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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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!
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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!
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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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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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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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A new study published in September, reported by the American Journal of Managed Care, compared how quickly drugs are reimbursed in select countries, including Switzerland, the United States, Germany, Japan, and the United Kingdom. The US does not have an HTA process, and some believe that drugs could get to patients faster if it did have one.
The analysis compared approval-to-reimbursement time, reimbursement rate one month post-approval, and reimbursement rate 12 months post-approval, for 290 approved drugs between 2011–2022. The analysis did not include advanced therapies, pediatric medications, or diagnostics. Data was sourced from the Food and Drug Administration, European Medicines Agency, Swissmedic, and Medicines and Healthcare products Regulatory Agency.
Results: Switzerland had the fastest approval-to-reimbursement times, averaging 6 months, followed by Germany (7.4 months), the US (9.2 months), France (12.9 months), and the UK (17.7 months).
The country with the highest reimbursement rate after one month was France, standing at 25.9%, followed by Switzerland (9.7%), and the UK (0.7%). Neither Germany nor the US had reimbursed a drug within this timeframe.
After 12 months, however, the trend changed. In first place was Germany, with a 74.3% reimbursement rate, followed by the US (70.7%), Switzerland (62.8%), France (49.0%), and the UK (37.1%).
This analysis did not find that that the US was slower than Europe in fact. After one year, only Germany reimbursed more drugs than the US, and by a slight margin. The UK and France on the other hand took longer than the rest of the pack to bring drugs to market.
The full study can be found here.
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Payers are seeing increased costs due to the demand of GLP-1 drugs. It’s estimated that 57.4 million adults under the age of 65 could be eligible for this class of drugs, based on currently approved FDA indications. There are 36.2 million people with an obesity diagnosis alone in the US.
If 10% of eligible adults take GLP-1 medications for weight loss, a $15 increase could be seen in the per-member-per month costs. This number rises to $50 if one-third of eligible adults start taking these drugs. Zepbound, manufactured by Eli Lilly, has a list price of $1059 per month, whereas Novo Nordisk’s Wegovy costs $1349 for a one month supply. However, last month, Eli Lilly announced a major price cut for their weight loss drug. Now, a 4-week supply of their drug at 2.5 mg will cost $399, whereas 5 mg vials will cost $549.
The measure is aimed at improving patient access, while reducing the risk of counterfeit medications. This price reduction was made without changes to insurance policies, and the drugs are available through LillyDirect, the company’s online pharmacy.
Not all insurers want to cover weight loss drugs like Zepbound, Wegovy, Mounjaro, and Ozempic, and innovative strategies are being explored to manage costs while keeping them available. One strategy is a utilization cap, which sets stricter standards for who is eligible. Another strategy is mentioned in Evernorth’s EncircleRX plan, which provides a 15% cost cap or a 3:1 savings guarantee when the medication is covered for weight loss.
The value of these drugs is still being investigated. If these medications can provide additional health benefits, there could be additional savings for payers down the road. Of note, studies have found reductions in cardiovascular death and sleep apnea when the drugs were used for weight loss.
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A new study investigated how drug rebates affect out-of-pocket costs for health plan beneficiaries. Rebates lower costs for payers, but depending on the health plan, they can raise costs for the patient.
There is a lot of secrecy surrounding the final price paid for a drug at the pharmacy, as official data on drug prices does not factor in rebates or the end price for the patient. The rebates paid by manufacturers to pharmacy benefit managers is not publicly available. The study therefore sought out to understand the relationship between rebates and the prices paid by insurers and beneficiaries.
Results: The negotiated price, defined as the price paid by the beneficiary at the pharmacy and by the payer after rebates are taken into account, rose 4.3% from 2007 to 2020. However, the out-of-pocket price, or that paid by the patient at the pharmacy, rose 5.8% annually. Retail pharmacy prices increased 9.1% annually.
Implications: Low-income families may be especially impacted by plans with higher deductibles and lower premiums, as they are not prepared for surprise costs associated with cost-sharing. As the authors stated: “consumers with a low deductible or capped copays appear to be shielded from steep pharmacy price increases.” The main contributor to increases in out-of-pocket expenses were increasing deductibles and co-insurance payments.
The authors emphasize that drug price transparency is important for health policy recommendations and more work needs to be done to understand drug price inflation.
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Para agilizar el proceso de Evaluación de Tecnologías Sanitarias (ETS) en los estados miembros de la UE, se implementarán cambios significativos en enero de 2025. En lugar de que los fabricantes de nuevas tecnologías sanitarias deban presentar datos clínicos en cada estado miembro, según el Reglamento (UE) 2021/2282, la evaluación se llevará a cabo de manera conjunta. Los fabricantes solo necesitarán presentar las evaluaciones clínicas una vez, aunque los estados miembros aún podrán realizar evaluaciones complementarias.
Es importante destacar los 9 dominios de evaluación, de los cuales 4 son clínicos y 5 no clínicos. Las 4 evaluaciones clínicas incluyen:
Los 5 dominios no clínicos incluyen:
España publicó su Proyecto de Real Decreto el 12 de agosto, que está abierto a comentarios hasta el 20 de septiembre, donde se detalla cómo se alinearán con la Directiva. Este esfuerzo involucra a la Oficina de Evaluación de la Eficiencia de los Medicamentos, que opera como una unidad funcional bajo la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
Además de las evaluaciones clínicas conjuntas en Europa, también habrá consultas científicas conjuntas. El objetivo de esta Directiva es reducir el trabajo administrativo duplicado y eliminar barreras a la innovación, al tiempo que se mejora el resultado para los pacientes.
A medida que estos cambios redefinen el panorama, es crucial que las empresas farmacéuticas y de tecnología médica se adapten rápidamente. Lyfegen puede ayudarle a mantenerse a la vanguardia con nuestras soluciones innovadoras:
Reserve una demostración con nosotros hoy para explorar cómo las herramientas y la experiencia de Lyfegen pueden apoyar su negocio bajo el nuevo marco de ETS en España.
Reserve su demostración aquí: https://www.lyfegen.com/demo
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Un cambio importante en Medicare Parte D entrará en vigor el próximo año, como resultado de la Ley de Reducción de la Inflación. Lo más notable es que el tope de gastos de bolsillo se reducirá de $3,300 a $2,000.
Esto nos lleva a otro desarrollo importante.
Actualización del Programa de Negociación de Precios de Medicamentos de Medicare
El CMS anunció su selección de 10 medicamentos cuyo precio fue negociado hace unos días, el 15 de agosto. Los medicamentos seleccionados se identificaron como “medicamentos de fuente única”, lo que significa que no tienen equivalente genérico o biosimilar, y es poco probable que lo tengan en el futuro cercano. Se estima que los nuevos precios ahorrarán $6 mil millones en costos netos de medicamentos recetados, lo que representa una reducción del 22% en el gasto. Los nuevos precios entrarán en vigor el 1 de enero de 2026.
A medida que la industria farmacéutica atraviesa estos cambios, es crucial contar con las herramientas adecuadas. Aquí es donde Lyfegen entra en juego con sus soluciones innovadoras como el Simulador de Contratación de Medicamentos, una herramienta diseñada para ayudar a los equipos de Acceso al Mercado y Precios a mantenerse a la vanguardia en este panorama:
💡 Modelado eficiente de escenarios de precios: Cree y pruebe una amplia gama de contratos de reembolso de medicamentos, lo que le permite evaluar rápidamente el impacto en los ingresos brutos y los costos netos.
🤝 Colaborativo y diseñado para su propósito: Deje atrás las herramientas basadas en Excel con nuestra plataforma dedicada, diseñada para los equipos de Acceso al Mercado y Precios, reutilizable en diferentes mercados y activos.
⚡ Acuerdos más rápidos y mejores: Simplifique la creación de acuerdos de reembolso en un entorno colaborativo, ayudándole a responder de manera más efectiva a las nuevas presiones de precios.
No pierda la oportunidad de mantenerse a la vanguardia en este nuevo entorno regulatorio. Reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo