Spain’s National Court recently invalidated the proposed plan for consolidating therapeutic positioning reports, leading to the cessation of functions for assessment institutions like the Red de Evaluacion de Medicamentos (REValMed). The primary objective of the REValMed was to implement a revised process, streamlining the development of therapeutic positioning reports and incorporating pharmacoeconomic evaluations. However, the court ruled that the plan was developed without adhering to legal protocols, raising concerns about the legal basis of including economic analysis in the reports and making them mandatory before pricing decisions.
The main aim of the proposed plan was to establish therapeutic positioning reports as a crucial reference instrument for assessing the positioning and cost-effectiveness of new drugs before they could be eligible for reimbursement. These reports included an economic analysis conducted by the Dirección General de Cartera Común de Servicios del SNS y Farmacia in collaboration with regional authorities. However, the court emphasised that this responsibility should solely lie with the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), as mandated by the third Disposición Adicional (DA) of Law 10/2013. The plan’s non-compliance with this regulatory hierarchy was a critical factor leading to its annulment.
Additionally, the court expressed concerns about the inclusion of economic analysis in the therapeutic positioning reports, emphasizing that they should exclusively focus on scientific aspects without considering economic issues. This departure from the established framework further added to the plan’s vulnerability and ultimately contributed to its annulment. The court’s decision underscores the importance of adhering to proper legal procedures and maintaining a clear regulatory hierarchy in shaping healthcare policies and decision-making processes.
The annulment of Spain’s proposed plan for the consolidation of therapeutic positioning reports has created uncertainty within the pharmaceutical industry and raised concerns about patient access to new treatments. With the cessation of functions for REValMed, the assessment of new drugs might face disruptions until a clear alternative process is established. Furthermore, the recent changes in health policies following the July 23rd elections have added further complexities to the situation, potentially prolonging the time it takes for innovative therapies to reach patients—especially those with serious or rare medical conditions who may have limited treatment options available to them.
Sources:
- https://www.farmaindustria.es/web/prensa/notas-de-prensa/2023/07/24/farmaindustria-valora-la-sentencia-que-anula-el-plan-para-la-consolidacion-de-los-ipt-y-recuerda-la-necesidad-de-dotar-de-mas-claridad-y-objetividad-al-proceso-de-financiacion-de-nuevos-medicamentos/
- https://www.consalud.es/politica/ministerio-sanidad/audiencia-nacional-tumba-plan-aprobacion-farmacos-sanidad-lacruz_132636_102.html