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Federal Trade Commission inquiry could eventually lead to overhaul of prescription drug rebate system

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Federal Trade Commission inquiry could eventually lead to overhaul of prescription drug rebate system

In June, the U.S. Federal Trade Commission (FTC) voted unanimously (5-0) to examine rising list prices of insulin, but also to probe possible anti-competitive practices by pharmacy benefit managers (PBMs) with respect to the use of rebate arrangements. Rebates are payments from drug manufacturers to PBMs in exchange for moving market share towards so-called preferred products on the formulary.

 

The FTC has specifically cited instances in which cheaper generics and biosimilars are excluded from PBM formularies, as this may violate competition and consumer protection laws.

The FTC inquiry into pharmacy benefit manager (PBM) practices could lead to legal action prohibiting certain rebate practices. In turn, this could induce major changes in the U.S. rebate system. Formulary management could become increasingly value- or outcomes-based, rather than simply a function of a financial power play between drug makers and PBMs. Or, rebates could fall by the wayside altogether, to be replaced by a combination of upfront discounts in lieu of rebates and value-based pricing arrangements. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.

The FTC has warned of legal action against PBMs if its inquiries find proof of anti-competitive practices. Here, the agency raised the stakes when it included terms like “commercial bribery” in its statements to describe what it perceives as anti-competitive rebates in the insulin market.

The latest FTC inquiries follow a recent investigation by Senators Grassley (R-Iowa) and Wyden (D-Oregon), which blamed rebate schemes for much of what ails the prescription drug market. Furthermore, nearly two years ago, Senator Klobuchar (D-Minnesota) and colleagues commissioned the General Accounting Office (GAO) to examine rebates. The GAO report is due out this fall.

PBMs receive rebates from drug manufacturers in exchange for preferred positioning on the formulary, which in turn drives market share. Experts have criticized rebates for the fact that payers often don’t base their decisions to include a drug on comparative clinical- and cost-effectiveness. Rather, decisions are strictly based on financial terms, namely which manufacturer offers a higher rebate payment to the PBM; a financial power play in which PBMs may threaten not to cover certain drugs if they don’t get the rebate they want. This applies to insulin as well as numerous other therapeutic categories.

What’s worse is when rebate traps or walls are involved. Branded manufacturers leverage their position as market leaders by offering financial incentives to PBMs and health insurers in the form of “all or nothing” conditional volume-based rebates, in exchange for (virtually) exclusive positioning on the formulary. This can mean keeping competitors off the formulary entirely, or severely limiting formulary access to a competing drug with drug utilization management tools like step edits. Here, a patient must use a preferred drug and fail on it (a so-called “fail-first” policy) before “stepping up” to a non-preferred drug.

Because the portion of the rebate retained by PBMs is often calculated as a percentage of a drug’s list price, PBMs can have incentives to establish formularies that favor branded drugs with higher list prices and larger rebates over lower priced biosimilars, specialty generics, or even branded competitors. Rival drugs entering the market lack sufficient sales volume to be able to offer the same level of rebates to PBMs that originator firms can provide.

Proof of the establishment of anti-competitive practices could lead to legal action being taken against PBMs. The question then becomes what would replace rebates? Payers may establish an entirely different formulary management system that is more value-based. Surely, it would be a system that’s less contingent on the role of the financial power play between drug makers and PBMs.

In areas such as immunotherapy targeting certain cancers, cell and gene therapy, and rheumatology, there are already a growing number of value-based agreements.

Girisha Fernando, CEO and Founder of Lyfegen, which offers a platform to track value-based agreements with real-world data, said that many outcomes-based deals are kept secret and therefore under the radar, so to speak. Commercial payers generally don’t share publicly what types of value-based deals they have with drug companies to maintain their competitive advantage. Yet, in an interview with Endpoints News Fernando stated that he’s observed at least a 300% increase in value-based agreements over the last five years. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.

Fallout from the FTC inquiry – should rebates be identified as anti-competitive - may entail further increases in value-based dealmaking.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst n a variety of research, teaching, speaking, editing, and writing projects.

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Healthcare providers hold real-world evidence about a drug’s value. How to convince them to share the data?

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Healthcare providers hold real-world evidence about a drug’s value. How to convince them to share the data?

With the right tools, healthcare providers can collect real-world evidence about a drug’s value and benefit. How do we convince them to share the data through value-based purchasing arrangements?

 

In the U.S., lawmakers, payers, and the public are putting pressure on healthcare providers to help transform the healthcare system in the U.S. Despite resistance from healthcare providers to abandon traditional fee-for-service models, the U.S. healthcare industry continues trending towards the adoption of value-based payment models. This transformation includes the ambitious but necessary goals of producing better public health outcomes, decreasing health disparities, increasing affordability for patients, and decreasing the cost of healthcare overall.

At the heart of value-based pharmaceutical pricing is collecting the right data to measure and assess the benefit of a treatment. Real-world evidence is needed to determine a drug’s contribution to health outcomes. As workers on the front lines, healthcare providers are in an excellent position to collect data on a drug’s performance. With this information, decision-makers can arrive at a drug price that reflects its true value to patient health outcomes.

Patients are having trouble paying for their prescriptions

A 2019 Kaiser Family Foundation Health Tracking Poll revealed three out of ten patients surveyed—ages 50 to 64 years old—stated they had difficulty paying for their medications. Drug prices, price increases, and copays and deductibles are preventing some patients from starting, or continuing, the treatments they need.

In the U.S., hospital system clinicians and independent physician practices are expected to choose the best treatments for their patients without consideration of the patient’s insurance coverage status. Providers often have little to no idea of the costs their patients will bear without insurance, after insurance deductibles and copays are met, or after a drug maker’s patient assistance program intervenes.

A patient’s cost-related nonadherence may include not filling prescriptions, skipping doses, taking a lower dose than prescribed, and experimenting with non-prescription, over-the-counter treatments; these strategies affect patient health outcomes.

When patients are already struggling to cover prescription costs, they can’t afford to waste money on low-quality treatments that are ineffective or of little benefit to their health outcomes. Providers also don’t want to waste time with treatments that don’t produce better health outcomes. Therefore, most healthcare providers are open to exploring value-based pharmaceutical purchasing agreements that can allow access to newer, more effective treatments that patients can afford.

The benefits of value-based purchasing arrangements for healthcare providers and patients

Healthcare providers willing to enter value-based pharmaceutical purchasing arrangements are rewarded with many benefits, including:

• Improved quality of care and better health outcomes for patients

Providers in value-based purchasing arrangements gather real-world evidence of the effectiveness of a drug. They collect data that reveal which treatments are the most clinically effective and which add little or no value to patient health outcomes. This could lead to new insights into best practices and new clinical guidelines and protocols.

• Increased access to innovative, more effective treatments

Under value-based purchasing arrangements, providers and patients can gain access to brand new, high-cost prescription drugs. Real-world data gathered during contract implementation reveal the new drug’s benefit to health outcomes. Value-based purchasing can also encourage providers to try other lower-cost treatment options like biosimilars and new generics.

• Greater operational efficiency and reduced overall cost of healthcare

Identifying and eliminating low-value treatments through value-based arrangements reduces the waste of resources and time for both providers and patients. The provider’s clinical operations can become more efficient and cost-effective, with positive effects on revenue and patient satisfaction.

Healthcare providers have concerns about value-based purchasing arrangements

Despite the upside, providers are wary; value-based purchasing arrangements are complex. They require careful consideration of what metrics are to be measured. Stakeholder partners must navigate a new level of transparency and data sharing. And naturally, each partner in the agreement wants to include as many protective contingencies clauses as they can think of.

Providers want to be sure implementation of the agreement doesn’t become an untenable administrative burden for their staff. There are concerns about the technology upgrades needed to collect, protect, and analyze the data generated by value-based purchasing agreements. Will there be interoperability issues with the existing electronic medical records system? How will the data be interpreted and presented to provide actionable insights?

The safest and easiest way to overcome these barriers and get help to operationalize value-based purchasing agreements is to use a vendor partner with a customizable software solution.

The Lyfegen software solution

Lyfegen created a software solution that addresses these concerns about shifting from fee-for-service payment models to value-based purchasing arrangements. We help healthcare providers, insurances, pharma, and medtech companies implement and scale value-based contracts for specialty drugs with greater efficiency and transparency.

The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost in value-based contracts. In supporting the transition from volume-based to value-based purchasing arrangements, Lyfegen increases affordability and access to health treatments for patients.

To learn more about Lyfegen’s value-based contracting platform, book a demo.

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How to overcome hurdles to implement value-based pricing

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How to overcome hurdles to implement value-based pricing

The transition to value-based care is happening at a slower pace than policymakers and healthcare industry leaders had hoped. Stakeholders are struggling to negotiate and then operationalize these complex agreements.

 

The adoption of value-based drug pricing agreements is not widespread in the U.S., despite the stated strong interest from policymakers and the healthcare industry in tying the price of drugs to their benefit to patient outcomes and value to the health system. Outside of the government Medicare and Medicaid programs, the fee-for-service, volume-based payment model still accounted for almost 56% of commercial health payer contracts as of 2018.

Many value-based pharmaceutical arrangements are not disclosed publicly, making it difficult to know how many are implemented in the U.S. each year. According to the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), there were 73 publicly disclosed value-based drug contracts at the end of 2019. A study published the same year in the American Journal of Managed Care (AJMC) suggested that, because of the confidentiality surrounding most agreements, analysts are underestimating the number of value-based pricing arrangements in effect and their impact on the U.S. pharmaceutical market.

In this article, we will highlight some concerns a payer and manufacturer considering a value-based drug pricing arrangement may each face, and give some insight into why these agreements aren't more widely accepted.

Payers modeling risk

A 2019 survey by the National Pharmaceutical Council (NPC) and the Duke-Margolis Center for Health policy showed that for payers, top deal-breakers in negotiations for value-based pricing arrangements were disagreements over incentive mechanisms for participation and financial terms. From the payer’s standpoint, a new, high-cost drug–especially one that addresses unmet needs or rare and orphan diseases–is worth the risk if it brings innovative, effective treatment for patients who may have no other options. But payers want to share that risk with the manufacturer when there’s the potential for a substantial impact on the payer’s budget.

Based on publicly available information, oncology, hematology, cardiology, and endocrinology drug treatments are common subjects of value-based pricing arrangements. These treatments have well-defined patient populations, easy-to-see impact measures, endpoints, and cures that make them more appealing to payers. It’s much more difficult to objectively measure the patient health outcomes for treatments covering pain management or mental health.

Payers also prefer treatments that show clinical results in a few months, not years. Tracking a patient’s health to confirm a drug’s value becomes more difficult when a drug takes years to show evidence of long-term benefits. For example, a longer-term benefit of treatment may be the avoidance of hospitalization. In the U.S., patients may leave a payer’s plan at any time, so this future cost may not be captured in the data collection under a current agreement.

Manufacturers sharing risk

When considering coverage of a new drug, payers might question the results of clinical trials, especially if there is limited real-world data because of an expedited FDA approval. So manufacturers must continue to create opportunities to generate real-world evidence that convinces payers of their drug’s value. And they must be ready and willing to share in the risk that a drug may not meet expectations in phase 4 confirmatory trials.

When a new drug has strong competition in the market, manufacturers need real-world evidence to differentiate their product and show their treatment brings better clinical outcomes and value than other options available. Value-based drug pricing agreements are an opportunity to fill that knowledge gap. Pharmaceutical companies not willing to do them to get that real-world evidence may lose out to those who are ready to take on innovative pharmaceutical agreements.

Contract partners building data-gathering and analytics capacity

In the 2019 NPC survey, manufacturers cited data collection challenges and disagreements on outcome measures among their top deal breakers.

Choosing the right contract model to fit the product and the capabilities of the contract partners is the first step. This means researching publicly available value-based drug pricing arrangements to learn the rewards and pitfalls of various contract models. All the contract partners must agree on the key metrics to be measured and how the data will be used to determine a drug’s value to patient health outcomes.

For the data-sharing component of value-based pricing arrangements, contract partners must develop a relationship that includes trust, cooperation, and an unusual level of transparency. Sometimes this relationship is best fostered and protected by the support services of a neutral third party, especially when one or both of the contract partners doesn’t have the technical capacity or administrative staff to operationalize a value-based drug pricing agreement.

 

The Lyfegen Solution

Value-based drug pricing arrangements are hard, but Lyfegen can make them easier. If your organization is considering a value-based pricing agreement, start by researching real-world examples of drug pricing arrangements in Lyfegen’s Models and Agreements Library. With a collection of more than 20 drug pricing models and over 1000 value-based agreements in use worldwide, the Lyfegen Library can help you discern what pricing arrangement is appropriate for your goals, your current operational capabilities, and your contract partners.

Lyfegen’s value-based contracting software can then operationalize the contract model you choose. We help healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost.

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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Indication-specific pricing to make inroads in the U.S.

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Indication-specific pricing to make inroads in the U.S.

Signs point to a greater role for indication-specific pricing in Medicare and Medicaid

 

Indication-specific pricing is a differential pricing method used by payers. Conceptually, it’s based on the idea that certain drugs with multiple indications have differential relative clinical benefit for each indication, or for each distinct patient subpopulation. The rationale behind indication-specific pricing is that the comparative clinical value of a drug can vary widely across indications, accordingly, so should the price if price and value are to align.

The figure below shows the difference between a uniform price – in this case, the price for indication A; green line – applied to all indications versus indication-based pricing.

Figure: Indication-specific pricing

 

Source: Institute for Clinical and Economic Review

 

The standard pricing model for pharmaceuticals constitutes a single price across all indications; in this instance, the price for indication A. It’s straightforward, as there is only one price. Besides, it’s the model stakeholders in the healthcare system have been accustomed to for decades. Moving to indication-specific pricing implies different prices for the four indications A, B, C, and D.

The most straightforward approach to indication-specific pricing by payers for a drug approved for, say, two different indications is to simply treat it as two different drugs. This would require two types of packaging, unique sets of National Drug Codes, for instance, for each of the packages, and for injectable drugs, two different Healthcare Common Procedure Coding System (HCPCS) J codes.

Indication-specific pricing is appealing because it supports value-based healthcare by aligning price and value. But it’s not an easy task for both drug manufacturers and payers to set indication-specific prices, as this requires patient stratification, and ultimately anchoring of prices to certain measures of cost-effectiveness, such as the cost per Quality-Adjusted-Life-Year (QALY).

Thus far, the use of indication-specific pricing has been limited in the U.S. to several pilot programs. Specifically, the pharmacy benefit manager (PBM) Express Scripts employs indication-specific pricing in number of different classes of cancer drugs, and the PBM CVS Caremark does this for several auto-immune diseases.

According to the PBMs, indication-specific pricing can provide a justification for higher prices for secondary indications that provide greater clinical benefits. In the context of value being assessed, this may help address payer resistance to expanding coverage to include supplemental indications. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of indication-specific pricing arrangements. The Lyfegen platform identifies and operationalizes value-based indication-specific models in a cost-effective manner.

Indication specific pricing could alter prices for the biologic Avastin (bevacizumab), for example, when used for cervical cancer and colon cancer, respectively, depending on the willingness to pay threshold, which in turn may be based on different cost per QALY estimates.

Also, there are differences in the comparative value of the cancer drug Herceptin (trastuzumab) when used in different indications (metastatic versus adjuvant HER-2 positive breast cancer). A possible solution to this problem is for Herceptin to have two prices, one for its metastatic indication, and another for its adjuvant indication.

When Novartis won its groundbreaking CAR-T approval, Kymriah (tisagenlecleucel) in 2018, both the drugmaker and U.S. policymakers at Centers for Medicare and Medicaid Services (CMS) touted performance-based and indication-specific pricing as ways to help finance the $475,000 therapy. Unfortunately, the CMS backed away from a plan to implement a value-based contract for Kymriah. This decision may be revisited, as the pipeline is filled with cell and gene therapies that have large upfront costs for CMS, which must somehow be managed.

Moreover, given the many value-based experiments state Medicaid agencies are currently involved in – from value-based formularies to subscription models for the purchase of hepatitis C medications – this could spur more use of indication-specific pricing in Medicaid.

New “best price” rules in Medicaid went into effect July 1, 2022. The reason for changes in best price rules is to induce more use of value-based contract arrangements, including indication-specific pricing. Newly established protocols allow for the reporting of multiple best prices.

Specifically, to facilitate the broad adoption of these types of contracts, the novel best price rule allows drug manufacturers to report a range of best prices to the extent they may be determined by varying discounts under value-based pricing arrangements, along with the regular best price under any non-value-based pricing arrangements.

Here, value-based pricing arrangements are outcomes-based contracts which vary rebates based on patient outcomes. This can be stratified by indication. In this context, lower discounts may be offered for patients with better-than-expected outcomes in certain indications, and higher discounts for poorer outcomes and lower-than-expected clinical effectiveness of a drug in one or more indications.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst and consultant on a variety of research, teaching, speaking, editing, and writing projects.

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How Lyfegen’s value-based contracting platform was inspired by Airbnb

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How Lyfegen’s value-based contracting platform was inspired by Airbnb

How Lyfegen improved user experience and satisfaction through user interface design optimization



When was the last time you used a business software or platform with a seamless user experience? Was it fun? Was it visually appealing? Probably not.

 

In this article, we consider the benefits of drastically improving the user experience of contracting software with examples of companies that have taken this step and inspired Lyfegen.



Contracting Software


Contracting software has usually been perceived as boring and unsophisticated, until recently. It takes careful application of innovation, user empathy, and design thinking to create unique, memorable experiences. Contracting software should focus on providing a pleasant user experience, especially when it is about patients. It takes away a whole lot of burden from the users while providing the most value.


There are new innovative designs of forms, pages, and workflows that keep users engaged and satisfied. Enjoyable contracting software should provide the most value while reducing the negative impacts.

Why great user experience is paramount to user satisfaction

Lyfegen takes cues from consumer web applications where innovation thrives. In 2020, Lyfegen conducted a big user experience review, where our product team needed to get to the bottom of what can make using the platform more enjoyable. “Why can't my business software look and feel enjoyable?" At Lyfegen we think that it can and it should. Every software should look and feel enjoyable.


We learned how users interact with the approval workflow using real-world data and feedback from customers. With these learnings, we further optimize the user experience and address issues or concerns that appear consistently. Users will bring expectations raised by consumer apps to their business applications. In response, we raise the bar to make work software equally appealing.


Lyfegen makes the whole process a breeze by rewarding customers with an amazing design experience, stepping up the game by making value-based contracting fun.


Some successful real-world examples


In consumer web applications, there are so many companies that are making drastic changes from the old design patterns to newer more innovative designs. These brands took the bold step of doing things differently while still providing the desired results. These are also the ones that Lyfegen took inspiration from.

1. Airbnb

Airbnb.com enables contracts between guests and hosts.

 

- Big beautiful imagery. People, smiles, quirky architecture.


- Emotional scenes that make you want to be there: cottage in the woods, hut on the beach, or a comfy townhouse.

 

But also clever UX: Forms disguised as slick toolbars. Generous date pickers that are easy to click

 



2. Mobile.de

Mobile.de enables contracts between car buyers and sellers.

 

- Sensible defaults bootstrap your car search with a single click.


- Common search patterns detected from thousands of users turn into quick search shortcuts such as "City car" and "Family car.”


- Kickstarting a search avoids having to fill many form fields.

 



3. Upwork

Upwork.com enables contracts between job seekers (talent) and hiring clients.

 

- The contracting path is optimized for speed. Both parties want to get the work under way quickly.


- Templates bootstrap and automate repetitive tasks. Why write every contract from scratch when you can extract best practices into a common library. Hint! This is what the Model Library will do in the Lyfegen Platform, watch out for a future blog post.

 


Lyfegen Platform mechanisms that bring speed and joy


The Lyfegen Platform enables contracts with pharmaceutical companies, healthcare payers and healthcare providers. At Lyfegen we understand that great user experience is paramount to user satisfaction. Hence, the reason why we pay critical attention to existing problems and proffer appropriate solutions to them is to create experiences that have the most long-lasting impact on the users.


What do we do differently to make these contracts fluid and useful?


- Forms: We use sensible defaults to make filling forms faster. Quick date pickers with popular date ranges (“Last month”, “This week”) help when scheduling is a big part of your work. Progressive disclosure reduces information overflow on forms – show only what the user needs to fill in right now to complete the task.


- Approvals: What is a modern way to do contract approvals? Chat threads! Users are familiar with chats from WhatsApp, Facebook and many other tools. A chat thread can be attached to virtually any item on the platform: agreements, claims, cases and refunds. The chat stays with the item so users don't lose context of what happened to the item.


- Tasks: How does the user know what they should be focusing on today? On the Home screen, the My tasks widget, email notifications, and the Recent Activity widget collect essential platform activity. You can see instantly what needs your attention today.


- Collaboration: @-mentions and chat threads offer quick resolution to questions. Tag a colleague and ask a question. They get a notification and provide an answer in the same thread. Problem resolved, move on! Chat works particularly well when conversation heats up and many users talk concurrently in real time.


- Interactive insights. Showing KPIs and key results on a dashboard is common practice. In fact, a dashboard is the favorite starting screen for many users. But charts really come alive when you interact with them. Have you used a mortgage calculator on a bank website? We also let users model alternative scenarios and see projections. “What will happen in my agreement next year if we continue like this?”



In conclusion, these are only a few examples of usage patterns that make contracting software modern and enjoyable. There is more room for improvement and the possibilities are endless. It requires the expertise which we at Lyfegen provide. Through our platform, we create brand new experiences in value-based contracting. Care to know more about contracting software? make sure to keep an eye out for our future posts.



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Breaking News: Lyfegen Raises Additional CHF 2 Million to Advance Value-Based Healthcare Contracting

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Breaking News: Lyfegen Raises Additional CHF 2 Million to Advance Value-Based Healthcare Contracting

Lyfegen HealthTech AG announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. Read the full press release.



BASEL, Switzerland, Sept. 1, 2020 /PRNewswire/ --

- Investors back Lyfegen's mission to make innovative healthcare therapies more accessible and affordable

- Funding secures market-leading position prior to Series A opening in 2021

Lyfegen HealthTech AG, a Swiss health technology company, announced today that it has raised CHF 2 million of additional capital, bringing its total funding to CHF 3 million. The additional funding was completed by private investors and the innovation program of one of Switzerland's largest banks.

Lyfegen has developed a ground-breaking software solution to accelerate value-based healthcare contracting, pioneering in a global market that could reach USD 400 billion by 2024, according to the latest estimates by research firm MarketsandMarkets™. Some of the world's 10-largest pharmaceutical and medical technologies companies are already employing Lyfegen's platform in strategic markets in Europe and South America.

Girisha Fernando, Chief Executive Office and co-founder, said: "Increasingly, healthcare systems around the world are transitioning from fee-for-service payment schemes to value-based contracting. Our solutions support the shift towards sustainable payment models that help ensure patients get the treatments they need at prices they can afford, while healthcare companies make an adequate return on their investment. We are proud to have strong partners and investors on board to support us in this challenging and rewarding mission."

The new funding, combined with the seed capital raised in April 2019 and the founders' contributions, secures the development of Lyfegen's proprietary technology as it continues to roll out its value-based contracting solution in the U.S. as well as additional European and Latin American markets in the areas of oncology, rare diseases and medical devices.

Michel Mohler, Chief Financial Officer and co-founder, added: "We continue delivering on our ambitious goals prior to opening our Series A funding in 2021. This latest additional funding confirms the growing interest of international investors in innovative healthcare technology built for a data-driven world. The funds will be used to further strengthen our leading market position as we prepare for a strong Series A funding round."

About Lyfegen

Lyfegen HealthTech AG is a Swiss healthcare technology company that is pioneering digital value-based healthcare contracting. Lyfegen's patent-pending, ground-breaking software analyses complex healthcare data sets in order to help patients access innovative therapies that focus on the healthcare outcomes that matter most to them. Lyfegen's solutions collect the patient's specific medical profile whilst ensuring the strictest data privacy protocols. Lyfegen's founders Girisha Fernando, Michel Mohler, Nico Mros, and Leon Rebolledo have combined their expertise in life sciences and financial services to create a holistic solution that enables life sciences companies, healthcare payers and healthcare providers to develop and roll out digital value-based healthcare, a market that is set to grow to USD 400 billion by 2024.

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Lyfegen and Switzerland’s EGK Insurance Partner to Reduce Prices for High-cost Drugs

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Lyfegen and Switzerland’s EGK Insurance Partner to Reduce Prices for High-cost Drugs

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.

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Read on PR newswire in German

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Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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

yael@gkpr.com

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At the forefront of value-based healthcare: Lyfegen and KPMG Switzerland release whitepaper together

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At the forefront of value-based healthcare: Lyfegen and KPMG Switzerland release whitepaper together

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 THE WHITEPAPER

 

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Lyfegen raises CHF 750‘000 in Seed Capital

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Lyfegen raises CHF 750‘000 in Seed Capital

Basel, Switzerland | April 17th, 2019 – Lyfegen HealthTech AG successfully closes its seed financing round, raising a total of CHF 750‘000. The funding was led by Swiss private investors. The funds will be used to further build Lyfegen’s value-based payments platform Lyfevalue and conduct further pilots with partners in the US, Africa, and the EU, including the UK.

Lyfegen is a healthcare technology company that has developed a ground-breaking solution to accelerate value-based healthcare, entering a market set to grow to USD 390.7 billion by 2024 according to latest market research. Its platform, Lyfevalue, collects, analyses & reconciles disparate healthcare data for the purpose of automating value-based healthcare contracting. The platform enables life sciences companies, national and private healthcare payers and healthcare providers to operationalise value-based healthcare strategies whilst benefiting from a single holistic solution for their value-based healthcare operations, visit checklistmaids.com. In addition, the platform allows for personalised healthcare by enabling patient level pricing, fostering accelerated and facilitated access to innovative treatments for patients.

“Enabling the shift to sustainable healthcare is a huge challenge, giving us at Lyfegen great purpose and we are honoured to work with individuals that truly care about making a difference for patients around the world,” said Girisha Fernando, Lyfegen’s CEO & Founder.

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Hello to our new team member: Meet efficacy expert Anca Marin!

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Hello to our new team member: Meet efficacy expert Anca Marin!

Lyfegen is building the leading contracting software solution to support value-based drug pricing arrangements. This mission requires a hands-on team to optimize all our processes. With Anca Marin joining our team as the new business analyst, we are set up for success.

 

We sat down with Anca to learn about her experience, her goals, and her aspirations.

Hello Anca, and welcome to Lyfegen! Please tell us a little about yourself: Where are you from, and what’s your educational and professional background?

Hello, my name is Anca. I am based in Bucharest, Romania. I graduated with a bachelor’s degree in accounting and later earned a master’s degree in business management. Before joining Lyfegen, I worked in finance for three and a half years in various industries, such banking, insurance, and ICT.

What excites you about being a business analyst?

The novelty – I believe it is a role where you never get bored as there is always a new situation, idea, or feature to build up, and it is exactly the challenge I want.

Why did you decide to join Lyfegen?

I find meaning and desire in making a change for the better. I also enjoy the work culture and the idea of being part of an innovative company while making a real impact.

What is something you want to learn or improve this year?

This is my first role as a business analyst. Therefore, this year, I want to focus on growing my knowledge and skills as a business analyst, as well as in software development and the healthcare industry.

How will your know-how help to improve our customers’ experience of the Lyfegen platform?

Given my previous roles, I would say that I was usually the one handling challenging and complex situations when dealing with customers. Through these experiences, I learned to find ways to deliver the best results for customers, and I will continue to do so. I also describe myself as being super detail-oriented – and details always make the difference.

Let’s get personal: What are your favorite things to do in your free time?

Besides my full-time job at Lyfegen, I am also a handball goalkeeper. I have been playing since I was 11 years old, and I usually go to two to three training sessions a week. However, I like sports in general, so if I am not on the handball court, I am probably playing other sports, like basketball or tennis.

I also like traveling and nature and activities away from the big cities, such as hiking, backpacking, and camping.

 

Is there anything else you are looking forward to outside of work this year?

Outside of work, my plans for this year are to get a motorcycle, take trips to the mountains, and make great memories!

 

We are proud to have you with us, Anca!

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At Lyfegen, the security of patient data is of utmost importance! We are proud to announce that we are ISO 27001 certified, an internationally recognised information security standard!

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At Lyfegen, the security of patient data is of utmost importance! We are proud to announce that we are ISO 27001 certified, an internationally recognised information security standard!

What is ISO 27001?

ISO 27001 is one of the most widely recognized and internationally accepted information security standards. ISO 27001 defines how an organization should manage and treat information more securely, including applicable security controls.

It requires a company to have an information security management system, which means having a documented process for managing sensitive company information, processes, and IT systems.



What this mean for Lyfegen?

To achieve the certification,  security compliance was validated by an independent audit firm after a rigorous process of demonstrating an ongoing and systematic approach to managing and protecting company and customer data.

Being a company that manages sensitive health-data points, it is of utmost importance to us to ensure the best tech processes and security mechanisms are in place.

At Lyfegen, we are committed to complying to the highest tech security standard, continuously improving our solutions & processes, as we move forward with the operationalisation of value-& data driven contracts for a fast & sustainable access to innovative therapies. In turn, this will benefit patients worldwide!

We are audited on yearly basis by an accredited third-party auditor to keep our ISO status valid.

Want to discover our solutions?

 

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Lyfegen is at the World Pharma Pricing, Evidence & Market Access Congress!

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Lyfegen is at the World Pharma Pricing, Evidence & Market Access Congress!

Join in from anywhere in the world for three days of incredibly interesting presentations and round-tables by industry experts all around the topic of pricing and market access in healthcare.

Only a week left to go! The incredibly exciting annual World Pricing, Evidence & Market Access Congress is taking place from the 23rd to the 25th of September virtually... giving attendees the opportunity to join from anywhere in the world! This is set to be the largest and most comprehensive yet, with over 1000 attendees and more than 230 speakers!

Lyfegen's Girisha Fernando and Nico Mros will be moderating a round-table “How do you include the patient perspective in an outcomes-based contract?” on the 23rd of September at 15:05 CET. Join us! Lyfegen has a digital booth so feel free to get in touch via the swapcard app, if you are already signed up.

See the full program

 

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João Marques-Gomes, PhD, joins Lyfegen Advisory Board

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João Marques-Gomes, PhD, joins Lyfegen Advisory Board

Lyfegen is proud to announce that João Marques-Gomes has joined the company’s Advisory Board. João is a university professor, a scientific researcher, and a management consultant in health management.

He is the Chair of Nova University Lisbon’s institute for Value-Based Health Care (VBHC), and the professor of the semester course “VBHC” at the Nova School of Business & Economics and at the Nova Medical School.

His research has been repeatedly funded by FCT – Foundation for Science and Technology, the Portuguese public agency for scientific research. As a management consultant, João Marques-Gomes has worked for public and private hospitals in Europe and Latin America, the European Commission, the Portuguese Ministry of Health, the Portuguese Pharmaceutical Society, and for pharmaceutical companies that are among the world’s top 10 pharmaceutical companies in sales.

In the past, João worked with ICHOM – International Consortium for Health Outcomes Measurement, as part of the implementation team. He is currently the Vice-President of IBRAVS – Brazilian Institute for Value in Health. João’s actions have had an important impact on the Portuguese society.

João has co-led the Cascais Agreement movement, which gathers the 80+ major stakeholders that have publicly signed the agreement that establishes that by 2021 1/3+ of the Portuguese health care providers must have had an experience with VBHC.

 

Lyfegen makes it possible for innovation to always have an open door in any market in the world. Thanks to Lyfegen, millions of people will have access to innovative treatments and will enjoy much healthier lives because of this.

João Marques-Gomes



João Marques-Gomes has a PhD in economics from the University of Evora (Portugal), and an MBA from the FIA Business School (Brazil). Part of his PhD studies was done at the University College London (UK), and at the Toulouse School of Economics (France). João did his training in VBHC at ICHOM (UK), at the Harvard Business School, and at the Dell Medical School, UT Austin (USA).

With his vast experience in health economics and value-based healthcare, João will support Lyfegen to achieve its mission of accelerating value-based healthcare to improve the life of patients.

 

 

 

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Former New York State Medicaid Director Jason Helgerson joins Lyfegen advisory board

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Former New York State Medicaid Director Jason Helgerson joins Lyfegen advisory board

 

Lyfegen is proud to announce that former New York State Medicaid Director, Jason Helgerson, has joined the Lyfegen Advisory Board.

 

Lyfegen, the provider of the leading value-based agreements platform for pharmacy, is proud to announce that Jason Helgerson has joined its advisory board. He brings his rich experience in value-based healthcare and more than 20 years of public service to this role. Jason’s forte is in creating effective value-based payment systems, facilitating successful cross-sector collaboration, and delivering transformative stakeholder engagement - all elements that underpin a successful value-based health and social care strategy.

“Seeing how Lyfegen uses advanced technology to solve the immense problem of drug pricing & affordability by enabling value-based agreements made my decision to join Lyfegen’s advisory board an easy one. I am excited about the value Lyfegen can deliver to healthcare payers, providers, and patients in the US and across the world,” says Jason.

In addition to serving as Lyfegen advisor, Jason is the managing director of Helgerson Solutions. He is a nationally recognized leader in value-based healthcare, healthcare & delivery system reform.

Most recently, he was New York State’s Medicaid Director, a role he held for over seven years, managing an annual budget in excess of $68 billion. During his time leading the Medicaid program in New York, Jason drove New York State’s Delivery System Reform Incentive Payment program (DSRIP). Over five years, the DSRIP program in New York created local, multi-sectoral partnerships with the aim of fundamentally restructuring the delivery of healthcare in New York & transitioning 80% of Medicaid payments into value-based arrangements. Jason became an internationally-recognized leader in public sector health care as part of his leadership of New York’s Medicaid Redesign Team, which helped reshape the program to lower costs – tackling a budget deficit – and improve health care quality.

Jason Helgerson earned a BA from American University in 1993, and his Master’s in Public Policy from University of Chicago in 1995. He also attended the London School of Economics’ Summer Graduate School Program in International Economics in 1994. He has worked in a variety of local and state governments, including the City of Milwakee, City of San Jose, CA, State of Wisconsin, and New York. He has served as the Medicaid Director for both the State of Wisconsin and the State of New York.

With vast experience in value-based healthcare, Jason will advance Lyfegen’s mission of accelerating value-based healthcare to improve patients’ lives in the USA.

 

About Lyfegen

Lyfegen is an independent, global software analytics company providing a value and outcome-based agreement platform for Health Insurances, Pharma, MedTech & Hospitals around the globe. The secure Lyfegen Platform identifies and operationalizes value-based payment models cost-effectively and at scale using a variety of real-world data and machine learning. With Lyfegen’s patent-pending platform, Health Insurances & Hospitals can implement and scale value-based healthcare, improving access to treatments, patient health outcomes and affordability.

Lyfegen is based in the USA & Switzerland and has been founded by individuals with decades of experience in healthcare, pharma & technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare.

More about Lyfegen: https://www.lyfegen.com

 

Related Links:

Linkedin: https://www.linkedin.com/company/lyfegenhealth

Contact Press:  press@lyfegen.com

 

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

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Lyfegen Secures additional CHF 5 Million in Series A Funding to Scale Its Drug Rebate Management Platform Globally

Basel, Switzerland / Boston, USA – December 11, 2024

Lyfegen, a global leader in drug rebate management technology, today announced the successful close of its additional CHF 5 million Series A funding round. The round was led by TX Ventures, a leading European fintech investor, with additional participation from aMoon, a global health-tech venture capital firm, and other institutional investors. This funding represents a significant milestone for Lyfegen, enabling the company to accelerate its global expansion and innovation efforts, with a focus on extending its reach beyond Europe into new markets worldwide.

Addressing Rising Drug Costs with Intelligent Drug Pricing and Rebate Solutions

The healthcare industry faces increasing challenges with rising drug costs and the complexity of managing growing volumes of rebate agreements. For payers and pharmaceutical companies, manual processes often lead to inefficiencies, compliance risks, and operational delays. Lyfegen is transforming this process with its fully automated platform that ensures secure, real-time tracking, compliance, and operational efficiency at scale.

Today, 50+ leading healthcare organizations across 8 geographical markets rely on Lyfegen’s solutions to streamline 4'000+ rebate agreements while tracking over $1 billion in pharmaceutical revenue and managing over $0.5 billion in rebates annually. These solutions enable healthcare organizations to improve pricing strategies, accelerate access to modern treatments, and better manage rebate complexities.

Scaling Globally with a Leading Rebate Management Platform

Already used by healthcare payers and pharmaceutical companies in Europe, North America, and the Middle East, Lyfegen’s platform is poised for broader global deployment. By automating rebate management, the platform enables healthcare organizations to simplify complex agreements, save time, reduce errors, and enhance financial performance.

“The market for innovative and personalized treatments is expanding rapidly, but with that comes increasingly complex and costly pricing models,” says Girisha Fernando, CEO of Lyfegen. “Lyfegen’s automated solution simplifies this complexity, helping payers and pharmaceutical companies unlock the full potential of rebates while improving patient access to modern treatments. With this funding and our new partners, we’re ideally positioned to accelerate our growth and make a meaningful impact globally.”

Jens Schleuniger, Partner at TX Ventures, adds: “Lyfegen is at the forefront of innovation, offering payers and pharmaceutical companies a powerful solution to address the rising complexities of pharma rebates. We’re proud to lead this funding round and support Lyfegen’s mission to bring greater efficiency and cost savings to healthcare systems worldwide.”


About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand the full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.

About TX Ventures

TX Ventures is one of Europe’s emerging leaders in early-stage fintech investing. The venture capital fund invests predominantly in B2B Fintech across Europe - preferably in seed to series A stage. 


For more information about Lyfegen’s solutions or to schedule an interview, please contact:
marketing@lyfegen.com 

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Rare Disease Therapies and the Case for Outcomes-Based Agreements

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Rare Disease Therapies and the Case for Outcomes-Based Agreements

Treatments for rare diseases, such as spinal muscular atrophy or CAR-T therapies like tisagenlecleucel, hold transformative potential for patients. Yet, they often come with significant challenges—uncertainties around long-term efficacy, high costs, and the need for tailored patient selection. Outcomes-Based Agreements (OBAs) offer a structured way to address these challenges, aligning financial risk with therapeutic outcomes. However, their implementation requires careful consideration and planning.

The Promise and Practicalities of OBAs

1. What Makes OBAs Valuable?

OBAs shift the focus from upfront costs to real-world outcomes, creating a more sustainable framework for funding innovative therapies. They enable:

Risk Sharing: Payers and manufacturers align costs with actual therapeutic results.

Patient-Centric Focus: Treatments are tied to measurable improvements, emphasizing value rather than volume.

Increased Access: By mitigating cost risks, OBAs can support the introduction of high-cost therapies in resource-constrained settings.

2. Implementation Challenges

Despite their promise, OBAs are not without hurdles:

Administrative Complexity: Managing OBA agreements involves data sharing, contract monitoring, and performance assessments—all requiring robust systems.

Data Availability and Quality: Real-world evidence is critical, but gaps in data collection, reporting, and standardization can limit success.

Stakeholder Collaboration: Successful OBAs require alignment between payers, manufacturers, and healthcare providers. Misaligned priorities or unclear accountability can derail agreements.

How Lyfegen Supports OBA Implementation

Learning from Global Examples

Lyfegen’s Agreements Library—featuring 6,700 public agreements and 20 pricing models from 33 countries—offers invaluable insights into how OBAs have been implemented worldwide. By analyzing these examples, stakeholders can identify models that best suit their unique challenges, reducing the trial-and-error phase of implementation.

Streamlined Scenario Analysis

The Lyfegen Drug Contracting Simulator enables stakeholders to simulate OBA scenarios using real-world data. From adherence-based contracts to outcome guarantees, the Simulator helps users:

• Assess feasibility through scenario modeling.

• Forecast financial implications with real-world inputs.

• Compare multiple pricing models to find the most suitable solution.

Simplifying Administration

Managing the administrative burden of OBAs is crucial. Lyfegen’s tools offer:

• Centralized contract management for version control and compliance tracking.

• Automated data processing to ensure performance metrics are accurately reported.

• Detailed dashboards and trend reports to facilitate collaborative decision-making.

Key Considerations for OBA Success

1. Feasibility Studies Are Essential

Not every therapy or market is suited for OBAs. Conducting thorough feasibility assessments helps determine the viability of such agreements.

2. Data Plans Need Clarity

Reliable outcomes-based contracts depend on well-defined metrics and data collection processes. Establishing these frameworks early is crucial.

3. Commitment from All Stakeholders

OBAs thrive on collaboration. Shared goals, transparent communication, and clear accountability among all parties can ensure smoother execution.

Conclusion

Outcomes-Based Agreements represent an important step forward in addressing the challenges of high-cost, high-impact therapies for rare diseases. With the right tools, insights, and preparation, healthcare stakeholders can unlock the potential of OBAs to improve access, manage costs, and focus on patient outcomes.

Discover how Lyfegen can simplify your journey to outcomes-based contracting. Schedule a demo today to explore our solutions in action.

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The Shift to Financially Optimized Clinical Trials

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The Shift to Financially Optimized Clinical Trials

As value-based contracting (VBCs) becomes the standard, the role of clinical trials has shifted significantly. They are now essential not only for demonstrating safety and efficacy but also for enhancing financial performance. By creating trials that meet the criteria of VBCs, pharmaceutical companies can increase their financial gains, minimize pricing risks, and facilitate smoother negotiations with payers.

According to a report by Deloitte, aligning clinical trials with value-based pricing strategies can lead to improvements in revenue predictability and cost management by as much as 20% for drugs with high market access potential. This improvement stems from linking trial outcomes to real-world efficacy, which reassures payers and reduces the financial risk for manufacturers by basing pricing on demonstrated effectiveness  

For CFOs and Pricing Directors, the Financial Impact is Clear

For CFOs and Directors of Pricing, the financial implications of optimized trials in a VBC framework are significant. When trial designs focus on outcomes that matter most to payers—like reductions in hospitalization or improved quality of life—pricing becomes more flexible, and revenue can be projected more accurately. McKinsey & Company points out that outcome-based models also provide a safeguard against pricing volatility, allowing pharmaceutical companies to stabilize revenue by tying payments to real-world performance metrics.  

Efficiency Gains through Outcome-Focused Trial Design

Beyond revenue predictability, operational efficiencies are another key benefit. A focus on outcome-based trials reduces the time and resources needed to negotiate with payers, as the trial data itself becomes a compelling point in payer discussions. For Market Access Directors, outcome-driven trial designs support quicker market entry and stronger, data-backed negotiations that build payer confidence.

Lyfegen’s Platform: Streamlining Trial Optimization for Value-Based Contracts

Optimizing clinical trials for VBC is complex, but Lyfegen’s all in one platform simplifies this process. By enabling real-time pricing simulations based on clinical outcomes or financial goals, Lyfegen helps pharmaceutical companies design financially viable reimbursement contracts and align them with value-based pricing. This empowers pricing teams to model financial outcomes, enhancing both operational efficiency and contract efficiency.

Interested in learning how outcome-focused trials can support your pricing and financial goals? Lyfegen’s Simulator offers the tools you need to optimize clinical trials for success in a VBCs framework.

Schedule a demo today to explore how we can streamline your pricing and contract strategies: https://www.lyfegen.com/demo

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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

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Clinical Trial Outcomes: The Key to Driving Drug Pricing and Market Access

In value-based contracts (VBCs), clinical trial outcomes are no longer just about proving safety and efficacy—they’re now critical to driving drug pricing and market access strategies. As payers and healthcare systems shift towards outcome-based models, trial data is becoming the foundation for negotiating both price and reimbursement.

Payers are increasingly prioritizing data from real-world evidence and clinical trials for value-based arrangements. The real-world data aligns closely with payers' needs to predict the cost-effectiveness of drugs and determine coverage. For Market Access Directors and Directors of Pricing, this means that clinical trial results can either accelerate or hinder the process of getting drugs to market. Strong trial outcomes not only justify premium pricing but also provide a solid basis for faster, smoother payer negotiations.

This is especially crucial in markets where budgetary pressures and stringent healthcare regulations make it difficult for new therapies to gain market access. The ability to present data-driven evidence of a drug’s real-world impact can significantly shorten time to market and improve access.

Novartis’ Zolgensma, a gene therapy for spinal muscular atrophy, used a value-based contract with installment payments and performance guarantees, adjusting reimbursement if outcomes fell short—demonstrating flexibility for high-cost therapies in outcome-based pricing models  

For CFOs, using clinical trial data means greater financial predictability. By tying pricing to outcomes, companies can secure more stable revenue streams, with lower financial risk from market variability.

Are you ready to leverage clinical trial data to improve your pricing strategy and market access? Lyfegen’s Simulator helps you model pricing scenarios based on trial outcomes, ensuring a smoother path to market and better payer alignment.

Schedule a demo today to see how we can support your pricing and market access strategies: https://www.lyfegen.com/demo

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How Value-Based Contracts Are Redefining Drug Pricing Through Clinical Trials

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How Value-Based Contracts Are Redefining Drug Pricing Through Clinical Trials

The pharmaceutical industry is increasingly moving towards value-based contracts (VBCs), where drug pricing is tied to real-world patient outcomes rather than traditional volume-based models. This shift is transforming how clinical trials are designed and executed, and it’s profoundly impacting drug pricing strategies.

According to the IQVIA Institute for Human Data Science, value-based contracts are expected to account for a larger share of pharmaceutical revenue, with the global market projected to reach $1.3 trillion by 2026, driven by the need for more outcome-driven healthcare solutions.

For CFOs and Directors of Pricing, this shift provides new opportunities to de-risk pricing models. By linking drug prices to clinical outcomes, pharmaceutical companies can reduce financial risk while ensuring that prices reflect the actual value delivered to patients. In this context, clinical trials become critical—not just for regulatory approval, but for pricing strategy development. The data generated in trials helps justify flexible, dynamic pricing models that payers can support.

Moreover, value-based contracts align perfectly with reducing healthcare costs while improving outcomes. This model can also strengthen relationships with payers, who increasingly demand proof of value before agreeing to reimburse drugs at premium prices.

Interested in transforming clinical trial results into smarter, value-based pricing? Lyfegen’s Simulator offers the solution by streamlining pricing models and linking them directly to trial outcomes, helping you reduce risk and enhance financial predictability.

Schedule a personalized demo today to see how we can help you transform your pricing strategy: https://www.lyfegen.com/demo

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