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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Nico Mros, Lyfegen’s COO, explains why Lyfegen is a firm believer in the UN Sustainable Development Goals and how the company works towards Goal # 3: Good Health & Well Being.
Chances are that since the pandemic hit, you have at least heard of the UN Sustainable Development Goals. But what do these mean and how does a company like Lyfegen incorporate these in their business?
The Basics
The 17 goals were set in 2015 by the United Nations General Assembly with the intention of reaching these by 2030. The interlinked goals are a “blueprint to achieve a better and more sustainable future for all. They address the global challenges we face, including poverty, inequality, climate change, environmental degradation, peace and justice.” Each of the 17 goals outlines even more specific targets, which are constantly monitored and discussed between countries.
Lyfegen & Sustainable Development Goal #3: Good Health & Well being
Ensuring healthy lives for all and promoting well being is an essential goal, even more so since the pandemic affected millions worldwide. That said, this goal aims at improving the health of millions of people, increasing their life expectancy and reducing child and maternal mortality. In addition, it addresses persistent and emerging health issues, focusing on providing more efficient funding of health systems. This in turn, enabling millions of people worldwide to have more widespread access to the medication they need.
Specifically, Sustainable Development Goal #3 outlines the following target:
“3.8 Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”
Sounds familiar? Lyfegen’s mission is to help patients to access innovative therapies by driving value-based healthcare. In other words: Doing what’s right for patients!
The pay-for-performance model, which Lyfegen enables through their value-based contracting platform, allows for more people worldwide to have access to innovative and often expensive medication. This directly addressing the UN’s goal to “provide more efficient funding of health systems” and have more “widespread access to medication”.
With some of the leading manufacturers, payers, and care providers already using Lyfegen’s solutions, a clear step towards supporting the UN Sustainable Development Goals is taken. We are proud to be a part of this journey towards a better future!
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To build the best software ever, you also need the best team ever. We are meticulous in our selection and delighted to announce that we have found a gem for our junior quality engineer position: Alina Bratu has joined Lyfegen to improve the quality and user experience of our platform. We sat down with Alina to learn about her experience, her goals, and her aspirations.
Hello Alina, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?
Hi! I grew up in the city of Buzau in Romania and currently live in Bucharest. In college, I studied public administration and later decided to pursue a career in analytics. With the recommendation of friends, I decided to move towards software testing – which is the best decision I’ve made!
What excites you about being a junior quality engineer?
I like to view software testing as the work of a detective who follows clues that eventually help them to solve a case. It is a challenging and ever-changing line of work, and the best thing about it is that it truly impacts the delivery of quality products in a tech-driven world.
Why did you decide to join Lyfegen?
The company’s mission to make healthcare more accessible resonated with me, and I was really excited about the opportunity to work on a project that has the potential to impact the world. Working in a start-up environment with such a motivated and talented team is an amazing chance for me as a junior QA to develop my career while applying the knowledge I gained in the past year to something new and meaningful.
What do you want to learn or improve on this year?
My main goal this year is to learn more about the healthcare industry while also expanding my QA knowledge and expertise.
How will your know-how help to improve our customers’ experience of the Lyfegen platform?
As a QA engineer, I am responsible for tracking down any defects that might affect the users’ interaction with the platform. As I enjoy doing this ‘detective work’ and challenging the software in different ways, together with the developers, I can ensure that the user experience will be pleasant and the platform will look and act accordingly.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I enjoy reading fiction and self-development books and traveling as these activities help me to gain a new perspective and relax. When I’m not engaging in these hobbies, I enjoy cooking, watching movies, and playing board games with my friends.
Is there anything else you’re looking forward to outside of work this year?
I want to achieve balance and start enjoying and practicing my hobbies more. I am also planning to dust off my driving skills as I’ve postponed this for quite some time!
We are super happy to have you with us, Alina!
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Our CEO, Girisha Fernando, gives first-hand insights to what it means to be a “Mindful Leader” and how the COVID19 pandemic has impacted his leadership style.
Admit it, you clicked on this blogpost because the question itself raises endless questions. What is mindful leadership? Is it really possible to be a mindful leader in a high-paced (stressful and sleepless) startup environment? Now add the physiological stress of a pandemic to the equation.
Recently I came across one of the live lectures of Simon Sinek (if you don’t know him: google him), focusing on the topic of “mindful meditation for focused leadership”. I was pleasantly surprised to see that mindfulness and mindful leadership is gaining well-deserved attention in the workplace. Before I dive into how I live by this leadership style at Lyfegen, let’s quickly dive into what it means:
What is Mindful Leadership (without writing a Wikipedia essay)?
Mindful leadership is leading while being aware in the present, focusing (in our case) on the road to success rather than success itself, all while interacting humbly within the team and with customers.
When confronted with challenges, a mindful leader will focus on action rather than control, remaining as agile and calm as possible. After all, you cannot always control the output but can influence how the team gets to it.
Example: It unexpectedly starts raining. A controlling leader will focus on the unforeseen rain and how the team failed to get sunshine (despite it not having necessarily been in their power), micromanaging every consequent step.
A mindful leader will stay calm, gearing up on raincoats & boots for his team, enabling and helping them to adapt their strategy in order to reach sunshine.
While this is a rather simplistic way of looking at mindful leadership, you get the overall idea and how this encourages a high confidence, creative, agile, and cooperative environment.
Mindful Leadership at Lyfegen
I am by no means an expert in mindful leadership and have made my share of mistakes. My Buddhist family background has taught me a lot about mindfulness, incorporating meditation into my daily routine.
However, one would think that practicing mindful leadership is harder in a high-paced start-up environment. I disagree: it is exactly in such an environment that, despite the 14+ hour workdays, one needs to stay present. Focus on the now and continuously fine-tune how to “reach the sunshine”, learning from mistakes on the way.
When the COVID-19 pandemic hit Switzerland hard in March, our team was faced with various challenges in terms of business and speed of implementation. However, team-work was not one of them and for that I greatly attribute this leadership style.
We took everyday as it came and continued, even digitally, to work together like an orchestra in perfect harmony. When comparing to the analogy above, COVID-19 was a true thunderstorm and at the same time, it gave light to a rainbow of opportunities.
My 5 key takeaways for becoming a more mindful leader:
- Focus on the now: optimize how your team works together. The goal will follow as a direct result.
- Focus on the essential: if everything is a priority then nothing is a priority. As a leader, make sure everyone is working towards the same milestones along the road rather than mainly focusing on the goal.
- Always remain humble: treat others the way you expect them to treat you (unfortunately a lot of people in other companies know this but don’t live by it).
- Never be afraid to fail. Let go of fear to unlock maximum potential.
- Always take a moment, as a leader, for self-reflection & calm. At Lyfegen, we have a little room in our office with some bean-bags where anyone can retreat and meditate during the day. If you don’t find me at my desk, this is where you’ll find me.
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Lyfegen is excited to announce that co-founder Nico Mros is taking on a new role as Chief Customer Experience Officer (CXO). Until recently, Nico held the position of Chief Operating Officer (COO) of Lyfegen. Nico gives first-hand insights on what this shift means for him and Lyfegen.
The choice to transition into this new and exciting role is a logical one as Lyfegen continues to evolve and center all decisions and platform optimizations around the customers and patients needs.
With more than 8 years of experience in healthcare, Nico is a value-based healthcare leader with a strong skill set in project and change management. He is and stays responsible for customer experience and success at Lyfegen and leads the digitization projects for value-based agreements and real-world data insights of Lyfegen’s platform. This change helps to advance Lyfegen’s mission which is to create the most disruptive health tech company by driving the world’s transition to value-based and data-driven healthcare.
What does Nico have to say about his new title and the reasons for the change? We asked our new CXO to share his thoughts with us:
“At Lyfegen, we lived customer centricity since the beginning. This change in title comes natural and underlines for everyone what our existing customers tell us regularly – they feel understood, motivated and purpose-driven when working with us.” Nico says. “As a Co-Founder of Lyfegen I gladly accept this new title, letting go of my previous title as COO which, I honestly never liked. The choice to change this title feels obvious and necessary at the same time. I would say – just right. “
Furthermore Nico sees three main reasons for the renaming of the position which are:
1. The happiness of the customers at Lyfegen is of utmost importance, it is even a key factor for success at Lyfegen. Hence, Lyfegen wants to establish a point of view that focuses unconditionally on customer happiness, allowing to establish trusted and long-lasting relationships with clear point of contacts.
2. Besides acting directly with the customers, a customer-first environment within Lyfegen is crucial. Embedding the customer perspective in every decision, beginning with product design and ending with company strategy, allows Lyfegen to be the customer-centered company we want to be.
3. Keep it simple and understandable. While a COO can have many focuses, the Customer Experience Officer has just ONE: the customer's best possible experience and success.
Further Nico adds: “It is my firm belief that helping customers to gain success and delivering superior experience in every point of contact can be a major competitive advantage, even a unique selling point. As CXO I can guarantee this kind of philosophy from the product to personal interactions. In combination with innovative technology, this is the key to sustainable success.”
Are you ready to become a happy customer?
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Lyfegen is proud to announce that Professor Jens Grueger, PhD, has joined the company´s Advisory Board. Jens is the former Head of Global Access at F. Hoffmann-La Roche and has led country, regional, and global health economics and outcomes research, pricing, and market access organizations for SmithKline Beecham, Novartis, Pfizer and Roche.
He is a healthtech pioneer, founding his first digital disease management start-up in 1997, has been a long-time scientific reviewer for Value in Health and is the President Elect at ISPOR, the leading professional society for health economics and outcomes research. Throughout his various roles he has been promoting value-based pricing models across healthcare systems. Jens holds a PhD in Mathematical Statistics from the Technical University of Dortmund and is Affiliate Professor at the CHOICE Institute at University of Washington School of Pharmacy in Seattle, USA.
With his vast experience and expertise in healthcare, Jens will support Lyfegen to achieve its mission of facilitating and accelerating value-based healthcare to improve the life of patients.
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Introduction
Donald Trump has been elected as the 47th President of the United States. With healthcare remaining a critical issue, it’s valuable to revisit some of Trump’s past healthcare reforms and examine a particularly controversial policy that could significantly impact drug pricing in the U.S. From efforts to lower out-of-pocket costs to transparency initiatives aimed at increasing competition, Trump’s past healthcare policies reveal a complex approach to improving accessibility and affordability. Here, we also explore how these initiatives have evolved under the Biden-Harris administration and what their potential implications could mean for the future of American healthcare.
Let’s examine some of his past reforms to improve healthcare and discuss a controversial policy that could greatly alter drug pricing.
Conclusion
The evolving landscape of American healthcare policy, influenced by both Trump and Biden’s administrations, reflects an ongoing effort to address cost, transparency, and access to treatment. Trump’s initiatives laid the groundwork for healthcare cost transparency and patient protections, while the Biden-Harris administration has expanded these initiatives and introduced groundbreaking policies like Medicare drug price negotiation. As these changes continue to unfold, the healthcare industry, patients, and policymakers alike will need to adapt to new dynamics, shaping the future of healthcare in the United States.
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Introduction
Canada’s Drug Agency has recently awarded funding to multiple rare disease registries to enhance the “pan-Canadian evidence landscape.” This funding is aimed at bolstering the quality and accessibility of data that can guide regulatory and reimbursement decisions for rare disease therapies. As Canada focuses on building a comprehensive evidence base, pharmaceutical companies, payers, and stakeholders must adapt to the evolving landscape for market access and contracting. Lyfegen’s Agreements Library and Drug Contracting Simulator offer vital tools to navigate these complexities with greater precision and transparency.
Key Takeaways for Pharma and Payers
1. Strengthening Data Quality and Accessibility
• What’s Changing: The new funding will support initiatives to improve data accuracy, completeness, and accessibility within rare disease registries across Canada. This enriched data landscape will play a crucial role in guiding therapeutic decisions for rare diseases.
• Impact: With access to more comprehensive data, pharma companies and payers can make more informed decisions regarding therapy efficacy and patient outcomes. This data-driven approach is essential for adapting market strategies to address the specific needs of rare disease populations in Canada.
2. Supporting Regulatory and Reimbursement Decisions
• What’s Changing: The funding will enable the development of evidence needed to meet Health Canada’s regulatory requirements and the Canadian Agency for Drugs and Technologies in Health (CADTH) reimbursement criteria for rare disease treatments.
• Impact: A robust evidence base will accelerate the approval and reimbursement process for rare disease therapies. Pharma and payers can benefit from shorter timelines for market entry and more predictable pricing models aligned with outcomes-based agreements, ensuring that patient needs are met in a timely manner.
3. Advancing Outcome-Based Metrics and Digital Health Solutions
• What’s Changing: Emphasis on outcome-based evidence and digital health transformation within rare disease registries will promote a transparent, efficient healthcare ecosystem for these high-cost therapies.
• Impact: Outcome-based metrics provide pharma and payers the opportunity to structure contracts that reflect real-world patient outcomes, supporting more sustainable pricing models that align with the health outcomes valued by Canadian healthcare providers.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library, a vast digital repository of drug pricing agreements, offers valuable insights into historical trends and pricing models that support evidence-based contracting decisions. By leveraging over 6,000 agreements and diverse pricing models, pharma and payers can develop contracts that align with Canada’s specific regulatory and reimbursement frameworks.
2. Drug Contracting Simulator: Lyfegen’s Drug Contracting Simulator enables teams to model various pricing scenarios, allowing them to understand potential outcomes and financial risks associated with rare disease therapies. By simulating real-world conditions, stakeholders can make informed contracting decisions that support the Canadian healthcare system’s goal of data-driven, sustainable solutions for rare diseases.
Conclusion
Canada’s initiative to strengthen its rare disease data landscape marks a significant step forward in improving access to and affordability of rare disease therapies. For pharma companies, payers, and other stakeholders, this shift provides opportunities to develop innovative contracts that align with Canadian healthcare goals. Lyfegen’s Agreements Library and Drug Contracting Simulator offer the tools needed to support evidence-based decision-making, enabling healthcare players to navigate Canada’s evolving market access landscape confidently.
Book your demo today to discover how our tools can transform your approach to rare disease therapy access in Canada: https://www.lyfegen.com/demo
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Introduction
The FDA has launched an innovative pilot program to expedite patient access to essential therapies: the Split Real Time Application Review (STAR). Starting December 2, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will begin accepting a limited number of marketing applications under this new initiative. By focusing on early and continuous review processes, the STAR program aims to minimize the time between final submission and the FDA’s action date, providing faster access to treatments for patients with unmet medical needs.
Key Takeaways for Pharma and Healthcare Providers
1. Accelerated Review Process for Unmet Needs
• What’s Changing: The STAR program is designed to review applications in segments, allowing FDA reviewers to assess data in real time as it becomes available. This continuous review approach differs from traditional methods, where applications are evaluated in full only after complete submission.
• Impact: For pharmaceutical companies, this streamlined process could mean faster paths to market, particularly for therapies targeting critical, unmet needs. It emphasizes the FDA’s commitment to addressing patient needs more swiftly, which could reduce financial burdens on developers facing lengthy approval processes.
2. Collaboration Between CDER and CBER
• What’s Changing: The STAR program is a collaborative effort involving both CDER and CBER, expanding its applicability to a broad range of therapies, including new drugs and biologics. This joint approach signals the FDA’s intention to standardize and extend this model across diverse therapeutic areas.
• Impact: By involving multiple FDA centers, the STAR program encourages broader participation from biotech and pharmaceutical companies developing biologics, vaccines, and innovative therapies. For patients, it represents a promising step toward quicker access to a wider array of advanced treatment options.
3. Focus on Real-Time Data and Incremental Submissions
• What’s Changing: Unlike traditional application reviews that rely on fully completed submissions, STAR’s approach allows the FDA to review segments as they are completed. This real-time data review supports a more dynamic evaluation process and could accelerate decision-making.
• Impact: For the pharma industry, this shift may lead to shorter regulatory timelines and a more predictable approval process. By providing early feedback on submitted data, the FDA enables companies to address potential issues proactively, ultimately supporting faster market access for breakthrough therapies.
Conclusion
The FDA’s STAR program represents a transformative approach to regulatory review, one that aligns with the needs of modern healthcare. By focusing on continuous, real-time reviews, the FDA is paving the way for faster patient access to treatments that address critical health needs. For pharmaceutical companies and healthcare providers, this new pathway offers a chance to bring innovations to patients more swiftly and efficiently. As the STAR program unfolds, its success could shape the future of regulatory review, setting a new standard for timely patient access in the U.S. healthcare system.
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Introduction
Switzerland has taken steps to streamline drug approvals and make essential therapies more accessible by revising Swissmedic’s fast-track and temporary authorization procedures, effective as of October 15, 2024. These changes aim to expedite market access for crucial treatments, especially for those addressing urgent healthcare needs. Recently, the Federal Office of Public Health (FOPH) conducted a Health Technology Assessment (HTA) on Calcitonin gene-related peptide (CGRP) receptor antagonists, a class of anti-migraine drugs. The analysis determined that these drugs are more cost-effective for chronic migraine sufferers than for those with episodic migraines, influencing how they may be priced and reimbursed.
Key Takeaways for Pharma and Payers
1. Revised Fast-Track and Temporary Authorization Processes
• What’s Changing: Swissmedic has updated its fast-track and temporary authorization procedures, intended to speed up drug approval times. This revision allows for quicker access to therapies that address significant healthcare needs, supporting patients in receiving timely treatments.
• Impact: For pharmaceutical companies, these changes open up opportunities to bring their innovations to market faster, particularly for therapies that address chronic and complex conditions. With the fast-track pathway, companies can achieve quicker regulatory approval, which could help with meeting demand and advancing critical treatments for conditions like chronic migraine.
2. Pricing Adjustments Based on Cost-Effectiveness Analysis
• What’s Changing: The FOPH’s recent HTA on CGRP receptor antagonists for migraines concluded that these drugs offer higher cost-effectiveness for chronic versus episodic migraine patients. As a result, FOPH has proposed a price reduction to align with the value provided, ensuring that patients benefit from more affordable access to these treatments.
• Impact: For payers and pharma, this emphasis on value-based pricing represents a growing trend in Switzerland. Drug prices are being set based on real-world evidence and cost-effectiveness, pushing the industry towards more sustainable, outcome-driven pricing models.
3. Inclusion in the List of Pharmaceutical Specialities (LS)
• What’s Changing: FOPH re-evaluates drug prices every three years and decides if they should remain on the List of Pharmaceutical Specialities (LS), which comprises all drugs covered by basic insurance. For certain treatments, such as CGRP receptor antagonists, drugs may be included with limitations—meaning they will only be reimbursed under specific conditions.
• Impact: This conditional reimbursement approach supports more targeted healthcare spending, benefiting patients who meet specific criteria. For pharmaceutical companies, meeting these requirements is essential to ensure ongoing reimbursement and access to Switzerland’s market.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library offers a comprehensive resource of pricing agreements, enabling pharma and payers to explore pricing models that align with Switzerland’s emphasis on cost-effectiveness. With access to over 6,000 agreements, pharma teams can develop flexible, outcome-based pricing strategies that meet Swiss regulatory and reimbursement requirements.
2. Drug Contracting Simulator: The Drug Contracting Simulator provides a powerful tool for modeling various pricing scenarios. By simulating real-world conditions, stakeholders can assess the financial and clinical outcomes of fast-track approved therapies, enabling them to create tailored, data-driven agreements that reflect the FOPH’s cost-effectiveness criteria.
Conclusion
Switzerland’s recent adjustments to its fast-track drug approval processes and value-based approach to anti-migraine drug pricing underscore the country’s commitment to accessible, cost-effective healthcare. For pharmaceutical companies and payers, these changes represent an opportunity to align market access strategies with Switzerland’s evolving regulatory landscape. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential support for navigating these complexities, helping stakeholders design effective, outcome-driven agreements that meet Switzerland’s regulatory standards.
Book a personalized demo today to see how Lyfegen can transform your market access strategy under Switzerland’s new reforms: https://www.lyfegen.com/demo
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Introduction
Spain is making strides in healthcare by prioritizing education, innovation, and cost-effective care. Recently, the Spanish Council of Ministers allocated over 44 million euros from pharmaceutical sales to support various public health initiatives, focusing on two critical areas: reducing unnecessary care and enhancing Health Technology Assessment (HTA) education for healthcare professionals. These investments are aimed at improving the efficiency of healthcare delivery, reducing costs, and supporting more informed decision-making around drug use and preventive care.
Key Takeaways for Pharma and Payers
1. Funding for HTA Education and Training
• What’s Changing: Part of the allocated funds will go toward continuing education programs for healthcare professionals, specifically to improve their understanding of Health Technology Assessment (HTA). By deepening professionals’ knowledge of HTA, Spain aims to ensure that drug evaluation and therapeutic positioning are guided by evidence-based practices.
• Impact: For pharmaceutical companies, this initiative means greater scrutiny of drug effectiveness and cost-effectiveness, especially as healthcare providers become more proficient in HTA principles. Payers may also benefit, as a well-informed healthcare workforce can make better use of resources, potentially lowering overall costs.
2. De-prescription of Unnecessary Drugs and Promotion of Preventive Care
• What’s Changing: The initiative will also fund programs aimed at de-prescribing unnecessary medications to reduce healthcare costs. Alongside this, Spain is placing a stronger emphasis on preventive care, which not only improves patient outcomes but also curtails spending on unnecessary treatments.
• Impact: For pharma, this push towards de-prescription may affect demand for certain drugs, particularly those deemed low-value or non-essential. However, it also presents an opportunity to align with Spain’s focus on value-based care, potentially promoting medications that are supported by strong evidence of efficacy. For payers, preventive care investments mean a healthier population with fewer costs linked to chronic diseases, reducing the financial burden on the healthcare system.
3. Supporting Innovation Through Therapeutic Positioning Reports
• What’s Changing: Another portion of the funding will support the consolidation of therapeutic positioning reports. These reports will help evaluate and position drugs more effectively within the healthcare system, ensuring that innovative treatments are assessed rigorously before they reach patients.
• Impact: Pharmaceutical companies may see a more streamlined and transparent pathway for introducing new drugs to the Spanish market. This approach promotes fair competition and emphasizes innovation, aligning with Spain’s broader goals of delivering cost-effective, impactful healthcare solutions.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library provides access to an extensive collection of value-based agreements that can help pharma companies align with Spain’s focus on cost-effective treatments. This resource allows pharma to explore agreements and pricing models suited to Spain’s HTA-driven environment, improving the chances of successful market access.
2. Drug Contracting Simulator: With the Drug Contracting Simulator, stakeholders can simulate pricing models that reflect Spain’s emphasis on evidence-based evaluation. By assessing various pricing scenarios and outcomes, pharma companies can design agreements that align with Spain’s value-based healthcare priorities, supporting successful negotiations and reimbursement strategies.
Conclusion
Spain’s recent investments in HTA education, de-prescription, and preventive care reflect the country’s commitment to a sustainable, efficient healthcare system. For pharmaceutical companies and payers, these changes highlight the need to align market access strategies with Spain’s goals of evidence-based care and cost containment. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential tools to navigate these shifts, enabling stakeholders to create outcome-driven agreements that support Spain’s healthcare objectives.
Book a personalized demo today to see how Lyfegen can empower your market access strategy in Spain’s evolving healthcare landscape: https://www.lyfegen.com/demo