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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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Exploring Value-Based Contracts: Featured Public Agreements in Canada, Denmark, and Brazil

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Exploring Value-Based Contracts: Featured Public Agreements in Canada, Denmark, and Brazil


For this blog, we chose select agreements in Canada, Denmark, and Brazil. Each of these agreements vary, and we chose them so you can see how manufacturers tackle market access for different drugs and regions. Value-based contracts in these markets speed patient access while sharing financial risk between pharma and payers—a win-win situation.

Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals).  

Indication: Cystic fibrosis

Country: Canada

Agreement type: Coverage with evidence development (CED), restricted coverage, outcomes-based guarantee.

Date: July 2022.  

The Canadian Agency for Drugs and Technologies in Health requires a 94% price reduction on the price of Trikafta, in order for the treatment to be cost-effective. Children with cystic fibrosis between the ages of 2–5 are evaluated after 1 year, to show that they benefit from the treatment. Patients must meet a number of criteria to be eligible for treatment, making the agreement a combination of coverage with evidence development, restricted coverage, and outcomes-based.  

Trikafta was already approved for use in children over 6 years of age, but conducting a clinical trial in children between two and five years of age was deemed “ethically challenging.” An uncontrolled trial however in this age group found that the treatment was well-tolerated and reduced biomarkers of the condition. To address unmet needs while acknowledging the lack of data in this patient population, a CED contract with a drastic price reduction was negotiated.  

Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)

Indication: Cystic fibrosis

Country: Brazil

Agreement type: Restricted coverage, CED

Date: April 2024

The Brazil Health Ministry came to an agreement with Vertex to allow restricted access to this treatment while regularly monitoring patients at 30 days and 3 months after initiation of treatment. The agreement includes refunds is the treatment does not achieve desired clinical outcomes, aligning pricing with effectiveness.

Kalydeco (ivactafor, Vertex Pharmaceuticals)

Indication: Cystic fibrosis

Country: Denmark

Agreement type: Price-volume agreement; portfolio pricing

Date: October 2018

The Danish procurement body, Amgros, and Vertex Pharmaceuticals, came to an agreement that provides access to a portfolio of drugs for cystic fibrosis, including Orkambi (lumacaftor/ivacaftor) and future therapies, in 2019. Despite this taking place five years ago, it’s a great example of portfolio-based pricing, where payers agree to pay a set fee for a group of related drugs. The more patients that use them, the lower the price per patient.  

Lynparza (Olaparib, AstraZeneca)

Indication: Ovarian cancer  

Country: Brazil

Agreement type: Restricted coverage, outcome guarantee

Date: May 2022

This agreement was made between AstraZeneca and private insurers throughout Brazil. The treatment is made available without additional costs to the patient and combines features of restricted coverage with outcomes guarantees. Continued coverage is dependent on achieving partial or complete response.  


Zolgensma (onasemnogene abeparvovec, Novartis)

Indication: Spinal muscular atrophy (SMA)

Country: Brazil

Agreement type: Outcome guarantee, CED, installment payments

Date: December, 2022

Novarits’ gene therapy Zolgensma is reimbursed based on the need for additional evidence, referred to as coverage with evidence development. This involves using coverage as a means to obtain real-world evidence, to make up for the lack of robust patient data coming from the pivotal trial. The agreement also divides risk between payers and manufacturers , by tying reimbursement to outcomes achieved. Because of the therapy’s great potential to improve the quality of life of children living with SMA, the agreement allows eligible patients to quickly start receiving treatment.


Want to see the library for yourself? Book a demo today here: https://www.lyfegen.com/demo

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Preparing for Medicare Part D Redesign in 2025: Are You Ready?

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Preparing for Medicare Part D Redesign in 2025: Are You Ready?

Major changes are on the horizon for Medicare’s outpatient drug benefit in 2025, particularly following the release of negotiated drug prices under the Inflation Reduction Act. These changes will significantly impact both payers and drug makers, requiring careful planning and strategy.

One of the most critical updates is the reduction of the out-of-pocket spending cap for beneficiaries, which will decrease from $3,300 this year to $2,000 in 2025. While this cap will help patients manage their healthcare costs, it also increases the financial responsibility for payers and pharmaceutical companies.

Challenges for Specialty Drug Makers

Specialty drug makers, especially those in oncology, will face new challenges with the introduction of a 20% discount during the catastrophic phase of Medicare Part D. Since many patients will reach the $2,000 cap early in the year, this discount will apply for a significant portion of the year, impacting drug pricing strategies.

Impact on Medicare Advantage Plans

Medicare Advantage plans and stand-alone prescription drug plans will also see changes. Their liability for drug costs during the catastrophic phase will increase from 20% to 60%, as the federal government reduces its reinsurance contribution from 80% to 20%. This shift will require plans to adopt new cost management strategies.

How Lyfegen Can Help

As the Medicare Part D redesign approaches, it’s crucial for payers and drug makers to prepare effectively. Traditional cost management methods, like prior authorization, will need to be complemented by innovative approaches such as value-based pricing and market access solutions.

Lyfegen offers essential tools to support these efforts. Our Lyfegen Drug Contracting Simulator allows you to model various drug pricing scenarios, evaluate their impact on revenue and costs, and strengthen your market access strategies. By utilizing this tool, payers and pharmaceutical companies can better navigate the upcoming changes and optimize their drug market access strategies.

Start Preparing Today

Preparing for these changes is essential to maintain effective drug pricing strategies in the evolving Medicare market. Lyfegen’s solutions can assist in designing Medicare Part D formularies tailored to your needs, and in identifying the most appropriate value-based arrangements from our comprehensive database.

Don’t wait—boost your negotiating leverage now. With 2025 fast approaching, the time to act is today. Start using the Lyfegen Drug Contracting Simulator to stay ahead. Book a demo today to get started.

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Finding the right insulin products for payers to cover

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Finding the right insulin products for payers to cover

Insulin is going through monumental shifts in pricing and reimbursement in the U.S. It started with the announcement of reductions in list prices by drug companies last year. First, Novo Nordisk announced plans to reduce the list prices of several of its insulin products beginning January 1, 2024. This included lowering the price of NovoLog and Levemir by at least 65%. This move was followed by a similar commitment by competitor Eli Lilly to reduce Humalog’s price, among others, and came just days before Sanofi’s announcement to decrease Lantus’s price.

Moreover, biosimilar competition is ramping up, particularly in the long-acting insulin glargine space. Rezvoglar and Basaglar are leading the way, as they gain traction on payer formularies, especially in the public Medicaid market.

And this year, owing to implementation of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services began negotiating the net prices of both NovoLog and Fiasp, with public disclosure of said prices due to be revealed by September. Payers will soon be able to use these net prices as benchmarks to leverage better deals in markets besides Medicare. Also, CMS capped monthly out-of-pocket costs of insulin products for Medicare beneficiaries at $35.

For their large populations of insulin-dependent diabetics, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.

Because both list and net prices have come down, payers will likely lose out on some portion of the rebates—which reflect the difference between gross and net price—that they had grown accustomed to getting in the past. At the same time, the increasing number of payers that are adopting a rebate-free, net cost approach to formulary design will benefit from lower net prices.

And cheaper treatment options for patients may translate into better adherence to drug regimens which in turn could lead to improved health outcomes. For payers with a long-term perspective and comparatively little churn or enrollee turnover the potential downstream cost savings could be beneficial.

Lyfegen can assist in the calculations of value for all insulin products, both short- and long-acting, in addition to the design of appropriate formularies.

If you wish to improve your negotiating leverage for insulin products you can do so with real-world simulations for effective prescription drug contracts. Discover the Lyfegen Drug Contracting Simulator, our intuitive solution for streamlining iterative, collaborative drug contracting design.

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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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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.”

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

 

READ THE OFFICIAL PRESS RELEASE

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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.  

 

READ THE OFFICIAL PRESS RELEASE

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The tech team is growing at full-speed! Welcome to the Lyfegen team, tech-genius Dima!

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The tech team is growing at full-speed! Welcome to the Lyfegen team, tech-genius Dima!

He loves innovative tech and spending his free time reading Hi-tech books! Yes, we are proud to announce Lyfegen’s latest addition to the Kiev team: “Full-Stack Developer”, Dima Guzyk!



“Dima is extremely talented and with his passion to develop new and exciting technology that helps patients, Lyfegen’s products will reach new levels. We are very proud to have him in the team! ” says Lyfegen’s CEO, Girisha Fernando.

We sat down with him to give you a little more insight behind the book-loving “Full-Stack Developer”:

Hi Dima! Tell us a little about yourself: where are you from and what is your work experience background?

Hello! I’ve lived in Kiev almost all my life. This is such a beautiful city. For any lifestyle or interest, the city offers amazing opportunities to live out your dreams!

Regarding my work experience: After I graduated from university, I started working at Intellect Service, the biggest electronic document flow solutions developer in Ukraine. Gradually, my professional and communication skills developed and I became Team Lead of the company’s product. It was a great experience and led me to stay with them for 5 years!

My latest experience was at KPMG as a Software Engineer, where I participated in the development of various corporate information systems. Only after a short year, I had the fantastic opportunity to grow and take over the role of Senior Software Engineer.

This is your first experience in the Health Tech industry – what triggered this move?

This is my first experience in the Health Tech industry and I’m so happy! Working at Lyfegen gives even a tech development job a greater purpose: my work will indirectly support greater access for patients to innovative therapies – helping to save lives!

You are joining Lyfegen as a Full-Stack Developer. In simple terms: what will you be working on?

I participate in all the stages of software development, following the business requirements. In addition, I also analyze the domain in detail, propose architectural solutions to the problems we discover, write code, write unit tests, and help with creation of a reliable, scalable and secure application environment! In simple terms, I will bring the technical solutions of Lyfegen to life!

What are your next personal goals with Lyfegen?

My goal is to constantly discover new approaches and technologies, being able to make comparisons between them and implement the best to the work I do.

What motivated you to join?

When I discovered what Lyfegen was doing, giving patients worldwide access to innovative therapies, I knew I had to be a part of the team! Innovative therapies are necessary for humankind – it’s just that no one has been able to make these more accessible to a wider range of patients. This greater purpose and the impact that this technology has, was the key driver!

Enough about work! What passions do you have outside of Lyfegen?

I am an incredibly curious person! I have a wide range of passions that interest me but most of all I enjoy reading historical and Hi-tech books and magazines.

We are proud to have the Lyfegen team continue to grow with such fantastic team-members!

 

MEET THE LYFEGEN TEAM

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Our new Customer Success Hero: Welcome to the Lyfegen team, Simon Amstutz!

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Our new Customer Success Hero: Welcome to the Lyfegen team, Simon Amstutz!

The Lyfegen Team is proud to announce that as of this month, Simon has taken on the new role of “Customer Success Hero” at Lyfegen!



Simon joined Lyfegen 6 months ago as a working student and very quickly, full of motivation and enthusiasm, took on important responsibilities. Supporting Nico in the management of Lyfegen’s customer relations, which include some of the largest pharma companies worldwide, Simon will be accompanying the customers during the entire journey starting with supporting the customer’s in identifying suitable models up to the continuous support of Lyfegen's solutions. By gaining a comprehensive understanding of Lyfegen's customers' needs, he will also be working together with the technical development team to further enhance Lyfegen's solutions.

We are proud to have him as part of the team and sat down with him to give you a little more insight behind the bike-riding, FIFA-loving, “Customer Success Hero”!





Hi Simon, so tell us: why are you leaving large corporates like Roche and UBS to join the start-up Lyfegen?

After working at these two large corporates for several years I felt like I needed to see something completely different outside the corporate world. I was getting too much into a routine and wanted to take on a new challenge. I always had this entrepreneurial spirit in me and when I got the chance to start at Lyfegen, I didn’t have to think twice. Lyfegen offers me the perfect environment and has a great purpose.

You are working already since January 2020 at Lyfegen; what fascinates you the most?

I am really fascinated by the huge enthusiasm and passion of the whole team! Everyone here is very dedicated to leading Lyfegen to success and to driving value-based healthcare forward. I am also fascinated with how many new things I learn every single day and I am very delighted about how much responsibility I could already take over in this short time.

How do you experience the collaboration with the team?

The team has a great spirit and I felt very welcome and involved from the first second. The communication within the team is very transparent and open-minded. Issues can be addressed openly and critique is always given in a constructive way.

Healthcare is changing to value- and data driven models. How do you experience this change with our customers?

Our customers are all very interested in value- and data driven healthcare, but these models are often a new experience for them. With our technical solutions and our know-how, we support our clients to make the transition to value-based healthcare happen. We are now at a stage where we are pioneers and proactively shape the future environment for such models together with our clients.

What are your personal next goals with Lyfegen?

My personal goal is to further grow with the company. Growing not only personally by gaining more experience and continuously taking over more and more responsibility, but also to help Lyfegen achieve its next milestones. I am looking forward to be part of this journey.

We currently have two open positions - What are your recommendation for other talents that are applying at Lyfegen?

If you are applying at Lyfegen I recommend you to be aware of what it means to work in a start-up. You need to be ready to step outside your comfort-zone, be willing to actively drive things forward and take ownership. If this is what you are looking for, then Lyfegen is the perfect fit for you. Lyfegen offers you the perfect environment to further develop yourself and to work on exciting projects that have a real impact and a great purpose, helping patients to access innovative therapies.

Enough about work! What passions do you have outside of Lyfegen?

I love bike racing and being in nature! I can often be found on weekends biking my way up hills and testing my limits! It’s a great way to disconnect and focus on nature. But I’m not always in nature – I must admit, I do love playing video games too, especially FIFA (and am the proud winner of our last Lyfegen FIFA tournament – yes, the team got together for a 8 hour challenge one weekend!). Work hard, play hard!



We are proud to have the Lyfegen team continue to grow with such fantastic team-members!



MEET THE LYFEGEN TEAM

 

 

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A new face is on board! Welcome to Lyfegen, Tech-Guru Andrei

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A new face is on board! Welcome to Lyfegen, Tech-Guru Andrei

We are pleased to welcome the latest addition to our tech team! Andrei joins Lyfegen as a full-stack developer. He brings his wealth of backend and frontend experience to elevate our platform.



"I am excited to welcome Andrei to our Tech Team as a talented and motivated Full-Stack developer. Andrei brings great skills and knowledge to our team and will support us in further building our applications." Says CTO, Frederico Braga.

To introduce our newest addition, we interviewed Andrei.

Welcome to the Team, Andrei! Tell us a little about yourself.

Hi! My name is Andrei. I am from Romania, and I graduated from the Technical University of Cluj Napoca. In the last seven years, I have worked as a software developer at different companies and with different technologies like .net, iOS, Angular, Typescript, MSSQL, Mongo DB, SoapUI.

What drives you to be a full-stack developer?

I chose to be a full developer because I like to be involved in every phase of a software application, from the UI side to the server. In the last eight years, the modern technologies used for building stack server-side applications and client-side applications became much easier to use, which allows us to learn multiple technologies on both sides.

What motivated you to join Lyfegen?

At the beginning of my career, I worked for another startup company. I remember my satisfaction when someone used our product, and I want to feel that again. Lyfegen is giving me many opportunities to positively impact the world because we are driving things in the right direction. I consider value-based contracts the best solution for patients, healthcare payers and Pharma companies.

What is your first impression as of now?

I like and appreciate the whole team. All my colleagues have brilliant ideas that are bringing the Lyfegen platform to its best form. The Lyfegen platform is one of the strongest I have seen so far in my career, and this is because everyone has a voice within the team.

How will your know-how help the Lyfegen customers experience our platform the best way possible?

Throughout my career, I have worked on several big projects in different fields providing technical solutions for different problems on the frontend side and the backend side. These experiences have taught me the importance of accessibility features, and I would like to bring that knowledge to improve the user experience of Lyfegen users. I can help the Lyfegen customers better interact with the platform in terms of performance.

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

I am looking forward to improving my understanding of the healthcare and pharmaceutical industry. From a technical perspective, I'm excited to work and learn Grandstack technologies.

What passions do you pursue outside of work?

I love to play board games, tennis and football. During the summer weekends, I like to go hiking, and in winter, I enjoy skiing. I also have an interest in politics, and I try to stay updated with trends in the IT industry because of my passion for new technologies.

What else are you looking forward to?

I look forward to deepening my relationship with my teammates. I strongly believe that working in an atmosphere that promotes teamwork makes our lives much more enjoyable. At the same time, it has a positive impact on the project.



 

MEET THE LYFEGEN TEAM

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Welcome to the Lyfegen Team, Mastermind-Developer, Thungu!

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Welcome to the Lyfegen Team, Mastermind-Developer, Thungu!

He loves innovation and thrives on solving problems using code. Besides developing and studying he plays basketball, travels and reads. We are proud to welcome the newest talent to the Lyfegen team: “Junior Developer” Thungu!



“The motivation and the skills of Thungu are undisputed. Among other things, that is what makes him and Lyfegen a perfect match. Constant evolution and progression are some of the most important objectives at Lyfegen, that is why Thungu will join our Team to help us add new UI components to our products and automate our testing processes in coordination with the UI/UX designers and Business Analysts, resulting in a higher overall quality and user satisfaction of our products. We are looking forward to work with Thungu here at Lyfegen.” Says CTO, Frederico Braga

To introduce our newest talented team member, we virtually sat down with Thungu for an interview.

Welcome to the team Thungu! Tell us a little about yourself.

Hi, my name is Thungu, and I am from Colombo, Sri Lanka. I am a Software Engineering undergraduate at the University of Westminster in my second year while working here at Lyfegen. I also volunteer for the IEEE student branch of my university to organize hackathons, webinars and other tech related events.

What drives you to be a developer?

I love figuring things out, exploring new technologies and solving problems with code. When facing challenges as a developer I always explore the “yes” and try to figure things out before accepting a “no”. That figuring out part is what drives me to be a better developer and what I enjoy mostly about being a developer.

What was your motivation to join Lyfegen?

I wanted my first work experience to be in an innovative company which has a positive impact on the world and when I got to know what Lyfegen does, I knew this was it. With value-based healthcare in its early stages, I see it’s huge potential and the unprecedented value it brings towards humanity. I knew I had to be a part of this great journey!

What are your first impressions so far?

It has been a very pleasant experience. I am enjoying the startup culture - everyone is very close, friendly and welcoming. The flexibility at Lyfegen is one of the things that I appreciate most, as it is really important for me to have an evenly work and university life balance. I am also very impressed by how dynamic and motivated the team is. Everyone is ready to move mountains for patients!

How will you improve the customer experience on the Lyfegen platform?

I will be focusing mainly on Frontend Development and Testing which includes building new components with the help of our Kateryna, our UI/UX designer and testing the functionalities of our products together with Pavlo.

What do you want to learn and improve this year?

I am looking forward to improving my skills and helping Lyfegen in other stages of Software Development in addition to Frontend Development and Testing. I also want to improve my understanding of the healthcare industry.

What are you especially looking forward to as you take on this new role?

Although I enjoy all the virtual coffees, I am very much looking forward to meeting everyone in person someday. I’m also looking forward to grow as a professional and becoming a better and experienced developer. I feel very grateful to work with such an amazing team of experienced developers and other team members.

What passions do you pursue outside of work?

I love to play basketball, create travel videos and also photography is my passion. I read books focusing on life and spirituality, I learn new technologies, and sometimes I play the guitar.



We are proud to welcome Thungu to the Lyfegen team!

 

 

MEET THE LYFEGEN TEAM

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Our team is growing! Welcome to Lyfegen, Tech-Genius Giancarlo!

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Our team is growing! Welcome to Lyfegen, Tech-Genius Giancarlo!

We are thrilled to announce that our tech team continues to grow: A warm welcome to Giancarlo, Lyfegen’s new Full-Stack Developer! With his background as a security engineer, he knows how to make our platform even safer!



“I am excited to welcome Giancarlo to our Tech Team as a Full-Stack developer. Giancarlo’s experience in the areas of Machine Learning, Security and Software Development are critical to our long term success and development of the Lyfegen Platform.” Says CTO, Frederico Braga

To introduce our newest team member, we virtually interviewed Giancarlo.

Welcome to the team Giancarlo! Tell us a little about yourself.

My name is Giancarlo and I live in Chur, Switzerland. I hold a bachelor’s degree in computer science. I previously worked as a security engineer, designing and implementing big data applications at a Swiss telecom company. At Lyfegen I will be working on improving our platform as a full stack developer.

What drives you to be a full stack developer?

For me, the variety of tasks is the biggest appeal of being a full stack developer: One day you could be working on low level database tasks and the next day on implementing user-interface (UI) elements. This keeps the job challenging and interesting!

What motivated you to join Lyfegen?

Until now, I was working for a rather big company where my impact was small. I wanted to change that. At Lyfegen I am able to create something meaningful from the ground up.

What is your first impression as of now?

My first impression was very positive: The people at Lyfegen are kind, helpful and smart. A perfect mix in my opinion! I’m looking forward to all the interesting tasks, complex problems and engaging conversations with my colleagues.

How will your know-how help the Lyfegen customers experience our platform the best way possible?

As a former security engineer, I know the most common threats and pitfalls when it comes to creating a software. I hope to use my expierence and knowledge to make our platform safer and more resilient to potential threats in the future.

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

In previous jobs I was mainly developing backend applications. This year I want to improve on the frontend side and learn new technologies when it comes to graph databases. I always wanted to improve my Italian, so maybe 2021 is the year where I take some time to do just that!

What passions do you pursue outside of work?

I play lacrosse in our local club twice a week. Food is another passion of mine: I also love to cook and try new restaurants. On rainy Sundays, you’ll find me playing boardgames or Dungeons and Dragons with my friends.

 

MEET THE LYFEGEN TEAM

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Exploring Value-Based Contracts: Featured Public Agreements in Canada, Denmark, and Brazil

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Exploring Value-Based Contracts: Featured Public Agreements in Canada, Denmark, and Brazil


For this blog, we chose select agreements in Canada, Denmark, and Brazil. Each of these agreements vary, and we chose them so you can see how manufacturers tackle market access for different drugs and regions. Value-based contracts in these markets speed patient access while sharing financial risk between pharma and payers—a win-win situation.

Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals).  

Indication: Cystic fibrosis

Country: Canada

Agreement type: Coverage with evidence development (CED), restricted coverage, outcomes-based guarantee.

Date: July 2022.  

The Canadian Agency for Drugs and Technologies in Health requires a 94% price reduction on the price of Trikafta, in order for the treatment to be cost-effective. Children with cystic fibrosis between the ages of 2–5 are evaluated after 1 year, to show that they benefit from the treatment. Patients must meet a number of criteria to be eligible for treatment, making the agreement a combination of coverage with evidence development, restricted coverage, and outcomes-based.  

Trikafta was already approved for use in children over 6 years of age, but conducting a clinical trial in children between two and five years of age was deemed “ethically challenging.” An uncontrolled trial however in this age group found that the treatment was well-tolerated and reduced biomarkers of the condition. To address unmet needs while acknowledging the lack of data in this patient population, a CED contract with a drastic price reduction was negotiated.  

Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)

Indication: Cystic fibrosis

Country: Brazil

Agreement type: Restricted coverage, CED

Date: April 2024

The Brazil Health Ministry came to an agreement with Vertex to allow restricted access to this treatment while regularly monitoring patients at 30 days and 3 months after initiation of treatment. The agreement includes refunds is the treatment does not achieve desired clinical outcomes, aligning pricing with effectiveness.

Kalydeco (ivactafor, Vertex Pharmaceuticals)

Indication: Cystic fibrosis

Country: Denmark

Agreement type: Price-volume agreement; portfolio pricing

Date: October 2018

The Danish procurement body, Amgros, and Vertex Pharmaceuticals, came to an agreement that provides access to a portfolio of drugs for cystic fibrosis, including Orkambi (lumacaftor/ivacaftor) and future therapies, in 2019. Despite this taking place five years ago, it’s a great example of portfolio-based pricing, where payers agree to pay a set fee for a group of related drugs. The more patients that use them, the lower the price per patient.  

Lynparza (Olaparib, AstraZeneca)

Indication: Ovarian cancer  

Country: Brazil

Agreement type: Restricted coverage, outcome guarantee

Date: May 2022

This agreement was made between AstraZeneca and private insurers throughout Brazil. The treatment is made available without additional costs to the patient and combines features of restricted coverage with outcomes guarantees. Continued coverage is dependent on achieving partial or complete response.  


Zolgensma (onasemnogene abeparvovec, Novartis)

Indication: Spinal muscular atrophy (SMA)

Country: Brazil

Agreement type: Outcome guarantee, CED, installment payments

Date: December, 2022

Novarits’ gene therapy Zolgensma is reimbursed based on the need for additional evidence, referred to as coverage with evidence development. This involves using coverage as a means to obtain real-world evidence, to make up for the lack of robust patient data coming from the pivotal trial. The agreement also divides risk between payers and manufacturers , by tying reimbursement to outcomes achieved. Because of the therapy’s great potential to improve the quality of life of children living with SMA, the agreement allows eligible patients to quickly start receiving treatment.


Want to see the library for yourself? Book a demo today here: https://www.lyfegen.com/demo

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Preparing for Medicare Part D Redesign in 2025: Are You Ready?

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Preparing for Medicare Part D Redesign in 2025: Are You Ready?

Major changes are on the horizon for Medicare’s outpatient drug benefit in 2025, particularly following the release of negotiated drug prices under the Inflation Reduction Act. These changes will significantly impact both payers and drug makers, requiring careful planning and strategy.

One of the most critical updates is the reduction of the out-of-pocket spending cap for beneficiaries, which will decrease from $3,300 this year to $2,000 in 2025. While this cap will help patients manage their healthcare costs, it also increases the financial responsibility for payers and pharmaceutical companies.

Challenges for Specialty Drug Makers

Specialty drug makers, especially those in oncology, will face new challenges with the introduction of a 20% discount during the catastrophic phase of Medicare Part D. Since many patients will reach the $2,000 cap early in the year, this discount will apply for a significant portion of the year, impacting drug pricing strategies.

Impact on Medicare Advantage Plans

Medicare Advantage plans and stand-alone prescription drug plans will also see changes. Their liability for drug costs during the catastrophic phase will increase from 20% to 60%, as the federal government reduces its reinsurance contribution from 80% to 20%. This shift will require plans to adopt new cost management strategies.

How Lyfegen Can Help

As the Medicare Part D redesign approaches, it’s crucial for payers and drug makers to prepare effectively. Traditional cost management methods, like prior authorization, will need to be complemented by innovative approaches such as value-based pricing and market access solutions.

Lyfegen offers essential tools to support these efforts. Our Lyfegen Drug Contracting Simulator allows you to model various drug pricing scenarios, evaluate their impact on revenue and costs, and strengthen your market access strategies. By utilizing this tool, payers and pharmaceutical companies can better navigate the upcoming changes and optimize their drug market access strategies.

Start Preparing Today

Preparing for these changes is essential to maintain effective drug pricing strategies in the evolving Medicare market. Lyfegen’s solutions can assist in designing Medicare Part D formularies tailored to your needs, and in identifying the most appropriate value-based arrangements from our comprehensive database.

Don’t wait—boost your negotiating leverage now. With 2025 fast approaching, the time to act is today. Start using the Lyfegen Drug Contracting Simulator to stay ahead. Book a demo today to get started.

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Finding the right insulin products for payers to cover

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Finding the right insulin products for payers to cover

Insulin is going through monumental shifts in pricing and reimbursement in the U.S. It started with the announcement of reductions in list prices by drug companies last year. First, Novo Nordisk announced plans to reduce the list prices of several of its insulin products beginning January 1, 2024. This included lowering the price of NovoLog and Levemir by at least 65%. This move was followed by a similar commitment by competitor Eli Lilly to reduce Humalog’s price, among others, and came just days before Sanofi’s announcement to decrease Lantus’s price.

Moreover, biosimilar competition is ramping up, particularly in the long-acting insulin glargine space. Rezvoglar and Basaglar are leading the way, as they gain traction on payer formularies, especially in the public Medicaid market.

And this year, owing to implementation of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services began negotiating the net prices of both NovoLog and Fiasp, with public disclosure of said prices due to be revealed by September. Payers will soon be able to use these net prices as benchmarks to leverage better deals in markets besides Medicare. Also, CMS capped monthly out-of-pocket costs of insulin products for Medicare beneficiaries at $35.

For their large populations of insulin-dependent diabetics, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.

Because both list and net prices have come down, payers will likely lose out on some portion of the rebates—which reflect the difference between gross and net price—that they had grown accustomed to getting in the past. At the same time, the increasing number of payers that are adopting a rebate-free, net cost approach to formulary design will benefit from lower net prices.

And cheaper treatment options for patients may translate into better adherence to drug regimens which in turn could lead to improved health outcomes. For payers with a long-term perspective and comparatively little churn or enrollee turnover the potential downstream cost savings could be beneficial.

Lyfegen can assist in the calculations of value for all insulin products, both short- and long-acting, in addition to the design of appropriate formularies.

If you wish to improve your negotiating leverage for insulin products you can do so with real-world simulations for effective prescription drug contracts. Discover the Lyfegen Drug Contracting Simulator, our intuitive solution for streamlining iterative, collaborative drug contracting design.

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Tailoring biosimilar coverage policies to the client

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Tailoring biosimilar coverage policies to the client

The next wave of biosimilars, including Humira-, Eylea-, and Stelara-referenced products, is upon us.

In the U.S., 10 Humira-referenced biosimilars are on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing, as the number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary.

CVS Caremark—the largest pharmacy benefit manager in the U.S.— removed Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product). Hyrimoz appears to be the most favored biosimilar. Similar moves have been signaled by the PBM Express Scripts and its parent company Cigna to be enacted this month, but this time Simlandi will be the most preferred biosimilar.

The FDA also recently approved two interchangeable biosimilars to Eylea, which will produce additional competition for the pharma’s blockbuster as key patent protections are set to expire.

And the biologic Stelara, which was selected as one of the first 10 drugs for Medicare price negotiations, will have its net price disclosed in September of this year in addition to facing biosimilar competition in 2025. The downward pressure on Stelara's price, but also Stelara-referenced biosimilars, will likely be significant.

For their large populations of covered lives who take products in the Humira, Eylea and Stelara-related therapeutic classes, payers will need to implement value-based coverage decisions that provide for the most optimal solutions for health plans and employers but also the lowest out-of-pocket costs for patients.

Improved access to biosimilars will offer patients expanded, less costly treatment options. For uptake to happen, payers must educate healthcare providers and patients on the value of biosimilars so that they are on board, whether they are designated by the Food and Drug Administration as therapeutically interchangeable or not.

Hyrimoz and Simlandi are therapeutically interchangeable and favored due to the formulary moves by CVS Caremark and Express Scripts, respectively.

The therapeutic interchangeability designation still plays a role in the U.S., because for biosimilars to be automatically substitutable at the pharmacy they must have proven interchangeability in addition to biosimilarity. As a result, physicians have expressed a preference for biosimilars that have the designation.

But for the many biosimilars that don’t have the therapeutic interchangeability designation, to boost their adoption manufacturers and payers must overcome this de facto regulatory barrier by informing healthcare providers and patients that proof of biosimilarity is sufficient.

Lyfegen can assist in the design of formularies tailored to clients' objectives. It can also accommodate information requests concerning which value-based arrangements are the most appropriate, given the scope of its library database as well as other client services.

If you wish to improve your negotiating leverage you can do so with real-world simulations for effective prescription drug contracts.

Discover the Lyfegen Simulator.

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Managing the cost of novel non-opioid pain medications

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Managing the cost of novel non-opioid pain medications

Vertex Pharmaceuticals may soon obtain Food and Drug Administration approval for a non-opioid analgesic, dubbed VX-548, for moderate to severe pain. But will insurers pay, given that there are so many cheap generic prescription opioids and other pain medicines on the market?

Presumably, the new non-opioid pain medication will be substantially more expensive per unit than generic opioids. Given the large numbers of patients needing pain drugs, for post-surgery, for instance, payers will need to manage the cost.

Prescription opioid medications remain a common treatment for pain despite decreases in the total number of opioid prescriptions after 2012. They’re cheap but also effective.

Should VX-548 obtain FDA approval, payers might be reluctant to cover the drug without clear and consistent evidence that the drug works as well or better than prescription opioids. Recent examples of non-opioid analgesics, including Exparel (bupivacaine) and Zynrelef (bupivacaine/meloxicam), demonstrate the kinds of reimbursement challenges drug makers may face, particularly early following their approval by the FDA.

Nevertheless, prescription opioids can be misused, abused, and diverted. In this regard, the non-opioid medicines Exparel, Zynrelef and, if approved, VX-548, do meet an important unmet need. However, not every patient will require access to more expensive medications. And so, it will be imperative to differentiate patient sub-populations by risk factors, in addition to comparing the clinical- and cost-effectiveness of non-opioid treatments to prescription opioids.

Lyfegen can assist in the calculations of value for both prescription opioid and non-opioid analgesics, in addition to the design of appropriate formularies.

Managing pain, whether acute or chronic, invariably involves a balancing act in which doctors, patients and insurers must consider appropriate forms of treatment. Proper patient stratification includes an assessment of the benefits and risks of both opioid and non-opioid medications to individual patients.

Lyfegen can navigate the different ways in which payers and drug makers negotiate contracts for pain medications. In the Lyfegen Library you can find the right model to use as a benchmark during pricing and reimbursement negotiations, which in turn will increase the chances of success. To explore strategies that enhance your ability to negotiate and implement successful pricing and reimbursement agreements for pain medications, visit the Lyfegen Library at lyfegen.com/library.

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