Abstract
The pricing & reimbursement (P&R) decision for a new drug in Spain is based on the criteria set in the Law on Guarantees and Rational Use of Medicinal Products (Royal Decree 1/2015) and the Therapeutic Positioning Report (TPR). Despite a clear framework, the weight of the different factors used is not transparent. This study aims to understand the main factors influencing P&R decisions in the first negotiated indication of oncology and onco-hematology drugs in Spain as well as future trends. The factors explored are related to the clinical trial design, efficacy results, orphan drug designation, perceived added clinical value, and time-to-market.
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