Insights & Articles

Cómo se está preparando España para la nueva normativa europea


Para agilizar el proceso de Evaluación de Tecnologías Sanitarias (ETS) en los estados miembros de la UE, se implementarán cambios significativos en enero de 2025. En lugar de que los fabricantes de nuevas tecnologías sanitarias deban presentar datos clínicos en cada estado miembro, según el Reglamento (UE) 2021/2282, la evaluación se llevará a cabo de manera conjunta. Los fabricantes solo necesitarán presentar las evaluaciones clínicas una vez, aunque los estados miembros aún podrán realizar evaluaciones complementarias.

Es importante destacar los 9 dominios de evaluación, de los cuales 4 son clínicos y 5 no clínicos. Las 4 evaluaciones clínicas incluyen:

  • Evaluación de la enfermedad y el panorama actual del tratamiento
  • Examen de la nueva tecnología sanitaria
  • Seguridad
  • Eficacia

Los 5 dominios no clínicos incluyen:

  • Costo y evaluación económica
  • Ética
  • Impactos organizacionales
  • Impactos sociales
  • Aspectos legales

España publicó su Proyecto de Real Decreto el 12 de agosto, que está abierto a comentarios hasta el 20 de septiembre, donde se detalla cómo se alinearán con la Directiva. Este esfuerzo involucra a la Oficina de Evaluación de la Eficiencia de los Medicamentos, que opera como una unidad funcional bajo la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

Además de las evaluaciones clínicas conjuntas en Europa, también habrá consultas científicas conjuntas. El objetivo de esta Directiva es reducir el trabajo administrativo duplicado y eliminar barreras a la innovación, al tiempo que se mejora el resultado para los pacientes.

A medida que estos cambios redefinen el panorama, es crucial que las empresas farmacéuticas y de tecnología médica se adapten rápidamente. Lyfegen puede ayudarle a mantenerse a la vanguardia con nuestras soluciones innovadoras:

  • Navegue por los nuevos requisitos regulatorios: Acceda a nuestra extensa Biblioteca de Acuerdos, que incluye más de 5,000 acuerdos de precios de medicamentos públicos y 20 modelos de precios, para asegurar el cumplimiento con los últimos estándares de ETS.
  • Optimice la toma de decisiones: Utilice nuestro Simulador de Contratación de Medicamentos para crear casos de negocio basados en datos y realizar simulaciones en tiempo real que se alineen con las nuevas directrices de ETS en España.
  • Simplifique y automatice la contratación: Nuestras soluciones de análisis de reembolsos automatizan los cálculos de reembolsos y devoluciones, asegurando precisión, transparencia y una reducción significativa de la carga administrativa.

Reserve una demostración con nosotros hoy para explorar cómo las herramientas y la experiencia de Lyfegen pueden apoyar su negocio bajo el nuevo marco de ETS en España.

Reserve su demostración aquí: https://www.lyfegen.com/demo  

Related blogs

Why Q1 Is Critical for Pharma Rebate Management

READ MORE

Why Q1 Is Critical for Pharma Rebate Management

The first quarter of the year is a pivotal time for the pharmaceutical industry. As budgets are finalized and contracts renegotiated, Q1 sets the stage for how effectively organizations manage rebates, optimize costs, and deliver value.

For those navigating the complexities of pharma rebate management, Q1 offers unique opportunities to streamline workflows, review existing agreements, and ensure every rebate maximizes its potential. This period isn’t just about planning, it’s about implementing smarter processes to stay ahead in an increasingly dynamic healthcare landscape.

Why Rebate Management Deserves Q1 Attention

  1. Reviewing Performance

Q1 is the ideal time to evaluate rebate performance from the previous year. Were the agreements aligned with expectations? Did they deliver the promised value?

By assessing past performance, teams can identify underperforming agreements and opportunities for improvement. This ensures resources are allocated to agreements that drive measurable results.

  1. Optimizing Current Workflows

Rebate workflows are often complex, requiring significant manual effort for tracking, reconciliation, and reporting. In Q1, organizations have the opportunity to implement systems that:

  • Reduce administrative burdens.
  • Automate repetitive tasks.
  • Provide real-time visibility into rebate performance.

Streamlining workflows early in the year creates efficiencies that save time and resources throughout the year.

  1. Negotiating Future Agreements

The first quarter is also critical for renegotiating rebate terms with manufacturers and payers. Updated contracts may include:

  • A move to outcome-based agreements, which tie rebates to specific performance metrics.
  • Adjustments to existing terms based on market changes.

Teams equipped with data from previous agreements are better positioned to negotiate terms that align with strategic goals.

The Role of Technology in Pharma Rebate Management

Technology is transforming how organizations approach pharma rebate management. Tools like those offered by Lyfegen enable teams to:

  • Automate workflows: Reduce manual effort in tracking and reconciliation.
  • Gain transparency: Access clear, real-time insights into rebate agreements.
  • Optimize decisions: Use data-driven analytics to evaluate and renegotiate agreements.

For example, Lyfegen’s platform simplifies rebate tracking and provides actionable insights, ensuring organizations maximize their rebate potential while minimizing inefficiencies.

Start your year smarter!

Q1 is the time to rethink and refine your approach to pharma rebate management. With smarter workflows, clearer insights, and a focus on data-driven strategies, your team can unlock measurable savings and operational excellence.

Book a demo today to discover how Lyfegen’s solutions can simplify your rebate workflows and set you up for success in 2025.

Read More

Rethinking Medicine Payments with Smarter Drug Rebate Management Solutions

READ MORE

Rethinking Medicine Payments with Smarter Drug Rebate Management Solutions

Rising drug costs continue to challenge healthcare systems worldwide. In the UK, the proposed Voluntary Pricing Access Scheme (VPAG) and the NHS’s Accelerated Access Collaborative (AAC) are clear signals of the need for sustainable, transparent approaches to branded medicine pricing. These frameworks aim to control costs through 2028 while ensuring patient access to innovative treatments. Drug rebate management solutions are key to navigating these evolving frameworks. By automating complex workflows, providing real-time insights, and streamlining rebate tracking, these tools reduce administrative burdens, enhance transparency, and unlock significant cost savings.

Key Benefits of Modern Drug Rebate Management Solutions

  1. Automation Simplifies Operations

Traditional rebate management involves resource-heavy processes prone to delays and errors. Modern drug rebate management solutions automate tasks like reconciliation, reporting, and contract tracking, enabling healthcare providers to focus on negotiating better contracts and ensuring compliance with policies like VPAG.

  1. Transparency Reveals Opportunities

Rebate platforms provide granular visibility into contracts, helping organizations identify cost-effective therapies and maximize rebate potential. This transparency aligns with NHS AAC’s goal of improving value and ensuring public funds are spent efficiently.

  1. Real-Time Data Drives Smarter Decisions

Access to live rebate and claims data allows stakeholders to evaluate agreement performance and adjust strategies quickly. With real-time insights, healthcare providers can ensure rebates are optimized, costs are minimized, and patient access is preserved.  

This capability supports NHS AAC’s commitment to accelerating access to innovative medicines while maintaining value for taxpayers.

  1. Faster Auditing Improves Accountability

Delayed reconciliation often creates inefficiencies and compliance risks. Modern drug rebate management solutions provide real-time rebate tracking and payment reconciliation, ensuring accurate auditing and faster resolution of discrepancies. These features are critical for meeting the transparency and accountability goals of initiatives like VPAG.

Why Now?

The VPAG and AAC frameworks prioritize:

  • Optimizing branded medicine spending while maintaining access to innovation.
  • Enhancing transparency for payers, providers, and the public.
  • Redirecting savings to high-impact therapies and improved patient care.

Modern drug rebate management solutions directly address these priorities by simplifying rebate processes, supporting compliance, and enabling healthcare providers to align with evolving regulatory frameworks.

Smarter Practices in Action

Lyfegen is an all-in-one platform designed to streamline rebate workflows, improve transparency, and deliver actionable analytics. By leveraging tools like Lyfegen, healthcare organizations can navigate regulatory changes like VPAG with confidence, ensuring efficient operations and measurable savings.

Looking ahead

As healthcare systems face rising costs and increasing complexity, adopting a modern drug rebate management solution is no longer optional, it’s essential. These tools provide the automation, transparency, and real-time insights needed to comply with frameworks like VPAG while driving cost savings and supporting innovation.

Ready to simplify your rebate workflows? Sign up for a demo today to see how smarter solutions can transform your strategy.

Read More