OBJECTIVES: Achieving fair pricing and ensuring long-term sustainability of health care systems and access for patients is one of the biggest challenges for health &pharmaceutical systems in Egypt. To describe the current pricing regulatory and reimbursement framework and position of innovative drugs in main disease areas. METHODS: A variety of sources informed the evidence, including a broad-ranging literature review of local data of Pricing department &PE unit in Ministry of Health. The primary research and data component is based on direct input from decision makers (governmental, Private sectors, and pharma). A detailed questionnaire was developed and issued to all participants. which addressed a number of key questions, including:Does a country-specific definition of high-cost or innovative medicines exist? What are the key challenges to the funding these medicines? What the need actions to improve the pricing and reimbursement process? Are there specific pricing policies for innovative medicines compared to ordinary medicines? and Which requirements needed for the assessment? RESULTS: The key disease areas are:1-diabetes, 2-cancer, 3-rheumatoid arthritis, 4-hepatitis C, 5-orphan conditions respectively. These treatments represent examples of innovative medicines which carry considerable implications for the country' health budgets because they can be considered either "high volume" for treating many patients or "high cost" because of the price of a single course of treatment. The Current regulations require comparability for quality, efficacy, and safety assessments. No specific innovation regulations are adopted for pricing. There is a gap in introduction and/or management of these medicines by careful handling to ensure that access and equity are maintained, along with sustainable financing. till now, the main instrument influencing the market entry prices in Egypt is ERP. CONCLUSIONS: The conceded recommendations were: adoption a further initiatives/policies to better manage the entry of new medicines. MCDA should be designed to study the criteria critical to uptake of innovative drugs.
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