Lina Balaisyte1, Angelika Joos2, Mickaël Hiligsmann3. 1. Faculty of Health, Medicine and Life Sciences,Maastricht Universitybalaisyte.lina@gmail.com. 2. Global Regulatory Policy,MSD,Brussels,Belgium. 3. Department of Health Services Research,CAPHRI Care and Public Health Research Institute,Maastricht University.
Abstract
OBJECTIVES: This study aims to assess participants' views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe. METHODS: Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings. RESULTS: All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge. CONCLUSIONS: This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.
OBJECTIVES: This study aims to assess participants' views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe. METHODS: Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings. RESULTS: All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge. CONCLUSIONS: This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.
Entities:
Keywords:
Alignment; Early dialogue (ED); Europe; Future perspectives; Health technology assessment (HTA); Qualitative; Requirements; Synergies
Authors: Lourens T Bloem; Rick A Vreman; Niels W L Peeters; Jarno Hoekman; Menno E van der Elst; Hubert G M Leufkens; Olaf H Klungel; Wim G Goettsch; Aukje K Mantel-Teeuwisse Journal: Clin Transl Sci Date: 2021-05-01 Impact factor: 4.689