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- W2316919792 abstract "Therapeutic Positioning Reports (TPRs) were introduced to the Spanish P&R process in May 2013. TPRs evaluate comparative efficacy and safety and introduce usage and monitoring criteria for new drugs and existing drugs seeking reimbursement. The procedure was set-up by the Spanish Medicines Agency (AEMPS) and the Ministry of Health with the aim to accelerate the P&R process and to generate a single, national relative effectiveness report avoiding additional regional evaluations, contributing to reducing the long-delays in market access timelines experienced in the last few years. The objective of this ongoing work is to describe and analyze both the metrics of the process and the contents and Results of TPRs. Descriptive study based on public information available from the European and Spanish Medicines Agencies (May 2013-ongoing). From June 2013 to May 2014 the Therapeutic Positioning Coordinating Group (TPCG) has officially launched 60 TPR plus 7 use protocols (UP) at the request of the Interministerial Price Council (IMPC). 75% of TPR involve new chemical entities (82% of those with a positive opinion from the CHMP between May 2013-April 2014) and assess a single entity (48% specialty care) indicated, mainly, for patients with neoplastic (28%) and endocrine (18%) diseases. All UP affect targeted therapies with approval between Jan2010-Dec2012. Since its establishment in May 2013, the TPCG has released 26 TPR (57% of those expected according to the pre-established procedure -3 months working time) with a median release time of 7,1 months. Only 1 has been published. The rest await for P&R decisions. Other 5 pilots have been published in parallel. In total 5 TPR recommend to further restrict the European label. TPR are not being released at the expected rate. Follow up is necessary to predict its impact in P&R and market access in regions across Spain." @default.
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- W2316919792 date "2014-11-01" @default.
- W2316919792 modified "2023-10-17" @default.
- W2316919792 title "Therapeutic Positioning Report: New Collaborative Network of Drug Assessment in Spain - The Start Of P&R Based On Relative Effectiveness?" @default.
- W2316919792 doi "https://doi.org/10.1016/j.jval.2014.08.993" @default.
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