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ICER: Hero or Villain in the Story of Value-Based Drug Pricing?

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ICER: Hero or Villain in the Story of Value-Based Drug Pricing?

 

This influential player in the U.S. pharmaceutical sector is changing the dynamics of price negotiations between payers and drug manufacturers. But is ICER helping bring healthcare costs down or contributing to rising drug prices?

 

Who is ICER?

Over the last decade, a small, Boston-based independent, nonprofit research organization has become a powerful influence over the formulary exclusion decisions and drug prices commercial and government payers will pay. Founded in 2006, The Institute for Clinical and Economic Review (ICER) was relatively unknown before 2014. But after gaining national recognition for an assessment about the cost-effectiveness of a Hepatitis C therapy regime, ICER quickly became a trusted source of data and pharmaceutical economics research.

ICER’s assessments are cited in national policy debate and in pharmaceutical price negotiations between insurers and drug manufacturers. According to ICER, the U.S. Department of Veterans Affairs, some state Medicaid agencies and over 75% of private insurers, pharmacy benefit managers, and self-insuring organizations now use ICER’s drug pricing assessments and resources in their policy decision making.

What does ICER do?

ICER conducts clinical and economic assessments of drug treatments to calculate what it considers a drug’s fair market price. They consider a drug’s value and effectiveness for treating the illness for which it was designed, followed by a budget impact analysis to estimate how much the national health system could save with its suggested cost-effective pricing. Using this data, ICER analyses calculate a suggested drug price for payers where cost-effectiveness aligns with the value of the increased benefit to the patient’s health. ICER says it seeks feedback from all stakeholders—manufacturers, clinicians, payers, patients and families.

How is ICER affecting national drug prices?

A leading pharmaceutical economics expert, Dr. Adam J. Fein of Drug Channels Institute, reports that pharmaceutical list prices rose by up to 15% from 2010 to 2015. During the next five years, up to mid-2020—as ICER rose to national prominence—list price growth dropped to 4.2%.

In 2018, ICON, a leading healthcare industry consultant, conducted a survey about the influence of ICER’s work on drug pricing and national healthcare costs. The ICON survey revealed that ICER’s cost effectiveness metrics and price recommendations are affecting contract negotiations between drug manufacturers and payers and driving drug prices down.

Most payers are no longer willing to accept whatever price drug manufacturers decide to charge. Over a third of the payers in the ICON survey stated it was likely, or extremely likely, that they would ask for a rebate from the drug manufacturer to reduce the cost of a drug to match ICER’s suggested price. In response, manufacturers will increase their drug list price, then offset part of the price increase with larger rebates to payers—this is known as the gross-to-net bubble.

How is ICER affecting access to expensive drug treatments?

Out of the 90 participants ICON surveyed during a pharmaceutical industry webinar, 65% believed ICER had a moderate to significant impact on formulary decisions; ICON’s research also showed that payers who use ICER’s cost-effective pricing were more likely to use strict prior authorization requirements for some drugs to encourage clinicians and patients to use the most cost-effective drug treatments. Critics point to this as one of the harmful consequences of ICER’s work.

What do critics of ICER say?

Some patient advocate groups—with the support of pharmaceutical manufacturers—are concerned that by encouraging payers to exclude less cost-effective but still clinically effective treatments in their formularies, ICER is promoting payer discrimination against some patients who need expensive specialty medications, such as the elderly, people with disabilities, and those living with rare diseases.

Critics such as The Alliance for Aging Research point to data that show ICER’s impact on payer demands for higher rebates are causing increasing out-of-pocket costs for seniors using Part D Medicare benefits. Manufacturers raise their list prices, then meet payer demands for ICER’s suggested drug pricing using the gross-to-net bubble rebates. However, some payers still calculate the co-insurance percentages that patients pay for their prescriptions based on the manufacturer’s full, undiscounted list price.

Lyfegen can help implement value-based drug pricing agreements

Despite the debate about whether ICER is a help or a hinderance in the work of healthcare cost containment and better patient access, ICER’s influence will probably continue to grow as value-based contracts and risk-sharing agreements become more common. Lyfegen’s value-based contracting platform operationalizes and manages these complex drug pricing payment arrangements by seamlessly capturing and analyzing data.

Lyfegen’s software can help your organization implement any value-based contract, covering multiple therapeutic areas, with public or private payers. Contact us to learn more about our platform and to book a demo.

 

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How Far Would You go to Save Your Child?

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How Far Would You go to Save Your Child?

Families forced to hold a fundraiser because their child’s healthcare system won’t save his life.



Recently, the news has once again been covering a family that is struggling to cover the cost of the most expensive drug in America for their son, Devdan. The insurer refused coverage of the treatment for his rare disease, totaling $2.125 million.

Devdan was born with Spinal Muscle Atrophy (SMA). SMA damages the nerve cells in the brain and spinal cord, causing progressive muscle weakness and problems breathing, speaking, swallowing, and walking. Zolgensma’s onetime gene therapy treats SMA and has earned the title of the most expensive drug in America.

It is currently Devdan’s only hope for a normal life. In this case, to save their child’s health and future, the parent’s initiated a fundraiser through Ray of Hope Foundation.

Most of us probably don’t consider what or how hospitals pay for their supplies. When we pay our medical insurance premiums, we buy a plan and think we’re covered in case of a medical emergency. But what many families of children with rare disease have learned, that’s not always the case. Rare diseases aren’t funded the same way common medical conditions are paid for. There aren’t enough patients to warrant extensive research and treatment developments. Consequently, medical care is often unconventional. As a result of these novel treatments, patients with rare disease often receive Surprise Medical Billing or are denied coverage altogether.

Value Based Healthcare (VBHC) Saves Lives

Medications and treatments that deviate from the routine can be a financial disaster for hospitals, families, care providers, and health systems. And organizations with a strong commitment to value-based healthcare have seen sustainable gains. In this case, had Devdan’s medical facility operated under a value-based healthcare reimbursement model, this life-saving treatment would have been available and the critical care for this child could have begun without delay.

Calculating value-based reimbursements measures numerous points of quality and the overall health of a population. Unlike a fee-for-service model, value-based healthcare providers must report data to payers and demonstrate improvement. The VBHC model has many advantages, including improved patient satisfaction, a reduction in healthcare delivery costs, and better health for the patient populations being served.

Better management of financial challenges with Lyfegen

The VBHC model has many advantages, including improved patient satisfaction, a reduction in healthcare delivery costs, and better health for the patient populations being served. Luckily, Devdan’s Ray of Hope fundraising effort has achieved the needed target of $2.86M. More than 29’000 people came together to raise this enormous amount in such a short period of time to give Devdan a second chance at life.


This unfortunate scenario is common for those dealing with rare disease, and those in need of extraordinary medical care. Had Devdan’s insurance participated in a value-based program, the necessary medicine could have been provided for with no delay in treatment. As the health care market adjusts to the pandemic and prepares for the future, leaders must decide whether to accelerate their participation in value-based healthcare to meet the clinical and financial challenges that will remain for years to come.

To learn more about Lyfegen and request a free demo, contact us today.

 

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Industry experts agree outcome-based contracting is vital to the future of cell and gene therapies

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Industry experts agree outcome-based contracting is vital to the future of cell and gene therapies

 

Manufacturers, payers, and health systems disagree on how to assess the value of new, high-cost treatments such as cell and gene therapies. These stakeholders see a solution in outcome-based drug pricing agreements.

 

Girisha Fernando, CEO of Lyfegen, was recently invited to take part in a roundtable discussion about cell and gene therapies (CGTs), hosted by the global consulting firm, Oliver Wyman. Over 20 industry leaders, payers, and third-party solution providers were in attendance.

Oliver Wyman released a white paper that summarizes the insights, challenges, and opportunities uncovered during the discussion. A major area of concern among the participants is preparing and equipping payers and health systems with the means to assess the value and health benefits of new, high-cost CGTs.

Outcome-based contracting is the future for cell and gene therapies

According to marketresearch.com, the global CGTs market—valued just short of USD $5 billion in 2021—is forecast to reach almost USD $37 billion by 2027. In anticipation of an estimated total of 60 CGTs available on the market by the end of the decade, industry and health system stakeholders recognize the need to move towards contracting that includes an outcome-based drug pricing component.

Learn more about Pharmaceutical Forecasting Software

The roundtable participants agreed that using outcome-based contracts (OBCs) for CGTs is a critical lever for ensuring patient access to innovative therapies. OBCs can reward manufacturers for new drug development while addressing the payers’ concerns about clinical effectiveness and management of financial risk.

Why outcome-based contracting is best for cell and gene therapies

The Oliver Wyman white paper lists a few reasons CGTs are well suited for value-based drug pricing through outcome-based contracting, including:

• A lack of real-world clinical evidence about the therapy when first introduced to market

• Uncertainty about the product’s value proposition

• High perceived cost versus the current standard of care

Fernando adds an additional perspective to the conversation: “Another underlying need for OBCs and underlying innovative payment models is the fact that the Pharma’s business model is changed with CGTs. Since they promise significant patient benefit, and in many cases even cure, this cure is being priced into one price. This contrasts with the previous pharma model of gaining continuous revenue by supplying continuous treatments over several cycles.”

Challenges to implementation of outcome-based contracts

At present, several challenges hinder the widespread adoption of outcome-based agreements. Oliver Wyman’s analyses point to difficulties such as agreement on a starting price, deciding how to measure patient outcomes, and choosing appropriate follow-up timelines.

Another one of the fundamental difficulties in executing OBCs is capturing quality real-world data. There was consensus among the roundtable participants about the need to collaborate to build innovative multi-stakeholder data infrastructure and systems that support real-world evidence collection about patient outcomes. Current attempts to build performance data gathering into existing data systems often lead to increased fragmentation of data across different systems that are not interoperable.

For many reasons, the real-world data that is available is often incomplete or of poor quality. All industry and health system stakeholders want to balance transparency with safeguarding proprietary information. Healthcare providers don’t see data collection as their priority; they must be incentivized or compensated for taking on this additional administrative burden. And patients asked to self-report outcomes want to feel in control of how and with whom they share their health outcomes.

Collecting quality patient data

Empowering patients as decision-makers in their care encourages them to report their treatment results. Regarding patient self-reporting of health outcomes, Fernando poses some additional considerations:

“Should patients receiving a CGT also have a “responsibility” in terms of data reporting etc. as health systems commit to curing these patients? This would be needed to track long-term outcomes of patients, as well as provide a positive effect on evidence & learnings.”

Fernando also sees more patient-centric opportunities for growth: “In addition to the CGT, what other kinds of services should be built around these patients to improve patient health outcomes?”

A supportive ecosystem for outcome-based contracts

The roundtable identified three key principles for advancing the data infrastructure and ecosystem needed for executing OBC: data ownership, data interoperability, and data access and security. They uplifted the role of third-party innovators and solution providers like Lyfegen, whose value-based contracting software addresses these difficult IT issues and simplifies the execution of complex pricing models. By facilitating the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases affordability and access to high-cost healthcare treatments like CGTs.

 

The Lyfegen Platform

Lyfegen’s software platform helps 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 in value-based contracts.

To learn more about the Lyfegen Platform and software solutions, contact us to book a demo.

 

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Is this new drug worth the cost? Payers decide using value-based purchasing agreements

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Is this new drug worth the cost? Payers decide using value-based purchasing agreements

Healthcare payers and insurance companies are under pressure to fight rising drug prices in the U.S. Payers have the difficult task of figuring out if a manufacturer’s proposed wholesale price for a new drug is justified. Value-based purchasing agreements facilitate the data sharing needed to determine a drug’s fair price.

 

U.S. drug expenditures are among the highest in the world

It’s well-documented that the U.S. spends more on prescription drugs than other high-income countries. After adjusting for rebates and discounts, U.S. drug prices are almost 200% of prices in other comparable countries, according to a 2021 Rand Corporation report.

High drug prices in the U.S. translate to a per capita expenditure almost double what consumers and payers in other developed countries are paying. Peterson-KFF’s Health System Tracker shows that in 2019, U.S. payers and consumers spent a yearly average of $1,126 per capita for prescription medications, with $963 covered by payers and $164 in patient out-of-pocket costs. In other high-income countries, average annual drug expenditures were $552 per capita, with $88 in yearly out-of-pocket costs for patients.

U.S. drug expenditures keep rising

The American Society of Health-System Pharmacists reports that in 2021 overall pharmaceutical expenditures in the U.S. grew by 7.7% over the previous year’s costs; and for 2022, they predict another 4-6% increase in drug spending.

According to the healthcare consulting firm IQVIA, a total of 6.3 billion prescriptions were filled in the U.S. in 2020. Around 90% of those prescriptions were filled using lower-priced generic drugs. Lower-priced generic and biosimilar drugs have helped slow the rise of the annual national drug expenditures, however these account for only around 20% of total drug costs.

Increased use of pharmaceuticals (especially generics), drug price hikes, and high-cost new drugs coming to the market are contributing to the rise in overall drug expenditures. In particular, new, brand-name specialty drugs for conditions such as diabetes, cancer, autoimmune, and other rare diseases are bringing up the average of drug prices.

The use of specialty drugs increased from 27% of total U.S. drug spending in 2010 to 53% in 2020, according to IQVIA. They forecast up to 55 new pharmaceutical products per year will be brought to market between 2020 and 2025. Pharmaceutical forecasting software can help you stay on top of these changes and plan effectively.

Payers will have to decide whether to cover the cost of these new products and at what price. New-to-market specialty drugs are excellent candidates for value-based purchasing agreements.

Value-based purchasing contracts provide the data that reveal if a drug is worth its price

Payers have the difficult task of figuring out if a manufacturer’s proposed wholesale price for a new drug is justified. They need to protect their bottom line by minimizing the risk of paying for ineffective, over-priced drugs. Private insurance plans, Medicaid, and the Veterans Administration often negotiate prices for new treatments with pharmaceutical companies without real-world data to demonstrate the drug’s clinical and cost-effectiveness compared to other treatments for the same health condition.

If their product is eligible, some pharmaceutical manufacturers conduct fast-track clinical trials for FDA approval using surrogate endpoint measures to show that a new drug is safe and more effective than a placebo. But these trials provide limited data and they aren’t the comprehensive comparative effectiveness review (CER) needed for determining the value and fair price for the drug. Independent research firms, such as the Institute for Clinical and Economic Review (ICER) and the Patient-Centered Outcomes Research Institute (PCORI), conduct CERs that provide insight into pricing for drug categories, but they don’t research every new drug coming onto the market.

Value-based purchasing agreements fill this knowledge gap by collecting the real-world evidence of a new drug’s clinical value. The data sharing among stakeholders that comes with these outcome-based contracts gives a fuller picture of the drug’s impact on patient health outcomes.

Value-based purchasing contracts strengthen stakeholder partnerships

While acknowledging that the future of healthcare is moving from fee-for-service to value-based healthcare, providers and payers have been slow to adopt value-based contracting. Operationalizing these agreements is complex. They consume large amounts of time and financial resources at start-up, not to mention the trust, cooperation, and commitment required from stakeholders.

It can be quite difficult to agree on a drug price that satisfies all stakeholders in terms of evidence-based clinical value and comparative competitor pricing. What and who determines a drug’s value? Value-based purchasing arrangements align the stakeholders’ metrics for measuring value to determine a fair price for a drug. Over time, this new level of transparency and cooperation can foster greater trust between contract partners and help break down the barriers blocking the transition out of fee-for-service to value-based healthcare.

The Lyfegen Platform

Manufacturers, payers, and providers all possess part of the data about a drug’s value in their databases. In the past, automated tools to safely collect, centralize, and analyze stakeholder data were non-existent. Thanks to innovations in artificial intelligence, new software platforms for value-based contracts can facilitate efficient coordination among the stakeholders to achieve a high level of secure data sharing.

Lyfegen’s software platform helps healthcare insurances, pharma and medtech companies implement and scale value-based purchasing contracts with greater efficiency and transparency. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable insights on drug performance and cost in value-based contracts. By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

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Leveraging clinical- and cost-effectiveness data to inform drug pricing and reimbursement

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Leveraging clinical- and cost-effectiveness data to inform drug pricing and reimbursement

How the U.S. Institute for Clinical and Economic Review is reshaping market access

 

In the U.S., comparative clinical effectiveness analyses are gaining traction as ways to inform coverage, pricing, and reimbursement of pharmaceuticals by both public and commercial payers. And, while use of cost-effectiveness data to inform coverage decisions is prohibited in the public sector (Medicare and Medicaid) it can be used in the commercial sector.

A recently released Xcenda analysis shows that 70% of U.S. commercial payers identified comparative clinical- and cost-effectiveness evidence in the Institute for Clinical and Economic Review’s (ICER) published reviews as the most important items in the reports with respect to informing coverage and reimbursement decisions.

Additionally, 50% of payers said that long-term cost-effectiveness – for example, cost-per-Quality-Adjusted-Life-Year – is “very impactful” in informing the decision-making process. And, as the figure below shows, 52% used results from an ICER assessment in pricing negotiations while 38% implemented a prior authorization protocol based on an ICER evaluation.

Source: Xcenda, International Society for Health Economics and Outcomes Research (ISPOR) annual meeting presentation, May 2022

Further bolstering the Xcenda analysis, an Evidera study from late 2019 suggested that ICER can influence value-based benchmark prices. The use of value-based pricing is increasing in the U.S. And, where appropriate, ICER favors the use of value-based contracting to align price and value. In fact, in certain instances such as gene therapies, ICER believes that such treatments can only be viewed as being cost-effective if value-based contracting is applied. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.

To illustrate the impact ICER assessments can have with respect to pricing and reimbursement decisions, let’s consider ICER’s evaluation of PCSK9 inhibitors – indicated for individuals with inadequately treated levels of LDL-cholesterol. In 2016, two PCSK9 inhibitors were approved by the Food and Drug Administration: Alirocumab (Praluent) and evolocumab (Repatha). ICER reviewed the drugs’ clinical- and cost-effectiveness and suggested the list prices needed to be substantially reduced to make the treatments cost-effective.

What ensued was the establishment of several ICER-payer partnerships that led to formulary exclusions of these therapies and subsequent “price wars” as manufacturers of Praluent and Repatha drastically lowered their list prices to remain competitive.

Broadly, cardiovascular disease represents a competitive market with an established standard of care that includes numerous therapeutic options for most patients. Here, payers were able to leverage ICER’s assessment of the PCSK9 inhibitors in negotiations with drug manufacturers. In turn, this led, for example, to one manufacturer lowering the wholesale acquisition cost of Praluent to $5,850, down from $14,600.

In other therapeutic categories with much less competition, ICER’s impact is less clear-cut. For example, in a therapeutic area such as spinal muscular atrophy, characterized by low prevalence, high mortality rates, and lack of effective treatments, ICER’s cost-effectiveness analysis either did not influence payer coverage - as with the drug Spinraza (nusinersen) - or may have been leveraged by the manufacturer to push for wider acceptance among payers -as with Zolgensma (onasemnogene abeparvovec).

In 2019, ICER published its final recommendations on spinal muscular atrophy therapies. To meet an ICER-imposed cost-effectiveness threshold of up to $150,000 per life year gained, Spinraza would need to be priced at a maximum of $145,000 for the first year of treatment and $72,000 annually for subsequent years. This was considerably lower than Spinraza’s list price of $750,000 for the first year and $375,000 annually for subsequent years. ICER also recommended that Zolgensma could be priced at up to $2.1 million per treatment to be considered cost-effective, which turned out to be in line with its list price of $2.125 million at launch.

Interestingly, although ICER’s analysis found that Zolgensma was cost-effective while Spinraza was not, payer coverage for both drugs followed a similar trend over time, with payers restricting access in the initial periods immediately after launch and later relaxing these criteria.

The shift in coverage criteria could be due to an initial reflex response that payers have to restrict access to extremely expensive medications, followed by a loosening of criteria. Historically, this has been the case. Subsequently, after acknowledging the dramatic clinical benefits that Spinraza and Zolgensma have demonstrated in clinical trials for treating a disease with no other therapeutic options, payers relent, if you will. Also, in the case of Zolgensma, ICER’s evaluation may have led to a further easing of payer restrictions.

Of course, cost-effectiveness analyses, such as the ones published by ICER, must invariably be adapted for local use. Context matters, nationally, but also intra-nationally, in different jurisdictions and sub-markets. Further challenges include local or federal (national) regulations which may prevent the use of cost-effectiveness analyses under certain circumstances; stakeholders’ resistance to adopting such analyses or be bound by their findings; and the general lack of available (and appropriate) cost-effectiveness data.

Nevertheless, there is a consistent trend which points to the growing influence of ICER evaluations on payer decision making, specifically with respect to drug pricing and reimbursement. Clinical- and cost-effectiveness data can be used to determine whether to cover a technology, inform the use of prior authorization or other conditions of reimbursement, and serve as a benchmark for price negotiations with manufacturers.

 

About the author

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

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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.

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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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

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A New Era in Canadian Healthcare: Lyfegen's CEO Discusses Groundbreaking Collaboration

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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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

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Lyfegen Launches the World's Largest Database of Value-Based Drug Agreements

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.”

Learn more about Pharmaceutical Healthcare Solution

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.

Learn more and start your free trial now

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

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Swiss health insurance Sympany implements Lyfegen Platform to efficiently execute complex value & data-driven agreements for high-priced medication.

 

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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Breaking News: Lyfegen platform supports Johnson & Johnson to further drive value-based healthcare strategy

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Breaking News: Lyfegen platform supports Johnson & Johnson to further drive value-based healthcare strategy

 

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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Conozca a David Duro, nuestro nuevo Vicepresidente de Ventas y Desarrollo de Negocio - Un líder que conecta con sus clientes y les ofrece soluciones eficaces

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Conozca a David Duro, nuestro nuevo Vicepresidente de Ventas y Desarrollo de Negocio - Un líder que conecta con sus clientes y les ofrece soluciones eficaces

Antes de unirse a nosotros en Lyfegen, David adquirió una gran experiencia y conocimientos en la industria de la salud y las finanzas, mientras perfeccionaba sus habilidades como Ejecutivo de Ventas Globales. Su curiosidad por la naturaleza humana y su amor por la humanidad es lo que alimenta su pasión por marcar la diferencia allí donde más importa.

Afincado en España y licenciado en Ingeniería Informática Con su amplia experiencia en la introducción de productos disruptivos en el mercado, ha llegado a comprender que es primordial destacar cómo las tareas diarias del usuario conectan con nuestra plataforma y guiar a través del proceso. Cuando se le pide que describa cómo ve su papel, David dice: "Todo el mundo busca algo. Mi trabajo consiste en entender qué es lo que realmente buscan". Cuándo le preguntamos qué es lo que más le gusta de su trabajo, respondió: "Bucear por debajo de las palabras y entender las necesidades de la gente,para luego conectar esas necesidades con las soluciones que Lyfegen puede aportar."

¿Qué es lo que quiere emprender este año? Siendo un aprendiz permanente, David quiere profundizar en el ciclo completo de nuestro servicio y explorar tanto la gestión de proyectos como la parte técnica. Apasionado de la buena música, pasa su tiempo libre con amigos que disfrutan de los mismos intereses. Es un creyente en la humanidad y en los actos de bondad al azar, está deseando conocer gente nueva este año de todo el mundo y tener la oportunidad de conectar experiencias y trabajar en un entorno internacional.

Girisha Fernando, Directora General de Lyfegen, está encantada de dar la bienvenida a David a nuestro equipo. 'Estamos encantados de tener a David Duro a bordo. Su inestimable pericia y amplia experiencia aportarán sin duda un inmenso valor al éxito de Lyfegen. Esto marca un hito importante en nuestros esfuerzos de expansión internacional, y estoy ansioso por anticipar las nuevas oportunidades que se avecinan'.

Desde Lyfegen, damos una calurosa bienvenida a David y esperamos crecer juntos.

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Meet David Duro, Our New VP of Sales & Business Development - A Leader Who Connects with his Customers and Helps Them Find Powerful Solutions

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Meet David Duro, Our New VP of Sales & Business Development - A Leader Who Connects with his Customers and Helps Them Find Powerful Solutions

Before joining us at Lyfegen, David gained a wealth of experience and knowledge in the healthcare and finance industry while honing his skills as a Global Sales Executive. His curiosity of human nature and love for humanity is what fuels his passion to make a difference where it matters most.

Based in Spain with a qualification in Computer Engineering, David is no stranger to bringing disruptive products to the market. With his extensive experience bringing disruptive products to the market, he has come to understand that it is paramount to highlight how our platform connects to the daily tasks of the user and prefers to guide them through the process. When asked to describe how he views his role, David said, “Everyoneis looking for something. My job is to understand what it is that you are really looking for”. When we asked what he likes the most about his job, he replied “diving below the words and understanding the needs of the people, then connecting those needs with the solutions that Lyfegen can provide.”

What is something he wants to take up this year? Being a curious lifelong learner, David eventually wants to deep dive into the full cycle of our service and explore both the project management and the tech side. Passionate about good music, he spends his free time with friends who enjoy the same interests. While being a tremendous believer in humanity and random acts of kindness, he looks forward to connecting with new people this year from all around the world and having the opportunity to connect experiences and work in an international environment.

Girisha Fernando, CEO of Lyfegen, is extremely excited to welcome David into our team. 'We are thrilled to have David Duro on board! His invaluable expertise and extensive experience will undoubtedly bring immense value to Lyfegen’s success. This marks a significant milestone in our international expansion efforts, and I am eagerly anticipating the new opportunities ahead.'

From all of us at Lyfegen, we warmly welcome David and look forward to growing together!

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

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Meet Olga Dragos, Our Newest Key Member and Efficiency Champion

We are delighted to welcome our new executive assistant, Olga Dragos to the Lyfegen team! Olga joined us after making her final decision to work only with an enterprise that is directly impacting the lives of many for the better.

When we asked what fuels her purpose, she said, “The most exciting part of my profession is that I get to be key in streamlining processes that save time for our teams, which in turn helps get our product in front of more patients and increases our capacity to brainstorm new projects.”

With a solid background spanning over more than fifteen years in Executive and Administrative Support, Olga is a highly experienced professional that has worked in the US market for several corporates and small businesses in the medical insurance and transportation industries.

Originally from Belarus, Olga immigrated to the US in 1996 and further moved to Romania in 2021 where she is happily settled now with her husband and son. Being an avid traveler at heart with a passion for diverse cultures and their delicacies, Olga takes solace in both nature and outdoor activities where she’s been known to take scenic canoe rides down the river in early spring. While she has an adventurous spirit, family and cooking is her first love and creating her own recipes for them to enjoy while spending quality time together is a high priority.

When we asked what’s next for this year outside of work, we were not surprised to discover her warm philanthropic nature has steered her on the path of finding a new organization where she can volunteer her time to make a difference.

We give a very warm welcome to Olga and look forward to having her vibrant personality, and sound expertise to propel our team forward.

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Envisioning solutions that solve meaningful real-world problems – meet Andrei Cantea, our new visionary Senior Product Designer

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Envisioning solutions that solve meaningful real-world problems – meet Andrei Cantea, our new visionary Senior Product Designer

After graduating in Computer Science from Babeș-Bolyai University in Romania, Andrei co-founded a digital health start-up that was laser focused on assisting patients and clinicians alike, to reach better health outcomes. His keen interest in UX design and problem solving has been the driving force behind his success in creating and building meaningful experiences and solutions in the digital healthcare arena.  

However, his story doesn’t start there.  

Andrei’s first interactions with design started in his high school years, where he took part in numerous competitions within the digital solutions and education space – this being where he realized his true passion for design and creating solutions that would positively impact the lives of many.  

When we asked Andrei what excited him the most about joining Lyfegen as the new Senior Product Designer, his answer was clear cut – “I am allowed to be an active part in envisioning, designing and building meaningful solutions that can help users, which in turn helps patients and saves lives – this is what I find exciting and refreshing.

Joining Lyfegen has been a perfect synergy between Andrei’s personal views on digital healthcare and Lyfegen’s impactful approach in the sector – solving deep complex issues, while still remaining mindful and deeply empathetic towards its users and end goals. This is what fuels his motivation in contributing his valuable expertise in the process, while working alongside his incredible team.  

While in his spare time, Andrei has been known to catch up with his video games when time allows, play board games, watch his favorite science channels, read a good book, and of course spend quality time with his friends and family, when he’s not outdoors enjoying some nature.

We warmly welcome Andrei to our team and look forward to revolutionizing the industry side-by-side.

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

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CMA & Lyfegen Present Joint Value-Based Contracting Platform for Pharmacy at Medicaid’s Most Important Conference

Each year, the NAMD (National Association of Medicaid Directors) Conference in Washington D.C. brings together the nation's Medicaid directors, leaders in the industry, and key decision-makers for a one-of-a-kind conference. With the global public health emergency, the Medicaid system and the work of Medicaid directors and their staff has never been more important. While COVID-19 has disrupted health care at all levels, it has shown the importance of more innovative payment models and the need for broader access to treatments. The shift towards value-based healthcare has become one of Medicaid’s hottest topics, with CMA and Lyfegen joining forces to present the latest value-based contracting technology at this year’s NAMD Conference.

We sat down for a brief interview with CMA’s President, Ken Romanski, and Lyfegen’s CEO, Girisha Fernando, to gain more insights into the importance of this partnership:

Thanks for joining us, Ken and Girisha. Can you tell us why this partnership is an important milestone, both for CMA and Lyfegen?

Ken: Our partnership with Lyfegen is a key milestone for CMA as we expand and complement our portfolio of technology-based solutions with extremely high-value business analytics products. Our utmost priority is to support Medicaid programs by lowering costs, while at the same time improving health outcomes for vulnerable citizens.

Girisha: This partnership sets the basis to create enormous value for our state healthcare payers and pharma. By partnering together, we enable our customers to implement value-based pharmacy agreements, actively managing the budget impact of new treatments and aligning existing formulary spending with value for beneficiaries.

For Lyfegen, this is a market entry into the U.S. – why CMA?

Girisha: CMA’s experience and technical expertise are unique. CMA is a highly recognized technology partner for State Healthcare Payers across the nation, with over 20 years of experience. Lyfegen has made a conscious decision to combine its capabilities with CMA to enable our customers to leverage the potential of value-based agreements for their pharmacy programs.

What is the value of this partnership for healthcare payers?

Ken: CMA is very excited to work with Lyfegen and our clients to deliver tens of millions of dollars in savings per year by leveraging our experience in Medicaid data management to implement this robust value-based analytics platform.

Girisha: Our customers benefit from the combined years of experience and unique expertise in data and value-based healthcare solutions. We focus on providing the first proven, scalable, highly secure value-based agreement platform for State Medicaid that allows our customers on average to avoid 54 million dollars in treatment costs that do not work and gain 7 million dollars in efficiency due to the fully automated end-to-end process. We are extremely excited to present all aspects of our partnership and present the value and opportunities our platform can bring to State Medicaid programs at NAMD.

Join CMA and Lyfegen at NAMD and understand first-hand how they can support you to realize savings for your pharmacy programs, improving patient health outcomes with their unique value-based agreement platform.



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Principales Fabricantes y Pagadores en Brasil

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Principales Fabricantes y Pagadores en Brasil


En Brasil, encontramos que los principales fabricantes que proponen contratos basados en el valor fueron Novartis, Pfizer, J&J Innovative Medicine y Roche. Entre los pagadores, identificamos 21 aseguradoras privadas entre 2021 y 2024. También agregamos a ANVISA (Agencia Nacional de Vigilancia Sanitaria de Brasil) y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC), el organismo de evaluación de tecnologías sanitarias (ETS) de Brasil.

Áreas Terapéuticas

Las áreas terapéuticas que identificamos en los acuerdos públicos de Brasil incluyen:

  • Enfermedades infecciosas
  • Oncología
  • Enfermedades metabólicas
  • Cardiovascular
  • Hematología

Modelos de Precios

Nuevos modelos de precios de Brasil incluyen:

  • Cobertura restringida
  • Descuento fijo
  • Cobertura con desarrollo de evidencia
  • Garantía de resultados
  • Límite de presupuesto

Acuerdos Destacados

Estos acuerdos se destacan porque abordan enfermedades raras y de alto costo, y demuestran enfoques únicos para el acceso a medicamentos y reembolsos, incluyendo cobertura con desarrollo de evidencia, garantías de resultados y pagos a plazos.

Fibrosis Quística:

  1. Orkambi (2024): CED, Cobertura restringida, Pagos a plazos
  1. Trikafta (2023): CED, Garantía de resultados, Cobertura restringida
  1. Kalydeco (2020): CED, Cobertura restringida


Atrofia Muscular Espinal Infantil:

  1. Zolgensma (2022): Garantía de resultados, CED, Pagos a plazos

Cáncer de Ovario:

  1. Lynparza (2022): Cobertura restringida, CED (con aseguradoras privadas)

Principales Fabricantes:

  • Novartis
  • Varios fabricantes (para genéricos)
  • Pfizer
  • J&J Innovative Medicine
  • Roche

Entendiendo el Proceso de ETS para la Aprobación de Medicamentos en Brasil

En Brasil, el proceso de Evaluación de Tecnologías Sanitarias (ETS) es gestionado por ANVISA y la Comisión Nacional de Incorporación de Tecnologías en el Sistema Único de Salud (CONITEC). El proceso incluye varios pasos:

  1. Aplicación: Las compañías solicitan que sus medicamentos sean evaluados.
  1. Evaluación: ANVISA y CONITEC evalúan los medicamentos.
  1. Negociación y fijación de precios: Se negocian precios y términos.
  1. Inclusión: Los medicamentos aprobados se incorporan al sistema con precios establecidos.
  1. Reembolso: Los medicamentos listados son reembolsados bajo el sistema de salud pública.

A medida que Brasil se convierte en un mercado clave para las empresas farmacéuticas, nuestra biblioteca ofrece información esencial para ayudarle a ingresar a este mercado de manera eficiente y antes que la competencia.

Para obtener más información sobre los acuerdos de acceso a medicamentos en Brasil o acceder a nuestra biblioteca, reserve una demostración con nosotros hoy: https://www.lyfegen.com/demo

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Explorando Contratos Basados en el Valor: Acuerdos Públicos Destacados en Canadá, Dinamarca y Brasil

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Explorando Contratos Basados en el Valor: Acuerdos Públicos Destacados en Canadá, Dinamarca y Brasil


En este blog, seleccionamos acuerdos específicos en Canadá, Dinamarca y Brasil. Cada uno de estos acuerdos varía, y los elegimos para que pueda ver cómo los fabricantes abordan el acceso al mercado para diferentes medicamentos y regiones. Los contratos basados en el valor en estos mercados aceleran el acceso de los pacientes mientras comparten el riesgo financiero entre la industria farmacéutica y los pagadores, una situación en la que todos ganan.

Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Canadá
  • Tipo de acuerdo: Cobertura con desarrollo de evidencia (CED), cobertura restringida, garantía basada en resultados.
  • Fecha: Julio 2022

La Agencia Canadiense de Medicamentos y Tecnologías en Salud requiere una reducción del 94% en el precio de Trikafta para que el tratamiento sea rentable. Los niños con fibrosis quística de entre 2 y 5 años son evaluados después de 1 año, para demostrar que se benefician del tratamiento. Los pacientes deben cumplir con una serie de criterios para ser elegibles para el tratamiento, lo que convierte al acuerdo en una combinación de cobertura con desarrollo de evidencia, cobertura restringida y basada en resultados.

Trikafta ya había sido aprobado para su uso en niños mayores de 6 años, pero realizar un ensayo clínico en niños de entre dos y cinco años se consideró “éticamente desafiante”. Sin embargo, un ensayo no controlado en este grupo de edad encontró que el tratamiento fue bien tolerado y redujo los biomarcadores de la condición. Para abordar las necesidades no satisfechas, reconociendo la falta de datos en esta población de pacientes, se negoció un contrato de CED con una reducción drástica en el precio.

Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Brasil
  • Tipo de acuerdo: Cobertura restringida, CED
  • Fecha: Abril 2024

El Ministerio de Salud de Brasil llegó a un acuerdo con Vertex para permitir el acceso restringido a este tratamiento, mientras monitorea regularmente a los pacientes a los 30 días y a los 3 meses después de iniciar el tratamiento. El acuerdo incluye reembolsos si el tratamiento no logra los resultados clínicos deseados, alineando los precios con la efectividad.

Kalydeco (ivacaftor, Vertex Pharmaceuticals)

  • Indicación: Fibrosis quística
  • País: Dinamarca
  • Tipo de acuerdo: Acuerdo de precio-volumen; precios de cartera
  • Fecha: Octubre 2018

El organismo de adquisición danés, Amgros, y Vertex Pharmaceuticals llegaron a un acuerdo que proporciona acceso a una cartera de medicamentos para la fibrosis quística, incluyendo Orkambi (lumacaftor/ivacaftor) y futuras terapias, en 2019. A pesar de que esto ocurrió hace cinco años, es un excelente ejemplo de precios basados en cartera, donde los pagadores acuerdan pagar una tarifa fija por un grupo de medicamentos relacionados. Cuantos más pacientes los utilicen, menor será el precio por paciente.

Lynparza (Olaparib, AstraZeneca)

  • Indicación: Cáncer de ovario
  • País: Brasil
  • Tipo de acuerdo: Cobertura restringida, garantía basada en resultados
  • Fecha: Mayo 2022

Este acuerdo se realizó entre AstraZeneca y aseguradoras privadas en todo Brasil. El tratamiento se pone a disposición sin costos adicionales para el paciente y combina características de cobertura restringida con garantías de resultados. La cobertura continua depende de lograr una respuesta parcial o completa.

Zolgensma (onasemnogene abeparvovec, Novartis)

  • Indicación: Atrofia muscular espinal (AME)
  • País: Brasil
  • Tipo de acuerdo: Garantía de resultados, CED, pagos a plazos
  • Fecha: Diciembre, 2022

La terapia génica de Novartis, Zolgensma, se reembolsa en función de la necesidad de evidencia adicional, conocida como cobertura con desarrollo de evidencia. Esto implica usar la cobertura como un medio para obtener evidencia del mundo real, para compensar la falta de datos robustos de pacientes provenientes del ensayo clave. El acuerdo también divide el riesgo entre los pagadores y los fabricantes, al vincular el reembolso con los resultados obtenidos. Debido al gran potencial de la terapia para mejorar la calidad de vida de los niños con AME, el acuerdo permite que los pacientes elegibles comiencen a recibir el tratamiento rápidamente.

¿Quiere ver la biblioteca por sí mismo? Reserve una demostración hoy aquí: https://www.lyfegen.com/demo

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How Spain is Preparing for Europe’s New Regulation

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How Spain is Preparing for Europe’s New Regulation


To streamline the HTA process across EU member states, sweeping changes will go into effect in January of 2025. Instead of manufacturers of new health technologies needing to submit clinical data to each member state, under Regulation (EU) 2021/2282, the assessment will be conducted jointly. Manufacturers will only need to submit clinical assessments once, but member states can still conduct complementary assessments.

Important to note are the 9 assessment domains, of which 4 are clinical and 5 are non-clinical. The 4 clinical assessments include:  

  • Evaluation of the disease and the current treatment landscape
  • Examination of the new health technology
  • Safety
  • Effectiveness

The 5 non-clinical domains include:  

  • Cost and economic evaluation
  • Ethics
  • Organizational impacts
  • Social impacts
  • Legal aspects


Spain released its Draft Royal Decree on the 12th of August, which is open for comments until the 20th of September, outlining how they will align with the Directive. This effort involves the Office for the Evaluation of the Efficiency of Medicines operating as a functional unit under the Spanish Agency of Medicines and Medical Devices (AEMPS).


In addition to joint clinical assessments in Europe, there will also be joint scientific consultations. The goal of this Directive is to reduce duplicate administrative work and remove barriers to innovation while aiming to improve patient outcomes.  


As these changes reshape the landscape, it's crucial for pharmaceutical and medical technology companies to adapt swiftly. Lyfegen can help you stay ahead with our cutting-edge solutions:


- Navigate New Regulatory Requirements: Access our extensive Agreements Library, featuring over 5,000+ public drug pricing agreements and 20 pricing models, to ensure compliance with the latest HTA standards.

- Optimize Decision-Making: Utilize our Drug Contracting Simulator to create data-driven business cases and run real-time simulations that align with Spain's new HTA guidelines.

- Streamline and Automate Contracting: Our Rebate Analytics solutions automate rebate and refund calculations, ensuring accuracy, transparency, and a significant reduction in administrative burdens.


Book a demo with us today to explore how Lyfegen’s tools and expertise can support your business under Spain’s new HTA framework.
Book your demo here: https://www.lyfegen.com/demo

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Medicare Part D’s 2025 Overhaul

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Medicare Part D’s 2025 Overhaul


A major change to Medicare Part D will go into effect next year, as a result of the Inflation Reduction Act. Most notably, the cap on out-of-pocket expenditures will be reduced from $3,300 to $2,000.  

  • Beneficiaries will be able to enroll in the Medicare Prescription Payment Plan, which involves monthly payments of under $200 instead of a lump sum at the pharmacy.  
  • The share of total drug costs will change. This year, 20% of catastrophic coverage costs are covered by the Part D plan and 80% by Medicare. Next year, 60% will be covered by Part D, only 20% by Medicare, and 20% by the manufacturer.  
  • The 5% coinsurance requirement will be eliminated, which will save patients thousands in out-of-pocket costs, especially for those on more expensive medications.  

This brings us to another major development.  

Update to Medicare Drug Price Negotiation Program

CMS announced its selection of 10 drugs that were negotiated down in price, on August 15th. The selected drugs were identified as “single source drugs,” meaning there is no generic or biosimilar equivalent, and there is unlikely to be so in the near future. The new prices are estimated to save $6 billion in net prescription drug costs, representing a 22% reduction in spending. The new prices will go into effect on the 1st of January, 2026.  

As the pharmaceutical industry goes through these changes, it’s crucial to have the right tools in place. This is where Lyfegen comes into play with its cutting-edge solutions like the Drug Contracting Simulator, an innovative tool designed to help Market Access and Pricing teams stay ahead in this landscape:

💡 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁𝗹𝘆 𝗠𝗼𝗱𝗲𝗹 𝗣𝗿𝗶𝗰𝗶𝗻𝗴 𝗦𝗰𝗲𝗻𝗮𝗿𝗶𝗼𝘀: Build and test a wide range of drug rebate contracts, allowing you to quickly assess the impact on gross-to-net revenue and costs.

🤝 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗣𝘂𝗿𝗽𝗼𝘀𝗲-𝗕𝘂𝗶𝗹𝘁: Move away from Excel-based tools with our dedicated platform, designed for Market Access and Pricing teams, and re-usable across different markets and assets.

⚡ 𝗙𝗮𝘀𝘁𝗲𝗿, 𝗕𝗲𝘁𝘁𝗲𝗿 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀: Streamline the creation of rebate agreements in a collaborative environment, helping you respond more effectively to new pricing pressures.Don’t miss out on staying ahead in this new regulatory environment. Book a demo with us today: https://www.lyfegen.com/demo

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Brazil’s Key Manufacturers and Payers

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Brazil’s Key Manufacturers and Payers


In Brazil, we found that the main manufacturers proposing value-based contracts were Novartis, Pfizer, J&J Innovative Medicine, and Roche. Among payers, we identified 21 private insurers between 2021 and 2024. We also added ANVISA (Brazilian Health Regulatory Agency) and the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC), Brazil’s health technology assessment (HTA) body.  

Therapeutic Areas  

The therapeutic areas we identified in Brazil’s public agreements include:

  • Infectious diseases
  • Oncology
  • Metabolic diseases
  • Cardiovascular
  • Hematology

Pricing Models

New pricing models from Brazil include:  

  • Restricted coverage
  • Fixed discount
  • Coverage with evidence development
  • Outcome guarantee
  • Budget cap

Featured Agreements

These agreements are highlighted because they address high-cost, rare diseases and demonstrate unique approaches to drug access and reimbursement, including coverage with evidence development, outcome guarantees, and installment payments

Cystic Fibrosis:

  1. Orkambi (2024): CED, Restricted coverage, Installments
  1. Trikafta (2023): CED, Outcome guarantee, Restricted coverage
  1. Kalydeco (2020): CED, Restricted coverage

Infantile Spinal Muscular Atrophy:

  1. Zolgensma (2022): Outcome guarantee, CED, Installment

Ovarian Cancer:

  1. Lynparza (2022): Restricted coverage, CED (with private insurers)

Main Manufacturers:

  • Novartis
  • Various manufacturers (for generics)
  • Pfizer
  • J&J Innovative Medicine
  • Roche

Understanding the HTA Process for Drug Approval in Brazil

In Brazil, the Health Technology Assessment (HTA) process is managed by ANVISA & the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC). The process involves several steps:

  1. Application: Companies apply for their drugs to be assessed.
  1. Evaluation: ANVISA & CONITEC assess the drugs.
  1. Negotiation and Pricing: Prices and terms are negotiated.
  1. Inclusion: Successful drugs are incorporated into the system with set prices.
  1. Reimbursement: Listed drugs are reimbursed under the public health system.

As Brazil becomes a key market for Pharma companies, our library offers essential information to help you enter this market efficiently and ahead of the competition.

To learn more about Brazil’s Drug Access Agreements or get access to our library, book a demo with us today: https://www.lyfegen.com/demo

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