Value-based pricing vs best price? Medicaid's best price problem
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Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug pricing arrangements. Policy makers hope with this potential contracting risk and liability gone, manufacturers and healthcare payers will increase their participation in value-based drug pricing agreements.
In 1990, the Medicaid Prescription Drug Rebate Program (MDRP) was created to help slow the expenditures of outpatient prescription drugs to Medicaid patients. Under the MDRP, drug manufacturers who want their drugs covered by state-run Medicaid programs must sign a National Drug Rebate Agreement (NDRA) with the Department of Health and Human Services (HHS).
The NDRA requires participating manufacturers to reveal the lowest available price of their products and pay rebates on their products. According to the Centers for Medicare and Medicaid (CMS), there are around 780 drug manufacturers with NDRAs currently in effect.
The rebates of the Medicaid Best Price Policy
Under the MDRP, manufacturers must inform CMS of the “best price” available for its products. Excluding the price negotiated with some government programs, manufacturers are required to report the lowest price it offers to any drug wholesaler, retail outlet, or healthcare provider. This best price is then used to calculate rebates. Manufacturers pay rebates quarterly to states for the drugs covered under state Medicaid programs.
The rebate for most brand name drugs (excluding certain clotting drugs and pediatric drugs) is 23.1% of the average manufacturer price (AMP) paid by wholesalers and retail pharmacies. If the difference between the AMP and the best price on the market is more than the AMP, then this percentage would become the rebate. The rebate amount for generic drugs does not include a best price provision and stands at 13%.
Rebate analysis plays a critical role in understanding these calculations, as it enables manufacturers and payers to evaluate the financial implications of pricing agreements and compliance with regulatory requirements under the MDRP.
Outcome-based drug pricing can affect rebates
Despite the industry-wide push from stakeholders and policy makers towards value-based drug pricing arrangements, manufacturers have been wary of signing on to these agreements. They argue these outcomes-based pricing agreements could have unintended consequences that affect the AMP and best price. This, in turn, can skew the calculations for a manufacturer’s rebate liability.
In value-based drug pricing, a drug’s purchase price is linked to the effectiveness of the drug; if the drug underperforms, the manufacturer must pay a rebate, or other form of reimbursement, to the purchaser. Depending on the terms of the value-based pricing arrangement, this could be a substantial reimbursement to a payer for poor patient outcomes. The reduced price after the rebate–even if it’s paid on behalf of only one patient’s poor outcome–could become the new, lower best price.
The new Multiple Best Price policy
Before the multiple best price policy went into effect, manufacturers feared that, in theory, if the terms of a pricing agreement resulted in a 100% reimbursement to a payer for a drug proven to be ineffective, the manufacturer could find themselves in a situation where they had to give away their drug for free to every state Medicaid program.
In response to this interpretation of the best price policy–which became a regulatory barrier to value-based drug pricing arrangements–CMS revised the best price policy with the Final Rule. Under the Final Rule, as of July 2022, manufacturers can now report multiple best prices: the single best price for traditional sales and the prices negotiated under value-based pricing arrangements.
This option to report multiple best prices to CMS is only available for manufacturers who offer states the same terms negotiated in the value-based drug pricing arrangements with commercial insurances. State Medicaid programs can choose to take part in the value-based arrangements or continue to make purchases using the traditional best price.
Critique of the Multiple Best Price policy
Although CMS’ goal with the multiple best price policy was to reduce a significant regulatory barrier, this change still draws critics. And CMS has acknowledged that there will be implementation challenges. Here are some examples of criticisms of the new multiple best price policy.
• Critics find the Final Rule’s updated definition of a value-based drug pricing agreement to be too narrow or too broad. Before the Final Rule went into effect, organizations such as the Coalition for Affordable Prescription Drugs (CAPD) and the Pharmaceutical Research and Manufacturers of America (PhRMA) were concerned the CMS definition of value-based contracting is too narrow and will exclude some value-based pricing arrangements that are already in effect or in negotiations.
By contrast, AARP worried there is a lack of clarity on the definition of value in the Final Rule that could lead to the designation of almost any drug purchasing agreement as a value-based agreement and open the door to fewer rebates for Medicaid programs and more revenue for manufacturers. Time will tell which is the real problem.
• There may not be a non-value-based price for a drug. If a manufacturer is not offering its product outside of a value-based pricing arrangement, there may not be a single, traditional best price to report. When there are no non-value-based sales to look at, CMS advises manufacturers to use reasonable assumptions to set a non-value-based price. Critics, of course, question the loose guidance of a “reasonable assumption” and see this as an opportunity for manufacturers to game the system.
Some stakeholders are also concerned manufacturers will shift most traditional sales contracts to value-based pricing arrangements with the goal of eliminating less profitable, non-value-based best prices. AARP and National Association of Medicaid Directors (NAMD) have warned that the new rule could undermine the MDRP best price policy that has been so successful in reducing Medicaid drug expenditures.
• There may be technological and operational barriers for State Medicaid programs who want to take part in value-based drug pricing agreements. Like NAMD and AARP, the National Organization for Rare Disorders (NORD) worries manufacturers could be working to erode the MDRP’s best price policy by providing better rebates to commercial insurance companies under value-based pricing arrangements.
Manufacturers and CMS know that some state Medicaid programs will not have the infrastructure needed to implement value-based pricing agreements with more favorable terms. In its Technical Guidance for using multiple best prices, CMS makes suggestions for creating alternative, innovative agreements when intensive data collection and analysis are not feasible.
Related Post: Indication-specific pricing to make inroads in the U.S.
The Lyfegen Solution
A lack of resources and staff prevents some state Medicaid programs from operationalizing value-based drug pricing arrangements. Lyfgen assesses an organization’s current data gathering capacity, then offers customized solutions using its contracting software platform to support the execution of value-based drug pricing arrangements.
Lyfegen’s Platform helps healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. By collecting real-world data and using intelligent algorithms, the Lyfegen solution can provide valuable insights into drug performance and cost in value-based contracts.
Lyfegen helps increase affordability and access to healthcare treatments by enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact us to learn more about Lyfegen’s software solutions and to book a demo.
Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug...
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When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare their budgets and formularies to launch value-based drug pricing arrangements as soon as a new treatment receives FDA approval. Pre-approval data sharing between manufacturers and payers gives patients quicker access to newly approved treatments.
As the healthcare system in the U.S. continues its transition from fee-for-service to value-based care, the sharing of healthcare economic information (HCEI) is becoming increasingly important to pharmaceutical manufacturers and healthcare payers seeking to enter value-based drug pricing arrangements.
In the past, drug manufacturers were hesitant to share HCEI and other pre-approval information with payers because regulations were unclear about the legal limits of this type of communication. But payers want HCEI from drug manufacturers for planning, formulary design, budgeting, and purchasing decisions. And lawmakers want to eliminate legislative barriers that inhibit the sharing of HCEI and the increased adoption of value-based healthcare.
The history of legislation surrounding manufacturer/payer communications
Policymakers and regulators, like the Food and Drug Administration (FDA), recognize the importance of big data and the sharing of HCEI for promoting value-based payment arrangements. Their first attempts to remove the legislative barriers to the exchange of HCEI between drug and device manufacturers and population healthcare managers did not produce the desired effects.
The first U.S. federal consumer protection law, the Food and Drugs Act, was enacted in 1906. This law’s consumer protections and law enforcement capabilities were strengthened by the 1938 Food, Drug, and Cosmetic Act (FD&C). Section 502(a) of the FD&C introduced and defined HCEI, giving the pharmaceutical industry their first instructions about what kind of economic data promotion could be communicated and with whom. But manufacturers refused to share information, fearing the penalties of accidentally disseminating off-label information.
Section 114 of the FDA Modernization Act (FDAMA) of 1997, amended FD&C Section 502(a) and provided a safe harbor for HCEI sharing. But manufacturers continued to resist sharing economic data because they felt the guidelines were still too vague about some topics, such as the definition of reliable scientific evidence and who was authorized to receive HCEI. The FDA failed to issue guidance on how to interpret the law.
The industry-wide push towards value-based care after the Affordable Care Act passed made clarification of Section 114 a priority again. In 2016, policymakers issued clarifying guidance about communications and transparency of HCEI, both pre- and post- FDA approval. The 21st Century Cures Act, Section 3037 further defined what types of HCEI and analyses could be used for drug promotion and to whom the HCEI should be communicated. The FDA published a draft payer guidance document in 2017 and then final guidance documents in 2018 suggesting ways to operationalize communications between pharmaceutical manufacturers and payers.
Current FDA guidance
An FDA press statement from June 2018 emphasizes that the 2018 guidance documents are meant to help pharmaceutical manufacturers provide payers with truthful, non-misleading background and contextual information about their products. Furthermore, manufacturers are encouraged to share both clinical data and HCEI payers need to make informed decisions about formulary management, cost effectiveness and reimbursement; this may be more and different data than the safety and efficacy data submitted by the manufacturer to the FDA for drug approval decisions.
The guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities–Questions and Answers, expands upon the sources of scientific evidence for HCEI as defined under Section 502(a). And the guidance clarifies who can receive HCEI, including public and private sector payers, formulary committees, technology assessment panels, third-party administrators, and other multidisciplinary parties.
This first guidance also addresses manufacturers’ communications with payers regarding unapproved uses of FDA-approved products. The FDA does not object to the sharing of this type of information as long as the manufacturer makes it abundantly clear in its communications what uses the product is not approved for.
The second guidance introduced in the FDA press statement is titled Medical Product Communications That Are Consistent With FDA-Required Labeling–Questions and Answers. It pertains to information not included in a drug’s labeling but information that a manufacturer may want to share with payers. Examples can include data from pre- and post-market studies or surveillance of patient compliance that can affect the measurement of a drug’s benefits to health outcomes in value-based contracts. (The first guidance offers safe harbor for communications related to the negotiations or implementation of value-based drug pricing agreements.)
Timing of information exchanges
Payers prefer to receive information regularly from manufacturers during the latter part of the FDA drug approval process. Annual budgets and formulary planning are more difficult to forecast if payers don’t have data in advance to prepare for the coverage of a new drug. Payers are more likely to make a newly approved treatment available to patients without delay when manufacturers share the clinical data and HCEI needed to make formulary and pricing decisions during pre-approval.
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Under the FDA’s accelerated approval process, therapies sometimes become available to patients even before the publication of clinical trial data is complete. Payers say, ideally, they would like clinical and HCEI data about new products 12 to 18 months before the projected FDA approval date.
Many manufacturers wait to begin communications with payers until just 6 to 12 months before their product’s expected approval date. Recognizing the importance of HCEI in negotiating value-based drug pricing arrangements, some manufacturers have included HCEI in their FDA product dossier and promotional materials for payers.
The FDA guidance recommends increased transparency about cost data, including price range, price parity with competitors, price premiums, discounts, and inflation adjustments. Some manufacturers and payers prefer to wait for final clinical trial data before discussing pricing. Post-approval data-sharing of real-world evidence must continue between manufacturers and payers to implement value-based drug pricing agreements.
The Lyfegen solution
With most regulatory barriers removed and value-based contract communications exempted from FDA reporting, policymakers hope to see an increase in value-based drug pricing arrangements. Manufacturers and payers can partner with third-party vendors like Lyfegen to employ technology that facilitates easy, continued data-sharing for innovative pricing agreements.
Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to implement value-based drug pricing arrangements with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable information about drug performance and cost.
By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about our services and the Lyfegen Platform, book a demo.
When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare...
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U.S. and European healthcare payers are increasing their utilization of value-based drug pricing agreements to hold down drug costs, bring better value and improvements to health outcomes, and determine a fair price for new drugs. The question of who does the assessments to determine a drug’s fair price is answered differently in the EU than in the U.S.
National healthcare leaders have a common problem to solve and a common goal to achieve. The problem is how to protect national healthcare budgets from overwhelming drug costs without discouraging pharmaceutical manufacturers from developing new products. The goal is to provide populations with equitable access to innovative, safe, clinically effective, and cost-effective healthcare therapies.
In the U.S., payers and policymakers are trying to control drug expenditures and determine the value of new drugs in an opaque, free-market environment. In Europe, government price controls and centralized clinical and economic evaluations of new drugs are standard. For both these pharmaceutical markets, drug pricing agreements based on value instead of volume are gaining traction.
The problem: drug prices keep rising
Pharmaceutical sales in Europe are almost a quarter of all drug sales globally. From 2015 to 2020, the top five European markets–the UK, Germany, France, Italy, and Spain–accounted for 17.4% of sales of new drug therapies. These top five markets are predicted to increase spending by $51 billion through 2026.
North America is the largest pharmaceutical market, accounting for almost half of the total global sales. From 2015 through 2020, the U.S. purchased 63.7% of all the new medicines introduced. The U.S. is expected to increase drug spending by an estimated $119 billion through 2026.
According to IQVIA, a leading healthcare consulting firm, the change in drug spending in the U.S. and European markets through 2026 will be due, in large part, to new brands.
The goal: access to new, high-quality drug treatments at a fair price
Healthcare payers don’t want to take on the financial risk and clinical uncertainty of a new, high-cost pharmaceutical product. Payers want to provide patients with equitable access to innovative treatments that improve health outcomes, especially in therapeutic areas with unmet health needs.
Value-based drug pricing arrangements address these concerns with evidence-driven, outcome-based agreements. The payer and manufacturer share the risks of a new drug not performing as expected. In both the U.S. and the EU, payers and manufacturers are engaged in more finance-based drug pricing contracts than performance-based contracts–but this trend is shifting.
Assessing a drug’s value in the EU healthcare system
Value-based drug pricing arrangements are called managed entry agreements (MEAs) in Europe. MEAs between drug manufacturers and healthcare payers can be finance-based (FBAs), performance-based (PBAs), or service-based agreements (SBAs).
Unlike the U.S., the EU has a centralized system for assessing a drug’s value. Each EU member state has an agency that uses an evidence-based data gathering process called health technology assessments (HTAs). HTAs include nine domains for assessment–four clinical and five non-clinical–that evaluate the efficacy and added value of a new drug compared to other treatment options already available on the market.
The work of the member states’ HTA bodies is coordinated by the European Network for Health Technology Assessment (EUnetHTA). However, conclusions and decisions related to drug pricing and reimbursement remain de-centralized.
Coverage with Evidence Development (CED) may be a part of an MEA and come after the HTA. CED is a way for urgently needed treatments to come to market under conditional approval while real-world evidence continues to be collected. This additional data should help payers decide about coverage. CED use varies by country, with the most CED found in the UK and the U.S. (through Medicare).
Related Post: Indication-specific pricing to make inroads in the U.S.
Assessing a drug’s value in the US healthcare system
The possibility of developing a centralized Health Technology Assessment for the U.S. Healthcare System was the focus and title of a white paper published in early 2020 by the University of Southern California Leonard D. Schaeffer Center for Health Policy & Economics.
The white paper describes the complexities of creating a national HTA organization in the U.S. It examines the difficult dynamics of the many stakeholders in the healthcare system; few are operating with enough transparency and coordination with other stakeholders to support value-based drug pricing. The authors conclude that in the current polarized legislative environment in the U.S., an attempt to develop a national HTA organization would be met with strong political resistance.
In the absence of the European-style centralized HTA body, U.S. payers look to alternative sources for the data they need for drug pricing negotiations. Private and public payers may find clinical and economic evaluations from various agencies that do HTAs on a limited scale. These include government and independent organizations, such as the Department of Veteran’s Affairs, Medicaid, the Patient-Centered Outcomes Research Institute (PCORI), and the Agency for Healthcare Research and Quality (AHRQ). One of the most influential organizations in this space is the independent, non-profit Institute for Clinical and Economic Review (ICER).
Unfortunately, these organizations don’t do value-based pricing evaluations for every drug that comes on the market, and some of their work is not publicly available. Even if analysis of a selected drug is available, it may not cover the key metrics a customized value-based drug pricing agreement needs to track.
When real-world data about a drug’s performance is limited, it’s often up to the manufacturer and payer entering the value-based contract to develop the framework and the data collection and analysis capability, either in-house or through a third-party vendor.
The Lyfegen Solution
The Lyfegen Platform is a customizable solution for healthcare payers, pharma, and medtech companies who need to gather and analyze real-world evidence about a drug’s performance for value-based drug pricing agreements. Lyfegen’s value-based contracting software collects real-world data and uses intelligent algorithms to provide valuable insights into clinical effectiveness and costs.
Lyfegen’s contracting platform helps implement and scale value-based drug pricing contracts with greater efficiency and transparency. By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about Lyfegen’s software solutions, contact us to book a demo.
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In the heart of innovation, where technology meets healthcare, Girisha Fernando, CEO of Lyfegen, stands as a beacon of transformation. We sat down with him to discuss the groundbreaking launch of the Lyfegen Drug Contracting Simulator, a tool set to revolutionize drug access, pricing and contracting.
Fernando begins by outlining the quintessential challenge that spurred the creation of this novel tool. “Drug access, pricing and contracting has been entangled in the complexities of payer negotiations for far too long. Traditional methods like manually modeling pricing and contracting scenarios are not just cumbersome; they’re archaic, in light of the innovative drugs we are seeing, such as gene therapies.”
On the quest for a solution that addresses the underlying issues such as uncertainties that prolong or event prevent access, and finding a win-win scenario that both pharma & payers are happy with, Lyfegen has developed a groundbreaking solution – the Lyfegen Drug Contracting Simulator. The innovation embodies Lyfegen’s ambition to streamline and revolutionize the drug pricing and contracting process.
“What we’ve created is not just a better Excel, but a solution - intuitive, real-time, limitless. It was made to close the gap between old practices and new innovations within the healthcare space. It’s the future of drug access.”
As we delve deeper into the conversation, Fernando's enthusiasm for the simulator's potential benefits becomes palpable. “It’s about accelerating strategies, saving time, and fostering better decision-making,” he asserts. “The Lyfegen Drug Contracting Simulator is a multi-faceted solution that combines drug pricing, contracting, and business case generation, all within a collaborative and innovative framework.” The uniqueness of the Lyfegen Drug Contracting Simulator lies in its features, as Fernando highlights.
“We’re talking about a simulator that not only runs real-world simulations but also provides data-driven insights to empower negotiations.” This level of sophistication, according to Fernando, addresses concerns beyond simple discounts and delves into the nuances of value-based and outcome-based contracting models. What strikes most about Fernando’s vision is incorporating AI to guide users on optimal pricing and rebate models. “In today’s world, the intelligent use of data is crucial. The simulator can help pharma and payers to become more efficient and successful.”
As our conversation nears its end, Fernando touches upon a crucial aspect – data security. “Data privacy is non-negotiable. Lyfegen is committed to rigorous adherence to international data privacy standards and state-of-the-art data security.” Fernando’s final thoughts encapsulate the essence of the Lyfegen Simulator. “The Lyfegen Simulator is a paradigm shift in how the pharmaceutical industry will approach drug pricing. It’s about turning uncertainty into understanding, and that’s a powerful change.”
As we part ways, it’s clear that the Lyfegen Drug Contracting Simulator isn’t just another product launch. It’s a vision brought to life, a testament to Fernando’s belief in the transformative power of technology in healthcare. With this launch, Lyfegen isn't just offering a solution; it's shaping the future of drug access and contracting.
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In a year marked by landmark legislative changes in support of value-based drug pricing, Medicare has recently received authorization to negotiate directly with drug manufacturers under the health provisions of the Inflation Reduction Act of 2022. Proponents of the law are hoping value-based pricing negotiations and inflation-based rate hike rebates for the country’s largest public healthcare payers will lower national drug costs and save U.S. taxpayers hundreds of billions over the next decade. Of course, pharmaceutical companies disagree.
In 2022, the pharmaceutical industry spent $187 million in lobbying funds fighting–unsuccessfully–to stop passage of a law that would grant Medicare negotiating authority for drug prices. The Inflation Reduction Act (IRA) of 2022 brought to life a legislative fix patient advocates, physician groups, and Democratic legislators have been trying to enact for decades as a tool to help lower prescription drug costs.
When the Medicare Part D retail prescription drug program was created in 2003, Republican legislators added the “noninterference clause” to the law to prevent Medicare from negotiating drug prices. Private health plans run the Medicare Part D drug program, but they set formularies and conduct drug price negotiations without Medicare’s input. The IRA establishes Medicare’s voice in drug price negotiations with drug manufacturers under the Drug Price Negotiation Program set to begin in 2023.
Medicare will be authorized to negotiate directly with manufacturers to find Maximum Fair Prices (MFPs) for a limited number of drugs that have no generic or biosimilar competition. The law also limits price increases year-over-year for Medicare Part D and Part B units sold (not for commercial units sold). Outside of a few product exceptions, drug makers who increase their prices more than the rate of inflation will have to pay rebates to Medicare.
Which drug prices can Medicare negotiate?
According to the new law, each year the Secretary of the Department of Health and Human Services (HHS) will select from a list of qualified single-source drugs with the highest total Medicare spending. The list of negotiation-eligible drugs will consist of the 50 costliest drugs from Medicare’s Part D program and (after 2028) the 50 costliest drugs from Medicare Part B (for drugs physician-administered on an outpatient basis).
A timeline for the changes enacted by the new legislation gives pharmaceutical manufacturers and health insurers time to adjust. The first step of the Drug Price Negotiation Program gives Medicare the authority to negotiate the 10 most expensive Part D drugs, with the negotiated price starting in 2026. The program expands to 15 eligible Part D drugs by 2027. Beginning in 2028, some Part B drugs may also be included in the list of 15 products that can be negotiated. From 2029 forward, Medicare can negotiate pricing for up to 20 Part D and Part B drugs. In total, Medicare will be able to negotiate prices on up to 60 eligible drugs by 2029.
The drugs for price negotiations under the IRA must meet certain standards, including the following:
· The drug may not have a generic substitute.
· For small-molecule drugs, it must be at least 7 years since FDA approval was granted.
· For biologics, it must be at least 11 years since FDA approval was granted.
· New drug formulations or treatments for rare diseases are excluded.
· Treatments extracted or developed from human blood or plasma are not eligible for price negotiations.
· A drug is excluded if Medicare’s total expenditures for the drug are no more than 1% of total Part D expenditures.
· Most drugs developed by small biotechnology companies are excluded.
Not surprisingly, pharmaceutical companies see the passage of the IRA as an unfavorable development and view the Medicare negotiation process as price setting, not negotiations. The HHS and manufacturers are required to negotiate and agree on MFPs for negotiation-eligible drugs; negotiations are not optional. The drug manufacturer has 30 days to accept or counter the price offer Medicare makes. If a manufacturer refuses to cooperate with HHS or fails to negotiate in good faith, HHS can impose civil monetary penalties and an excise tax for non-compliance. It’s likely the pharma industry will challenge the law in court.
What analysts predict about industry impact and cost savings
In July 2022, the Congressional Budget Office (CBO) published the latest estimate of the budgetary effects of the health provisions in the IRA. The CBO expects Medicare’s ability to negotiate drug prices will save $102 billion in public sector healthcare costs over 10 years. During the same period, the CBO estimates an additional $62 billion in savings will result from the cap on drug price hikes at the rate of inflation.
The CBO expects manufacturers will increase launch prices for their new products to counteract the IRA’s inflation-rebate provision which slows the growth of prices over time. The analysts predict this will lead to an increase in Medicaid spending because Medicaid’s rebate program, triggered by the higher launch prices, would not fully offset the price increases. The CBO says Medicare Part B may also be affected by higher launch prices since that program uses the market’s average sales price of a drug to determine its reimbursement rate.
Analysts from Moody’s Investors Service expect there will be both price reductions for some drugs and limited price growth for other drugs. Moody’s analysts warn manufacturers that show high Medicare spending–due to their high prices, not patient consumption–will feel the impact of these regulatory changes the most.
Using the data from value-based drug purchasing arrangements
Proponents of Medicare’s authorization to negotiate drug prices believe the prescription drug provisions in the IRA are a suitable compromise that allows drug manufacturers to realize a reasonable profit while increasing the health benefits, accessibility, and affordability of prescription drugs for Medicare patients. Value-based purchasing arrangements will be an important tool at the core of this compromise.
Part of the criteria the HHS Secretary will consider when negotiating an MFP is the drug’s value to health outcomes and its cost-effectiveness compared with alternative treatments. Industry experts recognize that one of the best ways to gather insights into a drug’s performance is from the data collected in the implementation of value-based drug agreements. The data can either provide real-world evidence of a drug’s cost-effectiveness and benefit to patient health outcomes or reinforce the terms of a rebate for a drug’s underperformance.
Since negotiation-eligible drugs include those approved by the FDA at least 7 years ago, performance data may already be available from past value-based drug agreements for the first round of Medicare price negotiations. Manufacturers can prepare for future negotiations with Medicare by seeking value-based purchasing arrangements for their newer products as soon as possible after FDA approval.
The Lyfegen solution
Lyfegen, an independent global software analytics company, offers a contracting platform solution that helps health insurances, pharma, medtech, and hospitals implement value-based payment models with efficiency and transparency. Lyfegen’s Platform performs real-time, end-to-end, data collection and analysis through intelligent algorithms that can operationalize any value-based pharmaceutical purchasing arrangement and provide deep insights into a drug’s performance.
By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.
To learn more about our services and the Lyfegen Platform.
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Basel, Switzerland / Boston, USA – December 11, 2024
Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.
Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions
The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.
Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.
Learn more about Retrospective Payment System
Scaling Globally with a Leading Rebate Management Platform
Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.
“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”
Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”
About Lyfegen
Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand the full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.
About TX Ventures
TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage.
For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com
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In an industry often characterized by incremental changes, Girisha Fernando, the CEO and founder of Lyfegen, is making leaps. We sat down with Fernando to discuss the recent landmark partnership between Lyfegen and Newfoundland and Labrador Health Services—a collaboration that heralds a significant shift in the Canadian healthcare landscape.
Your partnership with Newfoundland and Labrador Health Services is quite a milestone. Can you share with us what this means for the current state of rebate management in Newfoundland?
Girisha Fernando (GF): Absolutely. This partnership is a transformative step for rebate management in Newfoundland. The current system, largely manual and complex, is ripe for innovation. With our digital platform, we're bringing a level of automation and accuracy that was previously unattainable. This means more efficient processing, less room for error, and a better allocation of resources, which is critical in healthcare.
That’s quite an advancement. And how does this impact the management of drug products, especially in areas like oncology?
GF: It’s a game-changer, especially for critical areas like oncology. Newfoundland and Labrador, as the first in Canada to use our platform, sets a precedent. The region, through the pan-Canadian Pharmaceutical Alliance, has been managing complex product listing agreements for drugs, including those for oncology. These agreements are vital for making treatments affordable. Our platform simplifies this, managing the various terms of these agreements efficiently, which is crucial for timely and affordable access to treatments.
It seems like a significant step forward for healthcare management. How does this align with the broader goals of Lyfegen?
GF: This partnership aligns perfectly with our goal to make healthcare more accessible and efficient. Automating the rebate process in Newfoundland and Labrador, especially for critical treatments in oncology, directly contributes to the sustainability and accessibility of healthcare treatments.
Looking to the future, what does this partnership mean for Lyfegen and healthcare systems globally?
GF: This is just the beginning. We're looking to extend our platform to healthcare systems around the world. Our aim is to make this technology a standard in healthcare management, fostering more efficient, sustainable, and equitable healthcare systems globally.
Read more about the partnership in the official press release.
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New York, NY - March 29, 2023 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced at the World EPA Congress the launch of its latest solution: the Model & Agreement Library. The purpose of the library is to help payers and pharma negotiate better drug prices while providing an in-depth view on current international drug pricing models and value-based agreements. The database library serves as the basis for successful drug pricing negotiations, resulting in accelerated access and drug prices better aligned to their value for the patient.
The shift towards value-based healthcare, rather than volume-based, has been steadily increasing over the years. This evolution has further reinforced Lyfegen's mission to remain at the forefront of analytics and digital automated solutions for the healthcare sector. Indoing so, Lyfegen’s solutions help to accelerate access and increase affordability of healthcare treatments.
“Because of rising healthcare costs and the increase of medical innovations, the thirst for knowledge and need for value-based healthcare capabilities has surged among healthcare payers, and pharma companies across the world”, said Girisha Fernando, CEO of Lyfegen. “That is why we are so excited about launching the world’s largest database of real-world value-based agreements. It gives payers, and pharma a unique insight into how to structure value-based agreements.”
The Lyfegen Model & Agreement Library was developed as an accelerated negotiation resource for both manufacturers and payers – allowing them to save on time, money; and for the first time – an opportunity to learn at their own pace without incurring large research projects or hiring expensive external experts. Users of the library are now enabled to make informed decisions in determining the most suitable drug pricing models and agreements for their products.
The database holds over 2'500+ public value-based agreements and 18+ drug pricing models – spanning across 550 drugs,35 disease areas and 150 pharma companies. Its search capabilities are spread across product, country, drug manufacturer and payer – with all the knowledge, insights, current pricing and reimbursement activities shown in near real-timeacross the industry.
“Just an academic taxonomy of models is intellectually exciting but it's not really helping your typical customer”, said Jens Grüger, Director and Partner at Boston Consulting Group (BCG). “The Lyfegen Platform goes several steps further. Payers and pharma have a problem and they want a solution. The Lyfegen Model & Agreement Library is practical. It offers case examples.”
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The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.
“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.
This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.
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Basel, Switzerland, October 27, 2021
Lyfegen announces that Swiss health insurance Sympany is using the Lyfegen Platform to implement & execute complex drug pricing models. Sympany applies the Lyfegen Platform to execute and efficiently manage all value and data-driven pricing models. Sympany gains efficiency and transparency in managing pricing models with the Lyfegen Platform. It offers many pricing models, including pay-for-performance, combination therapy and indication-based models.
The Lyfegen Software Platform digitalises all pricing models and automates the management and execution of these agreements between health insurances and pharmaceutical companies. This is done using real-world data and machine learning enabled algorithms. With the Lyfegen Platform, Sympany is also creating the basis for sustainably handling the increasing number of value-based healthcare agreements for drugs and personalized Cell and Gene therapies. These new pricing models allow health insurances to better manage their financial risk by only paying for drugs and therapies that benefit patients.
"The Lyfegen Platform helps Sympany execute complex pricing models efficiently, securely and transparently. We are pleased to extend our pioneering role in the health insurance industry by working with Lyfegen. This is another step for Sympany to provide our customers with the best possible access to therapies in a sustainable way," says Nico Camuto, Head of Benefits at Sympany, about the use of the Lyfegen Platform.
Girisha Fernando, CEO of Lyfegen, says: "We are very proud to support Sympany in strengthening its focus on value creation, efficiency and transparency amidst the growing complexity of pricing models. It is clear that the trend is increasingly towards complex pay-for-performance arrangements. Ultimately, our goal is to help patients receive their much-needed treatments while helping health insurances better manage risk and cost."
The Lyfegen Platform aims to help patients access innovative medicines and treatments by enabling innovative drug pricing agreements. The Platform collects and analyzes real-time pricing data, allowing health insurances and pharmaceutical companies to obtain relevant information on drug benefits and related financial planning.
About Sympany
Sympany is the refreshingly different insurance company that offers tailored protection and unbureaucratic assistance. Sympany is active in the health and accident insurance business for private individuals and companies, as well as in the property and liability insurance business, and is headquartered in Basel. The group of companies under the umbrella of Sympany Holding AG comprises the insurance companies Vivao Sympany AG, Moove Sympany AG, Kolping Krankenkasse AG, and Sympany Versicherungen AG, as well as the service company Sympany Services AG.
In 2020, profit amounted to CHF 68.8 million, of which Sympany allocated CHF 27.5 million to the surplus fund for the benefit of its policyholders. Total premium volume amounted to CHF 1,058 million. With 575 employees, the company serves around 257,100 private customers, of which around 204,500 are basic insurance policyholders under the KVG. In the corporate customer business, Sympany offers loss of earnings and accident insurance.
More about Sympany: https://www.sympany.ch
About Lyfegen
Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.
Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.
Contact Press: press@lyfegen.com
Contact Investors: investors@lyfegen.com
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Basel, Switzerland, August 3rd, 2021
Lyfegen announces that its value-based healthcare contracting platform has been implemented together with Johnson & Johnson Medical Devices Companies Switzerland (Johnson & Johnson) and a leading Swiss Hospital.
Through this new value-based healthcare approach, Lyfegen and its partners drive the shift towards what matters most to patients: improved patient health outcomes and more efficient use of financial and human resources, enabling a sustainable post-COVID-19 healthcare environment.
The shift towards a value-based healthcare in Switzerland and globally can only be achieved through the support of innovative technologies. Lyfegen’s platform is a key enabler for this transition. The platform digitalises and automates the execution of value-based healthcare agreements, paving the way for the resource-efficient scaling of such novel agreements.
“COVID-19 has shown us the urgent need for a more sustainable healthcare system. With the implementation of value-based healthcare agreements on the Lyfegen platform, we are extremely proud to help Johnson & Johnson and hospitals to accelerate the transition to value-based healthcare and improve patient health outcomes at reduced cost.” says Lyfegen’s CEO, Girisha Fernando.
Lyfegen's compliant, secure and patent-protected value-based healthcare contracting platform automates the collection and analysis of patient-level data. Users receive transparency on actionable health outcomes and agreement performance. Lyfegen’s contribution to this partnership is a blueprint for the scaling of value-based healthcare models across hospitals, health insurances, medical device & pharma companies globally. The partnership marks another important milestone for Lyfegen, as the company continues to grow and has recently opened its next investment round.
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He loves innovative tech and spending his free time reading Hi-tech books! Yes, we are proud to announce Lyfegen’s latest addition to the Kiev team: “Full-Stack Developer”, Dima Guzyk!
“Dima is extremely talented and with his passion to develop new and exciting technology that helps patients, Lyfegen’s products will reach new levels. We are very proud to have him in the team! ” says Lyfegen’s CEO, Girisha Fernando.
We sat down with him to give you a little more insight behind the book-loving “Full-Stack Developer”:
Hi Dima! Tell us a little about yourself: where are you from and what is your work experience background?
Hello! I’ve lived in Kiev almost all my life. This is such a beautiful city. For any lifestyle or interest, the city offers amazing opportunities to live out your dreams!
Regarding my work experience: After I graduated from university, I started working at Intellect Service, the biggest electronic document flow solutions developer in Ukraine. Gradually, my professional and communication skills developed and I became Team Lead of the company’s product. It was a great experience and led me to stay with them for 5 years!
My latest experience was at KPMG as a Software Engineer, where I participated in the development of various corporate information systems. Only after a short year, I had the fantastic opportunity to grow and take over the role of Senior Software Engineer.
This is your first experience in the Health Tech industry – what triggered this move?
This is my first experience in the Health Tech industry and I’m so happy! Working at Lyfegen gives even a tech development job a greater purpose: my work will indirectly support greater access for patients to innovative therapies – helping to save lives!
You are joining Lyfegen as a Full-Stack Developer. In simple terms: what will you be working on?
I participate in all the stages of software development, following the business requirements. In addition, I also analyze the domain in detail, propose architectural solutions to the problems we discover, write code, write unit tests, and help with creation of a reliable, scalable and secure application environment! In simple terms, I will bring the technical solutions of Lyfegen to life!
What are your next personal goals with Lyfegen?
My goal is to constantly discover new approaches and technologies, being able to make comparisons between them and implement the best to the work I do.
What motivated you to join?
When I discovered what Lyfegen was doing, giving patients worldwide access to innovative therapies, I knew I had to be a part of the team! Innovative therapies are necessary for humankind – it’s just that no one has been able to make these more accessible to a wider range of patients. This greater purpose and the impact that this technology has, was the key driver!
Enough about work! What passions do you have outside of Lyfegen?
I am an incredibly curious person! I have a wide range of passions that interest me but most of all I enjoy reading historical and Hi-tech books and magazines.
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
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The Lyfegen Team is proud to announce that as of this month, Simon has taken on the new role of “Customer Success Hero” at Lyfegen!
Simon joined Lyfegen 6 months ago as a working student and very quickly, full of motivation and enthusiasm, took on important responsibilities. Supporting Nico in the management of Lyfegen’s customer relations, which include some of the largest pharma companies worldwide, Simon will be accompanying the customers during the entire journey starting with supporting the customer’s in identifying suitable models up to the continuous support of Lyfegen's solutions. By gaining a comprehensive understanding of Lyfegen's customers' needs, he will also be working together with the technical development team to further enhance Lyfegen's solutions.
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 bike-riding, FIFA-loving, “Customer Success Hero”!
Hi Simon, so tell us: why are you leaving large corporates like Roche and UBS to join the start-up Lyfegen?
After working at these two large corporates for several years I felt like I needed to see something completely different outside the corporate world. I was getting too much into a routine and wanted to take on a new challenge. I always had this entrepreneurial spirit in me and when I got the chance to start at Lyfegen, I didn’t have to think twice. Lyfegen offers me the perfect environment and has a great purpose.
You are working already since January 2020 at Lyfegen; what fascinates you the most?
I am really fascinated by the huge enthusiasm and passion of the whole team! Everyone here is very dedicated to leading Lyfegen to success and to driving value-based healthcare forward. I am also fascinated with how many new things I learn every single day and I am very delighted about how much responsibility I could already take over in this short time.
How do you experience the collaboration with the team?
The team has a great spirit and I felt very welcome and involved from the first second. The communication within the team is very transparent and open-minded. Issues can be addressed openly and critique is always given in a constructive way.
Healthcare is changing to value- and data driven models. How do you experience this change with our customers?
Our customers are all very interested in value- and data driven healthcare, but these models are often a new experience for them. With our technical solutions and our know-how, we support our clients to make the transition to value-based healthcare happen. We are now at a stage where we are pioneers and proactively shape the future environment for such models together with our clients.
What are your personal next goals with Lyfegen?
My personal goal is to further grow with the company. Growing not only personally by gaining more experience and continuously taking over more and more responsibility, but also to help Lyfegen achieve its next milestones. I am looking forward to be part of this journey.
We currently have two open positions - What are your recommendation for other talents that are applying at Lyfegen?
If you are applying at Lyfegen I recommend you to be aware of what it means to work in a start-up. You need to be ready to step outside your comfort-zone, be willing to actively drive things forward and take ownership. If this is what you are looking for, then Lyfegen is the perfect fit for you. Lyfegen offers you the perfect environment to further develop yourself and to work on exciting projects that have a real impact and a great purpose, helping patients to access innovative therapies.
Enough about work! What passions do you have outside of Lyfegen?
I love bike racing and being in nature! I can often be found on weekends biking my way up hills and testing my limits! It’s a great way to disconnect and focus on nature. But I’m not always in nature – I must admit, I do love playing video games too, especially FIFA (and am the proud winner of our last Lyfegen FIFA tournament – yes, the team got together for a 8 hour challenge one weekend!). Work hard, play hard!
We are proud to have the Lyfegen team continue to grow with such fantastic team-members!
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We are pleased to welcome the latest addition to our tech team! Andrei joins Lyfegen as a full-stack developer. He brings his wealth of backend and frontend experience to elevate our platform.
"I am excited to welcome Andrei to our Tech Team as a talented and motivated Full-Stack developer. Andrei brings great skills and knowledge to our team and will support us in further building our applications." Says CTO, Frederico Braga.
To introduce our newest addition, we interviewed Andrei.
Welcome to the Team, Andrei! Tell us a little about yourself.
Hi! My name is Andrei. I am from Romania, and I graduated from the Technical University of Cluj Napoca. In the last seven years, I have worked as a software developer at different companies and with different technologies like .net, iOS, Angular, Typescript, MSSQL, Mongo DB, SoapUI.
What drives you to be a full-stack developer?
I chose to be a full developer because I like to be involved in every phase of a software application, from the UI side to the server. In the last eight years, the modern technologies used for building stack server-side applications and client-side applications became much easier to use, which allows us to learn multiple technologies on both sides.
What motivated you to join Lyfegen?
At the beginning of my career, I worked for another startup company. I remember my satisfaction when someone used our product, and I want to feel that again. Lyfegen is giving me many opportunities to positively impact the world because we are driving things in the right direction. I consider value-based contracts the best solution for patients, healthcare payers and Pharma companies.
What is your first impression as of now?
I like and appreciate the whole team. All my colleagues have brilliant ideas that are bringing the Lyfegen platform to its best form. The Lyfegen platform is one of the strongest I have seen so far in my career, and this is because everyone has a voice within the team.
How will your know-how help the Lyfegen customers experience our platform the best way possible?
Throughout my career, I have worked on several big projects in different fields providing technical solutions for different problems on the frontend side and the backend side. These experiences have taught me the importance of accessibility features, and I would like to bring that knowledge to improve the user experience of Lyfegen users. I can help the Lyfegen customers better interact with the platform in terms of performance.
What is something you want to learn or improve this year?
I am looking forward to improving my understanding of the healthcare and pharmaceutical industry. From a technical perspective, I'm excited to work and learn Grandstack technologies.
What passions do you pursue outside of work?
I love to play board games, tennis and football. During the summer weekends, I like to go hiking, and in winter, I enjoy skiing. I also have an interest in politics, and I try to stay updated with trends in the IT industry because of my passion for new technologies.
What else are you looking forward to?
I look forward to deepening my relationship with my teammates. I strongly believe that working in an atmosphere that promotes teamwork makes our lives much more enjoyable. At the same time, it has a positive impact on the project.
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He loves innovation and thrives on solving problems using code. Besides developing and studying he plays basketball, travels and reads. We are proud to welcome the newest talent to the Lyfegen team: “Junior Developer” Thungu!
“The motivation and the skills of Thungu are undisputed. Among other things, that is what makes him and Lyfegen a perfect match. Constant evolution and progression are some of the most important objectives at Lyfegen, that is why Thungu will join our Team to help us add new UI components to our products and automate our testing processes in coordination with the UI/UX designers and Business Analysts, resulting in a higher overall quality and user satisfaction of our products. We are looking forward to work with Thungu here at Lyfegen.” Says CTO, Frederico Braga
To introduce our newest talented team member, we virtually sat down with Thungu for an interview.
Welcome to the team Thungu! Tell us a little about yourself.
Hi, my name is Thungu, and I am from Colombo, Sri Lanka. I am a Software Engineering undergraduate at the University of Westminster in my second year while working here at Lyfegen. I also volunteer for the IEEE student branch of my university to organize hackathons, webinars and other tech related events.
What drives you to be a developer?
I love figuring things out, exploring new technologies and solving problems with code. When facing challenges as a developer I always explore the “yes” and try to figure things out before accepting a “no”. That figuring out part is what drives me to be a better developer and what I enjoy mostly about being a developer.
What was your motivation to join Lyfegen?
I wanted my first work experience to be in an innovative company which has a positive impact on the world and when I got to know what Lyfegen does, I knew this was it. With value-based healthcare in its early stages, I see it’s huge potential and the unprecedented value it brings towards humanity. I knew I had to be a part of this great journey!
What are your first impressions so far?
It has been a very pleasant experience. I am enjoying the startup culture - everyone is very close, friendly and welcoming. The flexibility at Lyfegen is one of the things that I appreciate most, as it is really important for me to have an evenly work and university life balance. I am also very impressed by how dynamic and motivated the team is. Everyone is ready to move mountains for patients!
How will you improve the customer experience on the Lyfegen platform?
I will be focusing mainly on Frontend Development and Testing which includes building new components with the help of our Kateryna, our UI/UX designer and testing the functionalities of our products together with Pavlo.
What do you want to learn and improve this year?
I am looking forward to improving my skills and helping Lyfegen in other stages of Software Development in addition to Frontend Development and Testing. I also want to improve my understanding of the healthcare industry.
What are you especially looking forward to as you take on this new role?
Although I enjoy all the virtual coffees, I am very much looking forward to meeting everyone in person someday. I’m also looking forward to grow as a professional and becoming a better and experienced developer. I feel very grateful to work with such an amazing team of experienced developers and other team members.
What passions do you pursue outside of work?
I love to play basketball, create travel videos and also photography is my passion. I read books focusing on life and spirituality, I learn new technologies, and sometimes I play the guitar.
We are proud to welcome Thungu to the Lyfegen team!
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We are thrilled to announce that our tech team continues to grow: A warm welcome to Giancarlo, Lyfegen’s new Full-Stack Developer! With his background as a security engineer, he knows how to make our platform even safer!
“I am excited to welcome Giancarlo to our Tech Team as a Full-Stack developer. Giancarlo’s experience in the areas of Machine Learning, Security and Software Development are critical to our long term success and development of the Lyfegen Platform.” Says CTO, Frederico Braga
To introduce our newest team member, we virtually interviewed Giancarlo.
Welcome to the team Giancarlo! Tell us a little about yourself.
My name is Giancarlo and I live in Chur, Switzerland. I hold a bachelor’s degree in computer science. I previously worked as a security engineer, designing and implementing big data applications at a Swiss telecom company. At Lyfegen I will be working on improving our platform as a full stack developer.
What drives you to be a full stack developer?
For me, the variety of tasks is the biggest appeal of being a full stack developer: One day you could be working on low level database tasks and the next day on implementing user-interface (UI) elements. This keeps the job challenging and interesting!
What motivated you to join Lyfegen?
Until now, I was working for a rather big company where my impact was small. I wanted to change that. At Lyfegen I am able to create something meaningful from the ground up.
What is your first impression as of now?
My first impression was very positive: The people at Lyfegen are kind, helpful and smart. A perfect mix in my opinion! I’m looking forward to all the interesting tasks, complex problems and engaging conversations with my colleagues.
How will your know-how help the Lyfegen customers experience our platform the best way possible?
As a former security engineer, I know the most common threats and pitfalls when it comes to creating a software. I hope to use my expierence and knowledge to make our platform safer and more resilient to potential threats in the future.
What is something you want to learn or improve this year?
In previous jobs I was mainly developing backend applications. This year I want to improve on the frontend side and learn new technologies when it comes to graph databases. I always wanted to improve my Italian, so maybe 2021 is the year where I take some time to do just that!
What passions do you pursue outside of work?
I play lacrosse in our local club twice a week. Food is another passion of mine: I also love to cook and try new restaurants. On rainy Sundays, you’ll find me playing boardgames or Dungeons and Dragons with my friends.
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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
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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!
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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
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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.
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References
“Welcome to brighter.” Mercer, https://www.mercer.com/en-us/.
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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.
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