Michael Porter’s VBHC Theory Explained by Lyfegen’s Customer Success Hero, Simon Amstutz
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Through the eyes of Simon Amstutz, briefly dive into the history of Michael Porter’s value-based healthcare theory.
For those who follow Lyfegen and our blog, chances are that you already fully grasp the concept of value-based healthcare (VBHC). That said, I came to Lyfegen from a completely different field, banking, and was intrigued by the history of how this theory came to be. While my intention is not to bore you with a history class, for all future posts it is important to have a common knowledge of the framework that lies behind VBHC.
In 2006, Harvard Professor Michael Porter and his fellow academic Elizabeth Teisberg published the book Redefining Health Care: Creating Value-Based Competition on Results . This book set the fundament of VBHC.
In this book they argue that competition in healthcare should be occurring in diagnosis, treatment (outcomes), and prevention of certain health conditions rather than between insurance plans and hospitals. They propose that the healthcare system should be restructured by having competition focus clearly on improved patient outcomes. The proposed model focuses on the value (yes, hence the name) that the medication or care brings to the patient. In other words, value is measured by the best outcome for the patient per dollar spent.
This being a monumental change from the current healthcare model, which operates on a fee-for-service/product basis. Under the conventional model, drugs and therapies have to be paid for regardless of whether they actually helped the patient. .
In order to achieve such a change, Porter argues that the healthcare system needs to be able to quantify health-care processes, outcomes, patient’s experiences, and organizational systems to evaluate the effectiveness of delivered care/medication as it benefits for the patient – this seeming like the greatest challenge back in 2006. But since then, technology and processes have evolved. This is where Lyfegen comes in: the challenges that our system was faced with 14 years ago now have a clear solution: Lyfeapp and Lyfevalue.
While Porter is most definitely not the only thought leader in the VBHC sector, his book shook and rattled the healthcare industry, identifying a clear need for solutions like those proposed by Lyfegen.
To find out more about our solutions:
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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.
Is ICER helping or hurting value-based pricing?
Find out what role it really plays in our latest article.
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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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
Need help navigating rebate options?
Explore how to choose the right drug rebate management solution.
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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Lyfegen is proud to announce that former New York State Medicaid Director, Jason Helgerson, has joined the Lyfegen Advisory Board.
Lyfegen, the provider of the leading value-based agreements platform for pharmacy, is proud to announce that Jason Helgerson has joined its advisory board. He brings his rich experience in value-based healthcare and more than 20 years of public service to this role. Jason’s forte is in creating effective value-based payment systems, facilitating successful cross-sector collaboration, and delivering transformative stakeholder engagement - all elements that underpin a successful value-based health and social care strategy.
“Seeing how Lyfegen uses advanced technology to solve the immense problem of drug pricing & affordability by enabling value-based agreements made my decision to join Lyfegen’s advisory board an easy one. I am excited about the value Lyfegen can deliver to healthcare payers, providers, and patients in the US and across the world,” says Jason.
In addition to serving as Lyfegen advisor, Jason is the managing director of Helgerson Solutions. He is a nationally recognized leader in value-based healthcare, healthcare & delivery system reform.
Most recently, he was New York State’s Medicaid Director, a role he held for over seven years, managing an annual budget in excess of $68 billion. During his time leading the Medicaid program in New York, Jason drove New York State’s Delivery System Reform Incentive Payment program (DSRIP). Over five years, the DSRIP program in New York created local, multi-sectoral partnerships with the aim of fundamentally restructuring the delivery of healthcare in New York & transitioning 80% of Medicaid payments into value-based arrangements. Jason became an internationally-recognized leader in public sector health care as part of his leadership of New York’s Medicaid Redesign Team, which helped reshape the program to lower costs – tackling a budget deficit – and improve health care quality.
Jason Helgerson earned a BA from American University in 1993, and his Master’s in Public Policy from University of Chicago in 1995. He also attended the London School of Economics’ Summer Graduate School Program in International Economics in 1994. He has worked in a variety of local and state governments, including the City of Milwakee, City of San Jose, CA, State of Wisconsin, and New York. He has served as the Medicaid Director for both the State of Wisconsin and the State of New York.
With vast experience in value-based healthcare, Jason will advance Lyfegen’s mission of accelerating value-based healthcare to improve patients’ lives in the USA.
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.
More about Lyfegen: https://www.lyfegen.com
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Linkedin: https://www.linkedin.com/company/lyfegenhealth
Contact Press: press@lyfegen.com
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Lyfegen is proud to announce that João Marques-Gomes has joined the company’s Advisory Board. João is a university professor, a scientific researcher, and a management consultant in health management.
He is the Chair of Nova University Lisbon’s institute for Value-Based Health Care (VBHC), and the professor of the semester course “VBHC” at the Nova School of Business & Economics and at the Nova Medical School.
His research has been repeatedly funded by FCT – Foundation for Science and Technology, the Portuguese public agency for scientific research. As a management consultant, João Marques-Gomes has worked for public and private hospitals in Europe and Latin America, the European Commission, the Portuguese Ministry of Health, the Portuguese Pharmaceutical Society, and for pharmaceutical companies that are among the world’s top 10 pharmaceutical companies in sales.
In the past, João worked with ICHOM – International Consortium for Health Outcomes Measurement, as part of the implementation team. He is currently the Vice-President of IBRAVS – Brazilian Institute for Value in Health. João’s actions have had an important impact on the Portuguese society.
João has co-led the Cascais Agreement movement, which gathers the 80+ major stakeholders that have publicly signed the agreement that establishes that by 2021 1/3+ of the Portuguese health care providers must have had an experience with VBHC.
Lyfegen makes it possible for innovation to always have an open door in any market in the world. Thanks to Lyfegen, millions of people will have access to innovative treatments and will enjoy much healthier lives because of this.
João Marques-Gomes
João Marques-Gomes has a PhD in economics from the University of Evora (Portugal), and an MBA from the FIA Business School (Brazil). Part of his PhD studies was done at the University College London (UK), and at the Toulouse School of Economics (France). João did his training in VBHC at ICHOM (UK), at the Harvard Business School, and at the Dell Medical School, UT Austin (USA).
With his vast experience in health economics and value-based healthcare, João will support Lyfegen to achieve its mission of accelerating value-based healthcare to improve the life of patients.
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Join in from anywhere in the world for three days of incredibly interesting presentations and round-tables by industry experts all around the topic of pricing and market access in healthcare.
Only a week left to go! The incredibly exciting annual World Pricing, Evidence & Market Access Congress is taking place from the 23rd to the 25th of September virtually... giving attendees the opportunity to join from anywhere in the world! This is set to be the largest and most comprehensive yet, with over 1000 attendees and more than 230 speakers!
Lyfegen's Girisha Fernando and Nico Mros will be moderating a round-table “How do you include the patient perspective in an outcomes-based contract?” on the 23rd of September at 15:05 CET. Join us! Lyfegen has a digital booth so feel free to get in touch via the swapcard app, if you are already signed up.
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What is ISO 27001?
ISO 27001 is one of the most widely recognized and internationally accepted information security standards. ISO 27001 defines how an organization should manage and treat information more securely, including applicable security controls.
It requires a company to have an information security management system, which means having a documented process for managing sensitive company information, processes, and IT systems.
What this mean for Lyfegen?
To achieve the certification, security compliance was validated by an independent audit firm after a rigorous process of demonstrating an ongoing and systematic approach to managing and protecting company and customer data.
Being a company that manages sensitive health-data points, it is of utmost importance to us to ensure the best tech processes and security mechanisms are in place.
At Lyfegen, we are committed to complying to the highest tech security standard, continuously improving our solutions & processes, as we move forward with the operationalisation of value-& data driven contracts for a fast & sustainable access to innovative therapies. In turn, this will benefit patients worldwide!
We are audited on yearly basis by an accredited third-party auditor to keep our ISO status valid.
Want to discover our solutions?
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Lyfegen is building the leading contracting software solution to support value-based drug pricing arrangements. This mission requires a hands-on team to optimize all our processes. With Anca Marin joining our team as the new business analyst, we are set up for success.
We sat down with Anca to learn about her experience, her goals, and her aspirations.
Hello Anca, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?
Hello, my name is Anca. I am based in Bucharest, Romania. I graduated with a bachelor’s degree in accounting and later earned a master’s degree in business management. Before joining Lyfegen, I worked in finance for three and a half years in various industries, such banking, insurance, and ICT.
What excites you about being a business analyst?
The novelty – I believe it is a role where you never get bored as there is always a new situation, idea, or feature to build up, and it is exactly the challenge I want.
Why did you decide to join Lyfegen?
I find meaning and desire in making a change for the better. I also enjoy the work culture and the idea of being part of an innovative company while making a real impact.
What is something you want to learn or improve this year?
This is my first role as a business analyst. Therefore, this year, I want to focus on growing my knowledge and skills as a business analyst, as well as in software development and the healthcare industry.
How will your know-how help to improve our customers’ experience of the Lyfegen platform?
Given my previous roles, I would say that I was usually the one handling challenging and complex situations when dealing with customers. Through these experiences, I learned to find ways to deliver the best results for customers, and I will continue to do so. I also describe myself as being super detail-oriented – and details always make the difference.
Let’s get personal: What are your favorite things to do in your free time?
Besides my full-time job at Lyfegen, I am also a handball goalkeeper. I have been playing since I was 11 years old, and I usually go to two to three training sessions a week. However, I like sports in general, so if I am not on the handball court, I am probably playing other sports, like basketball or tennis.
I also like traveling and nature and activities away from the big cities, such as hiking, backpacking, and camping.
Is there anything else you are looking forward to outside of work this year?
Outside of work, my plans for this year are to get a motorcycle, take trips to the mountains, and make great memories!
We are proud to have you with us, Anca!
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In June, the U.S. Federal Trade Commission (FTC) voted unanimously (5-0) to examine rising list prices of insulin, but also to probe possible anti-competitive practices by pharmacy benefit managers (PBMs) with respect to the use of rebate arrangements. Rebates are payments from drug manufacturers to PBMs in exchange for moving market share towards so-called preferred products on the formulary.
The FTC has specifically cited instances in which cheaper generics and biosimilars are excluded from PBM formularies, as this may violate competition and consumer protection laws.
The FTC inquiry into pharmacy benefit manager (PBM) practices could lead to legal action prohibiting certain rebate practices. In turn, this could induce major changes in the U.S. rebate system. Formulary management could become increasingly value- or outcomes-based, rather than simply a function of a financial power play between drug makers and PBMs. Or, rebates could fall by the wayside altogether, to be replaced by a combination of upfront discounts in lieu of rebates and value-based pricing arrangements. 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.
The FTC has warned of legal action against PBMs if its inquiries find proof of anti-competitive practices. Here, the agency raised the stakes when it included terms like “commercial bribery” in its statements to describe what it perceives as anti-competitive rebates in the insulin market.
The latest FTC inquiries follow a recent investigation by Senators Grassley (R-Iowa) and Wyden (D-Oregon), which blamed rebate schemes for much of what ails the prescription drug market. Furthermore, nearly two years ago, Senator Klobuchar (D-Minnesota) and colleagues commissioned the General Accounting Office (GAO) to examine rebates. The GAO report is due out this fall.
PBMs receive rebates from drug manufacturers in exchange for preferred positioning on the formulary, which in turn drives market share. Experts have criticized rebates for the fact that payers often don’t base their decisions to include a drug on comparative clinical- and cost-effectiveness. Rather, decisions are strictly based on financial terms, namely which manufacturer offers a higher rebate payment to the PBM; a financial power play in which PBMs may threaten not to cover certain drugs if they don’t get the rebate they want. This applies to insulin as well as numerous other therapeutic categories.
What’s worse is when rebate traps or walls are involved. Branded manufacturers leverage their position as market leaders by offering financial incentives to PBMs and health insurers in the form of “all or nothing” conditional volume-based rebates, in exchange for (virtually) exclusive positioning on the formulary. This can mean keeping competitors off the formulary entirely, or severely limiting formulary access to a competing drug with drug utilization management tools like step edits. Here, a patient must use a preferred drug and fail on it (a so-called “fail-first” policy) before “stepping up” to a non-preferred drug.
Because the portion of the rebate retained by PBMs is often calculated as a percentage of a drug’s list price, PBMs can have incentives to establish formularies that favor branded drugs with higher list prices and larger rebates over lower priced biosimilars, specialty generics, or even branded competitors. Rival drugs entering the market lack sufficient sales volume to be able to offer the same level of rebates to PBMs that originator firms can provide.
Proof of the establishment of anti-competitive practices could lead to legal action being taken against PBMs. The question then becomes what would replace rebates? Payers may establish an entirely different formulary management system that is more value-based. Surely, it would be a system that’s less contingent on the role of the financial power play between drug makers and PBMs.
In areas such as immunotherapy targeting certain cancers, cell and gene therapy, and rheumatology, there are already a growing number of value-based agreements.
Girisha Fernando, CEO and Founder of Lyfegen, which offers a platform to track value-based agreements with real-world data, said that many outcomes-based deals are kept secret and therefore under the radar, so to speak. Commercial payers generally don’t share publicly what types of value-based deals they have with drug companies to maintain their competitive advantage. Yet, in an interview with Endpoints News Fernando stated that he’s observed at least a 300% increase in value-based agreements over the last five years. 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.
Fallout from the FTC inquiry – should rebates be identified as anti-competitive - may entail further increases in value-based dealmaking.
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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CMS may want to consider value-based purchasing arrangements for Alzheimer’s Disease drugs
The Alzheimer’s Disease biologic Aduhelm (aducanumab) – a beta amyloid-directed monoclonal antibody - has experienced a tremendous amount of controversy regarding its safety and efficacy, both before and after its approval by the Food and Drug Administration (FDA) in June 2021.
A decision in April of this year by the Centers for Medicare and Medicaid Services (CMS) to place severe limitations on coverage of Aduhelm has all but killed the drug’s chances of success. And, even after Aduhelm’s original wholesale acquisition cost (WAC) of $56,000 was cut in half, there were very few takers in both the public and commercial payer spaces. Aduhelm’s “failure” to this point is partly to blame for the departure of Biogen’s CEO, Michel Vounatsos.
Could Biogen’s Aduhelm have been saved by a value-based purchasing agreement with CMS, in which Medicare Administrative Contractors and Medicare Advantage Plans only pay for Aduhelm if it provides clinical benefits to patients? Possibly. Moreover, and perhaps more importantly, such an arrangement could still be used for other beta amyloid-directed monoclonal antibodies that are currently in late stages of development and are less controversial than Aduhelm.
Under the final national coverage determination (NCD) issued in April by CMS, Medicare will severely restrict coverage of Aduhelm. Concretely, the decision implies that only Medicare beneficiaries who have enrolled in CMS-authorized randomized controlled clinical trials will get coverage of Aduhelm.
In addition, under the NCD, CMS states that, if approved by FDA, the entire class of beta amyloid-directed monoclonal antibodies will be subject to restricted reimbursement. For example, all accelerated approvals must undergo post-marketing clinical trials, analogous to the stringent requirements imposed on Aduhelm. And even beta amyloid-directed Alzheimer’s Disease drugs that go through the regular approval process must enter a coverage with evidence development protocol, which implies that post-approval collection of data in patient registries will be mandatory.
In its NCD decision, CMS did not mention a value-based purchasing agreement. Nor did it reference Aduhelm’s WAC. Given that CMS is not permitted to take cost or cost-effectiveness into account, it perhaps makes sense that Aduhelm’s WAC wasn’t mentioned.
Nevertheless, at a regional level, a value-based purchasing agreement is something Medicare Administrative Contractors and Medicare Advantage Plans could have pursued. In addition, nationally, the Center for Medicare and Medicaid Innovation has the authority to test models which modify Medicare payments for certain high-priced drugs. These models are designed to introduce a value-based approach for drugs that have been approved with limited evidence. Certainly, the class of beta amyloid-directed monoclonal antibodies fit this description.
Here, a linkage between pay and performance would need to be established, along with the proper timing of the measurement of cognitive decline in Alzheimer’s Disease patients. Performance measures could include the kinds of validated cognitive assessments outlined in the NCD.
Last year, the Institute for Clinical and Economic Review conducted a preliminary analysis of Aduhelm, extrapolating from Phase 3 data. ICER concluded that Aduhelm was not cost-effective, given the drug’s WAC, and that a cost-effective price benchmark range for would be between $3,000 and $8,400 per year for early-stage Alzheimer’s Disease patients, which is much lower than the current WAC of $28,000.
ICER’s assessment was not based on real world evidence, however. In any CMS-initiated value-based purchasing arrangement, there would be real world evidence, and accordingly adjustments could be made to the acceptable price range of the product. This could have applied to Aduhelm, but may still be relevant in future with respect to other beta amyloid-directed monoclonal antibodies, which are presently in Phase 3. These include Biogen/Eisai’s lecanemab, Roche’s donanemab, and Roche’s gantenerumab.
Aduhelm’s ship has perhaps sailed, with the baggage of the FDA approval controversy and the requirement of a randomized controlled clinical trial for any coverage at all. Nevertheless, value-based arrangements could very much be in play for other beta amyloid-directed monoclonal antibodies.
Undoubtedly this would be a major undertaking, particularly logistically. And, getting CMS to buy in won’t be easy. But, there’s precedent for CMS wanting to pursue value-based agreements. To illustrate, at the time of FDA’s approval of the CAR-T therapy Kymriah (tisagenlecleucel) in 2017 – indicated for acute lymphoblastic leukemia - it was accompanied by the announcement of a novel outcomes-based agreement with CMS, in which CMS would pay for Kymriah only if patients had responded to it by the end of the first month. Without disclosing why, CMS quietly backed away from that agreement.
Maybe the substantial unmet need in Alzheimer’s Disease will trigger CMS to consider alternative approaches to reimbursement. And, if any of the beta-amyloid directed monoclonal antibodies are approved in Europe or the U.K., similar value-based arrangements may be an option for payers.
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 purchasing agreements. The Lyfegen platform identifies and operationalizes value-based payment models in a cost-effective manner.
About the author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
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Pharma says they want greater competition within the industry and more incentives for pharmaceutical innovation; value-based purchasing agreements can provide both.
Value-based purchasing arrangements first appeared in the European markets in the 1990s, while U.S. healthcare markets did little with value-based contracts for pharmaceuticals until the 2000s. The high cost of new drugs coming to market, large annual increases in existing drug prices, and political pressure from lawmakers on payers to address the high cost of healthcare have encouraged stakeholders to make greater use of value-based purchasing arrangements.
It's easy to understand the appeal of value-based purchasing agreements for private and public payers. Value-based purchasing is one way both U.S. and European payers are using to reduce overall healthcare spending.
For drug companies, value-based purchasing puts an end to their unencumbered pricing strategy. But pharmaceutical manufacturers realize value-based purchasing agreements are the best way, and maybe the only way, to get their new, higher-priced products covered by payers and into the treatment plans of patients.
How do pharmaceutical companies determine their drug prices?
Pharmaceutical companies are in business to generate as much revenue as possible without jeopardizing patients’ access to their treatments. In the U.S., where drug pricing is unregulated, pharmaceutical manufacturers can charge any price they want for their products. In the EU, member states use regulations such as direct control over pricing, referencing the average price of a drug among all EU members to set a national price, or regulating the drug manufacturers’ profit.
When deciding on a new drug’s retail price, the manufacturer considers several areas of concern such as the drug’s competition, government-granted exclusivity, patents in force, and a drug’s clinical effectiveness and benefit to patient outcomes.
Pricing a drug incorrectly can have severe consequences for the manufacturer’s bottom line. Private and public payers in the U.S. have ways of restricting patients’ access to drugs that they consider overpriced. In European countries, drug manufacturers risk being fined by authorities for unfair prices and excessive price hikes.
Value-based purchasing promotes competition in the pharmaceutical market
In the U.S., there are economic policies and legal loopholes that manipulate competition in the drug industry. The Biden administration considers this one of the key problems to address to support drug pricing reform. The president’s Executive Order 14036, the Competition Executive Order, calls for increased transparency, innovation, and competition.
Even though manufacturers take advantage of U.S. government protections that create temporary monopolies for some drugs, the large industry trade group PhRMA has joined the call for reforms that fix the current distortions in the market that stifle competition.
Manufacturers producing new drugs with in-class competition from other manufacturers—such as generics, biosimilars, or new uses or combinations of older drugs—use the real-world evidence gathered from value-based purchasing agreements to demonstrate the greater clinical value of their treatments compared to their competitors’ products. Data that show a drug’s uniqueness and effectiveness may be used to justify a manufacturer’s higher-than-average price.
In addition, manufacturers hope aligning a drug’s price to its clinical value will shift payers’ focus away from approving treatments based solely on the lowest price to covering similar treatments that might be more expensive but produce better health outcomes for patients.
Value-based purchasing incentivizes research and development (R&D) of new drugs
The post-market clinical data gathered under value-based purchasing can facilitate data-driven drug development. For example, the drug company Novartis published a position paper in which they stated they use real-world evidence to support the development of customized interventions and to invest in research in areas of the highest value for patients.
In the U.S.market in recent years, the number of clinical trials and an overall increase in spending on brand-name prescription drugs suggest that pharmaceutical manufacturers have been concentrating their research and development dollars on new high-cost specialty drugs for complex, chronic, or rare conditions they expect will be the most profitable.
New treatments like these, where the drug’s value is yet to be established for payers, are good candidates for value-based purchasing arrangements. The successful implementation of value-based purchasing contracts—with better health outcomes for patients, cost controls for payers, and fair prices for manufacturers—encourages even more data-driven drug development.
The Lyfegen Platform
Value-based purchasing agreements are a complex but necessary part of doing business for pharmaceutical manufacturers. They provide a framework for assessing a drug’s value using shared outcome measures and provide real-world evidence of the benefits of their products for patient health outcomes. Manufacturers who are unwilling to enter into value-based purchasing contracts with payers may find themselves at a disadvantage in negotiations with other stakeholders.
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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Beginning July 1, 2022, according to a final rule released by the U.S. Centers for Medicare and Medicaid Services (CMS), drug manufacturers will be able to report varying “best price” points (that is, multiple best prices) for a covered drug to the Medicaid Drug Rebate Program, provided they’re pursuing a value-based purchasing (VBP) arrangement that aligns pricing with outcomes-based clinical and economic measures, such as positive clinical benefits, improved quality of life, fewer physician visits, and reduced hospitalizations. 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 VBPs.
Since 1990, the statutory Medicaid rebate has ensured that states obtain lower net prices for pharmaceuticals. For brand name drugs, the rebate is 23.1% of Average Manufacturer Price (AMP) or the difference between AMP and “best price,” whichever is greater. Here, best price is defined as the lowest available price to any wholesaler, retailer, or provider, excluding certain government programs, such as the Department of Veteran Affairs program. The AMP is the average price paid to drug manufacturers by wholesalers and retail pharmacies. It is proprietary and therefore not publicly available.
The best price stipulation can, however, hamper manufacturers and payers who wish to experiment with value-based arrangements. Suppose a drug manufacturer offers a payer a 100% money-back guarantee for a treatment it is launching. Then, in case the treatment being sold is ineffective, this would imply the possibility of a Medicaid best price of zero dollars. In turn, this would require that the drug be given away free of charge to every state Medicaid program.
The new rule allows manufacturers to report multiple “best prices” for a single dosage form and strength of a therapeutic, provided the prices are tied to one or more VBPs. Further bolstering the rule is proposed bipartisan legislation – Medicaid VBPs for Patients Act – which, if passed, would codify the best price rule. Importantly, the reporting of multiple best prices under different VBPs does not impact the best price for sales outside of the VBPs.
Drug manufacturers and health insurers have long considered linking reimbursement of certain treatments, particularly cell and gene therapies, to health outcomes. Here, VBPs tie reimbursement to the actual benefits that patients receive. Accordingly, VBPs alleviate the significant risk payers take on when they reimburse the high upfront costs of cell and gene therapies; treatments which still need to demonstrate durability over time. However, drug makers and insurers have been stymied by the Medicaid best price rules. The CMS rule change aims to encourage insurers to negotiate value-based outcome deals with drug makers.
For the sake of illustration, suppose a manufacturer has a $2,000,000 gene therapy to treat a rare disease, and is willing to sign a contract which stipulates that the treatment will have its intended therapeutic effect in 80% of the patients who take it. In the VBP, the manufacturer agrees to provide a payer with an 80% rebate if a patient or subgroup of patients does not respond positively to the therapy.
In the event of treatment failure, as a signatory to the Medicaid Drug Rebate Program subject to the best price requirement, the manufacturer would be forced to extend the 80% discount – the best price of the therapy in this case is $400,000 - to the entire Medicaid program, nationwide, because it represents the best price offered to all relevant U.S. purchasers.
Under the new approach in which multiple best prices can be used, as the manufacturer of a $2,000,000 gene therapy, it can structure a VBP with a payer that promises an 80% rebate in the event a patient or subgroup of patients fails to meet pre-specified clinical outcomes. But, for the drug maker the good news is that the 80% discount will not trigger an 80% best price across all Medicaid programs.
It’s hoped that beginning in July 2022 manufacturers in the U.S. will be more willing to negotiate VBPs with payers, including Medicaid. When the rule goes into effect this summer, Lyfegen will be ready to assist companies establish successful VBPs.
About the Author
Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.
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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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