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Sickle cell disease gene therapies are here, but how is society going to pay for them?

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Sickle cell disease gene therapies are here, but how is society going to pay for them?

On November 16th, the UK’s MHRA approved Casgevy (exagamglogene autotemcel) or exa-cel for sickle cell disease and beta thalassemia. And this month the FDA is expected to license exa-cel and lovo-cel (lovotibeglogene autotemcel), both of which attack SCD at its genetic root.

For these advanced gene therapies the challenge of access through Medicaid and other programs looms large. Medicaid will be the predominant payer for the 25,000 patients who could be eligible for these gene therapies. And it must figure out a budget-conscious way to pay for these potential one-time “cures.”

In April, the Institute for Clinical and Economic Review issued a draft report on the cost-effectiveness of exa-cel and lovo-cel. ICER noted that the proportion of patients achieving treatment success was 97% for both therapies. Even at the placeholder price of nearly $2 million per dose, ICER says both treatments could be cost-effective. But ICER cautioned that a prerequisite is their durability over time and the establishment of value-based pricing agreements between payers and manufacturers.

The Centers for Medicare and Medicaid Services is therefore pursuing a two-pronged approach to value-based pricing and reimbursement of cell and gene therapies such as exa-cel and lovo-cel.

Related Post: A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

First, a proposed rule would require manufacturers with the highest drug Medicaid spending per claim to turn over confidential information justifying their prices. CMS would post this information online, seek public comment, and compel manufacturers to “address” their pricing in a public forum.

Second, CMS is planning on “testing of payment models” based on outcomes-based agreements on behalf of all 50 state Medicaid programs, rather than having them done separately by individual states.

Innovative payment models such as these require the ability to analyze patient outcomes and negotiate prices based on those outcomes. Digital platforms, such as those offered by Lyfegen, are designed to implement value-based contracting models. This investment can yield operational efficiency, recovery of missed revenues, and provide critical access for patients to life-saving drug therapies.

Lyfegen offers solutions to identify the right drug pricing agreements, simulate and understand the financial impacts of those agreements, and automate the execution and adjudication of them—thus delivering a measurable reduction in administrative effort in rebate management and optimization.

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Health technology assessment will inform Medicare drug price negotiations

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Health technology assessment will inform Medicare drug price negotiations

The Centers for Medicare and Medicaid Services is leveraging third-party health technology assessments to inform its offer price in February 2024 for the 10 drugs it has selected for price negotiations. To illustrate, the drug cost watchdog the Institute for Clinical and Economic Review published a report on the blockbuster blood thinners Xarelto and Eliquis and submitted it to CMS. Xarelto and Eliquis are two of the 10 drugs set to face the first round of Medicare price negotiations under the Inflation Reduction Act.

The ICER report modeled the comparative effectiveness of these products over generic warfarin in stroke prevention, myocardial infarction prevention and major bleeding episodes. This includes an assessment of the justifiable price premiums for the two branded products given several different cost-effectiveness thresholds. The table below shows ICER’s calculations of price premiums for Eliquis relative to the generic comparator warfarin and the branded comparator Pradaxa (dabigatran).

Source: ICER

Drug manufacturers and payers impacted by the IRA will need to gather and evaluate this kind of information, as well as evidence from peer-reviewed articles and other sources. In turn, they must use the data to inform the price negotiation process for selected drugs but also competing products in the same therapeutic classes.

Launching soon, the Lyfegen Drug Pricing Simulator is a dynamic tool that gathers data inputs and runs real-time simulations that help users understand potential rebate, revenue, cash flow, and budget impacts for the different types and combinations of drug pricing models.

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Drug makers and payers will leverage IRA maximum fair prices

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Drug makers and payers will leverage IRA maximum fair prices

The Inflation Reduction Act authorizes Medicare for the first time to negotiate prices at the national level for a limited subset of single-source drugs. Recently, the Centers for Medicare and Medicaid Services selected the first 10 drugs to be negotiated. The 10 high-cost drugs in the table below represent 20% of total outpatient spend in the Medicare program from June 2022 through May 2023.

Source: Centers for Medicare and Medicaid Services

Prices will be negotiated over a one-year period with an offer and counteroffer process between CMS and drug manufacturers in which maximum fair prices will be established and posted in the fall of 2024 and implemented in January 2026.

Makers of drugs selected for negotiation should consider how payers in the Medicaid and commercial markets will leverage the published MFP information when negotiating rebates. Also, manufacturers of drugs competing with those selected for negotiation should consider how payers will leverage the published MFP information when making pricing, rebating and reimbursement decisions in the Medicid and commercial markets.

At the time a drug’s negotiated MFP price is posted, competitors may react to the published price by trying to undercut it, perhaps by offering even higher rebates, which in turn may cause the manufacturer of the selected drug to lower the net price of a drug a year prior to the MFP being implemented. Also, once MFPs are posted, payers will have publicly available information on the negotiated prices for the selected drugs as well as evidence used to inform the offer and counteroffers. This may then be utilized as leverage in negotiations for competing products in the same therapeutic classes.

The Lyfegen Rebate Analytics Platform is a cloud-based software that can manage all the complexities of drug rebate administration for payers and pharmaceutical companies affected by the IRA. The data-driven platform automates identifying, calculating, and tracking rebates in a timely manner, all of which help to ensure agreement compliance and reduce revenue leakage.

Learn more: lyfegen.com/products/ara

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What Will It Take to Advance Value-Based Pharmaceutical Contracts?

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What Will It Take to Advance Value-Based Pharmaceutical Contracts?

Prices for drugs in the U.S. continue to rise – faster than the rate of inflation – according to a Harvard study that shows nearly half of new drugs marketed now cost $150,000 or more annually. Insurers, along with consumers and regulators, are anxiously seeking ways to lower costs and to make sure patients get the treatments they need. One solution that is gaining interest is value-based pharmaceutical contracting, where costs are tied to results; the more effective a drug, the more a payer will allocate for that drug.

This model isn’t new and it has proven to be successful in Europe, where many value-based pharma contracting are showing positive results for payers, patients, and pharmaceutical companies. As a result, some companies that cater to the U.S. market are moving towards this model, although there are challenges.

Value-based contracting is especially applicable for the growing number of cell and gene therapies and other new ultra-expensive treatments. By allowing insurers and other payers to pay in installments that are dependent on patient outcomes, or even to receive refunds if the drug does not perform as expected, pharma companies are sharing the risk with payers. And there is great value in that shared risk. Payers, for example, are able to realize better patient outcomes when drugs proving to be ineffective can be replaced with more effective ones. At the same time, pharmaceutical firms are incentivized to ensure that the treatments they offer payers are truly effective ones, spurring better and more effective research.

In addition to making sure that prices reflect patient outcome, value-based contracting helps expand the amount of data associated with a treatment. With more data on the effectiveness of treatments recorded – and more tracking of patients over time – researchers will have more data to draw on when developing new treatments. That data can include details on all aspects of a patient's care and even factor in the patient's adherence to medication schedules. This data can also help pharma companies advance their research.Finally, healthcare providers benefit from value-based contracting because they will be able to get a more accurate picture of their patients' overall health situations, which will allow them to provide higher-quality care. Despite all of the advantages for all parties involved, value-based contracting has not yet been widely embraced by payers or pharma companies. A survey of 180 large employers, insurers, and unions with health benefit programs shows just 12% use value-based contracting for specialty drugs, which are usually the most expensive treatments, and fewer than 1% of organizations are using them for more common drugs.

This apparent reluctance to adopt value-based contracting is surprising because payers who have leveraged this approach are finding that their pharma costs are falling.

But challenges do remain for both payers and insurance companies in adopting value-based contracting. In order to speed up the adoption of value-based contracting, there needs to be a willingness to change business culture and long-entrenched processes; an acknowledgement that value-based contracting can expand insights and opportunities for pharma companies, but more clear incentives are necessary; and more dialogue around industry standards and regulatory flexibility that take this contracting model into account.

Industries like insurance and pharma often have institutional, or legacy, systems and processes that no longer best serve the organization and market opportunity. Innovative new opportunities like value-based contracting likely requires change–changes to systems, to processes, and to people’s day-to-day operations. Some organizations find the implementation of value-based contracting models complicated because they require analyzing patient outcomes, negotiating prices based on those outcomes, and determining which drugs should be included in the program. All of these steps require access to–and analysis of–a great deal of data, which can be a significant investment. However, there are digital platforms that are designed to implement value-based contracting without overcomplicating the process–and the investment can yield operational efficiency, recovery of missed revenues, and, most importantly, provide critical access for patients to life-saving drug therapies.

Within the industry, there is an assumption among pharma companies that there is a limited return on their investment with value-based contracting, or even the possibility of lower revenues due to lower prices. But with the transparency that value-based contracting can bring to pharma companies through real-world data from patients taking their drugs, there comes expanded opportunities to understand drug performance and patient outcomes, both of which are valuable for future drug development and marketing. A KPMG report notes another important benefit of value-based contracting–for example, such agreements can enable pharma companies access to currently highly-regulated markets that they were unable to sell in before, thus serving as a competitive advantage. In order to keep pushing pharma companies in this direction, there need to be more clear incentives that can help them with access challenges.

As value-based contracting continues to be more commonplace, it is likely that there will be more standardization within the industry and regulatory parties. However, these changes should be happening now.  For example, standards are needed regarding what factors should be included when evaluating the effectiveness or value of a drug. Furthermore, value is a dynamic concept and the definition changes depending upon the viewpoint–value for a payer is different from value for pharma is different from value for a patient. The industry also needs to sort out what happens in outcome-based contracts when patients switch insurers.

Regulations can also stand in the way. While Medicaid has adopted a value-based contracting model for a small selection of drugs, most others are not covered by that arrangement. Most drugs are subject to Medicaid's Best Price policy where prices aren't connected to effectiveness or results, thus perpetuating the disconnect between price and value. The good news is that CMS, the government agency responsible for Medicaid and Medicare services, plans to extend and expand the value-based contracting model already in effect as they continue working towards the goals of improving health outcomes and lowering costs.

Change can be challenging. But as drug prices rapidly rise, the need for change has never been greater. Value-based contracting is the innovative solution that leverages the right data, at the right time, and with the right level of transparency to reduce costs, recover lost revenues, ensure more effective outcomes, help patients get healthier, and provide valuable data insights for future drugs and treatments. It's time to start implementing them.

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A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

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A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

Advanced gene therapies that could “practically curepatients suffering from sickle-cell disease (SCD) are just over the horizon. But they may not reach the people who need them most, many of whom are minorities with fewer financial resources and are reliant on Medicaid for their health coverage. Figuring out how to pay for their treatment looms as one of the biggest questions – both economic and ethical - facing US public health policymakers in the coming years.

Amid Medicaid’s efforts to cut spending, the dilemma of how to cover these drugs could end up increasing rancor and anger in the country – or it could spur budgetary creativity. While programs like Medicaid have traditionally filled the gap between availability and lack of affordability in treatment, the cost of SCD therapies developed by Vertex and CRISPR – estimated at nearly $2 million a dose – could quickly overwhelm even Medicaid's robust resources, especially in states that have higher rates of the disease. And this is just the beginning. As more ultra-expensive drug and cell therapies are developed for numerous conditions in the coming years, the question of how to pay for them looms large.

The American healthcare system has been long accused of discriminating against the poor and minorities – and that discrimination is likely to come into far greater focus when millions of the poorest Americans who could benefit from new therapies are unable to take advantage of them. Altogether, there are over 40,000 SCD patients on Medicare in any given year - about 60% of the estimated 100,000 victims of the disease in the US. Of the 74,817 hospitalized for sickle cell disease in 2023, 69,889 (93.4%) were African-American; on average, one of every 13 Black babies are born with sickle-cell trait (SCT), a forerunner of the disease. Even for SCD patients who can afford private insurance, the out-of-pocket cost for therapy is very burdensome. But for the poor and others who lack private health coverage, Medicaid is a singular life raft – the difference between life and a possibly very abrupt death.

Given the situation, it's likely that patient advocacy groups will make a strong bid for increased government funding. And given the issues of social justice and racism surrounding the historic lack of interest in SCD by the medical establishment, there's a good chance that funding will be forthcoming. But budgets are still budgets; if Medicaid is going to spend more on SCD therapies, it is going to have to cut other payments, especially given the strong pressure to cut Medicaid spending – both on the federal and state level, even in states where the incidence of SCD is high.

Related Post: Sickle cell disease gene therapies are here, but how is society going to pay for them?

This could be the time for Medicaid to follow in the footsteps of Medicare, and implement changes in the way it pays for treatments, specifically implementing models where payment is based on patient outcome. Indeed, Medicaid has proposed doing this, but it must move much faster if it wants to help those with SCD benefit from treatments expected to be approved by the end of the year.

Medicare recently adopted a limited form of results-based drug pricing for some of its most expensive drugs. The legislation initially covers ten high-priced drugs, with the list expanded to 20 by the end of the decade. Under the program, the government will pay a price closer to that demanded by the drug’s maker if a drug does in fact significantly reduce the costs of lifetime treatment. But if a drug does not have the desired result, the cost would be significantly lower. Experts are predicting significant savings for the government.

Medicaid, through CMS/CMMI, plans to do something similar - negotiate results--based contracts for gene-based therapies on behalf of all 50 state Medicaid programs. According to government data, the lifetime cost for treating SCD patients through 64 years of age is also close to $2 million. So Medicaid would be spending roughly the same amount on each patient receiving gene-based therapies, while reducing or eliminating costs for treatment of those over 64. These outcome-based contracts, also called value-based contracts, would allow drug-makers to be paid full price only if the treatment does end up working. These contracts could also allow Medicaid to pay in installments, rather than upfront. In addition, if treatment works faster or better than expected in some patients, there could be room in these contracts for drugmakers to be paid more, or paid earlier. Drug companies and science would also benefit from the extended real-world data involved in these contracts, which track the progress of treated patients for years.

But this model is likely to come too late for many with SCD: CMS/CMMI will only be running a pilot negotiation program in 2026 at the earliest. This means that it's very possible that Medicaid will have to, at least temporarily, ignore very promising gene-based therapies that could help hundreds of thousands of people because it can't pay for them.

Meanwhile, the public pressure and demand for widespread implementation of SCD gene therapies is likely to be very high. Lives are at stake; as is correcting a historic injustice. So how will officials deal with an increase in public pressure to pay for therapies? One possibility is to appeal to the private sector for help. Infact, the NIH will be partnering with the Bill & Melinda Gates Foundation to provide some $200 million to increase the development of affordable gene therapies for SCD and HIV by providing funding to researchers to develop lower-cost therapies, and assistance to those who need treatment. Another option could be transferring unused state Medicaid allocations for SCD from states with very low incidence rates, like Idaho, to states with higher incidence rates, like Mississippi.

Regardless of the solution Medicaid adopts, there's no question that a storm has been raging for years over who gets what in the American healthcare system – and that storm is likely to strengthen as gene-based therapies for SCD become available. Given the history of how the establishment has dealt with that disease – and the people who are its biggest victims – it's likely that changes to how Medicaid pays for expensive therapies will come sooner rather than later. These changes must happen, or inequality in the American health system will only become worse as the pipeline of life-changing gene and cell therapies grows.

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Lyfegen and EVERSANA Collaborate to Revolutionize Drug Pricing and Access with AI-Driven Insights

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Lyfegen and EVERSANA Collaborate to Revolutionize Drug Pricing and Access with AI-Driven Insights

Basel, Switzerland –28, January 2025 -  Lyfegen, a global innovator in drug market access, pricing, and rebate management, has announced a transformative collaboration with EVERSANA®, a leading provider of global commercial services to the life sciences industry, to revolutionize drug pricing and access through artificial intelligence-driven insights.  

By combining data and information from the global pricing and market access platform, NAVLIN by EVERSANA®, with Lyfegen’s Public Drug Agreement Library, the two organizations will harness cutting-edge AI to empower market access and pricing professionals and payers with actionable insights. The joint agreement marks a key step in tackling rising drug costs and improving patient access globally.

Simplifying Complexity with AI

Drug pricing and access are increasingly difficult to navigate, with healthcare payers and pharmaceutical companies facing inefficiencies, missed opportunities, and delays in delivering therapies to patients.

The collaboration combines two leading platforms to address these challenges:

  • NAVLIN by EVERSANA: The industry’s most comprehensive platform, delivers real-time access to global price and access data across 100+ countries and 50+ HTA bodies.  
  • Lyfegen’s Public Drug Agreements Library: A repository of over 7,000 public access agreements, recognized as the world’s most complete repository, delivering real-world strategies for smarter decision-making.

Together, these tools deliver a 360-degree view of pricing trends and access frameworks, enhanced by AI-driven capabilities. This integration helps users:

  • Efficiently link Public Drug Agreements and Price & Access Data in one environment.  
  • Discover agreements tailored to specific market needs.
  • Streamline decision-making using predictive analytics.
  • Quickly adapt to changing market trends and regulations.

Driving Smarter and Fairer Decisions  

Together, Lyfegen and EVERSANA will empower market access teams to make smarter, faster, and more equitable decisions. By combining AI-driven insights with robust data, payers and pharmaceutical companies can reduce inefficiencies and ensure patients receive timely access to life-saving therapies.
 

“Together with Lyfegen we can harness the power of AI to address one of the biggest challenges in healthcare—helping patients get timely access to life-saving medicines,” said Jim Lang, CEO, EVERSANA. “By uniting our expertise and our global pricing innovations, we have the opportunity to deliver a solution that simplifies decision-making and improves access in healthcare systems worldwide.”

A Vision for the Future of Drug Access

The healthcare industry is rapidly adopting AI to drive efficiency and innovation. This partnership positions Lyfegen and EVERSANA at the forefront of this transformation, enabling stakeholders to overcome affordability and access challenges.

“Our mission at Lyfegen has always been to create a more sustainable and equitable healthcare environment,” said Girisha Fernando, CEO of Lyfegen. “Through this partnership with EVERSANA, we are taking a giant step toward that future. By integrating EVERSANA’s price and access data into our combined offerings, we’re not just solving today’s challenges—we’re building a foundation for a smarter, more efficient drug access and pricing landscape.”

About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. With the world’s largest repository of drug access agreements and a powerful pricing simulator, Lyfegen helps payers and pharma implement and optimize rebates, reduce administrative effort, and understand financial impacts. Founded in 2018, Lyfegen is headquartered in Basel, Switzerland. Learn more at Lyfegen.com or connect with us on LinkedIn.  

About EVERSANA

EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X. 

Media Contacts

For Lyfegen

marketing@lyfegen.com  

For EVERSANA

Matt Braun

Vice President, Corporate Communications

matt.braun@eversana.com  

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

Basel, Switzerland / Boston, USA – December 11, 2024

Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.

Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions

The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.

Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.

Learn more about Retrospective Payment System

Scaling Globally with a Leading Rebate Management Platform

Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s rebate management platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.

“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”

Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”


About Lyfegen

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

About TX Ventures

TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage. 


For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com 

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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

In an industry often characterized by incremental changes, Girisha Fernando, the CEO and founder of Lyfegen, is making leaps. We sat down with Fernando to discuss the recent landmark partnership between Lyfegen and Newfoundland and Labrador Health Services—a collaboration that heralds a significant shift in the Canadian healthcare landscape.

 

Your partnership with Newfoundland and Labrador Health Services is quite a milestone. Can you share with us what this means for the current state of rebate management in Newfoundland?

Girisha Fernando (GF): Absolutely. This partnership is a transformative step for rebate management in Newfoundland. The current system, largely manual and complex, is ripe for innovation. With our digital platform, we're bringing a level of automation and accuracy that was previously unattainable. This means more efficient processing, less room for error, and a better allocation of resources, which is critical in healthcare.

That’s quite an advancement. And how does this impact the management of drug products, especially in areas like oncology?

GF: It’s a game-changer, especially for critical areas like oncology. Newfoundland and Labrador, as the first in Canada to use our platform, sets a precedent. The region, through the pan-Canadian Pharmaceutical Alliance, has been managing complex product listing agreements for drugs, including those for oncology. These agreements are vital for making treatments affordable. Our platform simplifies this, managing the various terms of these agreements efficiently, which is crucial for timely and affordable access to treatments.

It seems like a significant step forward for healthcare management. How does this align with the broader goals of Lyfegen?

GF: This partnership aligns perfectly with our goal to make healthcare more accessible and efficient. Automating the rebate process in Newfoundland and Labrador, especially for critical treatments in oncology, directly contributes to the sustainability and accessibility of healthcare treatments.

Looking to the future, what does this partnership mean for Lyfegen and healthcare systems globally?

GF: This is just the beginning. We're looking to extend our platform to healthcare systems around the world. Our aim is to make this technology a standard in healthcare management, fostering more efficient, sustainable, and equitable healthcare systems globally.

Read more about the partnership in the official press release.

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

 

Basel, Switzerland, October 27, 2021

Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.

 

The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.

 

"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.

Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."

The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.

 

About Sympany

Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.

In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.

More about Sympany: https://www.sympany.ch

 

About Lyfegen

Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.

Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.

Contact Press: press@lyfegen.com

Contact Investors: investors@lyfegen.com

 

READ THE OFFICIAL PRESS RELEASE

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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

New York, NY - March 29, 2023 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced at the World EPA Congress the launch of its latest solution: the Model & Agreement Library. The purpose of the library is to help payers and pharma negotiate better drug prices while providing an in-depth view on current international drug pricing models and value-based agreements. The database library serves as the basis for successful drug pricing negotiations, resulting in accelerated access and drug prices better aligned to their value for the patient.

 

The shift towards value-based healthcare, rather than volume-based, has been steadily increasing over the years. This evolution has further reinforced Lyfegen's mission to remain at the forefront of analytics and digital automated solutions for the healthcare sector. Indoing so, Lyfegen’s solutions help to accelerate access and increase affordability of healthcare treatments.

 

“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers, and pharma companies across the world”, said Girisha Fernando, CEO of Lyfegen. “That is why we are so excited about launching the world’s largest database of real-world value-based agreements. It gives payers, and pharma a unique insight into how to structure value-based agreements.”

The Lyfegen Model & Agreement Library was developed as an accelerated negotiation resource for both manufacturers and payers – allowing them to save on time, money; and for the first time – an opportunity to learn at their own pace without incurring large research projects or hiring expensive external experts. Users of the library are now enabled to make informed decisions in determining the most suitable drug pricing models and agreements for their products.

The database holds over 2'500+ public value-based agreements and 18+ drug pricing models – spanning across 550 drugs,35 disease areas and 150 pharma companies. Its search capabilities are spread across product, country, drug manufacturer and payer – with all the knowledge, insights, current pricing and reimbursement activities shown in near real-timeacross the industry.

“Just an academic taxonomy of models is intellectually exciting but it's not really helping your typical customer”, said Jens Grüger, Director and Partner at Boston Consulting Group (BCG). “The Lyfegen Platform goes several steps further. Payers and pharma have a problem and they want a solution. The Lyfegen Model & Agreement Library is practical. It offers case examples.”

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The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.

“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.

This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.

Learn more and start your free trial now

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

Each year, the NAMD (National Association of Medicaid Directors) Conference in Washington D.C. brings together the nation's Medicaid directors, leaders in the industry, and key decision-makers for a one-of-a-kind conference. With the global public health emergency, the Medicaid system and the work of Medicaid directors and their staff has never been more important. While COVID-19 has disrupted health care at all levels, it has shown the importance of more innovative payment models and the need for broader access to treatments. The shift towards value-based healthcare has become one of Medicaid’s hottest topics, with CMA and Lyfegen joining forces to present the latest value-based contracting technology at this year’s NAMD Conference.

We sat down for a brief interview with CMA’s President, Ken Romanski, and Lyfegen’s CEO, Girisha Fernando, to gain more insights into the importance of this partnership:

Thanks for joining us, Ken and Girisha. Can you tell us why this partnership is an important milestone, both for CMA and Lyfegen?

Ken: Our partnership with Lyfegen is a key milestone for CMA as we expand and complement our portfolio of technology-based solutions with extremely high-value business analytics products. Our utmost priority is to support Medicaid programs by lowering costs, while at the same time improving health outcomes for vulnerable citizens.

Girisha: This partnership sets the basis to create enormous value for our state healthcare payers and pharma. By partnering together, we enable our customers to implement value-based pharmacy agreements, actively managing the budget impact of new treatments and aligning existing formulary spending with value for beneficiaries.

For Lyfegen, this is a market entry into the U.S. – why CMA?

Girisha: CMA’s experience and technical expertise are unique. CMA is a highly recognized technology partner for State Healthcare Payers across the nation, with over 20 years of experience. Lyfegen has made a conscious decision to combine its capabilities with CMA to enable our customers to leverage the potential of value-based agreements for their pharmacy programs.

What is the value of this partnership for healthcare payers?

Ken: CMA is very excited to work with Lyfegen and our clients to deliver tens of millions of dollars in savings per year by leveraging our experience in Medicaid data management to implement this robust value-based analytics platform.

Girisha: Our customers benefit from the combined years of experience and unique expertise in data and value-based healthcare solutions. We focus on providing the first proven, scalable, highly secure value-based agreement platform for State Medicaid that allows our customers on average to avoid 54 million dollars in treatment costs that do not work and gain 7 million dollars in efficiency due to the fully automated end-to-end process. We are extremely excited to present all aspects of our partnership and present the value and opportunities our platform can bring to State Medicaid programs at NAMD.

Join CMA and Lyfegen at NAMD and understand first-hand how they can support you to realize savings for your pharmacy programs, improving patient health outcomes with their unique value-based agreement platform.



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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

                    Fünf Männer aus der Region wollen die Gesundheitsbranche aufmischen. Im 2018 wurden sie von der Plattform «Innovation Basel» für ihre visionäre Idee nominiert: Eine digitale Plattform, die eine Kombination aus Blockchain und Cloud verwendet, um faire Medikamentenpreise zwischen Herstellern und Versicherungen auszuhandeln. Was heisst das aber und was ist dabei so visionär?            

                    (Bild: zVg) Das Lyfegen Team: Diese fünf Männer haben eine Vision und eine Mission. Die Idee liess Girisha Fernando nicht mehr los: Der 29-jährige Basler wollte nach neun Jahren bei der Roche im Market Access, Pricing und IT unbedingt «etwas noch Spannenderes, Revolutionäres machen», wodurch Patienten im Dschungel des Gesundheitswesens geholfen wird. Aber es sollte dabei auch für Pharmaunternehmen und Versicherer eine Win-Win-Situation entstehen.          

         Zusammen mit seinen Mitstreitern Leon Rebolledo, Michel Mohler und Nico Mros gründete er 2018 «Lyfegen» und entwickelte eine bahnbrechende Idee: Eine auf Blockchain und Cloud basierte Software Lösung, die es Versicherern und Herstellern von Medikamenten erlaubt faire Preise anhand deren Wirksamkeit für den einzelnen Patienten auszuhandeln.                      

   

     

         

           

         

         

            Faire Preise bedeuten unter anderem auch, dass die Vergütung dieser Medikamente auf der Wirkung des Medikaments basiert. Wenn ein Medikament bei einem Patienten besser wirkt, dann wird ein Preis A bezahlt. Wenn ein Medikament bei einem anderen nicht so gut anschlägt, dann wird Preis B vom Versicherer an den Hersteller fällig oder sogar nichts bezahlt. Unser Tool ermöglicht genau diese faire, wirkungsorientierte Preisgestaltung, was sich auch Value-based Healthcare nennt. So ein Tool gibt es auf der ganzen Welt bisher nicht.             Name Surname
Position, Copmany          

     

   

                 Fachleute sprechen hierbei von «Wertbasierter Gesundheitsversorgung». Dieses Thema ist aktueller denn je, auch in der Schweiz, in der steigende Behandlungs- und Medikamentenpreise zu höheren Kosten für die Bevölkerung führen. Es müssen neue, nachhaltige Modelle eingeführt werden, um die Kostenexplosion im Gesundheitswesen aufzuhalten.          

   

     

         Transparenz bei Preisgestaltung und Wirkungsgrad          

Warum aber ist so ein Tool wertvoll? «Weil unser Tool Daten sicher sammelt, analysiert und dann den jeweiligen Partnern, sei es ein Versicherer oder ein Hersteller wie Pharmaunternehmen, die Daten anonym, automatisiert und gleichzeitig zuspielt.» Dies geschieht mit Hilfe der Blockchain (eine dezentralisierte Form der Datenverarbeitung und -sicherung, die beispielsweise Geldeinheiten, Wertpapiere, Besitz- oder Grundrechte verwaltet, siehe Erklärung in der Infobox), ganz ohne Kryptowährung, betonen die fünf innovativen Köpfe.

     

   

 

   

     

       

         

           

         

       

                 

         

           

         

       

     

   

 

                     (Bilder: PEXELS) Im Gesundheitswesen explodieren die Kosten. Eine revolutionäre Idee könnte dieser Entwicklung entgegen wirken.            

            Die Idee hat schon für viel Wirbel in der «Szene» gesorgt. Und sie gehen mit ihrer Idee aufs Ganze: «Wir haben schon 750’000 CHF von einer Gruppe von Basler Business Angels erhalten», sagen die Lyfegen-Gründer. Diese Business Angels seien selbst erfolgreiche Unternehmer. Namen dürfe man leider keine bekannt geben. Zudem müsse man zu 100 Prozent hinter einer Innovation, einer Vision oder einer Idee stehen, die der Gesellschaft helfen könne, betonen sie. Fernando: «Ich bin fest davon überzeugt, dass nicht nur unsere Lösung, sondern auch die Denkprozesse, die wir bei unseren Kunden anregen, die Implementierung einer wertbasierten Gesundheitsversorgung vorantreibt. Konzept und Lösung sind innovativ.»                        

   

     

         

     

   

               Vertrauen und Transparenz zwischen Ärzten und Patienten ist immens wichtig. Darauf basiert auch das Konzept des Value-based Healthcare.      

      Zwar sei man bei Lyfegen sehr technisch veranlagt, jedoch steht der Kundennutzen und der so genannten «Impact» für alle Parteien im Vordergrund. Also auch für die Versicherten und für das gesamte Gesundheitswesen. «Unsere Lösung trägt dazu bei, Patienten Zugang zu innovativen Behandlungen und der bestmöglichen Gesundheitsversorgung zu ermöglichen. Wir wollen Leben retten. Punkt», betont CTO Leon Reborello. Girisha Fernando kann aus eigener Erfahrung berichten: «Mein Grossvater hatte Prostatakrebs und die Ärzte sagten, dass es Medikamente gibt um seine Lebensdauer zu verlängern. Aber die Versicherung wollte aus Kostengründen nicht für das Medikament bezahlen. Dies muss aufhören – durch wertbasierte Vergütung würden die besten und innovativsten Medikamente für Patienten und Ärzte zugänglich. Mit unserer Lösung tragen wir dazu bei, dies zu verwirklichen.»          

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The Shift to Financially Optimized Clinical Trials

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The Shift to Financially Optimized Clinical Trials

As value-based contracting (VBCs) becomes the standard, the role of clinical trials has shifted significantly. They are now essential not only for demonstrating safety and efficacy but also for enhancing financial performance. By creating trials that meet the criteria of VBCs, pharmaceutical companies can increase their financial gains, minimize pricing risks, and facilitate smoother negotiations with payers.

According to a report by Deloitte, aligning clinical trials with value-based pricing strategies can lead to improvements in revenue predictability and cost management by as much as 20% for drugs with high market access potential. This improvement stems from linking trial outcomes to real-world efficacy, which reassures payers and reduces the financial risk for manufacturers by basing pricing on demonstrated effectiveness  

For CFOs and Pricing Directors, the Financial Impact is Clear

For CFOs and Directors of Pricing, the financial implications of optimized trials in a VBC framework are significant. When trial designs focus on outcomes that matter most to payers—like reductions in hospitalization or improved quality of life—pricing becomes more flexible, and revenue can be projected more accurately. McKinsey & Company points out that outcome-based models also provide a safeguard against pricing volatility, allowing pharmaceutical companies to stabilize revenue by tying payments to real-world performance metrics.  

Efficiency Gains through Outcome-Focused Trial Design

Beyond revenue predictability, operational efficiencies are another key benefit. A focus on outcome-based trials reduces the time and resources needed to negotiate with payers, as the trial data itself becomes a compelling point in payer discussions. For Market Access Directors, outcome-driven trial designs support quicker market entry and stronger, data-backed negotiations that build payer confidence.

Lyfegen’s Platform: Streamlining Trial Optimization for Value-Based Contracts

Optimizing clinical trials for VBC is complex, but Lyfegen’s all in one platform simplifies this process. By enabling real-time pricing simulations based on clinical outcomes or financial goals, Lyfegen helps pharmaceutical companies design financially viable reimbursement contracts and align them with value-based pricing. This empowers pricing teams to model financial outcomes, enhancing both operational efficiency and contract efficiency.

Interested in learning how outcome-focused trials can support your pricing and financial goals? Lyfegen’s Simulator offers the tools you need to optimize clinical trials for success in a VBCs framework.

Schedule a demo today to explore how we can streamline your pricing and contract strategies: https://www.lyfegen.com/demo

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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

In value-based contracts (VBCs), clinical trial outcomes are no longer just about proving safety and efficacy—they’re now critical to driving drug pricing and market access strategies. As payers and healthcare systems shift towards outcome-based models, trial data is becoming the foundation for negotiating both price and reimbursement.

Payers are increasingly prioritizing data from real-world evidence and clinical trials for value-based arrangements. The real-world data aligns closely with payers' needs to predict the cost-effectiveness of drugs and determine coverage. For Market Access Directors and Directors of Pricing, this means that clinical trial results can either accelerate or hinder the process of getting drugs to market. Strong trial outcomes not only justify premium pricing but also provide a solid basis for faster, smoother payer negotiations.

This is especially crucial in markets where budgetary pressures and stringent healthcare regulations make it difficult for new therapies to gain market access. The ability to present data-driven evidence of a drug’s real-world impact can significantly shorten time to market and improve access.

Novartis’ Zolgensma, a gene therapy for spinal muscular atrophy, used a value-based contract with installment payments and performance guarantees, adjusting reimbursement if outcomes fell short—demonstrating flexibility for high-cost therapies in outcome-based pricing models  

For CFOs, using clinical trial data means greater financial predictability. By tying pricing to outcomes, companies can secure more stable revenue streams, with lower financial risk from market variability.

Are you ready to leverage clinical trial data to improve your pricing strategy and market access? Lyfegen’s Simulator helps you model pricing scenarios based on trial outcomes, ensuring a smoother path to market and better payer alignment.

Schedule a demo today to see how we can support your pricing and market access strategies: https://www.lyfegen.com/demo

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UK: Standardizing the economic evaluation of AI tech

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UK: Standardizing the economic evaluation of AI tech

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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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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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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