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How Gene Therapies Are Reshaping Patient Outcomes and Payer Expectations

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How Gene Therapies Are Reshaping Patient Outcomes and Payer Expectations

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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The role of value-based care in patient access

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The role of value-based care in patient access

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:  

  • Programs that work on delivering care more effectively
  • Payment models that involve sharing risk between the payer and the manufacturer  
  • Population-based payments to provider organizations
  • Patient-centered care: focusing on the needs and wants of the patient
  • Restricting access to medications only for those for whom it would be more effective

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:  

  • Pay-for-performance (P4P)
  • Coverage with evidence development (CED)
  • Outcomes guarantees
  • Installment payments
  • Managed entry agreements

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:  

  • Limiting who may receive care
  • Managing revenues
  • Integrating healthcare services  
  • Measuring clinical outcomes

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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Drug Market Access Strategies in 2024: Key Considerations for Pharma Companies

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Drug Market Access Strategies in 2024: Key Considerations for Pharma Companies

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): A New Era for Market Access Strategies in the EU

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The Joint Clinical Assessment (JCA): A New Era for Market Access Strategies in the EU

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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The Cost of Innovation: Budget Impact of Gene Therapy for Sickle Cell Disease on Medicaid Plans

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The Cost of Innovation: Budget Impact of Gene Therapy for Sickle Cell Disease on Medicaid Plans

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

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

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

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

Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions

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

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

Scaling Globally with a Leading Rebate Management Platform

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

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

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


About Lyfegen

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

About TX Ventures

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


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

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

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

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

 

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

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

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

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

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

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

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

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

Read more about the partnership in the official press release.

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

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

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

 

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

 

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

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

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

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

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

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

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

Learn more and start your free trial now

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

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

 

Basel, Switzerland, October 27, 2021

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

 

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

 

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

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

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

 

About Sympany

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

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

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

 

About Lyfegen

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

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

Contact Press: press@lyfegen.com

Contact Investors: investors@lyfegen.com

 

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

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

 

Basel, Switzerland, August 3rd, 2021

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

 

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

 

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

 

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

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

 

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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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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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Canada: Investing in RWE for rare diseases

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Canada: Investing in RWE for rare diseases

Introduction

Canada’s Drug Agency has recently awarded funding to multiple rare disease registries to enhance the “pan-Canadian evidence landscape.” This funding is aimed at bolstering the quality and accessibility of data that can guide regulatory and reimbursement decisions for rare disease therapies. As Canada focuses on building a comprehensive evidence base, pharmaceutical companies, payers, and stakeholders must adapt to the evolving landscape for market access and contracting. Lyfegen’s Agreements Library and Drug Contracting Simulator offer vital tools to navigate these complexities with greater precision and transparency.

Key Takeaways for Pharma and Payers

1. Strengthening Data Quality and Accessibility

What’s Changing: The new funding will support initiatives to improve data accuracy, completeness, and accessibility within rare disease registries across Canada. This enriched data landscape will play a crucial role in guiding therapeutic decisions for rare diseases.

Impact: With access to more comprehensive data, pharma companies and payers can make more informed decisions regarding therapy efficacy and patient outcomes. This data-driven approach is essential for adapting market strategies to address the specific needs of rare disease populations in Canada.

2. Supporting Regulatory and Reimbursement Decisions

What’s Changing: The funding will enable the development of evidence needed to meet Health Canada’s regulatory requirements and the Canadian Agency for Drugs and Technologies in Health (CADTH) reimbursement criteria for rare disease treatments.

Impact: A robust evidence base will accelerate the approval and reimbursement process for rare disease therapies. Pharma and payers can benefit from shorter timelines for market entry and more predictable pricing models aligned with outcomes-based agreements, ensuring that patient needs are met in a timely manner.

3. Advancing Outcome-Based Metrics and Digital Health Solutions

What’s Changing: Emphasis on outcome-based evidence and digital health transformation within rare disease registries will promote a transparent, efficient healthcare ecosystem for these high-cost therapies.

Impact: Outcome-based metrics provide pharma and payers the opportunity to structure contracts that reflect real-world patient outcomes, supporting more sustainable pricing models that align with the health outcomes valued by Canadian healthcare providers.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library, a vast digital repository of drug pricing agreements, offers valuable insights into historical trends and pricing models that support evidence-based contracting decisions. By leveraging over 6,000 agreements and diverse pricing models, pharma and payers can develop contracts that align with Canada’s specific regulatory and reimbursement frameworks.

2. Drug Contracting Simulator: Lyfegen’s Drug Contracting Simulator enables teams to model various pricing scenarios, allowing them to understand potential outcomes and financial risks associated with rare disease therapies. By simulating real-world conditions, stakeholders can make informed contracting decisions that support the Canadian healthcare system’s goal of data-driven, sustainable solutions for rare diseases.

Conclusion

Canada’s initiative to strengthen its rare disease data landscape marks a significant step forward in improving access to and affordability of rare disease therapies. For pharma companies, payers, and other stakeholders, this shift provides opportunities to develop innovative contracts that align with Canadian healthcare goals. Lyfegen’s Agreements Library and Drug Contracting Simulator offer the tools needed to support evidence-based decision-making, enabling healthcare players to navigate Canada’s evolving market access landscape confidently.

Book your demo today to discover how our tools can transform your approach to rare disease therapy access in Canada: https://www.lyfegen.com/demo

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FDA Launches a new program to speed patient access

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FDA Launches a new program to speed patient access

Introduction

The FDA has launched an innovative pilot program to expedite patient access to essential therapies: the Split Real Time Application Review (STAR). Starting December 2, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will begin accepting a limited number of marketing applications under this new initiative. By focusing on early and continuous review processes, the STAR program aims to minimize the time between final submission and the FDA’s action date, providing faster access to treatments for patients with unmet medical needs.

Key Takeaways for Pharma and Healthcare Providers

1. Accelerated Review Process for Unmet Needs

What’s Changing: The STAR program is designed to review applications in segments, allowing FDA reviewers to assess data in real time as it becomes available. This continuous review approach differs from traditional methods, where applications are evaluated in full only after complete submission.

Impact: For pharmaceutical companies, this streamlined process could mean faster paths to market, particularly for therapies targeting critical, unmet needs. It emphasizes the FDA’s commitment to addressing patient needs more swiftly, which could reduce financial burdens on developers facing lengthy approval processes.

2. Collaboration Between CDER and CBER

What’s Changing: The STAR program is a collaborative effort involving both CDER and CBER, expanding its applicability to a broad range of therapies, including new drugs and biologics. This joint approach signals the FDA’s intention to standardize and extend this model across diverse therapeutic areas.

Impact: By involving multiple FDA centers, the STAR program encourages broader participation from biotech and pharmaceutical companies developing biologics, vaccines, and innovative therapies. For patients, it represents a promising step toward quicker access to a wider array of advanced treatment options.

3. Focus on Real-Time Data and Incremental Submissions

What’s Changing: Unlike traditional application reviews that rely on fully completed submissions, STAR’s approach allows the FDA to review segments as they are completed. This real-time data review supports a more dynamic evaluation process and could accelerate decision-making.

Impact: For the pharma industry, this shift may lead to shorter regulatory timelines and a more predictable approval process. By providing early feedback on submitted data, the FDA enables companies to address potential issues proactively, ultimately supporting faster market access for breakthrough therapies.

Conclusion

The FDA’s STAR program represents a transformative approach to regulatory review, one that aligns with the needs of modern healthcare. By focusing on continuous, real-time reviews, the FDA is paving the way for faster patient access to treatments that address critical health needs. For pharmaceutical companies and healthcare providers, this new pathway offers a chance to bring innovations to patients more swiftly and efficiently. As the STAR program unfolds, its success could shape the future of regulatory review, setting a new standard for timely patient access in the U.S. healthcare system.

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Switzerland. Improving the fast-track process and anti-migraine drugs

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Switzerland. Improving the fast-track process and anti-migraine drugs

Introduction

Switzerland has taken steps to streamline drug approvals and make essential therapies more accessible by revising Swissmedic’s fast-track and temporary authorization procedures, effective as of October 15, 2024. These changes aim to expedite market access for crucial treatments, especially for those addressing urgent healthcare needs. Recently, the Federal Office of Public Health (FOPH) conducted a Health Technology Assessment (HTA) on Calcitonin gene-related peptide (CGRP) receptor antagonists, a class of anti-migraine drugs. The analysis determined that these drugs are more cost-effective for chronic migraine sufferers than for those with episodic migraines, influencing how they may be priced and reimbursed.

Key Takeaways for Pharma and Payers

1. Revised Fast-Track and Temporary Authorization Processes

What’s Changing: Swissmedic has updated its fast-track and temporary authorization procedures, intended to speed up drug approval times. This revision allows for quicker access to therapies that address significant healthcare needs, supporting patients in receiving timely treatments.

Impact: For pharmaceutical companies, these changes open up opportunities to bring their innovations to market faster, particularly for therapies that address chronic and complex conditions. With the fast-track pathway, companies can achieve quicker regulatory approval, which could help with meeting demand and advancing critical treatments for conditions like chronic migraine.

2. Pricing Adjustments Based on Cost-Effectiveness Analysis

What’s Changing: The FOPH’s recent HTA on CGRP receptor antagonists for migraines concluded that these drugs offer higher cost-effectiveness for chronic versus episodic migraine patients. As a result, FOPH has proposed a price reduction to align with the value provided, ensuring that patients benefit from more affordable access to these treatments.

Impact: For payers and pharma, this emphasis on value-based pricing represents a growing trend in Switzerland. Drug prices are being set based on real-world evidence and cost-effectiveness, pushing the industry towards more sustainable, outcome-driven pricing models.

3. Inclusion in the List of Pharmaceutical Specialities (LS)

What’s Changing: FOPH re-evaluates drug prices every three years and decides if they should remain on the List of Pharmaceutical Specialities (LS), which comprises all drugs covered by basic insurance. For certain treatments, such as CGRP receptor antagonists, drugs may be included with limitations—meaning they will only be reimbursed under specific conditions.

Impact: This conditional reimbursement approach supports more targeted healthcare spending, benefiting patients who meet specific criteria. For pharmaceutical companies, meeting these requirements is essential to ensure ongoing reimbursement and access to Switzerland’s market.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library offers a comprehensive resource of pricing agreements, enabling pharma and payers to explore pricing models that align with Switzerland’s emphasis on cost-effectiveness. With access to over 6,000 agreements, pharma teams can develop flexible, outcome-based pricing strategies that meet Swiss regulatory and reimbursement requirements.

2. Drug Contracting Simulator: The Drug Contracting Simulator provides a powerful tool for modeling various pricing scenarios. By simulating real-world conditions, stakeholders can assess the financial and clinical outcomes of fast-track approved therapies, enabling them to create tailored, data-driven agreements that reflect the FOPH’s cost-effectiveness criteria.

Conclusion

Switzerland’s recent adjustments to its fast-track drug approval processes and value-based approach to anti-migraine drug pricing underscore the country’s commitment to accessible, cost-effective healthcare. For pharmaceutical companies and payers, these changes represent an opportunity to align market access strategies with Switzerland’s evolving regulatory landscape. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential support for navigating these complexities, helping stakeholders design effective, outcome-driven agreements that meet Switzerland’s regulatory standards.

Book a personalized demo today to see how Lyfegen can transform your market access strategy under Switzerland’s new reforms: https://www.lyfegen.com/demo

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Spain: Reducing unnecessary care and improving HTA education

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Spain: Reducing unnecessary care and improving HTA education

Introduction

Spain is making strides in healthcare by prioritizing education, innovation, and cost-effective care. Recently, the Spanish Council of Ministers allocated over 44 million euros from pharmaceutical sales to support various public health initiatives, focusing on two critical areas: reducing unnecessary care and enhancing Health Technology Assessment (HTA) education for healthcare professionals. These investments are aimed at improving the efficiency of healthcare delivery, reducing costs, and supporting more informed decision-making around drug use and preventive care.

Key Takeaways for Pharma and Payers

1. Funding for HTA Education and Training

What’s Changing: Part of the allocated funds will go toward continuing education programs for healthcare professionals, specifically to improve their understanding of Health Technology Assessment (HTA). By deepening professionals’ knowledge of HTA, Spain aims to ensure that drug evaluation and therapeutic positioning are guided by evidence-based practices.

Impact: For pharmaceutical companies, this initiative means greater scrutiny of drug effectiveness and cost-effectiveness, especially as healthcare providers become more proficient in HTA principles. Payers may also benefit, as a well-informed healthcare workforce can make better use of resources, potentially lowering overall costs.

2. De-prescription of Unnecessary Drugs and Promotion of Preventive Care

What’s Changing: The initiative will also fund programs aimed at de-prescribing unnecessary medications to reduce healthcare costs. Alongside this, Spain is placing a stronger emphasis on preventive care, which not only improves patient outcomes but also curtails spending on unnecessary treatments.

Impact: For pharma, this push towards de-prescription may affect demand for certain drugs, particularly those deemed low-value or non-essential. However, it also presents an opportunity to align with Spain’s focus on value-based care, potentially promoting medications that are supported by strong evidence of efficacy. For payers, preventive care investments mean a healthier population with fewer costs linked to chronic diseases, reducing the financial burden on the healthcare system.

3. Supporting Innovation Through Therapeutic Positioning Reports

What’s Changing: Another portion of the funding will support the consolidation of therapeutic positioning reports. These reports will help evaluate and position drugs more effectively within the healthcare system, ensuring that innovative treatments are assessed rigorously before they reach patients.

Impact: Pharmaceutical companies may see a more streamlined and transparent pathway for introducing new drugs to the Spanish market. This approach promotes fair competition and emphasizes innovation, aligning with Spain’s broader goals of delivering cost-effective, impactful healthcare solutions.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library provides access to an extensive collection of value-based agreements that can help pharma companies align with Spain’s focus on cost-effective treatments. This resource allows pharma to explore agreements and pricing models suited to Spain’s HTA-driven environment, improving the chances of successful market access.

2. Drug Contracting Simulator: With the Drug Contracting Simulator, stakeholders can simulate pricing models that reflect Spain’s emphasis on evidence-based evaluation. By assessing various pricing scenarios and outcomes, pharma companies can design agreements that align with Spain’s value-based healthcare priorities, supporting successful negotiations and reimbursement strategies.

Conclusion

Spain’s recent investments in HTA education, de-prescription, and preventive care reflect the country’s commitment to a sustainable, efficient healthcare system. For pharmaceutical companies and payers, these changes highlight the need to align market access strategies with Spain’s goals of evidence-based care and cost containment. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential tools to navigate these shifts, enabling stakeholders to create outcome-driven agreements that support Spain’s healthcare objectives.

Book a personalized demo today to see how Lyfegen can empower your market access strategy in Spain’s evolving healthcare landscape: https://www.lyfegen.com/demo

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