CAN THE ETHICAL DILEMMAS FOR HEALTH CARE DECISION MAKING ON DRUG REIMBURSMENT BE TACKLED THROUGH HOLISTIC MCDA- AN ADAPTATION OF THE EVIDEM FRAMEWORK IN REAL-WORLD SETTING - THE CATALAN EXPERIENCE
Author(s)
Badia X1, Khoury H2, Merino-Montero S1, Fontanet M3, Torrent-Farnell J3, Catalan A4, Prat A5, Gilabert Perramon A6, Goetghebeur MM7
1Omakase Consulting, Barcelona, Spain, 2LASER Analytica, Montreal, QC, Canada, 3Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 4Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain, 5Servei Català de la Salut (CatSalut), Barcelona, Spain, 6Catalan Health Service (CatSalut), Barcelona, Spain, 7LASER Analytica and School of Public Health, University of Montreal, Montreal, QC, Canada
OBJECTIVES: As healthcare systems are struggling to ensure high quality and affordable healthcare for all those who need it, ethical dilemmas in decisionmaking are reaching a climax, while the demand for accountable decisions and decisions processes is increasing at all levels. The EVIDEM framework embeds the many ethical aspects that are faced by healthcare decisionmakers providing an accountable methodology to tackle them. The objective of this study was to explore the usefulness and adapt the EVIDEM framework to the processes of the Catalan CATSALUT PASFTAC program for complex treatments, including for rare diseases. METHODS: Current PASFTAC processes and criteria considered were analysed using documentation and interviews with key personnel, and compared with the EVIDEM process to explore feasibility. PASFTAC program personnel and external experts were invited to a panel session during which they selected the criteria suitable to their context, provided criteria weights using two elicitation methods and discussed specific needs and adaptation. RESULTS: PASFTAC process is similar to EVIDEM methods in terms of systematic review of evidence, multidisciplinary involvement, and considerations of most aspects made explicit in EVIDEM whether at the evaluation phase (CAMUH) or the decisionmaking phase (CATFAC). A majority (>75%) of participants indicated that all EVIDEM criteria should be maintained, except for “Environmental impact” and “Mandate of healthcare system” which were deemed irrelevant by 56% and 44% of participants. Relative weights were similar for both elicitation methods (5-points scale and hierarchical point allocation) and were highest for criteria Disease severity (15%), Unmet needs (13%), Comparative effectiveness, Type of therapeutic benefit and Quality of evidence (all 10%). All participants indicated that EVIDEM would be useful. CONCLUSIONS: EVIDEM provides a feasible and useful framework to optimize current processes for evaluation of complex treatments by CATSALUT and facilitates tackling ethical dilemmas. Further piloting is on-going to implement the adapted framework in real-world setting.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PHP34
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Multiple Diseases
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