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

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

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

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

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

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

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

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Learn more on: lyfegen.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pharmaceutical regulating authorities in the U.S. and Europe are under increasing pressure to approve new treatments as quickly as possible. Expedited approval programs were created to speed up patients’ access to innovative treatments that meet unmet health needs or treat life-threatening diseases. But concerns about post-approval follow-up persist. Value-based drug pricing arrangements are a solution that generates real-world data and evidence of a drug’s safety and benefit to health outcomes.

Global health authorities must consider the risks of bringing a new drug to market quickly with limited data about a product’s safety and effectiveness–these risks versus the potential benefits of a new drug that addresses an unmet medical need, alleviates a public health emergency, or saves a patient’s life. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the ones weighing those risks and benefits and guarding the safety of pharmaceutical products and medical devices.

The usual approval process for pharmaceutical products is similar for both agencies. It includes pre-clinical testing, three clinical trials, and a final approval before manufacturers can sell their drugs to patients. Drugs that show potential and meet certain criteria may qualify for an expedited approval process.

Expedited drug approval programs

Both the European and U.S. agencies have developed expedited approval programs to speed up the process of drug development and approval when a treatment shows the potential to meet an unmet medical need or treat a life-threatening condition. A new drug may qualify for consideration under more than one expedited approval program.

FDA programs:

• Priority-review designation (PR) – started in 1992, ensures the submission application will be reviewed within 6 months instead of the usual 12 months

• Accelerated approval (AA) – started in 1992, allows drugs to be approved using a surrogate endpoint instead of the outcomes of a clinical trial

• Fast-track designation (FTD) – started in 1997, a process to expedite the development and review of drugs designed to treat unmet medical needs and serious, life-threatening conditions

• Breakthrough-therapy designation (BTD) – started in 2012, speeds the development and review of drugs with the potential for better health outcomes compared to the results of current treatments on the market

EMA programs:

• Accelerated assessment – started in 2004, a review of the application to be completed in 150 days instead of 210 days if there are no major objections from the authorizing agency

• Exceptional circumstances authorization – started in 2005, eligible for drugs that treat extremely rare diseases and where it is not possible to conduct large clinical trials

• Conditional marketing authorization (CMA) – started in 2006, accelerates approval of drugs designed to meet an unmet medical need or serious, life-threatening disease

• Priority medicines scheme (PRIME) – started in 2016, reviewers are appointed earlier than usual in the development process, mostly used for orphan medicines

Comparing FDA and EMA use of expedited approvals

A study published in 2020 in The BMJ (British Medical Journal) compares the use of expedited approval programs by the FDA and the EMA. The focus of the study included approvals of new medicines from 2007 to 2017. During that time, the FDA approved 320 new drugs, and the EMA approved 268.

The study shows that, as of April 2020, there was an overlap of 75% (239) of new drugs which were approved by both the FDA and the EMA. Most of the drugs approved by both agencies were developed to treat cancer, digestive and metabolic disorders, or blood and cardiovascular disorders.

Out of the 320 drugs the FDA approved, 57% (181) of the new drugs qualified for at least one of the FDA’s accelerated approval programs. Out of the 268 drugs approved by the EMA, only 15% (39) qualified for one of the EMA’s expedited approvals.

A different study of global drug approval programs, covering January 2007 to May 2020, focused on expedited approvals for 128 new cancer drugs. The EMA approved 73% (94) out of the 128 new drugs and qualified 46% of them through expedited approval. The FDA expedited 91% (117) of the new cancer drugs through at least one accelerated approval program. (In 2019, all the cancer drugs the FDA approved during the year qualified for expedited approval.)

Of the six jurisdictions in the study, the FDA was the first to approve 80% (102) of the new cancer drugs. In Europe, delays in submissions of regulatory applications slowed many of the approvals. The EMA’s approvals of the same 102 drugs took an additional median time of 9.7 months.

Post-approval confirmatory trials

The expedited approval process in both Europe and the U.S. relies on post-market, real-world clinical data to confirm the safety and effectiveness of a drug. After the FDA or EMA grants expedited approval and the drug is on the market, the manufacturer is required to conduct confirmatory trials to gather enough real-world evidence to transition the drug from an expedited approval to a regular approval. Both the FDA and the EMA carry a backlog of confirmatory trials that were not completed on time.

An NPR (National Public Radio) analysis of FDA and National Institutes of Health data showed there are around 200 drugs with expedited approvals currently on the U.S. market. Many drugs, especially cancer treatments, have more than one accelerated approval to cover expanded uses. Close to half of these drugs transitioned to standard approvals after confirmatory trials, and another 9% were withdrawn.

The 30 years of data NPR reviewed also revealed that 42% of confirmatory trials didn’t start within the first year after the drug was made available to patients. Some confirmatory trials were delayed by three or more years, and even up to ten years.

The EMA also appears to have a substantial percentage of manufacturers who are slow to transition expedited approvals to standard approvals. In 2016, only about half of the drugs that received expedited approvals from the EMA had converted to standard approvals. Manufacturers who switched to standard approvals took an average of 4 years to complete the conversion process.

Gathering real-world evidence through value-based drug pricing arrangements

Both healthcare payers and drug manufacturers benefit from value-based drug purchasing arrangements for drug treatments that come to market under expedited approval programs.

For manufacturers, the real-world evidence generated by a value-based agreement may be quite helpful for a few reasons. First, the data could satisfy the requirements for post-approval confirmatory trials. Second, manufacturers can show with real-world evidence that their treatment offers better benefits to patient outcomes as compared to competitors’ products. Third, manufacturers can use the data supporting the real-world effectiveness of their product to negotiate and justify their drug’s list price and preferential position on a payer’s formulary.

While payers want the expedited approval process to bring treatments for unmet needs to patients as quickly as possible, they may still have unanswered questions post-approval about a new drug’s benefits. Under a value-based arrangement, payers can collect and analyze real-world evidence to address their uncertainty and concerns about a drug’s safety, benefit to patient health outcomes, and cost-effectiveness.

Value-based pricing agreements between payers and manufacturers allow both parties to share the financial risk of a drug not performing as expected. And if a drug underperforms, real-world data from the value-based agreement can reinforce the terms of a manufacturer’s rebate. Therefore, manufacturers willing to share risk and enter value-based drug purchasing arrangements with payers have a competitive advantage.

The Lyfegen Solution

Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to participate in value-based drug pricing agreements. Lyfegen’s software platform includes three-fold functionality to implement value-based, data-driven agreements with greater efficiency and transparency: data ingestion, agreement execution, and insights generation. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable information about drug performance and cost.

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

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

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Biosimilars are launching soon in several categories, including auto-immune disorders and ophthalmology

2023 will likely be a pivotal year for biosimilars, as Humira-referenced adalimumab products launch in the U.S. Worldwide, Humira has been a massive blockbuster for AbbVie, but also a drain on payer budgets. Once Humira-referenced biosimilars were marketed in Europe, they took off in many countries, as payers sought to reduce financial exposure with heavily discounted products. Steep discounts and tender offers, in which the best bid gets the lion’s share of the market, have helped boost uptake of biosimilars. Additionally, European payers have bought into the value proposition that biosimilars are cost-effective.

Besides auto-immune disorders, biosimilars are entering new therapeutic areas such as ophthalmology. Together with Samsung Bioepis, Biogen is launching Byooviz (ranibizumab) this month. Byooviz is a biosimilar referencing Lucentis. Approved by the FDA in September of last year, the drug will soon become the first ophthalmology biosimilar in the U.S. Byooviz’s approved indications include wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Byooviz is being offered at a list price of $1,130 per single-use vial, which is a 40% discount off the wholesale acquisition cost of Roche’s originator, Lucentis. It’s expected that the price of Lucentis will also drop.

But, selling biosimilars like Byooviz to payers and clinics isn’t as simple as discounting the price. As with any new biosimilar, detailing Byooviz’s launch – demonstrating its value - will be an elaborate endeavor, which involves engaging doctors, payers, and patient advocacy groups to facilitate access and appropriate physician and patient support. Biogen, for instance, has said it will be educating ophthalmologists about the science and value of biosimilars, as well as the regulatory framework for its approval.

In the U.S., policymakers firmly believe that safe, effective, and lower-cost biosimilars must be made available to all who need them. However, biosimilars have sometimes been excluded from formularies owing to rebate schemes. In this context, higher-priced originator medications are sometimes preferred by some U.S. payers as rebates are larger for those products. Indeed, perverse financial incentives in the U.S. have been a limiting factor with respect to increasing adoption of biosimilars.

Nevertheless, with employers and patients demanding more pass-through of rebates and the role of cost-effectiveness and value-based pricing gradually becoming more important to payers, it’s expected that biosimilars will ascend in market share across all therapeutic categories where they are available.

Indeed, after a painfully slow start from 2015 to 2019, the U.S. has finally been experiencing a sustained uptick in the uptake of biosimilars in the past few years. Robust biosimilar penetration is now apparent across several therapeutic classes. In addition to the filgrastims and pegfilgrastims, there’s been erosion of the originator biologic market share in the trastuzumab, rituximab, and bevacizumab classes.

Biosimilar usage can be bolstered by value-based contracts in which financial incentives of key stakeholders – payers, drug manufacturers, and healthcare providers - are aligned. For example, payers can institute capitated contracts with healthcare providers which hold those who prescribe originator biologics and biosimilars accountable in part for the total cost of care. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based purchasing agreements. The Lyfegen platform identifies and operationalizes value-based payment models in a cost-effective manner.

Undoubtedly, payers who are less reliant on rebate arrangements and therefore more cost- and value-conscious will be able to achieve a decrease in overall costs, as lower-priced biosimilars introduce market competition within therapeutic classes. In turn, this sparks steeper discounts across all drugs, including originator products.

What may further ameliorate the adoption of biosimilars Is the granting of therapeutic interchangeability designation to certain products. To illustrate, on July 28th, 2021, the FDA approved the first interchangeable biosimilar product, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. This has ushered in more competition, specifically in the insulin glargine class. Furthermore, one of the six biosimilars referencing Humira (adalimumab), Cyltezo, is now approved as therapeutically interchangeable and may be automatically substituted for its reference product Humira. All six approved biosimilars, including Cyltezo, are slated to enter the U.S. market at different points in 2023.

When determining the cost-effectiveness and budgetary impact of biosimilars, payers must consider dynamics, such as the distinguishing between the initiation of treatment-naïve patients on a biosimilar and therapeutic switching practices, as well as price competition with alternative therapies, and the effect of originator companies who can introduce biobetters, or improvements – often in terms of formulation and dosing – on their original product. Lyfegen can assist with evaluation of the cost-effectiveness of biosimilars and biobetters.

Armed with information about biosimilar and originator biologic clinical efficacy, patient preference, and treatment costs - which Lyfegen can provide - payers will be positioned to make appropriate coverage decisions.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.

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The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help patients around the world. We dived into a conversation with our CEO Girisha Fernando on why this partnership holds so much value for Lyfegen.


Girisha, why was the partnership with Johnson & Johnson such an important milestone for Lyfegen?

Girisha Fernando: Johnson & Johnson and Lyfegen share the same vision of sustainable & a value-based healthcare environment. Our goal is to help patients to receive the healthcare treatments they need and with this partnership, Lyfegen is proud to have been a key enabler for Johnson & Johnson and hospitals to deliver better health outcomes for patients.

How can this partnership be a blueprint for future collaborations?

Girisha Fernando: The increasing demand for healthcare measured against the limited financial resources is forcing the healthcare system to deliver innovative technologies to patients at sustainable costs. This can be done with value-based healthcare approaches and value-based agreements. The partnership between hospitals, Johnson & Johnson and Lyfegen shows how healthcare providers, manufacturers and an innovative tech company can deliver more value to patients whilst making efficient use of limited resources.

What would you suggest healthcare payers and hospitals to do if they are considering to implement value-based healthcare agreements with manufacturers?

Girisha Fernando: I believe it is important to focus on how to deliver better patient outcomes at lower cost. Value-based healthcare agreements can be used as a value-maximising method. It allows payers and hospitals to measure health outcomes and the adjacent cost to achieve these outcomes. Thus, hospitals can pivot on focusing their resources on value-adding healthcare treatments whilst addressing financial risk and uncertainty. It will take initial & minimal investment, but the return on investing in value-based healthcare and technology will be in the form of more value for money and better quality and patient health outcomes.

Why is Lyfegen the right platform for this?

Girisha Fernando: With over 120 value-based healthcare agreements running on the Lyfegen platform, we provide the necessary expertise, knowledge and technical competence to our customers. With these capabilities, we break down the complexity of implementing and managing value-based healthcare agreements. And lastly, we ensure that our customers can improve patient health outcomes by using value-based agreements at scale, efficiently.

Learn more about our platform by booking a demo today:

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Barcelona, April 9, 2024

The Consortium of Health and Social Services of Catalonia has begun to work on value-based drug purchasing models by incorporating new tools for information management and negotiation with the pharmaceutical industry. This is an innovative project in collaboration with the health technology brand Lyfegen, which has developed the largest platform for managing public agreements in the world and a drug contracting simulator that allows for better deals by maximizing value in the purchasing process.

The goal of this innovative initiative is to increase the processes of value-based drug procurement, allowing CSC-affiliated health centers to focus on the evaluation of the clinical, economic, and social benefits that the drug can provide in relation to its cost.

For the design of these new procurement models, the "Lyfegen Agreements Library" database and the “Lyfegen Drug Contracting Simulator” were used, and work was done on the automation of administrative tasks and on improving interoperability among hospitals and health administrations. These tools allow the CSC to model various agreements and improve the drug management process in the central contracting office. The Health and Social Consortium of Catalonia thus becomes the first organization in Spain to incorporate these tools.

"From the Consortium, we are convinced that access to innovation and the sustainability of the health system relies on reaching innovative management agreements with pharmaceutical laboratories," says Josep Maria Guiu, director of the Pharmacy and Medication Area of the CSC. "The alliance with Lyfegen gives us a tool to work in this direction and to advance in the establishment of satisfactory agreements that facilitate access to innovation and contribute to the sustainability of the health system."

Girisha Fernando, CEO of Lyfegen, comments that "We are proud to help the Consortium lead access to innovation to improve patient care in Catalonia." "By using our advanced solutions, more than 100 health organizations throughout the region can research, model, and efficiently manage agreements, as well as value-based drug procurement," he adds.

“This allows professionals to really focus on what matters most: patient care.”

The collaboration with Lyfegen reflects the commitment of the Health and Social Consortium of Catalonia to value-based drug procurement and to access to pharmacological innovation, as well as the will to continue working for the implementation of solutions that ensure equity and sustainability of the health system.

The total contracting volume of the CSC, which acts as the purchasing center for the subsidized health sector of Catalonia, was 1.497 billion euros in 2023. Of this amount, 90% corresponded to medicines and 10% to sanitary products.

In recent years, the Consortium of Health and Social Services of Catalonia has incorporated social value aspects into the purchasing processes. For example, it has committed to ensuring that 100% of its drug and sanitary product tenders incorporate environmental clauses by 2024.

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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 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 CONSORCI

The Consortium of Health and Social of Catalonia (CSC) is a public entity with a local and associative basis, founded in 1983, which has its origin in the municipal movement. The CSC, a reference to the sector and with a clear vocation for service, has as a mission: to promote excellent and sustainable health and social models to improve the quality of life of the people, offering services of high added value to its partners. CSC wants to be the main reference for knowledge and capacity for cooperation, influence and anticipation in the face of the new challenges of the health and social system. All CSC associates are public or private non-profit bodies. For more information, please visit https://www.consorci.org/el-csc/en_index

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Die Vertragssoftware von Lyfegen wird von Kostenträgern im Gesundheitswesen und führenden Pharmaunternehmen eingesetzt, darunter Novartis, Roche, MSD, Bristol Myers Squibb (BMS) und Johnson & Johnson.

NEW YORK/BASEL, 20. September 2022 /PRNewswire/ – Lyfegen, ein globales Healthtech-SaaS-Unternehmen, das den Übergang von volume-zu value-based Healthcare für hochpreisige Medikamente vorantreibt, gab heute eine überzeichnete Serie-A-Finanzierungsrunde über 8 Millionen Dollar bekannt, die vom Investmentfonds aMoon mit zusätzlicher Beteiligung von APEX Ventures und weiteren Investoren angeführt wurde.

Derzeit sind weniger als 2 % der Krankenversicherten, die Spezialarzneimittel benötigen, für 51 % der Arzneimittelausgaben verantwortlich. Die Kosten für Spezialarzneimittel in den USA laufen aus dem Ruder: Sie stiegen allein von 2020 bis 2021 um 12 % – und es gibt keine Anzeichen für eine Verlangsamung, denn es kommen immer mehr Zell- und Gentherapien auf den Markt. Infolgedessen wird Value-Based Contracting, die Nutzung wertorientierter Verträge, für die Kostenträger des Gesundheitswesens zu der entscheidenden Alternative, um nur für Medikamente zu zahlen, die tatsächlich wirken.

Bis 2025 werden die Nettoausgaben für Medikamente in den USA voraussichtlich bis zu 400 Milliarden US-Dollar betragen. Darüber hinaus kommen regelmässig neue Medikamente auf den Markt. Es fällt Pharmaunternehmen immer schwerer, sich mit den Kostenträgern auf kommerzielle Bedingungen zu einigen. Damit steigt die Gefahr, dass Patienten keinen Zugang zu lebensrettenden Therapien erhalten. Lyfegen hilft Regulierungsbehörden, Pharmaunternehmen und Kostenträgern bei der Einführung wertorientierter Zahlungsmodelle, indem sie den gesamten Prozess der Datenerfassung, Anonymisierung und Vertragsverhandlungen für alle Parteien digitalisiert. So kann die Preisgestaltung und Kostenerstattung für Medikamente vereinfacht werden.

„Wir freuen uns, diese Finanzierungsrunde bekannt zu geben und dieses Vertrauensvotum von aMoon, APEX und weiteren Investoren zu haben, die den Wandel im Gesundheitswesen verstehen und unser Bestreben um den Ausbau der Lyfegen-Plattform unterstützen", sagte Girisha Fernando, CEO und Gründer von Lyfegen. „Wir arbeiten derzeit mit führenden staatlichen Kostenträgern, Krankenversicherungen in Europa, den USA und dem Nahen Osten sowie mit einigen der weltweit grössten Pharmaunternehmen zusammen. Wir beabsichtigen nun, unsere Präsenz in den USA weiter auszubauen und Partnerschaften mit privaten und öffentlichen Krankenversicherungen einzugehen. Die Abkehr von der volumenbasierten Gesundheitsversorgung war noch nie so notwendig wie heute, und wir freuen uns, dass wir eine wichtige Rolle bei der Umstellung auf Value-Based Contracting spielen können."

„Lyfegen adressiert einen bedeutenden Marktbedarf in einer Branche, die sich dramatisch und schnell verändert, und wir sind begeistert, dass wir mit unserer Investition dazu beitragen können, ihre Anstrengungen zu unterstützen", erläuterte Moshic Mor, General Partner bei aMoon und ehemaliger Partner bei Greylock and Greylock Israel. „In Zeiten von Budgetdruck und Rezession im Gesundheitswesen braucht die Welt Lösungen wie die von Lyfegen mehr denn je. Wir sind stolz mit diesem erfahrenen Führungsteam zusammenzuarbeiten, das weiterhin den Zugang zu neuen Medikamenten verbessert, während es die wertorientierte Gesundheitsversorgung immer mehr zum Mainstream macht."

Informationen zu Lyfegen

Lyfegen ist ein unabhängiges, globales Softwareanalyseunternehmen, das eine wert- und ergebnisbasierte Vertragsplattform für Krankenversicherungen, Pharma- und Medizintechnikunternehmen sowie Krankenhäuser auf der ganzen Welt bietet. Die sichere Plattform identifiziert und operationalisiert wertbasierte Zahlungsmodelle kostengünstig und macht diese mit einer Vielzahl von realen Daten und maschinellem Lernen skalierbar. Mit der zum Patent angemeldeten Plattform von Lyfegen können Krankenversicherungen und Krankenhäuser eine wertorientierte Gesundheitsversorgung einführen und skalieren und so den Zugang zu Behandlungen, die Gesundheitsergebnisse der Patienten und die Kostenersparnis verbessern.

Lyfegen hat seinen Sitz in den USA und der Schweiz und wurde von Persönlichkeiten mit jahrzehntelanger Erfahrung im Gesundheitswesen, in der Pharmaindustrie und im Technologiebereich gegründet, um den Übergang von der volumenbasierten und kostenpflichtigen Gesundheitsversorgung zur wertorientierten Gesundheitsversorgung zu ermöglichen. Weitere Informationen finden Sie auf www.lyfegen.com.

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Pressekontakt: yael@gkpr.com

Ansprechpartner für Investoren: investors@lyfegen.com

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EGK nutzt die Lyfegen-Plattform, um komplexe Preismodelle für die On- und Off-Label-Verwendung von mehr als 80 Medikamenten zu verwalten.

Basel, Schweiz - 29. November 2022 - Lyfegen, ein globales Healthtech-SaaS-Unternehmen, das den weltweiten Übergang von einer volumen- zu einer wertbasierten (value-based) Gesundheitsversorgung für hochpreisige Arzneimittel vorantreibt, gab heute bekannt, dass die EGK-Gesundheitskasse sich seinem Portfolio von Versicherungspartnern anschliesst, um alle ihre Verträge zur wertbasierten Preisgestaltung für hochpreisige Arzneimittel effizient, sicher und transparent auszuführen.

Die Schweiz, mit den vierthöchsten Arzneimittelausgaben pro Kopf, gab in den ersten neun Monaten des Jahres 2022 8 Milliarden Franken (8,1 Milliarden Euro) für Medikamente aus, die für bestimmte Krankheiten verschrieben wurden. Um die hohen Arzneimittelausgaben zu bekämpfen, hat die Schweiz in den letzten fünf Jahren eine wachsende Zahl von Rabattmodellen für den On- und Off-Label-Einsatz von Medikamenten eingeführt. Die Komplexität der Preismodelle führt jedoch dazu, dass die Versicherer Millionenbeträge für die Überwachung und Beurteilung der Preismodelle ausgeben, was zu entgangenen Rabatten in zwei- bis dreistelliger Millionenhöhe führt.

Mit der Software von Lyfegen kann die EGK mit minimalem Aufwand und maximaler Transparenz Rabatte aus 141 Medikamentenpreismodellen von 32 Herstellern identifizieren und einfordern. Dazu gehören Fälle von seltenen oder chronischen Krankheiten, vielversprechende Therapien, die ausserhalb der zugelassenen Indikation eingesetzt werden können, oder neue Medikamente, die in der Schweiz noch nicht erhältlich oder zugelassen sind. Die Plattform von Lyfegen adressiert die Bedürfnisse der Schweizer Krankenversicherer nach Kosteneffizienz und Digitalisierung. Sie hilft, bestehende Komplexitäten im System zu lösen und wirkt hohen Versicherungsprämien entgegen.

„Wir freuen uns, die EGK zu unterstützen und eine aktive Rolle bei der Bewältigung der zunehmenden Komplexität von Medikamentenpreismodellen zu übernehmen, um den nachhaltigen Zugang zu innovativen Medikamenten und Therapien in der Schweiz zu unterstützen“ sagte Nico Mros, CXO und Mitgründer von Lyfegen. „Indem wir uns darauf konzentrierten, die Implementierung der Plattform so einfach wie möglich zu gestalten und auf die EGK einzugehen, konnten wir schnell Ergebnisse präsentieren und die Zusammenarbeit erfolgreich starten!“

"Mit der Lyfegen-Plattform baut die EGK ihren Fokus auf Nachhaltigkeit und Effizienz zum Wohle ihrer Versicherten weiter aus", sagt Carolina Pirelli, Leiterin Leistungen und stv. Geschäftsleiterin bei der EGK. "Die immer grösser werdende Zahl von Preismodellen für Medikamente stellt die Versicherer vor Herausforderungen in Bezug auf Ressourcen und Prozesse. Mit der automatisierten Verarbeitung von Preismodellen über die Lyfegen-Plattform können wir unsere aktuellen Anforderungen perfekt erfüllen und sehen uns mit der Flexibilität, dem Fokus und dem Verständnis von Lyfegen in guten Händen."

Über Lyfegen

Lyfegen ist ein globales SaaS-Analyseunternehmen im Gesundheitsbereich, das eine Plattform für wert- und ergebnisbasierte Verträge für Medikamente, Therapien und Medizingeräte anbietet.

Krankenversicherungen, Pharma- und Medizintechnikunternehmen sowie Spitäler nutzen die sichere Plattform für Tausende von Preismodellen in der Schweiz, Europa, dem Nahen Osten und Nordamerika. Die Lyfegen Plattform unterstützt die Verhandlungen und ermöglicht die automatisierte Ausführung von wertbasierten Preismodellen durch die Analyse von real-world Daten durch intelligente, lernfähige Algorithmen.

Weltweit renommierte Krankenversicherungen, Spitäler, Pharma- und Medizintechnikunternehmen haben die zum Patent angemeldete Plattform von Lyfegen bereits implementiert, um wertbasierte Preismodelle für Medikamente, Therapien und Medizingeräte zu skalieren und damit den Zugang zu Behandlungen sowie Therapieergebnisse für Patienten zu verbessern.

Lyfegen wurde von Personen mit jahrzehntelanger Erfahrung in den Bereichen Gesundheitswesen, Pharma und Technologie gegründet und leistet Pionierarbeit bei der Umstellung von der volumenbasierten und kostenpflichtigen Gesundheitsversorgung auf die wertbasierten Gesundheitsversorgung. Weitere Informationen finden Sie unter www.lyfegen.com.

Über die EGK-Gesundheitskasse

Die EGK-Gesundheitskasse ist ein KMU-Krankenversicherer mit Sitz in Laufen (BL). Die EGK-Gruppe umfasst die EGK Grundversicherungen AG (Grundversicherung nach KVG), die EGK Privatversicherungen AG (Zusatzversicherung nach VVG) sowie die EGK Services AG (Verwaltung). Sie versichert schweizweit rund 100'000 Personen in der Grundversicherung, 80% von diesen verfügen auch über eine EGK-Zusatzversicherung.

Natürlichkeit und Nachhaltigkeit gehören zur Werthaltung der EGK. Sie gilt als Pionierin beim uneingeschränkten Zugang zu exzellenter Komplementärmedizin. Sie lanciert und unterstützt in der ganzen Schweiz Aktivitäten zur natürlichen Stärkung der Gesundheit.

Read on PR newswire in German

Read on PR newswire in English

In light of today’s anticipated press release and exclusive article with AXIOS, we would like to extend a heartfelt thank you to our investors, customers, and team for sharing our vision to transform the healthcare system, helping patients to receive the healthcare treatments they need. The closing of our oversubscribed series A, led by aMoon Fund with additional participation from APEX Ventures and others, marks an important milestone.

Skyrocketing drug prices–especially for high-cost specialty drugs like cell and gene therapies–are accelerating the demand for value-based drug pricing. The move away from volume-based healthcare has never been more needed, and we are happy to play an important role in the shift to a value-based future.

With the $8 million in funding, we will expand our presence in Europe and the U.S. to increase drug affordability for more customers and, more importantly, more patients.

Together, we save lives.

Read the official Press Release

Read the Exclusive article with AXIOS

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Girisha Fernando
CEO & Founder[/caption]

He loves innovative tech and spending his free time reading Hi-tech books! Yes, we are proud to announce Lyfegen’s latest addition to the Kiev team: “Full-Stack Developer”, Dima Guzyk!

“Dima is extremely talented and with his passion to develop new and exciting technology that helps patients, Lyfegen’s products will reach new levels. We are very proud to have him in the team! ” says Lyfegen’s CEO, Girisha Fernando.

We sat down with him to give you a little more insight behind the book-loving “Full-Stack Developer”:

Hi Dima! Tell us a little about yourself: where are you from and what is your work experience background?

Hello! I’ve lived in Kiev almost all my life. This is such a beautiful city. For any lifestyle or interest, the city offers amazing opportunities to live out your dreams!

Regarding my work experience: After I graduated from university, I started working at Intellect Service, the biggest electronic document flow solutions developer in Ukraine. Gradually, my professional and communication skills developed and I became Team Lead of the company’s product. It was a great experience and led me to stay with them for 5 years!

My latest experience was at KPMG as a Software Engineer, where I participated in the development of various corporate information systems. Only after a short year, I had the fantastic opportunity to grow and take over the role of Senior Software Engineer.

This is your first experience in the Health Tech industry – what triggered this move?

This is my first experience in the Health Tech industry and I’m so happy! Working at Lyfegen gives even a tech development job a greater purpose: my work will indirectly support greater access for patients to innovative therapies – helping to save lives!

You are joining Lyfegen as a Full-Stack Developer. In simple terms: what will you be working on?

I participate in all the stages of software development, following the business requirements. In addition, I also analyze the domain in detail, propose architectural solutions to the problems we discover, write code, write unit tests, and help with creation of a reliable, scalable and secure application environment! In simple terms, I will bring the technical solutions of Lyfegen to life!

What are your next personal goals with Lyfegen?

My goal is to constantly discover new approaches and technologies, being able to make comparisons between them and implement the best to the work I do.

What motivated you to join?

When I discovered what Lyfegen was doing, giving patients worldwide access to innovative therapies, I knew I had to be a part of the team! Innovative therapies are necessary for humankind – it’s just that no one has been able to make these more accessible to a wider range of patients. This greater purpose and the impact that this technology has, was the key driver!

Enough about work! What passions do you have outside of Lyfegen?

I am an incredibly curious person! I have a wide range of passions that interest me but most of all I enjoy reading historical and Hi-tech books and magazines.

We are proud to have the Lyfegen team continue to grow with such fantastic team-members!

MEET THE LYFEGEN TEAM

The Lyfegen Team is proud to announce that as of this month, Simon has taken on the new role of “Customer Success Hero” at Lyfegen!

Simon joined Lyfegen 6 months ago as a working student and very quickly, full of motivation and enthusiasm, took on important responsibilities. Supporting Nico in the management of Lyfegen’s customer relations, which include some of the largest pharma companies worldwide, Simon will be accompanying the customers during the entire journey starting with supporting the customer’s in identifying suitable models up to the continuous support of Lyfegen's solutions. By gaining a comprehensive understanding of Lyfegen's customers' needs, he will also be working together with the technical development team to further enhance Lyfegen's solutions.

We are proud to have him as part of the team and sat down with him to give you a little more insight behind the bike-riding, FIFA-loving, “Customer Success Hero”!

Hi Simon, so tell us: why are you leaving large corporates like Roche and UBS to join the start-up Lyfegen?

After working at these two large corporates for several years I felt like I needed to see something completely different outside the corporate world. I was getting too much into a routine and wanted to take on a new challenge. I always had this entrepreneurial spirit in me and when I got the chance to start at Lyfegen, I didn’t have to think twice. Lyfegen offers me the perfect environment and has a great purpose.

You are working already since January 2020 at Lyfegen; what fascinates you the most?

I am really fascinated by the huge enthusiasm and passion of the whole team! Everyone here is very dedicated to leading Lyfegen to success and to driving value-based healthcare forward. I am also fascinated with how many new things I learn every single day and I am very delighted about how much responsibility I could already take over in this short time.

How do you experience the collaboration with the team?

The team has a great spirit and I felt very welcome and involved from the first second. The communication within the team is very transparent and open-minded. Issues can be addressed openly and critique is always given in a constructive way.

Healthcare is changing to value- and data driven models. How do you experience this change with our customers?

Our customers are all very interested in value- and data driven healthcare, but these models are often a new experience for them. With our technical solutions and our know-how, we support our clients to make the transition to value-based healthcare happen. We are now at a stage where we are pioneers and proactively shape the future environment for such models together with our clients.

What are your personal next goals with Lyfegen?

My personal goal is to further grow with the company. Growing not only personally by gaining more experience and continuously taking over more and more responsibility, but also to help Lyfegen achieve its next milestones. I am looking forward to be part of this journey.

We currently have two open positions - What are your recommendation for other talents that are applying at Lyfegen?

If you are applying at Lyfegen I recommend you to be aware of what it means to work in a start-up. You need to be ready to step outside your comfort-zone, be willing to actively drive things forward and take ownership. If this is what you are looking for, then Lyfegen is the perfect fit for you. Lyfegen offers you the perfect environment to further develop yourself and to work on exciting projects that have a real impact and a great purpose, helping patients to access innovative therapies.

Enough about work! What passions do you have outside of Lyfegen?

I love bike racing and being in nature! I can often be found on weekends biking my way up hills and testing my limits! It’s a great way to disconnect and focus on nature. But I’m not always in nature – I must admit, I do love playing video games too, especially FIFA (and am the proud winner of our last Lyfegen FIFA tournament – yes, the team got together for a 8 hour challenge one weekend!). Work hard, play hard!

We are proud to have the Lyfegen team continue to grow with such fantastic team-members!

MEET THE LYFEGEN TEAM

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

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

To introduce our newest addition, we interviewed Andrei.

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

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

What drives you to be a full-stack developer?

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

What motivated you to join Lyfegen?

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

What is your first impression as of now?

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

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

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

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

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

What passions do you pursue outside of work?

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

What else are you looking forward to?

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

MEET THE LYFEGEN TEAM

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

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

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

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

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

What drives you to be a developer?

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

What was your motivation to join Lyfegen?

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

What are your first impressions so far?

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

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

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

What do you want to learn and improve this year?

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

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

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

What passions do you pursue outside of work?

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

We are proud to welcome Thungu to the Lyfegen team!

MEET THE LYFEGEN TEAM

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

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

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

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

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

What drives you to be a full stack developer?

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

What motivated you to join Lyfegen?

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

What is your first impression as of now?

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

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

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

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

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

What passions do you pursue outside of work?

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

MEET THE LYFEGEN TEAM