA process plays an important role as its recommendations can lead to the acceptance or rejection of medicines by the governmental bodies. However, this deliberative process may differ from one country to another and it is not always standardized and harmonized. There are intrinsic qualitative elements influencing the final decision and these are not clear and explicit.

To address this concern and understand the reasons behind the deliberative process of the HTA evaluation in Europe, I propose to develop and elaborate on the following aspects:

  • To perform a Systematic Literature Review of the deliberative process
  • To review of the HTA most relevant in Europe and describe precisely the deliberative process
  • To develop an HTA deliberative process mapping with the function of this process by country
  • To conduct HTA decision makers interviews: qualitative study with a semi-structured questionnaire.
  • Develop a database with variable describing the overall process based on publicly available intervention and information collected during stakeholder’s interviews.
  • To generate a typology based on multivariate analysis of the database described above
  • To assess the outcome of HTA based on specific type of organization
  • To evaluate the strengths and weaknesses of the deliberative process per typology
  • To develop a deliberative process standardization tool
  • Pilot and adjustment of the standardize deliberative process
  • Conclusion and perspective.