Medicare Part D redesign could reboot U.S. prescription drug market for cancer drugs, making pricing more value-based

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With passage of the Inflation Reduction Act, the Medicare Part D (outpatient drug benefit) will be undergoing a comprehensive redesign, which will be implemented in 2025. There will be a dramatic shift towards payer responsibility of costs, particularly in the catastrophic phase of the Medicare Part D benefit.
Currently, during the calendar year there are four phases a Medicare beneficiary goes through when obtaining coverage of outpatient drugs: Deductible, initial coverage, coverage gap, and catastrophic. Here, catastrophic refers to the point when a beneficiary’s total prescription drug costs for a calendar year have reached a set maximum level. At present, the catastrophic threshold is set at $7,100. In a given year, once beneficiaries hit the threshold they will have spent $3,250 out of pocket, at which point they begin paying 5% co-insurance in the catastrophic phase.
Over a five-year period from 2016 to 2021, nearly three million enrollees in Medicare Part D spent above the catastrophic threshold at least once. And, currently more than 1.5 million beneficiaries are in the catastrophic phase. That number is expected to grow steadily in the coming years. Moreover, at present, spending in the catastrophic phase now accounts for about 45% of total Medicare Part D expenditures.
The redesigned Medicare Part D benefit features a $2,000 hard cap on beneficiary out-of-pocket spending. At the same time, there will be a massive shift in cost management liability in the catastrophic phase. Currently, Medicare picks up the tab for 80% of costs in the catastrophic phase (the government is essentially the reinsurer in the catastrophic phase); plans, 15%; and beneficiaries, 5%. In the restructured Part D benefit, starting in 2025, the drug manufacturer will be responsible for 20% of catastrophic costs; plans, 60%; Medicare, 20%; and Medicare beneficiaries, 0%.
This $2,000 cap will obviously reduce Medicare beneficiaries’ financial burden considerably, especially those who are prescribed high-priced specialty cancer drugs, many of which put them in the catastrophic phase by the end of January in a given year, with no limit on out-of-pocket expenditures. In all probability, the $2,000 cap will lead to more utilization of specialty drugs and better patient adherence.
The Part D overhaul will also force payers and drug makers to rethink their strategies vis-à-vis cancer drug pricing and reimbursement. Payers will have to strike a harder bargain with drug makers when purchasing specialty pharmaceuticals. As payers won’t be able to fully offset their higher burden of cost management by raising premiums – there will be a 6% annual cap on premium increases. There will very likely be increased use of utilization management tools. And, perhaps most importantly, a more competitive market with more use of utilization management tools, such as prior authorization, step edits, and quantity limits. Also more use of outcomes-based pricing models. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.
Historically, as new checkpoint inhibitors, anti-PD-1 and PD-L1 agents, have gained approval – such as Jemperli (dostarlimab) in April of 2021 - price competition has not been a factor. This is extraordinarily unusual, given how relatively crowded the various oncology indications targeted by checkpoint inhibitors have become; from breast, renal, and colorectal cancer, to melanoma and non-small cell lung cancer. Several companies, including traditional ones like Lilly but also new entrants such as EQRx, are seeking to disrupt this space by offering lower-priced alternatives.
Outside the U.S., oncology drug pricing is generally heavily regulated. And, we observe that certain drugs may not be reimbursed by government (monopsonist) purchasers if there isn’t sufficient clinical benefit to justify the price. Moreover, in international markets, outcome- or value-based pricing strategies for cancer drugs are commonplace, which they aren’t yet in the U.S.
However, Medicare Part D restructuring alters the competitive landscape considerably. For high-priced specialty pharmaceuticals, in particular, it will become increasingly important for payers to contain costs by way of utilization management, promote the use of generics and biosimilars, and negotiate value-based prices. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.
About the author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst on a variety of research, teaching, speaking, editing, and writing projects.
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Despite majority public support for authorizing Medicare to negotiate drug prices, legislators struggle to reverse the non-interference clause that makes it illegal.
The non-interference clause
Medicare is legally prohibited from negotiating drug prices directly with manufacturers thanks to the non-interference clause in the 2003 law that created Part D, the prescription drug program for Medicare beneficiaries. The non-interference clause disallows Medicare from negotiating drug prices directly with pharmaceutical manufacturers, interfering in negotiations by Medicare contractors, or publishing any information about negotiated drug rebates.
Instead, the private health insurance plans and prescription drug programs Medicare contracts to implement benefits conduct negotiations for discounts with drug manufacturers. Meanwhile, other government programs — Medicaid and the Veterans Administration—have successfully lowered drug costs by negotiating directly for discounted drug prices and rebates.
Strong public support stands for allowing Medicare to negotiate drug prices
According to a KFF (Kaiser Family Foundation) poll published in October 2021, there is broad-based public support for ending the non-interference clause. The poll showed that 83% of the survey participants favored allowing Medicare to negotiate drug prices directly with manufacturers. Those in favor included a mix of 71% Republican, 82% of independents, and 95% Democrats.
Proponents of allowing Medicare to negotiate drug prices in Parts B and D see Medicare’s ability to negotiate value-based drug pricing as an important part of the overall strategy for driving the U.S. health system towards value-based healthcare and lower drug prices, especially if the outcomes of the negotiations are made known to commercial insurance plans, the Marketplace, and self-insured employers.
Opponents believe that the Medicare system of price negotiations through contracted health plans and prescription drug plans promotes competition among drug manufacturers and protects patient access to drugs. They also cite a Congressional Budget Office (CBO) letter that states giving broad Medicare negotiating authority to the Secretary of Health and Human Services (HHS) would, by itself, “likely have a negligible effect on federal spending”.
Recent legislative actions attempting to eliminate the non-interference clause
In 2019, the U.S. House of Representatives passed bill H.R.3, The Elijah E. Cummings Lower Drug Costs Now Act. Among other proposed fixes, the bill would authorize the Health and Human Services (HHS) Secretary to negotiate prices for single-source, brand-name drugs that met certain criteria. When H.R.3 went to the Senate for approval, its progress stalled. In 2021, H.R.3 was reintroduced in Congress.
In November 2021, the the Build Back Better Act (BBBA) passed the U.S. House of Representatives but was also stopped dead in the Senate. Within that bill was an exemption to the non-interference clause to allow Medicare to negotiate prices for expensive drugs covered under Medicare Parts B and D. Despite the defeat of the BBBA, President Biden used his State of the Union address on March 1, 2022 to keep up the pressure and repeated his call to lawmakers to address the problem of drug pricing.
Value-based administrative levers
In 2016 a pilot project for Medicare Part B drugs was created to test the results of allowing Medicare to conduct drug pricing negotiations. It was designed to institute value-based drug pricing using an international pricing index for the few drugs covered under Part B. The prices of some Part B biologics and single-source drugs were tied to their lower average overseas price.
Although the pilot project could have been implemented without congressional approval, several lawsuits and injunctions prevented the implementation of the model. Finally, the Biden administration rescinded the proposed model in August 2021.
Besides the recent unsuccessful legislative efforts for Medicare drug price negotiations, HHS outlined some other possible administrative actions for drug pricing reforms based on President Biden’s September 2021 Executive Order 14036, Promoting Competition in the American Economy. Among the proposals suggested is the use of value-based pricing models:
• To improve transparency about pricing, rebates, and out-of-pocket spending through data collection from health insurers and pharmacy benefit managers
• Implementing Medicare total cost of care models to find ways to reduce spending, affect drug utilization, and improve patient outcomes
The need for drug pricing reforms in Medicare holds bipartisan support, especially as it relates to lowering out-of-pocket expenses for seniors. However, passing the legislation needed to realize those reforms remains a controversial and complicated matter. While work continues to pass drug price reform legislation, value-based payment models can provide data analytics to support drug price reductions in both the public and private sectors.
Lyfegen’s value-based contracting platform
The Lyfegen platform helps organizations join in the healthcare industry’s movement towards value-based care. Our contracting platform organizes the actionable, real-time data needed to implement value-based contracting while relieving the complexity and administrative burden of transitioning out of fee-for-service models.
Contact us for more information about our software solutions and to book a demo.
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How the U.S. Institute for Clinical and Economic Review is reshaping market access
In the U.S., comparative clinical effectiveness analyses are gaining traction as ways to inform coverage, pricing, and reimbursement of pharmaceuticals by both public and commercial payers. And, while use of cost-effectiveness data to inform coverage decisions is prohibited in the public sector (Medicare and Medicaid) it can be used in the commercial sector.
A recently released Xcenda analysis shows that 70% of U.S. commercial payers identified comparative clinical- and cost-effectiveness evidence in the Institute for Clinical and Economic Review’s (ICER) published reviews as the most important items in the reports with respect to informing coverage and reimbursement decisions.
Additionally, 50% of payers said that long-term cost-effectiveness – for example, cost-per-Quality-Adjusted-Life-Year – is “very impactful” in informing the decision-making process. And, as the figure below shows, 52% used results from an ICER assessment in pricing negotiations while 38% implemented a prior authorization protocol based on an ICER evaluation.
Source: Xcenda, International Society for Health Economics and Outcomes Research (ISPOR) annual meeting presentation, May 2022
Further bolstering the Xcenda analysis, an Evidera study from late 2019 suggested that ICER can influence value-based benchmark prices. The use of value-based pricing is increasing in the U.S. And, where appropriate, ICER favors the use of value-based contracting to align price and value. In fact, in certain instances such as gene therapies, ICER believes that such treatments can only be viewed as being cost-effective if value-based contracting is applied. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.
To illustrate the impact ICER assessments can have with respect to pricing and reimbursement decisions, let’s consider ICER’s evaluation of PCSK9 inhibitors – indicated for individuals with inadequately treated levels of LDL-cholesterol. In 2016, two PCSK9 inhibitors were approved by the Food and Drug Administration: Alirocumab (Praluent) and evolocumab (Repatha). ICER reviewed the drugs’ clinical- and cost-effectiveness and suggested the list prices needed to be substantially reduced to make the treatments cost-effective.
What ensued was the establishment of several ICER-payer partnerships that led to formulary exclusions of these therapies and subsequent “price wars” as manufacturers of Praluent and Repatha drastically lowered their list prices to remain competitive.
Broadly, cardiovascular disease represents a competitive market with an established standard of care that includes numerous therapeutic options for most patients. Here, payers were able to leverage ICER’s assessment of the PCSK9 inhibitors in negotiations with drug manufacturers. In turn, this led, for example, to one manufacturer lowering the wholesale acquisition cost of Praluent to $5,850, down from $14,600.
In other therapeutic categories with much less competition, ICER’s impact is less clear-cut. For example, in a therapeutic area such as spinal muscular atrophy, characterized by low prevalence, high mortality rates, and lack of effective treatments, ICER’s cost-effectiveness analysis either did not influence payer coverage - as with the drug Spinraza (nusinersen) - or may have been leveraged by the manufacturer to push for wider acceptance among payers -as with Zolgensma (onasemnogene abeparvovec).
In 2019, ICER published its final recommendations on spinal muscular atrophy therapies. To meet an ICER-imposed cost-effectiveness threshold of up to $150,000 per life year gained, Spinraza would need to be priced at a maximum of $145,000 for the first year of treatment and $72,000 annually for subsequent years. This was considerably lower than Spinraza’s list price of $750,000 for the first year and $375,000 annually for subsequent years. ICER also recommended that Zolgensma could be priced at up to $2.1 million per treatment to be considered cost-effective, which turned out to be in line with its list price of $2.125 million at launch.
Interestingly, although ICER’s analysis found that Zolgensma was cost-effective while Spinraza was not, payer coverage for both drugs followed a similar trend over time, with payers restricting access in the initial periods immediately after launch and later relaxing these criteria.
The shift in coverage criteria could be due to an initial reflex response that payers have to restrict access to extremely expensive medications, followed by a loosening of criteria. Historically, this has been the case. Subsequently, after acknowledging the dramatic clinical benefits that Spinraza and Zolgensma have demonstrated in clinical trials for treating a disease with no other therapeutic options, payers relent, if you will. Also, in the case of Zolgensma, ICER’s evaluation may have led to a further easing of payer restrictions.
Of course, cost-effectiveness analyses, such as the ones published by ICER, must invariably be adapted for local use. Context matters, nationally, but also intra-nationally, in different jurisdictions and sub-markets. Further challenges include local or federal (national) regulations which may prevent the use of cost-effectiveness analyses under certain circumstances; stakeholders’ resistance to adopting such analyses or be bound by their findings; and the general lack of available (and appropriate) cost-effectiveness data.
Nevertheless, there is a consistent trend which points to the growing influence of ICER evaluations on payer decision making, specifically with respect to drug pricing and reimbursement. Clinical- and cost-effectiveness data can be used to determine whether to cover a technology, inform the use of prior authorization or other conditions of reimbursement, and serve as a benchmark for price negotiations with manufacturers.
About the author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst n a variety of research, teaching, speaking, editing, and writing projects.
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Healthcare payers and insurance companies are under pressure to fight rising drug prices in the U.S. Payers have the difficult task of figuring out if a manufacturer’s proposed wholesale price for a new drug is justified. Value-based purchasing agreements facilitate the data sharing needed to determine a drug’s fair price.
U.S. drug expenditures are among the highest in the world
It’s well-documented that the U.S. spends more on prescription drugs than other high-income countries. After adjusting for rebates and discounts, U.S. drug prices are almost 200% of prices in other comparable countries, according to a 2021 Rand Corporation report.
High drug prices in the U.S. translate to a per capita expenditure almost double what consumers and payers in other developed countries are paying. Peterson-KFF’s Health System Tracker shows that in 2019, U.S. payers and consumers spent a yearly average of $1,126 per capita for prescription medications, with $963 covered by payers and $164 in patient out-of-pocket costs. In other high-income countries, average annual drug expenditures were $552 per capita, with $88 in yearly out-of-pocket costs for patients.
U.S. drug expenditures keep rising
The American Society of Health-System Pharmacists reports that in 2021 overall pharmaceutical expenditures in the U.S. grew by 7.7% over the previous year’s costs; and for 2022, they predict another 4-6% increase in drug spending.
According to the healthcare consulting firm IQVIA, a total of 6.3 billion prescriptions were filled in the U.S. in 2020. Around 90% of those prescriptions were filled using lower-priced generic drugs. Lower-priced generic and biosimilar drugs have helped slow the rise of the annual national drug expenditures, however these account for only around 20% of total drug costs.
Increased use of pharmaceuticals (especially generics), drug price hikes, and high-cost new drugs coming to the market are contributing to the rise in overall drug expenditures. In particular, new, brand-name specialty drugs for conditions such as diabetes, cancer, autoimmune, and other rare diseases are bringing up the average of drug prices.
The use of specialty drugs increased from 27% of total U.S. drug spending in 2010 to 53% in 2020, according to IQVIA. They forecast up to 55 new pharmaceutical products per year will be brought to market between 2020 and 2025. Pharmaceutical forecasting software can help you stay on top of these changes and plan effectively.
Payers will have to decide whether to cover the cost of these new products and at what price. New-to-market specialty drugs are excellent candidates for value-based purchasing agreements.
Value-based purchasing contracts provide the data that reveal if a drug is worth its price
Payers have the difficult task of figuring out if a manufacturer’s proposed wholesale price for a new drug is justified. They need to protect their bottom line by minimizing the risk of paying for ineffective, over-priced drugs. Private insurance plans, Medicaid, and the Veterans Administration often negotiate prices for new treatments with pharmaceutical companies without real-world data to demonstrate the drug’s clinical and cost-effectiveness compared to other treatments for the same health condition.
If their product is eligible, some pharmaceutical manufacturers conduct fast-track clinical trials for FDA approval using surrogate endpoint measures to show that a new drug is safe and more effective than a placebo. But these trials provide limited data and they aren’t the comprehensive comparative effectiveness review (CER) needed for determining the value and fair price for the drug. Independent research firms, such as the Institute for Clinical and Economic Review (ICER) and the Patient-Centered Outcomes Research Institute (PCORI), conduct CERs that provide insight into pricing for drug categories, but they don’t research every new drug coming onto the market.
Value-based purchasing agreements fill this knowledge gap by collecting the real-world evidence of a new drug’s clinical value. The data sharing among stakeholders that comes with these outcome-based contracts gives a fuller picture of the drug’s impact on patient health outcomes.
Value-based purchasing contracts strengthen stakeholder partnerships
While acknowledging that the future of healthcare is moving from fee-for-service to value-based healthcare, providers and payers have been slow to adopt value-based contracting. Operationalizing these agreements is complex. They consume large amounts of time and financial resources at start-up, not to mention the trust, cooperation, and commitment required from stakeholders.
It can be quite difficult to agree on a drug price that satisfies all stakeholders in terms of evidence-based clinical value and comparative competitor pricing. What and who determines a drug’s value? Value-based purchasing arrangements align the stakeholders’ metrics for measuring value to determine a fair price for a drug. Over time, this new level of transparency and cooperation can foster greater trust between contract partners and help break down the barriers blocking the transition out of fee-for-service to value-based healthcare.
The Lyfegen Platform
Manufacturers, payers, and providers all possess part of the data about a drug’s value in their databases. In the past, automated tools to safely collect, centralize, and analyze stakeholder data were non-existent. Thanks to innovations in artificial intelligence, new software platforms for value-based contracts can facilitate efficient coordination among the stakeholders to achieve a high level of secure data sharing.
Lyfegen’s software platform helps healthcare insurances, pharma and medtech companies implement and scale value-based purchasing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost in value-based contracts. By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
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Manufacturers, payers, and health systems disagree on how to assess the value of new, high-cost treatments such as cell and gene therapies. These stakeholders see a solution in outcome-based drug pricing agreements.
Girisha Fernando, CEO of Lyfegen, was recently invited to take part in a roundtable discussion about cell and gene therapies (CGTs), hosted by the global consulting firm, Oliver Wyman. Over 20 industry leaders, payers, and third-party solution providers were in attendance.
Oliver Wyman released a white paper that summarizes the insights, challenges, and opportunities uncovered during the discussion. A major area of concern among the participants is preparing and equipping payers and health systems with the means to assess the value and health benefits of new, high-cost CGTs.
Outcome-based contracting is the future for cell and gene therapies
According to marketresearch.com, the global CGTs market—valued just short of USD $5 billion in 2021—is forecast to reach almost USD $37 billion by 2027. In anticipation of an estimated total of 60 CGTs available on the market by the end of the decade, industry and health system stakeholders recognize the need to move towards contracting that includes an outcome-based drug pricing component.
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The roundtable participants agreed that using outcome-based contracts (OBCs) for CGTs is a critical lever for ensuring patient access to innovative therapies. OBCs can reward manufacturers for new drug development while addressing the payers’ concerns about clinical effectiveness and management of financial risk.
Why outcome-based contracting is best for cell and gene therapies
The Oliver Wyman white paper lists a few reasons CGTs are well suited for value-based drug pricing through outcome-based contracting, including:
• A lack of real-world clinical evidence about the therapy when first introduced to market
• Uncertainty about the product’s value proposition
• High perceived cost versus the current standard of care
Fernando adds an additional perspective to the conversation: “Another underlying need for OBCs and underlying innovative payment models is the fact that the Pharma’s business model is changed with CGTs. Since they promise significant patient benefit, and in many cases even cure, this cure is being priced into one price. This contrasts with the previous pharma model of gaining continuous revenue by supplying continuous treatments over several cycles.”
Challenges to implementation of outcome-based contracts
At present, several challenges hinder the widespread adoption of outcome-based agreements. Oliver Wyman’s analyses point to difficulties such as agreement on a starting price, deciding how to measure patient outcomes, and choosing appropriate follow-up timelines.
Another one of the fundamental difficulties in executing OBCs is capturing quality real-world data. There was consensus among the roundtable participants about the need to collaborate to build innovative multi-stakeholder data infrastructure and systems that support real-world evidence collection about patient outcomes. Current attempts to build performance data gathering into existing data systems often lead to increased fragmentation of data across different systems that are not interoperable.
For many reasons, the real-world data that is available is often incomplete or of poor quality. All industry and health system stakeholders want to balance transparency with safeguarding proprietary information. Healthcare providers don’t see data collection as their priority; they must be incentivized or compensated for taking on this additional administrative burden. And patients asked to self-report outcomes want to feel in control of how and with whom they share their health outcomes.
Collecting quality patient data
Empowering patients as decision-makers in their care encourages them to report their treatment results. Regarding patient self-reporting of health outcomes, Fernando poses some additional considerations:
“Should patients receiving a CGT also have a “responsibility” in terms of data reporting etc. as health systems commit to curing these patients? This would be needed to track long-term outcomes of patients, as well as provide a positive effect on evidence & learnings.”
Fernando also sees more patient-centric opportunities for growth: “In addition to the CGT, what other kinds of services should be built around these patients to improve patient health outcomes?”
A supportive ecosystem for outcome-based contracts
The roundtable identified three key principles for advancing the data infrastructure and ecosystem needed for executing OBC: data ownership, data interoperability, and data access and security. They uplifted the role of third-party innovators and solution providers like Lyfegen, whose value-based contracting software addresses these difficult IT issues and simplifies the execution of complex pricing models. By facilitating the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases affordability and access to high-cost healthcare treatments like CGTs.
The Lyfegen Platform
Lyfegen’s software platform helps healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost in value-based contracts.
To learn more about the Lyfegen Platform and software solutions, contact us to book a demo.
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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:
Together, these tools deliver a 360-degree view of pricing trends and access frameworks, enhanced by AI-driven capabilities. This integration helps users:
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.
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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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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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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
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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.
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Antes de unirse a nosotros en Lyfegen, David adquirió una gran experiencia y conocimientos en la industria de la salud y las finanzas, mientras perfeccionaba sus habilidades como Ejecutivo de Ventas Globales. Su curiosidad por la naturaleza humana y su amor por la humanidad es lo que alimenta su pasión por marcar la diferencia allí donde más importa.
Afincado en España y licenciado en Ingeniería Informática Con su amplia experiencia en la introducción de productos disruptivos en el mercado, ha llegado a comprender que es primordial destacar cómo las tareas diarias del usuario conectan con nuestra plataforma y guiar a través del proceso. Cuando se le pide que describa cómo ve su papel, David dice: "Todo el mundo busca algo. Mi trabajo consiste en entender qué es lo que realmente buscan". Cuándo le preguntamos qué es lo que más le gusta de su trabajo, respondió: "Bucear por debajo de las palabras y entender las necesidades de la gente,para luego conectar esas necesidades con las soluciones que Lyfegen puede aportar."
¿Qué es lo que quiere emprender este año? Siendo un aprendiz permanente, David quiere profundizar en el ciclo completo de nuestro servicio y explorar tanto la gestión de proyectos como la parte técnica. Apasionado de la buena música, pasa su tiempo libre con amigos que disfrutan de los mismos intereses. Es un creyente en la humanidad y en los actos de bondad al azar, está deseando conocer gente nueva este año de todo el mundo y tener la oportunidad de conectar experiencias y trabajar en un entorno internacional.
Girisha Fernando, Directora General de Lyfegen, está encantada de dar la bienvenida a David a nuestro equipo. 'Estamos encantados de tener a David Duro a bordo. Su inestimable pericia y amplia experiencia aportarán sin duda un inmenso valor al éxito de Lyfegen. Esto marca un hito importante en nuestros esfuerzos de expansión internacional, y estoy ansioso por anticipar las nuevas oportunidades que se avecinan'.
Desde Lyfegen, damos una calurosa bienvenida a David y esperamos crecer juntos.
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Before joining us at Lyfegen, David gained a wealth of experience and knowledge in the healthcare and finance industry while honing his skills as a Global Sales Executive. His curiosity of human nature and love for humanity is what fuels his passion to make a difference where it matters most.
Based in Spain with a qualification in Computer Engineering, David is no stranger to bringing disruptive products to the market. With his extensive experience bringing disruptive products to the market, he has come to understand that it is paramount to highlight how our platform connects to the daily tasks of the user and prefers to guide them through the process. When asked to describe how he views his role, David said, “Everyoneis looking for something. My job is to understand what it is that you are really looking for”. When we asked what he likes the most about his job, he replied “diving below the words and understanding the needs of the people, then connecting those needs with the solutions that Lyfegen can provide.”
What is something he wants to take up this year? Being a curious lifelong learner, David eventually wants to deep dive into the full cycle of our service and explore both the project management and the tech side. Passionate about good music, he spends his free time with friends who enjoy the same interests. While being a tremendous believer in humanity and random acts of kindness, he looks forward to connecting with new people this year from all around the world and having the opportunity to connect experiences and work in an international environment.
Girisha Fernando, CEO of Lyfegen, is extremely excited to welcome David into our team. 'We are thrilled to have David Duro on board! His invaluable expertise and extensive experience will undoubtedly bring immense value to Lyfegen’s success. This marks a significant milestone in our international expansion efforts, and I am eagerly anticipating the new opportunities ahead.'
From all of us at Lyfegen, we warmly welcome David and look forward to growing together!
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We are delighted to welcome our new executive assistant, Olga Dragos to the Lyfegen team! Olga joined us after making her final decision to work only with an enterprise that is directly impacting the lives of many for the better.
When we asked what fuels her purpose, she said, “The most exciting part of my profession is that I get to be key in streamlining processes that save time for our teams, which in turn helps get our product in front of more patients and increases our capacity to brainstorm new projects.”
With a solid background spanning over more than fifteen years in Executive and Administrative Support, Olga is a highly experienced professional that has worked in the US market for several corporates and small businesses in the medical insurance and transportation industries.
Originally from Belarus, Olga immigrated to the US in 1996 and further moved to Romania in 2021 where she is happily settled now with her husband and son. Being an avid traveler at heart with a passion for diverse cultures and their delicacies, Olga takes solace in both nature and outdoor activities where she’s been known to take scenic canoe rides down the river in early spring. While she has an adventurous spirit, family and cooking is her first love and creating her own recipes for them to enjoy while spending quality time together is a high priority.
When we asked what’s next for this year outside of work, we were not surprised to discover her warm philanthropic nature has steered her on the path of finding a new organization where she can volunteer her time to make a difference.
We give a very warm welcome to Olga and look forward to having her vibrant personality, and sound expertise to propel our team forward.
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After graduating in Computer Science from Babeș-Bolyai University in Romania, Andrei co-founded a digital health start-up that was laser focused on assisting patients and clinicians alike, to reach better health outcomes. His keen interest in UX design and problem solving has been the driving force behind his success in creating and building meaningful experiences and solutions in the digital healthcare arena.
However, his story doesn’t start there.
Andrei’s first interactions with design started in his high school years, where he took part in numerous competitions within the digital solutions and education space – this being where he realized his true passion for design and creating solutions that would positively impact the lives of many.
When we asked Andrei what excited him the most about joining Lyfegen as the new Senior Product Designer, his answer was clear cut – “I am allowed to be an active part in envisioning, designing and building meaningful solutions that can help users, which in turn helps patients and saves lives – this is what I find exciting and refreshing.
Joining Lyfegen has been a perfect synergy between Andrei’s personal views on digital healthcare and Lyfegen’s impactful approach in the sector – solving deep complex issues, while still remaining mindful and deeply empathetic towards its users and end goals. This is what fuels his motivation in contributing his valuable expertise in the process, while working alongside his incredible team.
While in his spare time, Andrei has been known to catch up with his video games when time allows, play board games, watch his favorite science channels, read a good book, and of course spend quality time with his friends and family, when he’s not outdoors enjoying some nature.
We warmly welcome Andrei to our team and look forward to revolutionizing the industry side-by-side.
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We are thrilled to welcome Denisa Filip to our tech team at Lyfegen as a Full Stack Developer. Denisa brings a wealth of experience and enthusiasm, and we sat down with her to learn more about her background, passions, and what excites her about joining Lyfegen.
Quick introduction – tell us a bit about yourself! Where are you from and what’s your educational and professional background?
I’m from the west of Romania and have been into informatics since high school. However, my real passion for technology started once I joined a robotics team where I was able to apply everything I had learned in a hands-on environment. I went on to earn a degree in Computer Science and began my career in cybersecurity. Along the way, I gained diverse experiences through volunteering and working with startups. Eventually, I found myself enjoying building websites more, which I now focus on.
What excites you about your job?
What excites me most about my role as a developer at Lyfegen is the opportunity to create new functionalities on our platform that truly end up helping those in need. I'm thrilled to be part of a company that shares my vision and is dedicated to making treatments more accessible to people. It's incredibly fulfilling to know that the work I do contributes to such a meaningful cause.
Why did you decide to join Lyfegen?
I was looking for a dynamic startup environment where I could grow and contribute to its evolution. I wanted to use my skills to leave a positive impact on the community, and I saw that same passion in the founders and team at Lyfegen. Their dedication to creating important change resonated with me and motivated me to be part of their mission of creating a lot of value.
What is something you want to learn or improve in the next 12 months?
I wish to improve my development skills to create amazing user experiences on Lyfegen’s platform while also exploring new relevant technologies. Additionally, I want to focus on my interpersonal abilities within the team, allowing me to contribute more effectively.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
In Lyfegen's dynamic startup environment, where legislations and requirements can change rapidly, agility is key. We must be quick to launch innovative and reliable solutions on the market, and my expertise in developing intricate products helps us to achieve this by delivering seamless and intuitive features. Also, I am very detail-oriented and try to anticipate various edge cases within our platform's logic, ensuring that many potential errors are addressed before they can reach our clients.
Let’s get personal: What are your favorite things to do in your free time?
I’ve recently developed a passion for graphic design, often working on various posters and creative projects. I also love cooking, experimenting with new recipes, or crafting some of my own. Otherwise, I enjoy traveling and I’m trying to explore more countries in the future.
Is there anything else you are looking forward to outside of work in the next few months?
I’m eager to dive deeper into my graphic design hobby, exploring more challenging projects and learning more about it. I’m also looking forward to an upcoming road trip through Greece where I plan to explore the stunning landscapes and rich culture.
We are excited to see Denisa grow and thrive in her role at Lyfegen. Welcome to the team, Denisa!
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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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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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Introduction
Spain is making strides in healthcare by prioritizing education, innovation, and cost-effective care. Recently, the Spanish Council of Ministers allocated over 44 million euros from pharmaceutical sales to support various public health initiatives, focusing on two critical areas: reducing unnecessary care and enhancing Health Technology Assessment (HTA) education for healthcare professionals. These investments are aimed at improving the efficiency of healthcare delivery, reducing costs, and supporting more informed decision-making around drug use and preventive care.
Key Takeaways for Pharma and Payers
1. Funding for HTA Education and Training
• What’s Changing: Part of the allocated funds will go toward continuing education programs for healthcare professionals, specifically to improve their understanding of Health Technology Assessment (HTA). By deepening professionals’ knowledge of HTA, Spain aims to ensure that drug evaluation and therapeutic positioning are guided by evidence-based practices.
• Impact: For pharmaceutical companies, this initiative means greater scrutiny of drug effectiveness and cost-effectiveness, especially as healthcare providers become more proficient in HTA principles. Payers may also benefit, as a well-informed healthcare workforce can make better use of resources, potentially lowering overall costs.
2. De-prescription of Unnecessary Drugs and Promotion of Preventive Care
• What’s Changing: The initiative will also fund programs aimed at de-prescribing unnecessary medications to reduce healthcare costs. Alongside this, Spain is placing a stronger emphasis on preventive care, which not only improves patient outcomes but also curtails spending on unnecessary treatments.
• Impact: For pharma, this push towards de-prescription may affect demand for certain drugs, particularly those deemed low-value or non-essential. However, it also presents an opportunity to align with Spain’s focus on value-based care, potentially promoting medications that are supported by strong evidence of efficacy. For payers, preventive care investments mean a healthier population with fewer costs linked to chronic diseases, reducing the financial burden on the healthcare system.
3. Supporting Innovation Through Therapeutic Positioning Reports
• What’s Changing: Another portion of the funding will support the consolidation of therapeutic positioning reports. These reports will help evaluate and position drugs more effectively within the healthcare system, ensuring that innovative treatments are assessed rigorously before they reach patients.
• Impact: Pharmaceutical companies may see a more streamlined and transparent pathway for introducing new drugs to the Spanish market. This approach promotes fair competition and emphasizes innovation, aligning with Spain’s broader goals of delivering cost-effective, impactful healthcare solutions.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library provides access to an extensive collection of value-based agreements that can help pharma companies align with Spain’s focus on cost-effective treatments. This resource allows pharma to explore agreements and pricing models suited to Spain’s HTA-driven environment, improving the chances of successful market access.
2. Drug Contracting Simulator: With the Drug Contracting Simulator, stakeholders can simulate pricing models that reflect Spain’s emphasis on evidence-based evaluation. By assessing various pricing scenarios and outcomes, pharma companies can design agreements that align with Spain’s value-based healthcare priorities, supporting successful negotiations and reimbursement strategies.
Conclusion
Spain’s recent investments in HTA education, de-prescription, and preventive care reflect the country’s commitment to a sustainable, efficient healthcare system. For pharmaceutical companies and payers, these changes highlight the need to align market access strategies with Spain’s goals of evidence-based care and cost containment. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential tools to navigate these shifts, enabling stakeholders to create outcome-driven agreements that support Spain’s healthcare objectives.
Book a personalized demo today to see how Lyfegen can empower your market access strategy in Spain’s evolving healthcare landscape: https://www.lyfegen.com/demo
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Introduction
Switzerland has taken steps to streamline drug approvals and make essential therapies more accessible by revising Swissmedic’s fast-track and temporary authorization procedures, effective as of October 15, 2024. These changes aim to expedite market access for crucial treatments, especially for those addressing urgent healthcare needs. Recently, the Federal Office of Public Health (FOPH) conducted a Health Technology Assessment (HTA) on Calcitonin gene-related peptide (CGRP) receptor antagonists, a class of anti-migraine drugs. The analysis determined that these drugs are more cost-effective for chronic migraine sufferers than for those with episodic migraines, influencing how they may be priced and reimbursed.
Key Takeaways for Pharma and Payers
1. Revised Fast-Track and Temporary Authorization Processes
• What’s Changing: Swissmedic has updated its fast-track and temporary authorization procedures, intended to speed up drug approval times. This revision allows for quicker access to therapies that address significant healthcare needs, supporting patients in receiving timely treatments.
• Impact: For pharmaceutical companies, these changes open up opportunities to bring their innovations to market faster, particularly for therapies that address chronic and complex conditions. With the fast-track pathway, companies can achieve quicker regulatory approval, which could help with meeting demand and advancing critical treatments for conditions like chronic migraine.
2. Pricing Adjustments Based on Cost-Effectiveness Analysis
• What’s Changing: The FOPH’s recent HTA on CGRP receptor antagonists for migraines concluded that these drugs offer higher cost-effectiveness for chronic versus episodic migraine patients. As a result, FOPH has proposed a price reduction to align with the value provided, ensuring that patients benefit from more affordable access to these treatments.
• Impact: For payers and pharma, this emphasis on value-based pricing represents a growing trend in Switzerland. Drug prices are being set based on real-world evidence and cost-effectiveness, pushing the industry towards more sustainable, outcome-driven pricing models.
3. Inclusion in the List of Pharmaceutical Specialities (LS)
• What’s Changing: FOPH re-evaluates drug prices every three years and decides if they should remain on the List of Pharmaceutical Specialities (LS), which comprises all drugs covered by basic insurance. For certain treatments, such as CGRP receptor antagonists, drugs may be included with limitations—meaning they will only be reimbursed under specific conditions.
• Impact: This conditional reimbursement approach supports more targeted healthcare spending, benefiting patients who meet specific criteria. For pharmaceutical companies, meeting these requirements is essential to ensure ongoing reimbursement and access to Switzerland’s market.
How Lyfegen’s Solutions Can Support Your Strategy
1. Agreements Library: Lyfegen’s Agreements Library offers a comprehensive resource of pricing agreements, enabling pharma and payers to explore pricing models that align with Switzerland’s emphasis on cost-effectiveness. With access to over 6,000 agreements, pharma teams can develop flexible, outcome-based pricing strategies that meet Swiss regulatory and reimbursement requirements.
2. Drug Contracting Simulator: The Drug Contracting Simulator provides a powerful tool for modeling various pricing scenarios. By simulating real-world conditions, stakeholders can assess the financial and clinical outcomes of fast-track approved therapies, enabling them to create tailored, data-driven agreements that reflect the FOPH’s cost-effectiveness criteria.
Conclusion
Switzerland’s recent adjustments to its fast-track drug approval processes and value-based approach to anti-migraine drug pricing underscore the country’s commitment to accessible, cost-effective healthcare. For pharmaceutical companies and payers, these changes represent an opportunity to align market access strategies with Switzerland’s evolving regulatory landscape. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential support for navigating these complexities, helping stakeholders design effective, outcome-driven agreements that meet Switzerland’s regulatory standards.
Book a personalized demo today to see how Lyfegen can transform your market access strategy under Switzerland’s new reforms: https://www.lyfegen.com/demo
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Introduction
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.