Cómo se está preparando España para la nueva normativa europea
READ MORE
.webp)
READ MORE
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
READ MORE
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
READ MORE
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
READ MORE
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
READ MORE
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
.jpg)
READ MORE
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.
Learn more about Retrospective Payment System
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
READ MORE
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.
READ MORE
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.”
Looking for a Pharmaceutical Healthcare Solution?
Get personalized advice and take the next step in optimizing your healthcare strategy with innovative solutions designed for the pharmaceutical industry.
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.
READ MORE
Basel, Switzerland, October 27, 2021
Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.
The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.
"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.
Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."
The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.
About Sympany
Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.
In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.
More about Sympany: https://www.sympany.ch
About Lyfegen
Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.
Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact Press: press@lyfegen.com
Contact Investors: investors@lyfegen.com
READ MORE
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.
READ MORE
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!
READ MORE
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!
READ MORE
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.
READ MORE
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?
READ MORE
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.
READ MORE
In a year marked by landmark legislative changes in support of value-based drug pricing, Medicare has recently received authorization to negotiate directly with drug manufacturers under the health provisions of the Inflation Reduction Act of 2022. Proponents of the law are hoping value-based pricing negotiations and inflation-based rate hike rebates for the country’s largest public healthcare payers will lower national drug costs and save U.S. taxpayers hundreds of billions over the next decade. Of course, pharmaceutical companies disagree.
In 2022, the pharmaceutical industry spent $187 million in lobbying funds fighting–unsuccessfully–to stop passage of a law that would grant Medicare negotiating authority for drug prices. The Inflation Reduction Act (IRA) of 2022 brought to life a legislative fix patient advocates, physician groups, and Democratic legislators have been trying to enact for decades as a tool to help lower prescription drug costs.
When the Medicare Part D retail prescription drug program was created in 2003, Republican legislators added the “noninterference clause” to the law to prevent Medicare from negotiating drug prices. Private health plans run the Medicare Part D drug program, but they set formularies and conduct drug price negotiations without Medicare’s input. The IRA establishes Medicare’s voice in drug price negotiations with drug manufacturers under the Drug Price Negotiation Program set to begin in 2023.
Medicare will be authorized to negotiate directly with manufacturers to find Maximum Fair Prices (MFPs) for a limited number of drugs that have no generic or biosimilar competition. The law also limits price increases year-over-year for Medicare Part D and Part B units sold (not for commercial units sold). Outside of a few product exceptions, drug makers who increase their prices more than the rate of inflation will have to pay rebates to Medicare.
Which drug prices can Medicare negotiate?
According to the new law, each year the Secretary of the Department of Health and Human Services (HHS) will select from a list of qualified single-source drugs with the highest total Medicare spending. The list of negotiation-eligible drugs will consist of the 50 costliest drugs from Medicare’s Part D program and (after 2028) the 50 costliest drugs from Medicare Part B (for drugs physician-administered on an outpatient basis).
A timeline for the changes enacted by the new legislation gives pharmaceutical manufacturers and health insurers time to adjust. The first step of the Drug Price Negotiation Program gives Medicare the authority to negotiate the 10 most expensive Part D drugs, with the negotiated price starting in 2026. The program expands to 15 eligible Part D drugs by 2027. Beginning in 2028, some Part B drugs may also be included in the list of 15 products that can be negotiated. From 2029 forward, Medicare can negotiate pricing for up to 20 Part D and Part B drugs. In total, Medicare will be able to negotiate prices on up to 60 eligible drugs by 2029.
The drugs for price negotiations under the IRA must meet certain standards, including the following:
• The drug may not have a generic substitute.
• For small-molecule drugs, it must be at least 7 years since FDA approval was granted.
• For biologics, it must be at least 11 years since FDA approval was granted.
• New drug formulations or treatments for rare diseases are excluded.
• Treatments extracted or developed from human blood or plasma are not eligible for price negotiations.
• A drug is excluded if Medicare’s total expenditures for the drug are no more than 1% of total Part D expenditures.
• Most drugs developed by small biotechnology companies are excluded.
Not surprisingly, pharmaceutical companies see the passage of the IRA as an unfavorable development and view the Medicare negotiation process as price setting, not negotiations. The HHS and manufacturers are required to negotiate and agree on MFPs for negotiation-eligible drugs; negotiations are not optional. The drug manufacturer has 30 days to accept or counter the price offer Medicare makes. If a manufacturer refuses to cooperate with HHS or fails to negotiate in good faith, HHS can impose civil monetary penalties and an excise tax for non-compliance. It’s likely the pharma industry will challenge the law in court.
What analysts predict about industry impact and cost savings
In July 2022, the Congressional Budget Office (CBO) published the latest estimate of the budgetary effects of the health provisions in the IRA. The CBO expects Medicare’s ability to negotiate drug prices will save $102 billion in public sector healthcare costs over 10 years. During the same period, the CBO estimates an additional $62 billion in savings will result from the cap on drug price hikes at the rate of inflation.
The CBO expects manufacturers will increase launch prices for their new products to counteract the IRA’s inflation-rebate provision which slows the growth of prices over time. The analysts predict this will lead to an increase in Medicaid spending because Medicaid’s rebate program, triggered by the higher launch prices, would not fully offset the price increases. The CBO says Medicare Part B may also be affected by higher launch prices since that program uses the market’s average sales price of a drug to determine its reimbursement rate.
Analysts from Moody’s Investors Service expect there will be both price reductions for some drugs and limited price growth for other drugs. Moody’s analysts warn manufacturers that show high Medicare spending–due to their high prices, not patient consumption–will feel the impact of these regulatory changes the most.
Using the data from value-based drug purchasing arrangements
Proponents of Medicare’s authorization to negotiate drug prices believe the prescription drug provisions in the IRA are a suitable compromise that allows drug manufacturers to realize a reasonable profit while increasing the health benefits, accessibility, and affordability of prescription drugs for Medicare patients. Value-based purchasing arrangements will be an important tool at the core of this compromise.
Part of the criteria the HHS Secretary will consider when negotiating an MFP is the drug’s value to health outcomes and its cost-effectiveness compared with alternative treatments. Industry experts recognize that one of the best ways to gather insights into a drug’s performance is from the data collected in the implementation of value-based drug agreements. The data can either provide real-world evidence of a drug’s cost-effectiveness and benefit to patient health outcomes or reinforce the terms of a rebate for a drug’s underperformance.
Since negotiation-eligible drugs include those approved by the FDA at least 7 years ago, performance data may already be available from past value-based drug agreements for the first round of Medicare price negotiations. Manufacturers can prepare for future negotiations with Medicare by seeking value-based purchasing arrangements for their newer products as soon as possible after FDA approval.
The Lyfegen solution
Lyfegen, an independent global software analytics company, offers a contracting platform solution that helps health insurances, pharma, medtech, and hospitals implement value-based payment models with efficiency and transparency. Lyfegen’s Platform performs real-time, end-to-end, data collection and analysis through intelligent algorithms that can operationalize any value-based pharmaceutical purchasing arrangement and provide deep insights into a drug’s performance.
By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about our services and the Lyfegen Platform, book a demo.
READ MORE
For cell and gene therapy companies to (re)enter the European market, value-based contracting will be imperative
Bluebird Bio – a biotechnology company that develops gene therapies for severe genetic disorders and cancer - has exited the European market. Evidently, this is because the company couldn’t strike deals with payers for its EMA-approved gene therapies, Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel). Payer reluctance to reimburse cell and gene therapies should send shock waves throughout the cell and gene therapy industry. Partnering with Lyfegen may be the solution for pharma and payers alike, as its platform can put users on the right track towards successful implementation of value-based arrangements.
The high price tag of cell and gene therapies has been a topic of discussion for several years and remains an unresolved challenge. Practically all approved cell and gene therapies are priced at more than $350,000 per dose. Zolgensma (onasemnogene abeparvovec-xioi) is currently the most expensive therapy ever launched, with a $2.1 million price tag.
Ideally, gene therapies address the root causes of disease with a single curative dose. If they can replace a lifetime of expensive maintenance treatments this may lead to cost savings in the long run. Yet, the high upfront costs and uncertainty surrounding long-term efficacy and adverse events have caused payer push-back.
Payer concerns are further exacerbated due to there being hundreds of cell and gene therapies in the pipeline, across a wide range of therapeutic categories, from sickle cell anemia to HIV. Should many of these therapies be approved in the coming decade the budgetary impact on payers could become overwhelming.
Payers are trying to find alternative reimbursement approaches. Examples of innovative reimbursement models include installment plans, which spread out payments, analogous to a mortgage; and value-based payments. Here, the manufacturer is paid the total cost of the therapy upfront, or in installments. Then, if the patient experiences disease progression, manufacturers must provide a partial or full refund.
One publicly known example of such an arrangement involves the gene therapy Luxturna (voretigene neparvovec). This treatment holds the promise to restore “functional vision” to certain patients with inherited blindness. After the product was approved by the FDA in 2017, the sponsor, Spark Therapeutics, set the price at $425,000 per eye. The insurer Harvard Pilgrim signed a value-based contract with Spark Therapeutics. In the deal, Harvard Pilgrim pays for Luxturna, but is refunded certain undisclosed amounts if the treatment wears off over time.
In 2019, Bluebird Bio told investors that in preparation for the possible approval of LentiGlobin - which is named Zynteglo in Europe - it was seeking what it called “installment plan contracts.” Bluebird Bio proposed that insurers would pay installments over a period of up to five years. Furthermore, after an initial charge, Bluebird Bio would only get reimbursed if the one-time infusion benefits patients.
There are, however, significant challenges in implementing these kinds of frameworks. For example, in many countries, healthcare budgets have one-to-five-year terms, which don’t suit longer payment cycles spanning a patient’s lifetime. In addition, in the U.S. there is substantial churn at insurers, as beneficiaries frequently switch plans, which lowers the potential return on investment for payers. They’re saddled with very high upfront costs without necessarily experiencing the downstream long-term benefits and cost offsets.
Looking to the future, it’s not as if drug companies appear to want to lower their price points. If its gene therapy for patients with hemophilia A is approved by the FDA this year, BioMarin is considering pricing Valrox (valoctocogene roxaparvovec) between $2 and $3 million, which would make it the most expensive treatment in the world. CEO Jean-Jacques Bienaimé asserts that insurers have indicated in preliminary discussions that they are “comfortable” with the proposed price range. Well certainly if Valrox proves durable and cures hemophilia A, the $2 to $3 million price per unit would compare favorably to the lifetime cost of treatment for hemophilia A using existing therapies, which is around $25 million.
But, in my experience talking to payers, they are still wary about high upfront costs, particularly given the uncertainties surrounding efficacy and safety, and possible durability issues. Indeed, European payer reluctance to engage with Bluebird Bio with respect to its two products indicates the need for price concessions coupled with evidence generation to establish proof of efficacy, safety, and durability.
Moving forward, a dynamic pricing structure will likely be required, using a combination of installment plans and value-based arrangements. Moreover, in the U.S. context a solution to the churn problem must be found; perhaps through enhanced portability, so that when patients change insurers there’s mutual recognition of value-based contracts across payers.
Learn more about our platform by booking a demo today:
About the Author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past 4 years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
READ MORE
Lyfegen HealthTech AG announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. Read the full press release.
BASEL, Switzerland, Sept. 1, 2020 /PRNewswire/ --
- Investors back Lyfegen's mission to make innovative healthcare therapies more accessible and affordable
- Funding secures market-leading position prior to Series A opening in 2021
Lyfegen HealthTech AG, a Swiss health technology company, announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. The additional funding was completed by private investors and the innovation program of one of Switzerland's largest banks.
Lyfegen has developed a ground-breaking software solution to accelerate value-based healthcare contracting, pioneering in a global market that could reach USD 400 billion by 2024, according to the latest estimates by research firm MarketsandMarkets™. Some of the world's 10-largest pharmaceutical and medical technologies companies are already employing Lyfegen's platform in strategic markets in Europe and South America.
Girisha Fernando, Chief Executive Office and co-founder, said: "Increasingly, healthcare systems around the world are transitioning from fee-for-service payment schemes to value-based contracting. Our solutions support the shift towards sustainable payment models that help ensure patients get the treatments they need at prices they can afford, while healthcare companies make an adequate return on their investment. We are proud to have strong partners and investors on board to support us in this challenging and rewarding mission."
The new funding, combined with the seed capital raised in April 2019 and the founders' contributions, secures the development of Lyfegen's proprietary technology as it continues to roll out its value-based contracting solution in the U.S. as well as additional European and Latin American markets in the areas of oncology, rare diseases and medical devices.
Michel Mohler, Chief Financial Officer and co-founder, added: "We continue delivering on our ambitious goals prior to opening our Series A funding in 2021. This latest additional funding confirms the growing interest of international investors in innovative healthcare technology built for a data-driven world. The funds will be used to further strengthen our leading market position as we prepare for a strong Series A funding round."
About Lyfegen
Lyfegen HealthTech AG is a Swiss healthcare technology company that is pioneering digital value-based healthcare contracting. Lyfegen's patent-pending, ground-breaking software analyses complex healthcare data sets in order to help patients access innovative therapies that focus on the healthcare outcomes that matter most to them. Lyfegen's solutions collect the patient's specific medical profile whilst ensuring the strictest data privacy protocols. Lyfegen's founders Girisha Fernando, Michel Mohler, Nico Mros, and Leon Rebolledo have combined their expertise in life sciences and financial services to create a holistic solution that enables life sciences companies, healthcare payers and healthcare providers to develop and roll out digital value-based healthcare, a market that is set to grow to USD 400 billion by 2024.
READ MORE
Each year, the NAMD (National Association of Medicaid Directors) Conference in Washington D.C. brings together the nation's Medicaid directors, leaders in the industry, and key decision-makers for a one-of-a-kind conference. With the global public health emergency, the Medicaid system and the work of Medicaid directors and their staff has never been more important. While COVID-19 has disrupted health care at all levels, it has shown the importance of more innovative payment models and the need for broader access to treatments. The shift towards value-based healthcare has become one of Medicaid’s hottest topics, with CMA and Lyfegen joining forces to present the latest value-based contracting technology at this year’s NAMD Conference.
We sat down for a brief interview with CMA’s President, Ken Romanski, and Lyfegen’s CEO, Girisha Fernando, to gain more insights into the importance of this partnership:
Thanks for joining us, Ken and Girisha. Can you tell us why this partnership is an important milestone, both for CMA and Lyfegen?
Ken: Our partnership with Lyfegen is a key milestone for CMA as we expand and complement our portfolio of technology-based solutions with extremely high-value business analytics products. Our utmost priority is to support Medicaid programs by lowering costs, while at the same time improving health outcomes for vulnerable citizens.
Girisha: This partnership sets the basis to create enormous value for our state healthcare payers and pharma. By partnering together, we enable our customers to implement value-based pharmacy agreements, actively managing the budget impact of new treatments and aligning existing formulary spending with value for beneficiaries.
For Lyfegen, this is a market entry into the U.S. – why CMA?
Girisha: CMA’s experience and technical expertise are unique. CMA is a highly recognized technology partner for State Healthcare Payers across the nation, with over 20 years of experience. Lyfegen has made a conscious decision to combine its capabilities with CMA to enable our customers to leverage the potential of value-based agreements for their pharmacy programs.
What is the value of this partnership for healthcare payers?
Ken: CMA is very excited to work with Lyfegen and our clients to deliver tens of millions of dollars in savings per year by leveraging our experience in Medicaid data management to implement this robust value-based analytics platform.
Girisha: Our customers benefit from the combined years of experience and unique expertise in data and value-based healthcare solutions. We focus on providing the first proven, scalable, highly secure value-based agreement platform for State Medicaid that allows our customers on average to avoid 54 million dollars in treatment costs that do not work and gain 7 million dollars in efficiency due to the fully automated end-to-end process. We are extremely excited to present all aspects of our partnership and present the value and opportunities our platform can bring to State Medicaid programs at NAMD.
Join CMA and Lyfegen at NAMD and understand first-hand how they can support you to realize savings for your pharmacy programs, improving patient health outcomes with their unique value-based agreement platform.
READ MORE
Beginning July 1, 2022, according to a final rule released by the U.S. Centers for Medicare and Medicaid Services (CMS), drug manufacturers will be able to report varying “best price” points (that is, multiple best prices) for a covered drug to the Medicaid Drug Rebate Program, provided they’re pursuing a value-based purchasing (VBP) arrangement that aligns pricing with outcomes-based clinical and economic measures, such as positive clinical benefits, improved quality of life, fewer physician visits, and reduced hospitalizations. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of VBPs.
Since 1990, the statutory Medicaid rebate has ensured that states obtain lower net prices for pharmaceuticals. For brand name drugs, the rebate is 23.1% of Average Manufacturer Price (AMP) or the difference between AMP and “best price,” whichever is greater. Here, best price is defined as the lowest available price to any wholesaler, retailer, or provider, excluding certain government programs, such as the Department of Veteran Affairs program. The AMP is the average price paid to drug manufacturers by wholesalers and retail pharmacies. It is proprietary and therefore not publicly available.
The best price stipulation can, however, hamper manufacturers and payers who wish to experiment with value-based arrangements. Suppose a drug manufacturer offers a payer a 100% money-back guarantee for a treatment it is launching. Then, in case the treatment being sold is ineffective, this would imply the possibility of a Medicaid best price of zero dollars. In turn, this would require that the drug be given away free of charge to every state Medicaid program.
The new rule allows manufacturers to report multiple “best prices” for a single dosage form and strength of a therapeutic, provided the prices are tied to one or more VBPs. Further bolstering the rule is proposed bipartisan legislation – Medicaid VBPs for Patients Act – which, if passed, would codify the best price rule. Importantly, the reporting of multiple best prices under different VBPs does not impact the best price for sales outside of the VBPs.
Drug manufacturers and health insurers have long considered linking reimbursement of certain treatments, particularly cell and gene therapies, to health outcomes. Here, VBPs tie reimbursement to the actual benefits that patients receive. Accordingly, VBPs alleviate the significant risk payers take on when they reimburse the high upfront costs of cell and gene therapies; treatments which still need to demonstrate durability over time. However, drug makers and insurers have been stymied by the Medicaid best price rules. The CMS rule change aims to encourage insurers to negotiate value-based outcome deals with drug makers.
For the sake of illustration, suppose a manufacturer has a $2,000,000 gene therapy to treat a rare disease, and is willing to sign a contract which stipulates that the treatment will have its intended therapeutic effect in 80% of the patients who take it. In the VBP, the manufacturer agrees to provide a payer with an 80% rebate if a patient or subgroup of patients does not respond positively to the therapy.
In the event of treatment failure, as a signatory to the Medicaid Drug Rebate Program subject to the best price requirement, the manufacturer would be forced to extend the 80% discount – the best price of the therapy in this case is $400,000 - to the entire Medicaid program, nationwide, because it represents the best price offered to all relevant U.S. purchasers.
Under the new approach in which multiple best prices can be used, as the manufacturer of a $2,000,000 gene therapy, it can structure a VBP with a payer that promises an 80% rebate in the event a patient or subgroup of patients fails to meet pre-specified clinical outcomes. But, for the drug maker the good news is that the 80% discount will not trigger an 80% best price across all Medicaid programs.
It’s hoped that beginning in July 2022 manufacturers in the U.S. will be more willing to negotiate VBPs with payers, including Medicaid. When the rule goes into effect this summer, Lyfegen will be ready to assist companies establish successful VBPs.
About the Author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
Sign up & be the first to know about INNOVATIONS
* By sending this message, you agree to our privacy policy.
