Feasibility study to characterize price and reimbursement decision-making criteria for the inclusion of new drugs in the Spanish National Health System: the cefiderocol example.

Calleja, Miguel ÁngelBadia, Xavier2023-05-032023-05-032022-05-20http://hdl.handle.net/10668/22577The reimbursement of medicines by the Spanish National Health System (NHS) is based on a set of criteria included in the Royal Legislative Decree 1/2015 (RDL 1/2015). The Interministerial Committee on Pricing of Medicines and Healthcare Products (CIPM) is responsible for the final price and reimbursement (P&R) decision, including on its resolutions the criteria listed in the law by which the reimbursement of a drug is approved or denied. Nevertheless, the information behind its reasoning is not provided. The present study aims to characterize the P&R criteria of the RDL 1/2015 through criteria definitions from other countries to improve the P&R evaluation in Spain. A multidisciplinary experts panel with relevant experience in drug evaluation and decision making at national, regional, and local level in Spain was selected for this study. A literature review to characterize the criteria listed in the RDL 1/2015 was performed based on the most relevant and recognized Health Technology Assessment (HTA) agencies in Europe, UK, and Canada. Eventually, a feasibility study was performed to evaluate the novel drug cefiderocol using the characterized criteria, including a reflective discussion of the results. Consensus was reached among the multidisciplinary experts on the characterization of the criteria set by the law. The feasibility of their application to a new drug was exploratory, notwithstanding it showed the potential to improve the transparency as well as to offer a more structured rationale for the CIPM to evaluate the inclusion of new drugs in the Spanish NHS.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/CefiderocolDrug evaluationP&R criteria characterizationP&R decision-making criteriaPricing and reimbursementCephalosporinsCosts and Cost AnalysisEuropeFeasibility StudiesTechnology Assessment, BiomedicalFeasibility study to characterize price and reimbursement decision-making criteria for the inclusion of new drugs in the Spanish National Health System: the cefiderocol example.research article35591781open access10.1017/S02664623220003321471-6348https://www.cambridge.org/core/services/aop-cambridge-core/content/view/C9217EFB97145ADBA6217B3D51B33BD5/S0266462322000332a.pdf/div-class-title-feasibility-study-to-characterize-price-and-reimbursement-decision-making-criteria-for-the-inclusion-of-new-drugs-in-the-spanish-national-health-system-the-cefiderocol-example-div.pdf