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Michael Porter’s VBHC Theory Explained by Lyfegen’s Customer Success Hero, Simon Amstutz

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Michael Porter’s VBHC Theory Explained by Lyfegen’s Customer Success Hero, Simon Amstutz

Through the eyes of Simon Amstutz, briefly dive into the history of Michael Porter’s value-based healthcare theory.



For those who follow Lyfegen and our blog, chances are that you already fully grasp the concept of value-based healthcare (VBHC). That said, I came to Lyfegen from a completely different field, banking, and was intrigued by the history of how this theory came to be. While my intention is not to bore you with a history class, for all future posts it is important to have a common knowledge of the framework that lies behind VBHC.

In 2006, Harvard Professor Michael Porter and his fellow academic Elizabeth Teisberg published the book Redefining Health Care: Creating Value-Based Competition on Results . This book set the fundament of VBHC.

In this book they argue that competition in healthcare should be occurring in diagnosis, treatment (outcomes), and prevention of certain health conditions rather than between insurance plans and hospitals. They propose that the healthcare system should be restructured by having competition focus clearly on improved patient outcomes. The proposed model focuses on the value (yes, hence the name) that the medication or care brings to the patient. In other words, value is measured by the best outcome for the patient per dollar spent.

This being a monumental change from the current healthcare model, which operates on a fee-for-service/product basis. Under the conventional model, drugs and therapies have to be paid for regardless of whether they actually helped the patient. .

In order to achieve such a change, Porter argues that the healthcare system needs to be able to quantify health-care processes, outcomes, patient’s experiences, and organizational systems to evaluate the effectiveness of delivered care/medication as it benefits for the patient – this seeming like the greatest challenge back in 2006. But since then, technology and processes have evolved. This is where Lyfegen comes in: the challenges that our system was faced with 14 years ago now have a clear solution: Lyfeapp and Lyfevalue.

While Porter is most definitely not the only thought leader in the VBHC sector, his book shook and rattled the healthcare industry, identifying a clear need for solutions like those proposed by Lyfegen.

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Medicare Part D redesign could reboot U.S. prescription drug market for cancer drugs, making pricing more value-based

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Medicare Part D redesign could reboot U.S. prescription drug market for cancer drugs, making pricing more value-based

With passage of the Inflation Reduction Act, the Medicare Part D (outpatient drug benefit) will be undergoing a comprehensive redesign, which will be implemented in 2025. There will be a dramatic shift towards payer responsibility of costs, particularly in the catastrophic phase of the Medicare Part D benefit.

 

Currently, during the calendar year there are four phases a Medicare beneficiary goes through when obtaining coverage of outpatient drugs: Deductible, initial coverage, coverage gap, and catastrophic. Here, catastrophic refers to the point when a beneficiary’s total prescription drug costs for a calendar year have reached a set maximum level. At present, the catastrophic threshold is set at $7,100. In a given year, once beneficiaries hit the threshold they will have spent $3,250 out of pocket, at which point they begin paying 5% co-insurance in the catastrophic phase.

Over a five-year period from 2016 to 2021, nearly three million enrollees in Medicare Part D spent above the catastrophic threshold at least once. And, currently more than 1.5 million beneficiaries are in the catastrophic phase. That number is expected to grow steadily in the coming years. Moreover, at present, spending in the catastrophic phase now accounts for about 45% of total Medicare Part D expenditures.

The redesigned Medicare Part D benefit features a $2,000 hard cap on beneficiary out-of-pocket spending. At the same time, there will be a massive shift in cost management liability in the catastrophic phase. Currently, Medicare picks up the tab for 80% of costs in the catastrophic phase (the government is essentially the reinsurer in the catastrophic phase); plans, 15%; and beneficiaries, 5%. In the restructured Part D benefit, starting in 2025, the drug manufacturer will be responsible for 20% of catastrophic costs; plans, 60%; Medicare, 20%; and Medicare beneficiaries, 0%.

This $2,000 cap will obviously reduce Medicare beneficiaries’ financial burden considerably, especially those who are prescribed high-priced specialty cancer drugs, many of which put them in the catastrophic phase by the end of January in a given year, with no limit on out-of-pocket expenditures. In all probability, the $2,000 cap will lead to more utilization of specialty drugs and better patient adherence.

The Part D overhaul will also force payers and drug makers to rethink their strategies vis-à-vis cancer drug pricing and reimbursement. Payers will have to strike a harder bargain with drug makers when purchasing specialty pharmaceuticals. As payers won’t be able to fully offset their higher burden of cost management by raising premiums – there will be a 6% annual cap on premium increases. There will very likely be increased use of utilization management tools. And, perhaps most importantly, a more competitive market with more use of utilization management tools, such as prior authorization, step edits, and quantity limits. Also more use of outcomes-based pricing models. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.

Historically, as new checkpoint inhibitors, anti-PD-1 and PD-L1 agents, have gained approval – such as Jemperli (dostarlimab) in April of 2021 - price competition has not been a factor. This is extraordinarily unusual, given how relatively crowded the various oncology indications targeted by checkpoint inhibitors have become; from breast, renal, and colorectal cancer, to melanoma and non-small cell lung cancer. Several companies, including traditional ones like Lilly but also new entrants such as EQRx, are seeking to disrupt this space by offering lower-priced alternatives.

Outside the U.S., oncology drug pricing is generally heavily regulated. And, we observe that certain drugs may not be reimbursed by government (monopsonist) purchasers if there isn’t sufficient clinical benefit to justify the price. Moreover, in international markets, outcome- or value-based pricing strategies for cancer drugs are commonplace, which they aren’t yet in the U.S.

However, Medicare Part D restructuring alters the competitive landscape considerably. For high-priced specialty pharmaceuticals, in particular, it will become increasingly important for payers to contain costs by way of utilization management, promote the use of generics and biosimilars, and negotiate value-based prices. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.


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 on a variety of research, teaching, speaking, editing, and writing projects.

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Medicare needs authority to negotiate drug prices to support its value-based healthcare strategy

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Medicare needs authority to negotiate drug prices to support its value-based healthcare strategy

 

Despite majority public support for authorizing Medicare to negotiate drug prices, legislators struggle to reverse the non-interference clause that makes it illegal.

 

The non-interference clause

Medicare is legally prohibited from negotiating drug prices directly with manufacturers thanks to the non-interference clause in the 2003 law that created Part D, the prescription drug program for Medicare beneficiaries. The non-interference clause disallows Medicare from negotiating drug prices directly with pharmaceutical manufacturers, interfering in negotiations by Medicare contractors, or publishing any information about negotiated drug rebates.

Instead, the private health insurance plans and prescription drug programs Medicare contracts to implement benefits conduct negotiations for discounts with drug manufacturers. Meanwhile, other government programs — Medicaid and the Veterans Administration—have successfully lowered drug costs by negotiating directly for discounted drug prices and rebates.

Strong public support stands for allowing Medicare to negotiate drug prices

According to a KFF (Kaiser Family Foundation) poll published in October 2021, there is broad-based public support for ending the non-interference clause. The poll showed that 83% of the survey participants favored allowing Medicare to negotiate drug prices directly with manufacturers. Those in favor included a mix of 71% Republican, 82% of independents, and 95% Democrats.

Proponents of allowing Medicare to negotiate drug prices in Parts B and D see Medicare’s ability to negotiate value-based drug pricing as an important part of the overall strategy for driving the U.S. health system towards value-based healthcare and lower drug prices, especially if the outcomes of the negotiations are made known to commercial insurance plans, the Marketplace, and self-insured employers.

Opponents believe that the Medicare system of price negotiations through contracted health plans and prescription drug plans promotes competition among drug manufacturers and protects patient access to drugs. They also cite a Congressional Budget Office (CBO) letter that states giving broad Medicare negotiating authority to the Secretary of Health and Human Services (HHS) would, by itself, “likely have a negligible effect on federal spending”.

Recent legislative actions attempting to eliminate the non-interference clause

In 2019, the U.S. House of Representatives passed bill H.R.3, The Elijah E. Cummings Lower Drug Costs Now Act. Among other proposed fixes, the bill would authorize the Health and Human Services (HHS) Secretary to negotiate prices for single-source, brand-name drugs that met certain criteria. When H.R.3 went to the Senate for approval, its progress stalled. In 2021, H.R.3 was reintroduced in Congress.

In November 2021, the the Build Back Better Act (BBBA) passed the U.S. House of Representatives but was also stopped dead in the Senate. Within that bill was an exemption to the non-interference clause to allow Medicare to negotiate prices for expensive drugs covered under Medicare Parts B and D. Despite the defeat of the BBBA, President Biden used his State of the Union address on March 1, 2022 to keep up the pressure and repeated his call to lawmakers to address the problem of drug pricing.

Value-based administrative levers

In 2016 a pilot project for Medicare Part B drugs was created to test the results of allowing Medicare to conduct drug pricing negotiations. It was designed to institute value-based drug pricing using an international pricing index for the few drugs covered under Part B. The prices of some Part B biologics and single-source drugs were tied to their lower average overseas price.

Although the pilot project could have been implemented without congressional approval, several lawsuits and injunctions prevented the implementation of the model. Finally, the Biden administration rescinded the proposed model in August 2021.

Besides the recent unsuccessful legislative efforts for Medicare drug price negotiations, HHS outlined some other possible administrative actions for drug pricing reforms based on President Biden’s September 2021 Executive Order 14036, Promoting Competition in the American Economy. Among the proposals suggested is the use of value-based pricing models:

• To improve transparency about pricing, rebates, and out-of-pocket spending through data collection from health insurers and pharmacy benefit managers

• Implementing Medicare total cost of care models to find ways to reduce spending, affect drug utilization, and improve patient outcomes

The need for drug pricing reforms in Medicare holds bipartisan support, especially as it relates to lowering out-of-pocket expenses for seniors. However, passing the legislation needed to realize those reforms remains a controversial and complicated matter. While work continues to pass drug price reform legislation, value-based payment models can provide data analytics to support drug price reductions in both the public and private sectors.

Lyfegen’s value-based contracting platform

The Lyfegen platform helps organizations join in the healthcare industry’s movement towards value-based care. Our contracting platform organizes the actionable, real-time data needed to implement value-based contracting while relieving the complexity and administrative burden of transitioning out of fee-for-service models.

Contact us for more information about our software solutions and to book a demo.

 

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

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

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

 

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

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

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

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

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

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

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

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

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

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

Is ICER helping or hurting value-based pricing?
Find out what role it really plays in our latest article.

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

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

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

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

 

About the author

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

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

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

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

 

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

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

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

U.S. drug expenditures keep rising

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

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

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

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

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

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

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

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

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

Value-based purchasing contracts strengthen stakeholder partnerships

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

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

The Lyfegen Platform

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

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

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Lyfegen erhält 8 Millionen Dollar, um Arzneimittelpreise zu senken und Patienten den Zugang zu lebensrettenden Medikamenten zu erleichtern

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Lyfegen erhält 8 Millionen Dollar, um Arzneimittelpreise zu senken und Patienten den Zugang zu lebensrettenden Medikamenten zu erleichtern

Die Vertragssoftware von Lyfegen wird von Kostenträgern im Gesundheitswesen und führenden Pharmaunternehmen eingesetzt, darunter Novartis, Roche, MSD, Bristol Myers Squibb (BMS) und Johnson & Johnson.

 

NEW YORK/BASEL, 20. September 2022 /PRNewswire/ – Lyfegen, ein globales Healthtech-SaaS-Unternehmen, das den Übergang von volume-zu value-based Healthcare für hochpreisige Medikamente vorantreibt, gab heute eine überzeichnete Serie-A-Finanzierungsrunde über 8 Millionen Dollar bekannt, die vom Investmentfonds aMoon mit zusätzlicher Beteiligung von APEX Ventures und weiteren Investoren angeführt wurde.

Derzeit sind weniger als 2 % der Krankenversicherten, die Spezialarzneimittel benötigen, für 51 % der Arzneimittelausgaben verantwortlich. Die Kosten für Spezialarzneimittel in den USA laufen aus dem Ruder: Sie stiegen allein von 2020 bis 2021 um 12 % – und es gibt keine Anzeichen für eine Verlangsamung, denn es kommen immer mehr Zell- und Gentherapien auf den Markt. Infolgedessen wird Value-Based Contracting, die Nutzung wertorientierter Verträge, für die Kostenträger des Gesundheitswesens zu der entscheidenden Alternative, um nur für Medikamente zu zahlen, die tatsächlich wirken.

Bis 2025 werden die Nettoausgaben für Medikamente in den USA voraussichtlich bis zu 400 Milliarden US-Dollar betragen. Darüber hinaus kommen regelmässig neue Medikamente auf den Markt. Es fällt Pharmaunternehmen immer schwerer, sich mit den Kostenträgern auf kommerzielle Bedingungen zu einigen. Damit steigt die Gefahr, dass Patienten keinen Zugang zu lebensrettenden Therapien erhalten. Lyfegen hilft Regulierungsbehörden, Pharmaunternehmen und Kostenträgern bei der Einführung wertorientierter Zahlungsmodelle, indem sie den gesamten Prozess der Datenerfassung, Anonymisierung und Vertragsverhandlungen für alle Parteien digitalisiert. So kann die Preisgestaltung und Kostenerstattung für Medikamente vereinfacht werden.

„Wir freuen uns, diese Finanzierungsrunde bekannt zu geben und dieses Vertrauensvotum von aMoon, APEX und weiteren Investoren zu haben, die den Wandel im Gesundheitswesen verstehen und unser Bestreben um den Ausbau der Lyfegen-Plattform unterstützen", sagte Girisha Fernando, CEO und Gründer von Lyfegen. „Wir arbeiten derzeit mit führenden staatlichen Kostenträgern, Krankenversicherungen in Europa, den USA und dem Nahen Osten sowie mit einigen der weltweit grössten Pharmaunternehmen zusammen. Wir beabsichtigen nun, unsere Präsenz in den USA weiter auszubauen und Partnerschaften mit privaten und öffentlichen Krankenversicherungen einzugehen. Die Abkehr von der volumenbasierten Gesundheitsversorgung war noch nie so notwendig wie heute, und wir freuen uns, dass wir eine wichtige Rolle bei der Umstellung auf Value-Based Contracting spielen können."

„Lyfegen adressiert einen bedeutenden Marktbedarf in einer Branche, die sich dramatisch und schnell verändert, und wir sind begeistert, dass wir mit unserer Investition dazu beitragen können, ihre Anstrengungen zu unterstützen", erläuterte Moshic Mor, General Partner bei aMoon und ehemaliger Partner bei Greylock and Greylock Israel. „In Zeiten von Budgetdruck und Rezession im Gesundheitswesen braucht die Welt Lösungen wie die von Lyfegen mehr denn je. Wir sind stolz mit diesem erfahrenen Führungsteam zusammenzuarbeiten, das weiterhin den Zugang zu neuen Medikamenten verbessert, während es die wertorientierte Gesundheitsversorgung immer mehr zum Mainstream macht."

 

Informationen zu Lyfegen

Lyfegen ist ein unabhängiges, globales Softwareanalyseunternehmen, das eine wert- und ergebnisbasierte Vertragsplattform für Krankenversicherungen, Pharma- und Medizintechnikunternehmen sowie Krankenhäuser auf der ganzen Welt bietet. Die sichere Plattform identifiziert und operationalisiert wertbasierte Zahlungsmodelle kostengünstig und macht diese mit einer Vielzahl von realen Daten und maschinellem Lernen skalierbar. Mit der zum Patent angemeldeten Plattform von Lyfegen können Krankenversicherungen und Krankenhäuser eine wertorientierte Gesundheitsversorgung einführen und skalieren und so den Zugang zu Behandlungen, die Gesundheitsergebnisse der Patienten und die Kostenersparnis verbessern.

Lyfegen hat seinen Sitz in den USA und der Schweiz und wurde von Persönlichkeiten mit jahrzehntelanger Erfahrung im Gesundheitswesen, in der Pharmaindustrie und im Technologiebereich gegründet, um den Übergang von der volumenbasierten und kostenpflichtigen Gesundheitsversorgung zur wertorientierten Gesundheitsversorgung zu ermöglichen. Weitere Informationen finden Sie auf www.lyfegen.com.

Verwandte Links:

https://lyfegen.com/

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

Pressekontakt: yael@gkpr.com

Ansprechpartner für Investoren: investors@lyfegen.com

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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

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Transforming Healthcare Access in Canada: Ina Hasani’s Vision at Lyfegen

We are thrilled to welcome Ina Hasani to our team at Lyfegen as Director of Sales & Business Development for Canada. Ina brings nearly a decade of experience in the life sciences sector, specializing in healthcare strategy, market access, and health economics. We sat down with Ina to learn more about her background, her vision for transforming healthcare in Canada, and what excites her most about joining Lyfegen.


Can you tell us a bit about your background and what led you to your role as Director, Sales &Business Development for Canada at Lyfegen?

I have spent close to  a decade in the life sciences sector, working with companies like Novartis  and Pfizer, where I gained deep expertise in healthcare strategy, market  access, and health economics. My passion has always been focused on improving  patient outcomes and the healthcare system. This led me to Lyfegen, a company  at the forefront of transforming healthcare through innovative solutions. The  opportunity to work with payers and drug manufacturers to ensure better and  sustainable access to innovative treatments for patients was a natural fit  for me, both professionally and personally.


What are the biggest challenges facing the healthcare market in Canada, particularly in terms of drug pricing and access?

The Canadian healthcare system is highly complex! The biggest challenge that we are facing is how to accelerate access to innovative therapies without compromising the sustainability of the healthcare system. Payors, including both public and private insurers, are struggling to balance their budgets with the rising costs of therapies, particularly for specialty drugs. Outcome based agreements are a potential solution to enable timely access to breakthrough therapies.  However, payors and pharmaceuticals don’t have the infrastructure in place to efficiently implement and operationalize such agreements.


What  opportunities do you see for growth in Lyfegen’s sales efforts in Canada? How  can we better support health insurers and government bodies?

There is tremendous  potential for growth. Currently, payors and pharmaceuticals adjudicate their  product listing agreements (PLAs) manually through Excel spreadsheets. It is  resource intensive, leaves room for errors and is a barrier to potential  innovative contracting. In addition, as Canada increasingly looks towards  value-based healthcare models, Lyfegen is an enabler by providing the digital  infrastructure for payor and manufacturers.


From your perspective, what key actions need to be taken in the  next 12 months to drive success for Lyfegen in the Canadian market?

In the next 12 months, we need to focus on deepening  our relationships with key stakeholders and demonstrate the value of our  digital solutions for payors, manufacturers, healthcare system and,  ultimately, the patients.


How do you see your role influencing the implementation of  value-based solutions in Canada, and what impact do you hope to have?

Lyfegen has extensive  experience in OBA implementation and operationalization in many countries. In  my role, I hope to bridge the gap from theory to practice in the  implementation of value-based healthcare in Canada.


In your opinion, what’s the most important aspect of building  strong client relationships in the healthcare industry? How do you approach  this in your role?

Trust and communication  are at the core of any strong client relationship in healthcare. Given the  complexity and sensitivity of the industry, clients need to know that you  understand their unique challenges and are committed to solving them. In my  role, I prioritize open and ongoing communication, ensuring that clients feel  heard and that their feedback is integrated into our solutions. I also work  hard to build trust by delivering results and being transparent about what we  can achieve together.

 
Looking ahead, what excites you most about the future of sales  and business development at Lyfegen in Canada?

I’m excited about the potential to be a catalyst for  significant change in the Canadian healthcare landscape. Lyfegen is in a  unique position to lead this transformation. The combination of increasing  demand for cost-effective healthcare solutions and our innovative approach  makes this an incredibly exciting time to be in sales and business  development.


Outside of work, what are some of your favorite things to do in  your free time?

Outside of work, I  enjoy spending quality time with my family and friends. I also prioritize my  health by being active on a daily basis. I also enjoy learning. Now that I  have completed my MBA, I’m on a mission to learn Spanish.

We are excited to see Ina grow and thrive in her role at Lyfegen. Welcome to the team, Ina!

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A Fable of the Blue Bird and Lyfegen's Wise Owls

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A Fable of the Blue Bird and Lyfegen's Wise Owls

Once upon a time, In a whimsical forest, there lived a smart and creative blue bird. This bird, known for its brilliance in the world of tiny forest biotech, had concocted a magical potion.

This potion was a wonder, a gene therapy to cure the forest creatures of a troublesome disease called sickle cell. Perched thoughtfully on a branch, the blue bird faced a whimsical yet vital challenge. The potion, potent in its healing, needed to be more than just a marvel of science – it had to be reachable and affordable for all in the forest. Additionally, this magical creation was still unnamed, a name that should echo its life-affirming qualities and the journey from a mere idea to a beacon of hope in the forest.

Amidst this puzzlement, the blue bird heard tales of the wise owls of Lyfegen, far beyond the forest. These owls were not just wise; they were masters of a different kind of magic – the magic of numbers and agreements that made health solutions reachable to all. Intrigued, the blue bird fluttered over to learn more.

As it learned about Lyfegen's remarkable ability to navigate the complex world of potion pricing and access, inspiration struck. "Ah-ha!" chirped blue bird, "If Lyfegen can make health solutions accessible, why not name my potion in honor of their work? Lyfgenia – a name that sings of life, hope, and the ingenuity of Lyfegen!"

And so, the potion was christened Lyfgenia, a nod to the owls of Lyfegen whose wisdom ensured that such medical marvels reached every nook and cranny of the forest without burdening its inhabitants.

With its new name, Lyfgenia became more than just a potion; it symbolized a harmonious blend of medical genius and financial savvy. The blue bird turned Lyfgenia into a symbol of hope and healing in the whimsical world of the forest.

Disclaimer: "A Fable of the Blue Bird and Lyfegen's Wise Owls" is a work of fiction, created solely for entertainment and illustrative purposes. This fable does not represent any real-life strategies, decisions, or actions of these entities, nor should it be interpreted as an endorsement or representation of their values, capabilities, or business practices.

Using Lyfegen's solutions can streamline the financial management of advanced therapies like Lyfgenia, leading to more effective pricing strategies and improved access for patients. Learn more about how our solutions enable value-based contracting for gene therapies: lyfegen.com

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Driving Growth: Welcoming Our New VP of Sales & Business Development, Simon Farrow

Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...

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Driving Growth: Welcoming Our New VP of Sales & Business Development, Simon Farrow

Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh perspective to our mission.

 

Quick introduction – tell us a bit about yourself!

I'm based out of the UK. I studied Law at University but soon realized that a career as a Solicitor wasn’t my calling. Post-university, I ventured into Software Sales, initially focusing on Cloud Solutions and then transitioning into the Life Sciences realm. Most of my career has been dedicated to building startups and introducing new ideas and products to the market.

 

What excites you about your job?

What really thrills me about joining Lyfegen is the potential impact I can have on those needing life-saving treatments. The core goal of the pharma industry is to enhance the health and wellbeing of society, and at Lyfegen, we're crafting solutions that make medications more accessible, allowing us to treat more people. It's also incredibly rewarding to collaborate with some of the world's leading pharma companies, supporting them as they launch new assets.

 

Why did you decide to join Lyfegen?

It was the founders' vision that drew me to Lyfegen. Their passion was evident right from our initial conversations. Joining Lyfegen is an incredible opportunity for me to contribute my experience to another startup, and together, we can continue to thrive on this exciting journey.

 

What is something you want to learn or improve in the next 12 months?

Over the next year, I aim to deepen my understanding of the market access space within the pharma industry. Launching assets is intricate, with many layers involved, and there's a wealth of knowledge I'm eager to absorb. It's fascinating to learn about the different approaches of various companies and how they navigate the market.

 

How will your know-how help improve our customers’ experience of Lyfegen solutions?

With my background in launching new solutions for startups, I'm well-acquainted with the challenges that can arise. We can be proactive in addressing these before they occur. As Lyfegen is growing rapidly, it’s crucial that we adapt while maintaining our high standards and always remembering that our customers are our biggest priority. My experience with Global enterprises has also given me insight into the ongoing support they need and the importance of fostering great relationships based on trust and understanding.

 

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

In my free time, I love to travel as much as I can, exploring different cultures and places, with my next plans to delve into more of Asia. When I'm in the UK, I spend time with my German Shepherd, Max, or playing water polo.

 

Is there anything else you are looking forward to outside of work in the next few months?

As we near the end of Q4, it's a busy period, but I'm looking forward to a well-deserved break over Christmas with friends and family, indulging in good food. It's the perfect time to recharge and gear up for a significant 2024 for Lyfegen, where we'll continue to serve our customers, engage with new ones, and grow as a company.

 

Our conversation with Simon ends on a high note, filled with anticipation for the contributions he will bring to Lyfegen. In the words of Girisha Fernando, our CEO, "we are very excited about Simon joining us. His experience is a valuable addition to our team, and we are confident he'll make a significant contribution to our mission. It's a pleasure to welcome him to Lyfegen." 

 

Here’s to new beginnings and transformative journeys! 

Welcome to our crew, Simon.

Amid the buzz of innovation at Lyfegen, we sat down with Simon, our newest team member, whose journey has brought a fresh...

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Exclusive interview with Girisha Fernando at the launch of Lyfegen’s Value-Based Agreement Library

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Exclusive interview with Girisha Fernando at the launch of Lyfegen’s Value-Based Agreement Library

At this years World Evidence, Pricing and Access event, Girisha Fernando, the CEO of Lyfegen, expressed excitement as he spoke about the company’s latest launched offering - the Lyfegen Model & Agreement Library. This unique learning resource is a true game-changer that builds upon the company’s existing product. It expands our horizons by allowing payers and market access & pricing professionals to explore over 2’500 real-life public agreements, and 18 drug pricing models from around the world. The library provides an unparalleled understanding of drug reimbursement models that help users make better informed choices like never before.


Selecting a drug reimbursement model is very complex, as manufacturers want quick market access, while payers may have many concerns, such as a drug’s efficacy and affordability. Fernando emphasized that the library bridges the gap by assisting payers and market access professionals in finding specific models that address each stakeholder’s concerns, and key real-life agreement examples, resulting in better-informed decision-making, and ultimately more efficient reimbursement processes.


“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 Fernando, “That is why we are 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.”


But that’s not all – Fernando explained that the database is constantly evolving, being updated weekly with new public agreements, allowing stakeholders to be up to date on public agreements.


Overall, it is clear that the Lyfegen Model & Agreement Library is an invaluable groundbreaking tool, that is becoming indispensable in increasing the knowledge on drug and Cell & Gene Therapy reimbursement.

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The Tech Team Keeps Growing! Welcome to the Lyfegen Team, Analytical-Superstar, Pavlo!

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The Tech Team Keeps Growing! Welcome to the Lyfegen Team, Analytical-Superstar, Pavlo!

He’s analytical, a techie and has a fantastic gift for music! Yes, we are talking about the latest addition to our team, our very own “Technical Business Analyst” and Ukrainian superstar: Pavlo Lupandin!



Just last month we announced the arrival of our Lead Developer, Daniel, and now more great news follows as Lyfegen continues to lay focus on the technical team: we have our very own Technical Business Analyst, Pavlo!

“Pavlo’s sharpness and problem-solving skills just made it clear that we needed him in our team! His drive and commitment will bring great value to our patients, our customers and Lyfegen as we continue to sharpen our platform” says Lyfegen’s CEO, Girisha Fernando.

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 musical talent and witty “Technical Business Analyst”:

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

Hello! I was born in the east of Ukraine, got the Master’s Degree in Economics in Kyiv, worked at one of the Big 4 companies for 3 years as an Auditor, following one year in the role of Business Analyst. After this experience, I found myself being a fresh ACCA Member, who wanted to dive into something not that accounting related. Business analysis has proven to be an interesting area where I can develop further capitalizing on my previous experience.

It’s interesting, that back in my audit days I’ve had some big healthcare-related projects. Who knew that it was only the beginning of working in this promising domain…

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

Pace of development. The Healthcare & IT industries are developing in overwhelming waves, and to ride the peak of those waves is a challenge – formidable, but a tempting one. As soon as this opportunity presented itself, I decided to chase it. We’ll see, where this decision will bring me in a couple of years.

You are joining Lyfegen as Technical Business Analyst. In simple terms: what will you be working on?

I would be occupied mainly with gathering, documenting and communicating the requirements of our customers. Ever heard of different communication barriers? Those I would try to eliminate, trying to grasp the very core of what has to be done for the maximum customer satisfaction and making sure the development team implements requirements as close as possible to the ideal.

What are your next personal goals with Lyfegen?

There are several of them. First, I strive for development as a professional, and I think Lyfegen will provide me with opportunities to do that. Second, I want to embrace that spirit of a high-growth startup – after working for a massive and complex company, the flexibility and freedom of Lyfegen is a breath of fresh air. And finally, I want to know new talented people. I already know, that the Lyfegen team has a great diversity, and I can’t wait to learn some interesting things from people of other countries and cultures.

What motivated you to join?

Purpose and value. As simple as that. I can see the purpose and value of what I’m doing. Obviously, we are at the beginning of this journey, and it’s a bit early to speak about “value-based pricing for everybody” or “pay only for what is really working” but…the concept is huge, and it will become the question of life and death for some patients. And I’ll do my best to make it as close to life as possible.

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

Oh, you don’t want to hear a full list, I assure you. Let me try to sum it up quickly…Music, videogames and tabletop games – I play them all. A small collection of musical instruments – some of them are quite exotic, especially for my home country (banjo and djembe, for example). A bigger collection of tabletop games in different genres – the Lyfegen team can definitely expect a session or two in the nearest future. And a vast collection of videogames on different platforms…without much details let’s just agree there are a lot.

There are some other hobbies of mine, but I’d prefer to keep a couple of surprises up my sleeve!



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

 

MEET THE LYFEGEN TEAM

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About the author

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

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

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

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

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

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

Figure: Indication-specific pricing

Source: Institute for Clinical and Economic Review

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

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

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

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

According to the PBMs, indication-specific pricing can provide a justification for higher prices for secondary indications that provide greater clinical benefits. In the context of value being assessed, this may help address payer resistance to expanding coverage to include supplemental indications.

Curious how value-based pricing decisions are made?
Read the full breakdown of ICER's role in drug pricing.

Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of indication-specific pricing arrangements. The Lyfegen platform identifies and operationalizes value-based indication-specific models in a cost-effective manner.

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

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

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

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

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

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

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

About the author

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

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

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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%.

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.

y 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 the 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.

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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Biosimilars appear ready for prime time in the U.S. as reimbursement is increasingly value-based

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Biosimilars appear ready for prime time in the U.S. as reimbursement is increasingly value-based

Biosimilars are launching soon in several categories, including auto-immune disorders and ophthalmology

2023 will likely be a pivotal year for biosimilars, as Humira-referenced adalimumab products launch in the U.S. Worldwide, Humira has been a massive blockbuster for AbbVie, but also a drain on payer budgets. Once Humira-referenced biosimilars were marketed in Europe, they took off in many countries, as payers sought to reduce financial exposure with heavily discounted products. Steep discounts and tender offers, in which the best bid gets the lion’s share of the market, have helped boost uptake of biosimilars. Additionally, European payers have bought into the value proposition that biosimilars are cost-effective.

Besides auto-immune disorders, biosimilars are entering new therapeutic areas such as ophthalmology. Together with Samsung Bioepis, Biogen is launching Byooviz (ranibizumab) this month. Byooviz is a biosimilar referencing Lucentis. Approved by the FDA in September of last year, the drug will soon become the first ophthalmology biosimilar in the U.S. Byooviz’s approved indications include wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Byooviz is being offered at a list price of $1,130 per single-use vial, which is a 40% discount off the wholesale acquisition cost of Roche’s originator, Lucentis. It’s expected that the price of Lucentis will also drop.

But, selling biosimilars like Byooviz to payers and clinics isn’t as simple as discounting the price. As with any new biosimilar, detailing Byooviz’s launch – demonstrating its value - will be an elaborate endeavor, which involves engaging doctors, payers, and patient advocacy groups to facilitate access and appropriate physician and patient support. Biogen, for instance, has said it will be educating ophthalmologists about the science and value of biosimilars, as well as the regulatory framework for its approval.

In the U.S., policymakers firmly believe that safe, effective, and lower-cost biosimilars must be made available to all who need them. However, biosimilars have sometimes been excluded from formularies owing to rebate schemes. In this context, higher-priced originator medications are sometimes preferred by some U.S. payers as rebates are larger for those products. Indeed, perverse financial incentives in the U.S. have been a limiting factor with respect to increasing adoption of biosimilars.

Nevertheless, with employers and patients demanding more pass-through of rebates and the role of cost-effectiveness and value-based pricing gradually becoming more important to payers, it’s expected that biosimilars will ascend in market share across all therapeutic categories where they are available.

Indeed, after a painfully slow start from 2015 to 2019, the U.S. has finally been experiencing a sustained uptick in the uptake of biosimilars in the past few years. Robust biosimilar penetration is now apparent across several therapeutic classes. In addition to the filgrastims and pegfilgrastims, there’s been erosion of the originator biologic market share in the trastuzumab, rituximab, and bevacizumab classes.

Biosimilar usage can be bolstered by value-based contracts in which financial incentives of key stakeholders – payers, drug manufacturers, and healthcare providers - are aligned. For example, payers can institute capitated contracts with healthcare providers which hold those who prescribe originator biologics and biosimilars accountable in part for the total cost of care. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based purchasing agreements. The Lyfegen platform identifies and operationalizes value-based payment models in a cost-effective manner.

Undoubtedly, payers who are less reliant on rebate arrangements and therefore more cost- and value-conscious will be able to achieve a decrease in overall costs, as lower-priced biosimilars introduce market competition within therapeutic classes. In turn, this sparks steeper discounts across all drugs, including originator products.

What may further ameliorate the adoption of biosimilars Is the granting of therapeutic interchangeability designation to certain products. To illustrate, on July 28th, 2021, the FDA approved the first interchangeable biosimilar product, Semglee (long-acting insulin glargine), which implies that it can be automatically substituted at the pharmacy counter. This has ushered in more competition, specifically in the insulin glargine class. Furthermore, one of the six biosimilars referencing Humira (adalimumab), Cyltezo, is now approved as therapeutically interchangeable and may be automatically substituted for its reference product Humira. All six approved biosimilars, including Cyltezo, are slated to enter the U.S. market at different points in 2023.

When determining the cost-effectiveness and budgetary impact of biosimilars, payers must consider dynamics, such as the distinguishing between the initiation of treatment-naïve patients on a biosimilar and therapeutic switching practices, as well as price competition with alternative therapies, and the effect of originator companies who can introduce biobetters, or improvements – often in terms of formulation and dosing – on their original product. Lyfegen can assist with evaluation of the cost-effectiveness of biosimilars and biobetters.

Armed with information about biosimilar and originator biologic clinical efficacy, patient preference, and treatment costs - which Lyfegen can provide - payers will be positioned to make appropriate coverage decisions.

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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