Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals.
OBJECTIVE
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.
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciencesskleijnen@zinl.nl.
Sarah
S
Kleijnen
Zorginstituut Nederland & Summaryx Ltd.
Iris
I
Pasternack
Rijksinstituut voor ziekte- en invaliditeitsverzekering, Directie Farmaceutisch Beleid & KU Leuven.
Marc
M
Van de Casteele
Directorate for Pharmaceutical Affairs (DPA), Ministry for Energy and Health.
Bernardette
B
Rossi
Italian Medicines Agency.
Agnese
A
Cangini
HTA Unit, "A.Gemelli" Teaching Hospital.
Rossella
R
Di Bidino
National institute of Public Health.
Marjetka
M
Jelenc
Zorginstituut Nederland.
Payam
P
Abrishami
The Social Insurance Institution.
Ilona
I
Autti-Rämö
Hauptverband der österreichischen Sozialversicherungsträger.
Hans
H
Seyfried
Hauptverband der österreichischen Sozialversicherungsträger.
Ingrid
I
Wildbacher
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences.
Wim G
WG
Goettsch
D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D016208:Databases, Factual; D005060:Europe; D006801:Humans; D007391:International Cooperation; D017146:Models, Organizational; D004364:Pharmaceutical Preparations / Q000592:standards*; D010865:Pilot Projects; D015397:Program Evaluation; D000091402:Prohibitins; D011786:Quality Control; D013673:Technology Assessment, Biomedical / Q000592:standards*; D013678:Technology, Pharmaceutical
C000717331:PHB2 protein, human; D004364:Pharmaceutical Preparations; D000091402:Prohibitins
Reimbursement