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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Basel, Switzerland / Boston, USA – December 11, 2024
Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.
Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions
The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.
Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.
Scaling Globally with a Leading Rebate Management Platform
Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.
“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”
Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”
About Lyfegen
Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand the full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.
About TX Ventures
TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage.
For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com
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In an industry often characterized by incremental changes, Girisha Fernando, the CEO and founder of Lyfegen, is making leaps. We sat down with Fernando to discuss the recent landmark partnership between Lyfegen and Newfoundland and Labrador Health Services—a collaboration that heralds a significant shift in the Canadian healthcare landscape.
Your partnership with Newfoundland and Labrador Health Services is quite a milestone. Can you share with us what this means for the current state of rebate management in Newfoundland?
Girisha Fernando (GF): Absolutely. This partnership is a transformative step for rebate management in Newfoundland. The current system, largely manual and complex, is ripe for innovation. With our digital platform, we're bringing a level of automation and accuracy that was previously unattainable. This means more efficient processing, less room for error, and a better allocation of resources, which is critical in healthcare.
That’s quite an advancement. And how does this impact the management of drug products, especially in areas like oncology?
GF: It’s a game-changer, especially for critical areas like oncology. Newfoundland and Labrador, as the first in Canada to use our platform, sets a precedent. The region, through the pan-Canadian Pharmaceutical Alliance, has been managing complex product listing agreements for drugs, including those for oncology. These agreements are vital for making treatments affordable. Our platform simplifies this, managing the various terms of these agreements efficiently, which is crucial for timely and affordable access to treatments.
It seems like a significant step forward for healthcare management. How does this align with the broader goals of Lyfegen?
GF: This partnership aligns perfectly with our goal to make healthcare more accessible and efficient. Automating the rebate process in Newfoundland and Labrador, especially for critical treatments in oncology, directly contributes to the sustainability and accessibility of healthcare treatments.
Looking to the future, what does this partnership mean for Lyfegen and healthcare systems globally?
GF: This is just the beginning. We're looking to extend our platform to healthcare systems around the world. Our aim is to make this technology a standard in healthcare management, fostering more efficient, sustainable, and equitable healthcare systems globally.
Read more about the partnership in the official press release.
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New York, NY - March 29, 2023 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced at the World EPA Congress the launch of its latest solution: the Model & Agreement Library. The purpose of the library is to help payers and pharma negotiate better drug prices while providing an in-depth view on current international drug pricing models and value-based agreements. The database library serves as the basis for successful drug pricing negotiations, resulting in accelerated access and drug prices better aligned to their value for the patient.
The shift towards value-based healthcare, rather than volume-based, has been steadily increasing over the years. This evolution has further reinforced Lyfegen's mission to remain at the forefront of analytics and digital automated solutions for the healthcare sector. Indoing so, Lyfegen’s solutions help to accelerate access and increase affordability of healthcare treatments.
“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers, and pharma companies across the world”, said Girisha Fernando, CEO of Lyfegen. “That is why we are so excited about launching the world’s largest database of real-world value-based agreements. It gives payers, and pharma a unique insight into how to structure value-based agreements.”
The Lyfegen Model & Agreement Library was developed as an accelerated negotiation resource for both manufacturers and payers – allowing them to save on time, money; and for the first time – an opportunity to learn at their own pace without incurring large research projects or hiring expensive external experts. Users of the library are now enabled to make informed decisions in determining the most suitable drug pricing models and agreements for their products.
The database holds over 2'500+ public value-based agreements and 18+ drug pricing models – spanning across 550 drugs,35 disease areas and 150 pharma companies. Its search capabilities are spread across product, country, drug manufacturer and payer – with all the knowledge, insights, current pricing and reimbursement activities shown in near real-timeacross the industry.
“Just an academic taxonomy of models is intellectually exciting but it's not really helping your typical customer”, said Jens Grüger, Director and Partner at Boston Consulting Group (BCG). “The Lyfegen Platform goes several steps further. Payers and pharma have a problem and they want a solution. The Lyfegen Model & Agreement Library is practical. It offers case examples.”
The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.
“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.
This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.
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Basel, Switzerland, October 27, 2021
Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.
The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.
"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.
Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."
The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.
About Sympany
Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.
In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.
More about Sympany: https://www.sympany.ch
About Lyfegen
Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.
Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact Press: press@lyfegen.com
Contact Investors: investors@lyfegen.com
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Basel, Switzerland, August 3rd, 2021
Lyfegen announces that its value-based healthcare contracting platform has been implemented together with Johnson & Johnson Medical Devices Companies Switzerland (Johnson & Johnson) and a leading Swiss Hospital.
Through this new value-based healthcare approach, Lyfegen and its partners drive the shift towards what matters most to patients: improved patient health outcomes and more efficient use of financial and human resources, enabling a sustainable post-COVID-19 healthcare environment.
The shift towards a value-based healthcare in Switzerland and globally can only be achieved through the support of innovative technologies. Lyfegen’s platform is a key enabler for this transition. The platform digitalises and automates the execution of value-based healthcare agreements, paving the way for the resource-efficient scaling of such novel agreements.
“COVID-19 has shown us the urgent need for a more sustainable healthcare system. With the implementation of value-based healthcare agreements on the Lyfegen platform, we are extremely proud to help Johnson & Johnson and hospitals to accelerate the transition to value-based healthcare and improve patient health outcomes at reduced cost.” says Lyfegen’s CEO, Girisha Fernando.
Lyfegen's compliant, secure and patent-protected value-based healthcare contracting platform automates the collection and analysis of patient-level data. Users receive transparency on actionable health outcomes and agreement performance. Lyfegen’s contribution to this partnership is a blueprint for the scaling of value-based healthcare models across hospitals, health insurances, medical device & pharma companies globally. The partnership marks another important milestone for Lyfegen, as the company continues to grow and has recently opened its next investment round.
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Join in from anywhere in the world for two hours of incredibly interesting presentations by industry experts all around the topic of value-based healthcare.
At this DayOne Experts event, organized in close collaboration with Deloitte, industry experts will give an overview of where the pay-for-performance discussion in healthcare stands; possible solutions; and show how value-based healthcare could, should, and will impact the industry.
During the webinar, which will include deep dive sessions, we will seek answers to some of the most pressing questions: “How to define the value of a health outcome; how to capture it? Check out san diego boudoir photographer. In which areas of intervention is the value-based healthcare approach feasible; where would it be desirable? To what extent will value-based healthcare create new opportunities and accelerate innovation?”
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To guarantee our users happiness when working with our software, we are welcoming a brand-new quality specialist at Lyfegen: Liubov Buzila has joined the team and will keep an eagle eye on our platform to ensure everything runs like clockwork.
We sat down with Liubov to learn about her experience, her goals and her aspirations.
Hello Liubov, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?
I’m Ukrainian, but I moved to Romania two years ago and currently live in the city of Iași. I have a bachelor’s degree in applied linguistic, and my first job as a QA engineer was five years ago during my fourth year at university. I have worked in this field ever since.
What excites you about being a QA engineer?
Being a QA engineer is always challenging, and that’s what I love about it. Every day I deal with a lot of things that force me to think outside of the box. A tester is not only a person who has to find problems in the system, but also a person who takes responsibility for the system’s quality; this is what makes me super excited about my work – I enjoy improving our software for the better.
Why did you decide to join Lyfegen?
I am always striving to learn something new, and Lyfegen’s startup spirit is a great fit for that. I have tested products in different fields, but I have never worked in the healthcare industry before. Personally, I think it’s a great opportunity to see how the system works from a new perspective and to gain new experience.
What is something you want to learn or improve this year?
QA is a field where you are constantly learning something new, starting with technologies used in the product and ending by gaining new soft skills as part of an amazing team. The healthcare industry is new territory for me; I’m looking forward to exploring it and gaining expertise.
How will your know-how help to improve our customers’ experience of the Lyfegen platform?
My main goal is to improve the quality of the Lyfegen platform and deliver a highly reliable and convenient product to our customers. The rule is very simple: less bugs, happier customers!
Let’s get personal: What are your favorite things to do in your free time?
I love to cook! Whenever I get any free time, I find new recipes and try to impress my family. I also like listening to music. Music is the thing that helps me to relax and forget about my troubles. And, of course, I like travelling – I have been to 20 countries already, and I look forward to exploring more.
Is there anything else you are looking forward to outside of work this year?
Nothing specific, just enjoying my free time and travelling.
We are happy to have you with us, Liubov!
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Last week Lyfegen announced exciting news! Out of hundreds of start-ups, Lyfegen is among the top 10 selected to join one of Europe’s most innovative acceleration programs: InnoPeaks by Groupe Mutuel.
The news is taken with much excitement by Lyfegen’s co-founder, Michel Mohler, who briefly explains why being selected for this three month program by one of Switzerland’s leading health insurance companies is a great achievement for Lyfegen.
Hi Michel, can you give us a little more insights on the InnoPeaks program?
InnoPeaks is a business-focused acceleration program that focuses on challenging, enabling, growing, and scaling a business through workshops, mentorship, networking, and implementing proof of concepts. Groupe Mutuel, one of Switzerland’s leading health insurances, organizes this program. Their specific goal is to drive innovation in the two topics which support their core business: healthtech and insuretech.
Lyfegen is amongst only 10 startups that have been selected out of hundreds. What is Groupe Mutuel’s interest in having you on board?
Lyfegen, being one of Switzerland’s most innovative start-ups, is solving a crucial challenge healthcare – improving health outcomes for patients. We do this with our ground-breaking technology, working together with health insurances to give patients faster access to the medicine they need. Considering high-cost, personalized and potentially curative drugs, the prices of drugs need to become dynamic and depend on how well they work for patients. This also known as value-based contracting. Until recently, we have seen mostly Pharma Companies advocating for such pricing models. Engaging with a leading health insurance with our platform, we will achieve to bring such models to life in Switzerland, for Swiss patients.
What does Lyfegen want to achieve by being part of this program?
Switzerland's Federal Council (“Bundesrat”) addresses value-based contracting as one of the key solutions to achieve a more sustainable Swiss healthcare system. Our goal is to speak and learn from other startups, talk to decision makers at Groupe Mutuel, exchange thoughts and inspire Groupe Mutuel. As a result, we want to understand the perspective of health insurances and engage in a proof of concept.
We look forward to evolving with InnoPeaks, Groupe Mutuel and the other Start-ups. The team will be live-covering the InnoPeaks accelerator program in October, so stay tuned for more!
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At Lyfegen, we live by the highest quality standards, continuously improving as we move forward with facilitating value-based healthcare agreements for a fast & sustainable access to innovative therapies.
What is ISO 9001:2015?
The ISO 9001:2015 standard provides guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements with quality being consistently improved.
This standard sets out the criteria for a quality management system used by many organization, large and small. Using ISO 9001:2015 helps ensure that customers get consistent, high quality products and services.
What this mean for Lyfegen?
At Lyfegen, we live by the highest quality standards, continuously improving our solutions & processes, as we move forward with the operationalisation of value-& data driven contracts for a fast & sustainable access to innovative therapies. In turn, this will benefit patients worldwide!
We are audited yearly by a third-party to keep our ISO status up to date.
Want to discover our solutions?
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“I am responsible for building the right products, and for building the products right.” Says Antti Hietala. Welcome to the Lyfegen Team!
As we embark on a new year, the great news start rolling in: Lyfegen welcomes its newest star, Antti Hietala, who takes on the key role of Product Owner.
As Antti arrives for his first day, Lyfegen’s CEO Girisha Fernando gives us his thoughts:
“Antti's excellent skills to think ahead and pull together industry, customer and technical perspectives to building a solid and ever-evolving product roadmap fills me with excitement, and will strengthen Lyfegen’s value for our customers even further. We are delighted to welcome Antti, a proud family man with values aligned with Lyfegen's values.”
We sat down with the ski-loving Product Owner to get a little more insight to who he is and what he will be doing at Lyfegen.
Hi Antti, tell us a little about yourself: where are you from and what is your professional background?
I come from the Arctic Circle. I grew up under the northern lights in a small town in northern Finland. I studied linguistics and computer science. My passion for content and technology led me to a career in technical writing. I wrote documentation for newspaper advertising systems and for financial asset management software.
Prior to joining Lyfegen I was the lead Product Manager at Magnolia where I built a content management solution. I’m a certified Scrum Product Owner and have worked with Product Managers and user experience designers in the past.
Why did you decide to join Lyfegen?
Lyfegen is my first venture into healthcare technology and it has an important mission: helping patients access innovative therapies by driving value-based healthcare. Removing obstacles that keep patients from getting the treatment or drugs they need is a high-level motivator. I’m also optimistic in our ability to make a big difference in the user experience of health technology and software.
I wanted to apply my product owner skills to an industry that is completely different from where I have worked before. Some say that it’s good to step out of your comfort zone and learn something completely new. The healthcare field is an exciting new challenge for me. I am thankful to the Lyfegen team for their confidence and trust that solid product management skills are universal and that I will apply them for a meaningful purpose.
You are joining Lyfegen as a Product Owner! In simple terms: what will you be working on?
I’m excited about joining Lyfegen! The team is packed with motivated and genuinely passionate people. We are on a path to build the most innovative contracting platform in the healthcare industry.
As Product Owner (PO) I am responsible for building the right products, and for building the products right. Concretely, this means talking to customers to understand their needs. I will define the product together with the Lyfegen team, translate the customer needs into features in our platform, together with our tech team.
My role has a strong outward-facing component. It’s critical for me to be in close contact with customers in order validate decisions quickly and build the right thing. My goal is to make our software valuable for our customers.
What are your next personal goals with Lyfegen?
Learning more about the healthcare and pharmaceutical industry is my first personal goal. There are so many new terms and abbreviations coming my way every day. It’s like the field has a language of its own.
On the product side, I’m very focused on optimizing the product-market fit. This means, finding the key features that really fulfill user needs and then amplifying those features in the product. I want to see users become fans! That’s a sign of a great product-market fit to me.
Enough about work! What passions do you have outside of Lyfegen?
I love to ski in the winter. I’m lucky to live in beautiful Switzerland where the Alps provide ample opportunity to hit the slopes. In the summer I do fly fishing in the Black Forest region of southern Germany or in Alsace, France. I’m also an avid pizza chef, forever improving my home-pizza game with the ultimate goal of authentic Neapolitan pie.
We are proud to welcome Antti to the Lyfegen team!
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En Brasil, encontramos que los principales fabricantes que proponen contratos basados en el valor fueron Novartis, Pfizer, J&J Innovative Medicine y Roche. Entre los pagadores, identificamos 21 aseguradoras privadas entre 2021 y 2024. También agregamos a ANVISA (Agencia Nacional de Vigilancia Sanitaria de Brasil) y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC), el organismo de evaluación de tecnologías sanitarias (ETS) de Brasil.
Áreas Terapéuticas
Las áreas terapéuticas que identificamos en los acuerdos públicos de Brasil incluyen:
Modelos de Precios
Nuevos modelos de precios de Brasil incluyen:
Acuerdos Destacados
Estos acuerdos se destacan porque abordan enfermedades raras y de alto costo, y demuestran enfoques únicos para el acceso a medicamentos y reembolsos, incluyendo cobertura con desarrollo de evidencia, garantías de resultados y pagos a plazos.
Fibrosis Quística:
Atrofia Muscular Espinal Infantil:
Cáncer de Ovario:
Principales Fabricantes:
Entendiendo el Proceso de ETS para la Aprobación de Medicamentos en Brasil
En Brasil, el proceso de Evaluación de Tecnologías Sanitarias (ETS) es gestionado por ANVISA y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC). El proceso incluye varios pasos:
A medida que Brasil se convierte en un mercado clave para las empresas farmacéuticas, nuestra biblioteca ofrece información esencial para ayudarle a ingresar a este mercado de manera eficiente y antes que la competencia.
Para obtener más información sobre los acuerdos de acceso a medicamentos en Brasil o acceder a nuestra biblioteca, reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo
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En este blog, seleccionamos acuerdos específicos en Canadá, Dinamarca y Brasil. Cada uno de estos acuerdos varía, y los elegimos para que pueda ver cómo los fabricantes abordan el acceso al mercado para diferentes medicamentos y regiones. Los contratos basados en el valor en estos mercados aceleran el acceso de los pacientes mientras comparten el riesgo financiero entre la industria farmacéutica y los pagadores, una situación en la que todos ganan.
Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals)
La Agencia Canadiense de Medicamentos y Tecnologías en Salud requiere una reducción del 94% en el precio de Trikafta para que el tratamiento sea rentable. Los niños con fibrosis quística de entre 2 y 5 años son evaluados después de 1 año, para demostrar que se benefician del tratamiento. Los pacientes deben cumplir con una serie de criterios para ser elegibles para el tratamiento, lo que convierte al acuerdo en una combinación de cobertura con desarrollo de evidencia, cobertura restringida y basada en resultados.
Trikafta ya había sido aprobado para su uso en niños mayores de 6 años, pero realizar un ensayo clínico en niños de entre dos y cinco años se consideró “éticamente desafiante”. Sin embargo, un ensayo no controlado en este grupo de edad encontró que el tratamiento fue bien tolerado y redujo los biomarcadores de la condición. Para abordar las necesidades no satisfechas, reconociendo la falta de datos en esta población de pacientes, se negoció un contrato de CED con una reducción drástica en el precio.
Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)
El Ministerio de Salud de Brasil llegó a un acuerdo con Vertex para permitir el acceso restringido a este tratamiento, mientras monitorea regularmente a los pacientes a los 30 días y a los 3 meses después de iniciar el tratamiento. El acuerdo incluye reembolsos si el tratamiento no logra los resultados clínicos deseados, alineando los precios con la efectividad.
Kalydeco (ivacaftor, Vertex Pharmaceuticals)
El organismo de adquisición danés, Amgros, y Vertex Pharmaceuticals llegaron a un acuerdo que proporciona acceso a una cartera de medicamentos para la fibrosis quística, incluyendo Orkambi (lumacaftor/ivacaftor) y futuras terapias, en 2019. A pesar de que esto ocurrió hace cinco años, es un excelente ejemplo de precios basados en cartera, donde los pagadores acuerdan pagar una tarifa fija por un grupo de medicamentos relacionados. Cuantos más pacientes los utilicen, menor será el precio por paciente.
Lynparza (Olaparib, AstraZeneca)
Este acuerdo se realizó entre AstraZeneca y aseguradoras privadas en todo Brasil. El tratamiento se pone a disposición sin costos adicionales para el paciente y combina características de cobertura restringida con garantías de resultados. La cobertura continua depende de lograr una respuesta parcial o completa.
Zolgensma (onasemnogene abeparvovec, Novartis)
La terapia génica de Novartis, Zolgensma, se reembolsa en función de la necesidad de evidencia adicional, conocida como cobertura con desarrollo de evidencia. Esto implica usar la cobertura como un medio para obtener evidencia del mundo real, para compensar la falta de datos robustos de pacientes provenientes del ensayo clave. El acuerdo también divide el riesgo entre los pagadores y los fabricantes, al vincular el reembolso con los resultados obtenidos. Debido al gran potencial de la terapia para mejorar la calidad de vida de los niños con AME, el acuerdo permite que los pacientes elegibles comiencen a recibir el tratamiento rápidamente.
¿Quiere ver la biblioteca por sí mismo? Reserve una demostración hoy aquí: https://www.lyfegen.com/demo
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To streamline the HTA process across EU member states, sweeping changes will go into effect in January of 2025. Instead of manufacturers of new health technologies needing to submit clinical data to each member state, under Regulation (EU) 2021/2282, the assessment will be conducted jointly. Manufacturers will only need to submit clinical assessments once, but member states can still conduct complementary assessments.
Important to note are the 9 assessment domains, of which 4 are clinical and 5 are non-clinical. The 4 clinical assessments include:
The 5 non-clinical domains include:
Spain released its Draft Royal Decree on the 12th of August, which is open for comments until the 20th of September, outlining how they will align with the Directive. This effort involves the Office for the Evaluation of the Efficiency of Medicines operating as a functional unit under the Spanish Agency of Medicines and Medical Devices (AEMPS).
In addition to joint clinical assessments in Europe, there will also be joint scientific consultations. The goal of this Directive is to reduce duplicate administrative work and remove barriers to innovation while aiming to improve patient outcomes.
As these changes reshape the landscape, it's crucial for pharmaceutical and medical technology companies to adapt swiftly. Lyfegen can help you stay ahead with our cutting-edge solutions:
- Navigate New Regulatory Requirements: Access our extensive Agreements Library, featuring over 5,000+ public drug pricing agreements and 20 pricing models, to ensure compliance with the latest HTA standards.
- Optimize Decision-Making: Utilize our Drug Contracting Simulator to create data-driven business cases and run real-time simulations that align with Spain's new HTA guidelines.
- Streamline and Automate Contracting: Our Rebate Analytics solutions automate rebate and refund calculations, ensuring accuracy, transparency, and a significant reduction in administrative burdens.
Book a demo with us today to explore how Lyfegen’s tools and expertise can support your business under Spain’s new HTA framework.
Book your demo here: https://www.lyfegen.com/demo
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A major change to Medicare Part D will go into effect next year, as a result of the Inflation Reduction Act. Most notably, the cap on out-of-pocket expenditures will be reduced from $3,300 to $2,000.
This brings us to another major development.
Update to Medicare Drug Price Negotiation Program
CMS announced its selection of 10 drugs that were negotiated down in price, on August 15th. The selected drugs were identified as “single source drugs,” meaning there is no generic or biosimilar equivalent, and there is unlikely to be so in the near future. The new prices are estimated to save $6 billion in net prescription drug costs, representing a 22% reduction in spending. The new prices will go into effect on the 1st of January, 2026.
As the pharmaceutical industry goes through these changes, it’s crucial to have the right tools in place. This is where Lyfegen comes into play with its cutting-edge solutions like the Drug Contracting Simulator, an innovative tool designed to help Market Access and Pricing teams stay ahead in this landscape:
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🤝 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗣𝘂𝗿𝗽𝗼𝘀𝗲-𝗕𝘂𝗶𝗹𝘁: Move away from Excel-based tools with our dedicated platform, designed for Market Access and Pricing teams, and re-usable across different markets and assets.
⚡ 𝗙𝗮𝘀𝘁𝗲𝗿, 𝗕𝗲𝘁𝘁𝗲𝗿 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀: Streamline the creation of rebate agreements in a collaborative environment, helping you respond more effectively to new pricing pressures.Don’t miss out on staying ahead in this new regulatory environment. Book a demo with us today: https://www.lyfegen.com/demo
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In Brazil, we found that the main manufacturers proposing value-based contracts were Novartis, Pfizer, J&J Innovative Medicine, and Roche. Among payers, we identified 21 private insurers between 2021 and 2024. We also added ANVISA (Brazilian Health Regulatory Agency) and the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC), Brazil’s health technology assessment (HTA) body.
Therapeutic Areas
The therapeutic areas we identified in Brazil’s public agreements include:
Pricing Models
New pricing models from Brazil include:
Featured Agreements
These agreements are highlighted because they address high-cost, rare diseases and demonstrate unique approaches to drug access and reimbursement, including coverage with evidence development, outcome guarantees, and installment payments
Cystic Fibrosis:
Infantile Spinal Muscular Atrophy:
Ovarian Cancer:
Main Manufacturers:
Understanding the HTA Process for Drug Approval in Brazil
In Brazil, the Health Technology Assessment (HTA) process is managed by ANVISA & the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC). The process involves several steps:
As Brazil becomes a key market for Pharma companies, our library offers essential information to help you enter this market efficiently and ahead of the competition.
To learn more about Brazil’s Drug Access Agreements or get access to our library, book a demo with us today: https://www.lyfegen.com/demo