Sarah Kleijnen1, Iris Pasternack2, Marc Van de Casteele3, Bernardette Rossi4, Agnese Cangini5, Rossella Di Bidino6, Marjetka Jelenc7, Payam Abrishami8, Ilona Autti-Rämö9, Hans Seyfried10, Ingrid Wildbacher10, Wim G Goettsch11. 1. Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciencesskleijnen@zinl.nl. 2. Zorginstituut Nederland & Summaryx Ltd. 3. Rijksinstituut voor ziekte- en invaliditeitsverzekering, Directie Farmaceutisch Beleid & KU Leuven. 4. Directorate for Pharmaceutical Affairs (DPA), Ministry for Energy and Health. 5. Italian Medicines Agency. 6. HTA Unit, "A.Gemelli" Teaching Hospital. 7. National institute of Public Health. 8. Zorginstituut Nederland. 9. The Social Insurance Institution. 10. Hauptverband der österreichischen Sozialversicherungsträger. 11. Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences.
Abstract
OBJECTIVES: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals. METHODS: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. RESULTS: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. CONCLUSIONS: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.
OBJECTIVES: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals. METHODS: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. RESULTS: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. CONCLUSIONS: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.
Authors: Ahmad Fasseeh; Rita Karam; Mouna Jameleddine; Mohsen George; Finn Børlum Kristensen; Abeer A Al-Rabayah; Abdulaziz H Alsaggabi; Maha El Rabbat; Maryam S Alowayesh; Julia Chamova; Adham Ismail; Sherif Abaza; Zoltán Kaló Journal: Front Pharmacol Date: 2020-02-21 Impact factor: 5.810