Medicare needs authority to negotiate drug prices to support its value-based healthcare strategy
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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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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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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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Lyfegen’s CFO, Michel Mohler, enlightens us on the recent measures presented by Switerland's Interior Minister Alain Berset against rising healthcare costs in Switzerland and what this means for Lyfegen.
In recent months it is difficult to ignore that various countries, also greatly due to the current pandemic, are challenging and revising their healthcare systems.
End of June, Nico reported on the Trump administration’s signed executive orders towards improving the healthcare system in the United States.
However, the wind is changing also in Switzerland as healthcare costs continue to rise. On August 19th, Switzerland’s Interior Minister Alain Berset (who also has healthcare under his responsibility) proposed a package of measures which would save the country approximately 1 Billion Swiss Francs (CHF), whilst boosting efficiency and the quality of health services.
The proposed plan includes the following measures:
1) Specialist care will only be covered if the patient first consults a general practitioner, HMO practice or a telemedical center. This will increase transparency and cost awareness throughout the entire process, ensuring that the patient only gets the treatment he/she needs from the right healthcare professional.
2) Networks of experts for coordinated care of chronic diseases are to be created on national level in order to improve the quality and efficiency of treatments, minimizing error in treatment.
3) Access to innovative but costly medication is improved through the legal consolidation of pricing-models. Pharma companies have to reimburse part of the costs to insurance companies however, until now, these were not regulated by the government. The legally set pricing models for Switzerland will be defined for reimbursement on price, sales volume, or pay-for-performance.
Overall, Berset aims at a closer cooperation between different players in the healthcare industry, increasing transparency and cost awareness.
What does this mean for Lyfegen?
Pay-for-performance is getting national recognition and legal regulation in the Swiss system. The proposed measures are now sent to cantons, political parties, institutions and organisations for consultation before the government presents its bill to parliament.
That said, this is a big step in the right direction for Lyfegen. Pay-for-performance would become a nationally recognized pricing model, meaning that Insurances will be more likely to adopt this model going forward – making the solutions of Lyfegen a necessity. Lyfeapp would allow for a facilitated methodology to collect data necessary for the value-based contracts on our Lyfevalue contracting solution. Lyfegen being the key pillar between pharma companies, insurance companies, and patients.
While we wait to see if this proposal is passed in parliament, we can now state with absolute confidence that Minister Berset’s clarity on pricing models goes hand in hand with Lyfegen’s mission: Doing what’s right for patients!
To find out more about our solutions:
Sources:https://www.admin.ch/gov/de/start/dokumentation/medienmitteilungen.msg-id-80111.html
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On Friday, President Donald Trump signed four executive orders aimed at lowering the high cost of prescription drugs in the United States. Our COO, Nico Mros, dives into the four executive orders.
“The four orders I’m signing today will completely restructure the prescription drug market in terms of pricing and everything else to make these medications affordable and accessible for all Americans,” Trump said at the White House last Friday.
Trump goes on to state that Americans often pay up to 80% higher prices for prescription drugs than countries like Germany and Canada.
And while the timing seems anything but coincidental, Lyfegen does not intend to discuss political views but rather understand what this could mean specifically for healthcare innovation, value-based contracting and the patients whose life depend on access to innovative therapies.
Let us briefly and in simple terms dissect the four executive orders, which are subject to the regulatory review process post Friday’s signature:
The first order targets high insulin prices and EpiPens, requiring federal community health centers to pass discounts they receive directly to patients.
The second order would allow states, pharmacies and wholesalers to import drugs from Canada, where prices are drastically lower. Importing drugs would increase competition and cause drug prices in the United States to decrease. Up until now, prices were maintained high because importing medications from other countries for personal use was illegal according to the Food and Drug Administration.
The third order is aimed at preventing “middlemen,” more commonly known in healthcare as health plan sponsors and pharmacy benefit managers (PBMs), to pocket “significant discounts” negotiated — these being “up to 50 percent of the cost of the drug” while retailing them without a discount.
The fourth order, which has been signed but is being held back until Aug. 24 to give the healthcare industry time to “come up with something” to reduce drug prices, would allow Medicare to purchase drugs at the same price as other countries by implementing a “international pricing index”.
The international pricing index would align U.S. prices to those of other countries, such as Britain, France and Canada – countries where the cost of the same drugs are substantially lower because Governments cap drug prices.
So what does this mean for pharmaceutical innovation?
Simply aligning prices to countries where governments cap drug prices (in the case of the fourth executive order) or opening the import of prescription drugs from neighboring countries (in the case of the second executive order) will result in billion dollar losses for pharmaceutical companies within the next decade, increasing the risk of losing the funds necessary to drive innovation substantially (specifically the Research & Development of cutting edge innovative therapies).
“We pay for all of the resources and all of the development and foreign countries pay absolutely nothing,” Trump said. “Americans are funding the enormous cost of drug resource for the entire planet.”
But could this mean that pharmaceutical companies, trying to compensate their losses, would (or better said, should) be forced to focus on the root problems of healthcare pricing and come up with more wide-spread innovative pricing models for a more sustainable future.
Value-based contracting and technological solutions, such as those of Lyfegen, could support such a future.
In a world where value-based pricing is the norm, world leaders would not only look over to neighboring countries for pricing levels but rather would have to focus on the value of drugs and how they improve patient health outcomes.
Pharmaceutical company executives were scheduled to meet at the White House today to discuss the executive orders but the meeting was cancelled. Moving forward, one can only hope that healthcare innovation can start coexisting with sustainable expenditure and patient access.
https://www.nytimes.com/reuters/2020/07/27/us/27reuters-usa-trump-drugprices-explainer.html/
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Lyfegen HealthTech AG announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. Read the full press release.
BASEL, Switzerland, Sept. 1, 2020 /PRNewswire/ --
- Investors back Lyfegen's mission to make innovative healthcare therapies more accessible and affordable
- Funding secures market-leading position prior to Series A opening in 2021
Lyfegen HealthTech AG, a Swiss health technology company, announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. The additional funding was completed by private investors and the innovation program of one of Switzerland's largest banks.
Lyfegen has developed a ground-breaking software solution to accelerate value-based healthcare contracting, pioneering in a global market that could reach USD 400 billion by 2024, according to the latest estimates by research firm MarketsandMarkets™. Some of the world's 10-largest pharmaceutical and medical technologies companies are already employing Lyfegen's platform in strategic markets in Europe and South America.
Girisha Fernando, Chief Executive Office and co-founder, said: "Increasingly, healthcare systems around the world are transitioning from fee-for-service payment schemes to value-based contracting. Our solutions support the shift towards sustainable payment models that help ensure patients get the treatments they need at prices they can afford, while healthcare companies make an adequate return on their investment. We are proud to have strong partners and investors on board to support us in this challenging and rewarding mission."
The new funding, combined with the seed capital raised in April 2019 and the founders' contributions, secures the development of Lyfegen's proprietary technology as it continues to roll out its value-based contracting solution in the U.S. as well as additional European and Latin American markets in the areas of oncology, rare diseases and medical devices.
Michel Mohler, Chief Financial Officer and co-founder, added: "We continue delivering on our ambitious goals prior to opening our Series A funding in 2021. This latest additional funding confirms the growing interest of international investors in innovative healthcare technology built for a data-driven world. The funds will be used to further strengthen our leading market position as we prepare for a strong Series A funding round."
About Lyfegen
Lyfegen HealthTech AG is a Swiss healthcare technology company that is pioneering digital value-based healthcare contracting. Lyfegen's patent-pending, ground-breaking software analyses complex healthcare data sets in order to help patients access innovative therapies that focus on the healthcare outcomes that matter most to them. Lyfegen's solutions collect the patient's specific medical profile whilst ensuring the strictest data privacy protocols. Lyfegen's founders Girisha Fernando, Michel Mohler, Nico Mros, and Leon Rebolledo have combined their expertise in life sciences and financial services to create a holistic solution that enables life sciences companies, healthcare payers and healthcare providers to develop and roll out digital value-based healthcare, a market that is set to grow to USD 400 billion by 2024.
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EGK uses the Lyfegen Platform to handle complex pricing models of on and off-label usage of more than 80 drugs
Basel, Switzerland - November 29, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced today that EGK-Gesundheitskasse is joining its portfolio of insurer partners to execute all of their value-based pricing contracts for high-cost drugs efficiently, securely, and transparently.
Switzerland, with the fourth-highest pharmaceutical spending per capita, spent CHF 8 Billion (8.1 billion euro) on drugs prescribed for specific diseases in the first nine months of 2022. In an effort to combat the high drug spending, Switzerland has implemented an increasing number of discount models for on and off-label drug usage over the last five years. While intending to ensure accessibility to patients at sustainable prices, the complexity of the price models leads to millions spent by insurers to monitor and adjudicate the price models, resulting in an estimated CHF two- to three-digit million range of missed rebates.
Lyfegen's software enables EGK to identify and claim rebates from 141 drug price models with 32 manufacturers, with minimal effort and maximum transparency. This includes cases of rare or chronic illnesses, promising therapies that may be used outside the approved indication, or new drugs not yet available or approved in Switzerland. Lyfegen's platform addresses the needs of Swiss health insurers for cost efficiency and digitalization, helps solve existing complexities in the system, and does its utmost to counteract high insurance premiums.
"We are delighted to support EGK and take an active role in addressing the growing complexity of drug pricing models to support sustainable access to innovative drugs and therapies in Switzerland,” said Nico Mros, CXO and Co-Founder of Lyfegen. “By focusing on making the implementation of the platform as easy as possible and being responsive to EGK, we were able to quickly present results and kickoff the collaboration to a successful start!"
“With the Lyfegen Platform, EGK is further expanding its focus on sustainability and efficiency for the benefit of our policyholders”, said Carolina Pirelli, Head of Benefits and Deputy CEO at EGK. “The ever-increasing number of pricing models for medications poses challenges for insurance companies in terms of resources and processes. With the automated processing of pricing models through the Lyfegen Platform, we are able to perfectly meet our current needs and with Lyfegen's flexibility, focus and understanding, we see ourselves in good hands.”
About Lyfegen
Lyfegen is a global healthtech SaaS analytics company providing a value-based agreement platform for drugs, therapies and devices. Health insurances, pharma, medtech companies & hospitals use the secure platform for thousands of payment models throughout Switzerland, Europe, the Middle East and North America. The Lyfegen Platform supports the negotiation and automated execution of value-based payment models cost-effectively and at scale using real-world data and machine learning. Globally renowned health insurances, hospitals, pharma & medtech companies have already implemented Lyfegen’s patent-pending platform to scale value-based payment models for drugs, therapies and devices, improving access to treatments and patient outcomes.
Lyfegen was founded by individuals with decades of experience in healthcare, pharma and technology, pioneering the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
About EGK-Gesundheitskasse
EGK-Gesundheitskasse is an SME health insurer based in Laufen (BL), Switzerland. The EGK Group comprises EGK Grundversicherungen AG (basic insurance in accordance with KVG), EGK Privatversicherungen AG (supplementary insurance in accordance with VVG) and EGK Services AG (administration). It insures around 100,000 people in basic insurance throughout Switzerland, 80% of them also have EGK supplementary insurance.
Naturalness and sustainability are part of EGK's values. It is considered a pioneer in providing unrestricted access to excellent complementary medicine. It launches and supports activities throughout Switzerland to strengthen health in a natural way.
Read on PR newswire in English
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Lyfegen’s value-based contracting software is used by healthcare payers and leading pharma companies, including Novartis, Roche, MSD, Bristol Myers Squibb (BMS) and Johnson & Johnson
New York, NY - September 20, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, today announced an oversubscribed $8 million Series A financing round led by aMoon, with additional participation from APEX Ventures and others.
Currently, less than 2% of the health insurance population requiring specialty drugs is responsible for 51% of drug spending. The cost of specialty drugs in the US is spiraling out of control, increasing 12% from 2020 to 2021 alone, with no sign of slowing down due to the increase of cell and gene therapies expected to come to market. As a result, value-based contracting is becoming a more viable alternative for healthcare payers to only pay for drugs that actually work.
By 2025, total net spending on medicine in the US is expected to reach up to $400B. Additionally, new drugs regularly enter the market, but when pharmaceutical companies fail to agree on commercial terms with payers, patients are at risk of being denied access to life saving therapies. Lyfegen’s platform helps regulators, pharma companies and payers more easily adopt value-based payment models by digitizing the end-to-end process of data collection, anonymization and contract negotiations for all parties to agree upon drug pricing and reimbursement.
“We are excited to be announcing this funding round and to have this vote of confidence from aMoon, APEX and our other investors who understand the shift in healthcare that we are experiencing, and are supporting our efforts to expand the Lyfegen platform,” said Girisha Fernando, CEO and founder of Lyfegen. “We currently work with leading government payers, health insurance companies in Europe, the US and the Middle East, and some of the world’s largest pharma companies. Our plan now is to further expand our presence in the US, partnering with both private and public healthcare insurance companies. The move away from volume-based healthcare has never been more needed, and we are happy to play an important role in the shift to value-based contracting.”
“Lyfegen is addressing a significant market need in an industry that is changing dramatically and rapidly, and we are thrilled to help validate their efforts through our investment,” said Moshic Mor, General Partner at aMoon, and former Partner at Greylock and Greylock Israel. “During a time of healthcare budget pressures and recessions, the world needs Lyfegen’s solution now more than ever. We look forward to seeing the company, led by an incredible executive team, continue to enhance access to new drugs as they drive value-based healthcare to become increasingly mainstream.”
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 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 was founded by individuals with decades of experience in healthcare, pharma and technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.
Media Contact
Yael Hart
GK for Lyfegen
Read the Exclusive article with AXIOS
Read the Press Release on PR Newswire
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The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment.
Official Communication by KPMG on 26.10.2020
KPMG addresses the most pressing challenges the healthcare sector is facing today and in the future. Society’s desire to obtain value from the wider healthcare system is not new, however recent experience shows that there is a need to rethink and move healthcare into a new age.
Two current megatrends are: 1) the redesign of pricing for health solutions, and 2) the value of data and the importance of patient access. It is important to address both elements within the Life Sciences ecosystem, including how to innovate, how to develop successful digitalization strategies, and how to get the most out of data.
How outcome-based contracts benefit healthcare
The pricing of services and products based on outcomes or value created is another intrinsic element of the future of healthcare. Rising healthcare costs impact patient budgets and hinder access to treatments. Incentivizing positive outcomes can only benefit patients, while payers gain confidence that they are only reimbursing effective treatments. Manufacturers and providers that buy into the outcome-based model are taking an important step towards making their business more sustainable while contributing to the wider interest of the healthcare ecosystem.
One of the key issues has always been defining the factors that represent value and deciding how to measure them. To give an example, how do you measure if a patient is symptom-free and how long should the observation period last? How is the impact on those caring for an individual considered and how is the societal or economic impact assessed, e.g., can the individual go back to pursuing a career? These questions are key in any reimbursement of pricing arrangements.
Helping the healthcare community
Teaming up with Lyfegen, a healthtech company facilitating access to innovative therapies, KPMG recently published a joint whitepaper (see link below) on the application of outcome-based contracting. Girisha Fernando (CEO and Founder of Lyfegen HealthTech AG) and Martin Rohrbach (Head of Life Sciences for KPMG Switzerland) discuss how this approach can deliver value for healthcare payers, providers and patients.
The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment. The combination of knowledge, reach, and technology specific to value-based healthcare, together with proven practical experience, brings unique insights into value and data-driven pricing agreements for healthcare stakeholders. The whitepaper focuses on why outcome-based contracting can address drug access and reimbursement challenges, and how such contracts can be enabled by innovative technology. There are some clear takeaways, serving as building blocks and opportunities to engage in outcome-based contracting for the benefit of healthcare systems.
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Basel, Switzerland | April 17th, 2019 – Lyfegen HealthTech AG successfully closes its seed financing round, raising a total of CHF 750‘000. The funding was led by Swiss private investors. The funds will be used to further build Lyfegen’s value-based payments platform Lyfevalue and conduct further pilots with partners in the US, Africa, and the EU, including the UK.
Lyfegen is a healthcare technology company that has developed a ground-breaking solution to accelerate value-based healthcare, entering a market set to grow to USD 390.7 billion by 2024 according to latest market research. Its platform, Lyfevalue, collects, analyses & reconciles disparate healthcare data for the purpose of automating value-based healthcare contracting. The platform enables life sciences companies, national and private healthcare payers and healthcare providers to operationalise value-based healthcare strategies whilst benefiting from a single holistic solution for their value-based healthcare operations, visit checklistmaids.com. In addition, the platform allows for personalised healthcare by enabling patient level pricing, fostering accelerated and facilitated access to innovative treatments for patients.
“Enabling the shift to sustainable healthcare is a huge challenge, giving us at Lyfegen great purpose and we are honoured to work with individuals that truly care about making a difference for patients around the world,” said Girisha Fernando, Lyfegen’s CEO & Founder.
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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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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.
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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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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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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
Related Links:
Linkedin: https://www.linkedin.com/company/lyfegenhealth
Contact Press: press@lyfegen.com
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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.
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 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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Treatments for rare diseases, such as spinal muscular atrophy or CAR-T therapies like tisagenlecleucel, hold transformative potential for patients. Yet, they often come with significant challenges—uncertainties around long-term efficacy, high costs, and the need for tailored patient selection. Outcomes-Based Agreements (OBAs) offer a structured way to address these challenges, aligning financial risk with therapeutic outcomes. However, their implementation requires careful consideration and planning.
The Promise and Practicalities of OBAs
1. What Makes OBAs Valuable?
OBAs shift the focus from upfront costs to real-world outcomes, creating a more sustainable framework for funding innovative therapies. They enable:
• Risk Sharing: Payers and manufacturers align costs with actual therapeutic results.
• Patient-Centric Focus: Treatments are tied to measurable improvements, emphasizing value rather than volume.
• Increased Access: By mitigating cost risks, OBAs can support the introduction of high-cost therapies in resource-constrained settings.
2. Implementation Challenges
Despite their promise, OBAs are not without hurdles:
• Administrative Complexity: Managing OBA agreements involves data sharing, contract monitoring, and performance assessments—all requiring robust systems.
• Data Availability and Quality: Real-world evidence is critical, but gaps in data collection, reporting, and standardization can limit success.
• Stakeholder Collaboration: Successful OBAs require alignment between payers, manufacturers, and healthcare providers. Misaligned priorities or unclear accountability can derail agreements.
How Lyfegen Supports OBA Implementation
Learning from Global Examples
Lyfegen’s Agreements Library—featuring 6,700 public agreements and 20 pricing models from 33 countries—offers invaluable insights into how OBAs have been implemented worldwide. By analyzing these examples, stakeholders can identify models that best suit their unique challenges, reducing the trial-and-error phase of implementation.
Streamlined Scenario Analysis
The Lyfegen Drug Contracting Simulator enables stakeholders to simulate OBA scenarios using real-world data. From adherence-based contracts to outcome guarantees, the Simulator helps users:
• Assess feasibility through scenario modeling.
• Forecast financial implications with real-world inputs.
• Compare multiple pricing models to find the most suitable solution.
Simplifying Administration
Managing the administrative burden of OBAs is crucial. Lyfegen’s tools offer:
• Centralized contract management for version control and compliance tracking.
• Automated data processing to ensure performance metrics are accurately reported.
• Detailed dashboards and trend reports to facilitate collaborative decision-making.
Key Considerations for OBA Success
1. Feasibility Studies Are Essential
Not every therapy or market is suited for OBAs. Conducting thorough feasibility assessments helps determine the viability of such agreements.
2. Data Plans Need Clarity
Reliable outcomes-based contracts depend on well-defined metrics and data collection processes. Establishing these frameworks early is crucial.
3. Commitment from All Stakeholders
OBAs thrive on collaboration. Shared goals, transparent communication, and clear accountability among all parties can ensure smoother execution.
Conclusion
Outcomes-Based Agreements represent an important step forward in addressing the challenges of high-cost, high-impact therapies for rare diseases. With the right tools, insights, and preparation, healthcare stakeholders can unlock the potential of OBAs to improve access, manage costs, and focus on patient outcomes.
Discover how Lyfegen can simplify your journey to outcomes-based contracting. Schedule a demo today to explore our solutions in action.
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As value-based contracting (VBCs) becomes the standard, the role of clinical trials has shifted significantly. They are now essential not only for demonstrating safety and efficacy but also for enhancing financial performance. By creating trials that meet the criteria of VBCs, pharmaceutical companies can increase their financial gains, minimize pricing risks, and facilitate smoother negotiations with payers.
According to a report by Deloitte, aligning clinical trials with value-based pricing strategies can lead to improvements in revenue predictability and cost management by as much as 20% for drugs with high market access potential. This improvement stems from linking trial outcomes to real-world efficacy, which reassures payers and reduces the financial risk for manufacturers by basing pricing on demonstrated effectiveness
For CFOs and Pricing Directors, the Financial Impact is Clear
For CFOs and Directors of Pricing, the financial implications of optimized trials in a VBC framework are significant. When trial designs focus on outcomes that matter most to payers—like reductions in hospitalization or improved quality of life—pricing becomes more flexible, and revenue can be projected more accurately. McKinsey & Company points out that outcome-based models also provide a safeguard against pricing volatility, allowing pharmaceutical companies to stabilize revenue by tying payments to real-world performance metrics.
Efficiency Gains through Outcome-Focused Trial Design
Beyond revenue predictability, operational efficiencies are another key benefit. A focus on outcome-based trials reduces the time and resources needed to negotiate with payers, as the trial data itself becomes a compelling point in payer discussions. For Market Access Directors, outcome-driven trial designs support quicker market entry and stronger, data-backed negotiations that build payer confidence.
Lyfegen’s Platform: Streamlining Trial Optimization for Value-Based Contracts
Optimizing clinical trials for VBC is complex, but Lyfegen’s all in one platform simplifies this process. By enabling real-time pricing simulations based on clinical outcomes or financial goals, Lyfegen helps pharmaceutical companies design financially viable reimbursement contracts and align them with value-based pricing. This empowers pricing teams to model financial outcomes, enhancing both operational efficiency and contract efficiency.
Interested in learning how outcome-focused trials can support your pricing and financial goals? Lyfegen’s Simulator offers the tools you need to optimize clinical trials for success in a VBCs framework.
Schedule a demo today to explore how we can streamline your pricing and contract strategies: https://www.lyfegen.com/demo
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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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The pharmaceutical industry is increasingly moving towards value-based contracts (VBCs), where drug pricing is tied to real-world patient outcomes rather than traditional volume-based models. This shift is transforming how clinical trials are designed and executed, and it’s profoundly impacting drug pricing strategies.
According to the IQVIA Institute for Human Data Science, value-based contracts are expected to account for a larger share of pharmaceutical revenue, with the global market projected to reach $1.3 trillion by 2026, driven by the need for more outcome-driven healthcare solutions.
For CFOs and Directors of Pricing, this shift provides new opportunities to de-risk pricing models. By linking drug prices to clinical outcomes, pharmaceutical companies can reduce financial risk while ensuring that prices reflect the actual value delivered to patients. In this context, clinical trials become critical—not just for regulatory approval, but for pricing strategy development. The data generated in trials helps justify flexible, dynamic pricing models that payers can support.
Moreover, value-based contracts align perfectly with reducing healthcare costs while improving outcomes. This model can also strengthen relationships with payers, who increasingly demand proof of value before agreeing to reimburse drugs at premium prices.
Interested in transforming clinical trial results into smarter, value-based pricing? Lyfegen’s Simulator offers the solution by streamlining pricing models and linking them directly to trial outcomes, helping you reduce risk and enhance financial predictability.
Schedule a personalized demo today to see how we can help you transform your pricing strategy: https://www.lyfegen.com/demo
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