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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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:
The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help...
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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.
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.
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.
Verwandte Links:
Linkedin: https://www.linkedin.com/company/lyfegenhealth
Pressekontakt: yael@gkpr.com
Ansprechpartner für Investoren: investors@lyfegen.com
Read the Exclusive article with AXIOS
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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.
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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
[caption id="attachment_3253" align="aligncenter" width="200"]
Girisha Fernando
CEO & Founder[/caption]
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We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.
Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?
I have spent close to a decade in the life sciences sector, working with companies like Novartis and Pfizer, where I gained deep expertise in healthcare strategy, market access, and health economics. My passion has always been focused on improving patient outcomes and the healthcare system. This led me to Lyfegen, a company at the forefront of transforming healthcare through innovative solutions. The opportunity to work with payers and drug manufacturers to ensure better and sustainable access to innovative treatments for patients was a natural fit for me, both professionally and personally.
What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?
The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies. However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.
What opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How can we better support health insurers and government bodies?
There is tremendous potential for growth. Currently, payors and pharmaceuticals adjudicate their product listing agreements (PLAs) manually through Excel spreadsheets. It is resource intensive, leaves room for errors and is a barrier to potential innovative contracting. In addition, as Canada increasingly looks towards value-based healthcare models, Lyfegen is an enabler by providing the digital infrastructure for payor and manufacturers.
From your perspective, what key actions need to be taken in the next 12 months to drive success for Lyfegen in the Canadian market?
In the next 12 months, we need to focus on deepening our relationships with key stakeholders and demonstrate the value of our digital solutions for payors, manufacturers, healthcare system and, ultimately, the patients.
How do you see your role influencing the implementation of value-based solutions in Canada, and what impact do you hope to have?
Lyfegen has extensive experience in OBA implementation and operationalization in many countries. In my role, I hope to bridge the gap from theory to practice in the implementation of value-based healthcare in Canada.
In your opinion, what’s the most important aspect of building strong client relationships in the healthcare industry? How do you approach this in your role?
Trust and communication are at the core of any strong client relationship in healthcare. Given the complexity and sensitivity of the industry, clients need to know that you understand their unique challenges and are committed to solving them. In my role, I prioritize open and ongoing communication, ensuring that clients feel heard and that their feedback is integrated into our solutions. I also work hard to build trust by delivering results and being transparent about what we can achieve together.
Looking ahead, what excites you most about the future of sales and business development at Lyfegen in Canada?
I’m excited about the potential to be a catalyst for significant change in the Canadian healthcare landscape. Lyfegen is in a unique position to lead this transformation. The combination of increasing demand for cost-effective healthcare solutions and our innovative approach makes this an incredibly exciting time to be in sales and business development.
Outside of work, what are some of your favorite things to do in your free time?
Outside of work, I enjoy spending quality time with my family and friends. I also prioritize my health by being active on a daily basis. I also enjoy learning. Now that I have completed my MBA, I’m on a mission to learn Spanish.
We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!
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Once upon a time, In a whimsical forest, there lived a smart and creative blue bird. This bird, known for its brilliance in the world of tiny forest biotech, had concocted a magical potion.
This potion was a wonder, a gene therapy to cure the forest creatures of a troublesome disease called sickle cell. Perched thoughtfully on a branch, the blue bird faced a whimsical yet vital challenge. The potion, potent in its healing, needed to be more than just a marvel of science – it had to be reachable and affordable for all in the forest. Additionally, this magical creation was still unnamed, a name that should echo its life-affirming qualities and the journey from a mere idea to a beacon of hope in the forest.
Amidst this puzzlement, the blue bird heard tales of the wise owls of Lyfegen, far beyond the forest. These owls were not just wise; they were masters of a different kind of magic – the magic of numbers and agreements that made health solutions reachable to all. Intrigued, the blue bird fluttered over to learn more.
As it learned about Lyfegen's remarkable ability to navigate the complex world of potion pricing and access, inspiration struck. "Ah-ha!" chirped blue bird, "If Lyfegen can make health solutions accessible, why not name my potion in honor of their work? Lyfgenia – a name that sings of life, hope, and the ingenuity of Lyfegen!"
And so, the potion was christened Lyfgenia, a nod to the owls of Lyfegen whose wisdom ensured that such medical marvels reached every nook and cranny of the forest without burdening its inhabitants.
With its new name, Lyfgenia became more than just a potion; it symbolized a harmonious blend of medical genius and financial savvy. The blue bird turned Lyfgenia into a symbol of hope and healing in the whimsical world of the forest.
Disclaimer: "A Fable of the Blue Bird and Lyfegen's Wise Owls" is a work of fiction, created solely for entertainment and illustrative purposes. This fable does not represent any real-life strategies, decisions, or actions of these entities, nor should it be interpreted as an endorsement or representation of their values, capabilities, or business practices.
Using Lyfegen's solutions can streamline the financial management of advanced therapies like Lyfgenia, leading to more effective pricing strategies and improved access for patients. Learn more about how our solutions enable value-based contracting for gene therapies: lyfegen.com
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Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
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At this years World Evidence, Pricing and Access event, Girisha Fernando, the CEO of Lyfegen, expressed excitement as he spoke about the company’s latest launched offering - the Lyfegen Model & Agreement Library. This unique learning resource is a true game-changer that builds upon the company’s existing product. It expands our horizons by allowing payers and market access & pricing professionals to explore over 2’500 real-life public agreements, and 18 drug pricing models from around the world. The library provides an unparalleled understanding of drug reimbursement models that help users make better informed choices like never before.
Selecting a drug reimbursement model is very complex, as manufacturers want quick market access, while payers may have many concerns, such as a drug’s efficacy and affordability. Fernando emphasized that the library bridges the gap by assisting payers and market access professionals in finding specific models that address each stakeholder’s concerns, and key real-life agreement examples, resulting in better-informed decision-making, and ultimately more efficient reimbursement processes.
“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 Fernando, “That is why we are 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.”
But that’s not all – Fernando explained that the database is constantly evolving, being updated weekly with new public agreements, allowing stakeholders to be up to date on public agreements.
Overall, it is clear that the Lyfegen Model & Agreement Library is an invaluable groundbreaking tool, that is becoming indispensable in increasing the knowledge on drug and Cell & Gene Therapy reimbursement.
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He’s analytical, a techie and has a fantastic gift for music! Yes, we are talking about the latest addition to our team, our very own “Technical Business Analyst” and Ukrainian superstar: Pavlo Lupandin!
Just last month we announced the arrival of our Lead Developer, Daniel, and now more great news follows as Lyfegen continues to lay focus on the technical team: we have our very own Technical Business Analyst, Pavlo!
“Pavlo’s sharpness and problem-solving skills just made it clear that we needed him in our team! His drive and commitment will bring great value to our patients, our customers and Lyfegen as we continue to sharpen our platform” says Lyfegen’s CEO, Girisha Fernando.
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 musical talent and witty “Technical Business Analyst”:
Hi Pavlo! Tell us a little about yourself: where are you from and what is your work experience background?
Hello! I was born in the east of Ukraine, got the Master’s Degree in Economics in Kyiv, worked at one of the Big 4 companies for 3 years as an Auditor, following one year in the role of Business Analyst. After this experience, I found myself being a fresh ACCA Member, who wanted to dive into something not that accounting related. Business analysis has proven to be an interesting area where I can develop further capitalizing on my previous experience.
It’s interesting, that back in my audit days I’ve had some big healthcare-related projects. Who knew that it was only the beginning of working in this promising domain…
This is your first experience in the Health Tech industry – what triggered this move?
Pace of development. The Healthcare & IT industries are developing in overwhelming waves, and to ride the peak of those waves is a challenge – formidable, but a tempting one. As soon as this opportunity presented itself, I decided to chase it. We’ll see, where this decision will bring me in a couple of years.
You are joining Lyfegen as Technical Business Analyst. In simple terms: what will you be working on?
I would be occupied mainly with gathering, documenting and communicating the requirements of our customers. Ever heard of different communication barriers? Those I would try to eliminate, trying to grasp the very core of what has to be done for the maximum customer satisfaction and making sure the development team implements requirements as close as possible to the ideal.
What are your next personal goals with Lyfegen?
There are several of them. First, I strive for development as a professional, and I think Lyfegen will provide me with opportunities to do that. Second, I want to embrace that spirit of a high-growth startup – after working for a massive and complex company, the flexibility and freedom of Lyfegen is a breath of fresh air. And finally, I want to know new talented people. I already know, that the Lyfegen team has a great diversity, and I can’t wait to learn some interesting things from people of other countries and cultures.
What motivated you to join?
Purpose and value. As simple as that. I can see the purpose and value of what I’m doing. Obviously, we are at the beginning of this journey, and it’s a bit early to speak about “value-based pricing for everybody” or “pay only for what is really working” but…the concept is huge, and it will become the question of life and death for some patients. And I’ll do my best to make it as close to life as possible.
Enough about work! What passions do you have outside of Lyfegen?
Oh, you don’t want to hear a full list, I assure you. Let me try to sum it up quickly…Music, videogames and tabletop games – I play them all. A small collection of musical instruments – some of them are quite exotic, especially for my home country (banjo and djembe, for example). A bigger collection of tabletop games in different genres – the Lyfegen team can definitely expect a session or two in the nearest future. And a vast collection of videogames on different platforms…without much details let’s just agree there are a lot.
There are some other hobbies of mine, but I’d prefer to keep a couple of surprises up my sleeve!
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
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En Brasil, encontramos que los principales fabricantes que proponen contratos basados en el valor fueron Novartis, Pfizer, J&J Innovative Medicine y Roche. Entre los pagadores, identificamos 21 aseguradoras privadas entre 2021 y 2024. También agregamos a ANVISA (Agencia Nacional de Vigilancia Sanitaria de Brasil) y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC), el organismo de evaluación de tecnologías sanitarias (ETS) de Brasil.
Áreas Terapéuticas
Las áreas terapéuticas que identificamos en los acuerdos públicos de Brasil incluyen:
Modelos de Precios
Nuevos modelos de precios de Brasil incluyen:
Acuerdos Destacados
Estos acuerdos se destacan porque abordan enfermedades raras y de alto costo, y demuestran enfoques únicos para el acceso a medicamentos y reembolsos, incluyendo cobertura con desarrollo de evidencia, garantías de resultados y pagos a plazos.
Fibrosis Quística:
Atrofia Muscular Espinal Infantil:
Cáncer de Ovario:
Principales Fabricantes:
Entendiendo el Proceso de ETS para la Aprobación de Medicamentos en Brasil
En Brasil, el proceso de Evaluación de Tecnologías Sanitarias (ETS) es gestionado por ANVISA y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC). El proceso incluye varios pasos:
A medida que Brasil se convierte en un mercado clave para las empresas farmacéuticas, nuestra biblioteca ofrece información esencial para ayudarle a ingresar a este mercado de manera eficiente y antes que la competencia.
Para obtener más información sobre los acuerdos de acceso a medicamentos en Brasil o acceder a nuestra biblioteca, reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo
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En este blog, seleccionamos acuerdos específicos en Canadá, Dinamarca y Brasil. Cada uno de estos acuerdos varía, y los elegimos para que pueda ver cómo los fabricantes abordan el acceso al mercado para diferentes medicamentos y regiones. Los contratos basados en el valor en estos mercados aceleran el acceso de los pacientes mientras comparten el riesgo financiero entre la industria farmacéutica y los pagadores, una situación en la que todos ganan.
Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals)
La Agencia Canadiense de Medicamentos y Tecnologías en Salud requiere una reducción del 94% en el precio de Trikafta para que el tratamiento sea rentable. Los niños con fibrosis quística de entre 2 y 5 años son evaluados después de 1 año, para demostrar que se benefician del tratamiento. Los pacientes deben cumplir con una serie de criterios para ser elegibles para el tratamiento, lo que convierte al acuerdo en una combinación de cobertura con desarrollo de evidencia, cobertura restringida y basada en resultados.
Trikafta ya había sido aprobado para su uso en niños mayores de 6 años, pero realizar un ensayo clínico en niños de entre dos y cinco años se consideró “éticamente desafiante”. Sin embargo, un ensayo no controlado en este grupo de edad encontró que el tratamiento fue bien tolerado y redujo los biomarcadores de la condición. Para abordar las necesidades no satisfechas, reconociendo la falta de datos en esta población de pacientes, se negoció un contrato de CED con una reducción drástica en el precio.
Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)
El Ministerio de Salud de Brasil llegó a un acuerdo con Vertex para permitir el acceso restringido a este tratamiento, mientras monitorea regularmente a los pacientes a los 30 días y a los 3 meses después de iniciar el tratamiento. El acuerdo incluye reembolsos si el tratamiento no logra los resultados clínicos deseados, alineando los precios con la efectividad.
Kalydeco (ivacaftor, Vertex Pharmaceuticals)
El organismo de adquisición danés, Amgros, y Vertex Pharmaceuticals llegaron a un acuerdo que proporciona acceso a una cartera de medicamentos para la fibrosis quística, incluyendo Orkambi (lumacaftor/ivacaftor) y futuras terapias, en 2019. A pesar de que esto ocurrió hace cinco años, es un excelente ejemplo de precios basados en cartera, donde los pagadores acuerdan pagar una tarifa fija por un grupo de medicamentos relacionados. Cuantos más pacientes los utilicen, menor será el precio por paciente.
Lynparza (Olaparib, AstraZeneca)
Este acuerdo se realizó entre AstraZeneca y aseguradoras privadas en todo Brasil. El tratamiento se pone a disposición sin costos adicionales para el paciente y combina características de cobertura restringida con garantías de resultados. La cobertura continua depende de lograr una respuesta parcial o completa.
Zolgensma (onasemnogene abeparvovec, Novartis)
La terapia génica de Novartis, Zolgensma, se reembolsa en función de la necesidad de evidencia adicional, conocida como cobertura con desarrollo de evidencia. Esto implica usar la cobertura como un medio para obtener evidencia del mundo real, para compensar la falta de datos robustos de pacientes provenientes del ensayo clave. El acuerdo también divide el riesgo entre los pagadores y los fabricantes, al vincular el reembolso con los resultados obtenidos. Debido al gran potencial de la terapia para mejorar la calidad de vida de los niños con AME, el acuerdo permite que los pacientes elegibles comiencen a recibir el tratamiento rápidamente.
¿Quiere ver la biblioteca por sí mismo? Reserve una demostración hoy aquí: https://www.lyfegen.com/demo
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To streamline the HTA process across EU member states, sweeping changes will go into effect in January of 2025. Instead of manufacturers of new health technologies needing to submit clinical data to each member state, under Regulation (EU) 2021/2282, the assessment will be conducted jointly. Manufacturers will only need to submit clinical assessments once, but member states can still conduct complementary assessments.
Important to note are the 9 assessment domains, of which 4 are clinical and 5 are non-clinical. The 4 clinical assessments include:
The 5 non-clinical domains include:
Spain released its Draft Royal Decree on the 12th of August, which is open for comments until the 20th of September, outlining how they will align with the Directive. This effort involves the Office for the Evaluation of the Efficiency of Medicines operating as a functional unit under the Spanish Agency of Medicines and Medical Devices (AEMPS).
In addition to joint clinical assessments in Europe, there will also be joint scientific consultations. The goal of this Directive is to reduce duplicate administrative work and remove barriers to innovation while aiming to improve patient outcomes.
As these changes reshape the landscape, it's crucial for pharmaceutical and medical technology companies to adapt swiftly. Lyfegen can help you stay ahead with our cutting-edge solutions:
- Navigate New Regulatory Requirements: Access our extensive Agreements Library, featuring over 5,000+ public drug pricing agreements and 20 pricing models, to ensure compliance with the latest HTA standards.
- Optimize Decision-Making: Utilize our Drug Contracting Simulator to create data-driven business cases and run real-time simulations that align with Spain's new HTA guidelines.
- Streamline and Automate Contracting: Our Rebate Analytics solutions automate rebate and refund calculations, ensuring accuracy, transparency, and a significant reduction in administrative burdens.
Book a demo with us today to explore how Lyfegen’s tools and expertise can support your business under Spain’s new HTA framework.
Book your demo here: https://www.lyfegen.com/demo
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A major change to Medicare Part D will go into effect next year, as a result of the Inflation Reduction Act. Most notably, the cap on out-of-pocket expenditures will be reduced from $3,300 to $2,000.
This brings us to another major development.
Update to Medicare Drug Price Negotiation Program
CMS announced its selection of 10 drugs that were negotiated down in price, on August 15th. The selected drugs were identified as “single source drugs,” meaning there is no generic or biosimilar equivalent, and there is unlikely to be so in the near future. The new prices are estimated to save $6 billion in net prescription drug costs, representing a 22% reduction in spending. The new prices will go into effect on the 1st of January, 2026.
As the pharmaceutical industry goes through these changes, it’s crucial to have the right tools in place. This is where Lyfegen comes into play with its cutting-edge solutions like the Drug Contracting Simulator, an innovative tool designed to help Market Access and Pricing teams stay ahead in this landscape:
💡 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁𝗹𝘆 𝗠𝗼𝗱𝗲𝗹 𝗣𝗿𝗶𝗰𝗶𝗻𝗴 𝗦𝗰𝗲𝗻𝗮𝗿𝗶𝗼𝘀: Build and test a wide range of drug rebate contracts, allowing you to quickly assess the impact on gross-to-net revenue and costs.
🤝 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗣𝘂𝗿𝗽𝗼𝘀𝗲-𝗕𝘂𝗶𝗹𝘁: Move away from Excel-based tools with our dedicated platform, designed for Market Access and Pricing teams, and re-usable across different markets and assets.
⚡ 𝗙𝗮𝘀𝘁𝗲𝗿, 𝗕𝗲𝘁𝘁𝗲𝗿 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀: Streamline the creation of rebate agreements in a collaborative environment, helping you respond more effectively to new pricing pressures.Don’t miss out on staying ahead in this new regulatory environment. Book a demo with us today: https://www.lyfegen.com/demo
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In Brazil, we found that the main manufacturers proposing value-based contracts were Novartis, Pfizer, J&J Innovative Medicine, and Roche. Among payers, we identified 21 private insurers between 2021 and 2024. We also added ANVISA (Brazilian Health Regulatory Agency) and the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC), Brazil’s health technology assessment (HTA) body.
Therapeutic Areas
The therapeutic areas we identified in Brazil’s public agreements include:
Pricing Models
New pricing models from Brazil include:
Featured Agreements
These agreements are highlighted because they address high-cost, rare diseases and demonstrate unique approaches to drug access and reimbursement, including coverage with evidence development, outcome guarantees, and installment payments
Cystic Fibrosis:
Infantile Spinal Muscular Atrophy:
Ovarian Cancer:
Main Manufacturers:
Understanding the HTA Process for Drug Approval in Brazil
In Brazil, the Health Technology Assessment (HTA) process is managed by ANVISA & the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC). The process involves several steps:
As Brazil becomes a key market for Pharma companies, our library offers essential information to help you enter this market efficiently and ahead of the competition.
To learn more about Brazil’s Drug Access Agreements or get access to our library, book a demo with us today: https://www.lyfegen.com/demo