A framework for monitoring of new drugs in Sweden. (2nd January 2019)

• Record Type: Journal Article
• Authors: Cars, Thomas; Lindhagen, Lars; Sundström, Johan
• Is Part Of: Upsala journal of medical sciences. Volume 124:Number 1(2019)
• Page Start: 46
• Page End: 50
• Publication Date: 2019-01-02
• Subjects: Comparative effectiveness research -- pharmacoepidemiology -- propensity score -- real-world evidence -- sequential monitoring; Medicine -- Periodicals; Medicine -- Periodicals; Electronic journals; 610.5
• DOI: 10.1080/03009734.2018.1550454
• Languages: English
• ISSNs: 0300-9734

Abstract

Abstract: In order to monitor the net public health benefit of new drugs, especially in the light of recent stepwise approval approaches, there is a need to optimize real-time post-marketing evaluation of new drugs using data collected in routine care. Sweden, with its unique possibilities for observational research, can provide these data. We herein propose a framework for continuous monitoring of the effectiveness, safety, and cost-effectiveness of new drugs, using prospectively determined protocols designed in collaboration between all relevant stakeholders. We believe that this framework can be a useful tool for healthcare authorities and reimbursement agencies in the introduction of new drugs.