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If gene therapies in the diabetes space gain approval, reimbursement challenges will reach a critical juncture

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If gene therapies in the diabetes space gain approval, reimbursement challenges will reach a critical juncture

Gene therapy’s biggest prize thus far in terms of market potential may be in the diabetes space, specifically diabetic complications, which are varied and afflict millions of diabetics. Several gene therapies targeting diabetic complications are in late-stage clinical development, including Engensis and RGX-314. These two gene therapies are projected to possibly receive U.S. marketing authorization in the second and fourth quarters of 2024, respectively.

As a treatment indicated for diabetic peripheral neuropathy, Engensis has a possible eligible population in the U.S. of 5.5 to 11.5 million adult patients. Meanwhile, as a treatment targeting diabetic retinopathy, RGX-314 has a potential eligible population of approximately 4.2 million adult patients.

If approved, these gene therapies could address deficiencies in care for these patients. Of course, not all eligible patients will be prescribed these treatments. Nevertheless, given the unmet need in this space, it’s projected that millions of patients would at least consider such therapies.

Diabetic peripheral neuropathy affects the feet and legs of patients first, followed by the hands and arms. Signs and symptoms include numbness or reduced ability to feel pain or temperature changes. Besides managing blood sugar to treat diabetic neuropathy, there’s a plethora of symptomatic relief medications which include nerve pain medications, anti-depressants, and anti-seizure medicines.

As an investigational non-viral gene therapy – to be taken at intervals, so not a one-time treatment - Engensis has the potential to become the first analgesic drug to significantly ameliorate and possibly reverse the progression of diabetic peripheral neuropathy. It holds great promise, but for payers the cost burden may be very difficult to manage.

Diabetic retinopathy is a leading cause of visual impairment. It is characterized by vascular lesions and neuronal damage of the retina. Treatment options for this condition are currently limited. Gene therapy has the potential to provide an alternative treatment for diabetic retinopathy with distinct advantages, such as longer therapeutic effect, less injection frequency, ability to intervene at disease onset, and potentially fewer side effects. RGX-314 is one such therapy –  an investigational recombinant adeno-associated virus vector – being developed as a potential one-time treatment for diabetic retinopathy and wet age-related macular degeneration. Similar to Engensis, the up-front costs for payers seeking access to RGX-314 may be very burdensome. Invariably the question is how, once these gene therapies gain regulatory approval, the healthcare system will be able to pay for these high-priced therapies that target such potentially large populations. Value-based pricing agreements, in which refunds would be offered in instances of treatments not attaining certain pre-determined outcomes, have proven to be highly effective.

The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts for all kinds of cell and gene therapies – including those targeting large populations – by using intelligent data-driven algorithms to capture and analyze patient-level drug cost data. The Lyfegen Model & Agreements Library can help stakeholders explore real-world models and identify which model are best-suited for the specific use-case and desired negotiation outcomes.

Learn more on: lyfegen.com

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One-time cell and gene therapies offer promises of cures, but payment challenges remain

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One-time cell and gene therapies offer promises of cures, but payment challenges remain

Roughly half a century ago, scientists first began hypothesizing that they could cure diseases by altering genes. Thanks to recent advances in the fields of molecular biology and gene editing, this hope of yesteryear has become a reality. Today, a growing number of cell and gene therapy products are being used to improve the health of patients around the world by fighting disease at the cellular level.

Most cell and gene therapy products are intended as one-time injection treatments, which in turn may offer durable cures. Until now, the overall costs - or budgetary impact to payers - of approved cell and gene therapies have mostly been manageable due to the (very) small populations being served. But this is about to change with the advent of treatments indicated for much larger populations and for much more common conditions such assickle cell disease, diabetic complications, and osteoarthritis.

However, without a feasible way for payers to pay for these treatments, patient access will remain a major impediment. In turn, this could ultimately result in a continued high societal burden for patients afflicted by diseases targeted by cell and gene therapies.

While upfront costs of cell and gene therapies can be very high on a per-unit basis, having a cure rather than a temporary and incomplete remedy or merely an alleviation of symptoms could lead to cost savings in the long run. And it’s been shown that certain cell and gene therapies may even be cost-effective in the short term, relatively soon after they’ve been administered.

But in order for this value proposition to become a more widespread accepted practice, payers must adopt a view that incorporates the concept of value-based pricing. Traditional methods of reimbursement that are commonly used for  maintenance medications such as anti-hypertensives and anti-depressants, aren't applicable. As a result, payers will need to implement value-based pricing arrangements like pay-for-performance schemes or warranty programs. With these type of arrangements evidence is gathered and analyzed to assess whether a cell and gene therapy is proving effective  over time—on other words, as a drug yields positive, intended outcomes for a patient, the therapy’s value is proven.

There are more than 1,000 clinical trials of cell and gene therapies underway worldwide. Consequently, experts forecast a wave of new cell and gene therapy approvals in the coming years across numerous therapeutic areas, including several with very large sub-populations numbering millions. Invariably the question becomes how patients, and the healthcare systems, will pay for these therapies.

Lyfegen is already working with payers and pharmaceutical companies to implement value-based pricing arrangements in multiple markets. The Lyfegen Platform is designed to enable more efficient and transparent management of value-based drug pricing contracts for cell and gene therapies by using intelligent algorithms to capture and analyze real-world, patient-level drug cost data. Additionally, the Lyfegen Model & Agreement Library contains over 18 innovative models and more than 2,000 agreements from global payers and pharma that can be invaluable resources when identifying the right model to propose during negotiations.

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Lyfegen co-founders announce leadership roles with the newly established European Association of Value-Based Healthcare

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Lyfegen co-founders announce leadership roles with the newly established European Association of Value-Based Healthcare

We proudly announce our role as contributors in the founding team of the newly established European Association of Value-Based Health Care (EAVBHC), launched at the European Parliament in Brussels this week. Girisha Fernando and Michel Mohler stand alongside visionary minds, leveraging their extensive expertise in value-based healthcare. We are delighted to offer our support to João Marques-Gomes, PhD, who serves as President of the Association and has been a member of the Lyfegen Advisory Board for many years.

EAVBHC represents a profound shift in European healthcare systems, moving away from supply-driven models to patient-centered care. The primary goal is to restructure healthcare by focusing on what truly matters to patients: improving outcomes, reducing costs, and enabling informed decision-making. Quality improvement, cost reduction, and empowering patients through data-driven answers are at the core of this new paradigm.

To achieve these goals, EAVBHC has launched various initiatives that will revolutionize healthcare practices:

The High Value Program engages with European politicians and decision-makers to integrate value-based healthcare principles into policies and actions. Through collaborative efforts, EAVBHC ensures that value-based healthcare becomes the cornerstone of healthcare systems across Europe.

The Centre for High-Value Care serves as a hub for scientific research, knowledge dissemination, and collaboration. Through research articles, case studies, and the European Research Consortium for VBHC, valuable insights and evidence are shared, empowering healthcare professionals with the knowledge to drive transformation in their organizations.

The VBHC Academy is committed to ensure that future clinicians and managers receive comprehensive training in value-based healthcare, shaping a new generation of healthcare leaders who will continue to build upon and push value-based healthcare  forward.

Our involvement in the EAVBHC is driven by our steady commitment to shaping healthcare, focusing on patient-centered care, and fostering a future where outcomes matter, costs are optimized, and healthcare decisions are data-driven. Our joint effort promises a brighter future, where value-based contracting makes a marked and meaningful difference in the lives of patients, ultimately improving the healthcare experience for all.

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Accelerating Drug Access: Lyfegen's Innovative Drug Contracting Simulator

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Accelerating Drug Access: Lyfegen's Innovative Drug Contracting Simulator

In the heart of innovation, where technology meets healthcare, Girisha Fernando, CEO of Lyfegen, stands as a beacon of transformation. We sat down with him to discuss the groundbreaking launch of the Lyfegen Drug Contracting Simulator, a tool set to revolutionize drug access, pricing and contracting.

Fernando begins by outlining the quintessential challenge that spurred the creation of this novel tool. “Drug access, pricing and contracting has been entangled in the complexities of payer negotiations for far too long. Traditional methods like manually modeling pricing and contracting scenarios are not just cumbersome; they’re archaic, in light of the innovative drugs we are seeing, such as gene therapies.”

On the quest for a solution that addresses the underlying issues such as uncertainties that prolong or event prevent access, and finding a win-win scenario that both pharma & payers are happy with, Lyfegen has developed a groundbreaking solution – the Lyfegen Drug Contracting Simulator. The innovation embodies Lyfegen’s ambition to streamline and revolutionize the drug pricing and contracting process.

“What we’ve created is not just a better Excel, but a solution - intuitive, real-time, limitless. It was made to close the gap between old practices and new innovations within the healthcare space. It’s the future of drug access.”

As we delve deeper into the conversation, Fernando's enthusiasm for the simulator's potential benefits becomes palpable. “It’s about accelerating strategies, saving time, and fostering better decision-making,” he asserts. “The Lyfegen Drug Contracting Simulator is a multi-faceted solution that combines drug pricing, contracting, and business case generation, all within a collaborative and innovative framework.” The uniqueness of the Lyfegen Drug Contracting Simulator lies in its features, as Fernando highlights.

“We’re talking about a simulator that not only runs real-world simulations but also provides data-driven insights to empower negotiations.” This level of sophistication, according to Fernando, addresses concerns beyond simple discounts and delves into the nuances of value-based and outcome-based contracting models. What strikes most about Fernando’s vision is incorporating AI to guide users on optimal pricing and rebate models. “In today’s world, the intelligent use of data is crucial. The simulator can help pharma and payers to become more efficient and successful.”

As our conversation nears its end, Fernando touches upon a crucial aspect – data security. “Data privacy is non-negotiable. Lyfegen is committed to rigorous adherence to international data privacy standards and state-of-the-art data security.” Fernando’s final thoughts encapsulate the essence of the Lyfegen Simulator. “The Lyfegen Simulator is a paradigm shift in how the pharmaceutical industry will approach drug pricing. It’s about turning uncertainty into understanding, and that’s a powerful change.”

As we part ways, it’s clear that the Lyfegen Drug Contracting Simulator isn’t just another product launch. It’s a vision brought to life, a testament to Fernando’s belief in the transformative power of technology in healthcare. With this launch, Lyfegen isn't just offering a solution; it's shaping the future of drug access and contracting.

Learn more about it here.

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Who does it better? Assessing a value-based drug price in Europe vs the US

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Who does it better? Assessing a value-based drug price in Europe vs the US

U.S. and European healthcare payers are increasing their utilization of value-based drug pricing agreements to hold down drug costs, bring better value and improvements to health outcomes, and determine a fair price for new drugs. The question of who does the assessments to determine a drug’s fair price is answered differently in the EU than in the U.S.

 

National healthcare leaders have a common problem to solve and a common goal to achieve. The problem is how to protect national healthcare budgets from overwhelming drug costs without discouraging pharmaceutical manufacturers from developing new products. The goal is to provide populations with equitable access to innovative, safe, clinically effective, and cost-effective healthcare therapies.

In the U.S., payers and policymakers are trying to control drug expenditures and determine the value of new drugs in an opaque, free-market environment. In Europe, government price controls and centralized clinical and economic evaluations of new drugs are standard. For both these pharmaceutical markets, drug pricing agreements based on value instead of volume are gaining traction.

The problem: drug prices keep rising

Pharmaceutical sales in Europe are almost a quarter of all drug sales globally. From 2015 to 2020, the top five European markets–the UK, Germany, France, Italy, and Spain–accounted for 17.4% of sales of new drug therapies. These top five markets are predicted to increase spending by $51 billion through 2026.

North America is the largest pharmaceutical market, accounting for almost half of the total global sales. From 2015 through 2020, the U.S. purchased 63.7% of all the new medicines introduced. The U.S. is expected to increase drug spending by an estimated $119 billion through 2026.

According to IQVIA, a leading healthcare consulting firm, the change in drug spending in the U.S. and European markets through 2026 will be due, in large part, to new brands.

The goal: access to new, high-quality drug treatments at a fair price

Healthcare payers don’t want to take on the financial risk and clinical uncertainty of a new, high-cost pharmaceutical product. Payers want to provide patients with equitable access to innovative treatments that improve health outcomes, especially in therapeutic areas with unmet health needs.

Value-based drug pricing arrangements address these concerns with evidence-driven, outcome-based agreements. The payer and manufacturer share the risks of a new drug not performing as expected. In both the U.S. and the EU, payers and manufacturers are engaged in more finance-based drug pricing contracts than performance-based contracts–but this trend is shifting.

Assessing a drug’s value in the EU healthcare system

Value-based drug pricing arrangements are called managed entry agreements (MEAs) in Europe. MEAs between drug manufacturers and healthcare payers can be finance-based (FBAs), performance-based (PBAs), or service-based agreements (SBAs).

Unlike the U.S., the EU has a centralized system for assessing a drug’s value. Each EU member state has an agency that uses an evidence-based data gathering process called health technology assessments (HTAs). HTAs include nine domains for assessment–four clinical and five non-clinical–that evaluate the efficacy and added value of a new drug compared to other treatment options already available on the market.

The work of the member states’ HTA bodies is coordinated by the European Network for Health Technology Assessment (EUnetHTA). However, conclusions and decisions related to drug pricing and reimbursement remain de-centralized.

Coverage with Evidence Development (CED) may be a part of an MEA and come after the HTA. CED is a way for urgently needed treatments to come to market under conditional approval while real-world evidence continues to be collected. This additional data should help payers decide about coverage. CED use varies by country, with the most CED found in the UK and the U.S. (through Medicare).

Related Post: Indication-specific pricing to make inroads in the U.S.

Assessing a drug’s value in the US healthcare system

The possibility of developing a centralized Health Technology Assessment for the U.S. Healthcare System was the focus and title of a white paper published in early 2020 by the University of Southern California Leonard D. Schaeffer Center for Health Policy & Economics.

The white paper describes the complexities of creating a national HTA organization in the U.S. It examines the difficult dynamics of the many stakeholders in the healthcare system; few are operating with enough transparency and coordination with other stakeholders to support value-based drug pricing. The authors conclude that in the current polarized legislative environment in the U.S., an attempt to develop a national HTA organization would be met with strong political resistance.

In the absence of the European-style centralized HTA body, U.S. payers look to alternative sources for the data they need for drug pricing negotiations. Private and public payers may find clinical and economic evaluations from various agencies that do HTAs on a limited scale. These include government and independent organizations, such as the Department of Veteran’s Affairs, Medicaid, the Patient-Centered Outcomes Research Institute (PCORI), and the Agency for Healthcare Research and Quality (AHRQ). One of the most influential organizations in this space is the independent, non-profit Institute for Clinical and Economic Review (ICER).

Unfortunately, these organizations don’t do value-based pricing evaluations for every drug that comes on the market, and some of their work is not publicly available. Even if analysis of a selected drug is available, it may not cover the key metrics a customized value-based drug pricing agreement needs to track.

When real-world data about a drug’s performance is limited, it’s often up to the manufacturer and payer entering the value-based contract to develop the framework and the data collection and analysis capability, either in-house or through a third-party vendor.

The Lyfegen Solution

The Lyfegen Platform is a customizable solution for healthcare payers, pharma, and medtech companies who need to gather and analyze real-world evidence about a drug’s performance for value-based drug pricing agreements. Lyfegen’s value-based contracting software collects real-world data and uses intelligent algorithms to provide valuable insights into clinical effectiveness and costs.

Lyfegen’s contracting platform helps implement and scale value-based drug pricing contracts with greater efficiency and transparency. By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about Lyfegen’s software solutions, contact us to book a demo.

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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.

Learn more about Retrospective Payment System

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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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

 

READ 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.”

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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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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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Professor Jens Grüger, PhD, joins Lyfegen Advisory Board

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Professor Jens Grüger, PhD, joins Lyfegen Advisory Board

Lyfegen is proud to announce that Professor Jens Grueger, PhD, has joined the company´s Advisory Board. Jens is the former Head of Global Access at F. Hoffmann-La Roche and has led country, regional, and global health economics and outcomes research, pricing, and market access organizations for SmithKline Beecham, Novartis, Pfizer and Roche.

He is a healthtech pioneer, founding his first digital disease management start-up in 1997, has been a long-time scientific reviewer for Value in Health and is the President Elect at ISPOR, the leading professional society for health economics and outcomes research. Throughout his various roles he has been promoting value-based pricing models across healthcare systems. Jens holds a PhD in Mathematical Statistics from the Technical University of Dortmund and is Affiliate Professor at the CHOICE Institute at University of Washington School of Pharmacy in Seattle, USA.

With his vast experience and expertise in healthcare, Jens will support Lyfegen to achieve its mission of facilitating and accelerating value-based healthcare to improve the life of patients.

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Nico Mros named Lyfegen’s Chief Customer Experience Officer (CXO)

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Nico Mros named Lyfegen’s Chief Customer Experience Officer (CXO)

Lyfegen is excited to announce that co-founder Nico Mros is taking on a new role as Chief Customer Experience Officer (CXO). Until recently, Nico held the position of Chief Operating Officer (COO) of Lyfegen. Nico gives first-hand insights on what this shift means for him and Lyfegen.



The choice to transition into this new and exciting role is a logical one as Lyfegen continues to evolve and center all decisions and platform optimizations around the customers and patients needs.

With more than 8 years of experience in healthcare, Nico is a value-based healthcare leader with a strong skill set in project and change management. He is and stays responsible for customer experience and success at Lyfegen and leads the digitization projects for value-based agreements and real-world data insights of Lyfegen’s platform. This change helps to advance Lyfegen’s mission which is to create the most disruptive health tech company by driving the world’s transition to value-based and data-driven healthcare.

What does Nico have to say about his new title and the reasons for the change? We asked our new CXO to share his thoughts with us:

“At Lyfegen, we lived customer centricity since the beginning. This change in title comes natural and underlines for everyone what our existing customers tell us regularly – they feel understood, motivated and purpose-driven when working with us.” Nico says. “As a Co-Founder of Lyfegen I gladly accept this new title, letting go of my previous title as COO which, I honestly never liked. The choice to change this title feels obvious and necessary at the same time. I would say – just right. “

Furthermore Nico sees three main reasons for the renaming of the position which are:

1. The happiness of the customers at Lyfegen is of utmost importance, it is even a key factor for success at Lyfegen. Hence, Lyfegen wants to establish a point of view that focuses unconditionally on customer happiness, allowing to establish trusted and long-lasting relationships with clear point of contacts.

2. Besides acting directly with the customers, a customer-first environment within Lyfegen is crucial. Embedding the customer perspective in every decision, beginning with product design and ending with company strategy, allows Lyfegen to be the customer-centered company we want to be.

3. Keep it simple and understandable. While a COO can have many focuses, the Customer Experience Officer has just ONE: the customer's best possible experience and success.


Further Nico adds: “It is my firm belief that helping customers to gain success and delivering superior experience in every point of contact can be a major competitive advantage, even a unique selling point. As CXO I can guarantee this kind of philosophy from the product to personal interactions. In combination with innovative technology, this is the key to sustainable success.”

Are you ready to become a happy customer?

 

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What does “Mindful Leadership” Mean for the CEO of a Health Tech Start-up – During a Pandemic Era?

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What does “Mindful Leadership” Mean for the CEO of a Health Tech Start-up – During a Pandemic Era?

Our CEO, Girisha Fernando, gives first-hand insights to what it means to be a “Mindful Leader” and how the COVID19 pandemic has impacted his leadership style.



Admit it, you clicked on this blogpost because the question itself raises endless questions. What is mindful leadership? Is it really possible to be a mindful leader in a high-paced (stressful and sleepless) startup environment? Now add the physiological stress of a pandemic to the equation.

Recently I came across one of the live lectures of Simon Sinek (if you don’t know him: google him), focusing on the topic of “mindful meditation for focused leadership”. I was pleasantly surprised to see that mindfulness and mindful leadership is gaining well-deserved attention in the workplace. Before I dive into how I live by this leadership style at Lyfegen, let’s quickly dive into what it means:

What is Mindful Leadership (without writing a Wikipedia essay)?

Mindful leadership is leading while being aware in the present, focusing (in our case) on the road to success rather than success itself, all while interacting humbly within the team and with customers.

When confronted with challenges, a mindful leader will focus on action rather than control, remaining as agile and calm as possible. After all, you cannot always control the output but can influence how the team gets to it.

Example: It unexpectedly starts raining. A controlling leader will focus on the unforeseen rain and how the team failed to get sunshine (despite it not having necessarily been in their power), micromanaging every consequent step.

A mindful leader will stay calm, gearing up on raincoats & boots for his team, enabling and helping them to adapt their strategy in order to reach sunshine.

While this is a rather simplistic way of looking at mindful leadership, you get the overall idea and how this encourages a high confidence, creative, agile, and cooperative environment.

Mindful Leadership at Lyfegen

I am by no means an expert in mindful leadership and have made my share of mistakes. My Buddhist family background has taught me a lot about mindfulness, incorporating meditation into my daily routine.

However, one would think that practicing mindful leadership is harder in a high-paced start-up environment. I disagree: it is exactly in such an environment that, despite the 14+ hour workdays, one needs to stay present. Focus on the now and continuously fine-tune how to “reach the sunshine”, learning from mistakes on the way.

When the COVID-19 pandemic hit Switzerland hard in March, our team was faced with various challenges in terms of business and speed of implementation. However, team-work was not one of them and for that I greatly attribute this leadership style.

We took everyday as it came and continued, even digitally, to work together like an orchestra in perfect harmony. When comparing to the analogy above, COVID-19 was a true thunderstorm and at the same time, it gave light to a rainbow of opportunities.

My 5 key takeaways for becoming a more mindful leader:

- Focus on the now: optimize how your team works together. The goal will follow as a direct result.

- Focus on the essential: if everything is a priority then nothing is a priority. As a leader, make sure everyone is working towards the same milestones along the road rather than mainly focusing on the goal.

- Always remain humble: treat others the way you expect them to treat you (unfortunately a lot of people in other companies know this but don’t live by it).

- Never be afraid to fail. Let go of fear to unlock maximum potential.

- Always take a moment, as a leader, for self-reflection & calm. At Lyfegen, we have a little room in our office with some bean-bags where anyone can retreat and meditate during the day. If you don’t find me at my desk, this is where you’ll find me.

 

 

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Meet our new in-house detective: Hello to Alina Bratu!

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Meet our new in-house detective: Hello to Alina Bratu!

To build the best software ever, you also need the best team ever. We are meticulous in our selection and delighted to announce that we have found a gem for our junior quality engineer position: Alina Bratu has joined Lyfegen to improve the quality and user experience of our platform. We sat down with Alina to learn about her experience, her goals, and her aspirations.

 

Hello Alina, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?

Hi! I grew up in the city of Buzau in Romania and currently live in Bucharest. In college, I studied public administration and later decided to pursue a career in analytics. With the recommendation of friends, I decided to move towards software testing – which is the best decision I’ve made!

What excites you about being a junior quality engineer?

I like to view software testing as the work of a detective who follows clues that eventually help them to solve a case. It is a challenging and ever-changing line of work, and the best thing about it is that it truly impacts the delivery of quality products in a tech-driven world.

Why did you decide to join Lyfegen?

The company’s mission to make healthcare more accessible resonated with me, and I was really excited about the opportunity to work on a project that has the potential to impact the world. Working in a start-up environment with such a motivated and talented team is an amazing chance for me as a junior QA to develop my career while applying the knowledge I gained in the past year to something new and meaningful.

What do you want to learn or improve on this year?

My main goal this year is to learn more about the healthcare industry while also expanding my QA knowledge and expertise.

How will your know-how help to improve our customers’ experience of the Lyfegen platform?

As a QA engineer, I am responsible for tracking down any defects that might affect the users’ interaction with the platform. As I enjoy doing this ‘detective work’ and challenging the software in different ways, together with the developers, I can ensure that the user experience will be pleasant and the platform will look and act accordingly.

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

In my free time, I enjoy reading fiction and self-development books and traveling as these activities help me to gain a new perspective and relax. When I’m not engaging in these hobbies, I enjoy cooking, watching movies, and playing board games with my friends.

Is there anything else you’re looking forward to outside of work this year?

I want to achieve balance and start enjoying and practicing my hobbies more. I am also planning to dust off my driving skills as I’ve postponed this for quite some time!

 

We are super happy to have you with us, Alina!

MEET THE LYFEGEN TEAM

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Lyfegen Supports the Sustainable Development Goal #3: Good Health & Well Being

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Lyfegen Supports the Sustainable Development Goal #3: Good Health & Well Being

Nico Mros, Lyfegen’s COO, explains why Lyfegen is a firm believer in the UN Sustainable Development Goals and how the company works towards Goal # 3: Good Health & Well Being.

Chances are that since the pandemic hit, you have at least heard of the UN Sustainable Development Goals. But what do these mean and how does a company like Lyfegen incorporate these in their business?

The Basics

The 17 goals were set in 2015 by the United Nations General Assembly with the intention of reaching these by 2030. The interlinked goals are a “blueprint to achieve a better and more sustainable future for all. They address the global challenges we face, including poverty, inequality, climate change, environmental degradation, peace and justice.” Each of the 17 goals outlines even more specific targets, which are constantly monitored and discussed between countries.

Lyfegen & Sustainable Development Goal #3: Good Health & Well being

Ensuring healthy lives for all and promoting well being is an essential goal, even more so since the pandemic affected millions worldwide. That said, this goal aims at improving the health of millions of people, increasing their life expectancy and reducing child and maternal mortality. In addition, it addresses persistent and emerging health issues, focusing on providing more efficient funding of health systems. This in turn, enabling millions of people worldwide to have more widespread access to the medication they need.

Specifically, Sustainable Development Goal #3 outlines the following target:

“3.8 Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”

Sounds familiar? Lyfegen’s mission is to help patients to access innovative therapies by driving value-based healthcare. In other words: Doing what’s right for patients!

The pay-for-performance model, which Lyfegen enables through their value-based contracting platform, allows for more people worldwide to have access to innovative and often expensive medication. This directly addressing the UN’s goal to “provide more efficient funding of health systems” and have more “widespread access to medication”.

With some of the leading manufacturers, payers, and care providers already using Lyfegen’s solutions, a clear step towards supporting the UN Sustainable Development Goals is taken. We are proud to be a part of this journey towards a better future!

DISCOVER LYFEVALUE

 

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Who does it better? Assessing a value-based drug price in Europe vs the US

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Who does it better? Assessing a value-based drug price in Europe vs the US

U.S. and European healthcare payers are increasing their utilization of value-based drug pricing agreements to hold down drug costs, bring better value and improvements to health outcomes, and determine a fair price for new drugs. The question of who does the assessments to determine a drug’s fair price is answered differently in the EU than in the U.S.

 

National healthcare leaders have a common problem to solve and a common goal to achieve. The problem is how to protect national healthcare budgets from overwhelming drug costs without discouraging pharmaceutical manufacturers from developing new products. The goal is to provide populations with equitable access to innovative, safe, clinically effective, and cost-effective healthcare therapies.

In the U.S., payers and policymakers are trying to control drug expenditures and determine the value of new drugs in an opaque, free-market environment. In Europe, government price controls and centralized clinical and economic evaluations of new drugs are standard. For both these pharmaceutical markets, drug pricing agreements based on value instead of volume are gaining traction.

The problem: drug prices keep rising

Pharmaceutical sales in Europe are almost a quarter of all drug sales globally. From 2015 to 2020, the top five European markets–the UK, Germany, France, Italy, and Spain–accounted for 17.4% of sales of new drug therapies. These top five markets are predicted to increase spending by $51 billion through 2026.

North America is the largest pharmaceutical market, accounting for almost half of the total global sales. From 2015 through 2020, the U.S. purchased 63.7% of all the new medicines introduced. The U.S. is expected to increase drug spending by an estimated $119 billion through 2026.

According to IQVIA, a leading healthcare consulting firm, the change in drug spending in the U.S. and European markets through 2026 will be due, in large part, to new brands.

The goal: access to new, high-quality drug treatments at a fair price

Healthcare payers don’t want to take on the financial risk and clinical uncertainty of a new, high-cost pharmaceutical product. Payers want to provide patients with equitable access to innovative treatments that improve health outcomes, especially in therapeutic areas with unmet health needs.

Value-based drug pricing arrangements address these concerns with evidence-driven, outcome-based agreements. The payer and manufacturer share the risks of a new drug not performing as expected. In both the U.S. and the EU, payers and manufacturers are engaged in more finance-based drug pricing contracts than performance-based contracts–but this trend is shifting.

Assessing a drug’s value in the EU healthcare system

Value-based drug pricing arrangements are called managed entry agreements (MEAs) in Europe. MEAs between drug manufacturers and healthcare payers can be finance-based (FBAs), performance-based (PBAs), or service-based agreements (SBAs).

Unlike the U.S., the EU has a centralized system for assessing a drug’s value. Each EU member state has an agency that uses an evidence-based data gathering process called health technology assessments (HTAs). HTAs include nine domains for assessment–four clinical and five non-clinical–that evaluate the efficacy and added value of a new drug compared to other treatment options already available on the market.

The work of the member states’ HTA bodies is coordinated by the European Network for Health Technology Assessment (EUnetHTA). However, conclusions and decisions related to drug pricing and reimbursement remain de-centralized.

Coverage with Evidence Development (CED) may be a part of an MEA and come after the HTA. CED is a way for urgently needed treatments to come to market under conditional approval while real-world evidence continues to be collected. This additional data should help payers decide about coverage. CED use varies by country, with the most CED found in the UK and the U.S. (through Medicare).

Related Post: Indication-specific pricing to make inroads in the U.S.

Assessing a drug’s value in the US healthcare system

The possibility of developing a centralized Health Technology Assessment for the U.S. Healthcare System was the focus and title of a white paper published in early 2020 by the University of Southern California Leonard D. Schaeffer Center for Health Policy & Economics.

The white paper describes the complexities of creating a national HTA organization in the U.S. It examines the difficult dynamics of the many stakeholders in the healthcare system; few are operating with enough transparency and coordination with other stakeholders to support value-based drug pricing. The authors conclude that in the current polarized legislative environment in the U.S., an attempt to develop a national HTA organization would be met with strong political resistance.

In the absence of the European-style centralized HTA body, U.S. payers look to alternative sources for the data they need for drug pricing negotiations. Private and public payers may find clinical and economic evaluations from various agencies that do HTAs on a limited scale. These include government and independent organizations, such as the Department of Veteran’s Affairs, Medicaid, the Patient-Centered Outcomes Research Institute (PCORI), and the Agency for Healthcare Research and Quality (AHRQ). One of the most influential organizations in this space is the independent, non-profit Institute for Clinical and Economic Review (ICER).

Unfortunately, these organizations don’t do value-based pricing evaluations for every drug that comes on the market, and some of their work is not publicly available. Even if analysis of a selected drug is available, it may not cover the key metrics a customized value-based drug pricing agreement needs to track.

When real-world data about a drug’s performance is limited, it’s often up to the manufacturer and payer entering the value-based contract to develop the framework and the data collection and analysis capability, either in-house or through a third-party vendor.

The Lyfegen Solution

The Lyfegen Platform is a customizable solution for healthcare payers, pharma, and medtech companies who need to gather and analyze real-world evidence about a drug’s performance for value-based drug pricing agreements. Lyfegen’s value-based contracting software collects real-world data and uses intelligent algorithms to provide valuable insights into clinical effectiveness and costs.

Lyfegen’s contracting platform helps implement and scale value-based drug pricing contracts with greater efficiency and transparency. By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about Lyfegen’s software solutions, contact us to book a demo.

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Value-based drug agreements are easier when drug manufacturers and payers follow FDA communication guidelines

When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare...

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Value-based drug agreements are easier when drug manufacturers and payers follow FDA communication guidelines

When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare their budgets and formularies to launch value-based drug pricing arrangements as soon as a new treatment receives FDA approval. Pre-approval data sharing between manufacturers and payers gives patients quicker access to newly approved treatments.

 

As the healthcare system in the U.S. continues its transition from fee-for-service to value-based care, the sharing of healthcare economic information (HCEI) is becoming increasingly important to pharmaceutical manufacturers and healthcare payers seeking to enter value-based drug pricing arrangements.

In the past, drug manufacturers were hesitant to share HCEI and other pre-approval information with payers because regulations were unclear about the legal limits of this type of communication. But payers want HCEI from drug manufacturers for planning, formulary design, budgeting, and purchasing decisions. And lawmakers want to eliminate legislative barriers that inhibit the sharing of HCEI and the increased adoption of value-based healthcare.

The history of legislation surrounding manufacturer/payer communications

Policymakers and regulators, like the Food and Drug Administration (FDA), recognize the importance of big data and the sharing of HCEI for promoting value-based payment arrangements. Their first attempts to remove the legislative barriers to the exchange of HCEI between drug and device manufacturers and population healthcare managers did not produce the desired effects.

The first U.S. federal consumer protection law, the Food and Drugs Act, was enacted in 1906. This law’s consumer protections and law enforcement capabilities were strengthened by the 1938 Food, Drug, and Cosmetic Act (FD&C). Section 502(a) of the FD&C introduced and defined HCEI, giving the pharmaceutical industry their first instructions about what kind of economic data promotion could be communicated and with whom. But manufacturers refused to share information, fearing the penalties of accidentally disseminating off-label information.

Section 114 of the FDA Modernization Act (FDAMA) of 1997, amended FD&C Section 502(a) and provided a safe harbor for HCEI sharing. But manufacturers continued to resist sharing economic data because they felt the guidelines were still too vague about some topics, such as the definition of reliable scientific evidence and who was authorized to receive HCEI. The FDA failed to issue guidance on how to interpret the law.

The industry-wide push towards value-based care after the Affordable Care Act passed made clarification of Section 114 a priority again. In 2016, policymakers issued clarifying guidance about communications and transparency of HCEI, both pre- and post- FDA approval. The 21st Century Cures Act, Section 3037 further defined what types of HCEI and analyses could be used for drug promotion and to whom the HCEI should be communicated. The FDA published a draft payer guidance document in 2017 and then final guidance documents in 2018 suggesting ways to operationalize communications between pharmaceutical manufacturers and payers.

Current FDA guidance

An FDA press statement from June 2018 emphasizes that the 2018 guidance documents are meant to help pharmaceutical manufacturers provide payers with truthful, non-misleading background and contextual information about their products. Furthermore, manufacturers are encouraged to share both clinical data and HCEI payers need to make informed decisions about formulary management, cost effectiveness and reimbursement; this may be more and different data than the safety and efficacy data submitted by the manufacturer to the FDA for drug approval decisions.

The guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities–Questions and Answers, expands upon the sources of scientific evidence for HCEI as defined under Section 502(a). And the guidance clarifies who can receive HCEI, including public and private sector payers, formulary committees, technology assessment panels, third-party administrators, and other multidisciplinary parties.

This first guidance also addresses manufacturers’ communications with payers regarding unapproved uses of FDA-approved products. The FDA does not object to the sharing of this type of information as long as the manufacturer makes it abundantly clear in its communications what uses the product is not approved for.

The second guidance introduced in the FDA press statement is titled Medical Product Communications That Are Consistent With FDA-Required Labeling–Questions and Answers. It pertains to information not included in a drug’s labeling but information that a manufacturer may want to share with payers. Examples can include data from pre- and post-market studies or surveillance of patient compliance that can affect the measurement of a drug’s benefits to health outcomes in value-based contracts. (The first guidance offers safe harbor for communications related to the negotiations or implementation of value-based drug pricing agreements.)

Timing of information exchanges

Payers prefer to receive information regularly from manufacturers during the latter part of the FDA drug approval process. Annual budgets and formulary planning are more difficult to forecast if payers don’t have data in advance to prepare for the coverage of a new drug. Payers are more likely to make a newly approved treatment available to patients without delay when manufacturers share the clinical data and HCEI needed to make formulary and pricing decisions during pre-approval.

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Under the FDA’s accelerated approval process, therapies sometimes become available to patients even before the publication of clinical trial data is complete. Payers say, ideally, they would like clinical and HCEI data about new products 12 to 18 months before the projected FDA approval date.

Many manufacturers wait to begin communications with payers until just 6 to 12 months before their product’s expected approval date. Recognizing the importance of HCEI in negotiating value-based drug pricing arrangements, some manufacturers have included HCEI in their FDA product dossier and promotional materials for payers.

The FDA guidance recommends increased transparency about cost data, including price range, price parity with competitors, price premiums, discounts, and inflation adjustments. Some manufacturers and payers prefer to wait for final clinical trial data before discussing pricing. Post-approval data-sharing of real-world evidence must continue between manufacturers and payers to implement value-based drug pricing agreements.

The Lyfegen solution

With most regulatory barriers removed and value-based contract communications exempted from FDA reporting, policymakers hope to see an increase in value-based drug pricing arrangements. Manufacturers and payers can partner with third-party vendors like Lyfegen to employ technology that facilitates easy, continued data-sharing for innovative pricing agreements.

Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to implement value-based drug pricing arrangements with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable information about drug performance and cost.

By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about our services and the Lyfegen Platform, book a demo.

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When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare...

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Our team is growing! Welcome to Lyfegen, Tech-Genius Giancarlo!

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Our team is growing! Welcome to Lyfegen, Tech-Genius Giancarlo!

We are thrilled to announce that our tech team continues to grow: A warm welcome to Giancarlo, Lyfegen’s new Full-Stack Developer! With his background as a security engineer, he knows how to make our platform even safer!



“I am excited to welcome Giancarlo to our Tech Team as a Full-Stack developer. Giancarlo’s experience in the areas of Machine Learning, Security and Software Development are critical to our long term success and development of the Lyfegen Platform.” Says CTO, Frederico Braga

To introduce our newest team member, we virtually interviewed Giancarlo.

Welcome to the team Giancarlo! Tell us a little about yourself.

My name is Giancarlo and I live in Chur, Switzerland. I hold a bachelor’s degree in computer science. I previously worked as a security engineer, designing and implementing big data applications at a Swiss telecom company. At Lyfegen I will be working on improving our platform as a full stack developer.

What drives you to be a full stack developer?

For me, the variety of tasks is the biggest appeal of being a full stack developer: One day you could be working on low level database tasks and the next day on implementing user-interface (UI) elements. This keeps the job challenging and interesting!

What motivated you to join Lyfegen?

Until now, I was working for a rather big company where my impact was small. I wanted to change that. At Lyfegen I am able to create something meaningful from the ground up.

What is your first impression as of now?

My first impression was very positive: The people at Lyfegen are kind, helpful and smart. A perfect mix in my opinion! I’m looking forward to all the interesting tasks, complex problems and engaging conversations with my colleagues.

How will your know-how help the Lyfegen customers experience our platform the best way possible?

As a former security engineer, I know the most common threats and pitfalls when it comes to creating a software. I hope to use my expierence and knowledge to make our platform safer and more resilient to potential threats in the future.

What is something you want to learn or improve this year?

In previous jobs I was mainly developing backend applications. This year I want to improve on the frontend side and learn new technologies when it comes to graph databases. I always wanted to improve my Italian, so maybe 2021 is the year where I take some time to do just that!

What passions do you pursue outside of work?

I play lacrosse in our local club twice a week. Food is another passion of mine: I also love to cook and try new restaurants. On rainy Sundays, you’ll find me playing boardgames or Dungeons and Dragons with my friends.

 

MEET THE LYFEGEN TEAM

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Welcome to the Lyfegen Team, Mastermind-Developer, Thungu!

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Welcome to the Lyfegen Team, Mastermind-Developer, Thungu!

He loves innovation and thrives on solving problems using code. Besides developing and studying he plays basketball, travels and reads. We are proud to welcome the newest talent to the Lyfegen team: “Junior Developer” Thungu!



“The motivation and the skills of Thungu are undisputed. Among other things, that is what makes him and Lyfegen a perfect match. Constant evolution and progression are some of the most important objectives at Lyfegen, that is why Thungu will join our Team to help us add new UI components to our products and automate our testing processes in coordination with the UI/UX designers and Business Analysts, resulting in a higher overall quality and user satisfaction of our products. We are looking forward to work with Thungu here at Lyfegen.” Says CTO, Frederico Braga

To introduce our newest talented team member, we virtually sat down with Thungu for an interview.

Welcome to the team Thungu! Tell us a little about yourself.

Hi, my name is Thungu, and I am from Colombo, Sri Lanka. I am a Software Engineering undergraduate at the University of Westminster in my second year while working here at Lyfegen. I also volunteer for the IEEE student branch of my university to organize hackathons, webinars and other tech related events.

What drives you to be a developer?

I love figuring things out, exploring new technologies and solving problems with code. When facing challenges as a developer I always explore the “yes” and try to figure things out before accepting a “no”. That figuring out part is what drives me to be a better developer and what I enjoy mostly about being a developer.

What was your motivation to join Lyfegen?

I wanted my first work experience to be in an innovative company which has a positive impact on the world and when I got to know what Lyfegen does, I knew this was it. With value-based healthcare in its early stages, I see it’s huge potential and the unprecedented value it brings towards humanity. I knew I had to be a part of this great journey!

What are your first impressions so far?

It has been a very pleasant experience. I am enjoying the startup culture - everyone is very close, friendly and welcoming. The flexibility at Lyfegen is one of the things that I appreciate most, as it is really important for me to have an evenly work and university life balance. I am also very impressed by how dynamic and motivated the team is. Everyone is ready to move mountains for patients!

How will you improve the customer experience on the Lyfegen platform?

I will be focusing mainly on Frontend Development and Testing which includes building new components with the help of our Kateryna, our UI/UX designer and testing the functionalities of our products together with Pavlo.

What do you want to learn and improve this year?

I am looking forward to improving my skills and helping Lyfegen in other stages of Software Development in addition to Frontend Development and Testing. I also want to improve my understanding of the healthcare industry.

What are you especially looking forward to as you take on this new role?

Although I enjoy all the virtual coffees, I am very much looking forward to meeting everyone in person someday. I’m also looking forward to grow as a professional and becoming a better and experienced developer. I feel very grateful to work with such an amazing team of experienced developers and other team members.

What passions do you pursue outside of work?

I love to play basketball, create travel videos and also photography is my passion. I read books focusing on life and spirituality, I learn new technologies, and sometimes I play the guitar.



We are proud to welcome Thungu to the Lyfegen team!

 

 

MEET THE LYFEGEN TEAM

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A new face is on board! Welcome to Lyfegen, Tech-Guru Andrei

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A new face is on board! Welcome to Lyfegen, Tech-Guru Andrei

We are pleased to welcome the latest addition to our tech team! Andrei joins Lyfegen as a full-stack developer. He brings his wealth of backend and frontend experience to elevate our platform.



"I am excited to welcome Andrei to our Tech Team as a talented and motivated Full-Stack developer. Andrei brings great skills and knowledge to our team and will support us in further building our applications." Says CTO, Frederico Braga.

To introduce our newest addition, we interviewed Andrei.

Welcome to the Team, Andrei! Tell us a little about yourself.

Hi! My name is Andrei. I am from Romania, and I graduated from the Technical University of Cluj Napoca. In the last seven years, I have worked as a software developer at different companies and with different technologies like .net, iOS, Angular, Typescript, MSSQL, Mongo DB, SoapUI.

What drives you to be a full-stack developer?

I chose to be a full developer because I like to be involved in every phase of a software application, from the UI side to the server. In the last eight years, the modern technologies used for building stack server-side applications and client-side applications became much easier to use, which allows us to learn multiple technologies on both sides.

What motivated you to join Lyfegen?

At the beginning of my career, I worked for another startup company. I remember my satisfaction when someone used our product, and I want to feel that again. Lyfegen is giving me many opportunities to positively impact the world because we are driving things in the right direction. I consider value-based contracts the best solution for patients, healthcare payers and Pharma companies.

What is your first impression as of now?

I like and appreciate the whole team. All my colleagues have brilliant ideas that are bringing the Lyfegen platform to its best form. The Lyfegen platform is one of the strongest I have seen so far in my career, and this is because everyone has a voice within the team.

How will your know-how help the Lyfegen customers experience our platform the best way possible?

Throughout my career, I have worked on several big projects in different fields providing technical solutions for different problems on the frontend side and the backend side. These experiences have taught me the importance of accessibility features, and I would like to bring that knowledge to improve the user experience of Lyfegen users. I can help the Lyfegen customers better interact with the platform in terms of performance.

What is something you want to learn or improve this year?

I am looking forward to improving my understanding of the healthcare and pharmaceutical industry. From a technical perspective, I'm excited to work and learn Grandstack technologies.

What passions do you pursue outside of work?

I love to play board games, tennis and football. During the summer weekends, I like to go hiking, and in winter, I enjoy skiing. I also have an interest in politics, and I try to stay updated with trends in the IT industry because of my passion for new technologies.

What else are you looking forward to?

I look forward to deepening my relationship with my teammates. I strongly believe that working in an atmosphere that promotes teamwork makes our lives much more enjoyable. At the same time, it has a positive impact on the project.



 

MEET THE LYFEGEN TEAM

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