Rare Disease Therapies and the Case for Outcomes-Based Agreements
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Treatments for rare diseases, such as spinal muscular atrophy or CAR-T therapies like tisagenlecleucel, hold transformative potential for patients. Yet, they often come with significant challenges—uncertainties around long-term efficacy, high costs, and the need for tailored patient selection. Outcomes-Based Agreements (OBAs) offer a structured way to address these challenges, aligning financial risk with therapeutic outcomes. However, their implementation requires careful consideration and planning.
The Promise and Practicalities of OBAs
1. What Makes OBAs Valuable?
OBAs shift the focus from upfront costs to real-world outcomes, creating a more sustainable framework for funding innovative therapies. They enable:
• Risk Sharing: Payers and manufacturers align costs with actual therapeutic results.
• Patient-Centric Focus: Treatments are tied to measurable improvements, emphasizing value rather than volume.
• Increased Access: By mitigating cost risks, OBAs can support the introduction of high-cost therapies in resource-constrained settings.
2. Implementation Challenges
Despite their promise, OBAs are not without hurdles:
• Administrative Complexity: Managing OBA agreements involves data sharing, contract monitoring, and performance assessments—all requiring robust systems.
• Data Availability and Quality: Real-world evidence is critical, but gaps in data collection, reporting, and standardization can limit success.
• Stakeholder Collaboration: Successful OBAs require alignment between payers, manufacturers, and healthcare providers. Misaligned priorities or unclear accountability can derail agreements.
How Lyfegen Supports OBA Implementation
Learning from Global Examples
Lyfegen’s Agreements Library—featuring 6,700 public agreements and 20 pricing models from 33 countries—offers invaluable insights into how OBAs have been implemented worldwide. By analyzing these examples, stakeholders can identify models that best suit their unique challenges, reducing the trial-and-error phase of implementation.
Streamlined Scenario Analysis
The Lyfegen Drug Contracting Simulator enables stakeholders to simulate OBA scenarios using real-world data. From adherence-based contracts to outcome guarantees, the Simulator helps users:
• Assess feasibility through scenario modeling.
• Forecast financial implications with real-world inputs.
• Compare multiple pricing models to find the most suitable solution.
Simplifying Administration
Managing the administrative burden of OBAs is crucial. Lyfegen’s tools offer:
• Centralized contract management for version control and compliance tracking.
• Automated data processing to ensure performance metrics are accurately reported.
• Detailed dashboards and trend reports to facilitate collaborative decision-making.
Key Considerations for OBA Success
1. Feasibility Studies Are Essential
Not every therapy or market is suited for OBAs. Conducting thorough feasibility assessments helps determine the viability of such agreements.
2. Data Plans Need Clarity
Reliable outcomes-based contracts depend on well-defined metrics and data collection processes. Establishing these frameworks early is crucial.
3. Commitment from All Stakeholders
OBAs thrive on collaboration. Shared goals, transparent communication, and clear accountability among all parties can ensure smoother execution.
Conclusion
Outcomes-Based Agreements represent an important step forward in addressing the challenges of high-cost, high-impact therapies for rare diseases. With the right tools, insights, and preparation, healthcare stakeholders can unlock the potential of OBAs to improve access, manage costs, and focus on patient outcomes.
Discover how Lyfegen can simplify your journey to outcomes-based contracting. Schedule a demo today to explore our solutions in action.
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As value-based contracting (VBCs) becomes the standard, the role of clinical trials has shifted significantly. They are now essential not only for demonstrating safety and efficacy but also for enhancing financial performance. By creating trials that meet the criteria of VBCs, pharmaceutical companies can increase their financial gains, minimize pricing risks, and facilitate smoother negotiations with payers.
According to a report by Deloitte, aligning clinical trials with value-based pricing strategies can lead to improvements in revenue predictability and cost management by as much as 20% for drugs with high market access potential. This improvement stems from linking trial outcomes to real-world efficacy, which reassures payers and reduces the financial risk for manufacturers by basing pricing on demonstrated effectiveness
For CFOs and Pricing Directors, the Financial Impact is Clear
For CFOs and Directors of Pricing, the financial implications of optimized trials in a VBC framework are significant. When trial designs focus on outcomes that matter most to payers—like reductions in hospitalization or improved quality of life—pricing becomes more flexible, and revenue can be projected more accurately. McKinsey & Company points out that outcome-based models also provide a safeguard against pricing volatility, allowing pharmaceutical companies to stabilize revenue by tying payments to real-world performance metrics.
Efficiency Gains through Outcome-Focused Trial Design
Beyond revenue predictability, operational efficiencies are another key benefit. A focus on outcome-based trials reduces the time and resources needed to negotiate with payers, as the trial data itself becomes a compelling point in payer discussions. For Market Access Directors, outcome-driven trial designs support quicker market entry and stronger, data-backed negotiations that build payer confidence.
Lyfegen’s Platform: Streamlining Trial Optimization for Value-Based Contracts
Optimizing clinical trials for VBC is complex, but Lyfegen’s all in one platform simplifies this process. By enabling real-time pricing simulations based on clinical outcomes or financial goals, Lyfegen helps pharmaceutical companies design financially viable reimbursement contracts and align them with value-based pricing. This empowers pricing teams to model financial outcomes, enhancing both operational efficiency and contract efficiency.
Interested in learning how outcome-focused trials can support your pricing and financial goals? Lyfegen’s Simulator offers the tools you need to optimize clinical trials for success in a VBCs framework.
Schedule a demo today to explore how we can streamline your pricing and contract strategies: https://www.lyfegen.com/demo
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In value-based contracts (VBCs), clinical trial outcomes are no longer just about proving safety and efficacy—they’re now critical to driving drug pricing and market access strategies. As payers and healthcare systems shift towards outcome-based models, trial data is becoming the foundation for negotiating both price and reimbursement.
Payers are increasingly prioritizing data from real-world evidence and clinical trials for value-based arrangements. The real-world data aligns closely with payers' needs to predict the cost-effectiveness of drugs and determine coverage. For Market Access Directors and Directors of Pricing, this means that clinical trial results can either accelerate or hinder the process of getting drugs to market. Strong trial outcomes not only justify premium pricing but also provide a solid basis for faster, smoother payer negotiations.
This is especially crucial in markets where budgetary pressures and stringent healthcare regulations make it difficult for new therapies to gain market access. The ability to present data-driven evidence of a drug’s real-world impact can significantly shorten time to market and improve access.
Novartis’ Zolgensma, a gene therapy for spinal muscular atrophy, used a value-based contract with installment payments and performance guarantees, adjusting reimbursement if outcomes fell short—demonstrating flexibility for high-cost therapies in outcome-based pricing models
For CFOs, using clinical trial data means greater financial predictability. By tying pricing to outcomes, companies can secure more stable revenue streams, with lower financial risk from market variability.
Are you ready to leverage clinical trial data to improve your pricing strategy and market access? Lyfegen’s Simulator helps you model pricing scenarios based on trial outcomes, ensuring a smoother path to market and better payer alignment.
Schedule a demo today to see how we can support your pricing and market access strategies: https://www.lyfegen.com/demo
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The pharmaceutical industry is increasingly moving towards value-based contracts (VBCs), where drug pricing is tied to real-world patient outcomes rather than traditional volume-based models. This shift is transforming how clinical trials are designed and executed, and it’s profoundly impacting drug pricing strategies.
According to the IQVIA Institute for Human Data Science, value-based contracts are expected to account for a larger share of pharmaceutical revenue, with the global market projected to reach $1.3 trillion by 2026, driven by the need for more outcome-driven healthcare solutions.
For CFOs and Directors of Pricing, this shift provides new opportunities to de-risk pricing models. By linking drug prices to clinical outcomes, pharmaceutical companies can reduce financial risk while ensuring that prices reflect the actual value delivered to patients. In this context, clinical trials become critical—not just for regulatory approval, but for pricing strategy development. The data generated in trials helps justify flexible, dynamic pricing models that payers can support.
Moreover, value-based contracts align perfectly with reducing healthcare costs while improving outcomes. This model can also strengthen relationships with payers, who increasingly demand proof of value before agreeing to reimburse drugs at premium prices.
Interested in transforming clinical trial results into smarter, value-based pricing? Lyfegen’s Simulator offers the solution by streamlining pricing models and linking them directly to trial outcomes, helping you reduce risk and enhance financial predictability.
Schedule a personalized demo today to see how we can help you transform your pricing strategy: https://www.lyfegen.com/demo
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Introduction
Donald Trump has been elected as the 47th President of the United States. With healthcare remaining a critical issue, it’s valuable to revisit some of Trump’s past healthcare reforms and examine a particularly controversial policy that could significantly impact drug pricing in the U.S. From efforts to lower out-of-pocket costs to transparency initiatives aimed at increasing competition, Trump’s past healthcare policies reveal a complex approach to improving accessibility and affordability. Here, we also explore how these initiatives have evolved under the Biden-Harris administration and what their potential implications could mean for the future of American healthcare.
Let’s examine some of his past reforms to improve healthcare and discuss a controversial policy that could greatly alter drug pricing.
Conclusion
The evolving landscape of American healthcare policy, influenced by both Trump and Biden’s administrations, reflects an ongoing effort to address cost, transparency, and access to treatment. Trump’s initiatives laid the groundwork for healthcare cost transparency and patient protections, while the Biden-Harris administration has expanded these initiatives and introduced groundbreaking policies like Medicare drug price negotiation. As these changes continue to unfold, the healthcare industry, patients, and policymakers alike will need to adapt to new dynamics, shaping the future of healthcare in the United States.
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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.
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EGK uses the Lyfegen Platform to handle complex pricing models of on and off-label usage of more than 80 drugs
Basel, Switzerland - November 29, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced today that EGK-Gesundheitskasse is joining its portfolio of insurer partners to execute all of their value-based pricing contracts for high-cost drugs efficiently, securely, and transparently.
Switzerland, with the fourth-highest pharmaceutical spending per capita, spent CHF 8 Billion (8.1 billion euro) on drugs prescribed for specific diseases in the first nine months of 2022. In an effort to combat the high drug spending, Switzerland has implemented an increasing number of discount models for on and off-label drug usage over the last five years. While intending to ensure accessibility to patients at sustainable prices, the complexity of the price models leads to millions spent by insurers to monitor and adjudicate the price models, resulting in an estimated CHF two- to three-digit million range of missed rebates.
Lyfegen's software enables EGK to identify and claim rebates from 141 drug price models with 32 manufacturers, with minimal effort and maximum transparency. This includes cases of rare or chronic illnesses, promising therapies that may be used outside the approved indication, or new drugs not yet available or approved in Switzerland. Lyfegen's platform addresses the needs of Swiss health insurers for cost efficiency and digitalization, helps solve existing complexities in the system, and does its utmost to counteract high insurance premiums.
"We are delighted to support EGK and take an active role in addressing the growing complexity of drug pricing models to support sustainable access to innovative drugs and therapies in Switzerland,” said Nico Mros, CXO and Co-Founder of Lyfegen. “By focusing on making the implementation of the platform as easy as possible and being responsive to EGK, we were able to quickly present results and kickoff the collaboration to a successful start!"
“With the Lyfegen Platform, EGK is further expanding its focus on sustainability and efficiency for the benefit of our policyholders”, said Carolina Pirelli, Head of Benefits and Deputy CEO at EGK. “The ever-increasing number of pricing models for medications poses challenges for insurance companies in terms of resources and processes. With the automated processing of pricing models through the Lyfegen Platform, we are able to perfectly meet our current needs and with Lyfegen's flexibility, focus and understanding, we see ourselves in good hands.”
About Lyfegen
Lyfegen is a global healthtech SaaS analytics company providing a value-based agreement platform for drugs, therapies and devices. Health insurances, pharma, medtech companies & hospitals use the secure platform for thousands of payment models throughout Switzerland, Europe, the Middle East and North America. The Lyfegen Platform supports the negotiation and automated execution of value-based payment models cost-effectively and at scale using real-world data and machine learning. Globally renowned health insurances, hospitals, pharma & medtech companies have already implemented Lyfegen’s patent-pending platform to scale value-based payment models for drugs, therapies and devices, improving access to treatments and patient outcomes.
Lyfegen was founded by individuals with decades of experience in healthcare, pharma and technology, pioneering the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
About EGK-Gesundheitskasse
EGK-Gesundheitskasse is an SME health insurer based in Laufen (BL), Switzerland. The EGK Group comprises EGK Grundversicherungen AG (basic insurance in accordance with KVG), EGK Privatversicherungen AG (supplementary insurance in accordance with VVG) and EGK Services AG (administration). It insures around 100,000 people in basic insurance throughout Switzerland, 80% of them also have EGK supplementary insurance.
Naturalness and sustainability are part of EGK's values. It is considered a pioneer in providing unrestricted access to excellent complementary medicine. It launches and supports activities throughout Switzerland to strengthen health in a natural way.
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Lyfegen’s value-based contracting software is used by healthcare payers and leading pharma companies, including Novartis, Roche, MSD, Bristol Myers Squibb (BMS) and Johnson & Johnson
New York, NY - September 20, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, today announced an oversubscribed $8 million Series A financing round led by aMoon, with additional participation from APEX Ventures and others.
Currently, less than 2% of the health insurance population requiring specialty drugs is responsible for 51% of drug spending. The cost of specialty drugs in the US is spiraling out of control, increasing 12% from 2020 to 2021 alone, with no sign of slowing down due to the increase of cell and gene therapies expected to come to market. As a result, value-based contracting is becoming a more viable alternative for healthcare payers to only pay for drugs that actually work.
By 2025, total net spending on medicine in the US is expected to reach up to $400B. Additionally, new drugs regularly enter the market, but when pharmaceutical companies fail to agree on commercial terms with payers, patients are at risk of being denied access to life saving therapies. Lyfegen’s platform helps regulators, pharma companies and payers more easily adopt value-based payment models by digitizing the end-to-end process of data collection, anonymization and contract negotiations for all parties to agree upon drug pricing and reimbursement.
“We are excited to be announcing this funding round and to have this vote of confidence from aMoon, APEX and our other investors who understand the shift in healthcare that we are experiencing, and are supporting our efforts to expand the Lyfegen platform,” said Girisha Fernando, CEO and founder of Lyfegen. “We currently work with leading government payers, health insurance companies in Europe, the US and the Middle East, and some of the world’s largest pharma companies. Our plan now is to further expand our presence in the US, partnering with both private and public healthcare insurance companies. The move away from volume-based healthcare has never been more needed, and we are happy to play an important role in the shift to value-based contracting.”
“Lyfegen is addressing a significant market need in an industry that is changing dramatically and rapidly, and we are thrilled to help validate their efforts through our investment,” said Moshic Mor, General Partner at aMoon, and former Partner at Greylock and Greylock Israel. “During a time of healthcare budget pressures and recessions, the world needs Lyfegen’s solution now more than ever. We look forward to seeing the company, led by an incredible executive team, continue to enhance access to new drugs as they drive value-based healthcare to become increasingly mainstream.”
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 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 was founded by individuals with decades of experience in healthcare, pharma and technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
Media Contact
Yael Hart
GK for Lyfegen
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The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment.
Official Communication by KPMG on 26.10.2020
KPMG addresses the most pressing challenges the healthcare sector is facing today and in the future. Society’s desire to obtain value from the wider healthcare system is not new, however recent experience shows that there is a need to rethink and move healthcare into a new age.
Two current megatrends are: 1) the redesign of pricing for health solutions, and 2) the value of data and the importance of patient access. It is important to address both elements within the Life Sciences ecosystem, including how to innovate, how to develop successful digitalization strategies, and how to get the most out of data.
How outcome-based contracts benefit healthcare
The pricing of services and products based on outcomes or value created is another intrinsic element of the future of healthcare. Rising healthcare costs impact patient budgets and hinder access to treatments. Incentivizing positive outcomes can only benefit patients, while payers gain confidence that they are only reimbursing effective treatments. Manufacturers and providers that buy into the outcome-based model are taking an important step towards making their business more sustainable while contributing to the wider interest of the healthcare ecosystem.
One of the key issues has always been defining the factors that represent value and deciding how to measure them. To give an example, how do you measure if a patient is symptom-free and how long should the observation period last? How is the impact on those caring for an individual considered and how is the societal or economic impact assessed, e.g., can the individual go back to pursuing a career? These questions are key in any reimbursement of pricing arrangements.
Helping the healthcare community
Teaming up with Lyfegen, a healthtech company facilitating access to innovative therapies, KPMG recently published a joint whitepaper (see link below) on the application of outcome-based contracting. Girisha Fernando (CEO and Founder of Lyfegen HealthTech AG) and Martin Rohrbach (Head of Life Sciences for KPMG Switzerland) discuss how this approach can deliver value for healthcare payers, providers and patients.
The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment. The combination of knowledge, reach, and technology specific to value-based healthcare, together with proven practical experience, brings unique insights into value and data-driven pricing agreements for healthcare stakeholders. The whitepaper focuses on why outcome-based contracting can address drug access and reimbursement challenges, and how such contracts can be enabled by innovative technology. There are some clear takeaways, serving as building blocks and opportunities to engage in outcome-based contracting for the benefit of healthcare systems.
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Basel, Switzerland | April 17th, 2019 – Lyfegen HealthTech AG successfully closes its seed financing round, raising a total of CHF 750‘000. The funding was led by Swiss private investors. The funds will be used to further build Lyfegen’s value-based payments platform Lyfevalue and conduct further pilots with partners in the US, Africa, and the EU, including the UK.
Lyfegen is a healthcare technology company that has developed a ground-breaking solution to accelerate value-based healthcare, entering a market set to grow to USD 390.7 billion by 2024 according to latest market research. Its platform, Lyfevalue, collects, analyses & reconciles disparate healthcare data for the purpose of automating value-based healthcare contracting. The platform enables life sciences companies, national and private healthcare payers and healthcare providers to operationalise value-based healthcare strategies whilst benefiting from a single holistic solution for their value-based healthcare operations, visit checklistmaids.com. In addition, the platform allows for personalised healthcare by enabling patient level pricing, fostering accelerated and facilitated access to innovative treatments for patients.
“Enabling the shift to sustainable healthcare is a huge challenge, giving us at Lyfegen great purpose and we are honoured to work with individuals that truly care about making a difference for patients around the world,” said Girisha Fernando, Lyfegen’s CEO & Founder.
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Antes de unirse a nosotros en Lyfegen, David adquirió una gran experiencia y conocimientos en la industria de la salud y las finanzas, mientras perfeccionaba sus habilidades como Ejecutivo de Ventas Globales. Su curiosidad por la naturaleza humana y su amor por la humanidad es lo que alimenta su pasión por marcar la diferencia allí donde más importa.
Afincado en España y licenciado en Ingeniería Informática Con su amplia experiencia en la introducción de productos disruptivos en el mercado, ha llegado a comprender que es primordial destacar cómo las tareas diarias del usuario conectan con nuestra plataforma y guiar a través del proceso. Cuando se le pide que describa cómo ve su papel, David dice: "Todo el mundo busca algo. Mi trabajo consiste en entender qué es lo que realmente buscan". Cuándo le preguntamos qué es lo que más le gusta de su trabajo, respondió: "Bucear por debajo de las palabras y entender las necesidades de la gente,para luego conectar esas necesidades con las soluciones que Lyfegen puede aportar."
¿Qué es lo que quiere emprender este año? Siendo un aprendiz permanente, David quiere profundizar en el ciclo completo de nuestro servicio y explorar tanto la gestión de proyectos como la parte técnica. Apasionado de la buena música, pasa su tiempo libre con amigos que disfrutan de los mismos intereses. Es un creyente en la humanidad y en los actos de bondad al azar, está deseando conocer gente nueva este año de todo el mundo y tener la oportunidad de conectar experiencias y trabajar en un entorno internacional.
Girisha Fernando, Directora General de Lyfegen, está encantada de dar la bienvenida a David a nuestro equipo. 'Estamos encantados de tener a David Duro a bordo. Su inestimable pericia y amplia experiencia aportarán sin duda un inmenso valor al éxito de Lyfegen. Esto marca un hito importante en nuestros esfuerzos de expansión internacional, y estoy ansioso por anticipar las nuevas oportunidades que se avecinan'.
Desde Lyfegen, damos una calurosa bienvenida a David y esperamos crecer juntos.
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Before joining us at Lyfegen, David gained a wealth of experience and knowledge in the healthcare and finance industry while honing his skills as a Global Sales Executive. His curiosity of human nature and love for humanity is what fuels his passion to make a difference where it matters most.
Based in Spain with a qualification in Computer Engineering, David is no stranger to bringing disruptive products to the market. With his extensive experience bringing disruptive products to the market, he has come to understand that it is paramount to highlight how our platform connects to the daily tasks of the user and prefers to guide them through the process. When asked to describe how he views his role, David said, “Everyoneis looking for something. My job is to understand what it is that you are really looking for”. When we asked what he likes the most about his job, he replied “diving below the words and understanding the needs of the people, then connecting those needs with the solutions that Lyfegen can provide.”
What is something he wants to take up this year? Being a curious lifelong learner, David eventually wants to deep dive into the full cycle of our service and explore both the project management and the tech side. Passionate about good music, he spends his free time with friends who enjoy the same interests. While being a tremendous believer in humanity and random acts of kindness, he looks forward to connecting with new people this year from all around the world and having the opportunity to connect experiences and work in an international environment.
Girisha Fernando, CEO of Lyfegen, is extremely excited to welcome David into our team. 'We are thrilled to have David Duro on board! His invaluable expertise and extensive experience will undoubtedly bring immense value to Lyfegen’s success. This marks a significant milestone in our international expansion efforts, and I am eagerly anticipating the new opportunities ahead.'
From all of us at Lyfegen, we warmly welcome David and look forward to growing together!
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We are delighted to welcome our new executive assistant, Olga Dragos to the Lyfegen team! Olga joined us after making her final decision to work only with an enterprise that is directly impacting the lives of many for the better.
When we asked what fuels her purpose, she said, “The most exciting part of my profession is that I get to be key in streamlining processes that save time for our teams, which in turn helps get our product in front of more patients and increases our capacity to brainstorm new projects.”
With a solid background spanning over more than fifteen years in Executive and Administrative Support, Olga is a highly experienced professional that has worked in the US market for several corporates and small businesses in the medical insurance and transportation industries.
Originally from Belarus, Olga immigrated to the US in 1996 and further moved to Romania in 2021 where she is happily settled now with her husband and son. Being an avid traveler at heart with a passion for diverse cultures and their delicacies, Olga takes solace in both nature and outdoor activities where she’s been known to take scenic canoe rides down the river in early spring. While she has an adventurous spirit, family and cooking is her first love and creating her own recipes for them to enjoy while spending quality time together is a high priority.
When we asked what’s next for this year outside of work, we were not surprised to discover her warm philanthropic nature has steered her on the path of finding a new organization where she can volunteer her time to make a difference.
We give a very warm welcome to Olga and look forward to having her vibrant personality, and sound expertise to propel our team forward.
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After graduating in Computer Science from Babeș-Bolyai University in Romania, Andrei co-founded a digital health start-up that was laser focused on assisting patients and clinicians alike, to reach better health outcomes. His keen interest in UX design and problem solving has been the driving force behind his success in creating and building meaningful experiences and solutions in the digital healthcare arena.
However, his story doesn’t start there.
Andrei’s first interactions with design started in his high school years, where he took part in numerous competitions within the digital solutions and education space – this being where he realized his true passion for design and creating solutions that would positively impact the lives of many.
When we asked Andrei what excited him the most about joining Lyfegen as the new Senior Product Designer, his answer was clear cut – “I am allowed to be an active part in envisioning, designing and building meaningful solutions that can help users, which in turn helps patients and saves lives – this is what I find exciting and refreshing.
Joining Lyfegen has been a perfect synergy between Andrei’s personal views on digital healthcare and Lyfegen’s impactful approach in the sector – solving deep complex issues, while still remaining mindful and deeply empathetic towards its users and end goals. This is what fuels his motivation in contributing his valuable expertise in the process, while working alongside his incredible team.
While in his spare time, Andrei has been known to catch up with his video games when time allows, play board games, watch his favorite science channels, read a good book, and of course spend quality time with his friends and family, when he’s not outdoors enjoying some nature.
We warmly welcome Andrei to our team and look forward to revolutionizing the industry side-by-side.
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Each year, the NAMD (National Association of Medicaid Directors) Conference in Washington D.C. brings together the nation's Medicaid directors, leaders in the industry, and key decision-makers for a one-of-a-kind conference. With the global public health emergency, the Medicaid system and the work of Medicaid directors and their staff has never been more important. While COVID-19 has disrupted health care at all levels, it has shown the importance of more innovative payment models and the need for broader access to treatments. The shift towards value-based healthcare has become one of Medicaid’s hottest topics, with CMA and Lyfegen joining forces to present the latest value-based contracting technology at this year’s NAMD Conference.
We sat down for a brief interview with CMA’s President, Ken Romanski, and Lyfegen’s CEO, Girisha Fernando, to gain more insights into the importance of this partnership:
Thanks for joining us, Ken and Girisha. Can you tell us why this partnership is an important milestone, both for CMA and Lyfegen?
Ken: Our partnership with Lyfegen is a key milestone for CMA as we expand and complement our portfolio of technology-based solutions with extremely high-value business analytics products. Our utmost priority is to support Medicaid programs by lowering costs, while at the same time improving health outcomes for vulnerable citizens.
Girisha: This partnership sets the basis to create enormous value for our state healthcare payers and pharma. By partnering together, we enable our customers to implement value-based pharmacy agreements, actively managing the budget impact of new treatments and aligning existing formulary spending with value for beneficiaries.
For Lyfegen, this is a market entry into the U.S. – why CMA?
Girisha: CMA’s experience and technical expertise are unique. CMA is a highly recognized technology partner for State Healthcare Payers across the nation, with over 20 years of experience. Lyfegen has made a conscious decision to combine its capabilities with CMA to enable our customers to leverage the potential of value-based agreements for their pharmacy programs.
What is the value of this partnership for healthcare payers?
Ken: CMA is very excited to work with Lyfegen and our clients to deliver tens of millions of dollars in savings per year by leveraging our experience in Medicaid data management to implement this robust value-based analytics platform.
Girisha: Our customers benefit from the combined years of experience and unique expertise in data and value-based healthcare solutions. We focus on providing the first proven, scalable, highly secure value-based agreement platform for State Medicaid that allows our customers on average to avoid 54 million dollars in treatment costs that do not work and gain 7 million dollars in efficiency due to the fully automated end-to-end process. We are extremely excited to present all aspects of our partnership and present the value and opportunities our platform can bring to State Medicaid programs at NAMD.
Join CMA and Lyfegen at NAMD and understand first-hand how they can support you to realize savings for your pharmacy programs, improving patient health outcomes with their unique value-based agreement platform.
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Introduction
The UK is taking critical steps to standardize the evaluation of AI technologies in healthcare. Last year, the National Institute for Health and Care Excellence (NICE) conducted a systematic review of health economic evaluation (HEE) studies on AI-based technologies, revealing variability in study quality. To address this, NICE introduced CHEERS-AI (Consolidated Health Economic Evaluation Reporting Standards for Interventions that Use Artificial Intelligence), a set of standards aimed at study authors and reviewers. Additionally, the UK Government has announced initiatives to boost exports, benefiting industries like pharmaceuticals by removing trade barriers, with a particular focus on entering the Brazilian market.
Key Takeaways for Pharma and AI Developers
1. CHEERS-AI Standards for Consistent AI Evaluation
• What’s Changing: The CHEERS-AI standards, announced by NICE, provide a framework to improve the quality and consistency of economic evaluations for AI-based healthcare technologies. By addressing gaps in reporting and methodology, NICE aims to make these evaluations more reliable, which is essential for determining the cost-effectiveness of AI solutions in healthcare.
• Impact: For AI developers and pharmaceutical companies, CHEERS-AI sets clearer expectations for the economic evaluation of AI products. A standardized approach facilitates more consistent assessments and could expedite the integration of effective AI technologies into healthcare settings. This initiative also ensures that AI innovations meet rigorous health economic standards, which could build trust among stakeholders and speed up adoption.
2. Removing Trade Barriers for Pharmaceutical Exports
• What’s Changing: The UK Government’s plan to eliminate certain trade barriers is expected to enhance export opportunities across several industries, with a focus on easing access to Brazil’s pharmaceutical market. This initiative includes a £2.3 million fund to support trade growth, with an anticipated boost of £5 billion over the next five years. For the pharmaceutical industry, this includes efforts to improve Brazil’s drug evaluation processes, particularly for cancer treatments.
• Impact: For UK pharmaceutical companies, the removal of trade barriers presents an opportunity to expand into Brazil—a significant and emerging market. Streamlined access to Brazil could lead to increased revenue and greater market diversity. Moreover, improving Brazil’s evaluation standards for cancer drugs aligns with the global shift toward ensuring drugs meet consistent, evidence-based criteria, promoting patient access to high-quality therapies.
Conclusion
The UK’s efforts to standardize the economic evaluation of AI technologies in healthcare and remove international trade barriers represent a proactive approach to fostering innovation and expanding market access. NICE’s CHEERS-AI standards provide the healthcare industry with a reliable framework for assessing AI interventions, setting a high standard for future health economic evaluations. Additionally, the government’s trade initiatives offer UK pharmaceutical companies promising avenues for growth in markets like Brazil. Together, these measures underscore the UK’s commitment to advancing healthcare technologies and supporting the global reach of its pharmaceutical industry.
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Introduction
Italy’s recent healthcare reform introduces a transformative approach to tackling longstanding challenges such as healthcare workforce shortages, regional disparities, and the modernization of infrastructure. As Italy prepares for these changes, pharmaceutical companies, payers, and other stakeholders will need to adapt their strategies for market access and contracting. Lyfegen’s Agreements Library and Drug Contracting Simulator provide essential tools to navigate these evolving demands with precision and efficiency.
Key Takeaways for Pharma and Payers
1. Workforce Expansion and Regional Equity
• What’s Changing: The reform aims to attract healthcare professionals to underserved regions and improve patient access across Italy.
• Impact: Pharma and payers will likely see more consistent healthcare delivery across Italy, leading to greater access to therapies. This broader market reach emphasizes the need for adaptable, data-driven contracting models.
2. Updated Training and Enhanced Medical Infrastructure
• What’s Changing: Italy’s healthcare workforce will benefit from enhanced training and infrastructure improvements, which could accelerate the adoption of innovative therapies.
• Impact: Pharma companies may experience streamlined pathways for introducing new treatments, while payers will benefit from a more robust healthcare system capable of supporting outcome-based agreements.
3. Digital Transformation and Outcome-Based Metrics
• What’s Changing: Emphasis on digital health infrastructure and outcome-based measures will create a more transparent and efficient healthcare environment, particularly for high-cost therapies.
• Impact: This focus on measurable outcomes provides pharma and payers with an opportunity to adopt innovative contracts based on real-world evidence, ensuring alignment with healthcare goals while managing financial risk.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: The world’s largest digital repository of drug pricing agreements, the Agreements Library offers over 6,000 public agreements and 20 unique pricing models from 33 countries. With data on more than 550 drugs and access to historical pricing trends, pharma and payers can confidently explore and tailor pricing agreements to the specific demands of Italy’s regions, ensuring that new market strategies meet regulatory requirements and regional healthcare needs.
2. Drug Contracting Simulator: The Drug Contracting Simulator enables teams to create simulations for various pricing models, from value-based to outcome-based. With the ability to run real-world scenarios and compare results, stakeholders can craft business cases that reflect real-world complexities and financial outcomes. This empowers teams to make informed contracting decisions, achieve faster negotiations, and support Italy’s focus on sustainable, transparent healthcare.
Conclusion
Italy’s healthcare reform marks a critical step toward a more equitable and efficient healthcare system. For pharmaceutical companies, payers, and other healthcare players, this shift opens doors to new contracting possibilities and requires a deep understanding of innovative market access models. Lyfegen’s Agreements Library and Drug Contracting Simulator offer the tools needed to stay competitive, adapt to regulatory shifts, and deliver patient-centric solutions that align with Italy’s healthcare goals.
Book your demo today to see how the right tools can transform your approach under this new reform: https://www.lyfegen.com/demo
Sources
• Anaao Assomed. (2023). Healthcare reform in Italy: Key changes and impacts on the medical workforce. Retrieved from https://www.anaao.it/content.php?cont=41425
• Quotidiano Sanità. (2023). Italy’s healthcare reform: Implications for science and pharmaceuticals. Retrieved from https://www.quotidianosanita.it/scienza-e-farmaci/articolo.php?articolo_id=125281
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Gene therapies are redefining modern healthcare, offering the potential to address the root causes of genetic disorders through targeted treatment rather than symptom management. For patients, this represents a profound improvement in quality of life, while for payers and pharmaceutical companies, gene therapies introduce new challenges in contract structuring, reimbursement, and financial planning. In this blog, we’ll explore how gene therapies are reshaping patient outcomes, impacting payer expectations, and how Lyfegen’s solutions, such as the Agreements Library and Drug Contracting Simulator, are enabling pharma and payers to navigate this evolving landscape.
A New Horizon for Patient Outcomes with Gene Therapies
Gene therapies bring transformative potential to patient care by addressing the underlying genetic causes of diseases. Unlike traditional therapies that require ongoing treatment, many gene therapies promise long-lasting effects from a single intervention. This shift enables patients to move away from chronic management, experiencing a better quality of life, fewer medical interventions, and improved long-term health.
Why It Matters: For patients with rare genetic conditions, gene therapies offer a new chance at health. However, the high upfront costs and uncertain long-term efficacy make it challenging for payers to determine optimal reimbursement models. Balancing patient access with financial sustainability is crucial as healthcare systems adjust to the realities of high-cost gene therapies.
Payer and Pharma Contracting: Managing Uncertainty with Precision
With the high cost of gene therapies, payers and pharmaceutical companies face increased pressure to implement contracts that account for uncertain outcomes and long-term impact. Traditional pricing models often fall short in accommodating these complexities. Today, payers need new contracting frameworks that incorporate clinical and financial outcomes over extended timeframes, while pharma companies seek efficient ways to communicate the value and manage the financial implications of these therapies.
Shifting Expectations in Payer-Pharma Relations: To mitigate risk, payers and pharma companies are exploring innovative drug contracting models that tie payment to therapeutic outcomes. However, implementing such models requires robust data, effective scenario planning, and tools that support transparent, collaborative processes across stakeholders.
Lyfegen’s Role in Optimizing Drug Contracting for Gene Therapies
To address the complexities of gene therapy contracts, Lyfegen offers tailored tools that support payers and pharma companies through every stage of the contracting process. Our Agreements Library and Drug Contracting Simulator streamline research, analysis, and contract execution, allowing stakeholders to engage in informed, data-driven decision-making.
1. The Lyfegen Agreements Library: As the world’s largest digital repository of drug pricing agreements, the Lyfegen Library gives users access to over 6,000 public agreements and 20 unique pricing models.
• Accelerate Effective Contracting: With a comprehensive database covering over 550 drugs and real-world agreements from 33 countries, payers and pharma teams can find, compare, and analyze pricing models that meet specific market and therapeutic needs.
• Support Pragmatic Contracting: By exploring data from more than 150 drug manufacturers, users can identify successful contracting models and structures that match the challenges of gene therapies. This ensures informed choices that support sustainable access to innovative treatments.
2. Lyfegen Drug Contracting Simulator: Our simulator enables pharma and payer teams to model various drug pricing scenarios, providing real-time insights to drive negotiations.
• Accelerate Negotiations with Real-World Simulations: The simulator allows users to run multiple pricing models, delivering scenario-based insights that reflect real-world financial implications. This helps pharma and payers create compelling business cases and select pricing models that suit both patient needs and budget constraints.
• Improve Collaboration Across Teams: With flexible, secure access, the Drug Contracting Simulator enables local and global teams to work collaboratively. Users can save and share simulations, compare scenarios, and make evidence-based decisions quickly.
By equipping stakeholders with essential tools for research and analysis, Lyfegen’s solutions reduce the complexities of payer-pharma contracting, allowing stakeholders to navigate the high stakes of gene therapy reimbursement effectively.
Shaping the Future of Gene Therapy Access with Lyfegen
Gene therapies represent a future of precision medicine and improved patient outcomes. Yet, making this future accessible requires innovative approaches to contracting and reimbursement. By leveraging Lyfegen’s solutions, payers and pharma companies can structure contracts that maximize patient access to these therapies while managing financial risk.
Lyfegen is committed to supporting stakeholders as they navigate the challenges of gene therapies, providing solutions that bring real-world data, evidence-based simulations, and efficient contracting processes to the forefront. With the Lyfegen Agreements Library and Drug Contracting Simulator, payers and pharmaceutical teams have the tools they need to secure the future of gene therapies in a way that’s both financially sustainable and patient-centered.
To explore how Lyfegen’s Agreements Library and Drug Contracting Simulator can support your contracting needs for gene therapies, connect with our team or schedule a demo today.
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With rising healthcare costs around the world, value-based care (VBC) is a paradigm shift poised to make healthcare more accessible and affordable. It’s a departure from the traditional fee-for-service (FFS) model, which pays providers each time they perform a service. In this type of care model, providers are rewarded for the volume of care they provide, rather than the quality.
Value-based care shifts the priority of healthcare to patient wellbeing and patient centeredness. Value-based care agreements incentivize healthcare stakeholders to achieve better outcomes, and may even penalize excessive spending or unnecessary procedures.
There are many approaches to providing and paying for value-based care, and they will be the subject of this article. Let’s take a broad look at what VBC is, its benefits, its challenges, and future directions.
Why value-based care is needed
Healthcare costs are rising across the globe, and patients are bearing the brunt of it, with out-of-pocket healthcare costs rising faster than costs to insurers. Drugs are also becoming more expensive, and insurers and employers are concerned about high-cost claims. Many insurers are refusing to cover expensive treatments, like cell and gene therapies, or GLP-1 agonists.
Although the fee-for-service model is still important, value-based care can fill the gaps to bring medicines to patients faster. Using cell and gene therapies as an example, VBC could prevent patients like Forrest VanPatten from dying during the process of jumping from insurer to insurer, hoping to find one that will cover the treatment.
Alternative payment models (ABMs), a core element in the delivery of VBC, help these therapies get to market faster, by lowering the financial burden of expensive therapies. This could include installment payments, among several types of value-based contracts.
Although pharmaceutical companies continue to improve patient outcomes by developing more effective medicines, healthcare costs include more than the price of the drugs. The total cost of care must also be managed and requires a close evaluation of how care is delivered to the patient.
Ultimately, value-based care is a strategy to deliver a better healthcare experience to the patient while utilizing resources more effectively. It is feasible to reward healthcare practitioners for improving patient health, whether it be keeping them out of the hospital, reducing their reliance on medication, or becoming completely disease-free. But there are many challenges in implementing these models, as we’ll discuss.
The types of value-based care
There are many forms of value-based care, and different terms are used interchangeably. Use the glossary table below while reading this article to better understand.
VBC can involve the following:
There are many ways medicine and care can be delivered to people in ways that support better outcomes. Let’s summarize the models above.
Effective care delivery
The accountable care organization (ACO) is a group of clinical entities and providers that in synchronization, aim to deliver efficient and cost-effective healthcare to patients. If the efforts are successful, saved costs can be distributed, providing an incentive to avoid unnecessary procedures. A key component of ACOs is that financial responsibility lies on caregivers. ACOs were a central component of the Affordable Care Act in the United States, and generally describe the American healthcare system. However in several European countries, similar models providing integrative care do exist.
This type of integrated care model may still rely on the fee-for-service model, but aim to reduce the volume of care.
Risk-sharing agreements
Several value-based drug pricing agreements foster risk-sharing between the manufacturer of the drug and the payer. The following are examples:
Many of the above terms overlap with each other. What they have in common is that they can address clinical uncertainty—payers may be reluctant to reimburse therapies with limited clinical evidence from the pivotal trial. However, to ensure patient access, risk-sharing agreements are way to allow patients to be treated for a steep discount, while gathering real-world evidence.
In a pay-for-performance agreement, payers will only have to pay for the treatment if anticipated patient outcomes are achieved. Several hybrid iterations of this type of agreement exist, including milestone payments, where payers receive rebates if disease progresses.
You can find specific examples of these kinds of agreements in our Agreements Library.
Population-based payments
Population-based payments facilitate integrative care delivery. They involve payments for either a specific condition, or for the care of an entire patient. However, unlike an ACO, population-based payments are value-based and are not based on the fee-for-service model.
The Health Care Payment Learning & Action Network (HCP LAN) defines population-based payments as a “single payment that encompasses a broad array of services.” This is also more widely referred to as capitation. Capitation can apply to the care for a specific condition, or the entire continuum of care.
NHS England defines capitation as “paying a provider or group of providers to cover the majority (or all) of the care provided to a specified population across different care settings. The regular payments are calculated as a lump sum per patient.”
Capitated payments typically involve a per-member-per-month fee. They provide predictable revenue for hospitals and providers while incentivizing them to provide quality care.
Restricted access
Another way to address clinical uncertainty is to limit who can receive treatment as real-world evidence is being gathered. By refining the eligibility criteria, patients most-likely to benefit from the treatment can receive access.
What are some of the challenges of implementing value-based care?
There are several challenges to implementing value-based care. They include:
One challenge with VBC is deciding on patient eligibility. Insurers may choose to cover a very select group of patients, denying others who may need treatment coverage, to ensure that they are incentivized accordingly. This leads to another challenge: choosing the right outcomes to measure. In the fee-for-service model, billing is tied to the condition and medication being prescribed, whereas in a value-based contract, financial incentives are tied to outcomes measured by a healthcare provider.
The chosen outcomes must be evidence-based and tracked accordingly. Collecting data, sharing it with various stakeholders, and integrating it into a patient’s care is another challenge. Great structural changes are needed to ensure the compliant sharing of this type of data.
For manufacturers and hospitals alike, another challenge is to manage revenues. Pharmaceutical companies may be unclear for example on how drug profitability could vary with a performance-based or utilization cap contract. One of our solutions to this largely manual process was to create a drug price simulator. This tool helps manufacturers of health technologies compare and contrast different value-based contracts during the negotiation process.
For hospitals, it’s imperative to correctly track rebates, especially if they are warranted after upfront payments: our rebate management platform helps hospital systems identify up to 30% more rebates.
Value-based care can balance innovation while lowering healthcare costs, but implementing it involves enhanced coordination of care delivery and significant organizational changes. VBC also involves innovative payment models that share risk with healthcare providers or place the burden of risk on them entirely to incentivize quality care.
Value-based payment models can reduce high upfront costs of expensive therapies while further evidence is gathered to justify the high costs. For providers, VBC may reduce burnout risk by incentivizing them to keep patients healthy.
The integration of value-based care in healthcare systems around the world requires data. At Lyfegen, we help pharma, MedTech, and providers understand the impact of value-based payment models with our innovative software. Let’s make this shift happen together.
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The pharmaceutical industry and its drug market access strategies are continuing to evolve as we move through 2024, driven by mounting pricing pressures, aggressive regulatory shifts, and heightened payer demands. For pharma companies, refining market access strategies is no longer optional—it’s essential to securing rapid market entry and sustained patient access in an increasingly challenging environment. Let’s explore the key considerations for pharma companies within this space.
Evolving Drug Market Access Strategies
Pharmaceutical companies must adapt their drug market access strategies to address a rapidly evolving landscape shaped by policies and regulations across various regions, including the U.S. and Europe. New legislation, such as the Inflation Reduction Act (IRA), introduces more stringent reimbursement criteria, which could impact profitability and influence launch decisions for new drugs. To mitigate these challenges, companies need to prioritize earlier and broader data collection efforts, focusing on generating robust real-world evidence (RWE) and health economic outcomes research (HEOR). This comprehensive evidence base is essential for demonstrating the value of new therapies beyond the scope of traditional clinical trials, ultimately playing a critical role in payer negotiations and securing optimized reimbursement (NIH).
Global market variations also demand a tailored approach to launch strategies. In Europe, new regulations mandate shorter market exclusivity periods unless drugs are launched across all member states within two years, compelling pharma companies to align their launch timelines more closely with diverse national pricing schemes (European Parliament). Meanwhile, in markets like Japan, frequent price revisions are pushing companies to adopt dynamic pricing strategies to stay competitive.
The Role of Healthcare Technology Solutions in Market Access
With the industry pivoting towards value-based care and personalized treatments, healthcare technology solutions are essential in aligning stakeholder needs. Platforms like Lyfegen are pivotal in this shift. By offering a comprehensive Healthcare technology solution for outcome-based contracting, the Lyfegen platform supports the efficient implementation of value-based agreements between pharma companies, payers, and healthcare providers. Using platforms like Lyfegen means that the administration of complex pricing models can be simplified, patient outcomes can be tracked in real-time, and transparency can be increased, all of which are crucial for pharma to gain and maintain market access.
We continue to watch as the pharmaceutical industry is shaped by evolving regulations, mounting pricing pressures, and shifting payer demands. But to ensure market access, pharma companies must act now by building robust data portfolios early, integrating clinical trial data with real-world evidence (RWE), adapting to global pricing pressures, and leveraging digital solutions.
Lyfegen’s platform is at the forefront of helping pharma companies tackle these challenges. With Lyfegen’s Drug Contracting Simulator, you can model dynamic pricing strategies, optimize your market access plans, and streamline value-based agreements. Combined with the Lyfegen Library of real-world evidence and pricing models, you’ll be equipped to make data-driven decisions, ensuring faster patient access and successful contract negotiations.
Act Now – Book a demo of Lyfegen’s platform and discover how we can support your market access strategy: https://www.lyfegen.com/demo