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Cómo se está preparando España para la nueva normativa europea

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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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La Reforma de Medicare Parte D en 2025

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La Reforma de Medicare Parte D en 2025


Un cambio importante en Medicare Parte D entrará en vigor el próximo año, como resultado de la Ley de Reducción de la Inflación. Lo más notable es que el tope de gastos de bolsillo se reducirá de $3,300 a $2,000.

  • Los beneficiarios podrán inscribirse en el Plan de Pago de Recetas de Medicare, que implica pagos mensuales de menos de $200 en lugar de un pago único en la farmacia.
  • La proporción de los costos totales de los medicamentos cambiará. Este año, el 20% de los costos de cobertura catastrófica están cubiertos por el plan Parte D y el 80% por Medicare. El próximo año, el 60% estará cubierto por la Parte D, solo el 20% por Medicare, y el 20% por el fabricante.
  • Se eliminará el requisito de un copago del 5%, lo que ahorrará a los pacientes miles de dólares en costos de bolsillo, especialmente para aquellos que toman medicamentos más costosos.

Esto nos lleva a otro desarrollo importante.

Actualización del Programa de Negociación de Precios de Medicamentos de Medicare

El CMS anunció su selección de 10 medicamentos cuyo precio fue negociado hace unos días, el 15 de agosto. Los medicamentos seleccionados se identificaron como “medicamentos de fuente única”, lo que significa que no tienen equivalente genérico o biosimilar, y es poco probable que lo tengan en el futuro cercano. Se estima que los nuevos precios ahorrarán $6 mil millones en costos netos de medicamentos recetados, lo que representa una reducción del 22% en el gasto. Los nuevos precios entrarán en vigor el 1 de enero de 2026.

A medida que la industria farmacéutica atraviesa estos cambios, es crucial contar con las herramientas adecuadas. Aquí es donde Lyfegen entra en juego con sus soluciones innovadoras como el Simulador de Contratación de Medicamentos, una herramienta diseñada para ayudar a los equipos de Acceso al Mercado y Precios a mantenerse a la vanguardia en este panorama:

💡 Modelado eficiente de escenarios de precios: Cree y pruebe una amplia gama de contratos de reembolso de medicamentos, lo que le permite evaluar rápidamente el impacto en los ingresos brutos y los costos netos.

🤝 Colaborativo y diseñado para su propósito: Deje atrás las herramientas basadas en Excel con nuestra plataforma dedicada, diseñada para los equipos de Acceso al Mercado y Precios, reutilizable en diferentes mercados y activos.

⚡ Acuerdos más rápidos y mejores: Simplifique la creación de acuerdos de reembolso en un entorno colaborativo, ayudándole a responder de manera más efectiva a las nuevas presiones de precios.

No pierda la oportunidad de mantenerse a la vanguardia en este nuevo entorno regulatorio. Reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo

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Principales Fabricantes y Pagadores en Brasil

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Principales Fabricantes y Pagadores en Brasil


En Brasil, encontramos que los principales fabricantes que proponen contratos basados en el valor fueron Novartis, Pfizer, J&J Innovative Medicine y Roche. Entre los pagadores, identificamos 21 aseguradoras privadas entre 2021 y 2024. También agregamos a ANVISA (Agencia Nacional de Vigilancia Sanitaria de Brasil) y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC), el organismo de evaluación de tecnologías sanitarias (ETS) de Brasil.

Áreas Terapéuticas

Las áreas terapéuticas que identificamos en los acuerdos públicos de Brasil incluyen:

  • Enfermedades infecciosas
  • Oncología
  • Enfermedades metabólicas
  • Cardiovascular
  • Hematología

Modelos de Precios

Nuevos modelos de precios de Brasil incluyen:

  • Cobertura restringida
  • Descuento fijo
  • Cobertura con desarrollo de evidencia
  • Garantía de resultados
  • Límite de presupuesto

Acuerdos Destacados

Estos acuerdos se destacan porque abordan enfermedades raras y de alto costo, y demuestran enfoques únicos para el acceso a medicamentos y reembolsos, incluyendo cobertura con desarrollo de evidencia, garantías de resultados y pagos a plazos.

Fibrosis Quística:

  1. Orkambi (2024): CED, Cobertura restringida, Pagos a plazos
  1. Trikafta (2023): CED, Garantía de resultados, Cobertura restringida
  1. Kalydeco (2020): CED, Cobertura restringida


Atrofia Muscular Espinal Infantil:

  1. Zolgensma (2022): Garantía de resultados, CED, Pagos a plazos

Cáncer de Ovario:

  1. Lynparza (2022): Cobertura restringida, CED (con aseguradoras privadas)

Principales Fabricantes:

  • Novartis
  • Varios fabricantes (para genéricos)
  • Pfizer
  • J&J Innovative Medicine
  • Roche

Entendiendo el Proceso de ETS para la Aprobación de Medicamentos en Brasil

En Brasil, el proceso de Evaluación de Tecnologías Sanitarias (ETS) es gestionado por ANVISA y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC). El proceso incluye varios pasos:

  1. Aplicación: Las compañías solicitan que sus medicamentos sean evaluados.
  1. Evaluación: ANVISA y CONITEC evalúan los medicamentos.
  1. Negociación y fijación de precios: Se negocian precios y términos.
  1. Inclusión: Los medicamentos aprobados se incorporan al sistema con precios establecidos.
  1. Reembolso: Los medicamentos listados son reembolsados bajo el sistema de salud pública.

A medida que Brasil se convierte en un mercado clave para las empresas farmacéuticas, nuestra biblioteca ofrece información esencial para ayudarle a ingresar a este mercado de manera eficiente y antes que la competencia.

Para obtener más información sobre los acuerdos de acceso a medicamentos en Brasil o acceder a nuestra biblioteca, reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo

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Explorando Contratos Basados en el Valor: Acuerdos Públicos Destacados en Canadá, Dinamarca y Brasil

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Explorando Contratos Basados en el Valor: Acuerdos Públicos Destacados en Canadá, Dinamarca y Brasil


En este blog, seleccionamos acuerdos específicos en Canadá, Dinamarca y Brasil. Cada uno de estos acuerdos varía, y los elegimos para que pueda ver cómo los fabricantes abordan el acceso al mercado para diferentes medicamentos y regiones. Los contratos basados en el valor en estos mercados aceleran el acceso de los pacientes mientras comparten el riesgo financiero entre la industria farmacéutica y los pagadores, una situación en la que todos ganan.

Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Canadá
  • Tipo de acuerdo: Cobertura con desarrollo de evidencia (CED), cobertura restringida, garantía basada en resultados.
  • Fecha: Julio 2022

La Agencia Canadiense de Medicamentos y Tecnologías en Salud requiere una reducción del 94% en el precio de Trikafta para que el tratamiento sea rentable. Los niños con fibrosis quística de entre 2 y 5 años son evaluados después de 1 año, para demostrar que se benefician del tratamiento. Los pacientes deben cumplir con una serie de criterios para ser elegibles para el tratamiento, lo que convierte al acuerdo en una combinación de cobertura con desarrollo de evidencia, cobertura restringida y basada en resultados.

Trikafta ya había sido aprobado para su uso en niños mayores de 6 años, pero realizar un ensayo clínico en niños de entre dos y cinco años se consideró “éticamente desafiante”. Sin embargo, un ensayo no controlado en este grupo de edad encontró que el tratamiento fue bien tolerado y redujo los biomarcadores de la condición. Para abordar las necesidades no satisfechas, reconociendo la falta de datos en esta población de pacientes, se negoció un contrato de CED con una reducción drástica en el precio.

Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Brasil
  • Tipo de acuerdo: Cobertura restringida, CED
  • Fecha: Abril 2024

El Ministerio de Salud de Brasil llegó a un acuerdo con Vertex para permitir el acceso restringido a este tratamiento, mientras monitorea regularmente a los pacientes a los 30 días y a los 3 meses después de iniciar el tratamiento. El acuerdo incluye reembolsos si el tratamiento no logra los resultados clínicos deseados, alineando los precios con la efectividad.

Kalydeco (ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Dinamarca
  • Tipo de acuerdo: Acuerdo de precio-volumen; precios de cartera
  • Fecha: Octubre 2018

El organismo de adquisición danés, Amgros, y Vertex Pharmaceuticals llegaron a un acuerdo que proporciona acceso a una cartera de medicamentos para la fibrosis quística, incluyendo Orkambi (lumacaftor/ivacaftor) y futuras terapias, en 2019. A pesar de que esto ocurrió hace cinco años, es un excelente ejemplo de precios basados en cartera, donde los pagadores acuerdan pagar una tarifa fija por un grupo de medicamentos relacionados. Cuantos más pacientes los utilicen, menor será el precio por paciente.

Lynparza (Olaparib, AstraZeneca)

  • Indicación: Cáncer de ovario
  • País: Brasil
  • Tipo de acuerdo: Cobertura restringida, garantía basada en resultados
  • Fecha: Mayo 2022

Este acuerdo se realizó entre AstraZeneca y aseguradoras privadas en todo Brasil. El tratamiento se pone a disposición sin costos adicionales para el paciente y combina características de cobertura restringida con garantías de resultados. La cobertura continua depende de lograr una respuesta parcial o completa.

Zolgensma (onasemnogene abeparvovec, Novartis)

  • Indicación: Atrofia muscular espinal (AME)
  • País: Brasil
  • Tipo de acuerdo: Garantía de resultados, CED, pagos a plazos
  • Fecha: Diciembre, 2022

La terapia génica de Novartis, Zolgensma, se reembolsa en función de la necesidad de evidencia adicional, conocida como cobertura con desarrollo de evidencia. Esto implica usar la cobertura como un medio para obtener evidencia del mundo real, para compensar la falta de datos robustos de pacientes provenientes del ensayo clave. El acuerdo también divide el riesgo entre los pagadores y los fabricantes, al vincular el reembolso con los resultados obtenidos. Debido al gran potencial de la terapia para mejorar la calidad de vida de los niños con AME, el acuerdo permite que los pacientes elegibles comiencen a recibir el tratamiento rápidamente.

¿Quiere ver la biblioteca por sí mismo? Reserve una demostración hoy aquí: https://www.lyfegen.com/demo

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How Spain is Preparing for Europe’s New Regulation

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How Spain is Preparing for Europe’s New Regulation


To streamline the HTA process across EU member states, sweeping changes will go into effect in January of 2025. Instead of manufacturers of new health technologies needing to submit clinical data to each member state, under Regulation (EU) 2021/2282, the assessment will be conducted jointly. Manufacturers will only need to submit clinical assessments once, but member states can still conduct complementary assessments.

Important to note are the 9 assessment domains, of which 4 are clinical and 5 are non-clinical. The 4 clinical assessments include:  

  • Evaluation of the disease and the current treatment landscape
  • Examination of the new health technology
  • Safety
  • Effectiveness

The 5 non-clinical domains include:  

  • Cost and economic evaluation
  • Ethics
  • Organizational impacts
  • Social impacts
  • Legal aspects


Spain released its Draft Royal Decree on the 12th of August, which is open for comments until the 20th of September, outlining how they will align with the Directive. This effort involves the Office for the Evaluation of the Efficiency of Medicines operating as a functional unit under the Spanish Agency of Medicines and Medical Devices (AEMPS).


In addition to joint clinical assessments in Europe, there will also be joint scientific consultations. The goal of this Directive is to reduce duplicate administrative work and remove barriers to innovation while aiming to improve patient outcomes.  


As these changes reshape the landscape, it's crucial for pharmaceutical and medical technology companies to adapt swiftly. Lyfegen can help you stay ahead with our cutting-edge solutions:


- Navigate New Regulatory Requirements: Access our extensive Agreements Library, featuring over 5,000+ public drug pricing agreements and 20 pricing models, to ensure compliance with the latest HTA standards.

- Optimize Decision-Making: Utilize our Drug Contracting Simulator to create data-driven business cases and run real-time simulations that align with Spain's new HTA guidelines.

- Streamline and Automate Contracting: Our Rebate Analytics solutions automate rebate and refund calculations, ensuring accuracy, transparency, and a significant reduction in administrative burdens.


Book a demo with us today to explore how Lyfegen’s tools and expertise can support your business under Spain’s new HTA framework.
Book your demo here: https://www.lyfegen.com/demo

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

Basel, Switzerland / Boston, USA – December 11, 2024

Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.

Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions

The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.

Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.

Scaling Globally with a Leading Rebate Management Platform

Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.

“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”

Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”


About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand the full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.

About TX Ventures

TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage. 


For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com 

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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

In an industry often characterized by incremental changes, Girisha Fernando, the CEO and founder of Lyfegen, is making leaps. We sat down with Fernando to discuss the recent landmark partnership between Lyfegen and Newfoundland and Labrador Health Services—a collaboration that heralds a significant shift in the Canadian healthcare landscape.

 

Your partnership with Newfoundland and Labrador Health Services is quite a milestone. Can you share with us what this means for the current state of rebate management in Newfoundland?

Girisha Fernando (GF): Absolutely. This partnership is a transformative step for rebate management in Newfoundland. The current system, largely manual and complex, is ripe for innovation. With our digital platform, we're bringing a level of automation and accuracy that was previously unattainable. This means more efficient processing, less room for error, and a better allocation of resources, which is critical in healthcare.

That’s quite an advancement. And how does this impact the management of drug products, especially in areas like oncology?

GF: It’s a game-changer, especially for critical areas like oncology. Newfoundland and Labrador, as the first in Canada to use our platform, sets a precedent. The region, through the pan-Canadian Pharmaceutical Alliance, has been managing complex product listing agreements for drugs, including those for oncology. These agreements are vital for making treatments affordable. Our platform simplifies this, managing the various terms of these agreements efficiently, which is crucial for timely and affordable access to treatments.

It seems like a significant step forward for healthcare management. How does this align with the broader goals of Lyfegen?

GF: This partnership aligns perfectly with our goal to make healthcare more accessible and efficient. Automating the rebate process in Newfoundland and Labrador, especially for critical treatments in oncology, directly contributes to the sustainability and accessibility of healthcare treatments.

Looking to the future, what does this partnership mean for Lyfegen and healthcare systems globally?

GF: This is just the beginning. We're looking to extend our platform to healthcare systems around the world. Our aim is to make this technology a standard in healthcare management, fostering more efficient, sustainable, and equitable healthcare systems globally.

Read more about the partnership in the official press release.

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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

New York, NY - March 29, 2023 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced at the World EPA Congress the launch of its latest solution: the Model & Agreement Library. The purpose of the library is to help payers and pharma negotiate better drug prices while providing an in-depth view on current international drug pricing models and value-based agreements. The database library serves as the basis for successful drug pricing negotiations, resulting in accelerated access and drug prices better aligned to their value for the patient.

 

The shift towards value-based healthcare, rather than volume-based, has been steadily increasing over the years. This evolution has further reinforced Lyfegen's mission to remain at the forefront of analytics and digital automated solutions for the healthcare sector. Indoing so, Lyfegen’s solutions help to accelerate access and increase affordability of healthcare treatments.

 

“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers, and pharma companies across the world”, said Girisha Fernando, CEO of Lyfegen. “That is why we are so excited about launching the world’s largest database of real-world value-based agreements. It gives payers, and pharma a unique insight into how to structure value-based agreements.”

The Lyfegen Model & Agreement Library was developed as an accelerated negotiation resource for both manufacturers and payers – allowing them to save on time, money; and for the first time – an opportunity to learn at their own pace without incurring large research projects or hiring expensive external experts. Users of the library are now enabled to make informed decisions in determining the most suitable drug pricing models and agreements for their products.

The database holds over 2'500+ public value-based agreements and 18+ drug pricing models – spanning across 550 drugs,35 disease areas and 150 pharma companies. Its search capabilities are spread across product, country, drug manufacturer and payer – with all the knowledge, insights, current pricing and reimbursement activities shown in near real-timeacross the industry.

“Just an academic taxonomy of models is intellectually exciting but it's not really helping your typical customer”, said Jens Grüger, Director and Partner at Boston Consulting Group (BCG). “The Lyfegen Platform goes several steps further. Payers and pharma have a problem and they want a solution. The Lyfegen Model & Agreement Library is practical. It offers case examples.”

The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.

“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.

This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.

Learn more and start your free trial now

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

 

Basel, Switzerland, October 27, 2021

Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.

 

The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.

 

"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.

Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."

The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.

 

About Sympany

Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.

In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.

More about Sympany: https://www.sympany.ch

 

About Lyfegen

Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.

Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.

Contact Press: press@lyfegen.com

Contact Investors: investors@lyfegen.com

 

READ THE OFFICIAL PRESS RELEASE

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Breaking News: Lyfegen platform supports Johnson & Johnson to further drive value-based healthcare strategy

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Breaking News: Lyfegen platform supports Johnson & Johnson to further drive value-based healthcare strategy

 

Basel, Switzerland, August 3rd, 2021

Lyfegen announces that its value-based healthcare contracting platform has been implemented together with Johnson & Johnson Medical Devices Companies Switzerland (Johnson & Johnson) and a leading Swiss Hospital.  

 

Through this new value-based healthcare approach, Lyfegen and its partners drive the shift towards what matters most to patients: improved patient health outcomes and more efficient use of financial and human resources, enabling a sustainable post-COVID-19 healthcare environment.  

 

The shift towards a value-based healthcare in Switzerland and globally can only be achieved through the support of innovative technologies. Lyfegen’s platform is a key enabler for this transition. The platform digitalises and automates the execution of value-based healthcare agreements, paving the way for the resource-efficient scaling of such novel agreements.   

 

“COVID-19 has shown us the urgent need for a more sustainable healthcare system. With the implementation of value-based healthcare agreements on the Lyfegen platform, we are extremely proud to help Johnson & Johnson and hospitals to accelerate the transition to value-based healthcare and improve patient health outcomes at reduced cost.” says Lyfegen’s CEO, Girisha Fernando.

Lyfegen's compliant, secure and patent-protected value-based healthcare contracting platform automates the collection and analysis of patient-level data. Users receive transparency on actionable health outcomes and agreement performance. Lyfegen’s contribution to this partnership is a blueprint for the scaling of value-based healthcare models across hospitals, health insurances, medical device & pharma companies globally. The partnership marks another important milestone for Lyfegen, as the company continues to grow and has recently opened its next investment round.  

 

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Conozca a David Duro, nuestro nuevo Vicepresidente de Ventas y Desarrollo de Negocio - Un líder que conecta con sus clientes y les ofrece soluciones eficaces

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Conozca a David Duro, nuestro nuevo Vicepresidente de Ventas y Desarrollo de Negocio - Un líder que conecta con sus clientes y les ofrece soluciones eficaces

Antes de unirse a nosotros en Lyfegen, David adquirió una gran experiencia y conocimientos en la industria de la salud y las finanzas, mientras perfeccionaba sus habilidades como Ejecutivo de Ventas Globales. Su curiosidad por la naturaleza humana y su amor por la humanidad es lo que alimenta su pasión por marcar la diferencia allí donde más importa.

Afincado en España y licenciado en Ingeniería Informática Con su amplia experiencia en la introducción de productos disruptivos en el mercado, ha llegado a comprender que es primordial destacar cómo las tareas diarias del usuario conectan con nuestra plataforma y guiar a través del proceso. Cuando se le pide que describa cómo ve su papel, David dice: "Todo el mundo busca algo. Mi trabajo consiste en entender qué es lo que realmente buscan". Cuándo le preguntamos qué es lo que más le gusta de su trabajo, respondió: "Bucear por debajo de las palabras y entender las necesidades de la gente,para luego conectar esas necesidades con las soluciones que Lyfegen puede aportar."

¿Qué es lo que quiere emprender este año? Siendo un aprendiz permanente, David quiere profundizar en el ciclo completo de nuestro servicio y explorar tanto la gestión de proyectos como la parte técnica. Apasionado de la buena música, pasa su tiempo libre con amigos que disfrutan de los mismos intereses. Es un creyente en la humanidad y en los actos de bondad al azar, está deseando conocer gente nueva este año de todo el mundo y tener la oportunidad de conectar experiencias y trabajar en un entorno internacional.

Girisha Fernando, Directora General de Lyfegen, está encantada de dar la bienvenida a David a nuestro equipo. 'Estamos encantados de tener a David Duro a bordo. Su inestimable pericia y amplia experiencia aportarán sin duda un inmenso valor al éxito de Lyfegen. Esto marca un hito importante en nuestros esfuerzos de expansión internacional, y estoy ansioso por anticipar las nuevas oportunidades que se avecinan'.

Desde Lyfegen, damos una calurosa bienvenida a David y esperamos crecer juntos.

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Meet David Duro, Our New VP of Sales & Business Development - A Leader Who Connects with his Customers and Helps Them Find Powerful Solutions

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Meet David Duro, Our New VP of Sales & Business Development - A Leader Who Connects with his Customers and Helps Them Find Powerful Solutions

Before joining us at Lyfegen, David gained a wealth of experience and knowledge in the healthcare and finance industry while honing his skills as a Global Sales Executive. His curiosity of human nature and love for humanity is what fuels his passion to make a difference where it matters most.

Based in Spain with a qualification in Computer Engineering, David is no stranger to bringing disruptive products to the market. With his extensive experience bringing disruptive products to the market, he has come to understand that it is paramount to highlight how our platform connects to the daily tasks of the user and prefers to guide them through the process. When asked to describe how he views his role, David said, “Everyoneis looking for something. My job is to understand what it is that you are really looking for”. When we asked what he likes the most about his job, he replied “diving below the words and understanding the needs of the people, then connecting those needs with the solutions that Lyfegen can provide.”

What is something he wants to take up this year? Being a curious lifelong learner, David eventually wants to deep dive into the full cycle of our service and explore both the project management and the tech side. Passionate about good music, he spends his free time with friends who enjoy the same interests. While being a tremendous believer in humanity and random acts of kindness, he looks forward to connecting with new people this year from all around the world and having the opportunity to connect experiences and work in an international environment.

Girisha Fernando, CEO of Lyfegen, is extremely excited to welcome David into our team. 'We are thrilled to have David Duro on board! His invaluable expertise and extensive experience will undoubtedly bring immense value to Lyfegen’s success. This marks a significant milestone in our international expansion efforts, and I am eagerly anticipating the new opportunities ahead.'

From all of us at Lyfegen, we warmly welcome David and look forward to growing together!

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

We are delighted to welcome our new executive assistant, Olga Dragos to the Lyfegen team! Olga joined us after making her final decision to work only with an enterprise that is directly impacting the lives of many for the better.

When we asked what fuels her purpose, she said, “The most exciting part of my profession is that I get to be key in streamlining processes that save time for our teams, which in turn helps get our product in front of more patients and increases our capacity to brainstorm new projects.”

With a solid background spanning over more than fifteen years in Executive and Administrative Support, Olga is a highly experienced professional that has worked in the US market for several corporates and small businesses in the medical insurance and transportation industries.

Originally from Belarus, Olga immigrated to the US in 1996 and further moved to Romania in 2021 where she is happily settled now with her husband and son. Being an avid traveler at heart with a passion for diverse cultures and their delicacies, Olga takes solace in both nature and outdoor activities where she’s been known to take scenic canoe rides down the river in early spring. While she has an adventurous spirit, family and cooking is her first love and creating her own recipes for them to enjoy while spending quality time together is a high priority.

When we asked what’s next for this year outside of work, we were not surprised to discover her warm philanthropic nature has steered her on the path of finding a new organization where she can volunteer her time to make a difference.

We give a very warm welcome to Olga and look forward to having her vibrant personality, and sound expertise to propel our team forward.

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Envisioning solutions that solve meaningful real-world problems – meet Andrei Cantea, our new visionary Senior Product Designer

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Envisioning solutions that solve meaningful real-world problems – meet Andrei Cantea, our new visionary Senior Product Designer

After graduating in Computer Science from Babeș-Bolyai University in Romania, Andrei co-founded a digital health start-up that was laser focused on assisting patients and clinicians alike, to reach better health outcomes. His keen interest in UX design and problem solving has been the driving force behind his success in creating and building meaningful experiences and solutions in the digital healthcare arena.  

However, his story doesn’t start there.  

Andrei’s first interactions with design started in his high school years, where he took part in numerous competitions within the digital solutions and education space – this being where he realized his true passion for design and creating solutions that would positively impact the lives of many.  

When we asked Andrei what excited him the most about joining Lyfegen as the new Senior Product Designer, his answer was clear cut – “I am allowed to be an active part in envisioning, designing and building meaningful solutions that can help users, which in turn helps patients and saves lives – this is what I find exciting and refreshing.

Joining Lyfegen has been a perfect synergy between Andrei’s personal views on digital healthcare and Lyfegen’s impactful approach in the sector – solving deep complex issues, while still remaining mindful and deeply empathetic towards its users and end goals. This is what fuels his motivation in contributing his valuable expertise in the process, while working alongside his incredible team.  

While in his spare time, Andrei has been known to catch up with his video games when time allows, play board games, watch his favorite science channels, read a good book, and of course spend quality time with his friends and family, when he’s not outdoors enjoying some nature.

We warmly welcome Andrei to our team and look forward to revolutionizing the industry side-by-side.

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

Each year, the NAMD (National Association of Medicaid Directors) Conference in Washington D.C. brings together the nation's Medicaid directors, leaders in the industry, and key decision-makers for a one-of-a-kind conference. With the global public health emergency, the Medicaid system and the work of Medicaid directors and their staff has never been more important. While COVID-19 has disrupted health care at all levels, it has shown the importance of more innovative payment models and the need for broader access to treatments. The shift towards value-based healthcare has become one of Medicaid’s hottest topics, with CMA and Lyfegen joining forces to present the latest value-based contracting technology at this year’s NAMD Conference.

We sat down for a brief interview with CMA’s President, Ken Romanski, and Lyfegen’s CEO, Girisha Fernando, to gain more insights into the importance of this partnership:

Thanks for joining us, Ken and Girisha. Can you tell us why this partnership is an important milestone, both for CMA and Lyfegen?

Ken: Our partnership with Lyfegen is a key milestone for CMA as we expand and complement our portfolio of technology-based solutions with extremely high-value business analytics products. Our utmost priority is to support Medicaid programs by lowering costs, while at the same time improving health outcomes for vulnerable citizens.

Girisha: This partnership sets the basis to create enormous value for our state healthcare payers and pharma. By partnering together, we enable our customers to implement value-based pharmacy agreements, actively managing the budget impact of new treatments and aligning existing formulary spending with value for beneficiaries.

For Lyfegen, this is a market entry into the U.S. – why CMA?

Girisha: CMA’s experience and technical expertise are unique. CMA is a highly recognized technology partner for State Healthcare Payers across the nation, with over 20 years of experience. Lyfegen has made a conscious decision to combine its capabilities with CMA to enable our customers to leverage the potential of value-based agreements for their pharmacy programs.

What is the value of this partnership for healthcare payers?

Ken: CMA is very excited to work with Lyfegen and our clients to deliver tens of millions of dollars in savings per year by leveraging our experience in Medicaid data management to implement this robust value-based analytics platform.

Girisha: Our customers benefit from the combined years of experience and unique expertise in data and value-based healthcare solutions. We focus on providing the first proven, scalable, highly secure value-based agreement platform for State Medicaid that allows our customers on average to avoid 54 million dollars in treatment costs that do not work and gain 7 million dollars in efficiency due to the fully automated end-to-end process. We are extremely excited to present all aspects of our partnership and present the value and opportunities our platform can bring to State Medicaid programs at NAMD.

Join CMA and Lyfegen at NAMD and understand first-hand how they can support you to realize savings for your pharmacy programs, improving patient health outcomes with their unique value-based agreement platform.



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The Joint Clinical Assessment (JCA): A New Era for Market Access Strategies in the EU

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The Joint Clinical Assessment (JCA): A New Era for Market Access Strategies in the EU

The Joint Clinical Assessment (JCA) is poised to fundamentally change how health technologies gain market access across the European Union. Designed to streamline the evaluation process, the JCA promises to bring greater consistency, transparency, and efficiency to how new therapies and medical technologies are assessed for clinical effectiveness. But what does this mean for your market access strategies?

What is the JCA?

The JCA is a central pillar of the EU’s updated Health Technology Assessment (HTA) regulations. Historically, pharmaceutical and medical device companies faced significant hurdles when introducing new health technologies across different EU member states. Each country has had its own HTA process, leading to duplicated efforts, inconsistent outcomes, and delays in patient access. With the JCA, clinical assessments will be conducted at the EU level, offering a unified approach to evaluating the relative effectiveness of new treatments.

Key Benefits of the JCA

The JCA is expected to address several long-standing challenges:

1. Streamlined market access: By replacing multiple national HTA evaluations with a single EU-level assessment, the JCA will reduce duplication and accelerate the time it takes for new health technologies to reach the market.

2. Consistency across the EU: With the JCA, companies can expect more predictable and transparent outcomes when navigating the regulatory landscape. This will help align market access efforts across all member states, making it easier for companies to plan and execute their market entry strategies.

3. Cost efficiency: By pooling resources and conducting joint clinical assessments, the JCA is expected to save HTA bodies across the EU millions of euros annually. This increased efficiency will also benefit pharmaceutical and medical technology companies by reducing the administrative and financial burden of complying with multiple HTA processes.

How Will the JCA Impact Your Market Access Strategy?

For companies looking to introduce new health technologies in the EU, the JCA will bring both opportunities and new considerations:

Early Engagement Will Be Key: The unified nature of the JCA means that companies will need to engage early with EU-level HTA bodies to ensure that their clinical data meets the requirements of the JCA. This early engagement can help smooth the path to market and avoid potential delays.

A Shift in Regulatory Focus: With clinical assessments now being handled at the EU level, companies may need to adjust their strategies for navigating national market access pathways. While the JCA will simplify the clinical assessment process, national bodies will still be responsible for non-clinical aspects, such as pricing and reimbursement decisions.

Data Consistency and Quality: The JCA emphasizes the importance of high-quality, consistent clinical data. Companies will need to ensure that their submissions are robust and aligned with the JCA’s methodology to avoid discrepancies and delays in the assessment process.

The Role of Technology in Managing Market Access

As market access strategies evolve with the implementation of the JCA, technology platforms like Lyfegen can play a crucial role in helping pharmaceutical and medical technology companies adapt. Lyfegen’s platform simplifies the process of planning, tracking, and managing health technology assessments, ensuring that companies are well-prepared to meet the requirements of the JCA.

By leveraging advanced analytics and real-time data management tools, Lyfegen enables companies to streamline their market access efforts, ensure compliance with EU-level assessments, and maintain transparency throughout the process. With the increasing complexity of market access in the EU, technology will be a critical factor in ensuring success.

Conclusion: Preparing for the Future of Market Access

The JCA is set to transform market access strategies across the EU by creating a more efficient, unified, and predictable pathway for introducing new health technologies. As companies navigate this new landscape, early preparation, high-quality clinical data, and the right technological tools will be essential to staying ahead.

Unlock smarter market access strategies with Lyfegen’s advanced tools! The Lyfegen Drug Contracting Simulator empowers you to navigate the complexities of the JCA, model various pricing scenarios, and optimize your market entry plans. Combined with the Lyfegen Library’s extensive collection of market access models, you’ll have everything you need to succeed in the EU’s evolving regulatory landscape.

Act Now – Book a demo of Lyfegen’s platform and learn how we can support your market access strategy: https://www.lyfegen.com/demo

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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.


Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?

I have spent close to  a decade in the life sciences sector, working with companies like Novartis  and Pfizer, where I gained deep expertise in healthcare strategy, market  access, and health economics. My passion has always been focused on improving  patient outcomes and the healthcare system. This led me to Lyfegen, a company  at the forefront of transforming healthcare through innovative solutions. The  opportunity to work with payers and drug manufacturers to ensure better and  sustainable access to innovative treatments for patients was a natural fit  for me, both professionally and personally.


What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?

The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies.  However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.


What  opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How  can we better support health insurers and government bodies?

There is tremendous  potential for growth. Currently, payors and pharmaceuticals adjudicate their  product listing agreements (PLAs) manually through Excel spreadsheets. It is  resource intensive, leaves room for errors and is a barrier to potential  innovative contracting. In addition, as Canada increasingly looks towards  value-based healthcare models, Lyfegen is an enabler by providing the digital  infrastructure for payor and manufacturers.


From your perspective, what key actions need to be taken in the  next 12 months to drive success for Lyfegen in the Canadian market?

In the next 12 months, we need to focus on deepening  our relationships with key stakeholders and demonstrate the value of our  digital solutions for payors, manufacturers, healthcare system and,  ultimately, the patients.


How do you see your role influencing the implementation of  value-based solutions in Canada, and what impact do you hope to have?

Lyfegen has extensive  experience in OBA implementation and operationalization in many countries. In  my role, I hope to bridge the gap from theory to practice in the  implementation of value-based healthcare in Canada.


In your opinion, what’s the most important aspect of building  strong client relationships in the healthcare industry? How do you approach  this in your role?

Trust and communication  are at the core of any strong client relationship in healthcare. Given the  complexity and sensitivity of the industry, clients need to know that you  understand their unique challenges and are committed to solving them. In my  role, I prioritize open and ongoing communication, ensuring that clients feel  heard and that their feedback is integrated into our solutions. I also work  hard to build trust by delivering results and being transparent about what we  can achieve together.

 
Looking ahead, what excites you most about the future of sales  and business development at Lyfegen in Canada?

I’m excited about the potential to be a catalyst for  significant change in the Canadian healthcare landscape. Lyfegen is in a  unique position to lead this transformation. The combination of increasing  demand for cost-effective healthcare solutions and our innovative approach  makes this an incredibly exciting time to be in sales and business  development.


Outside of work, what are some of your favorite things to do in  your free time?

Outside of work, I  enjoy spending quality time with my family and friends. I also prioritize my  health by being active on a daily basis. I also enjoy learning. Now that I  have completed my MBA, I’m on a mission to learn Spanish.

We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!

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The Cost of Innovation: Budget Impact of Gene Therapy for Sickle Cell Disease on Medicaid Plans

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The Cost of Innovation: Budget Impact of Gene Therapy for Sickle Cell Disease on Medicaid Plans

In December 2023, the U.S. Food and Drug Administration (FDA) approved two groundbreaking gene therapies for sickle cell disease (SCD), offering a new lease on life for individuals battling this severe condition. However, while these therapies bring significant clinical improvements, their cost has emerged as a formidable challenge, particularly for Medicaid, which covers approximately half of the 100,000 individuals in the U.S. with SCD.

The Financial Strain of Sickle Cell Disease on Medicaid

Gene therapy represents a revolutionary treatment for SCD, a condition that has traditionally required ongoing management through therapies like allogeneic hematopoietic stem cell transplants (HSCT). While HSCT offers a potential cure, its use has been limited due to donor availability and high toxicity. Now, gene therapy provides a much-needed alternative, but the steep price tags—approximately $2.29 million per treatment—pose a significant challenge for Medicaid programs across the country.

The latest budget impact analysis updates previous findings on how these high-cost therapies could impact 10 Medicaid plans with the highest prevalence of SCD. The study reveals that even cost-effective treatments with exceptional clinical benefits may be unaffordable for payers, particularly given the expanding Medicaid enrollment and higher-than-expected launch prices for these therapies.

Short-Term Costs vs. Long-Term Savings

For Medicaid plans, the financial challenge of gene therapy is primarily in the upfront, one-time cost of the treatment. The updated model projects that in the first year alone, gene therapy for SCD will result in an average budget impact of $65.8 million per state program, with a per-member per-month (PMPM) cost of $3.11 across the 10-state sample. Although the cost decreases over time—with the PMPM dropping to $2.08 by year five—the initial budgetary strain is a significant concern.

Despite these costs, the long-term benefits of gene therapy are undeniable. By offering a potentially curative solution, gene therapy could avert future medical expenses associated with SCD, such as hospitalizations, pain management, and ongoing treatments. The model conservatively assumes perfect effectiveness and durability, projecting that the therapy would eliminate all future SCD-related healthcare costs for treated patients. While these assumptions may not reflect real-world outcomes, they provide a glimpse into the potential for long-term savings.

Market Diffusion and Budgetary Impact

A critical factor influencing the budget impact is the market diffusion rate—the speed at which patients adopt the new therapy. The analysis assumes an annual diffusion rate of 7%, meaning that a subset of eligible Medicaid enrollees will receive the therapy each year. This rate could vary, influenced by factors such as manufacturing capacity, delivery center availability, and payer policies. Notably, if the diffusion rate falls below 4%, the PMPM cost could remain below the affordability benchmark set by prior high-cost treatments, such as sofosbuvir for hepatitis C, which generated a PMPM cost of $1.89 in 2024 dollars.

The model also reveals that 35% of Medicaid enrollees with SCD are expected to have a severe phenotype, defined by two or more severe pain episodes annually. This percentage is a key driver of cost, as patients with more severe disease are more likely to be eligible for gene therapy.

State Medicaid Plans Face Varying Impacts

The updated analysis highlights significant variability in how different state Medicaid plans will be affected. For example, in Georgia, where SCD prevalence is higher, the projected PMPM cost is $3.92 in the first year, while Florida faces a slightly lower cost of $2.50 PMPM. These variations reflect differences in both disease prevalence and state enrollment levels.

By the fifth year, the PMPM costs across all state programs are expected to decrease, driven by reduced new therapy adoption and the absence of ongoing SCD-related costs for treated patients. However, the affordability challenge remains a pressing concern, particularly in the early years of gene therapy adoption.

Balancing Access with Affordability

Medicaid plans, payers, and policymakers are now tasked with finding ways to balance the promise of gene therapies with their potential financial burden. The affordability challenge could limit patient access, echoing the struggles faced during the rollout of high-cost hepatitis C treatments.

One potential solution is the development of novel payment models, such as annuity-based approaches, which could spread the cost of gene therapy over several years, easing the immediate budgetary impact. Additionally, the Center for Medicare and Medicaid Innovation is exploring alternative payment strategies specifically for gene therapies within Medicaid, aiming to ensure access without jeopardizing the financial sustainability of state programs.

The Role of Technology in Managing Costs

As gene therapies become more prevalent, platforms like Lyfegen can play a key role in helping payers manage the financial complexities associated with these high-cost treatments. Lyfegen’s platform simplifies the process of tracking the economic impact of gene therapies, providing payers and providers with the tools they need to assess real-world outcomes, monitor costs, and adjust strategies accordingly. By leveraging technology, healthcare systems can better navigate the financial risks and ensure that patients continue to benefit from the latest innovations in care.

Unlock smarter budget management strategies with Lyfegen’s powerful tools! The Lyfegen Drug Contracting Simulator helps payers and healthcare providers model the financial impact of high-cost therapies like gene therapy for SCD, optimize payment strategies, and make informed decisions. Coupled with the Lyfegen Library’s extensive database of pricing models, you’ll be equipped to tackle the financial challenges posed by the latest innovations in healthcare.

Act Now – Book a demo of Lyfegen’s platform and discover how we can support your budgeting and contracting needs: https://www.lyfegen.com/demo

References

Meyer, K. B., Kilburg, M. M., Johnson, K. B., & Meyers, M. A. (2024). A budget impact analysis of gene therapy for sickle cell disease: an updated analysis. Blood Advances, 8(17), 4658–4666. https://ashpublications.org/bloodadvances/article/8/17/4658/517069/A-budget-impact-analysis-of-gene-therapy-for-sickle-cell-disease

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Linking Drug Prices to Success: The Power of Outcome-Based Agreements in the Ozempic Era

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Linking Drug Prices to Success: The Power of Outcome-Based Agreements in the Ozempic Era

Outcome-Based Contracts (OBAs) are set to revolutionize access to high-demand medications by linking drug prices to patient outcomes. Specifically, this model ensures that the cost of medication reflects its real-world effectiveness, thereby encouraging better healthcare and sustainable pharmaceutical spending. As outcome-based healthcare gains momentum, OBAs will further push pharmaceutical companies to focus on developing innovative, effective treatments rather than just boosting sales. GLP-1 drugs, such as Wegovy and Ozempic, which are popular for weight loss, could exemplify this shift.

Challenges in Patient Coverage

Right now, accessing GLP-1 drugs is tough due to their high costs and insurers' hesitance to cover expensive, newer treatments. Additionally, coverage decisions vary, and many employers do not include these medications in their health plans. According to Mercer’s 2025 Survey of Health and Benefits Strategies, only 42% of employers cover obesity medications, and only 3% plan to offer coverage for weight loss drugs. Therefore, employers face a tough balancing act between cost and access, especially with GLP-1 drugs like Zepbound, which costs $1,059.87—20% less than Wegovy but still pricey.

Outcome-based Healthcare: Aligning Costs with Effectiveness

As we move towards outcome-based healthcare the OBA’s that are its foundation address these challenges by tying drug costs to real-world effectiveness. Pharmaceutical companies and healthcare providers start by agreeing on specific patient health outcomes. If the medication meets these benchmarks, pricing reflects its success. If not, the price could be adjusted. Ultimately, this model promotes impactful treatments and makes life-changing medications more accessible. It is especially useful for chronic conditions like obesity, where patient outcomes are crucial measures of success.

Benefits for Healthcare Providers

OBAs also benefit healthcare providers by creating a reliable framework for prescribing new or expensive medications like GLP-1s. Providers can prescribe treatments with confidence, knowing they have a proven track record of success. In addition, this model fosters collaboration between providers and pharmaceutical companies, shifting the focus from sales to patient outcomes. As a result, this could lead to better resource allocation, improved patient satisfaction, and a more effective healthcare system overall (Mercer, 2024).

Impact on Pharmaceutical Companies

For pharmaceutical companies, OBAs drive innovation and accountability. By linking drug pricing to patient outcomes, these agreements push companies to focus on treatments that deliver real, measurable results. This shift compels them to invest in research and development, knowing that successful outcomes can boost both credibility and profits. Furthermore, OBAs not only streamline drug approvals but also offer a competitive advantage in the value-based healthcare market.

The Role of Technology

Technology platforms like Lyfegen can also play a crucial role in making OBAs more efficient. Lyfegen’s technology simplifies the complex process of planning, testing and creating OBA’s, as well as tracking rebates. Lyfegen’s all-in-one platform makes it easier to manage contracts with transparency. As demand for GLP-1 drugs continues to rise, such platforms ensure that access to these treatments is tied to proven success while keeping costs manageable.

In conclusion, OBAs could transform access to high-demand medications by aligning drug pricing with patient outcomes. Not only does this model make expensive treatments like GLP-1 drugs more accessible, but it also promotes responsible pharmaceutical spending. By leveraging platforms like Lyfegen, which simplify the process, OBAs offer a path to more equitable and value-driven healthcare.

Unlock smarter pricing and market access strategies with Lyfegen's powerful tools! The Lyfegen Drug Contracting Simulator lets you easily model various pricing scenarios, see their impact on revenue and costs, and refine your market access planning. Combined with the Lyfegen Library’s vast collection of pricing models and agreements, you'll have everything you need to make informed, strategic decisions. These tools empower payers and pharmaceutical companies to tackle pricing challenges head-on, streamline negotiations, and address payer concerns with confidence.

Act Now – Reserve Your Spot for a Live Lyfegen Demo here: https://www.lyfegen.com/demo







References

“Welcome to brighter.” Mercer, https://www.mercer.com/en-us/.  

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The BioSecure Act passes the House

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The BioSecure Act passes the House

In the US, a piece of proposed legislation with major ramifications on pharmaceutical manufacturing passed the House of Representatives, the first step in the law-making process, on September 9th. H.R.8333 - BIOSECURE Act has received bipartisan support and passed the House 306 to 81.  

The BioSecure Act alleges that some Chinese biotech companies post a national security threat, due to their affiliation with the Chinese Communist Party and their military or intelligence agencies. The draft bill mentions “military-civil fusion” being a central concern, a procedure by which under certain circumstances, Chinese companies, whether headquartered in China or not, must surrender all company data to the CCP.

Five companies were named as a “biotechnology company of concern” in the bill: BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and WuXi biologics. Companies relying on these providers have until 2032 to change suppliers, exactly the 8 years estimated to be needed to make the switch, according to a survey conducted by the Biotechnology Innovation Organization (BIO) earlier this year. The same survey found that 79% of the 124 biotech companies surveyed had at least one contract or product from a Chinese CDMO/CMO.  

It’s expected that Indian and South Korean CDMOs will see greater demand if this bill is signed into law by US President Joe Biden. In that case, there are concerns that pharmaceutical products could rise in price due to supply chain issues or that patients will lose access to important therapies. WuXi AppTec and sister company WuXi Biologics are involved in the manufacture of several approved drugs, including cell and gene therapies.  Shares of WuXi AppTec and WuXi Biologics fell 10% and 3.9% respectively on Tuesday, September 10th.  


Unlock smarter pricing strategies with Lyfegen’s tools to manage supply chain and pricing pressures. Act now and book a demo to see how Lyfegen can help optimize your market access: Book a Demo

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