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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  

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How to Choose the Right Drug Rebate Management Solution

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How to Choose the Right Drug Rebate Management Solution

Managing drug rebates effectively is critical for ensuring financial sustainability while maintaining patient access to essential treatments. With the rising complexity of rebate agreements and the increasing administrative burden on payers and healthcare systems, selecting the right drug rebate management solution is more important than ever. In this blog, we’ll explore key factors to consider when choosing a solution and how Lyfegen’s advanced rebate management platform can streamline the process and optimize financial performance.

The Growing Complexity of Drug Rebate Management

The pharmaceutical industry is shifting towards more intricate pricing and reimbursement models, with value-based agreements, outcome-driven pricing, and performance-based contracts becoming the norm. As a result, healthcare payers and providers need robust systems to accurately track, claim, and optimize rebates.

Traditional rebate management processes—often manual and reliant on spreadsheets—are inefficient and prone to errors, leading to missed rebate opportunities and financial leakage. A modern rebate management solution should offer automation, transparency, and scalability to address these challenges effectively.

Key Features to Look for in a Drug Rebate Management Solution

When evaluating rebate management solutions, payers and healthcare organizations should prioritize the following features:

1. Comprehensive Contract Compliance and Accuracy

Ensuring that all rebates are accurately calculated and claimed according to contract terms is fundamental. Many organizations miss out on significant rebate revenue due to errors in claim tracking, missed deadlines, or lack of visibility into agreement terms. A robust rebate management solution should offer real-time tracking, validation checks, and automated claim submissions to ensure full compliance and minimize financial losses.

2. Automation to Reduce Administrative Burden

Manual rebate processing is time-consuming, resource-intensive, and susceptible to human error. Automating rebate management can significantly reduce administrative costs while improving efficiency and accuracy. The right solution should provide automated data input, mapping, reconciliation, and dispute resolution, ensuring that rebates are processed smoothly without manual intervention.

3. Centralized Agreement Management

Managing multiple rebate agreements across different pharmaceutical manufacturers, products, and therapeutic areas can be overwhelming. A centralized platform allows users to track, update, and analyze agreements in one place, offering a structured repository for easy access to contract details, claims history, and invoicing records. This reduces the risk of mismanagement and enhances visibility across departments.

4. Secure and Transparent Data Sharing

Effective rebate management requires seamless collaboration between payers, manufacturers, and internal teams. A robust solution should offer secure data-sharing capabilities while maintaining privacy compliance. Role-based access control, encrypted transmissions, and audit trails help ensure that sensitive financial and patient data is protected while enabling necessary stakeholders to access relevant information when needed.

5. Forecasting and Analytics for Better Decision-Making

Beyond rebate tracking, a solution should provide actionable insights through analytics and forecasting. Organizations need visibility into past trends and future rebate expectations to make informed financial decisions. A comprehensive platform should offer reporting dashboards, real-time financial modeling, and historical data comparisons to support strategic planning and contract negotiations.

Why Lyfegen?

Choosing the right rebate management solution is not just about compliance and automation—it’s about unlocking financial opportunities and maximizing the impact of negotiated agreements. Lyfegen’s Rebate Analytics Platform (ARA) is designed to:

  • Ensure full contract compliance by accurately identifying and claiming all eligible rebates.
  • Reduce administrative burden by automating rebate calculations, validation, and dispute resolution.
  • Centralize agreement management with a secure, intuitive platform.
  • Facilitate transparent data-sharing with built-in security measures.
  • Provide robust analytics and forecasting for data-driven decision-making.

With automated data input, mapping, and validation, Lyfegen's ARA streamlines rebate calculations and dispute resolution. Customers using Lyfegen’s platform have identified up to 30% of missed rebates while reducing administrative workload by up to 97%.Additionally, Lyfegen’s solution offers real-time simulations, predictive modeling, and scenario comparisons, allowing payers and healthcare organizations to proactively assess financial impacts before finalizing agreements.

The Time to Act Is Now

With increasing pressures on healthcare budgets and the complexity of drug rebate agreements, organizations cannot afford inefficiencies in rebate management. Lyfegen’s solutions empower payers and healthcare organizations to simplify the process, recover lost revenue, and optimize financial performance.

Book a demo today to see how Lyfegen’s rebate management platform can transform your approach to drug contracting and financial optimization.

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Lyfegen and EVERSANA Collaborate to Revolutionize Drug Pricing and Access with AI-Driven Insights

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Lyfegen and EVERSANA Collaborate to Revolutionize Drug Pricing and Access with AI-Driven Insights

Basel, Switzerland –28, January 2025 -  Lyfegen, a global innovator in drug market access, pricing, and rebate management, has announced a transformative collaboration with EVERSANA®, a leading provider of global commercial services to the life sciences industry, to revolutionize drug pricing and access through artificial intelligence-driven insights.  

By combining data and information from the global pricing and market access platform, NAVLIN by EVERSANA®, with Lyfegen’s Public Drug Agreement Library, the two organizations will harness cutting-edge AI to empower market access and pricing professionals and payers with actionable insights. The joint agreement marks a key step in tackling rising drug costs and improving patient access globally.

Simplifying Complexity with AI

Drug pricing and access are increasingly difficult to navigate, with healthcare payers and pharmaceutical companies facing inefficiencies, missed opportunities, and delays in delivering therapies to patients.

The collaboration combines two leading platforms to address these challenges:

  • NAVLIN by EVERSANA: The industry’s most comprehensive platform, delivers real-time access to global price and access data across 100+ countries and 50+ HTA bodies.  
  • Lyfegen’s Public Drug Agreements Library: A repository of over 7,000 public access agreements, recognized as the world’s most complete repository, delivering real-world strategies for smarter decision-making.

Together, these tools deliver a 360-degree view of pricing trends and access frameworks, enhanced by AI-driven capabilities. This integration helps users:

  • Efficiently link Public Drug Agreements and Price & Access Data in one environment.  
  • Discover agreements tailored to specific market needs.
  • Streamline decision-making using predictive analytics.
  • Quickly adapt to changing market trends and regulations.

Driving Smarter and Fairer Decisions  

Together, Lyfegen and EVERSANA will empower market access teams to make smarter, faster, and more equitable decisions. By combining AI-driven insights with robust data, payers and pharmaceutical companies can reduce inefficiencies and ensure patients receive timely access to life-saving therapies.
 

“Together with Lyfegen we can harness the power of AI to address one of the biggest challenges in healthcare—helping patients get timely access to life-saving medicines,” said Jim Lang, CEO, EVERSANA. “By uniting our expertise and our global pricing innovations, we have the opportunity to deliver a solution that simplifies decision-making and improves access in healthcare systems worldwide.”

A Vision for the Future of Drug Access

The healthcare industry is rapidly adopting AI to drive efficiency and innovation. This partnership positions Lyfegen and EVERSANA at the forefront of this transformation, enabling stakeholders to overcome affordability and access challenges.

“Our mission at Lyfegen has always been to create a more sustainable and equitable healthcare environment,” said Girisha Fernando, CEO of Lyfegen. “Through this partnership with EVERSANA, we are taking a giant step toward that future. By integrating EVERSANA’s price and access data into our combined offerings, we’re not just solving today’s challenges—we’re building a foundation for a smarter, more efficient drug access and pricing landscape.”

About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. With the world’s largest repository of drug access agreements and a powerful pricing simulator, Lyfegen helps payers and pharma implement and optimize rebates, reduce administrative effort, and understand financial impacts. Founded in 2018, Lyfegen is headquartered in Basel, Switzerland. Learn more at Lyfegen.com or connect with us on LinkedIn.  

About EVERSANA

EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X. 

Media Contacts

For Lyfegen

marketing@lyfegen.com  

For EVERSANA

Matt Braun

Vice President, Corporate Communications

matt.braun@eversana.com  

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