Health technology assessment will inform Medicare drug price negotiations
READ MORE
READ MORE
The Centers for Medicare and Medicaid Services is leveraging third-party health technology assessments to inform its offer price in February 2024 for the 10 drugs it has selected for price negotiations. To illustrate, the drug cost watchdog the Institute for Clinical and Economic Review published a report on the blockbuster blood thinners Xarelto and Eliquis and submitted it to CMS. Xarelto and Eliquis are two of the 10 drugs set to face the first round of Medicare price negotiations under the Inflation Reduction Act.
The ICER report modeled the comparative effectiveness of these products over generic warfarin in stroke prevention, myocardial infarction prevention and major bleeding episodes. This includes an assessment of the justifiable price premiums for the two branded products given several different cost-effectiveness thresholds. The table below shows ICER’s calculations of price premiums for Eliquis relative to the generic comparator warfarin and the branded comparator Pradaxa (dabigatran).
Drug manufacturers and payers impacted by the IRA will need to gather and evaluate this kind of information, as well as evidence from peer-reviewed articles and other sources. In turn, they must use the data to inform the price negotiation process for selected drugs but also competing products in the same therapeutic classes.
Launching soon, the Lyfegen Drug Pricing Simulator is a dynamic tool that gathers data inputs and runs real-time simulations that help users understand potential rebate, revenue, cash flow, and budget impacts for the different types and combinations of drug pricing models.
READ MORE
The Inflation Reduction Act authorizes Medicare for the first time to negotiate prices at the national level for a limited subset of single-source drugs. Recently, the Centers for Medicare and Medicaid Services selected the first 10 drugs to be negotiated. The 10 high-cost drugs in the table below represent 20% of total outpatient spend in the Medicare program from June 2022 through May 2023.
Prices will be negotiated over a one-year period with an offer and counteroffer process between CMS and drug manufacturers in which maximum fair prices will be established and posted in the fall of 2024 and implemented in January 2026.
Makers of drugs selected for negotiation should consider how payers in the Medicaid and commercial markets will leverage the published MFP information when negotiating rebates. Also, manufacturers of drugs competing with those selected for negotiation should consider how payers will leverage the published MFP information when making pricing, rebating and reimbursement decisions in the Medicid and commercial markets.
At the time a drug’s negotiated MFP price is posted, competitors may react to the published price by trying to undercut it, perhaps by offering even higher rebates, which in turn may cause the manufacturer of the selected drug to lower the net price of a drug a year prior to the MFP being implemented. Also, once MFPs are posted, payers will have publicly available information on the negotiated prices for the selected drugs as well as evidence used to inform the offer and counteroffers. This may then be utilized as leverage in negotiations for competing products in the same therapeutic classes.
The Lyfegen Rebate Analytics Platform is a cloud-based software that can manage all the complexities of drug rebate administration for payers and pharmaceutical companies affected by the IRA. The data-driven platform automates identifying, calculating, and tracking rebates in a timely manner, all of which help to ensure agreement compliance and reduce revenue leakage.
Learn more: lyfegen.com/products/ara
READ MORE
Prices for drugs in the U.S. continue to rise – faster than the rate of inflation – according to a Harvard study that shows nearly half of new drugs marketed now cost $150,000 or more annually. Insurers, along with consumers and regulators, are anxiously seeking ways to lower costs and to make sure patients get the treatments they need. One solution that is gaining interest is value-based pharmaceutical contracting, where costs are tied to results; the more effective a drug, the more a payer will allocate for that drug.
This model isn’t new and it has proven to be successful in Europe, where many value-based pharma contracting are showing positive results for payers, patients, and pharmaceutical companies. As a result, some companies that cater to the U.S. market are moving towards this model, although there are challenges.
Value-based contracting is especially applicable for the growing number of cell and gene therapies and other new ultra-expensive treatments. By allowing insurers and other payers to pay in installments that are dependent on patient outcomes, or even to receive refunds if the drug does not perform as expected, pharma companies are sharing the risk with payers. And there is great value in that shared risk. Payers, for example, are able to realize better patient outcomes when drugs proving to be ineffective can be replaced with more effective ones. At the same time, pharmaceutical firms are incentivized to ensure that the treatments they offer payers are truly effective ones, spurring better and more effective research.
In addition to making sure that prices reflect patient outcome, value-based contracting helps expand the amount of data associated with a treatment. With more data on the effectiveness of treatments recorded – and more tracking of patients over time – researchers will have more data to draw on when developing new treatments. That data can include details on all aspects of a patient's care and even factor in the patient's adherence to medication schedules. This data can also help pharma companies advance their research.Finally, healthcare providers benefit from value-based contracting because they will be able to get a more accurate picture of their patients' overall health situations, which will allow them to provide higher-quality care. Despite all of the advantages for all parties involved, value-based contracting has not yet been widely embraced by payers or pharma companies. A survey of 180 large employers, insurers, and unions with health benefit programs shows just 12% use value-based contracting for specialty drugs, which are usually the most expensive treatments, and fewer than 1% of organizations are using them for more common drugs.
This apparent reluctance to adopt value-based contracting is surprising because payers who have leveraged this approach are finding that their pharma costs are falling.
But challenges do remain for both payers and insurance companies in adopting value-based contracting. In order to speed up the adoption of value-based contracting, there needs to be a willingness to change business culture and long-entrenched processes; an acknowledgement that value-based contracting can expand insights and opportunities for pharma companies, but more clear incentives are necessary; and more dialogue around industry standards and regulatory flexibility that take this contracting model into account.
Industries like insurance and pharma often have institutional, or legacy, systems and processes that no longer best serve the organization and market opportunity. Innovative new opportunities like value-based contracting likely requires change–changes to systems, to processes, and to people’s day-to-day operations. Some organizations find the implementation of value-based contracting models complicated because they require analyzing patient outcomes, negotiating prices based on those outcomes, and determining which drugs should be included in the program. All of these steps require access to–and analysis of–a great deal of data, which can be a significant investment. However, there are digital platforms that are designed to implement value-based contracting without overcomplicating the process–and the investment can yield operational efficiency, recovery of missed revenues, and, most importantly, provide critical access for patients to life-saving drug therapies.
Within the industry, there is an assumption among pharma companies that there is a limited return on their investment with value-based contracting, or even the possibility of lower revenues due to lower prices. But with the transparency that value-based contracting can bring to pharma companies through real-world data from patients taking their drugs, there comes expanded opportunities to understand drug performance and patient outcomes, both of which are valuable for future drug development and marketing. A KPMG report notes another important benefit of value-based contracting–for example, such agreements can enable pharma companies access to currently highly-regulated markets that they were unable to sell in before, thus serving as a competitive advantage. In order to keep pushing pharma companies in this direction, there need to be more clear incentives that can help them with access challenges.
As value-based contracting continues to be more commonplace, it is likely that there will be more standardization within the industry and regulatory parties. However, these changes should be happening now. For example, standards are needed regarding what factors should be included when evaluating the effectiveness or value of a drug. Furthermore, value is a dynamic concept and the definition changes depending upon the viewpoint–value for a payer is different from value for pharma is different from value for a patient. The industry also needs to sort out what happens in outcome-based contracts when patients switch insurers.
Regulations can also stand in the way. While Medicaid has adopted a value-based contracting model for a small selection of drugs, most others are not covered by that arrangement. Most drugs are subject to Medicaid's Best Price policy where prices aren't connected to effectiveness or results, thus perpetuating the disconnect between price and value. The good news is that CMS, the government agency responsible for Medicaid and Medicare services, plans to extend and expand the value-based contracting model already in effect as they continue working towards the goals of improving health outcomes and lowering costs.
Change can be challenging. But as drug prices rapidly rise, the need for change has never been greater. Value-based contracting is the innovative solution that leverages the right data, at the right time, and with the right level of transparency to reduce costs, recover lost revenues, ensure more effective outcomes, help patients get healthier, and provide valuable data insights for future drugs and treatments. It's time to start implementing them.
READ MORE
Advanced gene therapies that could “practically cure” patients suffering from sickle-cell disease (SCD) are just over the horizon. But they may not reach the people who need them most, many of whom are minorities with fewer financial resources and are reliant on Medicaid for their health coverage. Figuring out how to pay for their treatment looms as one of the biggest questions – both economic and ethical - facing US public health policymakers in the coming years.
Amid Medicaid’s efforts to cut spending, the dilemma of how to cover these drugs could end up increasing rancor and anger in the country – or it could spur budgetary creativity. While programs like Medicaid have traditionally filled the gap between availability and lack of affordability in treatment, the cost of SCD therapies developed by Vertex and CRISPR – estimated at nearly $2 million a dose – could quickly overwhelm even Medicaid's robust resources, especially in states that have higher rates of the disease. And this is just the beginning. As more ultra-expensive drug and cell therapies are developed for numerous conditions in the coming years, the question of how to pay for them looms large.
The American healthcare system has been long accused of discriminating against the poor and minorities – and that discrimination is likely to come into far greater focus when millions of the poorest Americans who could benefit from new therapies are unable to take advantage of them. Altogether, there are over 40,000 SCD patients on Medicare in any given year - about 60% of the estimated 100,000 victims of the disease in the US. Of the 74,817 hospitalized for sickle cell disease in 2023, 69,889 (93.4%) were African-American; on average, one of every 13 Black babies are born with sickle-cell trait (SCT), a forerunner of the disease. Even for SCD patients who can afford private insurance, the out-of-pocket cost for therapy is very burdensome. But for the poor and others who lack private health coverage, Medicaid is a singular life raft – the difference between life and a possibly very abrupt death.
Given the situation, it's likely that patient advocacy groups will make a strong bid for increased government funding. And given the issues of social justice and racism surrounding the historic lack of interest in SCD by the medical establishment, there's a good chance that funding will be forthcoming. But budgets are still budgets; if Medicaid is going to spend more on SCD therapies, it is going to have to cut other payments, especially given the strong pressure to cut Medicaid spending – both on the federal and state level, even in states where the incidence of SCD is high.
This could be the time for Medicaid to follow in the footsteps of Medicare, and implement changes in the way it pays for treatments, specifically implementing models where payment is based on patient outcome. Indeed, Medicaid has proposed doing this, but it must move much faster if it wants to help those with SCD benefit from treatments expected to be approved by the end of the year.
Medicare recently adopted a limited form of results-based drug pricing for some of its most expensive drugs. The legislation initially covers ten high-priced drugs, with the list expanded to 20 by the end of the decade. Under the program, the government will pay a price closer to that demanded by the drug’s maker if a drug does in fact significantly reduce the costs of lifetime treatment. But if a drug does not have the desired result, the cost would be significantly lower. Experts are predicting significant savings for the government.
Medicaid, through CMS/CMMI, plans to do something similar - negotiate results--based contracts for gene-based therapies on behalf of all 50 state Medicaid programs. According to government data, the lifetime cost for treating SCD patients through 64 years of age is also close to $2 million. So Medicaid would be spending roughly the same amount on each patient receiving gene-based therapies, while reducing or eliminating costs for treatment of those over 64. These outcome-based contracts, also called value-based contracts, would allow drug-makers to be paid full price only if the treatment does end up working. These contracts could also allow Medicaid to pay in installments, rather than upfront. In addition, if treatment works faster or better than expected in some patients, there could be room in these contracts for drugmakers to be paid more, or paid earlier. Drug companies and science would also benefit from the extended real-world data involved in these contracts, which track the progress of treated patients for years.
But this model is likely to come too late for many with SCD: CMS/CMMI will only be running a pilot negotiation program in 2026 at the earliest. This means that it's very possible that Medicaid will have to, at least temporarily, ignore very promising gene-based therapies that could help hundreds of thousands of people because it can't pay for them.
Meanwhile, the public pressure and demand for widespread implementation of SCD gene therapies is likely to be very high. Lives are at stake; as is correcting a historic injustice. So how will officials deal with an increase in public pressure to pay for therapies? One possibility is to appeal to the private sector for help. Infact, the NIH will be partnering with the Bill & Melinda Gates Foundation to provide some $200 million to increase the development of affordable gene therapies for SCD and HIV by providing funding to researchers to develop lower-cost therapies, and assistance to those who need treatment. Another option could be transferring unused state Medicaid allocations for SCD from states with very low incidence rates, like Idaho, to states with higher incidence rates, like Mississippi.
Regardless of the solution Medicaid adopts, there's no question that a storm has been raging for years over who gets what in the American healthcare system – and that storm is likely to strengthen as gene-based therapies for SCD become available. Given the history of how the establishment has dealt with that disease – and the people who are its biggest victims – it's likely that changes to how Medicaid pays for expensive therapies will come sooner rather than later. These changes must happen, or inequality in the American health system will only become worse as the pipeline of life-changing gene and cell therapies grows.
READ MORE
Forty cell and gene therapies may be launched in the coming five years. They could target as many as 33 million patients by the end of this decade. When a single dose of a gene therapy can cost millions of dollars, finding feasible and equitable ways to price and reimburse these products is a major challenge.
Cell and gene therapies began mostly in the ultra-orphan space, but with technological advancements in drug development, therapies are expanding into much larger populations. This evolution began last year with the approval of the CAR-T therapy Carvykti, which may be prescribed to more than 80,000 multiple myeloma patients annually by 2025.
In the gene therapy space, recent approvals of hemophilia A and B products, as well as the imminent launch of sickle cell disease therapies, expand new therapies reach to potentially hundreds of thousands. Then, as we look forward to a few years from now, gene therapies may enter the massive diabetes and osteoarthritis markets, which pushes their impact exponentially to millions of patients annually.
Most cell and gene therapy products are intended as one-time injection treatments, which in turn may offer durable cures. But the up-front costs are very high on a per-unit basis. And questions around the durability of novel gene therapies persist. As such, there are serious concerns about how to manage the considerable costs while ensuring equitable access.
Independent watchdog organization, ICER (Institute for Clinical and Economic Review), is helping to push the movement toward fair pricing and fair access forward—and it’s been shown that cell and gene therapies can be cost-effective. However, for this value proposition to become a universally accepted practice, payers must adopt a view that systematically incorporates the concept of value-based pricing. Traditional methods of reimbursement won’t work. As a consequence, payers will need to implement value-based pricing arrangements, such as pay-for-performance schemes or warranty programs, in which evidence is gathered and analyzed to assess whether cell and gene therapies prove their worth and are durable over time. Policymakers will need to turn to value-based contracting solutions, such as the ones Lyfegen offers.
Both pharma companies and payers are faced with the complex challenge of navigating the uncertainties of drug pricing agreements for cell and gene therapies. Lyfegen is an independent resource that provides powerful tools and resources for pharma and payers to leverage so that the right type of reimbursement model can be identified for a specific cell and gene therapy. The Lyfegen Model & Agreement Library contains more than 2,000 real-world, value-based agreements and 18 drug pricing models from around the world. And the Lyfegen Platform leverages intelligent algorithms to capture and analyze patient-level drug cost data that can then be run through a platform-based simulator to help customers negotiate the best agreements possible.
READ MORE
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.
READ MORE
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
READ MORE
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
READ MORE
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.
READ MORE
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.
READ MORE
We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.
Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?
I have spent close to a decade in the life sciences sector, working with companies like Novartis and Pfizer, where I gained deep expertise in healthcare strategy, market access, and health economics. My passion has always been focused on improving patient outcomes and the healthcare system. This led me to Lyfegen, a company at the forefront of transforming healthcare through innovative solutions. The opportunity to work with payers and drug manufacturers to ensure better and sustainable access to innovative treatments for patients was a natural fit for me, both professionally and personally.
What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?
The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies. However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.
What opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How can we better support health insurers and government bodies?
There is tremendous potential for growth. Currently, payors and pharmaceuticals adjudicate their product listing agreements (PLAs) manually through Excel spreadsheets. It is resource intensive, leaves room for errors and is a barrier to potential innovative contracting. In addition, as Canada increasingly looks towards value-based healthcare models, Lyfegen is an enabler by providing the digital infrastructure for payor and manufacturers.
From your perspective, what key actions need to be taken in the next 12 months to drive success for Lyfegen in the Canadian market?
In the next 12 months, we need to focus on deepening our relationships with key stakeholders and demonstrate the value of our digital solutions for payors, manufacturers, healthcare system and, ultimately, the patients.
How do you see your role influencing the implementation of value-based solutions in Canada, and what impact do you hope to have?
Lyfegen has extensive experience in OBA implementation and operationalization in many countries. In my role, I hope to bridge the gap from theory to practice in the implementation of value-based healthcare in Canada.
In your opinion, what’s the most important aspect of building strong client relationships in the healthcare industry? How do you approach this in your role?
Trust and communication are at the core of any strong client relationship in healthcare. Given the complexity and sensitivity of the industry, clients need to know that you understand their unique challenges and are committed to solving them. In my role, I prioritize open and ongoing communication, ensuring that clients feel heard and that their feedback is integrated into our solutions. I also work hard to build trust by delivering results and being transparent about what we can achieve together.
Looking ahead, what excites you most about the future of sales and business development at Lyfegen in Canada?
I’m excited about the potential to be a catalyst for significant change in the Canadian healthcare landscape. Lyfegen is in a unique position to lead this transformation. The combination of increasing demand for cost-effective healthcare solutions and our innovative approach makes this an incredibly exciting time to be in sales and business development.
Outside of work, what are some of your favorite things to do in your free time?
Outside of work, I enjoy spending quality time with my family and friends. I also prioritize my health by being active on a daily basis. I also enjoy learning. Now that I have completed my MBA, I’m on a mission to learn Spanish.
We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!
READ MORE
Once upon a time, In a whimsical forest, there lived a smart and creative blue bird. This bird, known for its brilliance in the world of tiny forest biotech, had concocted a magical potion.
This potion was a wonder, a gene therapy to cure the forest creatures of a troublesome disease called sickle cell. Perched thoughtfully on a branch, the blue bird faced a whimsical yet vital challenge. The potion, potent in its healing, needed to be more than just a marvel of science – it had to be reachable and affordable for all in the forest. Additionally, this magical creation was still unnamed, a name that should echo its life-affirming qualities and the journey from a mere idea to a beacon of hope in the forest.
Amidst this puzzlement, the blue bird heard tales of the wise owls of Lyfegen, far beyond the forest. These owls were not just wise; they were masters of a different kind of magic – the magic of numbers and agreements that made health solutions reachable to all. Intrigued, the blue bird fluttered over to learn more.
As it learned about Lyfegen's remarkable ability to navigate the complex world of potion pricing and access, inspiration struck. "Ah-ha!" chirped blue bird, "If Lyfegen can make health solutions accessible, why not name my potion in honor of their work? Lyfgenia – a name that sings of life, hope, and the ingenuity of Lyfegen!"
And so, the potion was christened Lyfgenia, a nod to the owls of Lyfegen whose wisdom ensured that such medical marvels reached every nook and cranny of the forest without burdening its inhabitants.
With its new name, Lyfgenia became more than just a potion; it symbolized a harmonious blend of medical genius and financial savvy. The blue bird turned Lyfgenia into a symbol of hope and healing in the whimsical world of the forest.
Disclaimer: "A Fable of the Blue Bird and Lyfegen's Wise Owls" is a work of fiction, created solely for entertainment and illustrative purposes. This fable does not represent any real-life strategies, decisions, or actions of these entities, nor should it be interpreted as an endorsement or representation of their values, capabilities, or business practices.
Using Lyfegen's solutions can streamline the financial management of advanced therapies like Lyfgenia, leading to more effective pricing strategies and improved access for patients. Learn more about how our solutions enable value-based contracting for gene therapies: lyfegen.com
READ MORE
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.
Quick introduction – tell us a bit about yourself!
I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.
What excites you about your job?
What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.
Why did you decide to join Lyfegen?
It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.
What is something you want to learn or improve in the next 12 months?
Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.
How will your know-how help improve our customers’ experience of Lyfegen solutions?
With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.
Let’s get personal: What are your favorite things to do in your free time?
In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.
Is there anything else you are looking forward to outside of work in the next few months?
As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.
Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen."
Here’s to new beginnings and transformative journeys!
Welcome to our crew, Simon.
Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...
Read MoreREAD MORE
At this years World Evidence, Pricing and Access event, Girisha Fernando, the CEO of Lyfegen, expressed excitement as he spoke about the company’s latest launched offering - the Lyfegen Model & Agreement Library. This unique learning resource is a true game-changer that builds upon the company’s existing product. It expands our horizons by allowing payers and market access & pricing professionals to explore over 2’500 real-life public agreements, and 18 drug pricing models from around the world. The library provides an unparalleled understanding of drug reimbursement models that help users make better informed choices like never before.
Selecting a drug reimbursement model is very complex, as manufacturers want quick market access, while payers may have many concerns, such as a drug’s efficacy and affordability. Fernando emphasized that the library bridges the gap by assisting payers and market access professionals in finding specific models that address each stakeholder’s concerns, and key real-life agreement examples, resulting in better-informed decision-making, and ultimately more efficient reimbursement processes.
“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers and pharma companies across the world”, said Fernando, “That is why we are excited about launching the world’s largest database of real-world value-based agreements. It gives payers and pharma a unique insight into how to structure value-based agreements.”
But that’s not all – Fernando explained that the database is constantly evolving, being updated weekly with new public agreements, allowing stakeholders to be up to date on public agreements.
Overall, it is clear that the Lyfegen Model & Agreement Library is an invaluable groundbreaking tool, that is becoming indispensable in increasing the knowledge on drug and Cell & Gene Therapy reimbursement.
READ MORE
He’s analytical, a techie and has a fantastic gift for music! Yes, we are talking about the latest addition to our team, our very own “Technical Business Analyst” and Ukrainian superstar: Pavlo Lupandin!
Just last month we announced the arrival of our Lead Developer, Daniel, and now more great news follows as Lyfegen continues to lay focus on the technical team: we have our very own Technical Business Analyst, Pavlo!
“Pavlo’s sharpness and problem-solving skills just made it clear that we needed him in our team! His drive and commitment will bring great value to our patients, our customers and Lyfegen as we continue to sharpen our platform” says Lyfegen’s CEO, Girisha Fernando.
We are proud to have him as part of the team and sat down with him to give you a little more insight behind the musical talent and witty “Technical Business Analyst”:
Hi Pavlo! Tell us a little about yourself: where are you from and what is your work experience background?
Hello! I was born in the east of Ukraine, got the Master’s Degree in Economics in Kyiv, worked at one of the Big 4 companies for 3 years as an Auditor, following one year in the role of Business Analyst. After this experience, I found myself being a fresh ACCA Member, who wanted to dive into something not that accounting related. Business analysis has proven to be an interesting area where I can develop further capitalizing on my previous experience.
It’s interesting, that back in my audit days I’ve had some big healthcare-related projects. Who knew that it was only the beginning of working in this promising domain…
This is your first experience in the Health Tech industry – what triggered this move?
Pace of development. The Healthcare & IT industries are developing in overwhelming waves, and to ride the peak of those waves is a challenge – formidable, but a tempting one. As soon as this opportunity presented itself, I decided to chase it. We’ll see, where this decision will bring me in a couple of years.
You are joining Lyfegen as Technical Business Analyst. In simple terms: what will you be working on?
I would be occupied mainly with gathering, documenting and communicating the requirements of our customers. Ever heard of different communication barriers? Those I would try to eliminate, trying to grasp the very core of what has to be done for the maximum customer satisfaction and making sure the development team implements requirements as close as possible to the ideal.
What are your next personal goals with Lyfegen?
There are several of them. First, I strive for development as a professional, and I think Lyfegen will provide me with opportunities to do that. Second, I want to embrace that spirit of a high-growth startup – after working for a massive and complex company, the flexibility and freedom of Lyfegen is a breath of fresh air. And finally, I want to know new talented people. I already know, that the Lyfegen team has a great diversity, and I can’t wait to learn some interesting things from people of other countries and cultures.
What motivated you to join?
Purpose and value. As simple as that. I can see the purpose and value of what I’m doing. Obviously, we are at the beginning of this journey, and it’s a bit early to speak about “value-based pricing for everybody” or “pay only for what is really working” but…the concept is huge, and it will become the question of life and death for some patients. And I’ll do my best to make it as close to life as possible.
Enough about work! What passions do you have outside of Lyfegen?
Oh, you don’t want to hear a full list, I assure you. Let me try to sum it up quickly…Music, videogames and tabletop games – I play them all. A small collection of musical instruments – some of them are quite exotic, especially for my home country (banjo and djembe, for example). A bigger collection of tabletop games in different genres – the Lyfegen team can definitely expect a session or two in the nearest future. And a vast collection of videogames on different platforms…without much details let’s just agree there are a lot.
There are some other hobbies of mine, but I’d prefer to keep a couple of surprises up my sleeve!
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
READ MORE
The Joint Clinical Assessment (JCA) is poised to fundamentally change how health technologies gain market access across the European Union. Designed to streamline the evaluation process, the JCA promises to bring greater consistency, transparency, and efficiency to how new therapies and medical technologies are assessed for clinical effectiveness. But what does this mean for your market access strategies?
What is the JCA?
The JCA is a central pillar of the EU’s updated Health Technology Assessment (HTA) regulations. Historically, pharmaceutical and medical device companies faced significant hurdles when introducing new health technologies across different EU member states. Each country has had its own HTA process, leading to duplicated efforts, inconsistent outcomes, and delays in patient access. With the JCA, clinical assessments will be conducted at the EU level, offering a unified approach to evaluating the relative effectiveness of new treatments.
Key Benefits of the JCA
The JCA is expected to address several long-standing challenges:
1. Streamlined market access: By replacing multiple national HTA evaluations with a single EU-level assessment, the JCA will reduce duplication and accelerate the time it takes for new health technologies to reach the market.
2. Consistency across the EU: With the JCA, companies can expect more predictable and transparent outcomes when navigating the regulatory landscape. This will help align market access efforts across all member states, making it easier for companies to plan and execute their market entry strategies.
3. Cost efficiency: By pooling resources and conducting joint clinical assessments, the JCA is expected to save HTA bodies across the EU millions of euros annually. This increased efficiency will also benefit pharmaceutical and medical technology companies by reducing the administrative and financial burden of complying with multiple HTA processes.
How Will the JCA Impact Your Market Access Strategy?
For companies looking to introduce new health technologies in the EU, the JCA will bring both opportunities and new considerations:
• Early Engagement Will Be Key: The unified nature of the JCA means that companies will need to engage early with EU-level HTA bodies to ensure that their clinical data meets the requirements of the JCA. This early engagement can help smooth the path to market and avoid potential delays.
• A Shift in Regulatory Focus: With clinical assessments now being handled at the EU level, companies may need to adjust their strategies for navigating national market access pathways. While the JCA will simplify the clinical assessment process, national bodies will still be responsible for non-clinical aspects, such as pricing and reimbursement decisions.
• Data Consistency and Quality: The JCA emphasizes the importance of high-quality, consistent clinical data. Companies will need to ensure that their submissions are robust and aligned with the JCA’s methodology to avoid discrepancies and delays in the assessment process.
The Role of Technology in Managing Market Access
As market access strategies evolve with the implementation of the JCA, technology platforms like Lyfegen can play a crucial role in helping pharmaceutical and medical technology companies adapt. Lyfegen’s platform simplifies the process of planning, tracking, and managing health technology assessments, ensuring that companies are well-prepared to meet the requirements of the JCA.
By leveraging advanced analytics and real-time data management tools, Lyfegen enables companies to streamline their market access efforts, ensure compliance with EU-level assessments, and maintain transparency throughout the process. With the increasing complexity of market access in the EU, technology will be a critical factor in ensuring success.
Conclusion: Preparing for the Future of Market Access
The JCA is set to transform market access strategies across the EU by creating a more efficient, unified, and predictable pathway for introducing new health technologies. As companies navigate this new landscape, early preparation, high-quality clinical data, and the right technological tools will be essential to staying ahead.
Unlock smarter market access strategies with Lyfegen’s advanced tools! The Lyfegen Drug Contracting Simulator empowers you to navigate the complexities of the JCA, model various pricing scenarios, and optimize your market entry plans. Combined with the Lyfegen Library’s extensive collection of market access models, you’ll have everything you need to succeed in the EU’s evolving regulatory landscape.
Act Now – Book a demo of Lyfegen’s platform and learn how we can support your market access strategy: https://www.lyfegen.com/demo
READ MORE
We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.
Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?
I have spent close to a decade in the life sciences sector, working with companies like Novartis and Pfizer, where I gained deep expertise in healthcare strategy, market access, and health economics. My passion has always been focused on improving patient outcomes and the healthcare system. This led me to Lyfegen, a company at the forefront of transforming healthcare through innovative solutions. The opportunity to work with payers and drug manufacturers to ensure better and sustainable access to innovative treatments for patients was a natural fit for me, both professionally and personally.
What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?
The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies. However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.
What opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How can we better support health insurers and government bodies?
There is tremendous potential for growth. Currently, payors and pharmaceuticals adjudicate their product listing agreements (PLAs) manually through Excel spreadsheets. It is resource intensive, leaves room for errors and is a barrier to potential innovative contracting. In addition, as Canada increasingly looks towards value-based healthcare models, Lyfegen is an enabler by providing the digital infrastructure for payor and manufacturers.
From your perspective, what key actions need to be taken in the next 12 months to drive success for Lyfegen in the Canadian market?
In the next 12 months, we need to focus on deepening our relationships with key stakeholders and demonstrate the value of our digital solutions for payors, manufacturers, healthcare system and, ultimately, the patients.
How do you see your role influencing the implementation of value-based solutions in Canada, and what impact do you hope to have?
Lyfegen has extensive experience in OBA implementation and operationalization in many countries. In my role, I hope to bridge the gap from theory to practice in the implementation of value-based healthcare in Canada.
In your opinion, what’s the most important aspect of building strong client relationships in the healthcare industry? How do you approach this in your role?
Trust and communication are at the core of any strong client relationship in healthcare. Given the complexity and sensitivity of the industry, clients need to know that you understand their unique challenges and are committed to solving them. In my role, I prioritize open and ongoing communication, ensuring that clients feel heard and that their feedback is integrated into our solutions. I also work hard to build trust by delivering results and being transparent about what we can achieve together.
Looking ahead, what excites you most about the future of sales and business development at Lyfegen in Canada?
I’m excited about the potential to be a catalyst for significant change in the Canadian healthcare landscape. Lyfegen is in a unique position to lead this transformation. The combination of increasing demand for cost-effective healthcare solutions and our innovative approach makes this an incredibly exciting time to be in sales and business development.
Outside of work, what are some of your favorite things to do in your free time?
Outside of work, I enjoy spending quality time with my family and friends. I also prioritize my health by being active on a daily basis. I also enjoy learning. Now that I have completed my MBA, I’m on a mission to learn Spanish.
We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!
READ MORE
In December 2023, the U.S. Food and Drug Administration (FDA) approved two groundbreaking gene therapies for sickle cell disease (SCD), offering a new lease on life for individuals battling this severe condition. However, while these therapies bring significant clinical improvements, their cost has emerged as a formidable challenge, particularly for Medicaid, which covers approximately half of the 100,000 individuals in the U.S. with SCD.
The Financial Strain of Sickle Cell Disease on Medicaid
Gene therapy represents a revolutionary treatment for SCD, a condition that has traditionally required ongoing management through therapies like allogeneic hematopoietic stem cell transplants (HSCT). While HSCT offers a potential cure, its use has been limited due to donor availability and high toxicity. Now, gene therapy provides a much-needed alternative, but the steep price tags—approximately $2.29 million per treatment—pose a significant challenge for Medicaid programs across the country.
The latest budget impact analysis updates previous findings on how these high-cost therapies could impact 10 Medicaid plans with the highest prevalence of SCD. The study reveals that even cost-effective treatments with exceptional clinical benefits may be unaffordable for payers, particularly given the expanding Medicaid enrollment and higher-than-expected launch prices for these therapies.
Short-Term Costs vs. Long-Term Savings
For Medicaid plans, the financial challenge of gene therapy is primarily in the upfront, one-time cost of the treatment. The updated model projects that in the first year alone, gene therapy for SCD will result in an average budget impact of $65.8 million per state program, with a per-member per-month (PMPM) cost of $3.11 across the 10-state sample. Although the cost decreases over time—with the PMPM dropping to $2.08 by year five—the initial budgetary strain is a significant concern.
Despite these costs, the long-term benefits of gene therapy are undeniable. By offering a potentially curative solution, gene therapy could avert future medical expenses associated with SCD, such as hospitalizations, pain management, and ongoing treatments. The model conservatively assumes perfect effectiveness and durability, projecting that the therapy would eliminate all future SCD-related healthcare costs for treated patients. While these assumptions may not reflect real-world outcomes, they provide a glimpse into the potential for long-term savings.
Market Diffusion and Budgetary Impact
A critical factor influencing the budget impact is the market diffusion rate—the speed at which patients adopt the new therapy. The analysis assumes an annual diffusion rate of 7%, meaning that a subset of eligible Medicaid enrollees will receive the therapy each year. This rate could vary, influenced by factors such as manufacturing capacity, delivery center availability, and payer policies. Notably, if the diffusion rate falls below 4%, the PMPM cost could remain below the affordability benchmark set by prior high-cost treatments, such as sofosbuvir for hepatitis C, which generated a PMPM cost of $1.89 in 2024 dollars.
The model also reveals that 35% of Medicaid enrollees with SCD are expected to have a severe phenotype, defined by two or more severe pain episodes annually. This percentage is a key driver of cost, as patients with more severe disease are more likely to be eligible for gene therapy.
State Medicaid Plans Face Varying Impacts
The updated analysis highlights significant variability in how different state Medicaid plans will be affected. For example, in Georgia, where SCD prevalence is higher, the projected PMPM cost is $3.92 in the first year, while Florida faces a slightly lower cost of $2.50 PMPM. These variations reflect differences in both disease prevalence and state enrollment levels.
By the fifth year, the PMPM costs across all state programs are expected to decrease, driven by reduced new therapy adoption and the absence of ongoing SCD-related costs for treated patients. However, the affordability challenge remains a pressing concern, particularly in the early years of gene therapy adoption.
Balancing Access with Affordability
Medicaid plans, payers, and policymakers are now tasked with finding ways to balance the promise of gene therapies with their potential financial burden. The affordability challenge could limit patient access, echoing the struggles faced during the rollout of high-cost hepatitis C treatments.
One potential solution is the development of novel payment models, such as annuity-based approaches, which could spread the cost of gene therapy over several years, easing the immediate budgetary impact. Additionally, the Center for Medicare and Medicaid Innovation is exploring alternative payment strategies specifically for gene therapies within Medicaid, aiming to ensure access without jeopardizing the financial sustainability of state programs.
The Role of Technology in Managing Costs
As gene therapies become more prevalent, platforms like Lyfegen can play a key role in helping payers manage the financial complexities associated with these high-cost treatments. Lyfegen’s platform simplifies the process of tracking the economic impact of gene therapies, providing payers and providers with the tools they need to assess real-world outcomes, monitor costs, and adjust strategies accordingly. By leveraging technology, healthcare systems can better navigate the financial risks and ensure that patients continue to benefit from the latest innovations in care.
Unlock smarter budget management strategies with Lyfegen’s powerful tools! The Lyfegen Drug Contracting Simulator helps payers and healthcare providers model the financial impact of high-cost therapies like gene therapy for SCD, optimize payment strategies, and make informed decisions. Coupled with the Lyfegen Library’s extensive database of pricing models, you’ll be equipped to tackle the financial challenges posed by the latest innovations in healthcare.
Act Now – Book a demo of Lyfegen’s platform and discover how we can support your budgeting and contracting needs: https://www.lyfegen.com/demo
References
Meyer, K. B., Kilburg, M. M., Johnson, K. B., & Meyers, M. A. (2024). A budget impact analysis of gene therapy for sickle cell disease: an updated analysis. Blood Advances, 8(17), 4658–4666. https://ashpublications.org/bloodadvances/article/8/17/4658/517069/A-budget-impact-analysis-of-gene-therapy-for-sickle-cell-disease
READ MORE
Outcome-Based Contracts (OBAs) are set to revolutionize access to high-demand medications by linking drug prices to patient outcomes. Specifically, this model ensures that the cost of medication reflects its real-world effectiveness, thereby encouraging better healthcare and sustainable pharmaceutical spending. As outcome-based healthcare gains momentum, OBAs will further push pharmaceutical companies to focus on developing innovative, effective treatments rather than just boosting sales. GLP-1 drugs, such as Wegovy and Ozempic, which are popular for weight loss, could exemplify this shift.
Challenges in Patient Coverage
Right now, accessing GLP-1 drugs is tough due to their high costs and insurers' hesitance to cover expensive, newer treatments. Additionally, coverage decisions vary, and many employers do not include these medications in their health plans. According to Mercer’s 2025 Survey of Health and Benefits Strategies, only 42% of employers cover obesity medications, and only 3% plan to offer coverage for weight loss drugs. Therefore, employers face a tough balancing act between cost and access, especially with GLP-1 drugs like Zepbound, which costs $1,059.87—20% less than Wegovy but still pricey.
Outcome-based Healthcare: Aligning Costs with Effectiveness
As we move towards outcome-based healthcare the OBA’s that are its foundation address these challenges by tying drug costs to real-world effectiveness. Pharmaceutical companies and healthcare providers start by agreeing on specific patient health outcomes. If the medication meets these benchmarks, pricing reflects its success. If not, the price could be adjusted. Ultimately, this model promotes impactful treatments and makes life-changing medications more accessible. It is especially useful for chronic conditions like obesity, where patient outcomes are crucial measures of success.
Benefits for Healthcare Providers
OBAs also benefit healthcare providers by creating a reliable framework for prescribing new or expensive medications like GLP-1s. Providers can prescribe treatments with confidence, knowing they have a proven track record of success. In addition, this model fosters collaboration between providers and pharmaceutical companies, shifting the focus from sales to patient outcomes. As a result, this could lead to better resource allocation, improved patient satisfaction, and a more effective healthcare system overall (Mercer, 2024).
Impact on Pharmaceutical Companies
For pharmaceutical companies, OBAs drive innovation and accountability. By linking drug pricing to patient outcomes, these agreements push companies to focus on treatments that deliver real, measurable results. This shift compels them to invest in research and development, knowing that successful outcomes can boost both credibility and profits. Furthermore, OBAs not only streamline drug approvals but also offer a competitive advantage in the value-based healthcare market.
The Role of Technology
Technology platforms like Lyfegen can also play a crucial role in making OBAs more efficient. Lyfegen’s technology simplifies the complex process of planning, testing and creating OBA’s, as well as tracking rebates. Lyfegen’s all-in-one platform makes it easier to manage contracts with transparency. As demand for GLP-1 drugs continues to rise, such platforms ensure that access to these treatments is tied to proven success while keeping costs manageable.
In conclusion, OBAs could transform access to high-demand medications by aligning drug pricing with patient outcomes. Not only does this model make expensive treatments like GLP-1 drugs more accessible, but it also promotes responsible pharmaceutical spending. By leveraging platforms like Lyfegen, which simplify the process, OBAs offer a path to more equitable and value-driven healthcare.
Unlock smarter pricing and market access strategies with Lyfegen's powerful tools! The Lyfegen Drug Contracting Simulator lets you easily model various pricing scenarios, see their impact on revenue and costs, and refine your market access planning. Combined with the Lyfegen Library’s vast collection of pricing models and agreements, you'll have everything you need to make informed, strategic decisions. These tools empower payers and pharmaceutical companies to tackle pricing challenges head-on, streamline negotiations, and address payer concerns with confidence.
Act Now – Reserve Your Spot for a Live Lyfegen Demo here: https://www.lyfegen.com/demo
References
“Welcome to brighter.” Mercer, https://www.mercer.com/en-us/.
READ MORE
In the US, a piece of proposed legislation with major ramifications on pharmaceutical manufacturing passed the House of Representatives, the first step in the law-making process, on September 9th. H.R.8333 - BIOSECURE Act has received bipartisan support and passed the House 306 to 81.
The BioSecure Act alleges that some Chinese biotech companies post a national security threat, due to their affiliation with the Chinese Communist Party and their military or intelligence agencies. The draft bill mentions “military-civil fusion” being a central concern, a procedure by which under certain circumstances, Chinese companies, whether headquartered in China or not, must surrender all company data to the CCP.
Five companies were named as a “biotechnology company of concern” in the bill: BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and WuXi biologics. Companies relying on these providers have until 2032 to change suppliers, exactly the 8 years estimated to be needed to make the switch, according to a survey conducted by the Biotechnology Innovation Organization (BIO) earlier this year. The same survey found that 79% of the 124 biotech companies surveyed had at least one contract or product from a Chinese CDMO/CMO.
It’s expected that Indian and South Korean CDMOs will see greater demand if this bill is signed into law by US President Joe Biden. In that case, there are concerns that pharmaceutical products could rise in price due to supply chain issues or that patients will lose access to important therapies. WuXi AppTec and sister company WuXi Biologics are involved in the manufacture of several approved drugs, including cell and gene therapies. Shares of WuXi AppTec and WuXi Biologics fell 10% and 3.9% respectively on Tuesday, September 10th.
Unlock smarter pricing strategies with Lyfegen’s tools to manage supply chain and pricing pressures. Act now and book a demo to see how Lyfegen can help optimize your market access: Book a Demo