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      Medicamentos de alto impacto económico y sanitario en la prestación farmacéutica hospitalaria Translated title: Medicines with high economic impact in the hospital setting

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          Abstract

          Resumen Objetivos: Los medicamentos de alto impacto económico (MAIE) constituyen un reto para los servicios de salud públicos de los países europeos. Sin embargo, no existe consenso sobre qué constituye un MAIE. El objetivo del estudio fue configurar una lista de MAIE dispensados por los servicios de farmacia hospitalarios y analizar la situación respecto a estos fármacos en España. Métodos: Se consideraron MAIE aquellos fármacos con un coste >10.000 €/año (MAC) o con un elevado volumen de consumo (MEC). Se estimaron los precios (PVL) por dosis diaria definida o dosis diaria prescrita. Resultados: Un total de 147 principios activos fueron considerados MAC, correspondiendo mayoritariamente con los grupos: L (69,4%), J (10,9%) y A (10,2%). El PVL medio diario de los MAC fue 218,6 € (28,6-2.892,5). El 38,8% de los MAC fueron innovadores, 26,5% huérfanos y 34,0% biológicos. Dieciséis medicamentos tuvieron un coste >10.000 €/envase. Los MEC pertenecieron principalmente al grupo L (45,0%) y J (35,0%). El PVL medio diario de los MEC fue 154,4 € (1,1-1.629,3). El 35,5% fueron innovadores, 5,0% huérfanos y 60,0% biológicos. Conclusiones: Un elevado número de MAIE son dispensados por los servicios de farmacia hospitalarios, principalmente antineoplásicos y antiinfecciosos. Aunque el PVL mínimo diario para considerar un medicamento de alto impacto es 27,4 €, el PVL medio diario de los MAC fue >200 €. Sin embargo, el elevado consumo de algunos fármacos, hace que medicamentos con un coste tan bajo como 1,1 € puedan ser considerados MAIE. Se puede establecer una nueva categoría de MAC para aquellos con un coste >10.000 €/envase.

          Translated abstract

          Abstract Objectives: High economic impact medicines (HIM) are challenging health services of the European countries. Nevertheless, there is no consensus on what constitutes a HIM. The aim of the study is to compile a list of HIM dispensed by Spanish hospital pharmacy services and to analyze the situation regarding those medicines in Spain. Methods: Drugs with a cost higher than €10,000 per year (HCM) or high volume of consumption (HVM) were considered HIM. The ex-factory price (PVL) per defined daily dosage or prescribed daily dose was calculated. Results: A total of 147 active ingredients were HCM, corresponding to ATC code: L (69.4%), J (10.9%) and A (10.2%). Mean daily PVL of HCM was € 218.6 (28.6-2,892.5). 38.8% were innovative drugs, 26.5% were orphan products and 34.0% were biological drugs. A total of 16 medicines (5.8%) were priced more than € 10,000/pack. The HVM belonged mainly to group L (45.0%) and J (35.0%). Average daily PVL of HVM was € 154.4 (1.1-1,629.3). 35% were first-in-class drugs, 5% orphan medicines and 60% biological drugs. Conclusions: This study shows that a large number of HIM are dispensed by the hospital pharmacy services, mainly antineoplastic and antiinfective drugs. Although the minimum daily PVL to consider a medicine as HCM was € 27.4. The average daily price of HCM was >€ 200. However, given the high consumption of some drugs, medicines with a daily cost as low as € 1.1 can be considered HIM. A new category of HCM, ultra-premium-priced medicines, could be established for drugs with a cost higher than € 10,000 per pack.

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          Most cited references25

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          Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

          Context Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Findings Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. Conclusion A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.
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            An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

            For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.
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              Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios

              (2006)
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                June 2022
                : 32
                : 2
                : 137-155
                Affiliations
                [1] Vigo orgnameHospital Povisa orgdiv1Servicio de Farmacia Hospitalaria España susana.fortes.gzlez@ 123456gmail.com
                Article
                S1699-714X2022000200005 S1699-714X(22)03200200005
                10.4321/s1699-714x2022000200005
                745caccc-d3cd-46c3-bccb-c47c873a13aa

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 24 November 2020
                : 19 October 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 25, Pages: 19
                Product

                SciELO Spain

                Categories
                Originales

                política sanitaria,Farmacoeconomía,drug costs,technology,high cost,health policy,pharmaceutical,Economics,coste de los medicamentos,tecnología de alto coste

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