Could 2024 Bring A Successful Spanish HTA Reform?

Despite changes to the IPT process in 2020, Spain continues to have a long and uncertain reimbursement process, where the average time to reimbursement is ~17 months. This article reviews the recent lawsuit against the Spanish MoH, and likely reforms for Spanish HTA processes in 2024.

2013 | Introduction of the IPT Process

IPTs (Informes de Posicionamiento Terapéutico - Therapeutic Positioning Reports) were introduced in 2013 to enhance coherence, efficiency, and continuity of the drug assessments in a step towards an objective, impartial and centralized evaluation. Previously, the evaluation of new medicines occurred at various levels (i.e., national, regional) resulting in delayed procedures with conflicting outcomes (1).

The role of the IPT was to evaluate comparative effectiveness and safety, along with criteria for use and monitoring. Optionally, economic evaluation could be included at the discretion of the GCPT (Therapeutic Positioning Coordination Group, in charge of the IPT generation). The decision to include economic information became a significant point of contention between national and regional administrations. Additionally, the criteria for cost-effectiveness analysis and budget impact was never established, generating confusion for manufacturers.(1,2)

2020 | Introduction of REvalMed

Due to disputes over economic evaluation and the prolonged assessment period, a new network named "REvalMed " was established in 2020. The goal was to streamline the IPT process to three months, evaluate the incremental clinical benefit and formally include pharmaco-economic evaluation (as a pilot program at the beginning) (2,3).

However, the evaluation criteria were uncertain. Definitions and a framework for the evaluation of incremental benefit were absent. The economic assessment, lacked criteria to establish which drugs would be evaluated; moreover the economic assessment relied on the methodology of the Genesis Group for hospital level evaluations, and as it was not deemed acceptable to estimate the economic impact at the national level, it resulted in heterogenous economic evaluations among IPTs (4).

In 2022, only 18% of assessments included economic evaluation and the average time to publication was approximately 17 months, driven by the lack of AEMPS evaluators and the lack of efficacy within the administrative system (4,5). These inefficiencies impeded the evaluation system, delaying the timely approval of pharmaceuticals.

2023 | Revoking REvalMed

Last year, Farmaindustria (National Association of the Pharmaceutical Industry) filed a lawsuit against the MoH seeking to annul the "Plan for the Consolidation of the IPT". The pharmaceutical industry alleged that ReValMed was created without following the legally established procedure. They argued the IPT had become a mandatory instrument for evaluating medicines with the participation of the DGCYF (the body in charge of pricing negotiations), when the responsibility should solely belong to AEMPS (6,7).

In June 2023, the National Court revoked the "Plan for the Consolidation of the IPT". The court ruled that the plan was 1) created without following the proper legal procedure and 2) violated regulatory hierarchy as it was approved by a body that did not have the authority to do so. It emphasized that economic analysis should not be part of Therapeutic Positioning Reports. It also specified that the exclusive authority to issue IPTs lies with AEMPS. The ruling underscored the necessity for a clear and fair pharmaceutical evaluation process (8–10).

Since the notification of the ruling, AEMPS has published 21 IPTs, omitting the logo of REvalMed, any mention of the nodes responsible for the drafts (including the autonomous communities) and any information on economic evaluation. The IPT process seems to be returning to the 2013-2020 method (pre-REvalMed) (11).

2024 | Royal Decree & Uncertain Future for HTA evaluations

With Farmaindustria celebrating the withdrawal of the IPT, manufacturers eagerly anticipate modifications that can address system flaws. As the legal and regulatory landscape evolves, the future of pharmaceutical evaluations in Spain remains uncertain.

Will regions re-gain more autonomy in conducting their own evaluation post-IPT publication? Will cost-effectiveness continue to be formally considered at the national level in Spain and increase in importance? Will Spain manage to shorten their P&MA timelines?

The MoH has requested a public consultation regarding the Royal Decree Project*. The overall goal is to solve the gap in the development of Heath Technology Assessment (HTA) in Spain as soon as possible. It aims to provide a legal platform for economic evaluation and specific criteria for the evaluation of efficacy and safety. Manufacturers should be informed about the requirements and information to be included and incorporated into their technologies in a transparent process (12). However, for now, the details continue undisclosed – perhaps 2024 will be the year that Spain finalize their methodology.

*Royal Legislative Decree is a legal rule having the force of a law in the Spanish legal system

**Could 2024 Bring A Successful Spanish HTA Reform?**
*By Itamar Carrillo, Senior Analyst, Windrose Consulting Group*

Sources:

1. García V, Corbalán L, Baquero S, García-Esquinas E, Sacristán JA. Informes de posicionamiento terapéutico: experiencia en España en el periodo 2013-2019. Aten Primaria. 2020 Dec;52(10):697–704.

2. Ruiz M. El futuro de los IPT, en juego mientras cumplen una década de vida [Internet]. EDS - Economiadelasalud.com. 2023 [cited 2024 Jan 11]. Available from: economiadelasalud.com

3. Comisión Permanente de Farmacia, MoH. Plan para la consolidación de los informes de posicionamiento terapéutico de los medicamentos en el Sistema Nacional de Salud [Internet]. Spanish Ministry of Health; 2020. Available from: sanidad.gob.es

4. Pulido S. La importancia de incorporar, y afinar, el criterio económico al analizar innovaciones [Internet]. EDS - Economiadelasalud.com. 2022 [cited 2024 Jan 11]. Available from: economiadelasalud.com

5. Diego B. revistas.eleconomista.es. 2022 [cited 2024 Jan 11]. Los informes para evaluar fármacos superan los 400 días de retraso. Available from: revistas.eleconomista.es

6. Farmaindustria. FarmaIndustria. 2023 [cited 2024 Jan 11]. Farmaindustria valora la sentencia que anula los IPT. Available from: farmaindustria.es

7. Sentencia de la Audiencia Nacional sobre Plan de Consolidacion de los IPT [Internet]. 2023. Available from: poderjudicial.es

8. ConSalud.es [Internet]. 2023 [cited 2024 Jan 11]. La Justicia tumba el plan de abrobación de fármacos del SNS. Available from: consalud.es

9. La Vanguardia [Internet]. 2023 [cited 2024 Jan 11]. Farmaindustria celebra la retirada del IPT de los medicamentos del Sistema Nacional de Salud. Available from: lavanguardia.com

10. Triay ML Elisabet Cots, Damia. Healthcare & Life Sciences Blog. 2023 [cited 2024 Jan 11]. Spanish Judgment May Shorten Price and Reimbursement Procedures for Medicines. Available from: healthcarelifesciences.bakermckenzie.com

11. Arganda C. diariofarma. 2023 [cited 2024 Jan 11]. La Aemps asume la sentencia que anuló Revalmed y cambia los IPT. Available from: diariofarma.com

12. Ministery of Health. CONSULTA PÚBLICA PREVIA Proyecto de Real Decreto por el que se regula la evaluación de las tecnologías sanitarias.