Developing a Multi-Criteria Framework for Innovation and Biologic Drugs Assessment Decision Making in Egypt

OBJECTIVES: Given the unmet medical needs, the search is optimal for achieving the balance between satisfaction of patient need, offering the fair price to the company and the best utilization of health care resources. This is even tougher for Egypt, Our analysis demonstrates that firstly, currently adopted reference and ceiling ration criteria was the key driver of the economic evaluation and pricing decisions and no other factors were considered. Second, Many of Innovative and biologic drugs according to current ICER are not cost-effective, due to high cost per QALY or when the benefits not captured by the QALY. Third, there is absence of the sufficient data about how the new drug will be used in practice. We aim to develop a local MCDA framework for evaluation and selection of innovation and biologic drugs. Provide practice guidelines for its application in pricing and reimbursement decisions. METHODS: Mapping out the proposed MCDA framework were based on a mixed approach: literature review, local document analysis, interviews v/ith stakeholders. Firstly a systematic literature review was conducted tc elicit the criteria to be used in the decision making process. Subsequently, the 'importance' of the core set of criteria was elicited with different stakeholder including policy makers, payers, professionals, academia, representatives of patients and pharma industry. Finally, validation the MCDA list. RESULTS: Based on our findings we suggest that the main criteria that can be the core of MCDA models for the assessment in our local setting are Health benefits and outcomes, Disease description, innovation level, the evidence provided and the socio-economic impact. CONCLUSIONS: MCDA is believed to be helpful tool to integrate different aspects into health-care decision. Also to demonstrate true drug benefit and enhance patient access where there is huge unmet need: by 1- Adapting different P&R outcomes compared to the standard process now. 2- Including wider societal perspectives.