How Gene Therapies Are Reshaping Patient Outcomes and Payer Expectations
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Gene therapies are redefining modern healthcare, offering the potential to address the root causes of genetic disorders through targeted treatment rather than symptom management. For patients, this represents a profound improvement in quality of life, while for payers and pharmaceutical companies, gene therapies introduce new challenges in contract structuring, reimbursement, and financial planning. In this blog, we’ll explore how gene therapies are reshaping patient outcomes, impacting payer expectations, and how Lyfegen’s solutions, such as the Agreements Library and Drug Contracting Simulator, are enabling pharma and payers to navigate this evolving landscape.
A New Horizon for Patient Outcomes with Gene Therapies
Gene therapies bring transformative potential to patient care by addressing the underlying genetic causes of diseases. Unlike traditional therapies that require ongoing treatment, many gene therapies promise long-lasting effects from a single intervention. This shift enables patients to move away from chronic management, experiencing a better quality of life, fewer medical interventions, and improved long-term health.
Why It Matters: For patients with rare genetic conditions, gene therapies offer a new chance at health. However, the high upfront costs and uncertain long-term efficacy make it challenging for payers to determine optimal reimbursement models. Balancing patient access with financial sustainability is crucial as healthcare systems adjust to the realities of high-cost gene therapies.
Payer and Pharma Contracting: Managing Uncertainty with Precision
With the high cost of gene therapies, payers and pharmaceutical companies face increased pressure to implement contracts that account for uncertain outcomes and long-term impact. Traditional pricing models often fall short in accommodating these complexities. Today, payers need new contracting frameworks that incorporate clinical and financial outcomes over extended timeframes, while pharma companies seek efficient ways to communicate the value and manage the financial implications of these therapies.
Shifting Expectations in Payer-Pharma Relations: To mitigate risk, payers and pharma companies are exploring innovative drug contracting models that tie payment to therapeutic outcomes. However, implementing such models requires robust data, effective scenario planning, and tools that support transparent, collaborative processes across stakeholders.
Lyfegen’s Role in Optimizing Drug Contracting for Gene Therapies
To address the complexities of gene therapy contracts, Lyfegen offers tailored tools that support payers and pharma companies through every stage of the contracting process. Our Agreements Library and Drug Contracting Simulator streamline research, analysis, and contract execution, allowing stakeholders to engage in informed, data-driven decision-making.
1. The Lyfegen Agreements Library: As the world’s largest digital repository of drug pricing agreements, the Lyfegen Library gives users access to over 6,000 public agreements and 20 unique pricing models.
• Accelerate Effective Contracting: With a comprehensive database covering over 550 drugs and real-world agreements from 33 countries, payers and pharma teams can find, compare, and analyze pricing models that meet specific market and therapeutic needs.
• Support Pragmatic Contracting: By exploring data from more than 150 drug manufacturers, users can identify successful contracting models and structures that match the challenges of gene therapies. This ensures informed choices that support sustainable access to innovative treatments.
2. Lyfegen Drug Contracting Simulator: Our simulator enables pharma and payer teams to model various drug pricing scenarios, providing real-time insights to drive negotiations.
• Accelerate Negotiations with Real-World Simulations: The simulator allows users to run multiple pricing models, delivering scenario-based insights that reflect real-world financial implications. This helps pharma and payers create compelling business cases and select pricing models that suit both patient needs and budget constraints.
• Improve Collaboration Across Teams: With flexible, secure access, the Drug Contracting Simulator enables local and global teams to work collaboratively. Users can save and share simulations, compare scenarios, and make evidence-based decisions quickly.
By equipping stakeholders with essential tools for research and analysis, Lyfegen’s solutions reduce the complexities of payer-pharma contracting, allowing stakeholders to navigate the high stakes of gene therapy reimbursement effectively.
Shaping the Future of Gene Therapy Access with Lyfegen
Gene therapies represent a future of precision medicine and improved patient outcomes. Yet, making this future accessible requires innovative approaches to contracting and reimbursement. By leveraging Lyfegen’s solutions, payers and pharma companies can structure contracts that maximize patient access to these therapies while managing financial risk.
Lyfegen is committed to supporting stakeholders as they navigate the challenges of gene therapies, providing solutions that bring real-world data, evidence-based simulations, and efficient contracting processes to the forefront. With the Lyfegen Agreements Library and Drug Contracting Simulator, payers and pharmaceutical teams have the tools they need to secure the future of gene therapies in a way that’s both financially sustainable and patient-centered.
To explore how Lyfegen’s Agreements Library and Drug Contracting Simulator can support your contracting needs for gene therapies, connect with our team or schedule a demo today.
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With rising healthcare costs around the world, value-based care (VBC) is a paradigm shift poised to make healthcare more accessible and affordable. It’s a departure from the traditional fee-for-service (FFS) model, which pays providers each time they perform a service. In this type of care model, providers are rewarded for the volume of care they provide, rather than the quality.
Value-based care shifts the priority of healthcare to patient wellbeing and patient centeredness. Value-based care agreements incentivize healthcare stakeholders to achieve better outcomes, and may even penalize excessive spending or unnecessary procedures.
There are many approaches to providing and paying for value-based care, and they will be the subject of this article. Let’s take a broad look at what VBC is, its benefits, its challenges, and future directions.
Why value-based care is needed
Healthcare costs are rising across the globe, and patients are bearing the brunt of it, with out-of-pocket healthcare costs rising faster than costs to insurers. Drugs are also becoming more expensive, and insurers and employers are concerned about high-cost claims. Many insurers are refusing to cover expensive treatments, like cell and gene therapies, or GLP-1 agonists.
Although the fee-for-service model is still important, value-based care can fill the gaps to bring medicines to patients faster. Using cell and gene therapies as an example, VBC could prevent patients like Forrest VanPatten from dying during the process of jumping from insurer to insurer, hoping to find one that will cover the treatment.
Alternative payment models (ABMs), a core element in the delivery of VBC, help these therapies get to market faster, by lowering the financial burden of expensive therapies. This could include installment payments, among several types of value-based contracts.
Although pharmaceutical companies continue to improve patient outcomes by developing more effective medicines, healthcare costs include more than the price of the drugs. The total cost of care must also be managed and requires a close evaluation of how care is delivered to the patient.
Ultimately, value-based care is a strategy to deliver a better healthcare experience to the patient while utilizing resources more effectively. It is feasible to reward healthcare practitioners for improving patient health, whether it be keeping them out of the hospital, reducing their reliance on medication, or becoming completely disease-free. But there are many challenges in implementing these models, as we’ll discuss.
The types of value-based care
There are many forms of value-based care, and different terms are used interchangeably. Use the glossary table below while reading this article to better understand.
VBC can involve the following:
There are many ways medicine and care can be delivered to people in ways that support better outcomes. Let’s summarize the models above.
Effective care delivery
The accountable care organization (ACO) is a group of clinical entities and providers that in synchronization, aim to deliver efficient and cost-effective healthcare to patients. If the efforts are successful, saved costs can be distributed, providing an incentive to avoid unnecessary procedures. A key component of ACOs is that financial responsibility lies on caregivers. ACOs were a central component of the Affordable Care Act in the United States, and generally describe the American healthcare system. However in several European countries, similar models providing integrative care do exist.
This type of integrated care model may still rely on the fee-for-service model, but aim to reduce the volume of care.
Risk-sharing agreements
Several value-based drug pricing agreements foster risk-sharing between the manufacturer of the drug and the payer. The following are examples:
Many of the above terms overlap with each other. What they have in common is that they can address clinical uncertainty—payers may be reluctant to reimburse therapies with limited clinical evidence from the pivotal trial. However, to ensure patient access, risk-sharing agreements are way to allow patients to be treated for a steep discount, while gathering real-world evidence.
In a pay-for-performance agreement, payers will only have to pay for the treatment if anticipated patient outcomes are achieved. Several hybrid iterations of this type of agreement exist, including milestone payments, where payers receive rebates if disease progresses.
You can find specific examples of these kinds of agreements in our Agreements Library.
Population-based payments
Population-based payments facilitate integrative care delivery. They involve payments for either a specific condition, or for the care of an entire patient. However, unlike an ACO, population-based payments are value-based and are not based on the fee-for-service model.
The Health Care Payment Learning & Action Network (HCP LAN) defines population-based payments as a “single payment that encompasses a broad array of services.” This is also more widely referred to as capitation. Capitation can apply to the care for a specific condition, or the entire continuum of care.
NHS England defines capitation as “paying a provider or group of providers to cover the majority (or all) of the care provided to a specified population across different care settings. The regular payments are calculated as a lump sum per patient.”
Capitated payments typically involve a per-member-per-month fee. They provide predictable revenue for hospitals and providers while incentivizing them to provide quality care.
Restricted access
Another way to address clinical uncertainty is to limit who can receive treatment as real-world evidence is being gathered. By refining the eligibility criteria, patients most-likely to benefit from the treatment can receive access.
What are some of the challenges of implementing value-based care?
There are several challenges to implementing value-based care. They include:
One challenge with VBC is deciding on patient eligibility. Insurers may choose to cover a very select group of patients, denying others who may need treatment coverage, to ensure that they are incentivized accordingly. This leads to another challenge: choosing the right outcomes to measure. In the fee-for-service model, billing is tied to the condition and medication being prescribed, whereas in a value-based contract, financial incentives are tied to outcomes measured by a healthcare provider.
The chosen outcomes must be evidence-based and tracked accordingly. Collecting data, sharing it with various stakeholders, and integrating it into a patient’s care is another challenge. Great structural changes are needed to ensure the compliant sharing of this type of data.
For manufacturers and hospitals alike, another challenge is to manage revenues. Pharmaceutical companies may be unclear for example on how drug profitability could vary with a performance-based or utilization cap contract. One of our solutions to this largely manual process was to create a drug price simulator. This tool helps manufacturers of health technologies compare and contrast different value-based contracts during the negotiation process.
For hospitals, it’s imperative to correctly track rebates, especially if they are warranted after upfront payments: our rebate management platform helps hospital systems identify up to 30% more rebates.
Value-based care can balance innovation while lowering healthcare costs, but implementing it involves enhanced coordination of care delivery and significant organizational changes. VBC also involves innovative payment models that share risk with healthcare providers or place the burden of risk on them entirely to incentivize quality care.
Value-based payment models can reduce high upfront costs of expensive therapies while further evidence is gathered to justify the high costs. For providers, VBC may reduce burnout risk by incentivizing them to keep patients healthy.
The integration of value-based care in healthcare systems around the world requires data. At Lyfegen, we help pharma, MedTech, and providers understand the impact of value-based payment models with our innovative software. Let’s make this shift happen together.
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The pharmaceutical industry and its drug market access strategies are continuing to evolve as we move through 2024, driven by mounting pricing pressures, aggressive regulatory shifts, and heightened payer demands. For pharma companies, refining market access strategies is no longer optional—it’s essential to securing rapid market entry and sustained patient access in an increasingly challenging environment. Let’s explore the key considerations for pharma companies within this space.
Evolving Drug Market Access Strategies
Pharmaceutical companies must adapt their drug market access strategies to address a rapidly evolving landscape shaped by policies and regulations across various regions, including the U.S. and Europe. New legislation, such as the Inflation Reduction Act (IRA), introduces more stringent reimbursement criteria, which could impact profitability and influence launch decisions for new drugs. To mitigate these challenges, companies need to prioritize earlier and broader data collection efforts, focusing on generating robust real-world evidence (RWE) and health economic outcomes research (HEOR). This comprehensive evidence base is essential for demonstrating the value of new therapies beyond the scope of traditional clinical trials, ultimately playing a critical role in payer negotiations and securing optimized reimbursement (NIH).
Global market variations also demand a tailored approach to launch strategies. In Europe, new regulations mandate shorter market exclusivity periods unless drugs are launched across all member states within two years, compelling pharma companies to align their launch timelines more closely with diverse national pricing schemes (European Parliament). Meanwhile, in markets like Japan, frequent price revisions are pushing companies to adopt dynamic pricing strategies to stay competitive.
The Role of Healthcare Technology Solutions in Market Access
With the industry pivoting towards value-based care and personalized treatments, healthcare technology solutions are essential in aligning stakeholder needs. Platforms like Lyfegen are pivotal in this shift. By offering a comprehensive Healthcare technology solution for outcome-based contracting, the Lyfegen platform supports the efficient implementation of value-based agreements between pharma companies, payers, and healthcare providers. Using platforms like Lyfegen means that the administration of complex pricing models can be simplified, patient outcomes can be tracked in real-time, and transparency can be increased, all of which are crucial for pharma to gain and maintain market access.
We continue to watch as the pharmaceutical industry is shaped by evolving regulations, mounting pricing pressures, and shifting payer demands. But to ensure market access, pharma companies must act now by building robust data portfolios early, integrating clinical trial data with real-world evidence (RWE), adapting to global pricing pressures, and leveraging digital solutions.
Lyfegen’s platform is at the forefront of helping pharma companies tackle these challenges. With Lyfegen’s Drug Contracting Simulator, you can model dynamic pricing strategies, optimize your market access plans, and streamline value-based agreements. Combined with the Lyfegen Library of real-world evidence and pricing models, you’ll be equipped to make data-driven decisions, ensuring faster patient access and successful contract negotiations.
Act Now – Book a demo of Lyfegen’s platform and discover how we can support your market access strategy: https://www.lyfegen.com/demo
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The Joint Clinical Assessment (JCA) is poised to fundamentally change how health technologies gain market access across the European Union. Designed to streamline the evaluation process, the JCA promises to bring greater consistency, transparency, and efficiency to how new therapies and medical technologies are assessed for clinical effectiveness. But what does this mean for your market access strategies?
What is the JCA?
The JCA is a central pillar of the EU’s updated Health Technology Assessment (HTA) regulations. Historically, pharmaceutical and medical device companies faced significant hurdles when introducing new health technologies across different EU member states. Each country has had its own HTA process, leading to duplicated efforts, inconsistent outcomes, and delays in patient access. With the JCA, clinical assessments will be conducted at the EU level, offering a unified approach to evaluating the relative effectiveness of new treatments.
Key Benefits of the JCA
The JCA is expected to address several long-standing challenges:
1. Streamlined market access: By replacing multiple national HTA evaluations with a single EU-level assessment, the JCA will reduce duplication and accelerate the time it takes for new health technologies to reach the market.
2. Consistency across the EU: With the JCA, companies can expect more predictable and transparent outcomes when navigating the regulatory landscape. This will help align market access efforts across all member states, making it easier for companies to plan and execute their market entry strategies.
3. Cost efficiency: By pooling resources and conducting joint clinical assessments, the JCA is expected to save HTA bodies across the EU millions of euros annually. This increased efficiency will also benefit pharmaceutical and medical technology companies by reducing the administrative and financial burden of complying with multiple HTA processes.
How Will the JCA Impact Your Market Access Strategy?
For companies looking to introduce new health technologies in the EU, the JCA will bring both opportunities and new considerations:
• Early Engagement Will Be Key: The unified nature of the JCA means that companies will need to engage early with EU-level HTA bodies to ensure that their clinical data meets the requirements of the JCA. This early engagement can help smooth the path to market and avoid potential delays.
• A Shift in Regulatory Focus: With clinical assessments now being handled at the EU level, companies may need to adjust their strategies for navigating national market access pathways. While the JCA will simplify the clinical assessment process, national bodies will still be responsible for non-clinical aspects, such as pricing and reimbursement decisions.
• Data Consistency and Quality: The JCA emphasizes the importance of high-quality, consistent clinical data. Companies will need to ensure that their submissions are robust and aligned with the JCA’s methodology to avoid discrepancies and delays in the assessment process.
The Role of Technology in Managing Market Access
As market access strategies evolve with the implementation of the JCA, technology platforms like Lyfegen can play a crucial role in helping pharmaceutical and medical technology companies adapt. Lyfegen’s platform simplifies the process of planning, tracking, and managing health technology assessments, ensuring that companies are well-prepared to meet the requirements of the JCA.
By leveraging advanced analytics and real-time data management tools, Lyfegen enables companies to streamline their market access efforts, ensure compliance with EU-level assessments, and maintain transparency throughout the process. With the increasing complexity of market access in the EU, technology will be a critical factor in ensuring success.
Conclusion: Preparing for the Future of Market Access
The JCA is set to transform market access strategies across the EU by creating a more efficient, unified, and predictable pathway for introducing new health technologies. As companies navigate this new landscape, early preparation, high-quality clinical data, and the right technological tools will be essential to staying ahead.
Unlock smarter market access strategies with Lyfegen’s advanced tools! The Lyfegen Drug Contracting Simulator empowers you to navigate the complexities of the JCA, model various pricing scenarios, and optimize your market entry plans. Combined with the Lyfegen Library’s extensive collection of market access models, you’ll have everything you need to succeed in the EU’s evolving regulatory landscape.
Act Now – Book a demo of Lyfegen’s platform and learn how we can support your market access strategy: https://www.lyfegen.com/demo
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In December 2023, the U.S. Food and Drug Administration (FDA) approved two groundbreaking gene therapies for sickle cell disease (SCD), offering a new lease on life for individuals battling this severe condition. However, while these therapies bring significant clinical improvements, their cost has emerged as a formidable challenge, particularly for Medicaid, which covers approximately half of the 100,000 individuals in the U.S. with SCD.
The Financial Strain of Sickle Cell Disease on Medicaid
Gene therapy represents a revolutionary treatment for SCD, a condition that has traditionally required ongoing management through therapies like allogeneic hematopoietic stem cell transplants (HSCT). While HSCT offers a potential cure, its use has been limited due to donor availability and high toxicity. Now, gene therapy provides a much-needed alternative, but the steep price tags—approximately $2.29 million per treatment—pose a significant challenge for Medicaid programs across the country.
The latest budget impact analysis updates previous findings on how these high-cost therapies could impact 10 Medicaid plans with the highest prevalence of SCD. The study reveals that even cost-effective treatments with exceptional clinical benefits may be unaffordable for payers, particularly given the expanding Medicaid enrollment and higher-than-expected launch prices for these therapies.
Short-Term Costs vs. Long-Term Savings
For Medicaid plans, the financial challenge of gene therapy is primarily in the upfront, one-time cost of the treatment. The updated model projects that in the first year alone, gene therapy for SCD will result in an average budget impact of $65.8 million per state program, with a per-member per-month (PMPM) cost of $3.11 across the 10-state sample. Although the cost decreases over time—with the PMPM dropping to $2.08 by year five—the initial budgetary strain is a significant concern.
Despite these costs, the long-term benefits of gene therapy are undeniable. By offering a potentially curative solution, gene therapy could avert future medical expenses associated with SCD, such as hospitalizations, pain management, and ongoing treatments. The model conservatively assumes perfect effectiveness and durability, projecting that the therapy would eliminate all future SCD-related healthcare costs for treated patients. While these assumptions may not reflect real-world outcomes, they provide a glimpse into the potential for long-term savings.
Market Diffusion and Budgetary Impact
A critical factor influencing the budget impact is the market diffusion rate—the speed at which patients adopt the new therapy. The analysis assumes an annual diffusion rate of 7%, meaning that a subset of eligible Medicaid enrollees will receive the therapy each year. This rate could vary, influenced by factors such as manufacturing capacity, delivery center availability, and payer policies. Notably, if the diffusion rate falls below 4%, the PMPM cost could remain below the affordability benchmark set by prior high-cost treatments, such as sofosbuvir for hepatitis C, which generated a PMPM cost of $1.89 in 2024 dollars.
The model also reveals that 35% of Medicaid enrollees with SCD are expected to have a severe phenotype, defined by two or more severe pain episodes annually. This percentage is a key driver of cost, as patients with more severe disease are more likely to be eligible for gene therapy.
State Medicaid Plans Face Varying Impacts
The updated analysis highlights significant variability in how different state Medicaid plans will be affected. For example, in Georgia, where SCD prevalence is higher, the projected PMPM cost is $3.92 in the first year, while Florida faces a slightly lower cost of $2.50 PMPM. These variations reflect differences in both disease prevalence and state enrollment levels.
By the fifth year, the PMPM costs across all state programs are expected to decrease, driven by reduced new therapy adoption and the absence of ongoing SCD-related costs for treated patients. However, the affordability challenge remains a pressing concern, particularly in the early years of gene therapy adoption.
Balancing Access with Affordability
Medicaid plans, payers, and policymakers are now tasked with finding ways to balance the promise of gene therapies with their potential financial burden. The affordability challenge could limit patient access, echoing the struggles faced during the rollout of high-cost hepatitis C treatments.
One potential solution is the development of novel payment models, such as annuity-based approaches, which could spread the cost of gene therapy over several years, easing the immediate budgetary impact. Additionally, the Center for Medicare and Medicaid Innovation is exploring alternative payment strategies specifically for gene therapies within Medicaid, aiming to ensure access without jeopardizing the financial sustainability of state programs.
The Role of Technology in Managing Costs
As gene therapies become more prevalent, platforms like Lyfegen can play a key role in helping payers manage the financial complexities associated with these high-cost treatments. Lyfegen’s platform simplifies the process of tracking the economic impact of gene therapies, providing payers and providers with the tools they need to assess real-world outcomes, monitor costs, and adjust strategies accordingly. By leveraging technology, healthcare systems can better navigate the financial risks and ensure that patients continue to benefit from the latest innovations in care.
Unlock smarter budget management strategies with Lyfegen’s powerful tools! The Lyfegen Drug Contracting Simulator helps payers and healthcare providers model the financial impact of high-cost therapies like gene therapy for SCD, optimize payment strategies, and make informed decisions. Coupled with the Lyfegen Library’s extensive database of pricing models, you’ll be equipped to tackle the financial challenges posed by the latest innovations in healthcare.
Act Now – Book a demo of Lyfegen’s platform and discover how we can support your budgeting and contracting needs: https://www.lyfegen.com/demo
References
Meyer, K. B., Kilburg, M. M., Johnson, K. B., & Meyers, M. A. (2024). A budget impact analysis of gene therapy for sickle cell disease: an updated analysis. Blood Advances, 8(17), 4658–4666. https://ashpublications.org/bloodadvances/article/8/17/4658/517069/A-budget-impact-analysis-of-gene-therapy-for-sickle-cell-disease
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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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We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.
Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?
I have spent close to a decade in the life sciences sector, working with companies like Novartis and Pfizer, where I gained deep expertise in healthcare strategy, market access, and health economics. My passion has always been focused on improving patient outcomes and the healthcare system. This led me to Lyfegen, a company at the forefront of transforming healthcare through innovative solutions. The opportunity to work with payers and drug manufacturers to ensure better and sustainable access to innovative treatments for patients was a natural fit for me, both professionally and personally.
What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?
The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies. However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.
What opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How can we better support health insurers and government bodies?
There is tremendous potential for growth. Currently, payors and pharmaceuticals adjudicate their product listing agreements (PLAs) manually through Excel spreadsheets. It is resource intensive, leaves room for errors and is a barrier to potential innovative contracting. In addition, as Canada increasingly looks towards value-based healthcare models, Lyfegen is an enabler by providing the digital infrastructure for payor and manufacturers.
From your perspective, what key actions need to be taken in the next 12 months to drive success for Lyfegen in the Canadian market?
In the next 12 months, we need to focus on deepening our relationships with key stakeholders and demonstrate the value of our digital solutions for payors, manufacturers, healthcare system and, ultimately, the patients.
How do you see your role influencing the implementation of value-based solutions in Canada, and what impact do you hope to have?
Lyfegen has extensive experience in OBA implementation and operationalization in many countries. In my role, I hope to bridge the gap from theory to practice in the implementation of value-based healthcare in Canada.
In your opinion, what’s the most important aspect of building strong client relationships in the healthcare industry? How do you approach this in your role?
Trust and communication are at the core of any strong client relationship in healthcare. Given the complexity and sensitivity of the industry, clients need to know that you understand their unique challenges and are committed to solving them. In my role, I prioritize open and ongoing communication, ensuring that clients feel heard and that their feedback is integrated into our solutions. I also work hard to build trust by delivering results and being transparent about what we can achieve together.
Looking ahead, what excites you most about the future of sales and business development at Lyfegen in Canada?
I’m excited about the potential to be a catalyst for significant change in the Canadian healthcare landscape. Lyfegen is in a unique position to lead this transformation. The combination of increasing demand for cost-effective healthcare solutions and our innovative approach makes this an incredibly exciting time to be in sales and business development.
Outside of work, what are some of your favorite things to do in your free time?
Outside of work, I enjoy spending quality time with my family and friends. I also prioritize my health by being active on a daily basis. I also enjoy learning. Now that I have completed my MBA, I’m on a mission to learn Spanish.
We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!
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Once upon a time, In a whimsical forest, there lived a smart and creative blue bird. This bird, known for its brilliance in the world of tiny forest biotech, had concocted a magical potion.
This potion was a wonder, a gene therapy to cure the forest creatures of a troublesome disease called sickle cell. Perched thoughtfully on a branch, the blue bird faced a whimsical yet vital challenge. The potion, potent in its healing, needed to be more than just a marvel of science – it had to be reachable and affordable for all in the forest. Additionally, this magical creation was still unnamed, a name that should echo its life-affirming qualities and the journey from a mere idea to a beacon of hope in the forest.
Amidst this puzzlement, the blue bird heard tales of the wise owls of Lyfegen, far beyond the forest. These owls were not just wise; they were masters of a different kind of magic – the magic of numbers and agreements that made health solutions reachable to all. Intrigued, the blue bird fluttered over to learn more.
As it learned about Lyfegen's remarkable ability to navigate the complex world of potion pricing and access, inspiration struck. "Ah-ha!" chirped blue bird, "If Lyfegen can make health solutions accessible, why not name my potion in honor of their work? Lyfgenia – a name that sings of life, hope, and the ingenuity of Lyfegen!"
And so, the potion was christened Lyfgenia, a nod to the owls of Lyfegen whose wisdom ensured that such medical marvels reached every nook and cranny of the forest without burdening its inhabitants.
With its new name, Lyfgenia became more than just a potion; it symbolized a harmonious blend of medical genius and financial savvy. The blue bird turned Lyfgenia into a symbol of hope and healing in the whimsical world of the forest.
Disclaimer: "A Fable of the Blue Bird and Lyfegen's Wise Owls" is a work of fiction, created solely for entertainment and illustrative purposes. This fable does not represent any real-life strategies, decisions, or actions of these entities, nor should it be interpreted as an endorsement or representation of their values, capabilities, or business practices.
Using Lyfegen's solutions can streamline the financial management of advanced therapies like Lyfgenia, leading to more effective pricing strategies and improved access for patients. Learn more about how our solutions enable value-based contracting for gene therapies: lyfegen.com
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Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
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At this years World Evidence, Pricing and Access event, Girisha Fernando, the CEO of Lyfegen, expressed excitement as he spoke about the company’s latest launched offering - the Lyfegen Model & Agreement Library. This unique learning resource is a true game-changer that builds upon the company’s existing product. It expands our horizons by allowing payers and market access & pricing professionals to explore over 2’500 real-life public agreements, and 18 drug pricing models from around the world. The library provides an unparalleled understanding of drug reimbursement models that help users make better informed choices like never before.
Selecting a drug reimbursement model is very complex, as manufacturers want quick market access, while payers may have many concerns, such as a drug’s efficacy and affordability. Fernando emphasized that the library bridges the gap by assisting payers and market access professionals in finding specific models that address each stakeholder’s concerns, and key real-life agreement examples, resulting in better-informed decision-making, and ultimately more efficient reimbursement processes.
“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 Fernando, “That is why we are 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.”
But that’s not all – Fernando explained that the database is constantly evolving, being updated weekly with new public agreements, allowing stakeholders to be up to date on public agreements.
Overall, it is clear that the Lyfegen Model & Agreement Library is an invaluable groundbreaking tool, that is becoming indispensable in increasing the knowledge on drug and Cell & Gene Therapy reimbursement.
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He’s analytical, a techie and has a fantastic gift for music! Yes, we are talking about the latest addition to our team, our very own “Technical Business Analyst” and Ukrainian superstar: Pavlo Lupandin!
Just last month we announced the arrival of our Lead Developer, Daniel, and now more great news follows as Lyfegen continues to lay focus on the technical team: we have our very own Technical Business Analyst, Pavlo!
“Pavlo’s sharpness and problem-solving skills just made it clear that we needed him in our team! His drive and commitment will bring great value to our patients, our customers and Lyfegen as we continue to sharpen our platform” says Lyfegen’s CEO, Girisha Fernando.
We are proud to have him as part of the team and sat down with him to give you a little more insight behind the musical talent and witty “Technical Business Analyst”:
Hi Pavlo! Tell us a little about yourself: where are you from and what is your work experience background?
Hello! I was born in the east of Ukraine, got the Master’s Degree in Economics in Kyiv, worked at one of the Big 4 companies for 3 years as an Auditor, following one year in the role of Business Analyst. After this experience, I found myself being a fresh ACCA Member, who wanted to dive into something not that accounting related. Business analysis has proven to be an interesting area where I can develop further capitalizing on my previous experience.
It’s interesting, that back in my audit days I’ve had some big healthcare-related projects. Who knew that it was only the beginning of working in this promising domain…
This is your first experience in the Health Tech industry – what triggered this move?
Pace of development. The Healthcare & IT industries are developing in overwhelming waves, and to ride the peak of those waves is a challenge – formidable, but a tempting one. As soon as this opportunity presented itself, I decided to chase it. We’ll see, where this decision will bring me in a couple of years.
You are joining Lyfegen as Technical Business Analyst. In simple terms: what will you be working on?
I would be occupied mainly with gathering, documenting and communicating the requirements of our customers. Ever heard of different communication barriers? Those I would try to eliminate, trying to grasp the very core of what has to be done for the maximum customer satisfaction and making sure the development team implements requirements as close as possible to the ideal.
What are your next personal goals with Lyfegen?
There are several of them. First, I strive for development as a professional, and I think Lyfegen will provide me with opportunities to do that. Second, I want to embrace that spirit of a high-growth startup – after working for a massive and complex company, the flexibility and freedom of Lyfegen is a breath of fresh air. And finally, I want to know new talented people. I already know, that the Lyfegen team has a great diversity, and I can’t wait to learn some interesting things from people of other countries and cultures.
What motivated you to join?
Purpose and value. As simple as that. I can see the purpose and value of what I’m doing. Obviously, we are at the beginning of this journey, and it’s a bit early to speak about “value-based pricing for everybody” or “pay only for what is really working” but…the concept is huge, and it will become the question of life and death for some patients. And I’ll do my best to make it as close to life as possible.
Enough about work! What passions do you have outside of Lyfegen?
Oh, you don’t want to hear a full list, I assure you. Let me try to sum it up quickly…Music, videogames and tabletop games – I play them all. A small collection of musical instruments – some of them are quite exotic, especially for my home country (banjo and djembe, for example). A bigger collection of tabletop games in different genres – the Lyfegen team can definitely expect a session or two in the nearest future. And a vast collection of videogames on different platforms…without much details let’s just agree there are a lot.
There are some other hobbies of mine, but I’d prefer to keep a couple of surprises up my sleeve!
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
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For this blog, we chose select agreements in Canada, Denmark, and Brazil. Each of these agreements vary, and we chose them so you can see how manufacturers tackle market access for different drugs and regions. Value-based contracts in these markets speed patient access while sharing financial risk between pharma and payers—a win-win situation.
Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals).
Indication: Cystic fibrosis
Country: Canada
Agreement type: Coverage with evidence development (CED), restricted coverage, outcomes-based guarantee.
Date: July 2022.
The Canadian Agency for Drugs and Technologies in Health requires a 94% price reduction on the price of Trikafta, in order for the treatment to be cost-effective. Children with cystic fibrosis between the ages of 2–5 are evaluated after 1 year, to show that they benefit from the treatment. Patients must meet a number of criteria to be eligible for treatment, making the agreement a combination of coverage with evidence development, restricted coverage, and outcomes-based.
Trikafta was already approved for use in children over 6 years of age, but conducting a clinical trial in children between two and five years of age was deemed “ethically challenging.” An uncontrolled trial however in this age group found that the treatment was well-tolerated and reduced biomarkers of the condition. To address unmet needs while acknowledging the lack of data in this patient population, a CED contract with a drastic price reduction was negotiated.
Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)
Indication: Cystic fibrosis
Country: Brazil
Agreement type: Restricted coverage, CED
Date: April 2024
The Brazil Health Ministry came to an agreement with Vertex to allow restricted access to this treatment while regularly monitoring patients at 30 days and 3 months after initiation of treatment. The agreement includes refunds is the treatment does not achieve desired clinical outcomes, aligning pricing with effectiveness.
Kalydeco (ivactafor, Vertex Pharmaceuticals)
Indication: Cystic fibrosis
Country: Denmark
Agreement type: Price-volume agreement; portfolio pricing
Date: October 2018
The Danish procurement body, Amgros, and Vertex Pharmaceuticals, came to an agreement that provides access to a portfolio of drugs for cystic fibrosis, including Orkambi (lumacaftor/ivacaftor) and future therapies, in 2019. Despite this taking place five years ago, it’s a great example of portfolio-based pricing, where payers agree to pay a set fee for a group of related drugs. The more patients that use them, the lower the price per patient.
Lynparza (Olaparib, AstraZeneca)
Indication: Ovarian cancer
Country: Brazil
Agreement type: Restricted coverage, outcome guarantee
Date: May 2022
This agreement was made between AstraZeneca and private insurers throughout Brazil. The treatment is made available without additional costs to the patient and combines features of restricted coverage with outcomes guarantees. Continued coverage is dependent on achieving partial or complete response.
Zolgensma (onasemnogene abeparvovec, Novartis)
Indication: Spinal muscular atrophy (SMA)
Country: Brazil
Agreement type: Outcome guarantee, CED, installment payments
Date: December, 2022
Novarits’ gene therapy Zolgensma is reimbursed based on the need for additional evidence, referred to as coverage with evidence development. This involves using coverage as a means to obtain real-world evidence, to make up for the lack of robust patient data coming from the pivotal trial. The agreement also divides risk between payers and manufacturers , by tying reimbursement to outcomes achieved. Because of the therapy’s great potential to improve the quality of life of children living with SMA, the agreement allows eligible patients to quickly start receiving treatment.
Want to see the library for yourself? Book a demo today here: https://www.lyfegen.com/demo
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Major changes are on the horizon for Medicare’s outpatient drug benefit in 2025, particularly following the release of negotiated drug prices under the Inflation Reduction Act. These changes will significantly impact both payers and drug makers, requiring careful planning and strategy.
One of the most critical updates is the reduction of the out-of-pocket spending cap for beneficiaries, which will decrease from $3,300 this year to $2,000 in 2025. While this cap will help patients manage their healthcare costs, it also increases the financial responsibility for payers and pharmaceutical companies.
Challenges for Specialty Drug Makers
Specialty drug makers, especially those in oncology, will face new challenges with the introduction of a 20% discount during the catastrophic phase of Medicare Part D. Since many patients will reach the $2,000 cap early in the year, this discount will apply for a significant portion of the year, impacting drug pricing strategies.
Impact on Medicare Advantage Plans
Medicare Advantage plans and stand-alone prescription drug plans will also see changes. Their liability for drug costs during the catastrophic phase will increase from 20% to 60%, as the federal government reduces its reinsurance contribution from 80% to 20%. This shift will require plans to adopt new cost management strategies.
How Lyfegen Can Help
As the Medicare Part D redesign approaches, it’s crucial for payers and drug makers to prepare effectively. Traditional cost management methods, like prior authorization, will need to be complemented by innovative approaches such as value-based pricing and market access solutions.
Lyfegen offers essential tools to support these efforts. Our Lyfegen Drug Contracting Simulator allows you to model various drug pricing scenarios, evaluate their impact on revenue and costs, and strengthen your market access strategies. By utilizing this tool, payers and pharmaceutical companies can better navigate the upcoming changes and optimize their drug market access strategies.
Start Preparing Today
Preparing for these changes is essential to maintain effective drug pricing strategies in the evolving Medicare market. Lyfegen’s solutions can assist in designing Medicare Part D formularies tailored to your needs, and in identifying the most appropriate value-based arrangements from our comprehensive database.
Don’t wait—boost your negotiating leverage now. With 2025 fast approaching, the time to act is today. Start using the Lyfegen Drug Contracting Simulator to stay ahead. Book a demo today to get started.
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Insulin is going through monumental shifts in pricing and reimbursement in the U.S. It started with the announcement of reductions in list prices by drug companies last year. First, Novo Nordisk announced plans to reduce the list prices of several of its insulin products beginning January 1, 2024. This included lowering the price of NovoLog and Levemir by at least 65%. This move was followed by a similar commitment by competitor Eli Lilly to reduce Humalog’s price, among others, and came just days before Sanofi’s announcement to decrease Lantus’s price.
Moreover, biosimilar competition is ramping up, particularly in the long-acting insulin glargine space. Rezvoglar and Basaglar are leading the way, as they gain traction on payer formularies, especially in the public Medicaid market.
And this year, owing to implementation of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services began negotiating the net prices of both NovoLog and Fiasp, with public disclosure of said prices due to be revealed by September. Payers will soon be able to use these net prices as benchmarks to leverage better deals in markets besides Medicare. Also, CMS capped monthly out-of-pocket costs of insulin products for Medicare beneficiaries at $35.
For their large populations of insulin-dependent diabetics, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.
Because both list and net prices have come down, payers will likely lose out on some portion of the rebates—which reflect the difference between gross and net price—that they had grown accustomed to getting in the past. At the same time, the increasing number of payers that are adopting a rebate-free, net cost approach to formulary design will benefit from lower net prices.
And cheaper treatment options for patients may translate into better adherence to drug regimens which in turn could lead to improved health outcomes. For payers with a long-term perspective and comparatively little churn or enrollee turnover the potential downstream cost savings could be beneficial.
Lyfegen can assist in the calculations of value for all insulin products, both short- and long-acting, in addition to the design of appropriate formularies.
If you wish to improve your negotiating leverage for insulin products you can do so with real-world simulations for effective prescription drug contracts. Discover the Lyfegen Drug Contracting Simulator, our intuitive solution for streamlining iterative, collaborative drug contracting design.
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The next wave of biosimilars, including Humira-, Eylea-, and Stelara-referenced products, is upon us.
In the U.S., 10 Humira-referenced biosimilars are on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing, as the number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary.
CVS Caremark—the largest pharmacy benefit manager in the U.S.— removed Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product). Hyrimoz appears to be the most favored biosimilar. Similar moves have been signaled by the PBM Express Scripts and its parent company Cigna to be enacted this month, but this time Simlandi will be the most preferred biosimilar.
The FDA also recently approved two interchangeable biosimilars to Eylea, which will produce additional competition for the pharma’s blockbuster as key patent protections are set to expire.
And the biologic Stelara, which was selected as one of the first 10 drugs for Medicare price negotiations, will have its net price disclosed in September of this year in addition to facing biosimilar competition in 2025. The downward pressure on Stelara's price, but also Stelara-referenced biosimilars, will likely be significant.
For their large populations of covered lives who take products in the Humira, Eylea and Stelara-related therapeutic classes, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.
Improved access to biosimilars will offer patients expanded, less costly treatment options. For uptake to happen, payers must educate healthcare providers and patients on the value of biosimilars so that they are on board, whether they are designated by the Food and Drug Administration as therapeutically interchangeable or not.
Hyrimoz and Simlandi are therapeutically interchangeable and favored due to the formulary moves by CVS Caremark and Express Scripts, respectively.
The therapeutic interchangeability designation still plays a role in the U.S., because for biosimilars to be automatically substitutable at the pharmacy they must have proven interchangeability in addition to biosimilarity. As a result, physicians have expressed a preference for biosimilars that have the designation.
But for the many biosimilars that don’t have the therapeutic interchangeability designation, to boost their adoption manufacturers and payers must overcome this de facto regulatory barrier by informing healthcare providers and patients that proof of biosimilarity is sufficient.
Lyfegen can assist in the design of formularies tailored to clients' objectives. It can also accommodate information requests concerning which value-based arrangements are the most appropriate, given the scope of its library database as well as other client services.
If you wish to improve your negotiating leverage you can do so with real-world simulations for effective prescription drug contracts.
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Vertex Pharmaceuticals may soon obtain Food and Drug Administration approval for a non-opioid analgesic, dubbed VX-548, for moderate to severe pain. But will insurers pay, given that there are so many cheap generic prescription opioids and other pain medicines on the market?
Presumably, the new non-opioid pain medication will be substantially more expensive per unit than generic opioids. Given the large numbers of patients needing pain drugs, for post-surgery, for instance, payers will need to manage the cost.
Prescription opioid medications remain a common treatment for pain despite decreases in the total number of opioid prescriptions after 2012. They’re cheap but also effective.
Should VX-548 obtain FDA approval, payers might be reluctant to cover the drug without clear and consistent evidence that the drug works as well or better than prescription opioids. Recent examples of non-opioid analgesics, including Exparel (bupivacaine) and Zynrelef (bupivacaine/meloxicam), demonstrate the kinds of reimbursement challenges drug makers may face, particularly early following their approval by the FDA.
Nevertheless, prescription opioids can be misused, abused, and diverted. In this regard, the non-opioid medicines Exparel, Zynrelef and, if approved, VX-548, do meet an important unmet need. However, not every patient will require access to more expensive medications. And so, it will be imperative to differentiate patient sub-populations by risk factors, in addition to comparing the clinical- and cost-effectiveness of non-opioid treatments to prescription opioids.
Lyfegen can assist in the calculations of value for both prescription opioid and non-opioid analgesics, in addition to the design of appropriate formularies.
Managing pain, whether acute or chronic, invariably involves a balancing act in which doctors, patients and insurers must consider appropriate forms of treatment. Proper patient stratification includes an assessment of the benefits and risks of both opioid and non-opioid medications to individual patients.
Lyfegen can navigate the different ways in which payers and drug makers negotiate contracts for pain medications. In the Lyfegen Library you can find the right model to use as a benchmark during pricing and reimbursement negotiations, which in turn will increase the chances of success. To explore strategies that enhance your ability to negotiate and implement successful pricing and reimbursement agreements for pain medications, visit the Lyfegen Library at lyfegen.com/library.