Adding a Medicare Part E benefit to pay for cell and gene therapies
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Despite their curative potential, the extraordinarily high price tags of cell and gene therapies have raised concerns about the U.S. and European healthcare systems' financial sustainability. This is especially true for recently approved treatments indicated for relatively sizable sub-populations, including multiple myeloma, beta thalassemia, sickle cell disease and different types of hemophilia.
To address these challenges, researchers have suggested creating a universal benefit in the U.S., named “Part E,” specifically designed for coverage of cell and gene therapies. Part E would technically fall under Medicare, but it would not have age- or disease-specific eligibility restrictions. In other words, it would be open to all who for whom the therapies are indicated and who may not be eligible for the Medicaid-specific model the Centers for Medicare and Medicaid Services are implementing (for information on this model, see previous microblog).
Upon the Food and Drug Administration approval of an eligible cell or gene therapy, Part E coverage and pricing would be determined centrally by CMS, whose mandate it would be to consider whether such products are deemed “reasonable and necessary” to treat the affected population, as CMS already does when it conducts National Coverage Determinations. Part E would be financed by an earmarked tax.
Any decision to cover a product would include outcomes-based agreements, in which the net price would depend on a product's performance over time. Alternatively, CMS could negotiate subscription-like payment models as some Medicaid programs have done in the hepatitis C space. Here, CMS would be responsible for a fixed payment regardless of the number of patients treated or the volume of a drug or therapy dispensed. In other words, unlike traditional payment arrangements, payment would not scale with volume.
In negotiating pricing and reimbursement for cell and gene therapies, CMS would establish a national risk pool across the Medicare, commercial and (part of the) Medicaid markets. In turn, this would decrease the level of financial risk borne in the system.
The Lyfegen Library offers you access to one central resource with more than 4,500 public price-based agreements and 20 innovative pricing models (including subscription-like payment arrangements) which can form the basis for outcomes-based agreements to be signed under an eventual Medicare Part E. This invaluable resource has all the market research in one place to gather intelligence on novel ways to establish innovative payment systems that are uniquely designed to suit business needs of key stakeholders such as drug manufacturers and health insurers.
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Newly approved gene therapies for hemophilia A and B, beta thalassemia and sickle cell disease come with multimillion dollar price tags that could bankrupt financially strapped state Medicaid programs. In many instances, the majority of patients affected by these diseases rely on Medicaid for healthcare coverage.
Last month, the federal government unveiled a novel “access model” - the Cell and Gene Therapy Access Model- designed to mitigate the costs state Medicaid programs incur when they pay for these potentially curative treatments and allow for patient access. The announcement by the Centers for Medicare and Medicaid Services marks a significant step towards addressing the access issue.
Similar to what is currently happening with a select group of prescription drugs under the Inflation Reduction Act, CMS plans to negotiate prices of these gene therapies with drug makers at the national level for all state Medicaid that decide to participate in the model. By facilitating access to potentially life-changing treatments and supporting outcomes-based agreements with manufacturers, the model has the potential to improve health outcomes and alleviate financial burdens on state Medicaid agencies.
At first, CMS intends to negotiate pricing and rebates with the drug manufacturers Vertex and bluebird bio over the next few months on behalf of state Medicaid agencies that voluntarily choose to join the program.
Bluebird bio says it has already established an outcomes-based agreement for its SCD therapy, Lyfgenia, with commercial insurers. The product is listed at $3.1 million. The company did not divulge further details. Vertex, which priced its SCD therapy, Casgevy, at $2.2 million, has declined to discuss its plans.
The fact sheet that CMS provides contains few details as to what kinds of pricing arrangements would be put in place for products such as Lyfgenia and Casgevy. Prior to deciding to participate in the model and allow CMS to negotiate prices on their behalf, Medicaid agency directors will want to know specifically what kinds of outcomes-based agreements CMS can turn to.
The Lyfegen Model & Agreements Library offers CMS and state Medicaid agencies access to one central resource with more than 4,000 public pricing agreements and 20 innovative pricing models, including outcomes-based agreements. This invaluable resource has all the market research in one place for stakeholders to gather intelligence on novel ways to establish innovative payment models that are uniquely designed to suit the needs of Medicaid payers, CMS, and drug makers alike. To further enhance the practicality of these models, our value-based contracting platform mitigates the high costs and administrative challenges involved in managing these contracts. It equips CMS, the States, and Pharma with a streamlined, cost-effective means to implement outcome-based agreements efficiently.
Medicaid directors will also seek information on methods of evidence gathering, outcomes measurement, the length of time needed to test durability of gene therapies and how this information will be provided to CMS, presumably via a patient registry. Lyfegen offers solutions to identify the right drug pricing agreements in which evidence generation and the use of patient registries are key.
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Ostensibly, patients who have “skin in the game” through cost-sharing motivates them to be good stewards of their pharmacy benefit. But in the present system in the U.S., cost-sharing is usually not outcomes-based. It’s simply a way for insurers to defray costs onto patients, even when it poses barriers to access.
On the other hand, value-based insurance design is an increasingly popular method used by payers in which prescription drugs considered of high value have correspondingly low or no patient cost-sharing and few if any other utilization restrictions. By contrast, treatments deemed of low value are assigned higher patient cost-sharing and more conditions of reimbursement.
Optimally, this leads to greater patient adherence to high-value drugs and better health outcomes.
This method is used in the commercial sector, though until now relatively sparingly. One of the more interesting recent initiatives is the Medicare Advantage Value-Based Insurance Design Model. Remarkably, the pilot is attracting many participants. Sixty-nine Medicare Advantage plans with nearly 9 million Medicare beneficiaries are signed up, an increase of almost 50% from 2023.
Aligning patient and payer financial incentives around the value of healthcare technologies and services implies the need to gather evidence and measure health outcomes. Broader implementation of value-based insurance design will entail the expanded use of incentive-based drug formulary models in which the most cost-effective pharmaceuticals have the lowest cost-sharing and the fewest reimbursement restrictions.
The Lyfegen Library offers you access to one central resource with more than 3,500 public pricing agreements and 20 innovative pricing models, including value-based insurance arrangements. This invaluable resource has all the market research in one place to gather intelligence on novel ways to establish innovative payment models that are uniquely designed to suit your business needs.
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The promise of gene therapy is to cure diseases associated with faulty or missing genes. Yet the high upfront costs, uncertainty surrounding long-term durability, and adverse events in some patients have often impeded market uptake.
So when the investment firm Cantor Fitzgerald said it expects a “very strong product launch” of a recently approved gene therapy made by Krystal Biotech, the topical gel Vyjuvek indicated for a rare skin disease called dystrophic epidermolysis bullosa, it caught people’s attention.
Successful commercialization of gene therapies has remained largely elusive, in part due to access hurdles erected by insurers. The current payer system is not particularly well suited to accommodate single-dose therapies for which long-term treatment efficacy, risk-benefit ratios and safety remain uncertain.
But Vyjuvek (beremagen geperparvec) is different. Unlike most current gene therapies on the market today, it’s not meant to be a one-off cure. Vyjuvek is the first and only Food and Drug Administration-approved topical gene therapy that can be re-dosed.
Listed at $630,500 annually per patient—$485,000 after mandatory government discounts in Medicaid—it is certainly expensive. But it is not nearly as high-priced as other gene therapies that have been approved in recent years.
The manufacturer has successfully pursued coverage agreements with payers in the commercial and public spaces. Further, Krystal is using an innovative payment model with its payer clients. The company is offering them a price cap of $900,000 annually per patient to account for patients who may require large numbers of vials of treatment.
The Lyfegen Library offers you access to one central resource with 3000+ public pricing agreements and 20 innovative pricing models—this invaluable resource has all the market research in one place to gather intelligence on innovative ways to establish innovative payment models, such as the one in place for Vyjuvek, that are uniquely designed to suit your business needs.
Learn more: https://www.lyfegen.com/products/model-and-agreement-library
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On November 16th, the UK’s MHRA approved Casgevy (exagamglogene autotemcel) or exa-cel for sickle cell disease and beta thalassemia. And this month the FDA is expected to license exa-cel and lovo-cel (lovotibeglogene autotemcel), both of which attack SCD at its genetic root.
For these advanced gene therapies the challenge of access through Medicaid and other programs looms large. Medicaid will be the predominant payer for the 25,000 patients who could be eligible for these gene therapies. And it must figure out a budget-conscious way to pay for these potential one-time “cures.”
In April, the Institute for Clinical and Economic Review issued a draft report on the cost-effectiveness of exa-cel and lovo-cel. ICER noted that the proportion of patients achieving treatment success was 97% for both therapies. Even at the placeholder price of nearly $2 million per dose, ICER says both treatments could be cost-effective. But ICER cautioned that a prerequisite is their durability over time and the establishment of value-based pricing agreements between payers and manufacturers.
The Centers for Medicare and Medicaid Services is therefore pursuing a two-pronged approach to value-based pricing and reimbursement of cell and gene therapies such as exa-cel and lovo-cel.
First, a proposed rule would require manufacturers with the highest drug Medicaid spending per claim to turn over confidential information justifying their prices. CMS would post this information online, seek public comment, and compel manufacturers to “address” their pricing in a public forum.
Second, CMS is planning on “testing of payment models” based on outcomes-based agreements on behalf of all 50 state Medicaid programs, rather than having them done separately by individual states.
Innovative payment models such as these require the ability to analyze patient outcomes and negotiate prices based on those outcomes. Digital platforms, such as those offered by Lyfegen, are designed to implement value-based contracting models. This investment can yield operational efficiency, recovery of missed revenues, and provide critical access for patients to life-saving drug therapies.
Lyfegen offers solutions to identify the right drug pricing agreements, simulate and understand the financial impacts of those agreements, and automate the execution and adjudication of them—thus delivering a measurable reduction in administrative effort in rebate management and optimization.
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Basel, Switzerland / Boston, USA – December 11, 2024
Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.
Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions
The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.
Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.
Scaling Globally with a Leading Rebate Management Platform
Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.
“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”
Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”
About Lyfegen
Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand the full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.
About TX Ventures
TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage.
For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com
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In an industry often characterized by incremental changes, Girisha Fernando, the CEO and founder of Lyfegen, is making leaps. We sat down with Fernando to discuss the recent landmark partnership between Lyfegen and Newfoundland and Labrador Health Services—a collaboration that heralds a significant shift in the Canadian healthcare landscape.
Your partnership with Newfoundland and Labrador Health Services is quite a milestone. Can you share with us what this means for the current state of rebate management in Newfoundland?
Girisha Fernando (GF): Absolutely. This partnership is a transformative step for rebate management in Newfoundland. The current system, largely manual and complex, is ripe for innovation. With our digital platform, we're bringing a level of automation and accuracy that was previously unattainable. This means more efficient processing, less room for error, and a better allocation of resources, which is critical in healthcare.
That’s quite an advancement. And how does this impact the management of drug products, especially in areas like oncology?
GF: It’s a game-changer, especially for critical areas like oncology. Newfoundland and Labrador, as the first in Canada to use our platform, sets a precedent. The region, through the pan-Canadian Pharmaceutical Alliance, has been managing complex product listing agreements for drugs, including those for oncology. These agreements are vital for making treatments affordable. Our platform simplifies this, managing the various terms of these agreements efficiently, which is crucial for timely and affordable access to treatments.
It seems like a significant step forward for healthcare management. How does this align with the broader goals of Lyfegen?
GF: This partnership aligns perfectly with our goal to make healthcare more accessible and efficient. Automating the rebate process in Newfoundland and Labrador, especially for critical treatments in oncology, directly contributes to the sustainability and accessibility of healthcare treatments.
Looking to the future, what does this partnership mean for Lyfegen and healthcare systems globally?
GF: This is just the beginning. We're looking to extend our platform to healthcare systems around the world. Our aim is to make this technology a standard in healthcare management, fostering more efficient, sustainable, and equitable healthcare systems globally.
Read more about the partnership in the official press release.
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New York, NY - March 29, 2023 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced at the World EPA Congress the launch of its latest solution: the Model & Agreement Library. The purpose of the library is to help payers and pharma negotiate better drug prices while providing an in-depth view on current international drug pricing models and value-based agreements. The database library serves as the basis for successful drug pricing negotiations, resulting in accelerated access and drug prices better aligned to their value for the patient.
The shift towards value-based healthcare, rather than volume-based, has been steadily increasing over the years. This evolution has further reinforced Lyfegen's mission to remain at the forefront of analytics and digital automated solutions for the healthcare sector. Indoing so, Lyfegen’s solutions help to accelerate access and increase affordability of healthcare treatments.
“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers, and pharma companies across the world”, said Girisha Fernando, CEO of Lyfegen. “That is why we are so excited about launching the world’s largest database of real-world value-based agreements. It gives payers, and pharma a unique insight into how to structure value-based agreements.”
The Lyfegen Model & Agreement Library was developed as an accelerated negotiation resource for both manufacturers and payers – allowing them to save on time, money; and for the first time – an opportunity to learn at their own pace without incurring large research projects or hiring expensive external experts. Users of the library are now enabled to make informed decisions in determining the most suitable drug pricing models and agreements for their products.
The database holds over 2'500+ public value-based agreements and 18+ drug pricing models – spanning across 550 drugs,35 disease areas and 150 pharma companies. Its search capabilities are spread across product, country, drug manufacturer and payer – with all the knowledge, insights, current pricing and reimbursement activities shown in near real-timeacross the industry.
“Just an academic taxonomy of models is intellectually exciting but it's not really helping your typical customer”, said Jens Grüger, Director and Partner at Boston Consulting Group (BCG). “The Lyfegen Platform goes several steps further. Payers and pharma have a problem and they want a solution. The Lyfegen Model & Agreement Library is practical. It offers case examples.”
The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.
“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.
This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.
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Basel, Switzerland, October 27, 2021
Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.
The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.
"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.
Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."
The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.
About Sympany
Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.
In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.
More about Sympany: https://www.sympany.ch
About Lyfegen
Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.
Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact Press: press@lyfegen.com
Contact Investors: investors@lyfegen.com
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Basel, Switzerland, August 3rd, 2021
Lyfegen announces that its value-based healthcare contracting platform has been implemented together with Johnson & Johnson Medical Devices Companies Switzerland (Johnson & Johnson) and a leading Swiss Hospital.
Through this new value-based healthcare approach, Lyfegen and its partners drive the shift towards what matters most to patients: improved patient health outcomes and more efficient use of financial and human resources, enabling a sustainable post-COVID-19 healthcare environment.
The shift towards a value-based healthcare in Switzerland and globally can only be achieved through the support of innovative technologies. Lyfegen’s platform is a key enabler for this transition. The platform digitalises and automates the execution of value-based healthcare agreements, paving the way for the resource-efficient scaling of such novel agreements.
“COVID-19 has shown us the urgent need for a more sustainable healthcare system. With the implementation of value-based healthcare agreements on the Lyfegen platform, we are extremely proud to help Johnson & Johnson and hospitals to accelerate the transition to value-based healthcare and improve patient health outcomes at reduced cost.” says Lyfegen’s CEO, Girisha Fernando.
Lyfegen's compliant, secure and patent-protected value-based healthcare contracting platform automates the collection and analysis of patient-level data. Users receive transparency on actionable health outcomes and agreement performance. Lyfegen’s contribution to this partnership is a blueprint for the scaling of value-based healthcare models across hospitals, health insurances, medical device & pharma companies globally. The partnership marks another important milestone for Lyfegen, as the company continues to grow and has recently opened its next investment round.
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Join in from anywhere in the world for two hours of incredibly interesting presentations by industry experts all around the topic of value-based healthcare.
At this DayOne Experts event, organized in close collaboration with Deloitte, industry experts will give an overview of where the pay-for-performance discussion in healthcare stands; possible solutions; and show how value-based healthcare could, should, and will impact the industry.
During the webinar, which will include deep dive sessions, we will seek answers to some of the most pressing questions: “How to define the value of a health outcome; how to capture it? Check out san diego boudoir photographer. In which areas of intervention is the value-based healthcare approach feasible; where would it be desirable? To what extent will value-based healthcare create new opportunities and accelerate innovation?”
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To guarantee our users happiness when working with our software, we are welcoming a brand-new quality specialist at Lyfegen: Liubov Buzila has joined the team and will keep an eagle eye on our platform to ensure everything runs like clockwork.
We sat down with Liubov to learn about her experience, her goals and her aspirations.
Hello Liubov, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?
I’m Ukrainian, but I moved to Romania two years ago and currently live in the city of Iași. I have a bachelor’s degree in applied linguistic, and my first job as a QA engineer was five years ago during my fourth year at university. I have worked in this field ever since.
What excites you about being a QA engineer?
Being a QA engineer is always challenging, and that’s what I love about it. Every day I deal with a lot of things that force me to think outside of the box. A tester is not only a person who has to find problems in the system, but also a person who takes responsibility for the system’s quality; this is what makes me super excited about my work – I enjoy improving our software for the better.
Why did you decide to join Lyfegen?
I am always striving to learn something new, and Lyfegen’s startup spirit is a great fit for that. I have tested products in different fields, but I have never worked in the healthcare industry before. Personally, I think it’s a great opportunity to see how the system works from a new perspective and to gain new experience.
What is something you want to learn or improve this year?
QA is a field where you are constantly learning something new, starting with technologies used in the product and ending by gaining new soft skills as part of an amazing team. The healthcare industry is new territory for me; I’m looking forward to exploring it and gaining expertise.
How will your know-how help to improve our customers’ experience of the Lyfegen platform?
My main goal is to improve the quality of the Lyfegen platform and deliver a highly reliable and convenient product to our customers. The rule is very simple: less bugs, happier customers!
Let’s get personal: What are your favorite things to do in your free time?
I love to cook! Whenever I get any free time, I find new recipes and try to impress my family. I also like listening to music. Music is the thing that helps me to relax and forget about my troubles. And, of course, I like travelling – I have been to 20 countries already, and I look forward to exploring more.
Is there anything else you are looking forward to outside of work this year?
Nothing specific, just enjoying my free time and travelling.
We are happy to have you with us, Liubov!
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Last week Lyfegen announced exciting news! Out of hundreds of start-ups, Lyfegen is among the top 10 selected to join one of Europe’s most innovative acceleration programs: InnoPeaks by Groupe Mutuel.
The news is taken with much excitement by Lyfegen’s co-founder, Michel Mohler, who briefly explains why being selected for this three month program by one of Switzerland’s leading health insurance companies is a great achievement for Lyfegen.
Hi Michel, can you give us a little more insights on the InnoPeaks program?
InnoPeaks is a business-focused acceleration program that focuses on challenging, enabling, growing, and scaling a business through workshops, mentorship, networking, and implementing proof of concepts. Groupe Mutuel, one of Switzerland’s leading health insurances, organizes this program. Their specific goal is to drive innovation in the two topics which support their core business: healthtech and insuretech.
Lyfegen is amongst only 10 startups that have been selected out of hundreds. What is Groupe Mutuel’s interest in having you on board?
Lyfegen, being one of Switzerland’s most innovative start-ups, is solving a crucial challenge healthcare – improving health outcomes for patients. We do this with our ground-breaking technology, working together with health insurances to give patients faster access to the medicine they need. Considering high-cost, personalized and potentially curative drugs, the prices of drugs need to become dynamic and depend on how well they work for patients. This also known as value-based contracting. Until recently, we have seen mostly Pharma Companies advocating for such pricing models. Engaging with a leading health insurance with our platform, we will achieve to bring such models to life in Switzerland, for Swiss patients.
What does Lyfegen want to achieve by being part of this program?
Switzerland's Federal Council (“Bundesrat”) addresses value-based contracting as one of the key solutions to achieve a more sustainable Swiss healthcare system. Our goal is to speak and learn from other startups, talk to decision makers at Groupe Mutuel, exchange thoughts and inspire Groupe Mutuel. As a result, we want to understand the perspective of health insurances and engage in a proof of concept.
We look forward to evolving with InnoPeaks, Groupe Mutuel and the other Start-ups. The team will be live-covering the InnoPeaks accelerator program in October, so stay tuned for more!
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At Lyfegen, we live by the highest quality standards, continuously improving as we move forward with facilitating value-based healthcare agreements for a fast & sustainable access to innovative therapies.
What is ISO 9001:2015?
The ISO 9001:2015 standard provides guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements with quality being consistently improved.
This standard sets out the criteria for a quality management system used by many organization, large and small. Using ISO 9001:2015 helps ensure that customers get consistent, high quality products and services.
What this mean for Lyfegen?
At Lyfegen, we live by the highest quality standards, continuously improving our solutions & processes, as we move forward with the operationalisation of value-& data driven contracts for a fast & sustainable access to innovative therapies. In turn, this will benefit patients worldwide!
We are audited yearly by a third-party to keep our ISO status up to date.
Want to discover our solutions?
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“I am responsible for building the right products, and for building the products right.” Says Antti Hietala. Welcome to the Lyfegen Team!
As we embark on a new year, the great news start rolling in: Lyfegen welcomes its newest star, Antti Hietala, who takes on the key role of Product Owner.
As Antti arrives for his first day, Lyfegen’s CEO Girisha Fernando gives us his thoughts:
“Antti's excellent skills to think ahead and pull together industry, customer and technical perspectives to building a solid and ever-evolving product roadmap fills me with excitement, and will strengthen Lyfegen’s value for our customers even further. We are delighted to welcome Antti, a proud family man with values aligned with Lyfegen's values.”
We sat down with the ski-loving Product Owner to get a little more insight to who he is and what he will be doing at Lyfegen.
Hi Antti, tell us a little about yourself: where are you from and what is your professional background?
I come from the Arctic Circle. I grew up under the northern lights in a small town in northern Finland. I studied linguistics and computer science. My passion for content and technology led me to a career in technical writing. I wrote documentation for newspaper advertising systems and for financial asset management software.
Prior to joining Lyfegen I was the lead Product Manager at Magnolia where I built a content management solution. I’m a certified Scrum Product Owner and have worked with Product Managers and user experience designers in the past.
Why did you decide to join Lyfegen?
Lyfegen is my first venture into healthcare technology and it has an important mission: helping patients access innovative therapies by driving value-based healthcare. Removing obstacles that keep patients from getting the treatment or drugs they need is a high-level motivator. I’m also optimistic in our ability to make a big difference in the user experience of health technology and software.
I wanted to apply my product owner skills to an industry that is completely different from where I have worked before. Some say that it’s good to step out of your comfort zone and learn something completely new. The healthcare field is an exciting new challenge for me. I am thankful to the Lyfegen team for their confidence and trust that solid product management skills are universal and that I will apply them for a meaningful purpose.
You are joining Lyfegen as a Product Owner! In simple terms: what will you be working on?
I’m excited about joining Lyfegen! The team is packed with motivated and genuinely passionate people. We are on a path to build the most innovative contracting platform in the healthcare industry.
As Product Owner (PO) I am responsible for building the right products, and for building the products right. Concretely, this means talking to customers to understand their needs. I will define the product together with the Lyfegen team, translate the customer needs into features in our platform, together with our tech team.
My role has a strong outward-facing component. It’s critical for me to be in close contact with customers in order validate decisions quickly and build the right thing. My goal is to make our software valuable for our customers.
What are your next personal goals with Lyfegen?
Learning more about the healthcare and pharmaceutical industry is my first personal goal. There are so many new terms and abbreviations coming my way every day. It’s like the field has a language of its own.
On the product side, I’m very focused on optimizing the product-market fit. This means, finding the key features that really fulfill user needs and then amplifying those features in the product. I want to see users become fans! That’s a sign of a great product-market fit to me.
Enough about work! What passions do you have outside of Lyfegen?
I love to ski in the winter. I’m lucky to live in beautiful Switzerland where the Alps provide ample opportunity to hit the slopes. In the summer I do fly fishing in the Black Forest region of southern Germany or in Alsace, France. I’m also an avid pizza chef, forever improving my home-pizza game with the ultimate goal of authentic Neapolitan pie.
We are proud to welcome Antti to the Lyfegen team!
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Introduction
Donald Trump has been elected as the 47th President of the United States. With healthcare remaining a critical issue, it’s valuable to revisit some of Trump’s past healthcare reforms and examine a particularly controversial policy that could significantly impact drug pricing in the U.S. From efforts to lower out-of-pocket costs to transparency initiatives aimed at increasing competition, Trump’s past healthcare policies reveal a complex approach to improving accessibility and affordability. Here, we also explore how these initiatives have evolved under the Biden-Harris administration and what their potential implications could mean for the future of American healthcare.
Let’s examine some of his past reforms to improve healthcare and discuss a controversial policy that could greatly alter drug pricing.
Conclusion
The evolving landscape of American healthcare policy, influenced by both Trump and Biden’s administrations, reflects an ongoing effort to address cost, transparency, and access to treatment. Trump’s initiatives laid the groundwork for healthcare cost transparency and patient protections, while the Biden-Harris administration has expanded these initiatives and introduced groundbreaking policies like Medicare drug price negotiation. As these changes continue to unfold, the healthcare industry, patients, and policymakers alike will need to adapt to new dynamics, shaping the future of healthcare in the United States.
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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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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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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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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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