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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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Finding novel ways to pay for new obesity drugs

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Finding novel ways to pay for new obesity drugs

While the recent wave of new obesity drugs appeals to many patients due to their effectiveness in reducing weight and even diminishing the risk of major cardiovascular events for some, data suggests that at current prices they’re not cost-effective. Amid increased concern about the costs of using therapeutics such as glucagon-like peptide 1 agonists, some U.S. insurers are imposing further restrictions or eliminating coverage of the drugs altogether.

To boost access, a recent Financial Times article discussed the possibility of introducing value-based pricing arrangements for weight loss drugs. Under such “risk-based contracts,” healthcare providers could spread the cost over a period of time during which savings are possible, for example, from not having to treat as many heart attacks. Alternatively, drug makers and payers may negotiate value-based contracts which include patient persistency as a prerequisite. Persistency is known to be an issue with obesity drugs, as many patients stop taking the medications owing to side effects and other issues. If patients discontinue treatment weight rebound occurs, which implies that payers and patients must be properly incentivized to be persistent.

To effectively implement value-based agreements requires reliable cost of care analytics, modeling capabilities and outcomes-based agreement templates, which Lyfegen can provide stakeholders to calculate and forecast return on investment for use in the contracting process.

Value-based arrangements could ease the projected financial burden for commercial insurers, but also public payers such as Medicaid and Medicare. At present, most Medicaid state agencies don’t reimburse obesity therapeutics, while Medicare still prohibits their coverage if prescribed as weight loss medications alone. The drug Wegovy (semaglutide) did secure a supplemental cardiovascular indication from the Food and Drug Administration in March. This allows limited access for certain Medicare beneficiaries who fulfill weight and major cardiovascular risk criteria. But it doesn’t follow that plans will necessarily jump to pay for the product, given the high cost and limited cost-effectiveness. Introducing pay-for-performance agreements could facilitate access.

Lyfegen can accommodate information requests concerning relevant measures. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public agreements and 20 innovative pricing models. For a deeper understanding of how value-based pricing models can transform the accessibility of obesity treatments and optimize your healthcare investments, book a demo with us.

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

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New net-cost reimbursement models may stimulate U.S. biosimilar uptake

As more biosimilars get approved and launched in the U.S., payers are making key decisions about their coverage and formulary positioning. Recently, this includes Humira-, Stelara- and Remicade-referenced products.

Historically, in the U.S., biosimilars have often failed to gain much traction owing to a Byzantine system of pricing and reimbursement which involves  opaque rebate schemes. Here, higher list-priced drugs often carry with them higher rebates, which can mean that pharmacy benefit managers may favor originator products such as Humira.

As an illustration of this, according to a federal government Medicare Payment Advisory Commission report, more than 40% of Medicare beneficiaries still have no access through their insurance to Humira-referenced biosimilars, despite several products having discounts of over 80% compared to the original Humira.

But novel approaches to pricing and reimbursement could change formulary decision-making significantly, establishing the basis for more use of outcomes-based decisions. CostVantage, for example, is a new cost-based pharmacy reimbursement approach that all PBMs will eventually be required to use if they contract with CVS retail pharmacies, the largest pharmacy in the nation.

The CostVantage model stipulates that prescription drug reimbursement will be based on net acquisition cost, a set mark-up and a fee that reflects the value of pharmacy services. CVS Pharmacy plans to launch CVS CostVantage with PBMs for their commercial payers in 2025.

Such net-cost reimbursement systems tend to stimulate the uptake of lower cost (and more cost-effective) biosimilars. We find evidence of this in Europe where cost-effective biosimilars generally have fairly rapid entry which then quickly displaces the market share of originator products. By the last quarter of 2019, within one year of Humira-referenced biosimilar entry into the European market, an average of 35% of patients across Europe had already switched to a biosimilar; in the U.K, the figure was 63% which was achieved just six months after biosimilars were allowed to compete; in Denmark, with its winner-takes-all tender, the number was 80% and was attained within three months of being on the market. Meanwhile, in the U.S., after 15 months of being on the market, Humira-referenced biosimilars have only achieved 2% market share.

The new net-cost model of reimbursement in the U.S. will likely lead to greater adoption of biosimilars, at least in the large CVS segment of the market. Lyfegen can navigate the different ways in which payers and drug makers are negotiating contracts for biosimilars. In addition, Lyfegen can help address the concerns payers may have about high-priced specialty drugs, such as originator biologics and biosimilars. In the Lyfegen Agreements Library you can find the right model to use as a reference during pricing and reimbursement negotiations, which in turn will increase the chances of success.

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

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Whichever instrument used – QALY or non-QALY – payers make evidence-based coverage decisions

In the face of scarce resources, healthcare entities must make hard choices. One can’t spend the same healthcare dollar twice, which means that policymakers have to ensure that each dollar goes as far as it can in terms of producing health outcomes for the population. Preferably decisions on how to allocate resources are informed by robust evidence that describes the benefits and harms related to medical interventions.

As U.S. and European healthcare policymakers debate different ways of measuring health outcomes accruing from the use of prescription drugs, it's important to convey that value-based pricing and reimbursement decisions can be informed by a variety of measures, including the Quality-Adjusted-Life-Year but also non-QALY measures such as the Disability-Adjusted-Life-Year, Equal-Value-Life-Year-Gained, Healthy-Life-Year-Equivalents and others. Lyfegen can accommodate information requests concerning all such measures, given the scope of its database as well as other client services. The Lyfegen Library specifically offers access to one central resource with more than 4,500 public pricing-based agreements and 20 innovative pricing models.

In the U.S., Medicare may soon formally ban use of the QALY because it’s supposedly “discriminatory” against older people and folks with disabilities. Nevertheless, the commercial market will continue to use it, particularly since it is still one of the most common measures of benefit. It’s also the predominant measure deployed by the Institute for Clinical and Economic Review. ICER has grown in stature in recent years, now informing more than half of payers’ formulary decisions in the private sector.

According to ICER, the QALY measures how well different kinds of medical treatments extend lives or improve patients’ quality of life. As a composite measure of the outcomes, quantity and quality of life, it enables comparisons across disease states and treatments. When combined with the costs associated with healthcare interventions, the QALY can be used to assess their relative worth from an economic perspective.

As a concept the QALY can accommodate several of the issues cited by critics, including being able to account for severity of disease. Alternatively, there are methods such as the EVLYG that can be employed to place the same value on additional years of life across diseases and populations which could alleviate concerns around discrimination.

The Lyfegen Library allows you to search for pricing models and agreements by countries and payers, making it easy to find the information you need regarding the appropriate measures based on your specific requirements and interests.

Learn more: lyfegen.com/library

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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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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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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.”

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The Model & Agreement Library lets the user see the specifics of agreements reached between manufacturers and payers, including which disease areas and drug/device innovations were targeted. This market-leading database allows for one-to-one comparisons of agreements while heightening increased leverage during the negotiations process.

“I like having a palette of contracts that fall under different domains, like disease state, the way the drug is administered, or available evidence. There are different ways to make a contract attractive to us, to pharma, and to our physicians”, said Chester Good, Senior Medical Director Center for Value Based Pharmacy Initiatives at UPMC Health Plan.

This resource represents a breakthrough in the healthcare industry that facilitates the sharing of knowledge – a strong point of discussion that is becoming increasingly more important. Lyfegen is currently providing a limited time opportunity for industry professionals who are interested to try out the Model & Agreement Library with a complimentary 7-day trial.

Learn more and start your free trial now

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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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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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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

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Girisha Fernando talks to Kantonsspital Baden AG about value-focused reimbursement of drugs based on the outcomes for patients in Switzerland and globally.-duplicate-1

                    Fünf Männer aus der Region wollen die Gesundheitsbranche aufmischen. Im 2018 wurden sie von der Plattform «Innovation Basel» für ihre visionäre Idee nominiert: Eine digitale Plattform, die eine Kombination aus Blockchain und Cloud verwendet, um faire Medikamentenpreise zwischen Herstellern und Versicherungen auszuhandeln. Was heisst das aber und was ist dabei so visionär?            

                    (Bild: zVg) Das Lyfegen Team: Diese fünf Männer haben eine Vision und eine Mission. Die Idee liess Girisha Fernando nicht mehr los: Der 29-jährige Basler wollte nach neun Jahren bei der Roche im Market Access, Pricing und IT unbedingt «etwas noch Spannenderes, Revolutionäres machen», wodurch Patienten im Dschungel des Gesundheitswesens geholfen wird. Aber es sollte dabei auch für Pharmaunternehmen und Versicherer eine Win-Win-Situation entstehen.          

         Zusammen mit seinen Mitstreitern Leon Rebolledo, Michel Mohler und Nico Mros gründete er 2018 «Lyfegen» und entwickelte eine bahnbrechende Idee: Eine auf Blockchain und Cloud basierte Software Lösung, die es Versicherern und Herstellern von Medikamenten erlaubt faire Preise anhand deren Wirksamkeit für den einzelnen Patienten auszuhandeln.                      

   

     

         

           

         

         

            Faire Preise bedeuten unter anderem auch, dass die Vergütung dieser Medikamente auf der Wirkung des Medikaments basiert. Wenn ein Medikament bei einem Patienten besser wirkt, dann wird ein Preis A bezahlt. Wenn ein Medikament bei einem anderen nicht so gut anschlägt, dann wird Preis B vom Versicherer an den Hersteller fällig oder sogar nichts bezahlt. Unser Tool ermöglicht genau diese faire, wirkungsorientierte Preisgestaltung, was sich auch Value-based Healthcare nennt. So ein Tool gibt es auf der ganzen Welt bisher nicht.             Name Surname
Position, Copmany          

     

   

                 Fachleute sprechen hierbei von «Wertbasierter Gesundheitsversorgung». Dieses Thema ist aktueller denn je, auch in der Schweiz, in der steigende Behandlungs- und Medikamentenpreise zu höheren Kosten für die Bevölkerung führen. Es müssen neue, nachhaltige Modelle eingeführt werden, um die Kostenexplosion im Gesundheitswesen aufzuhalten.          

   

     

         Transparenz bei Preisgestaltung und Wirkungsgrad          

Warum aber ist so ein Tool wertvoll? «Weil unser Tool Daten sicher sammelt, analysiert und dann den jeweiligen Partnern, sei es ein Versicherer oder ein Hersteller wie Pharmaunternehmen, die Daten anonym, automatisiert und gleichzeitig zuspielt.» Dies geschieht mit Hilfe der Blockchain (eine dezentralisierte Form der Datenverarbeitung und -sicherung, die beispielsweise Geldeinheiten, Wertpapiere, Besitz- oder Grundrechte verwaltet, siehe Erklärung in der Infobox), ganz ohne Kryptowährung, betonen die fünf innovativen Köpfe.

     

   

 

   

     

       

         

           

         

       

                 

         

           

         

       

     

   

 

                     (Bilder: PEXELS) Im Gesundheitswesen explodieren die Kosten. Eine revolutionäre Idee könnte dieser Entwicklung entgegen wirken.            

            Die Idee hat schon für viel Wirbel in der «Szene» gesorgt. Und sie gehen mit ihrer Idee aufs Ganze: «Wir haben schon 750’000 CHF von einer Gruppe von Basler Business Angels erhalten», sagen die Lyfegen-Gründer. Diese Business Angels seien selbst erfolgreiche Unternehmer. Namen dürfe man leider keine bekannt geben. Zudem müsse man zu 100 Prozent hinter einer Innovation, einer Vision oder einer Idee stehen, die der Gesellschaft helfen könne, betonen sie. Fernando: «Ich bin fest davon überzeugt, dass nicht nur unsere Lösung, sondern auch die Denkprozesse, die wir bei unseren Kunden anregen, die Implementierung einer wertbasierten Gesundheitsversorgung vorantreibt. Konzept und Lösung sind innovativ.»                        

   

     

         

     

   

               Vertrauen und Transparenz zwischen Ärzten und Patienten ist immens wichtig. Darauf basiert auch das Konzept des Value-based Healthcare.      

      Zwar sei man bei Lyfegen sehr technisch veranlagt, jedoch steht der Kundennutzen und der so genannten «Impact» für alle Parteien im Vordergrund. Also auch für die Versicherten und für das gesamte Gesundheitswesen. «Unsere Lösung trägt dazu bei, Patienten Zugang zu innovativen Behandlungen und der bestmöglichen Gesundheitsversorgung zu ermöglichen. Wir wollen Leben retten. Punkt», betont CTO Leon Reborello. Girisha Fernando kann aus eigener Erfahrung berichten: «Mein Grossvater hatte Prostatakrebs und die Ärzte sagten, dass es Medikamente gibt um seine Lebensdauer zu verlängern. Aber die Versicherung wollte aus Kostengründen nicht für das Medikament bezahlen. Dies muss aufhören – durch wertbasierte Vergütung würden die besten und innovativsten Medikamente für Patienten und Ärzte zugänglich. Mit unserer Lösung tragen wir dazu bei, dies zu verwirklichen.»          

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Value-based pricing vs best price? Medicaid's best price problem

Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug...

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Value-based pricing vs best price? Medicaid's best price problem

Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug pricing arrangements. Policy makers hope with this potential contracting risk and liability gone, manufacturers and healthcare payers will increase their participation in value-based drug pricing agreements.

 

In 1990, the Medicaid Prescription Drug Rebate Program (MDRP) was created to help slow the expenditures of outpatient prescription drugs to Medicaid patients. Under the MDRP, drug manufacturers who want their drugs covered by state-run Medicaid programs must sign a National Drug Rebate Agreement (NDRA) with the Department of Health and Human Services (HHS).

The NDRA requires participating manufacturers to reveal the lowest available price of their products and pay rebates on their products. According to the Centers for Medicare and Medicaid (CMS), there are around 780 drug manufacturers with NDRAs currently in effect.

The rebates of the Medicaid Best Price Policy

Under the MDRP, manufacturers must inform CMS of the “best price” available for its products. Excluding the price negotiated with some government programs, manufacturers are required to report the lowest price it offers to any drug wholesaler, retail outlet, or healthcare provider. This best price is then used to calculate rebates. Manufacturers pay rebates quarterly to states for the drugs covered under state Medicaid programs.

The rebate for most brand name drugs (excluding certain clotting drugs and pediatric drugs) is 23.1% of the average manufacturer price (AMP) paid by wholesalers and retail pharmacies. If the difference between the AMP and the best price on the market is more than the AMP, then this percentage would become the rebate. The rebate amount for generic drugs does not include a best price provision and stands at 13%.

Rebate analysis plays a critical role in understanding these calculations, as it enables manufacturers and payers to evaluate the financial implications of pricing agreements and compliance with regulatory requirements under the MDRP.

Outcome-based drug pricing can affect rebates

Despite the industry-wide push from stakeholders and policy makers towards value-based drug pricing arrangements, manufacturers have been wary of signing on to these agreements. They argue these outcomes-based pricing agreements could have unintended consequences that affect the AMP and best price. This, in turn, can skew the calculations for a manufacturer’s rebate liability.

In value-based drug pricing, a drug’s purchase price is linked to the effectiveness of the drug; if the drug underperforms, the manufacturer must pay a rebate, or other form of reimbursement, to the purchaser. Depending on the terms of the value-based pricing arrangement, this could be a substantial reimbursement to a payer for poor patient outcomes. The reduced price after the rebate–even if it’s paid on behalf of only one patient’s poor outcome–could become the new, lower best price.

The new Multiple Best Price policy

Before the multiple best price policy went into effect, manufacturers feared that, in theory, if the terms of a pricing agreement resulted in a 100% reimbursement to a payer for a drug proven to be ineffective, the manufacturer could find themselves in a situation where they had to give away their drug for free to every state Medicaid program.

In response to this interpretation of the best price policy–which became a regulatory barrier to value-based drug pricing arrangements–CMS revised the best price policy with the Final Rule. Under the Final Rule, as of July 2022, manufacturers can now report multiple best prices: the single best price for traditional sales and the prices negotiated under value-based pricing arrangements.

This option to report multiple best prices to CMS is only available for manufacturers who offer states the same terms negotiated in the value-based drug pricing arrangements with commercial insurances. State Medicaid programs can choose to take part in the value-based arrangements or continue to make purchases using the traditional best price.

Critique of the Multiple Best Price policy

Although CMS’ goal with the multiple best price policy was to reduce a significant regulatory barrier, this change still draws critics. And CMS has acknowledged that there will be implementation challenges. Here are some examples of criticisms of the new multiple best price policy.

• Critics find the Final Rule’s updated definition of a value-based drug pricing agreement to be too narrow or too broad. Before the Final Rule went into effect, organizations such as the Coalition for Affordable Prescription Drugs (CAPD) and the Pharmaceutical Research and Manufacturers of America (PhRMA) were concerned the CMS definition of value-based contracting is too narrow and will exclude some value-based pricing arrangements that are already in effect or in negotiations.

By contrast, AARP worried there is a lack of clarity on the definition of value in the Final Rule that could lead to the designation of almost any drug purchasing agreement as a value-based agreement and open the door to fewer rebates for Medicaid programs and more revenue for manufacturers. Time will tell which is the real problem.

• There may not be a non-value-based price for a drug. If a manufacturer is not offering its product outside of a value-based pricing arrangement, there may not be a single, traditional best price to report. When there are no non-value-based sales to look at, CMS advises manufacturers to use reasonable assumptions to set a non-value-based price. Critics, of course, question the loose guidance of a “reasonable assumption” and see this as an opportunity for manufacturers to game the system.

Some stakeholders are also concerned manufacturers will shift most traditional sales contracts to value-based pricing arrangements with the goal of eliminating less profitable, non-value-based best prices. AARP and National Association of Medicaid Directors (NAMD) have warned that the new rule could undermine the MDRP best price policy that has been so successful in reducing Medicaid drug expenditures.

• There may be technological and operational barriers for State Medicaid programs who want to take part in value-based drug pricing agreements. Like NAMD and AARP, the National Organization for Rare Disorders (NORD) worries manufacturers could be working to erode the MDRP’s best price policy by providing better rebates to commercial insurance companies under value-based pricing arrangements.

Manufacturers and CMS know that some state Medicaid programs will not have the infrastructure needed to implement value-based pricing agreements with more favorable terms. In its Technical Guidance for using multiple best prices, CMS makes suggestions for creating alternative, innovative agreements when intensive data collection and analysis are not feasible.

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

The Lyfegen Solution

A lack of resources and staff prevents some state Medicaid programs from operationalizing value-based drug pricing arrangements. Lyfgen assesses an organization’s current data gathering capacity, then offers customized solutions using its contracting software platform to support the execution of value-based drug pricing arrangements.

Lyfegen’s Platform helps healthcare insurances, pharma, and medtech companies implement and scale value-based drug pricing contracts with greater efficiency and transparency. By collecting real-world data and using intelligent algorithms, the Lyfegen solution can provide valuable insights into drug performance and cost in value-based contracts.

Lyfegen helps increase affordability and access to healthcare treatments by enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare.

Contact us to learn more about Lyfegen’s software solutions and to book a demo.

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Medicaid’s launched its multiple best price program in July 2022 to address a major regulatory barrier to value-based drug...

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What is value-based contracting with Lyfegen?

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What is value-based contracting with Lyfegen?

Value-based contracting focuses on patient outcomes by identifying value-based and outcomes-based measurable goals. By creating a set of outcomes as well as how to best measure them – value-based pricing for therapies can be determined.

As you can see – value-based contracting requires a lot of moving pieces and agreed-upon standards. This leaves the question of how best to facilitate these value-based healthcare agreements? The answer lies with Lyfegen.

Lyfegen works as a neutral third party with healthcare payers and manufacturers to implement a new way of paying for high-cost prescription drugs: value and outcome-based pricing and contracting. This groundbreaking platform enables patients to receive the best treatments and live a better and longer life.

With its innovative technology platform, Lyfegen is the catalyst for these entities to define, agree, and execute value-based and outcome-based pricing agreements while keeping costs at a sustainable level – allowing patients to receive innovative therapies at the right time and for the right price.

Lyfegen is the first of its kind, a company created to help patients in need. Lyfegen makes value-based healthcare contracting for high-cost therapies a reality for all healthcare stakeholders. With our expertise and secure state-of-the-art platform – we are trusted by some of the largest manufacturers, healthcare payers, and care providers in the world.

Lyfegen generates value-based contracts which combine outcome-based, pay-for-performance, and risk-sharing philosophies – creating value that matters:

-Better outcomes for patients-Accelerate, broaden, & sustain access to healthcare innovation-Facilitate & incorporate pay for performance healthcare pricing models-Improve appropriate use & compliance of treatments

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Hopp Schwiiz: Switzerland leading Innovation in Europe

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Hopp Schwiiz: Switzerland leading Innovation in Europe

In light of Swiss National Day on August 1st, Lyfegen’s CFO Michel Mohler gives his take on the recently released European Innovation Scoreboard & the role of the Swiss HealthTech industry.



A month ago, the European commission released the European Innovation Scoreboard, which provides a comparative analysis of innovation indicators between EU/European countries and regional neighbors. Based on scores for 27 separate indicators, the countries fall into four performance groups: Innovation Leaders, Strong Innovators, Moderate Innovators, and Modest Innovators.

Switzerland is the overall Innovation Leader in Europe, outperforming all EU Member States, as shown in the figure below.

Are we surprised? Since 2012, Switzerland’s performance relative to the EU countries has improved by 22.6% points. This being the second year where the Switzerland’s innovation score even surpassed the United States.

Source: European Innovation Scoreboard 2020



While most know Switzerland for its banks and timely precision, this little country has positioned itself globally as an innovation leader, scoring particularly high due to certain innovation dimensions. For the purpose of simplicity, we will focus on the three dimensions scoring the highest in relation to the EU.

1) “Human resources”: Switzerland scored particularly high when analyzing the quality of talent: this mainly being compromised of new doctorate graduates, population with a tertiary education and lifelong learning.

2) “Attractive research systems”: An attractive research ecosystem, leading in international scientific publications, most cited publication, and foreign doctorate students.

3) “Firm investments”: Overall company innovation and R&D expenditure.

Keeping in mind that the European Innovation Scoreboard is not specifically oriented towards indicators within the healthcare industry, it is unquestionable that the above mentioned dimensions are strongly influenced by the country’s leading position in Healthcare. Life Sciences being a pillar of the above seen growth, strongly dependent on skilled workforce and continuous innovation.

Lyfegen’s headquarters being in Basel, Switzerland, is not coincidental and allows us to be on the forefront of healthcare innovation, contributing actively.

The innovative Swiss ecosystem partnered with Lyfegen’s solutions and patent-pending technology are doubtlessly a winning combination for saving patient lives and driving Swiss innovation forward!

Read the Full report



Sources:https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1150

 

 

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U.S. Department of Health and Human Services’ Innovation Center Revamps Value-Based Payment Models

The U.S. Department of Health and Human Services is revamping value-based payment models, which it pursues at its so-called...

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U.S. Department of Health and Human Services’ Innovation Center Revamps Value-Based Payment Models

Innovation Center is Shifting Focus from Medicare to Medicaid

 

The U.S. Department of Health and Human Services is revamping value-based payment models, which it pursues at its so-called “Innovation Center” or Center for Medicare and Medicaid Innovation (CMMI). The CMMI implements alternative payment models in the government programs Medicare and Medicaid for the purpose of cost containment and improvement in quality of care.

Since its founding in 2010, CMMI has launched more than 50 alternative payment models. An oft-cited success story is the Medicare Part D (outpatient drugs) Senior Savings Model, which the Innovation Center set in motion to test the impact of offering Medicare beneficiaries prescription drug plan options that include comprehensive coverage of all insulin products – including medical devices - with considerably lower out-of-pocket costs. Thanks to a robust public-private partnership between the Centers for Medicare and Medicaid Services (CMS) and entities with whom it contracts - Medicare Advantage and Medicare Part D plans, as well as pharmaceutical companies - this model has achieved the goals laid out by the Innovation Center, which include cost savings, improved quality of care, and more equitable outcomes.

The CMMI payment models – sometimes called demonstration projects - are viewed as ways to bypass statutory or legislative obstacles, for the purpose of experimenting with new approaches to reimbursement. Though often piecemeal in nature, demonstration projects can be a fallback option if legislative efforts fail, as they appear to have done with the Build Back Better Act which is currently on ice.

For example, CMMI payment models are incorporating bundled payments for treatment episodes, to reduce Medicare Part B (physician-administered) drug spending through more prescribing of biosimilars and generics and a streamlining of healthcare services.

The CMMI is now shifting some of its focus of alternative payment models from Medicare to Medicaid. Continued Medicaid expansion appears to the impetus behind efforts by policymakers to prioritize equity and reduce inequality in health outcomes. Total Medicaid enrollment has grown to 86 million, an increase of 20% since February 2020.

In October of last year, the policy and programs group director at CMMI, Ellen Lukens, said that “models have been predominantly Medicare-oriented, and have disproportionately served white beneficiaries.” By contrast, relatively few models have centered around Medicaid beneficiaries, many of whom are minorities. That is about to change.

The CMS administrator, Chiquita Brooks-LaSure, has laid out a vision for the next decade, one in which CMMI will drive “meaningful change” towards an “equitable” and “value-based system of healthcare.”

To carry out the mission of improving equity, policymakers will explicitly address barriers to participation in CMMI payment models by healthcare providers that serve a high proportion of minority populations. Policymakers also want to entice more underserved patients to register to participate in pilot programs.

The CMMI has undertaken a major review of the Center’s existing payment models to determine what works and what doesn’t. The review calls on the Innovation Center to explore new forms of value-based models in Medicare and especially Medicaid. Here, payment would be tied not only to improved patient outcomes and decreased overall healthcare spending, but also reductions in health disparities and increased patient affordability (lower out-of-pocket costs). Partnering with Lyfegen may be the solution for manufacturers and payers alike, as Lyfegen's value-based payment solution is already widely being used by payers and pharma manufacturers in Europe.

As the Innovation Center embarks on a quest to improve the Medicaid program, using alternative payment models, it may need to consider adjusting its criteria of what counts as a successful model. The equity parts may be easier to measure than certain other objectives. For example, lowering federal expenditures appears to be the overriding goal of the CMMI models, and therefore cost savings to the government their standard measure of success. But, depending on the disease area in question, sometimes cost savings might not be easily achievable, even if the model is very much worth it and may save beneficiaries out-of-pocket expenses. In certain disease areas, improved health outcomes might be a better objective, along with a cost-effective use of additional resources.

About the author

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

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The U.S. Department of Health and Human Services is revamping value-based payment models, which it pursues at its so-called...

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The uphill battle for value-based drug pricing agreements may be coming to an end

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The uphill battle for value-based drug pricing agreements may be coming to an end

The high-costs of newer drug treatments make the adoption of non-traditional, value-based drug purchasing arrangements a necessity for healthcare payers and administrators trying to manage their budgets, provide patients with quicker access to the most effective treatments, and reduce wasteful spending on treatments that don’t work. Recent regulatory changes and advanced AI contracting software options are making value-based drug pricing arrangements easier.

 

Even before the onset of the pandemic, annual budgets for public and private healthcare insurers were strained by the high and increasing costs of prescription drugs. Meanwhile, pharmaceutical manufacturers are bringing new and even more expensive drug treatments to market each year. According to Bloomberg, the median list price for a year’s supply of a new drug introduced to the U.S. market in 2021 was $180,007.

Thanks to COVID-19 vaccines and COVID-related treatments, pharmaceutical sales reached record levels in 2021. Sales in North America account for close to half of the total $7.3 billion global market revenue for that year. And since prescription drug prices are higher in the U.S. than anywhere else in the world, the increasing costs of drugs are a top concern for policy makers, healthcare payers, and consumers.

New, more expensive drug therapies are in development

A growing niche and focus for pharmaceutical companies is high-cost cell and gene therapy products. Market analysis by Grand View Research forecasts the global cell and gene therapy clinical trials market to reach a compound annual growth rate of close to 15% and an estimated market revenue of USD 24.5 billion by 2030.

While the U.S. Food and Drug Administration (FDA) has approved only a limited number of cell and gene therapies so far, expedited approvals of new drugs and favorable designations of new therapies as orphan drug or breakthrough therapies support increasing consumption of these new drug therapies in the U.S. market. The FDA predicts that by 2025, it will approve up to 20 cell and gene therapy products a year.

Healthcare payers and consumers feel the pain of higher drug prices

Even though payers are getting rebates and not paying drug manufacturers’ full list prices, they still have cause for concern as drug prices increase annually. Payers need to protect their annual budgets from outsized expenditures, especially for specialty drugs.

Both payers and patients suffer the effects of high and increasing drug prices. A study of 14.4 million pharmacy claims made from 2010 to 2016 revealed the median healthcare insurer payments for specialty medications rose by 116%; the median patient out-of-pocket costs increased by 85%. Drug list prices during the same 7-year period more than doubled, rising faster than inflation.

Drug manufacturers recognize the need for non-traditional, value-based payment arrangements

A new cell or gene therapy’s price tag may generate as much attention as the drug’s ability to treat disease. For example, one of the most expensive drug therapies in the world is Zolgensma, approved by the FDA in 2019. Novartis Gene Therapies (formerly AveXis) developed the drug to be a cure for around 500 infants born each year in the U.S. with spinal muscular atrophy (SMA). A full course of treatment is priced at $2.125 million.

Soon after Zolgensma received FDA approval, some of the top U.S. insurers quickly set up tight restrictions limiting coverage of the treatment. To help payers manage the impact of the cost and ensure patient access to Zolgensma, Novartis offers insurers the option of either a 5-year, pay-over-time contract or an outcome-based agreement.

The list price of Zyntelgo, the latest gene therapy to be approved by the FDA, surpassed Zolgensma as the world’s most expensive one-time drug therapy. Zyntelgo was developed by bluebird bio as a single-use treatment for an inherited blood disorder, beta thalassemia. According to bluebird, Zyntelgo’s price of $2.8 million is a good value when compared to the estimated $6.4 million worth of lifetime care costs for a patient living with beta thalassemia.

Estimates suggest that only around 850 patients in the U.S. will meet the criteria for treatment with Zyntelgo, and not all of those who are eligible will want the drug. Predictions of Zyntelgo’s annual sales revenue range from $64 million to $200 million.

The majority of patients eligible for Zyntelgo are covered by commercial health insurance, with most of the rest using Medicaid. Bluebird is offering payers a sizeable refund if the treatment underperforms or fails. If patients still need blood transfusions within two years after receiving Zyntelgo, bluebird will refund the payer up to 80% of the treatment’s costs.

Payers recognize the benefits of using value-based drug pricing agreements

Outcome-based agreements help payers address any uncertainty about the effectiveness of a new treatment, gain insight into a drug’s value to patient health outcomes, and reduce the risk of overpaying for a low-value treatment. The real-world evidence collected while managing value-based drug arrangements helps manufacturers justify their list price and reinforces refunds and rebates to the payer if the treatment doesn’t deliver results as expected. So why has there not been greater use of value-based drug agreements?

Regulatory barriers to value-based drug purchasing arrangements eliminated

This year, U.S. legislators have addressed most of the legislative hurdles that, in the past, hindered value-based drug purchasing arrangements. Policymakers updated two pieces of legislation to support increased adoption of value-based drug pricing agreements.

The Medicaid Best Price rule was changed in July, allowing pharmaceutical manufacturers taking part in Medicaid to report multiple best prices. This was followed by the passage of the the Inflation Reduction Act in August, which allows Medicare to negotiate directly with drug manufacturers over the prices of some of the most expensive drugs covered by the Medicare program.

Overcoming technological challenges to implementing value-based drug agreements

Another significant obstacle to increased adoption of value-based drug pricing arrangements has been the difficulty in operationalizing complex, data-driven, outcome-based contracts. These non-traditional agreements require a powerful, interoperable contracting software platform with extensive data collection and analysis capabilities to make real-world evidence both accessible and insightful.

To take on an outcome-based contract, an organization has two options. The first is to develop the IT framework in-house and devote management resources to monitor compliance and data security. This option is expensive, time-consuming, and beyond the current capabilities of many organizations.

The second option is to outsource the administrative burden of an outcome-based contract. In recent years, third-party vendors have developed comprehensive contracting software to bridge the gap and help manufacturers, payers, and providers transition from fee-for-service into value-based agreements.

 

The Lyfegen Solution

Lyfegen is an independent, global analytics company that offers a software-as-a-service platform for healthcare insurances, pharma, and medtech companies wanting to participate in value-based drug pricing agreements without making large investments in software upgrades. With extensive industry expertise and a vast library of resources, we can assess your current capabilities and advise and guide you through pre-implementation. Deployment of our customizable and scalable contracting platform is quick and integrates seamlessly into your existing workflow without compromising data security or compliance.

Lyfegen’s software platform includes three-fold functionality to implement value-based, data-driven agreements with greater efficiency and transparency: data ingestion, agreement execution, and insights generation. The Lyfegen Platform collects real-world data and uses intelligent algorithms to provide valuable information about drug performance and cost.

By enabling the shift away from volume-based and fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about our services and the Lyfegen Platform, book a demo.

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