2026-04-17T06:46:13Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/103492025-10-24T10:16:26Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Pontes, Caridad author Vallano, Antonio author Agustí, Antònia author 2023-09-26T10:11:34Z 2023-09-26T10:11:34Z 2023-08-31 European Union; Antineoplastic agents; Drug costs Unió Europea; Agents antineoplàstics; Costos dels medicaments Unión Europea; Agentes antineoplásicos; Costos de medicamentos The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases. However, the resulting increase of medicines being marketed with conditional authorizations and in exceptional circumstances has lead to higher clinical uncertainty about their efficacy and safety than when the standard authorizations are applied. This uncertainty has significant implications for clinical practice and the negotiation of pricing and reimbursement, particularly as high prices are based on assumptions of high value, supported by regulatory prioritization. The burden of clinical development is often shifted towards public healthcare systems, resulting in increased spending budgets and opportunity costs. Effective management of uncertainty, through appropriate testing and evaluation, and fair reflection of costs and risks in prices, is crucial. However, it is important not to sacrifice essential elements of evidence-based healthcare for the sake of access to new treatments. Balancing sensitive and rational access to new treatments, ensuring their safety, efficacy, and affordability to healthcare systems requires thoughtful decision-making. Ultimately, a responsible approach to timely access to innovative medicines that balances the needs of patients with healthcare systems’ concerns is necessary. This approach emphasizes the importance of evidence-based decision-making and fair pricing and reimbursement. http://hdl.handle.net/11351/10349 Decisió, Presa de Cost-eficàcia Medicaments antineoplàstics Medicaments - Desenvolupament HEALTH CARE::Health Care Economics and Organizations::Economics::Costs and Cost Analysis TECHNOLOGY, INDUSTRY, AND AGRICULTURE::Technology, Industry, and Agriculture::Industry::Manufacturing Industry::Drug Industry::Orphan Drug Production ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Clinical Decision-Making CHEMICALS AND DRUGS::Pharmaceutical Preparations ATENCIÓN DE SALUD::economía y organizaciones para la atención de la salud::economía::costes y análisis de costes TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::industria::industria fabril::industria farmacéutica::producción de medicamentos huérfanos TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::toma de decisiones clínicas COMPUESTOS QUÍMICOS Y DROGAS::preparados farmacéuticos The challenges of access to innovative medicines with limited evidence in the European Union