Cómo se está preparando España para la nueva normativa europea
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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:
Los 5 dominios no clínicos incluyen:
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:
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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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.
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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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:
Modelos de Precios
Nuevos modelos de precios de Brasil incluyen:
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:
Atrofia Muscular Espinal Infantil:
Cáncer de Ovario:
Principales Fabricantes:
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:
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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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)
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)
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)
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)
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)
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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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:
The 5 non-clinical domains include:
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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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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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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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.
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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
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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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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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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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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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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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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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For this blog, we chose select agreements in Canada, Denmark, and Brazil. Each of these agreements vary, and we chose them so you can see how manufacturers tackle market access for different drugs and regions. Value-based contracts in these markets speed patient access while sharing financial risk between pharma and payers—a win-win situation.
Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals).
Indication: Cystic fibrosis
Country: Canada
Agreement type: Coverage with evidence development (CED), restricted coverage, outcomes-based guarantee.
Date: July 2022.
The Canadian Agency for Drugs and Technologies in Health requires a 94% price reduction on the price of Trikafta, in order for the treatment to be cost-effective. Children with cystic fibrosis between the ages of 2–5 are evaluated after 1 year, to show that they benefit from the treatment. Patients must meet a number of criteria to be eligible for treatment, making the agreement a combination of coverage with evidence development, restricted coverage, and outcomes-based.
Trikafta was already approved for use in children over 6 years of age, but conducting a clinical trial in children between two and five years of age was deemed “ethically challenging.” An uncontrolled trial however in this age group found that the treatment was well-tolerated and reduced biomarkers of the condition. To address unmet needs while acknowledging the lack of data in this patient population, a CED contract with a drastic price reduction was negotiated.
Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)
Indication: Cystic fibrosis
Country: Brazil
Agreement type: Restricted coverage, CED
Date: April 2024
The Brazil Health Ministry came to an agreement with Vertex to allow restricted access to this treatment while regularly monitoring patients at 30 days and 3 months after initiation of treatment. The agreement includes refunds is the treatment does not achieve desired clinical outcomes, aligning pricing with effectiveness.
Kalydeco (ivactafor, Vertex Pharmaceuticals)
Indication: Cystic fibrosis
Country: Denmark
Agreement type: Price-volume agreement; portfolio pricing
Date: October 2018
The Danish procurement body, Amgros, and Vertex Pharmaceuticals, came to an agreement that provides access to a portfolio of drugs for cystic fibrosis, including Orkambi (lumacaftor/ivacaftor) and future therapies, in 2019. Despite this taking place five years ago, it’s a great example of portfolio-based pricing, where payers agree to pay a set fee for a group of related drugs. The more patients that use them, the lower the price per patient.
Lynparza (Olaparib, AstraZeneca)
Indication: Ovarian cancer
Country: Brazil
Agreement type: Restricted coverage, outcome guarantee
Date: May 2022
This agreement was made between AstraZeneca and private insurers throughout Brazil. The treatment is made available without additional costs to the patient and combines features of restricted coverage with outcomes guarantees. Continued coverage is dependent on achieving partial or complete response.
Zolgensma (onasemnogene abeparvovec, Novartis)
Indication: Spinal muscular atrophy (SMA)
Country: Brazil
Agreement type: Outcome guarantee, CED, installment payments
Date: December, 2022
Novarits’ gene therapy Zolgensma is reimbursed based on the need for additional evidence, referred to as coverage with evidence development. This involves using coverage as a means to obtain real-world evidence, to make up for the lack of robust patient data coming from the pivotal trial. The agreement also divides risk between payers and manufacturers , by tying reimbursement to outcomes achieved. Because of the therapy’s great potential to improve the quality of life of children living with SMA, the agreement allows eligible patients to quickly start receiving treatment.
Want to see the library for yourself? Book a demo today here: https://www.lyfegen.com/demo
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Major changes are on the horizon for Medicare’s outpatient drug benefit in 2025, particularly following the release of negotiated drug prices under the Inflation Reduction Act. These changes will significantly impact both payers and drug makers, requiring careful planning and strategy.
One of the most critical updates is the reduction of the out-of-pocket spending cap for beneficiaries, which will decrease from $3,300 this year to $2,000 in 2025. While this cap will help patients manage their healthcare costs, it also increases the financial responsibility for payers and pharmaceutical companies.
Challenges for Specialty Drug Makers
Specialty drug makers, especially those in oncology, will face new challenges with the introduction of a 20% discount during the catastrophic phase of Medicare Part D. Since many patients will reach the $2,000 cap early in the year, this discount will apply for a significant portion of the year, impacting drug pricing strategies.
Impact on Medicare Advantage Plans
Medicare Advantage plans and stand-alone prescription drug plans will also see changes. Their liability for drug costs during the catastrophic phase will increase from 20% to 60%, as the federal government reduces its reinsurance contribution from 80% to 20%. This shift will require plans to adopt new cost management strategies.
How Lyfegen Can Help
As the Medicare Part D redesign approaches, it’s crucial for payers and drug makers to prepare effectively. Traditional cost management methods, like prior authorization, will need to be complemented by innovative approaches such as value-based pricing and market access solutions.
Lyfegen offers essential tools to support these efforts. Our Lyfegen Drug Contracting Simulator allows you to model various drug pricing scenarios, evaluate their impact on revenue and costs, and strengthen your market access strategies. By utilizing this tool, payers and pharmaceutical companies can better navigate the upcoming changes and optimize their drug market access strategies.
Start Preparing Today
Preparing for these changes is essential to maintain effective drug pricing strategies in the evolving Medicare market. Lyfegen’s solutions can assist in designing Medicare Part D formularies tailored to your needs, and in identifying the most appropriate value-based arrangements from our comprehensive database.
Don’t wait—boost your negotiating leverage now. With 2025 fast approaching, the time to act is today. Start using the Lyfegen Drug Contracting Simulator to stay ahead. Book a demo today to get started.
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Insulin is going through monumental shifts in pricing and reimbursement in the U.S. It started with the announcement of reductions in list prices by drug companies last year. First, Novo Nordisk announced plans to reduce the list prices of several of its insulin products beginning January 1, 2024. This included lowering the price of NovoLog and Levemir by at least 65%. This move was followed by a similar commitment by competitor Eli Lilly to reduce Humalog’s price, among others, and came just days before Sanofi’s announcement to decrease Lantus’s price.
Moreover, biosimilar competition is ramping up, particularly in the long-acting insulin glargine space. Rezvoglar and Basaglar are leading the way, as they gain traction on payer formularies, especially in the public Medicaid market.
And this year, owing to implementation of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services began negotiating the net prices of both NovoLog and Fiasp, with public disclosure of said prices due to be revealed by September. Payers will soon be able to use these net prices as benchmarks to leverage better deals in markets besides Medicare. Also, CMS capped monthly out-of-pocket costs of insulin products for Medicare beneficiaries at $35.
For their large populations of insulin-dependent diabetics, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.
Because both list and net prices have come down, payers will likely lose out on some portion of the rebates—which reflect the difference between gross and net price—that they had grown accustomed to getting in the past. At the same time, the increasing number of payers that are adopting a rebate-free, net cost approach to formulary design will benefit from lower net prices.
And cheaper treatment options for patients may translate into better adherence to drug regimens which in turn could lead to improved health outcomes. For payers with a long-term perspective and comparatively little churn or enrollee turnover the potential downstream cost savings could be beneficial.
Lyfegen can assist in the calculations of value for all insulin products, both short- and long-acting, in addition to the design of appropriate formularies.
If you wish to improve your negotiating leverage for insulin products you can do so with real-world simulations for effective prescription drug contracts. Discover the Lyfegen Drug Contracting Simulator, our intuitive solution for streamlining iterative, collaborative drug contracting design.
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The next wave of biosimilars, including Humira-, Eylea-, and Stelara-referenced products, is upon us.
In the U.S., 10 Humira-referenced biosimilars are on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing, as the number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary.
CVS Caremark—the largest pharmacy benefit manager in the U.S.— removed Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product). Hyrimoz appears to be the most favored biosimilar. Similar moves have been signaled by the PBM Express Scripts and its parent company Cigna to be enacted this month, but this time Simlandi will be the most preferred biosimilar.
The FDA also recently approved two interchangeable biosimilars to Eylea, which will produce additional competition for the pharma’s blockbuster as key patent protections are set to expire.
And the biologic Stelara, which was selected as one of the first 10 drugs for Medicare price negotiations, will have its net price disclosed in September of this year in addition to facing biosimilar competition in 2025. The downward pressure on Stelara's price, but also Stelara-referenced biosimilars, will likely be significant.
For their large populations of covered lives who take products in the Humira, Eylea and Stelara-related therapeutic classes, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.
Improved access to biosimilars will offer patients expanded, less costly treatment options. For uptake to happen, payers must educate healthcare providers and patients on the value of biosimilars so that they are on board, whether they are designated by the Food and Drug Administration as therapeutically interchangeable or not.
Hyrimoz and Simlandi are therapeutically interchangeable and favored due to the formulary moves by CVS Caremark and Express Scripts, respectively.
The therapeutic interchangeability designation still plays a role in the U.S., because for biosimilars to be automatically substitutable at the pharmacy they must have proven interchangeability in addition to biosimilarity. As a result, physicians have expressed a preference for biosimilars that have the designation.
But for the many biosimilars that don’t have the therapeutic interchangeability designation, to boost their adoption manufacturers and payers must overcome this de facto regulatory barrier by informing healthcare providers and patients that proof of biosimilarity is sufficient.
Lyfegen can assist in the design of formularies tailored to clients' objectives. It can also accommodate information requests concerning which value-based arrangements are the most appropriate, given the scope of its library database as well as other client services.
If you wish to improve your negotiating leverage you can do so with real-world simulations for effective prescription drug contracts.
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Vertex Pharmaceuticals may soon obtain Food and Drug Administration approval for a non-opioid analgesic, dubbed VX-548, for moderate to severe pain. But will insurers pay, given that there are so many cheap generic prescription opioids and other pain medicines on the market?
Presumably, the new non-opioid pain medication will be substantially more expensive per unit than generic opioids. Given the large numbers of patients needing pain drugs, for post-surgery, for instance, payers will need to manage the cost.
Prescription opioid medications remain a common treatment for pain despite decreases in the total number of opioid prescriptions after 2012. They’re cheap but also effective.
Should VX-548 obtain FDA approval, payers might be reluctant to cover the drug without clear and consistent evidence that the drug works as well or better than prescription opioids. Recent examples of non-opioid analgesics, including Exparel (bupivacaine) and Zynrelef (bupivacaine/meloxicam), demonstrate the kinds of reimbursement challenges drug makers may face, particularly early following their approval by the FDA.
Nevertheless, prescription opioids can be misused, abused, and diverted. In this regard, the non-opioid medicines Exparel, Zynrelef and, if approved, VX-548, do meet an important unmet need. However, not every patient will require access to more expensive medications. And so, it will be imperative to differentiate patient sub-populations by risk factors, in addition to comparing the clinical- and cost-effectiveness of non-opioid treatments to prescription opioids.
Lyfegen can assist in the calculations of value for both prescription opioid and non-opioid analgesics, in addition to the design of appropriate formularies.
Managing pain, whether acute or chronic, invariably involves a balancing act in which doctors, patients and insurers must consider appropriate forms of treatment. Proper patient stratification includes an assessment of the benefits and risks of both opioid and non-opioid medications to individual patients.
Lyfegen can navigate the different ways in which payers and drug makers negotiate contracts for pain medications. In the Lyfegen Library you can find the right model to use as a benchmark during pricing and reimbursement negotiations, which in turn will increase the chances of success. To explore strategies that enhance your ability to negotiate and implement successful pricing and reimbursement agreements for pain medications, visit the Lyfegen Library at lyfegen.com/library.
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