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Rare Disease Therapies and the Case for Outcomes-Based Agreements

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Rare Disease Therapies and the Case for Outcomes-Based Agreements

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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The Shift to Financially Optimized Clinical Trials

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The Shift to Financially Optimized Clinical Trials

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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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

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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How Value-Based Contracts Are Redefining Drug Pricing Through Clinical Trials

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How Value-Based Contracts Are Redefining Drug Pricing Through Clinical Trials

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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How could Donald Trump change US healthcare?

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How could Donald Trump change US healthcare?

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.

  1. The No Surprises Act, enacted by Donald Trump on December 27th 2020, was designed to lower out-of-pocket healthcare costs for Americans in the case they were covered by an out-of-network provider. In these cases, medical bills are more expensive than they would be if care was received in-network. The Biden-Harris administration expanded upon this legislation by improving the payment dispute process.
  1. Americans don’t have a reliable way of estimating their healthcare costs. The Trump administration issued an Executive Order leading to CMS establishing rules requiring hospitals to disclose upfront costs of their services. Another aim of this initiative was to encourage greater competition among hospitals, group health plans, and health insurance issuers. This initiative was rolled out by the Biden-Harris administration but is still in its early stages.  
  1. One controversial Trump policy was his “most favored nations” Executive Order, which aimed to price-match drugs with that of the lowest price among other wealthy nations. Many were fearful this effort would stifle competition and hinder pharmaceutical development in the United States. Trump said he would not plan to revive the policy if re-elected.
  1. One of the most groundbreaking changes made by the Biden-Harris Administration was to allow Medicare to negotiate drug prices directly with manufacturers, as part of the Inflation Reduction Act. The second round of negotiations involves 15 additional drugs to the 10 included in the first round and will be announced by February 1st next year. However, several Republicans have expressed interest in repealing these negotiations.  

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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Breaking News: Lyfegen Raises Additional CHF 2 Million to Advance Value-Based Healthcare Contracting

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Breaking News: Lyfegen Raises Additional CHF 2 Million to Advance Value-Based Healthcare Contracting

Lyfegen HealthTech AG announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. Read the full press release.



BASEL, Switzerland, Sept. 1, 2020 /PRNewswire/ --

- Investors back Lyfegen's mission to make innovative healthcare therapies more accessible and affordable

- Funding secures market-leading position prior to Series A opening in 2021

Lyfegen HealthTech AG, a Swiss health technology company, announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. The additional funding was completed by private investors and the innovation program of one of Switzerland's largest banks.

Lyfegen has developed a ground-breaking software solution to accelerate value-based healthcare contracting, pioneering in a global market that could reach USD 400 billion by 2024, according to the latest estimates by research firm MarketsandMarkets™. Some of the world's 10-largest pharmaceutical and medical technologies companies are already employing Lyfegen's platform in strategic markets in Europe and South America.

Girisha Fernando, Chief Executive Office and co-founder, said: "Increasingly, healthcare systems around the world are transitioning from fee-for-service payment schemes to value-based contracting. Our solutions support the shift towards sustainable payment models that help ensure patients get the treatments they need at prices they can afford, while healthcare companies make an adequate return on their investment. We are proud to have strong partners and investors on board to support us in this challenging and rewarding mission."

The new funding, combined with the seed capital raised in April 2019 and the founders' contributions, secures the development of Lyfegen's proprietary technology as it continues to roll out its value-based contracting solution in the U.S. as well as additional European and Latin American markets in the areas of oncology, rare diseases and medical devices.

Michel Mohler, Chief Financial Officer and co-founder, added: "We continue delivering on our ambitious goals prior to opening our Series A funding in 2021. This latest additional funding confirms the growing interest of international investors in innovative healthcare technology built for a data-driven world. The funds will be used to further strengthen our leading market position as we prepare for a strong Series A funding round."

About Lyfegen

Lyfegen HealthTech AG is a Swiss healthcare technology company that is pioneering digital value-based healthcare contracting. Lyfegen's patent-pending, ground-breaking software analyses complex healthcare data sets in order to help patients access innovative therapies that focus on the healthcare outcomes that matter most to them. Lyfegen's solutions collect the patient's specific medical profile whilst ensuring the strictest data privacy protocols. Lyfegen's founders Girisha Fernando, Michel Mohler, Nico Mros, and Leon Rebolledo have combined their expertise in life sciences and financial services to create a holistic solution that enables life sciences companies, healthcare payers and healthcare providers to develop and roll out digital value-based healthcare, a market that is set to grow to USD 400 billion by 2024.

Read the official Press Release

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Lyfegen and Switzerland’s EGK Insurance Partner to Reduce Prices for High-cost Drugs

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Lyfegen and Switzerland’s EGK Insurance Partner to Reduce Prices for High-cost Drugs

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 Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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

yael@gkpr.com

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At the forefront of value-based healthcare: Lyfegen and KPMG Switzerland release whitepaper together

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At the forefront of value-based healthcare: Lyfegen and KPMG Switzerland release whitepaper together

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.

READ THE WHITEPAPER

 

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Lyfegen raises CHF 750‘000 in Seed Capital

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Lyfegen raises CHF 750‘000 in Seed Capital

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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Empowering Change Through Code: Denisa Filip Joins Lyfegen

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Empowering Change Through Code: Denisa Filip Joins Lyfegen

We are thrilled to welcome Denisa Filip to our tech team at Lyfegen as a Full Stack Developer. Denisa brings a wealth of experience and enthusiasm, and we sat down with her to learn more about her background, passions, and what excites her about joining Lyfegen.

Quick introduction – tell us a bit about yourself! Where are you from and what’s your educational and professional background?

I’m from the west of Romania and have been into informatics since high school. However, my real passion for technology started once I joined a robotics team where I was able to apply everything I had learned in a hands-on environment. I went on to earn a degree in Computer Science and began my career in cybersecurity. Along the way, I gained diverse experiences through volunteering and working with startups. Eventually, I found myself enjoying building websites more, which I now focus on.

What excites you about your job?

What excites me most about my role as a developer at Lyfegen is the opportunity to create new functionalities on our platform that truly end up helping those in need. I'm thrilled to be part of a company that shares my vision and is dedicated to making treatments more accessible to people. It's incredibly fulfilling to know that the work I do contributes to such a meaningful cause.

Why did you decide to join Lyfegen?

I was looking for a dynamic startup environment where I could grow and contribute to its evolution. I wanted to use my skills to leave a positive impact on the community, and I saw that same passion in the founders and team at Lyfegen. Their dedication to creating important change resonated with me and motivated me to be part of their mission of creating a lot of value.

What is something you want to learn or improve in the next 12 months?

I wish to improve my development skills to create amazing user experiences on Lyfegen’s platform while also exploring new relevant technologies. Additionally, I want to focus on my interpersonal abilities within the team, allowing me to contribute more effectively.

How will your know-how help improve our customers’ experience of Lyfegen solutions?

In Lyfegen's dynamic startup environment, where legislations and requirements can change rapidly, agility is key. We must be quick to launch innovative and reliable solutions on the market, and my expertise in developing intricate products helps us to achieve this by delivering seamless and intuitive features. Also, I am very detail-oriented and try to anticipate various edge cases within our platform's logic, ensuring that many potential errors are addressed before they can reach our clients.

Let’s get personal: What are your favorite things to do in your free time?

I’ve recently developed a passion for graphic design, often working on various posters and creative projects. I also love cooking, experimenting with new recipes, or crafting some of my own. Otherwise, I enjoy traveling and I’m trying to explore more countries in the future.

Is there anything else you are looking forward to outside of work in the next few months?

I’m eager to dive deeper into my graphic design hobby, exploring more challenging projects and learning more about it. I’m also looking forward to an upcoming road trip through Greece where I plan to explore the stunning landscapes and rich culture.

We are excited to see Denisa grow and thrive in her role at Lyfegen. Welcome to the team, Denisa!

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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

                    Fünf Männer aus der Region wollen die Gesundheitsbranche aufmischen. Im 2018 wurden sie von der Plattform «Innovation Basel» für ihre visionäre Idee nominiert: Eine digitale Plattform, die eine Kombination aus Blockchain und Cloud verwendet, um faire Medikamentenpreise zwischen Herstellern und Versicherungen auszuhandeln. Was heisst das aber und was ist dabei so visionär?            

                    (Bild: zVg) Das Lyfegen Team: Diese fünf Männer haben eine Vision und eine Mission. Die Idee liess Girisha Fernando nicht mehr los: Der 29-jährige Basler wollte nach neun Jahren bei der Roche im Market Access, Pricing und IT unbedingt «etwas noch Spannenderes, Revolutionäres machen», wodurch Patienten im Dschungel des Gesundheitswesens geholfen wird. Aber es sollte dabei auch für Pharmaunternehmen und Versicherer eine Win-Win-Situation entstehen.          

         Zusammen mit seinen Mitstreitern Leon Rebolledo, Michel Mohler und Nico Mros gründete er 2018 «Lyfegen» und entwickelte eine bahnbrechende Idee: Eine auf Blockchain und Cloud basierte Software Lösung, die es Versicherern und Herstellern von Medikamenten erlaubt faire Preise anhand deren Wirksamkeit für den einzelnen Patienten auszuhandeln.                      

   

     

         

           

         

         

            Faire Preise bedeuten unter anderem auch, dass die Vergütung dieser Medikamente auf der Wirkung des Medikaments basiert. Wenn ein Medikament bei einem Patienten besser wirkt, dann wird ein Preis A bezahlt. Wenn ein Medikament bei einem anderen nicht so gut anschlägt, dann wird Preis B vom Versicherer an den Hersteller fällig oder sogar nichts bezahlt. Unser Tool ermöglicht genau diese faire, wirkungsorientierte Preisgestaltung, was sich auch Value-based Healthcare nennt. So ein Tool gibt es auf der ganzen Welt bisher nicht.             Name Surname
Position, Copmany          

     

   

                 Fachleute sprechen hierbei von «Wertbasierter Gesundheitsversorgung». Dieses Thema ist aktueller denn je, auch in der Schweiz, in der steigende Behandlungs- und Medikamentenpreise zu höheren Kosten für die Bevölkerung führen. Es müssen neue, nachhaltige Modelle eingeführt werden, um die Kostenexplosion im Gesundheitswesen aufzuhalten.          

   

     

         Transparenz bei Preisgestaltung und Wirkungsgrad          

Warum aber ist so ein Tool wertvoll? «Weil unser Tool Daten sicher sammelt, analysiert und dann den jeweiligen Partnern, sei es ein Versicherer oder ein Hersteller wie Pharmaunternehmen, die Daten anonym, automatisiert und gleichzeitig zuspielt.» Dies geschieht mit Hilfe der Blockchain (eine dezentralisierte Form der Datenverarbeitung und -sicherung, die beispielsweise Geldeinheiten, Wertpapiere, Besitz- oder Grundrechte verwaltet, siehe Erklärung in der Infobox), ganz ohne Kryptowährung, betonen die fünf innovativen Köpfe.

     

   

 

   

     

       

         

           

         

       

                 

         

           

         

       

     

   

 

                     (Bilder: PEXELS) Im Gesundheitswesen explodieren die Kosten. Eine revolutionäre Idee könnte dieser Entwicklung entgegen wirken.            

            Die Idee hat schon für viel Wirbel in der «Szene» gesorgt. Und sie gehen mit ihrer Idee aufs Ganze: «Wir haben schon 750’000 CHF von einer Gruppe von Basler Business Angels erhalten», sagen die Lyfegen-Gründer. Diese Business Angels seien selbst erfolgreiche Unternehmer. Namen dürfe man leider keine bekannt geben. Zudem müsse man zu 100 Prozent hinter einer Innovation, einer Vision oder einer Idee stehen, die der Gesellschaft helfen könne, betonen sie. Fernando: «Ich bin fest davon überzeugt, dass nicht nur unsere Lösung, sondern auch die Denkprozesse, die wir bei unseren Kunden anregen, die Implementierung einer wertbasierten Gesundheitsversorgung vorantreibt. Konzept und Lösung sind innovativ.»                        

   

     

         

     

   

               Vertrauen und Transparenz zwischen Ärzten und Patienten ist immens wichtig. Darauf basiert auch das Konzept des Value-based Healthcare.      

      Zwar sei man bei Lyfegen sehr technisch veranlagt, jedoch steht der Kundennutzen und der so genannten «Impact» für alle Parteien im Vordergrund. Also auch für die Versicherten und für das gesamte Gesundheitswesen. «Unsere Lösung trägt dazu bei, Patienten Zugang zu innovativen Behandlungen und der bestmöglichen Gesundheitsversorgung zu ermöglichen. Wir wollen Leben retten. Punkt», betont CTO Leon Reborello. Girisha Fernando kann aus eigener Erfahrung berichten: «Mein Grossvater hatte Prostatakrebs und die Ärzte sagten, dass es Medikamente gibt um seine Lebensdauer zu verlängern. Aber die Versicherung wollte aus Kostengründen nicht für das Medikament bezahlen. Dies muss aufhören – durch wertbasierte Vergütung würden die besten und innovativsten Medikamente für Patienten und Ärzte zugänglich. Mit unserer Lösung tragen wir dazu bei, dies zu verwirklichen.»          

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Finding novel ways to pay for new obesity drugs

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Finding novel ways to pay for new obesity drugs

While the recent wave of new obesity drugs appeals to many patients due to their effectiveness in reducing weight and even diminishing the risk of major cardiovascular events for some, data suggests that at current prices they’re not cost-effective. Amid increased concern about the costs of using therapeutics such as glucagon-like peptide 1 agonists, some U.S. insurers are imposing further restrictions or eliminating coverage of the drugs altogether.

To boost access, a recent Financial Times article discussed the possibility of introducing value-based pricing arrangements for weight loss drugs. Under such “risk-based contracts,” healthcare providers could spread the cost over a period of time during which savings are possible, for example, from not having to treat as many heart attacks. Alternatively, drug makers and payers may negotiate value-based contracts which include patient persistency as a prerequisite. Persistency is known to be an issue with obesity drugs, as many patients stop taking the medications owing to side effects and other issues. If patients discontinue treatment weight rebound occurs, which implies that payers and patients must be properly incentivized to be persistent.

To effectively implement value-based agreements requires reliable cost of care analytics, modeling capabilities and outcomes-based agreement templates, which Lyfegen can provide stakeholders to calculate and forecast return on investment for use in the contracting process.

Value-based arrangements could ease the projected financial burden for commercial insurers, but also public payers such as Medicaid and Medicare. At present, most Medicaid state agencies don’t reimburse obesity therapeutics, while Medicare still prohibits their coverage if prescribed as weight loss medications alone. The drug Wegovy (semaglutide) did secure a supplemental cardiovascular indication from the Food and Drug Administration in March. This allows limited access for certain Medicare beneficiaries who fulfill weight and major cardiovascular risk criteria. But it doesn’t follow that plans will necessarily jump to pay for the product, given the high cost and limited cost-effectiveness. Introducing pay-for-performance agreements could facilitate access.

Lyfegen can accommodate information requests concerning relevant measures. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public agreements and 20 innovative pricing models. For a deeper understanding of how value-based pricing models can transform the accessibility of obesity treatments and optimize your healthcare investments, book a demo with us.

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

As more biosimilars get approved and launched in the U.S., payers are making key decisions about their coverage and formulary positioning. Recently, this includes Humira-, Stelara- and Remicade-referenced products.

Historically, in the U.S., biosimilars have often failed to gain much traction owing to a Byzantine system of pricing and reimbursement which involves  opaque rebate schemes. Here, higher list-priced drugs often carry with them higher rebates, which can mean that pharmacy benefit managers may favor originator products such as Humira.

As an illustration of this, according to a federal government Medicare Payment Advisory Commission report, more than 40% of Medicare beneficiaries still have no access through their insurance to Humira-referenced biosimilars, despite several products having discounts of over 80% compared to the original Humira.

But novel approaches to pricing and reimbursement could change formulary decision-making significantly, establishing the basis for more use of outcomes-based decisions. CostVantage, for example, is a new cost-based pharmacy reimbursement approach that all PBMs will eventually be required to use if they contract with CVS retail pharmacies, the largest pharmacy in the nation.

The CostVantage model stipulates that prescription drug reimbursement will be based on net acquisition cost, a set mark-up and a fee that reflects the value of pharmacy services. CVS Pharmacy plans to launch CVS CostVantage with PBMs for their commercial payers in 2025.

Such net-cost reimbursement systems tend to stimulate the uptake of lower cost (and more cost-effective) biosimilars. We find evidence of this in Europe where cost-effective biosimilars generally have fairly rapid entry which then quickly displaces the market share of originator products. By the last quarter of 2019, within one year of Humira-referenced biosimilar entry into the European market, an average of 35% of patients across Europe had already switched to a biosimilar; in the U.K, the figure was 63% which was achieved just six months after biosimilars were allowed to compete; in Denmark, with its winner-takes-all tender, the number was 80% and was attained within three months of being on the market. Meanwhile, in the U.S., after 15 months of being on the market, Humira-referenced biosimilars have only achieved 2% market share.

The new net-cost model of reimbursement in the U.S. will likely lead to greater adoption of biosimilars, at least in the large CVS segment of the market. Lyfegen can navigate the different ways in which payers and drug makers are negotiating contracts for biosimilars. In addition, Lyfegen can help address the concerns payers may have about high-priced specialty drugs, such as originator biologics and biosimilars. In the Lyfegen Agreements Library you can find the right model to use as a reference during pricing and reimbursement negotiations, which in turn will increase the chances of success.

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

In the face of scarce resources, healthcare entities must make hard choices. One can’t spend the same healthcare dollar twice, which means that policymakers have to ensure that each dollar goes as far as it can in terms of producing health outcomes for the population. Preferably decisions on how to allocate resources are informed by robust evidence that describes the benefits and harms related to medical interventions.

As U.S. and European healthcare policymakers debate different ways of measuring health outcomes accruing from the use of prescription drugs, it's important to convey that value-based pricing and reimbursement decisions can be informed by a variety of measures, including the Quality-Adjusted-Life-Year but also non-QALY measures such as the Disability-Adjusted-Life-Year, Equal-Value-Life-Year-Gained, Healthy-Life-Year-Equivalents and others. Lyfegen can accommodate information requests concerning all such measures, given the scope of its database as well as other client services. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public pricing-based agreements and 20 innovative pricing models.

In the U.S., Medicare may soon formally ban use of the QALY because it’s supposedly “discriminatory” against older people and folks with disabilities. Nevertheless, the commercial market will continue to use it, particularly since it is still one of the most common measures of benefit. It’s also the predominant measure deployed by the Institute for Clinical and Economic Review. ICER has grown in stature in recent years, now informing more than half of payers’ formulary decisions in the private sector.

According to ICER, the QALY measures how well different kinds of medical treatments extend lives or improve patients’ quality of life. As a composite measure of the outcomes, quantity and quality of life, it enables comparisons across disease states and treatments. When combined with the costs associated with healthcare interventions, the QALY can be used to assess their relative worth from an economic perspective.

As a concept the QALY can accommodate several of the issues cited by critics, including being able to account for severity of disease. Alternatively, there are methods such as the EVLYG that can be employed to place the same value on additional years of life across diseases and populations which could alleviate concerns around discrimination.

The Lyfegen Library allows you to search for pricing models and agreements by countries and payers, making it easy to find the information you need regarding the appropriate measures based on your specific requirements and interests.

Learn more: lyfegen.com/library

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

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

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

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

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

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

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

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

Book a demo today.

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A novel Medicaid model to pay for latest gene therapies

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A novel Medicaid model to pay for latest gene therapies

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

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

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

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

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

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

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

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

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