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Adding a Medicare Part E benefit to pay for cell and gene therapies

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Adding a Medicare Part E benefit to pay for cell and gene therapies

Despite their curative potential, the extraordinarily high price tags of cell and gene therapies have raised concerns about the U.S. and European healthcare systems' financial sustainability. This is especially true for recently approved treatments indicated for relatively sizable sub-populations, including multiple myeloma, beta thalassemia, sickle cell disease and different types of hemophilia.

To address these challenges, researchers have suggested creating a universal benefit in the U.S., named “Part E,” specifically designed for coverage of cell and gene therapies. Part E would technically fall under Medicare, but it would not have age- or disease-specific eligibility restrictions. In other words, it would be open to all who for whom the therapies are indicated and who may not be eligible for the Medicaid-specific model the Centers for Medicare and Medicaid Services are implementing (for information on this model, see previous microblog).

Upon the Food and Drug Administration approval of an eligible cell or gene therapy, Part E coverage and pricing would be determined centrally by CMS, whose mandate it would be to consider whether such products are deemed “reasonable and necessary” to treat the affected population, as CMS already  does when it conducts National Coverage Determinations. Part E would be financed by an earmarked tax.

Any decision to cover a product would include outcomes-based agreements, in which the net price would depend on a product's performance over time. Alternatively, CMS could negotiate subscription-like payment models as some Medicaid programs have done in the hepatitis C space. Here, CMS would be responsible for a fixed payment regardless of the number of patients treated or the volume of a drug or therapy dispensed. In other words, unlike traditional payment arrangements, payment would not scale with volume.

In negotiating pricing and reimbursement for cell and gene therapies, CMS would establish a national risk pool across the Medicare, commercial and (part of the) Medicaid markets. In turn, this would decrease the level of financial risk borne in the system.

The Lyfegen Library offers you access to one central resource with more than 4,500 public price-based agreements and 20 innovative pricing models (including subscription-like payment arrangements) which can form the basis for outcomes-based agreements to be signed under an eventual Medicare Part E. This invaluable resource has all the market research in one place to gather intelligence on novel ways to establish innovative payment systems that are uniquely designed to suit business needs of key stakeholders such as drug manufacturers and health insurers.

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A novel Medicaid model to pay for latest gene therapies

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A novel Medicaid model to pay for latest gene therapies

Newly approved gene therapies for hemophilia A and B, beta thalassemia and sickle cell disease come with multimillion dollar price tags that could bankrupt financially strapped state Medicaid programs. In many instances, the majority of patients affected by these diseases rely on Medicaid for healthcare coverage.

Last month, the federal government unveiled a novel “access model” - the Cell and Gene Therapy Access Model- designed to mitigate the costs state Medicaid programs incur when they pay for these potentially curative treatments and allow for patient access. The announcement by the Centers for Medicare and Medicaid Services marks a significant step towards addressing the access issue.

Similar to what is currently happening with a select group of prescription drugs under the Inflation Reduction Act, CMS plans to negotiate prices of these gene therapies with drug makers at the national level for all state Medicaid that decide to participate in the model. By facilitating access to potentially life-changing treatments and supporting outcomes-based agreements with manufacturers, the model has the potential to improve health outcomes and alleviate financial burdens on state Medicaid agencies.

At first, CMS intends to negotiate pricing and rebates with the drug manufacturers Vertex and bluebird bio over the next few months on behalf of state Medicaid agencies that voluntarily choose to join the program.

Bluebird bio says it has already established an outcomes-based agreement for its SCD therapy, Lyfgenia, with commercial insurers. The product is listed at $3.1 million. The company did not divulge further details. Vertex, which priced its SCD therapy, Casgevy, at $2.2 million, has declined to discuss its plans.

The fact sheet that CMS provides contains few details as to what kinds of pricing arrangements would be put in place for products such as Lyfgenia and Casgevy. Prior to deciding to participate in the model and allow CMS to negotiate prices on their behalf, Medicaid agency directors will want to know specifically what kinds of outcomes-based agreements CMS can turn to.

The Lyfegen Model & Agreements Library offers CMS and state Medicaid agencies access to one central resource with more than 4,000 public pricing agreements and 20 innovative pricing models, including outcomes-based agreements. This invaluable resource has all the market research in one place for stakeholders to gather intelligence on novel ways to establish innovative payment models that are uniquely designed to suit the needs of Medicaid payers, CMS, and drug makers alike. To further enhance the practicality of these models, our value-based contracting platform mitigates the high costs and administrative challenges involved in managing these contracts. It equips CMS, the States, and Pharma with a streamlined, cost-effective means to implement outcome-based agreements efficiently.

Medicaid directors will also seek information on methods of evidence gathering, outcomes measurement, the length of time needed to test durability of gene therapies and how this information will be provided to CMS, presumably via a patient registry. Lyfegen offers solutions to identify the right drug pricing agreements in which evidence generation and the use of patient registries are key.

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Value-based insurance design is ready for primetime

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Value-based insurance design is ready for primetime

Ostensibly, patients who have “skin in the game” through cost-sharing motivates them to be good stewards of their pharmacy benefit. But in the present system in the U.S., cost-sharing is usually not outcomes-based. It’s simply a way for insurers to defray costs onto patients, even when it poses barriers to access.

On the other hand, value-based insurance design is an increasingly popular method used by payers in which prescription drugs considered of high value have correspondingly low or no patient cost-sharing and few if any other utilization restrictions. By contrast, treatments deemed of low value are assigned higher patient cost-sharing and more conditions of reimbursement.

Optimally, this leads to greater patient adherence to high-value drugs and better health outcomes.

This method is used in the commercial sector, though until now relatively sparingly. One of the more interesting recent initiatives is the Medicare Advantage Value-Based Insurance Design Model. Remarkably, the pilot is attracting many participants. Sixty-nine Medicare Advantage plans with nearly 9 million Medicare beneficiaries are signed up, an increase of almost 50% from 2023.

Aligning patient and payer financial incentives around the value of healthcare technologies and services implies the need to gather evidence and measure health outcomes. Broader implementation of value-based insurance design will entail the expanded use of incentive-based drug formulary models in which the most cost-effective pharmaceuticals have the lowest cost-sharing and the fewest reimbursement restrictions.

The Lyfegen Library offers you access to one central resource with more than 3,500 public pricing agreements and 20 innovative pricing models, including value-based insurance arrangements. This invaluable resource has all the market research in one place to gather intelligence on novel ways to establish innovative payment models that are uniquely designed to suit your business needs.

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Re-dosable gene therapy Vyjuvek’s initially successful launch offers lessons

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Re-dosable gene therapy Vyjuvek’s initially successful launch offers lessons

The promise of gene therapy is to cure diseases associated with faulty or missing genes. Yet the high upfront costs, uncertainty surrounding long-term durability, and adverse events in some patients have often impeded market uptake.

So when the investment firm Cantor Fitzgerald said it expects a “very strong product launch” of a recently approved gene therapy made by Krystal Biotech, the topical gel Vyjuvek indicated for a rare skin disease called dystrophic epidermolysis bullosa, it caught people’s attention.

Successful commercialization of gene therapies has remained largely elusive, in part due to access hurdles erected by insurers. The current payer system is not particularly well suited to accommodate single-dose therapies for which long-term treatment efficacy, risk-benefit ratios and safety remain uncertain.

But Vyjuvek (beremagen geperparvec) is different. Unlike most current gene therapies on the market today, it’s not meant to be a one-off cure. Vyjuvek is the first and only Food and Drug Administration-approved topical gene therapy that can be re-dosed.

Listed at $630,500 annually per patient—$485,000 after mandatory government discounts in Medicaid—it is certainly expensive. But it is not nearly as high-priced as other gene therapies that have been approved in recent years.

The manufacturer has successfully pursued coverage agreements with payers in the commercial and public spaces. Further, Krystal is using an innovative payment model with its payer clients. The company is offering them a price cap of $900,000 annually per patient to account for patients who may require large numbers of vials of treatment.

The Lyfegen Library offers you access to one central resource with 3000+ public pricing agreements and 20 innovative pricing models—this invaluable resource has all the market research in one place to gather intelligence on innovative ways to establish innovative payment models, such as the one in place for Vyjuvek, that are uniquely designed to suit your business needs.

Learn more: https://www.lyfegen.com/products/model-and-agreement-library

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Sickle cell disease gene therapies are here, but how is society going to pay for them?

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Sickle cell disease gene therapies are here, but how is society going to pay for them?

On November 16th, the UK’s MHRA approved Casgevy (exagamglogene autotemcel) or exa-cel for sickle cell disease and beta thalassemia. And this month the FDA is expected to license exa-cel and lovo-cel (lovotibeglogene autotemcel), both of which attack SCD at its genetic root.

For these advanced gene therapies the challenge of access through Medicaid and other programs looms large. Medicaid will be the predominant payer for the 25,000 patients who could be eligible for these gene therapies. And it must figure out a budget-conscious way to pay for these potential one-time “cures.”

In April, the Institute for Clinical and Economic Review issued a draft report on the cost-effectiveness of exa-cel and lovo-cel. ICER noted that the proportion of patients achieving treatment success was 97% for both therapies. Even at the placeholder price of nearly $2 million per dose, ICER says both treatments could be cost-effective. But ICER cautioned that a prerequisite is their durability over time and the establishment of value-based pricing agreements between payers and manufacturers.

The Centers for Medicare and Medicaid Services is therefore pursuing a two-pronged approach to value-based pricing and reimbursement of cell and gene therapies such as exa-cel and lovo-cel.

First, a proposed rule would require manufacturers with the highest drug Medicaid spending per claim to turn over confidential information justifying their prices. CMS would post this information online, seek public comment, and compel manufacturers to “address” their pricing in a public forum.

Second, CMS is planning on “testing of payment models” based on outcomes-based agreements on behalf of all 50 state Medicaid programs, rather than having them done separately by individual states.

Innovative payment models such as these require the ability to analyze patient outcomes and negotiate prices based on those outcomes. Digital platforms, such as those offered by Lyfegen, are designed to implement value-based contracting models. This investment can yield operational efficiency, recovery of missed revenues, and provide critical access for patients to life-saving drug therapies.

Lyfegen offers solutions to identify the right drug pricing agreements, simulate and understand the financial impacts of those agreements, and automate the execution and adjudication of them—thus delivering a measurable reduction in administrative effort in rebate management and optimization.

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

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

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

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

Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions

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

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

Scaling Globally with a Leading Rebate Management Platform

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

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

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


About Lyfegen

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

About TX Ventures

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


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

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

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

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

 

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

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

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

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

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

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

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

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

Read more about the partnership in the official press release.

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

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

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

 

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

 

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

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

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

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

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

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

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

Learn more and start your free trial now

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

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

 

Basel, Switzerland, October 27, 2021

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

 

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

 

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

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

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

 

About Sympany

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

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

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

 

About Lyfegen

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

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

Contact Press: press@lyfegen.com

Contact Investors: investors@lyfegen.com

 

READ THE OFFICIAL PRESS RELEASE

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

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

 

Basel, Switzerland, August 3rd, 2021

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

 

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

 

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

 

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

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

 

READ THE OFFICIAL PRESS RELEASE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

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

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

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

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

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

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

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

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

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

However, his story doesn’t start there.  

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is the value of this partnership for healthcare payers?

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

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

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



Book an appointment at NAMD

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Study: Approval-to-reimbursement times in the US vs. Europe

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Study: Approval-to-reimbursement times in the US vs. Europe

A new study published in September, reported by the American Journal of Managed Care, compared how quickly drugs are reimbursed in select countries, including Switzerland, the United States, Germany, Japan, and the United Kingdom. The US does not have an HTA process, and some believe that drugs could get to patients faster if it did have one.

The analysis compared approval-to-reimbursement time, reimbursement rate one month post-approval, and reimbursement rate 12 months post-approval, for 290 approved drugs between 2011–2022. The analysis did not include advanced therapies, pediatric medications, or diagnostics. Data was sourced from the Food and Drug Administration, European Medicines Agency, Swissmedic, and Medicines and Healthcare products Regulatory Agency.

Results: Switzerland had the fastest approval-to-reimbursement times, averaging 6 months, followed by Germany (7.4 months), the US (9.2 months), France (12.9 months), and the UK (17.7 months).  

The country with the highest reimbursement rate after one month was France, standing at 25.9%, followed by Switzerland (9.7%), and the UK (0.7%). Neither Germany nor the US had reimbursed a drug within this timeframe.  

After 12 months, however, the trend changed. In first place was Germany, with a 74.3% reimbursement rate, followed by the US (70.7%), Switzerland (62.8%), France (49.0%), and the UK (37.1%).  

This analysis did not find that that the US was slower than Europe in fact. After one year, only Germany reimbursed more drugs than the US, and by a slight margin. The UK and France on the other hand took longer than the rest of the pack to bring drugs to market.

The full study can be found here.  

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Ongoing debate around GLP-1 drug coverage

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Ongoing debate around GLP-1 drug coverage

Payers are seeing increased costs due to the demand of GLP-1 drugs. It’s estimated that 57.4 million adults under the age of 65 could be eligible for this class of drugs, based on currently approved FDA indications. There are 36.2 million people with an obesity diagnosis alone in the US.

If 10% of eligible adults take GLP-1 medications for weight loss, a $15 increase could be seen in the per-member-per month costs. This number rises to $50 if one-third of eligible adults start taking these drugs. Zepbound, manufactured by Eli Lilly, has a list price of $1059 per month, whereas Novo Nordisk’s Wegovy costs $1349 for a one month supply. However, last month, Eli Lilly announced a major price cut for their weight loss drug. Now, a 4-week supply of their drug at 2.5 mg will cost $399, whereas 5 mg vials will cost $549.

The measure is aimed at improving patient access, while reducing the risk of counterfeit medications. This price reduction was made without changes to insurance policies, and the drugs are available through LillyDirect, the company’s online pharmacy.  

Not all insurers want to cover weight loss drugs like Zepbound, Wegovy, Mounjaro, and Ozempic, and innovative strategies are being explored to manage costs while keeping them available. One strategy is a utilization cap, which sets stricter standards for who is eligible. Another strategy is mentioned in Evernorth’s EncircleRX plan, which provides a 15% cost cap or a 3:1 savings guarantee when the medication is covered for weight loss.  

The value of these drugs is still being investigated. If these medications can provide additional health benefits, there could be additional savings for payers down the road. Of note, studies have found reductions in cardiovascular death and sleep apnea when the drugs were used for weight loss.  

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Study: Out-of-pocket drug costs increasing 5.8% per year

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Study: Out-of-pocket drug costs increasing 5.8% per year

A new study investigated how drug rebates affect out-of-pocket costs for health plan beneficiaries. Rebates lower costs for payers, but depending on the health plan, they can raise costs for the patient.  

There is a lot of secrecy surrounding the final price paid for a drug at the pharmacy, as official data on drug prices does not factor in rebates or the end price for the patient. The rebates paid by manufacturers to pharmacy benefit managers is not publicly available. The study therefore sought out to understand the relationship between rebates and the prices paid by insurers and beneficiaries.  

Results: The negotiated price, defined as the price paid by the beneficiary at the pharmacy and by the payer after rebates are taken into account, rose 4.3% from 2007 to 2020. However, the out-of-pocket price, or that paid by the patient at the pharmacy, rose 5.8% annually. Retail pharmacy prices increased 9.1% annually.

Implications: Low-income families may be especially impacted by plans with higher deductibles and lower premiums, as they are not prepared for surprise costs associated with cost-sharing. As the authors stated: “consumers with a low deductible or capped copays appear to be shielded from steep pharmacy price increases.” The main contributor to increases in out-of-pocket expenses were increasing deductibles and co-insurance payments.  

The authors emphasize that drug price transparency is important for health policy recommendations and more work needs to be done to understand drug price inflation.

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Cómo se está preparando España para la nueva normativa europea

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Cómo se está preparando España para la nueva normativa europea


Para agilizar el proceso de Evaluación de Tecnologías Sanitarias (ETS) en los estados miembros de la UE, se implementarán cambios significativos en enero de 2025. En lugar de que los fabricantes de nuevas tecnologías sanitarias deban presentar datos clínicos en cada estado miembro, según el Reglamento (UE) 2021/2282, la evaluación se llevará a cabo de manera conjunta. Los fabricantes solo necesitarán presentar las evaluaciones clínicas una vez, aunque los estados miembros aún podrán realizar evaluaciones complementarias.

Es importante destacar los 9 dominios de evaluación, de los cuales 4 son clínicos y 5 no clínicos. Las 4 evaluaciones clínicas incluyen:

  • Evaluación de la enfermedad y el panorama actual del tratamiento
  • Examen de la nueva tecnología sanitaria
  • Seguridad
  • Eficacia

Los 5 dominios no clínicos incluyen:

  • Costo y evaluación económica
  • Ética
  • Impactos organizacionales
  • Impactos sociales
  • Aspectos legales

España publicó su Proyecto de Real Decreto el 12 de agosto, que está abierto a comentarios hasta el 20 de septiembre, donde se detalla cómo se alinearán con la Directiva. Este esfuerzo involucra a la Oficina de Evaluación de la Eficiencia de los Medicamentos, que opera como una unidad funcional bajo la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

Además de las evaluaciones clínicas conjuntas en Europa, también habrá consultas científicas conjuntas. El objetivo de esta Directiva es reducir el trabajo administrativo duplicado y eliminar barreras a la innovación, al tiempo que se mejora el resultado para los pacientes.

A medida que estos cambios redefinen el panorama, es crucial que las empresas farmacéuticas y de tecnología médica se adapten rápidamente. Lyfegen puede ayudarle a mantenerse a la vanguardia con nuestras soluciones innovadoras:

  • Navegue por los nuevos requisitos regulatorios: Acceda a nuestra extensa Biblioteca de Acuerdos, que incluye más de 5,000 acuerdos de precios de medicamentos públicos y 20 modelos de precios, para asegurar el cumplimiento con los últimos estándares de ETS.
  • Optimice la toma de decisiones: Utilice nuestro Simulador de Contratación de Medicamentos para crear casos de negocio basados en datos y realizar simulaciones en tiempo real que se alineen con las nuevas directrices de ETS en España.
  • Simplifique y automatice la contratación: Nuestras soluciones de análisis de reembolsos automatizan los cálculos de reembolsos y devoluciones, asegurando precisión, transparencia y una reducción significativa de la carga administrativa.

Reserve una demostración con nosotros hoy para explorar cómo las herramientas y la experiencia de Lyfegen pueden apoyar su negocio bajo el nuevo marco de ETS en España.

Reserve su demostración aquí: https://www.lyfegen.com/demo  

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La Reforma de Medicare Parte D en 2025

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La Reforma de Medicare Parte D en 2025


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

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

Esto nos lleva a otro desarrollo importante.

Actualización del Programa de Negociación de Precios de Medicamentos de Medicare

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

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

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

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

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

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

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