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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Lyfegen is building the leading contracting software solution to support value-based drug pricing arrangements. This mission requires a hands-on team to optimize all our processes. With Anca Marin joining our team as the new business analyst, we are set up for success.
We sat down with Anca to learn about her experience, her goals, and her aspirations.
Hello Anca, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?
Hello, my name is Anca. I am based in Bucharest, Romania. I graduated with a bachelor’s degree in accounting and later earned a master’s degree in business management. Before joining Lyfegen, I worked in finance for three and a half years in various industries, such banking, insurance, and ICT.
What excites you about being a business analyst?
The novelty – I believe it is a role where you never get bored as there is always a new situation, idea, or feature to build up, and it is exactly the challenge I want.
Why did you decide to join Lyfegen?
I find meaning and desire in making a change for the better. I also enjoy the work culture and the idea of being part of an innovative company while making a real impact.
What is something you want to learn or improve this year?
This is my first role as a business analyst. Therefore, this year, I want to focus on growing my knowledge and skills as a business analyst, as well as in software development and the healthcare industry.
How will your know-how help to improve our customers’ experience of the Lyfegen platform?
Given my previous roles, I would say that I was usually the one handling challenging and complex situations when dealing with customers. Through these experiences, I learned to find ways to deliver the best results for customers, and I will continue to do so. I also describe myself as being super detail-oriented – and details always make the difference.
Let’s get personal: What are your favorite things to do in your free time?
Besides my full-time job at Lyfegen, I am also a handball goalkeeper. I have been playing since I was 11 years old, and I usually go to two to three training sessions a week. However, I like sports in general, so if I am not on the handball court, I am probably playing other sports, like basketball or tennis.
I also like traveling and nature and activities away from the big cities, such as hiking, backpacking, and camping.
Is there anything else you are looking forward to outside of work this year?
Outside of work, my plans for this year are to get a motorcycle, take trips to the mountains, and make great memories!
We are proud to have you with us, Anca!
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What is ISO 27001?
ISO 27001 is one of the most widely recognized and internationally accepted information security standards. ISO 27001 defines how an organization should manage and treat information more securely, including applicable security controls.
It requires a company to have an information security management system, which means having a documented process for managing sensitive company information, processes, and IT systems.
What this mean for Lyfegen?
To achieve the certification, security compliance was validated by an independent audit firm after a rigorous process of demonstrating an ongoing and systematic approach to managing and protecting company and customer data.
Being a company that manages sensitive health-data points, it is of utmost importance to us to ensure the best tech processes and security mechanisms are in place.
At Lyfegen, we are committed to complying to the highest tech security standard, continuously improving our solutions & processes, as we move forward with the operationalisation of value-& data driven contracts for a fast & sustainable access to innovative therapies. In turn, this will benefit patients worldwide!
We are audited on yearly basis by an accredited third-party auditor to keep our ISO status valid.
Want to discover our solutions?
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Join in from anywhere in the world for three days of incredibly interesting presentations and round-tables by industry experts all around the topic of pricing and market access in healthcare.
Only a week left to go! The incredibly exciting annual World Pricing, Evidence & Market Access Congress is taking place from the 23rd to the 25th of September virtually... giving attendees the opportunity to join from anywhere in the world! This is set to be the largest and most comprehensive yet, with over 1000 attendees and more than 230 speakers!
Lyfegen's Girisha Fernando and Nico Mros will be moderating a round-table “How do you include the patient perspective in an outcomes-based contract?” on the 23rd of September at 15:05 CET. Join us! Lyfegen has a digital booth so feel free to get in touch via the swapcard app, if you are already signed up.
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Lyfegen is proud to announce that João Marques-Gomes has joined the company’s Advisory Board. João is a university professor, a scientific researcher, and a management consultant in health management.
He is the Chair of Nova University Lisbon’s institute for Value-Based Health Care (VBHC), and the professor of the semester course “VBHC” at the Nova School of Business & Economics and at the Nova Medical School.
His research has been repeatedly funded by FCT – Foundation for Science and Technology, the Portuguese public agency for scientific research. As a management consultant, João Marques-Gomes has worked for public and private hospitals in Europe and Latin America, the European Commission, the Portuguese Ministry of Health, the Portuguese Pharmaceutical Society, and for pharmaceutical companies that are among the world’s top 10 pharmaceutical companies in sales.
In the past, João worked with ICHOM – International Consortium for Health Outcomes Measurement, as part of the implementation team. He is currently the Vice-President of IBRAVS – Brazilian Institute for Value in Health. João’s actions have had an important impact on the Portuguese society.
João has co-led the Cascais Agreement movement, which gathers the 80+ major stakeholders that have publicly signed the agreement that establishes that by 2021 1/3+ of the Portuguese health care providers must have had an experience with VBHC.
Lyfegen makes it possible for innovation to always have an open door in any market in the world. Thanks to Lyfegen, millions of people will have access to innovative treatments and will enjoy much healthier lives because of this.
João Marques-Gomes
João Marques-Gomes has a PhD in economics from the University of Evora (Portugal), and an MBA from the FIA Business School (Brazil). Part of his PhD studies was done at the University College London (UK), and at the Toulouse School of Economics (France). João did his training in VBHC at ICHOM (UK), at the Harvard Business School, and at the Dell Medical School, UT Austin (USA).
With his vast experience in health economics and value-based healthcare, João will support Lyfegen to achieve its mission of accelerating value-based healthcare to improve the life of patients.
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Lyfegen is proud to announce that former New York State Medicaid Director, Jason Helgerson, has joined the Lyfegen Advisory Board.
Lyfegen, the provider of the leading value-based agreements platform for pharmacy, is proud to announce that Jason Helgerson has joined its advisory board. He brings his rich experience in value-based healthcare and more than 20 years of public service to this role. Jason’s forte is in creating effective value-based payment systems, facilitating successful cross-sector collaboration, and delivering transformative stakeholder engagement - all elements that underpin a successful value-based health and social care strategy.
“Seeing how Lyfegen uses advanced technology to solve the immense problem of drug pricing & affordability by enabling value-based agreements made my decision to join Lyfegen’s advisory board an easy one. I am excited about the value Lyfegen can deliver to healthcare payers, providers, and patients in the US and across the world,” says Jason.
In addition to serving as Lyfegen advisor, Jason is the managing director of Helgerson Solutions. He is a nationally recognized leader in value-based healthcare, healthcare & delivery system reform.
Most recently, he was New York State’s Medicaid Director, a role he held for over seven years, managing an annual budget in excess of $68 billion. During his time leading the Medicaid program in New York, Jason drove New York State’s Delivery System Reform Incentive Payment program (DSRIP). Over five years, the DSRIP program in New York created local, multi-sectoral partnerships with the aim of fundamentally restructuring the delivery of healthcare in New York & transitioning 80% of Medicaid payments into value-based arrangements. Jason became an internationally-recognized leader in public sector health care as part of his leadership of New York’s Medicaid Redesign Team, which helped reshape the program to lower costs – tackling a budget deficit – and improve health care quality.
Jason Helgerson earned a BA from American University in 1993, and his Master’s in Public Policy from University of Chicago in 1995. He also attended the London School of Economics’ Summer Graduate School Program in International Economics in 1994. He has worked in a variety of local and state governments, including the City of Milwakee, City of San Jose, CA, State of Wisconsin, and New York. He has served as the Medicaid Director for both the State of Wisconsin and the State of New York.
With vast experience in value-based healthcare, Jason will advance Lyfegen’s mission of accelerating value-based healthcare to improve patients’ lives in the USA.
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.
More about Lyfegen: https://www.lyfegen.com
Related Links:
Linkedin: https://www.linkedin.com/company/lyfegenhealth
Contact Press: press@lyfegen.com
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Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
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The Centers for Medicare and Medicaid Services is leveraging third-party health technology assessments to inform its offer price in February 2024 for the 10 drugs it has selected for price negotiations. To illustrate, the drug cost watchdog the Institute for Clinical and Economic Review published a report on the blockbuster blood thinners Xarelto and Eliquis and submitted it to CMS. Xarelto and Eliquis are two of the 10 drugs set to face the first round of Medicare price negotiations under the Inflation Reduction Act.
The ICER report modeled the comparative effectiveness of these products over generic warfarin in stroke prevention, myocardial infarction prevention and major bleeding episodes. This includes an assessment of the justifiable price premiums for the two branded products given several different cost-effectiveness thresholds. The table below shows ICER’s calculations of price premiums for Eliquis relative to the generic comparator warfarin and the branded comparator Pradaxa (dabigatran).
Drug manufacturers and payers impacted by the IRA will need to gather and evaluate this kind of information, as well as evidence from peer-reviewed articles and other sources. In turn, they must use the data to inform the price negotiation process for selected drugs but also competing products in the same therapeutic classes.
Launching soon, the Lyfegen Drug Pricing Simulator is a dynamic tool that gathers data inputs and runs real-time simulations that help users understand potential rebate, revenue, cash flow, and budget impacts for the different types and combinations of drug pricing models.
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The Inflation Reduction Act authorizes Medicare for the first time to negotiate prices at the national level for a limited subset of single-source drugs. Recently, the Centers for Medicare and Medicaid Services selected the first 10 drugs to be negotiated. The 10 high-cost drugs in the table below represent 20% of total outpatient spend in the Medicare program from June 2022 through May 2023.
Prices will be negotiated over a one-year period with an offer and counteroffer process between CMS and drug manufacturers in which maximum fair prices will be established and posted in the fall of 2024 and implemented in January 2026.
Makers of drugs selected for negotiation should consider how payers in the Medicaid and commercial markets will leverage the published MFP information when negotiating rebates. Also, manufacturers of drugs competing with those selected for negotiation should consider how payers will leverage the published MFP information when making pricing, rebating and reimbursement decisions in the Medicid and commercial markets.
At the time a drug’s negotiated MFP price is posted, competitors may react to the published price by trying to undercut it, perhaps by offering even higher rebates, which in turn may cause the manufacturer of the selected drug to lower the net price of a drug a year prior to the MFP being implemented. Also, once MFPs are posted, payers will have publicly available information on the negotiated prices for the selected drugs as well as evidence used to inform the offer and counteroffers. This may then be utilized as leverage in negotiations for competing products in the same therapeutic classes.
The Lyfegen Rebate Analytics Platform is a cloud-based software that can manage all the complexities of drug rebate administration for payers and pharmaceutical companies affected by the IRA. The data-driven platform automates identifying, calculating, and tracking rebates in a timely manner, all of which help to ensure agreement compliance and reduce revenue leakage.
Learn more: lyfegen.com/products/ara
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Prices for drugs in the U.S. continue to rise – faster than the rate of inflation – according to a Harvard study that shows nearly half of new drugs marketed now cost $150,000 or more annually. Insurers, along with consumers and regulators, are anxiously seeking ways to lower costs and to make sure patients get the treatments they need. One solution that is gaining interest is value-based pharmaceutical contracting, where costs are tied to results; the more effective a drug, the more a payer will allocate for that drug.
This model isn’t new and it has proven to be successful in Europe, where many value-based pharma contracting are showing positive results for payers, patients, and pharmaceutical companies. As a result, some companies that cater to the U.S. market are moving towards this model, although there are challenges.
Value-based contracting is especially applicable for the growing number of cell and gene therapies and other new ultra-expensive treatments. By allowing insurers and other payers to pay in installments that are dependent on patient outcomes, or even to receive refunds if the drug does not perform as expected, pharma companies are sharing the risk with payers. And there is great value in that shared risk. Payers, for example, are able to realize better patient outcomes when drugs proving to be ineffective can be replaced with more effective ones. At the same time, pharmaceutical firms are incentivized to ensure that the treatments they offer payers are truly effective ones, spurring better and more effective research.
In addition to making sure that prices reflect patient outcome, value-based contracting helps expand the amount of data associated with a treatment. With more data on the effectiveness of treatments recorded – and more tracking of patients over time – researchers will have more data to draw on when developing new treatments. That data can include details on all aspects of a patient's care and even factor in the patient's adherence to medication schedules. This data can also help pharma companies advance their research.Finally, healthcare providers benefit from value-based contracting because they will be able to get a more accurate picture of their patients' overall health situations, which will allow them to provide higher-quality care. Despite all of the advantages for all parties involved, value-based contracting has not yet been widely embraced by payers or pharma companies. A survey of 180 large employers, insurers, and unions with health benefit programs shows just 12% use value-based contracting for specialty drugs, which are usually the most expensive treatments, and fewer than 1% of organizations are using them for more common drugs.
This apparent reluctance to adopt value-based contracting is surprising because payers who have leveraged this approach are finding that their pharma costs are falling.
But challenges do remain for both payers and insurance companies in adopting value-based contracting. In order to speed up the adoption of value-based contracting, there needs to be a willingness to change business culture and long-entrenched processes; an acknowledgement that value-based contracting can expand insights and opportunities for pharma companies, but more clear incentives are necessary; and more dialogue around industry standards and regulatory flexibility that take this contracting model into account.
Industries like insurance and pharma often have institutional, or legacy, systems and processes that no longer best serve the organization and market opportunity. Innovative new opportunities like value-based contracting likely requires change–changes to systems, to processes, and to people’s day-to-day operations. Some organizations find the implementation of value-based contracting models complicated because they require analyzing patient outcomes, negotiating prices based on those outcomes, and determining which drugs should be included in the program. All of these steps require access to–and analysis of–a great deal of data, which can be a significant investment. However, there are digital platforms that are designed to implement value-based contracting without overcomplicating the process–and the investment can yield operational efficiency, recovery of missed revenues, and, most importantly, provide critical access for patients to life-saving drug therapies.
Within the industry, there is an assumption among pharma companies that there is a limited return on their investment with value-based contracting, or even the possibility of lower revenues due to lower prices. But with the transparency that value-based contracting can bring to pharma companies through real-world data from patients taking their drugs, there comes expanded opportunities to understand drug performance and patient outcomes, both of which are valuable for future drug development and marketing. A KPMG report notes another important benefit of value-based contracting–for example, such agreements can enable pharma companies access to currently highly-regulated markets that they were unable to sell in before, thus serving as a competitive advantage. In order to keep pushing pharma companies in this direction, there need to be more clear incentives that can help them with access challenges.
As value-based contracting continues to be more commonplace, it is likely that there will be more standardization within the industry and regulatory parties. However, these changes should be happening now. For example, standards are needed regarding what factors should be included when evaluating the effectiveness or value of a drug. Furthermore, value is a dynamic concept and the definition changes depending upon the viewpoint–value for a payer is different from value for pharma is different from value for a patient. The industry also needs to sort out what happens in outcome-based contracts when patients switch insurers.
Regulations can also stand in the way. While Medicaid has adopted a value-based contracting model for a small selection of drugs, most others are not covered by that arrangement. Most drugs are subject to Medicaid's Best Price policy where prices aren't connected to effectiveness or results, thus perpetuating the disconnect between price and value. The good news is that CMS, the government agency responsible for Medicaid and Medicare services, plans to extend and expand the value-based contracting model already in effect as they continue working towards the goals of improving health outcomes and lowering costs.
Change can be challenging. But as drug prices rapidly rise, the need for change has never been greater. Value-based contracting is the innovative solution that leverages the right data, at the right time, and with the right level of transparency to reduce costs, recover lost revenues, ensure more effective outcomes, help patients get healthier, and provide valuable data insights for future drugs and treatments. It's time to start implementing them.
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Advanced gene therapies that could “practically cure” patients suffering from sickle-cell disease (SCD) are just over the horizon. But they may not reach the people who need them most, many of whom are minorities with fewer financial resources and are reliant on Medicaid for their health coverage. Figuring out how to pay for their treatment looms as one of the biggest questions – both economic and ethical - facing US public health policymakers in the coming years.
Amid Medicaid’s efforts to cut spending, the dilemma of how to cover these drugs could end up increasing rancor and anger in the country – or it could spur budgetary creativity. While programs like Medicaid have traditionally filled the gap between availability and lack of affordability in treatment, the cost of SCD therapies developed by Vertex and CRISPR – estimated at nearly $2 million a dose – could quickly overwhelm even Medicaid's robust resources, especially in states that have higher rates of the disease. And this is just the beginning. As more ultra-expensive drug and cell therapies are developed for numerous conditions in the coming years, the question of how to pay for them looms large.
The American healthcare system has been long accused of discriminating against the poor and minorities – and that discrimination is likely to come into far greater focus when millions of the poorest Americans who could benefit from new therapies are unable to take advantage of them. Altogether, there are over 40,000 SCD patients on Medicare in any given year - about 60% of the estimated 100,000 victims of the disease in the US. Of the 74,817 hospitalized for sickle cell disease in 2023, 69,889 (93.4%) were African-American; on average, one of every 13 Black babies are born with sickle-cell trait (SCT), a forerunner of the disease. Even for SCD patients who can afford private insurance, the out-of-pocket cost for therapy is very burdensome. But for the poor and others who lack private health coverage, Medicaid is a singular life raft – the difference between life and a possibly very abrupt death.
Given the situation, it's likely that patient advocacy groups will make a strong bid for increased government funding. And given the issues of social justice and racism surrounding the historic lack of interest in SCD by the medical establishment, there's a good chance that funding will be forthcoming. But budgets are still budgets; if Medicaid is going to spend more on SCD therapies, it is going to have to cut other payments, especially given the strong pressure to cut Medicaid spending – both on the federal and state level, even in states where the incidence of SCD is high.
This could be the time for Medicaid to follow in the footsteps of Medicare, and implement changes in the way it pays for treatments, specifically implementing models where payment is based on patient outcome. Indeed, Medicaid has proposed doing this, but it must move much faster if it wants to help those with SCD benefit from treatments expected to be approved by the end of the year.
Medicare recently adopted a limited form of results-based drug pricing for some of its most expensive drugs. The legislation initially covers ten high-priced drugs, with the list expanded to 20 by the end of the decade. Under the program, the government will pay a price closer to that demanded by the drug’s maker if a drug does in fact significantly reduce the costs of lifetime treatment. But if a drug does not have the desired result, the cost would be significantly lower. Experts are predicting significant savings for the government.
Medicaid, through CMS/CMMI, plans to do something similar - negotiate results--based contracts for gene-based therapies on behalf of all 50 state Medicaid programs. According to government data, the lifetime cost for treating SCD patients through 64 years of age is also close to $2 million. So Medicaid would be spending roughly the same amount on each patient receiving gene-based therapies, while reducing or eliminating costs for treatment of those over 64. These outcome-based contracts, also called value-based contracts, would allow drug-makers to be paid full price only if the treatment does end up working. These contracts could also allow Medicaid to pay in installments, rather than upfront. In addition, if treatment works faster or better than expected in some patients, there could be room in these contracts for drugmakers to be paid more, or paid earlier. Drug companies and science would also benefit from the extended real-world data involved in these contracts, which track the progress of treated patients for years.
But this model is likely to come too late for many with SCD: CMS/CMMI will only be running a pilot negotiation program in 2026 at the earliest. This means that it's very possible that Medicaid will have to, at least temporarily, ignore very promising gene-based therapies that could help hundreds of thousands of people because it can't pay for them.
Meanwhile, the public pressure and demand for widespread implementation of SCD gene therapies is likely to be very high. Lives are at stake; as is correcting a historic injustice. So how will officials deal with an increase in public pressure to pay for therapies? One possibility is to appeal to the private sector for help. Infact, the NIH will be partnering with the Bill & Melinda Gates Foundation to provide some $200 million to increase the development of affordable gene therapies for SCD and HIV by providing funding to researchers to develop lower-cost therapies, and assistance to those who need treatment. Another option could be transferring unused state Medicaid allocations for SCD from states with very low incidence rates, like Idaho, to states with higher incidence rates, like Mississippi.
Regardless of the solution Medicaid adopts, there's no question that a storm has been raging for years over who gets what in the American healthcare system – and that storm is likely to strengthen as gene-based therapies for SCD become available. Given the history of how the establishment has dealt with that disease – and the people who are its biggest victims – it's likely that changes to how Medicaid pays for expensive therapies will come sooner rather than later. These changes must happen, or inequality in the American health system will only become worse as the pipeline of life-changing gene and cell therapies grows.
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