Canada: Investing in RWE for rare diseases
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Introduction
Canada’s Drug Agency has recently awarded funding to multiple rare disease registries to enhance the “pan-Canadian evidence landscape.” This funding is aimed at bolstering the quality and accessibility of data that can guide regulatory and reimbursement decisions for rare disease therapies. As Canada focuses on building a comprehensive evidence base, pharmaceutical companies, payers, and stakeholders must adapt to the evolving landscape for market access and contracting. Lyfegen’s Agreements Library and Drug Contracting Simulator offer vital tools to navigate these complexities with greater precision and transparency.
Key Takeaways for Pharma and Payers
1. Strengthening Data Quality and Accessibility
• What’s Changing: The new funding will support initiatives to improve data accuracy, completeness, and accessibility within rare disease registries across Canada. This enriched data landscape will play a crucial role in guiding therapeutic decisions for rare diseases.
• Impact: With access to more comprehensive data, pharma companies and payers can make more informed decisions regarding therapy efficacy and patient outcomes. This data-driven approach is essential for adapting market strategies to address the specific needs of rare disease populations in Canada.
2. Supporting Regulatory and Reimbursement Decisions
• What’s Changing: The funding will enable the development of evidence needed to meet Health Canada’s regulatory requirements and the Canadian Agency for Drugs and Technologies in Health (CADTH) reimbursement criteria for rare disease treatments.
• Impact: A robust evidence base will accelerate the approval and reimbursement process for rare disease therapies. Pharma and payers can benefit from shorter timelines for market entry and more predictable pricing models aligned with outcomes-based agreements, ensuring that patient needs are met in a timely manner.
3. Advancing Outcome-Based Metrics and Digital Health Solutions
• What’s Changing: Emphasis on outcome-based evidence and digital health transformation within rare disease registries will promote a transparent, efficient healthcare ecosystem for these high-cost therapies.
• Impact: Outcome-based metrics provide pharma and payers the opportunity to structure contracts that reflect real-world patient outcomes, supporting more sustainable pricing models that align with the health outcomes valued by Canadian healthcare providers.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library, a vast digital repository of drug pricing agreements, offers valuable insights into historical trends and pricing models that support evidence-based contracting decisions. By leveraging over 6,000 agreements and diverse pricing models, pharma and payers can develop contracts that align with Canada’s specific regulatory and reimbursement frameworks.
2. Drug Contracting Simulator: Lyfegen’s Drug Contracting Simulator enables teams to model various pricing scenarios, allowing them to understand potential outcomes and financial risks associated with rare disease therapies. By simulating real-world conditions, stakeholders can make informed contracting decisions that support the Canadian healthcare system’s goal of data-driven, sustainable solutions for rare diseases.
Conclusion
Canada’s initiative to strengthen its rare disease data landscape marks a significant step forward in improving access to and affordability of rare disease therapies. For pharma companies, payers, and other stakeholders, this shift provides opportunities to develop innovative contracts that align with Canadian healthcare goals. Lyfegen’s Agreements Library and Drug Contracting Simulator offer the tools needed to support evidence-based decision-making, enabling healthcare players to navigate Canada’s evolving market access landscape confidently.
Book your demo today to discover how our tools can transform your approach to rare disease therapy access in Canada: https://www.lyfegen.com/demo
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Introduction
The FDA has launched an innovative pilot program to expedite patient access to essential therapies: the Split Real Time Application Review (STAR). Starting December 2, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will begin accepting a limited number of marketing applications under this new initiative. By focusing on early and continuous review processes, the STAR program aims to minimize the time between final submission and the FDA’s action date, providing faster access to treatments for patients with unmet medical needs.
Key Takeaways for Pharma and Healthcare Providers
1. Accelerated Review Process for Unmet Needs
• What’s Changing: The STAR program is designed to review applications in segments, allowing FDA reviewers to assess data in real time as it becomes available. This continuous review approach differs from traditional methods, where applications are evaluated in full only after complete submission.
• Impact: For pharmaceutical companies, this streamlined process could mean faster paths to market, particularly for therapies targeting critical, unmet needs. It emphasizes the FDA’s commitment to addressing patient needs more swiftly, which could reduce financial burdens on developers facing lengthy approval processes.
2. Collaboration Between CDER and CBER
• What’s Changing: The STAR program is a collaborative effort involving both CDER and CBER, expanding its applicability to a broad range of therapies, including new drugs and biologics. This joint approach signals the FDA’s intention to standardize and extend this model across diverse therapeutic areas.
• Impact: By involving multiple FDA centers, the STAR program encourages broader participation from biotech and pharmaceutical companies developing biologics, vaccines, and innovative therapies. For patients, it represents a promising step toward quicker access to a wider array of advanced treatment options.
3. Focus on Real-Time Data and Incremental Submissions
• What’s Changing: Unlike traditional application reviews that rely on fully completed submissions, STAR’s approach allows the FDA to review segments as they are completed. This real-time data review supports a more dynamic evaluation process and could accelerate decision-making.
• Impact: For the pharma industry, this shift may lead to shorter regulatory timelines and a more predictable approval process. By providing early feedback on submitted data, the FDA enables companies to address potential issues proactively, ultimately supporting faster market access for breakthrough therapies.
Conclusion
The FDA’s STAR program represents a transformative approach to regulatory review, one that aligns with the needs of modern healthcare. By focusing on continuous, real-time reviews, the FDA is paving the way for faster patient access to treatments that address critical health needs. For pharmaceutical companies and healthcare providers, this new pathway offers a chance to bring innovations to patients more swiftly and efficiently. As the STAR program unfolds, its success could shape the future of regulatory review, setting a new standard for timely patient access in the U.S. healthcare system.
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Introduction
Switzerland has taken steps to streamline drug approvals and make essential therapies more accessible by revising Swissmedic’s fast-track and temporary authorization procedures, effective as of October 15, 2024. These changes aim to expedite market access for crucial treatments, especially for those addressing urgent healthcare needs. Recently, the Federal Office of Public Health (FOPH) conducted a Health Technology Assessment (HTA) on Calcitonin gene-related peptide (CGRP) receptor antagonists, a class of anti-migraine drugs. The analysis determined that these drugs are more cost-effective for chronic migraine sufferers than for those with episodic migraines, influencing how they may be priced and reimbursed.
Key Takeaways for Pharma and Payers
1. Revised Fast-Track and Temporary Authorization Processes
• What’s Changing: Swissmedic has updated its fast-track and temporary authorization procedures, intended to speed up drug approval times. This revision allows for quicker access to therapies that address significant healthcare needs, supporting patients in receiving timely treatments.
• Impact: For pharmaceutical companies, these changes open up opportunities to bring their innovations to market faster, particularly for therapies that address chronic and complex conditions. With the fast-track pathway, companies can achieve quicker regulatory approval, which could help with meeting demand and advancing critical treatments for conditions like chronic migraine.
2. Pricing Adjustments Based on Cost-Effectiveness Analysis
• What’s Changing: The FOPH’s recent HTA on CGRP receptor antagonists for migraines concluded that these drugs offer higher cost-effectiveness for chronic versus episodic migraine patients. As a result, FOPH has proposed a price reduction to align with the value provided, ensuring that patients benefit from more affordable access to these treatments.
• Impact: For payers and pharma, this emphasis on value-based pricing represents a growing trend in Switzerland. Drug prices are being set based on real-world evidence and cost-effectiveness, pushing the industry towards more sustainable, outcome-driven pricing models.
3. Inclusion in the List of Pharmaceutical Specialities (LS)
• What’s Changing: FOPH re-evaluates drug prices every three years and decides if they should remain on the List of Pharmaceutical Specialities (LS), which comprises all drugs covered by basic insurance. For certain treatments, such as CGRP receptor antagonists, drugs may be included with limitations—meaning they will only be reimbursed under specific conditions.
• Impact: This conditional reimbursement approach supports more targeted healthcare spending, benefiting patients who meet specific criteria. For pharmaceutical companies, meeting these requirements is essential to ensure ongoing reimbursement and access to Switzerland’s market.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library offers a comprehensive resource of pricing agreements, enabling pharma and payers to explore pricing models that align with Switzerland’s emphasis on cost-effectiveness. With access to over 6,000 agreements, pharma teams can develop flexible, outcome-based pricing strategies that meet Swiss regulatory and reimbursement requirements.
2. Drug Contracting Simulator: The Drug Contracting Simulator provides a powerful tool for modeling various pricing scenarios. By simulating real-world conditions, stakeholders can assess the financial and clinical outcomes of fast-track approved therapies, enabling them to create tailored, data-driven agreements that reflect the FOPH’s cost-effectiveness criteria.
Conclusion
Switzerland’s recent adjustments to its fast-track drug approval processes and value-based approach to anti-migraine drug pricing underscore the country’s commitment to accessible, cost-effective healthcare. For pharmaceutical companies and payers, these changes represent an opportunity to align market access strategies with Switzerland’s evolving regulatory landscape. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential support for navigating these complexities, helping stakeholders design effective, outcome-driven agreements that meet Switzerland’s regulatory standards.
Book a personalized demo today to see how Lyfegen can transform your market access strategy under Switzerland’s new reforms: https://www.lyfegen.com/demo
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Introduction
Spain is making strides in healthcare by prioritizing education, innovation, and cost-effective care. Recently, the Spanish Council of Ministers allocated over 44 million euros from pharmaceutical sales to support various public health initiatives, focusing on two critical areas: reducing unnecessary care and enhancing Health Technology Assessment (HTA) education for healthcare professionals. These investments are aimed at improving the efficiency of healthcare delivery, reducing costs, and supporting more informed decision-making around drug use and preventive care.
Key Takeaways for Pharma and Payers
1. Funding for HTA Education and Training
• What’s Changing: Part of the allocated funds will go toward continuing education programs for healthcare professionals, specifically to improve their understanding of Health Technology Assessment (HTA). By deepening professionals’ knowledge of HTA, Spain aims to ensure that drug evaluation and therapeutic positioning are guided by evidence-based practices.
• Impact: For pharmaceutical companies, this initiative means greater scrutiny of drug effectiveness and cost-effectiveness, especially as healthcare providers become more proficient in HTA principles. Payers may also benefit, as a well-informed healthcare workforce can make better use of resources, potentially lowering overall costs.
2. De-prescription of Unnecessary Drugs and Promotion of Preventive Care
• What’s Changing: The initiative will also fund programs aimed at de-prescribing unnecessary medications to reduce healthcare costs. Alongside this, Spain is placing a stronger emphasis on preventive care, which not only improves patient outcomes but also curtails spending on unnecessary treatments.
• Impact: For pharma, this push towards de-prescription may affect demand for certain drugs, particularly those deemed low-value or non-essential. However, it also presents an opportunity to align with Spain’s focus on value-based care, potentially promoting medications that are supported by strong evidence of efficacy. For payers, preventive care investments mean a healthier population with fewer costs linked to chronic diseases, reducing the financial burden on the healthcare system.
3. Supporting Innovation Through Therapeutic Positioning Reports
• What’s Changing: Another portion of the funding will support the consolidation of therapeutic positioning reports. These reports will help evaluate and position drugs more effectively within the healthcare system, ensuring that innovative treatments are assessed rigorously before they reach patients.
• Impact: Pharmaceutical companies may see a more streamlined and transparent pathway for introducing new drugs to the Spanish market. This approach promotes fair competition and emphasizes innovation, aligning with Spain’s broader goals of delivering cost-effective, impactful healthcare solutions.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library provides access to an extensive collection of value-based agreements that can help pharma companies align with Spain’s focus on cost-effective treatments. This resource allows pharma to explore agreements and pricing models suited to Spain’s HTA-driven environment, improving the chances of successful market access.
2. Drug Contracting Simulator: With the Drug Contracting Simulator, stakeholders can simulate pricing models that reflect Spain’s emphasis on evidence-based evaluation. By assessing various pricing scenarios and outcomes, pharma companies can design agreements that align with Spain’s value-based healthcare priorities, supporting successful negotiations and reimbursement strategies.
Conclusion
Spain’s recent investments in HTA education, de-prescription, and preventive care reflect the country’s commitment to a sustainable, efficient healthcare system. For pharmaceutical companies and payers, these changes highlight the need to align market access strategies with Spain’s goals of evidence-based care and cost containment. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential tools to navigate these shifts, enabling stakeholders to create outcome-driven agreements that support Spain’s healthcare objectives.
Book a personalized demo today to see how Lyfegen can empower your market access strategy in Spain’s evolving healthcare landscape: https://www.lyfegen.com/demo
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Introduction
The UK is taking critical steps to standardize the evaluation of AI technologies in healthcare. Last year, the National Institute for Health and Care Excellence (NICE) conducted a systematic review of health economic evaluation (HEE) studies on AI-based technologies, revealing variability in study quality. To address this, NICE introduced CHEERS-AI (Consolidated Health Economic Evaluation Reporting Standards for Interventions that Use Artificial Intelligence), a set of standards aimed at study authors and reviewers. Additionally, the UK Government has announced initiatives to boost exports, benefiting industries like pharmaceuticals by removing trade barriers, with a particular focus on entering the Brazilian market.
Key Takeaways for Pharma and AI Developers
1. CHEERS-AI Standards for Consistent AI Evaluation
• What’s Changing: The CHEERS-AI standards, announced by NICE, provide a framework to improve the quality and consistency of economic evaluations for AI-based healthcare technologies. By addressing gaps in reporting and methodology, NICE aims to make these evaluations more reliable, which is essential for determining the cost-effectiveness of AI solutions in healthcare.
• Impact: For AI developers and pharmaceutical companies, CHEERS-AI sets clearer expectations for the economic evaluation of AI products. A standardized approach facilitates more consistent assessments and could expedite the integration of effective AI technologies into healthcare settings. This initiative also ensures that AI innovations meet rigorous health economic standards, which could build trust among stakeholders and speed up adoption.
2. Removing Trade Barriers for Pharmaceutical Exports
• What’s Changing: The UK Government’s plan to eliminate certain trade barriers is expected to enhance export opportunities across several industries, with a focus on easing access to Brazil’s pharmaceutical market. This initiative includes a £2.3 million fund to support trade growth, with an anticipated boost of £5 billion over the next five years. For the pharmaceutical industry, this includes efforts to improve Brazil’s drug evaluation processes, particularly for cancer treatments.
• Impact: For UK pharmaceutical companies, the removal of trade barriers presents an opportunity to expand into Brazil—a significant and emerging market. Streamlined access to Brazil could lead to increased revenue and greater market diversity. Moreover, improving Brazil’s evaluation standards for cancer drugs aligns with the global shift toward ensuring drugs meet consistent, evidence-based criteria, promoting patient access to high-quality therapies.
Conclusion
The UK’s efforts to standardize the economic evaluation of AI technologies in healthcare and remove international trade barriers represent a proactive approach to fostering innovation and expanding market access. NICE’s CHEERS-AI standards provide the healthcare industry with a reliable framework for assessing AI interventions, setting a high standard for future health economic evaluations. Additionally, the government’s trade initiatives offer UK pharmaceutical companies promising avenues for growth in markets like Brazil. Together, these measures underscore the UK’s commitment to advancing healthcare technologies and supporting the global reach of its pharmaceutical industry.
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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
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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
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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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The transition to value-based care is happening at a slower pace than policymakers and healthcare industry leaders had hoped. Stakeholders are struggling to negotiate and then operationalize these complex agreements.
The adoption of value-based drug pricing agreements is not widespread in the U.S., despite the stated strong interest from policymakers and the healthcare industry in tying the price of drugs to their benefit to patient outcomes and value to the health system. Outside of the government Medicare and Medicaid programs, the fee-for-service, volume-based payment model still accounted for almost 56% of commercial health payer contracts as of 2018.
Many value-based pharmaceutical arrangements are not disclosed publicly, making it difficult to know how many are implemented in the U.S. each year. According to the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), there were 73 publicly disclosed value-based drug contracts at the end of 2019. A study published the same year in the American Journal of Managed Care (AJMC) suggested that, because of the confidentiality surrounding most agreements, analysts are underestimating the number of value-based pricing arrangements in effect and their impact on the U.S. pharmaceutical market.
In this article, we will highlight some concerns a payer and manufacturer considering a value-based drug pricing arrangement may each face, and give some insight into why these agreements aren't more widely accepted.
Payers modeling risk
A 2019 survey by the National Pharmaceutical Council (NPC) and the Duke-Margolis Center for Health policy showed that for payers, top deal-breakers in negotiations for value-based pricing arrangements were disagreements over incentive mechanisms for participation and financial terms. From the payer’s standpoint, a new, high-cost drug–especially one that addresses unmet needs or rare and orphan diseases–is worth the risk if it brings innovative, effective treatment for patients who may have no other options. But payers want to share that risk with the manufacturer when there’s the potential for a substantial impact on the payer’s budget.
Based on publicly available information, oncology, hematology, cardiology, and endocrinology drug treatments are common subjects of value-based pricing arrangements. These treatments have well-defined patient populations, easy-to-see impact measures, endpoints, and cures that make them more appealing to payers. It’s much more difficult to objectively measure the patient health outcomes for treatments covering pain management or mental health.
Payers also prefer treatments that show clinical results in a few months, not years. Tracking a patient’s health to confirm a drug’s value becomes more difficult when a drug takes years to show evidence of long-term benefits. For example, a longer-term benefit of treatment may be the avoidance of hospitalization. In the U.S., patients may leave a payer’s plan at any time, so this future cost may not be captured in the data collection under a current agreement.
Related Post: Value-based pricing vs best price? Medicaid's best price problem
Manufacturers sharing risk
When considering coverage of a new drug, payers might question the results of clinical trials, especially if there is limited real-world data because of an expedited FDA approval. So manufacturers must continue to create opportunities to generate real-world evidence that convinces payers of their drug’s value. And they must be ready and willing to share in the risk that a drug may not meet expectations in phase 4 confirmatory trials.
When a new drug has strong competition in the market, manufacturers need real-world evidence to differentiate their product and show their treatment brings better clinical outcomes and value than other options available. Value-based drug pricing agreements are an opportunity to fill that knowledge gap. Pharmaceutical companies not willing to do them to get that real-world evidence may lose out to those who are ready to take on innovative pharmaceutical agreements.
Contract partners building data-gathering and analytics capacity
In the 2019 NPC survey, manufacturers cited data collection challenges and disagreements on outcome measures among their top deal breakers.
Choosing the right contract model to fit the product and the capabilities of the contract partners is the first step. This means researching publicly available value-based drug pricing arrangements to learn the rewards and pitfalls of various contract models. All the contract partners must agree on the key metrics to be measured and how the data will be used to determine a drug’s value to patient health outcomes.
For the data-sharing component of value-based pricing arrangements, contract partners must develop a relationship that includes trust, cooperation, and an unusual level of transparency. Sometimes this relationship is best fostered and protected by the support services of a neutral third party, especially when one or both of the contract partners doesn’t have the technical capacity or administrative staff to operationalize a value-based drug pricing agreement.
The Lyfegen Solution
Value-based drug pricing arrangements are hard, but Lyfegen can make them easier. If your organization is considering a value-based pricing agreement, start by researching real-world examples of drug pricing arrangements in Lyfegen’s Models and Agreements Library. With a collection of more than 20 drug pricing models and over 1000 value-based agreements in use worldwide, the Lyfegen Library can help you discern what pricing arrangement is appropriate for your goals, your current operational capabilities, and your contract partners.
Lyfegen’s value-based contracting software can then operationalize the contract model you choose. We help healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost.
By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about Lyfegen’s software solutions, contact us to book a demo.
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Signs point to a greater role for indication-specific pricing in Medicare and Medicaid
Indication-specific pricing is a differential pricing method used by payers. Conceptually, it’s based on the idea that certain drugs with multiple indications have differential relative clinical benefit for each indication, or for each distinct patient subpopulation. The rationale behind indication-specific pricing is that the comparative clinical value of a drug can vary widely across indications, accordingly, so should the price if price and value are to align.
The figure below shows the difference between a uniform price – in this case, the price for indication A; green line – applied to all indications versus indication-based pricing.
Figure: Indication-specific pricing
Source: Institute for Clinical and Economic Review
The standard pricing model for pharmaceuticals constitutes a single price across all indications; in this instance, the price for indication A. It’s straightforward, as there is only one price. Besides, it’s the model stakeholders in the healthcare system have been accustomed to for decades. Moving to indication-specific pricing implies different prices for the four indications A, B, C, and D.
The most straightforward approach to indication-specific pricing by payers for a drug approved for, say, two different indications is to simply treat it as two different drugs. This would require two types of packaging, unique sets of National Drug Codes, for instance, for each of the packages, and for injectable drugs, two different Healthcare Common Procedure Coding System (HCPCS) J codes.
Indication-specific pricing is appealing because it supports value-based healthcare by aligning price and value. But it’s not an easy task for both drug manufacturers and payers to set indication-specific prices, as this requires patient stratification, and ultimately anchoring of prices to certain measures of cost-effectiveness, such as the cost per Quality-Adjusted-Life-Year (QALY).
Thus far, the use of indication-specific pricing has been limited in the U.S. to several pilot programs. Specifically, the pharmacy benefit manager (PBM) Express Scripts employs indication-specific pricing in number of different classes of cancer drugs, and the PBM CVS Caremark does this for several auto-immune diseases.
According to the PBMs, indication-specific pricing can provide a justification for higher prices for secondary indications that provide greater clinical benefits. In the context of value being assessed, this may help address payer resistance to expanding coverage to include supplemental indications. 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 indication-specific pricing arrangements. The Lyfegen platform identifies and operationalizes value-based indication-specific models in a cost-effective manner.
Indication specific pricing could alter prices for the biologic Avastin (bevacizumab), for example, when used for cervical cancer and colon cancer, respectively, depending on the willingness to pay threshold, which in turn may be based on different cost per QALY estimates.
Also, there are differences in the comparative value of the cancer drug Herceptin (trastuzumab) when used in different indications (metastatic versus adjuvant HER-2 positive breast cancer). A possible solution to this problem is for Herceptin to have two prices, one for its metastatic indication, and another for its adjuvant indication.
When Novartis won its groundbreaking CAR-T approval, Kymriah (tisagenlecleucel) in 2018, both the drugmaker and U.S. policymakers at Centers for Medicare and Medicaid Services (CMS) touted performance-based and indication-specific pricing as ways to help finance the $475,000 therapy. Unfortunately, the CMS backed away from a plan to implement a value-based contract for Kymriah. This decision may be revisited, as the pipeline is filled with cell and gene therapies that have large upfront costs for CMS, which must somehow be managed.
Moreover, given the many value-based experiments state Medicaid agencies are currently involved in – from value-based formularies to subscription models for the purchase of hepatitis C medications – this could spur more use of indication-specific pricing in Medicaid.
New “best price” rules in Medicaid went into effect July 1, 2022. The reason for changes in best price rules is to induce more use of value-based contract arrangements, including indication-specific pricing. Newly established protocols allow for the reporting of multiple best prices.
Specifically, to facilitate the broad adoption of these types of contracts, the novel best price rule allows drug manufacturers to report a range of best prices to the extent they may be determined by varying discounts under value-based pricing arrangements, along with the regular best price under any non-value-based pricing arrangements.
Here, value-based pricing arrangements are outcomes-based contracts which vary rebates based on patient outcomes. This can be stratified by indication. In this context, lower discounts may be offered for patients with better-than-expected outcomes in certain indications, and higher discounts for poorer outcomes and lower-than-expected clinical effectiveness of a drug in one or more indications.
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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When was the last time you used a business software or platform with a seamless user experience? Was it fun? Was it visually appealing? Probably not.
In this article, we consider the benefits of drastically improving the user experience of contracting software with examples of companies that have taken this step and inspired Lyfegen.
Contracting Software
Contracting software has usually been perceived as boring and unsophisticated, until recently. It takes careful application of innovation, user empathy, and design thinking to create unique, memorable experiences. Contracting software should focus on providing a pleasant user experience, especially when it is about patients. It takes away a whole lot of burden from the users while providing the most value.
There are new innovative designs of forms, pages, and workflows that keep users engaged and satisfied. Enjoyable contracting software should provide the most value while reducing the negative impacts.
Why great user experience is paramount to user satisfaction
Lyfegen takes cues from consumer web applications where innovation thrives. In 2020, Lyfegen conducted a big user experience review, where our product team needed to get to the bottom of what can make using the platform more enjoyable. “Why can't my business software look and feel enjoyable?" At Lyfegen we think that it can and it should. Every software should look and feel enjoyable.
We learned how users interact with the approval workflow using real-world data and feedback from customers. With these learnings, we further optimize the user experience and address issues or concerns that appear consistently. Users will bring expectations raised by consumer apps to their business applications. In response, we raise the bar to make work software equally appealing.
Lyfegen makes the whole process a breeze by rewarding customers with an amazing design experience, stepping up the game by making value-based contracting fun.
Some successful real-world examples
In consumer web applications, there are so many companies that are making drastic changes from the old design patterns to newer more innovative designs. These brands took the bold step of doing things differently while still providing the desired results. These are also the ones that Lyfegen took inspiration from.
Airbnb.com enables contracts between guests and hosts.
- Big beautiful imagery. People, smiles, quirky architecture.
- Emotional scenes that make you want to be there: cottage in the woods, hut on the beach, or a comfy townhouse.
But also clever UX: Forms disguised as slick toolbars. Generous date pickers that are easy to click
Mobile.de enables contracts between car buyers and sellers.
- Sensible defaults bootstrap your car search with a single click.
- Common search patterns detected from thousands of users turn into quick search shortcuts such as "City car" and "Family car.”
- Kickstarting a search avoids having to fill many form fields.
Upwork.com enables contracts between job seekers (talent) and hiring clients.
- The contracting path is optimized for speed. Both parties want to get the work under way quickly.
- Templates bootstrap and automate repetitive tasks. Why write every contract from scratch when you can extract best practices into a common library. Hint! This is what the Model Library will do in the Lyfegen Platform, watch out for a future blog post.
Lyfegen Platform mechanisms that bring speed and joy
The Lyfegen Platform enables contracts with pharmaceutical companies, healthcare payers and healthcare providers. At Lyfegen we understand that great user experience is paramount to user satisfaction. Hence, the reason why we pay critical attention to existing problems and proffer appropriate solutions to them is to create experiences that have the most long-lasting impact on the users.
What do we do differently to make these contracts fluid and useful?
- Forms: We use sensible defaults to make filling forms faster. Quick date pickers with popular date ranges (“Last month”, “This week”) help when scheduling is a big part of your work. Progressive disclosure reduces information overflow on forms – show only what the user needs to fill in right now to complete the task.
- Approvals: What is a modern way to do contract approvals? Chat threads! Users are familiar with chats from WhatsApp, Facebook and many other tools. A chat thread can be attached to virtually any item on the platform: agreements, claims, cases and refunds. The chat stays with the item so users don't lose context of what happened to the item.
- Tasks: How does the user know what they should be focusing on today? On the Home screen, the My tasks widget, email notifications, and the Recent Activity widget collect essential platform activity. You can see instantly what needs your attention today.
- Collaboration: @-mentions and chat threads offer quick resolution to questions. Tag a colleague and ask a question. They get a notification and provide an answer in the same thread. Problem resolved, move on! Chat works particularly well when conversation heats up and many users talk concurrently in real time.
- Interactive insights. Showing KPIs and key results on a dashboard is common practice. In fact, a dashboard is the favorite starting screen for many users. But charts really come alive when you interact with them. Have you used a mortgage calculator on a bank website? We also let users model alternative scenarios and see projections. “What will happen in my agreement next year if we continue like this?”
In conclusion, these are only a few examples of usage patterns that make contracting software modern and enjoyable. There is more room for improvement and the possibilities are endless. It requires the expertise which we at Lyfegen provide. Through our platform, we create brand new experiences in value-based contracting. Care to know more about contracting software? make sure to keep an eye out for our future posts.
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This influential player in the U.S. pharmaceutical sector is changing the dynamics of price negotiations between payers and drug manufacturers. But is ICER helping bring healthcare costs down or contributing to rising drug prices?
Who is ICER?
Over the last decade, a small, Boston-based independent, nonprofit research organization has become a powerful influence over the formulary exclusion decisions and drug prices commercial and government payers will pay. Founded in 2006, The Institute for Clinical and Economic Review (ICER) was relatively unknown before 2014. But after gaining national recognition for an assessment about the cost-effectiveness of a Hepatitis C therapy regime, ICER quickly became a trusted source of data and pharmaceutical economics research.
ICER’s assessments are cited in national policy debate and in pharmaceutical price negotiations between insurers and drug manufacturers. According to ICER, the U.S. Department of Veterans Affairs, some state Medicaid agencies and over 75% of private insurers, pharmacy benefit managers, and self-insuring organizations now use ICER’s drug pricing assessments and resources in their policy decision making.
What does ICER do?
ICER conducts clinical and economic assessments of drug treatments to calculate what it considers a drug’s fair market price. They consider a drug’s value and effectiveness for treating the illness for which it was designed, followed by a budget impact analysis to estimate how much the national health system could save with its suggested cost-effective pricing. Using this data, ICER analyses calculate a suggested drug price for payers where cost-effectiveness aligns with the value of the increased benefit to the patient’s health. ICER says it seeks feedback from all stakeholders—manufacturers, clinicians, payers, patients and families.
How is ICER affecting national drug prices?
A leading pharmaceutical economics expert, Dr. Adam J. Fein of Drug Channels Institute, reports that pharmaceutical list prices rose by up to 15% from 2010 to 2015. During the next five years, up to mid-2020—as ICER rose to national prominence—list price growth dropped to 4.2%.
In 2018, ICON, a leading healthcare industry consultant, conducted a survey about the influence of ICER’s work on drug pricing and national healthcare costs. The ICON survey revealed that ICER’s cost effectiveness metrics and price recommendations are affecting contract negotiations between drug manufacturers and payers and driving drug prices down.
Most payers are no longer willing to accept whatever price drug manufacturers decide to charge. Over a third of the payers in the ICON survey stated it was likely, or extremely likely, that they would ask for a rebate from the drug manufacturer to reduce the cost of a drug to match ICER’s suggested price. In response, manufacturers will increase their drug list price, then offset part of the price increase with larger rebates to payers—this is known as the gross-to-net bubble.
How is ICER affecting access to expensive drug treatments?
Out of the 90 participants ICON surveyed during a pharmaceutical industry webinar, 65% believed ICER had a moderate to significant impact on formulary decisions; ICON’s research also showed that payers who use ICER’s cost-effective pricing were more likely to use strict prior authorization requirements for some drugs to encourage clinicians and patients to use the most cost-effective drug treatments. Critics point to this as one of the harmful consequences of ICER’s work.
What do critics of ICER say?
Some patient advocate groups—with the support of pharmaceutical manufacturers—are concerned that by encouraging payers to exclude less cost-effective but still clinically effective treatments in their formularies, ICER is promoting payer discrimination against some patients who need expensive specialty medications, such as the elderly, people with disabilities, and those living with rare diseases.
Critics such as The Alliance for Aging Research point to data that show ICER’s impact on payer demands for higher rebates are causing increasing out-of-pocket costs for seniors using Part D Medicare benefits. Manufacturers raise their list prices, then meet payer demands for ICER’s suggested drug pricing using the gross-to-net bubble rebates. However, some payers still calculate the co-insurance percentages that patients pay for their prescriptions based on the manufacturer’s full, undiscounted list price.
Lyfegen can help implement value-based drug pricing agreements
Despite the debate about whether ICER is a help or a hinderance in the work of healthcare cost containment and better patient access, ICER’s influence will probably continue to grow as value-based contracts and risk-sharing agreements become more common. Lyfegen’s value-based contracting platform operationalizes and manages these complex drug pricing payment arrangements by seamlessly capturing and analyzing data.
Lyfegen’s software can help your organization implement any value-based contract, covering multiple therapeutic areas, with public or private payers. Contact us to learn more about our platform and to book a demo.
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Families forced to hold a fundraiser because their child’s healthcare system won’t save his life.
Recently, the news has once again been covering a family that is struggling to cover the cost of the most expensive drug in America for their son, Devdan. The insurer refused coverage of the treatment for his rare disease, totaling $2.125 million.
Devdan was born with Spinal Muscle Atrophy (SMA). SMA damages the nerve cells in the brain and spinal cord, causing progressive muscle weakness and problems breathing, speaking, swallowing, and walking. Zolgensma’s onetime gene therapy treats SMA and has earned the title of the most expensive drug in America.
It is currently Devdan’s only hope for a normal life. In this case, to save their child’s health and future, the parent’s initiated a fundraiser through Ray of Hope Foundation.
Most of us probably don’t consider what or how hospitals pay for their supplies. When we pay our medical insurance premiums, we buy a plan and think we’re covered in case of a medical emergency. But what many families of children with rare disease have learned, that’s not always the case. Rare diseases aren’t funded the same way common medical conditions are paid for. There aren’t enough patients to warrant extensive research and treatment developments. Consequently, medical care is often unconventional. As a result of these novel treatments, patients with rare disease often receive Surprise Medical Billing or are denied coverage altogether.
Value Based Healthcare (VBHC) Saves Lives
Medications and treatments that deviate from the routine can be a financial disaster for hospitals, families, care providers, and health systems. And organizations with a strong commitment to value-based healthcare have seen sustainable gains. In this case, had Devdan’s medical facility operated under a value-based healthcare reimbursement model, this life-saving treatment would have been available and the critical care for this child could have begun without delay.
Calculating value-based reimbursements measures numerous points of quality and the overall health of a population. Unlike a fee-for-service model, value-based healthcare providers must report data to payers and demonstrate improvement. The VBHC model has many advantages, including improved patient satisfaction, a reduction in healthcare delivery costs, and better health for the patient populations being served.
Better management of financial challenges with Lyfegen
The VBHC model has many advantages, including improved patient satisfaction, a reduction in healthcare delivery costs, and better health for the patient populations being served. Luckily, Devdan’s Ray of Hope fundraising effort has achieved the needed target of $2.86M. More than 29’000 people came together to raise this enormous amount in such a short period of time to give Devdan a second chance at life.
This unfortunate scenario is common for those dealing with rare disease, and those in need of extraordinary medical care. Had Devdan’s insurance participated in a value-based program, the necessary medicine could have been provided for with no delay in treatment. As the health care market adjusts to the pandemic and prepares for the future, leaders must decide whether to accelerate their participation in value-based healthcare to meet the clinical and financial challenges that will remain for years to come.
To learn more about Lyfegen and request a free demo, contact us today.
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