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Tailoring biosimilar coverage policies to the client

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Tailoring biosimilar coverage policies to the client

The next wave of biosimilars, including Humira-, Eylea-, and Stelara-referenced products, is upon us.

In the U.S., 10 Humira-referenced biosimilars are on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing, as the number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary.

CVS Caremark—the largest pharmacy benefit manager in the U.S.— removed Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product). Hyrimoz appears to be the most favored biosimilar. Similar moves have been signaled by the PBM Express Scripts and its parent company Cigna to be enacted this month, but this time Simlandi will be the most preferred biosimilar.

The FDA also recently approved two interchangeable biosimilars to Eylea, which will produce additional competition for the pharma’s blockbuster as key patent protections are set to expire.

And the biologic Stelara, which was selected as one of the first 10 drugs for Medicare price negotiations, will have its net price disclosed in September of this year in addition to facing biosimilar competition in 2025. The downward pressure on Stelara's price, but also Stelara-referenced biosimilars, will likely be significant.

For their large populations of covered lives who take products in the Humira, Eylea and Stelara-related therapeutic classes, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.

Improved access to biosimilars will offer patients expanded, less costly treatment options. For uptake to happen, payers must educate healthcare providers and patients on the value of biosimilars so that they are on board, whether they are designated by the Food and Drug Administration as therapeutically interchangeable or not.

Hyrimoz and Simlandi are therapeutically interchangeable and favored due to the formulary moves by CVS Caremark and Express Scripts, respectively.

The therapeutic interchangeability designation still plays a role in the U.S., because for biosimilars to be automatically substitutable at the pharmacy they must have proven interchangeability in addition to biosimilarity. As a result, physicians have expressed a preference for biosimilars that have the designation.

But for the many biosimilars that don’t have the therapeutic interchangeability designation, to boost their adoption manufacturers and payers must overcome this de facto regulatory barrier by informing healthcare providers and patients that proof of biosimilarity is sufficient.

Lyfegen can assist in the design of formularies tailored to clients' objectives. It can also accommodate information requests concerning which value-based arrangements are the most appropriate, given the scope of its library database as well as other client services.

If you wish to improve your negotiating leverage you can do so with real-world simulations for effective prescription drug contracts.

Discover the Lyfegen Simulator.

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Managing the cost of novel non-opioid pain medications

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Managing the cost of novel non-opioid pain medications

Vertex Pharmaceuticals may soon obtain Food and Drug Administration approval for a non-opioid analgesic, dubbed VX-548, for moderate to severe pain. But will insurers pay, given that there are so many cheap generic prescription opioids and other pain medicines on the market?

Presumably, the new non-opioid pain medication will be substantially more expensive per unit than generic opioids. Given the large numbers of patients needing pain drugs, for post-surgery, for instance, payers will need to manage the cost.

Prescription opioid medications remain a common treatment for pain despite decreases in the total number of opioid prescriptions after 2012. They’re cheap but also effective.

Should VX-548 obtain FDA approval, payers might be reluctant to cover the drug without clear and consistent evidence that the drug works as well or better than prescription opioids. Recent examples of non-opioid analgesics, including Exparel (bupivacaine) and Zynrelef (bupivacaine/meloxicam), demonstrate the kinds of reimbursement challenges drug makers may face, particularly early following their approval by the FDA.

Nevertheless, prescription opioids can be misused, abused, and diverted. In this regard, the non-opioid medicines Exparel, Zynrelef and, if approved, VX-548, do meet an important unmet need. However, not every patient will require access to more expensive medications. And so, it will be imperative to differentiate patient sub-populations by risk factors, in addition to comparing the clinical- and cost-effectiveness of non-opioid treatments to prescription opioids.

Lyfegen can assist in the calculations of value for both prescription opioid and non-opioid analgesics, in addition to the design of appropriate formularies.

Managing pain, whether acute or chronic, invariably involves a balancing act in which doctors, patients and insurers must consider appropriate forms of treatment. Proper patient stratification includes an assessment of the benefits and risks of both opioid and non-opioid medications to individual patients.

Lyfegen can navigate the different ways in which payers and drug makers negotiate contracts for pain medications. In the Lyfegen Library you can find the right model to use as a benchmark during pricing and reimbursement negotiations, which in turn will increase the chances of success. To explore strategies that enhance your ability to negotiate and implement successful pricing and reimbursement agreements for pain medications, visit the Lyfegen Library at lyfegen.com/library.

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Finding novel ways to pay for new obesity drugs

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Finding novel ways to pay for new obesity drugs

While the recent wave of new obesity drugs appeals to many patients due to their effectiveness in reducing weight and even diminishing the risk of major cardiovascular events for some, data suggests that at current prices they’re not cost-effective. Amid increased concern about the costs of using therapeutics such as glucagon-like peptide 1 agonists, some U.S. insurers are imposing further restrictions or eliminating coverage of the drugs altogether.

To boost access, a recent Financial Times article discussed the possibility of introducing value-based pricing arrangements for weight loss drugs. Under such “risk-based contracts,” healthcare providers could spread the cost over a period of time during which savings are possible, for example, from not having to treat as many heart attacks. Alternatively, drug makers and payers may negotiate value-based contracts which include patient persistency as a prerequisite. Persistency is known to be an issue with obesity drugs, as many patients stop taking the medications owing to side effects and other issues. If patients discontinue treatment weight rebound occurs, which implies that payers and patients must be properly incentivized to be persistent.

To effectively implement value-based agreements requires reliable cost of care analytics, modeling capabilities and outcomes-based agreement templates, which Lyfegen can provide stakeholders to calculate and forecast return on investment for use in the contracting process.

Value-based arrangements could ease the projected financial burden for commercial insurers, but also public payers such as Medicaid and Medicare. At present, most Medicaid state agencies don’t reimburse obesity therapeutics, while Medicare still prohibits their coverage if prescribed as weight loss medications alone. The drug Wegovy (semaglutide) did secure a supplemental cardiovascular indication from the Food and Drug Administration in March. This allows limited access for certain Medicare beneficiaries who fulfill weight and major cardiovascular risk criteria. But it doesn’t follow that plans will necessarily jump to pay for the product, given the high cost and limited cost-effectiveness. Introducing pay-for-performance agreements could facilitate access.

Lyfegen can accommodate information requests concerning relevant measures. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public agreements and 20 innovative pricing models. For a deeper understanding of how value-based pricing models can transform the accessibility of obesity treatments and optimize your healthcare investments, book a demo with us.

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

As more biosimilars get approved and launched in the U.S., payers are making key decisions about their coverage and formulary positioning. Recently, this includes Humira-, Stelara- and Remicade-referenced products.

Historically, in the U.S., biosimilars have often failed to gain much traction owing to a Byzantine system of pricing and reimbursement which involves  opaque rebate schemes. Here, higher list-priced drugs often carry with them higher rebates, which can mean that pharmacy benefit managers may favor originator products such as Humira.

As an illustration of this, according to a federal government Medicare Payment Advisory Commission report, more than 40% of Medicare beneficiaries still have no access through their insurance to Humira-referenced biosimilars, despite several products having discounts of over 80% compared to the original Humira.

But novel approaches to pricing and reimbursement could change formulary decision-making significantly, establishing the basis for more use of outcomes-based decisions. CostVantage, for example, is a new cost-based pharmacy reimbursement approach that all PBMs will eventually be required to use if they contract with CVS retail pharmacies, the largest pharmacy in the nation.

The CostVantage model stipulates that prescription drug reimbursement will be based on net acquisition cost, a set mark-up and a fee that reflects the value of pharmacy services. CVS Pharmacy plans to launch CVS CostVantage with PBMs for their commercial payers in 2025.

Such net-cost reimbursement systems tend to stimulate the uptake of lower cost (and more cost-effective) biosimilars. We find evidence of this in Europe where cost-effective biosimilars generally have fairly rapid entry which then quickly displaces the market share of originator products. By the last quarter of 2019, within one year of Humira-referenced biosimilar entry into the European market, an average of 35% of patients across Europe had already switched to a biosimilar; in the U.K, the figure was 63% which was achieved just six months after biosimilars were allowed to compete; in Denmark, with its winner-takes-all tender, the number was 80% and was attained within three months of being on the market. Meanwhile, in the U.S., after 15 months of being on the market, Humira-referenced biosimilars have only achieved 2% market share.

The new net-cost model of reimbursement in the U.S. will likely lead to greater adoption of biosimilars, at least in the large CVS segment of the market. Lyfegen can navigate the different ways in which payers and drug makers are negotiating contracts for biosimilars. In addition, Lyfegen can help address the concerns payers may have about high-priced specialty drugs, such as originator biologics and biosimilars. In the Lyfegen Agreements Library you can find the right model to use as a reference during pricing and reimbursement negotiations, which in turn will increase the chances of success.

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

In the face of scarce resources, healthcare entities must make hard choices. One can’t spend the same healthcare dollar twice, which means that policymakers have to ensure that each dollar goes as far as it can in terms of producing health outcomes for the population. Preferably decisions on how to allocate resources are informed by robust evidence that describes the benefits and harms related to medical interventions.

As U.S. and European healthcare policymakers debate different ways of measuring health outcomes accruing from the use of prescription drugs, it's important to convey that value-based pricing and reimbursement decisions can be informed by a variety of measures, including the Quality-Adjusted-Life-Year but also non-QALY measures such as the Disability-Adjusted-Life-Year, Equal-Value-Life-Year-Gained, Healthy-Life-Year-Equivalents and others. Lyfegen can accommodate information requests concerning all such measures, given the scope of its database as well as other client services. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public pricing-based agreements and 20 innovative pricing models.

In the U.S., Medicare may soon formally ban use of the QALY because it’s supposedly “discriminatory” against older people and folks with disabilities. Nevertheless, the commercial market will continue to use it, particularly since it is still one of the most common measures of benefit. It’s also the predominant measure deployed by the Institute for Clinical and Economic Review. ICER has grown in stature in recent years, now informing more than half of payers’ formulary decisions in the private sector.

According to ICER, the QALY measures how well different kinds of medical treatments extend lives or improve patients’ quality of life. As a composite measure of the outcomes, quantity and quality of life, it enables comparisons across disease states and treatments. When combined with the costs associated with healthcare interventions, the QALY can be used to assess their relative worth from an economic perspective.

As a concept the QALY can accommodate several of the issues cited by critics, including being able to account for severity of disease. Alternatively, there are methods such as the EVLYG that can be employed to place the same value on additional years of life across diseases and populations which could alleviate concerns around discrimination.

The Lyfegen Library allows you to search for pricing models and agreements by countries and payers, making it easy to find the information you need regarding the appropriate measures based on your specific requirements and interests.

Learn more: lyfegen.com/library

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The importance of working with Johnson & Johnson: An interview with our Lyfegen CEO & Founder, Girisha Fernando

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 importance of working with Johnson & Johnson: An interview with our Lyfegen CEO & Founder, Girisha Fernando

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


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

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

How can this partnership be a blueprint for future collaborations?

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

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

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

Why is Lyfegen the right platform for this?

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


Learn more about our platform by booking a demo today:


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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 Health and Social Consortium of Catalonia to Develop New Value-Based Purchasing Models Incorporating New Tools for Negotiation with the Pharmaceutical Industry

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The Health and Social Consortium of Catalonia to Develop New Value-Based Purchasing Models Incorporating New Tools for Negotiation with the Pharmaceutical Industry

Barcelona, April 9, 2024
The Consortium of Health and Social Services of Catalonia has begun to work on value-based drug purchasing models by incorporating new tools for information management and negotiation with the pharmaceutical industry. This is an innovative project in collaboration with the health technology brand Lyfegen, which has developed the largest platform for managing public agreements in the world and a drug contracting simulator that allows for better deals by maximizing value in the purchasing process.

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

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

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

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

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

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

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

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

About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.

About CONSORCI

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

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Lyfegen erhält 8 Millionen Dollar, um Arzneimittelpreise zu senken und Patienten den Zugang zu lebensrettenden Medikamenten zu erleichtern

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Lyfegen erhält 8 Millionen Dollar, um Arzneimittelpreise zu senken und Patienten den Zugang zu lebensrettenden Medikamenten zu erleichtern

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:

https://lyfegen.com/

Linkedin: https://www.linkedin.com/company/lyfegenhealth

Pressekontakt: yael@gkpr.com

Ansprechpartner für Investoren: investors@lyfegen.com

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Lyfegen und die Schweizerische Krankenversicherung EGK-Gesundheitskasse kooperieren bei der Senkung der Preise für teure Medikamente

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Lyfegen und die Schweizerische Krankenversicherung EGK-Gesundheitskasse kooperieren bei der Senkung der Preise für teure Medikamente

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

 

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

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

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

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

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

 

Über Lyfegen

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

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

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

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

Über die EGK-Gesundheitskasse

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

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

Read on PR newswire in German

Read on PR newswire in English

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A message from our CEO as Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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A message from our CEO as Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

 

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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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

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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A Fable of the Blue Bird and Lyfegen's Wise Owls

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A Fable of the Blue Bird and Lyfegen's Wise Owls

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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Driving Growth: Welcoming Our New VP of Sales & Business Development, Simon Farrow

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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Driving Growth: Welcoming Our New VP of Sales & Business Development, Simon Farrow

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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Exclusive interview with Girisha Fernando at the launch of Lyfegen’s Value-Based Agreement Library

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Exclusive interview with Girisha Fernando at the launch of Lyfegen’s Value-Based Agreement Library

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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The Tech Team Keeps Growing! Welcome to the Lyfegen Team, Analytical-Superstar, Pavlo!

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The Tech Team Keeps Growing! Welcome to the Lyfegen Team, Analytical-Superstar, Pavlo!

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!

 

MEET THE LYFEGEN TEAM

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How could Donald Trump change US healthcare?

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How could Donald Trump change US healthcare?

Introduction

Donald Trump has been elected as the 47th President of the United States. With healthcare remaining a critical issue, it’s valuable to revisit some of Trump’s past healthcare reforms and examine a particularly controversial policy that could significantly impact drug pricing in the U.S. From efforts to lower out-of-pocket costs to transparency initiatives aimed at increasing competition, Trump’s past healthcare policies reveal a complex approach to improving accessibility and affordability. Here, we also explore how these initiatives have evolved under the Biden-Harris administration and what their potential implications could mean for the future of American healthcare.

Let’s examine some of his past reforms to improve healthcare and discuss a controversial policy that could greatly alter drug pricing.

  1. The No Surprises Act, enacted by Donald Trump on December 27th 2020, was designed to lower out-of-pocket healthcare costs for Americans in the case they were covered by an out-of-network provider. In these cases, medical bills are more expensive than they would be if care was received in-network. The Biden-Harris administration expanded upon this legislation by improving the payment dispute process.
  1. Americans don’t have a reliable way of estimating their healthcare costs. The Trump administration issued an Executive Order leading to CMS establishing rules requiring hospitals to disclose upfront costs of their services. Another aim of this initiative was to encourage greater competition among hospitals, group health plans, and health insurance issuers. This initiative was rolled out by the Biden-Harris administration but is still in its early stages.  
  1. One controversial Trump policy was his “most favored nations” Executive Order, which aimed to price-match drugs with that of the lowest price among other wealthy nations. Many were fearful this effort would stifle competition and hinder pharmaceutical development in the United States. Trump said he would not plan to revive the policy if re-elected.
  1. One of the most groundbreaking changes made by the Biden-Harris Administration was to allow Medicare to negotiate drug prices directly with manufacturers, as part of the Inflation Reduction Act. The second round of negotiations involves 15 additional drugs to the 10 included in the first round and will be announced by February 1st next year. However, several Republicans have expressed interest in repealing these negotiations.  

Conclusion

The evolving landscape of American healthcare policy, influenced by both Trump and Biden’s administrations, reflects an ongoing effort to address cost, transparency, and access to treatment. Trump’s initiatives laid the groundwork for healthcare cost transparency and patient protections, while the Biden-Harris administration has expanded these initiatives and introduced groundbreaking policies like Medicare drug price negotiation. As these changes continue to unfold, the healthcare industry, patients, and policymakers alike will need to adapt to new dynamics, shaping the future of healthcare in the United States.

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Canada: Investing in RWE for rare diseases

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Canada: Investing in RWE for rare diseases

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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FDA Launches a new program to speed patient access

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FDA Launches a new program to speed patient access

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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Switzerland. Improving the fast-track process and anti-migraine drugs

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Switzerland. Improving the fast-track process and anti-migraine drugs

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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Spain: Reducing unnecessary care and improving HTA education

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Spain: Reducing unnecessary care and improving HTA education

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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