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Health technology assessment will inform Medicare drug price negotiations

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Health technology assessment will inform Medicare drug price negotiations

The Centers for Medicare and Medicaid Services is leveraging third-party health technology assessments to inform its offer price in February 2024 for the 10 drugs it has selected for price negotiations. To illustrate, the drug cost watchdog the Institute for Clinical and Economic Review published a report on the blockbuster blood thinners Xarelto and Eliquis and submitted it to CMS. Xarelto and Eliquis are two of the 10 drugs set to face the first round of Medicare price negotiations under the Inflation Reduction Act.

The ICER report modeled the comparative effectiveness of these products over generic warfarin in stroke prevention, myocardial infarction prevention and major bleeding episodes. This includes an assessment of the justifiable price premiums for the two branded products given several different cost-effectiveness thresholds. The table below shows ICER’s calculations of price premiums for Eliquis relative to the generic comparator warfarin and the branded comparator Pradaxa (dabigatran).

Source: ICER

Drug manufacturers and payers impacted by the IRA will need to gather and evaluate this kind of information, as well as evidence from peer-reviewed articles and other sources. In turn, they must use the data to inform the price negotiation process for selected drugs but also competing products in the same therapeutic classes.

Launching soon, the Lyfegen Drug Pricing Simulator is a dynamic tool that gathers data inputs and runs real-time simulations that help users understand potential rebate, revenue, cash flow, and budget impacts for the different types and combinations of drug pricing models.

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Drug makers and payers will leverage IRA maximum fair prices

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Drug makers and payers will leverage IRA maximum fair prices

The Inflation Reduction Act authorizes Medicare for the first time to negotiate prices at the national level for a limited subset of single-source drugs. Recently, the Centers for Medicare and Medicaid Services selected the first 10 drugs to be negotiated. The 10 high-cost drugs in the table below represent 20% of total outpatient spend in the Medicare program from June 2022 through May 2023.

Source: Centers for Medicare and Medicaid Services

Prices will be negotiated over a one-year period with an offer and counteroffer process between CMS and drug manufacturers in which maximum fair prices will be established and posted in the fall of 2024 and implemented in January 2026.

Makers of drugs selected for negotiation should consider how payers in the Medicaid and commercial markets will leverage the published MFP information when negotiating rebates. Also, manufacturers of drugs competing with those selected for negotiation should consider how payers will leverage the published MFP information when making pricing, rebating and reimbursement decisions in the Medicid and commercial markets.

At the time a drug’s negotiated MFP price is posted, competitors may react to the published price by trying to undercut it, perhaps by offering even higher rebates, which in turn may cause the manufacturer of the selected drug to lower the net price of a drug a year prior to the MFP being implemented. Also, once MFPs are posted, payers will have publicly available information on the negotiated prices for the selected drugs as well as evidence used to inform the offer and counteroffers. This may then be utilized as leverage in negotiations for competing products in the same therapeutic classes.

The Lyfegen Rebate Analytics Platform is a cloud-based software that can manage all the complexities of drug rebate administration for payers and pharmaceutical companies affected by the IRA. The data-driven platform automates identifying, calculating, and tracking rebates in a timely manner, all of which help to ensure agreement compliance and reduce revenue leakage.

Learn more: lyfegen.com/products/ara

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What Will It Take to Advance Value-Based Pharmaceutical Contracts?

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What Will It Take to Advance Value-Based Pharmaceutical Contracts?

Prices for drugs in the U.S. continue to rise – faster than the rate of inflation – according to a Harvard study that shows nearly half of new drugs marketed now cost $150,000 or more annually. Insurers, along with consumers and regulators, are anxiously seeking ways to lower costs and to make sure patients get the treatments they need. One solution that is gaining interest is value-based pharmaceutical contracting, where costs are tied to results; the more effective a drug, the more a payer will allocate for that drug.

This model isn’t new and it has proven to be successful in Europe, where many value-based pharma contracting are showing positive results for payers, patients, and pharmaceutical companies. As a result, some companies that cater to the U.S. market are moving towards this model, although there are challenges.

Value-based contracting is especially applicable for the growing number of cell and gene therapies and other new ultra-expensive treatments. By allowing insurers and other payers to pay in installments that are dependent on patient outcomes, or even to receive refunds if the drug does not perform as expected, pharma companies are sharing the risk with payers. And there is great value in that shared risk. Payers, for example, are able to realize better patient outcomes when drugs proving to be ineffective can be replaced with more effective ones. At the same time, pharmaceutical firms are incentivized to ensure that the treatments they offer payers are truly effective ones, spurring better and more effective research.

In addition to making sure that prices reflect patient outcome, value-based contracting helps expand the amount of data associated with a treatment. With more data on the effectiveness of treatments recorded – and more tracking of patients over time – researchers will have more data to draw on when developing new treatments. That data can include details on all aspects of a patient's care and even factor in the patient's adherence to medication schedules. This data can also help pharma companies advance their research.Finally, healthcare providers benefit from value-based contracting because they will be able to get a more accurate picture of their patients' overall health situations, which will allow them to provide higher-quality care. Despite all of the advantages for all parties involved, value-based contracting has not yet been widely embraced by payers or pharma companies. A survey of 180 large employers, insurers, and unions with health benefit programs shows just 12% use value-based contracting for specialty drugs, which are usually the most expensive treatments, and fewer than 1% of organizations are using them for more common drugs.

This apparent reluctance to adopt value-based contracting is surprising because payers who have leveraged this approach are finding that their pharma costs are falling.

But challenges do remain for both payers and insurance companies in adopting value-based contracting. In order to speed up the adoption of value-based contracting, there needs to be a willingness to change business culture and long-entrenched processes; an acknowledgement that value-based contracting can expand insights and opportunities for pharma companies, but more clear incentives are necessary; and more dialogue around industry standards and regulatory flexibility that take this contracting model into account.

Industries like insurance and pharma often have institutional, or legacy, systems and processes that no longer best serve the organization and market opportunity. Innovative new opportunities like value-based contracting likely requires change–changes to systems, to processes, and to people’s day-to-day operations. Some organizations find the implementation of value-based contracting models complicated because they require analyzing patient outcomes, negotiating prices based on those outcomes, and determining which drugs should be included in the program. All of these steps require access to–and analysis of–a great deal of data, which can be a significant investment. However, there are digital platforms that are designed to implement value-based contracting without overcomplicating the process–and the investment can yield operational efficiency, recovery of missed revenues, and, most importantly, provide critical access for patients to life-saving drug therapies.

Within the industry, there is an assumption among pharma companies that there is a limited return on their investment with value-based contracting, or even the possibility of lower revenues due to lower prices. But with the transparency that value-based contracting can bring to pharma companies through real-world data from patients taking their drugs, there comes expanded opportunities to understand drug performance and patient outcomes, both of which are valuable for future drug development and marketing. A KPMG report notes another important benefit of value-based contracting–for example, such agreements can enable pharma companies access to currently highly-regulated markets that they were unable to sell in before, thus serving as a competitive advantage. In order to keep pushing pharma companies in this direction, there need to be more clear incentives that can help them with access challenges.

As value-based contracting continues to be more commonplace, it is likely that there will be more standardization within the industry and regulatory parties. However, these changes should be happening now.  For example, standards are needed regarding what factors should be included when evaluating the effectiveness or value of a drug. Furthermore, value is a dynamic concept and the definition changes depending upon the viewpoint–value for a payer is different from value for pharma is different from value for a patient. The industry also needs to sort out what happens in outcome-based contracts when patients switch insurers.

Regulations can also stand in the way. While Medicaid has adopted a value-based contracting model for a small selection of drugs, most others are not covered by that arrangement. Most drugs are subject to Medicaid's Best Price policy where prices aren't connected to effectiveness or results, thus perpetuating the disconnect between price and value. The good news is that CMS, the government agency responsible for Medicaid and Medicare services, plans to extend and expand the value-based contracting model already in effect as they continue working towards the goals of improving health outcomes and lowering costs.

Change can be challenging. But as drug prices rapidly rise, the need for change has never been greater. Value-based contracting is the innovative solution that leverages the right data, at the right time, and with the right level of transparency to reduce costs, recover lost revenues, ensure more effective outcomes, help patients get healthier, and provide valuable data insights for future drugs and treatments. It's time to start implementing them.

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A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

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A Promising Sickle Cell Cure Is Almost Here. What About the Money to Pay for It?

Advanced gene therapies that could “practically curepatients suffering from sickle-cell disease (SCD) are just over the horizon. But they may not reach the people who need them most, many of whom are minorities with fewer financial resources and are reliant on Medicaid for their health coverage. Figuring out how to pay for their treatment looms as one of the biggest questions – both economic and ethical - facing US public health policymakers in the coming years.

Amid Medicaid’s efforts to cut spending, the dilemma of how to cover these drugs could end up increasing rancor and anger in the country – or it could spur budgetary creativity. While programs like Medicaid have traditionally filled the gap between availability and lack of affordability in treatment, the cost of SCD therapies developed by Vertex and CRISPR – estimated at nearly $2 million a dose – could quickly overwhelm even Medicaid's robust resources, especially in states that have higher rates of the disease. And this is just the beginning. As more ultra-expensive drug and cell therapies are developed for numerous conditions in the coming years, the question of how to pay for them looms large.

The American healthcare system has been long accused of discriminating against the poor and minorities – and that discrimination is likely to come into far greater focus when millions of the poorest Americans who could benefit from new therapies are unable to take advantage of them. Altogether, there are over 40,000 SCD patients on Medicare in any given year - about 60% of the estimated 100,000 victims of the disease in the US. Of the 74,817 hospitalized for sickle cell disease in 2023, 69,889 (93.4%) were African-American; on average, one of every 13 Black babies are born with sickle-cell trait (SCT), a forerunner of the disease. Even for SCD patients who can afford private insurance, the out-of-pocket cost for therapy is very burdensome. But for the poor and others who lack private health coverage, Medicaid is a singular life raft – the difference between life and a possibly very abrupt death.

Given the situation, it's likely that patient advocacy groups will make a strong bid for increased government funding. And given the issues of social justice and racism surrounding the historic lack of interest in SCD by the medical establishment, there's a good chance that funding will be forthcoming. But budgets are still budgets; if Medicaid is going to spend more on SCD therapies, it is going to have to cut other payments, especially given the strong pressure to cut Medicaid spending – both on the federal and state level, even in states where the incidence of SCD is high.

This could be the time for Medicaid to follow in the footsteps of Medicare, and implement changes in the way it pays for treatments, specifically implementing models where payment is based on patient outcome. Indeed, Medicaid has proposed doing this, but it must move much faster if it wants to help those with SCD benefit from treatments expected to be approved by the end of the year.

Medicare recently adopted a limited form of results-based drug pricing for some of its most expensive drugs. The legislation initially covers ten high-priced drugs, with the list expanded to 20 by the end of the decade. Under the program, the government will pay a price closer to that demanded by the drug’s maker if a drug does in fact significantly reduce the costs of lifetime treatment. But if a drug does not have the desired result, the cost would be significantly lower. Experts are predicting significant savings for the government.

Medicaid, through CMS/CMMI, plans to do something similar - negotiate results--based contracts for gene-based therapies on behalf of all 50 state Medicaid programs. According to government data, the lifetime cost for treating SCD patients through 64 years of age is also close to $2 million. So Medicaid would be spending roughly the same amount on each patient receiving gene-based therapies, while reducing or eliminating costs for treatment of those over 64. These outcome-based contracts, also called value-based contracts, would allow drug-makers to be paid full price only if the treatment does end up working. These contracts could also allow Medicaid to pay in installments, rather than upfront. In addition, if treatment works faster or better than expected in some patients, there could be room in these contracts for drugmakers to be paid more, or paid earlier. Drug companies and science would also benefit from the extended real-world data involved in these contracts, which track the progress of treated patients for years.

But this model is likely to come too late for many with SCD: CMS/CMMI will only be running a pilot negotiation program in 2026 at the earliest. This means that it's very possible that Medicaid will have to, at least temporarily, ignore very promising gene-based therapies that could help hundreds of thousands of people because it can't pay for them.

Meanwhile, the public pressure and demand for widespread implementation of SCD gene therapies is likely to be very high. Lives are at stake; as is correcting a historic injustice. So how will officials deal with an increase in public pressure to pay for therapies? One possibility is to appeal to the private sector for help. Infact, the NIH will be partnering with the Bill & Melinda Gates Foundation to provide some $200 million to increase the development of affordable gene therapies for SCD and HIV by providing funding to researchers to develop lower-cost therapies, and assistance to those who need treatment. Another option could be transferring unused state Medicaid allocations for SCD from states with very low incidence rates, like Idaho, to states with higher incidence rates, like Mississippi.

Regardless of the solution Medicaid adopts, there's no question that a storm has been raging for years over who gets what in the American healthcare system – and that storm is likely to strengthen as gene-based therapies for SCD become available. Given the history of how the establishment has dealt with that disease – and the people who are its biggest victims – it's likely that changes to how Medicaid pays for expensive therapies will come sooner rather than later. These changes must happen, or inequality in the American health system will only become worse as the pipeline of life-changing gene and cell therapies grows.

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Cell and gene therapy approvals will target much larger populations by end of decade

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Cell and gene therapy approvals will target much larger populations by end of decade

Forty cell and gene therapies may be launched in the coming five years. They could target as many as 33 million patients by the end of this decade. When a single dose of a gene therapy can cost millions of dollars, finding feasible and equitable ways to price and reimburse these products is a major challenge.

Cell and gene therapies began mostly in the ultra-orphan space, but with technological advancements in drug development, therapies are expanding into much larger populations. This evolution began last year with the approval of the CAR-T therapy Carvykti, which may be prescribed to more than 80,000 multiple myeloma patients annually by 2025.

In the gene therapy space, recent approvals of hemophilia A and B products, as well as the imminent launch of sickle cell disease therapies, expand new therapies reach to potentially hundreds of thousands. Then, as we look forward to a few years from now, gene therapies may enter the massive diabetes and osteoarthritis markets, which pushes their impact exponentially to millions of patients annually.

Most cell and gene therapy products are intended as one-time injection treatments, which in turn may offer durable cures. But the up-front costs are very high on a per-unit basis. And questions around the durability of novel gene therapies persist. As such, there are serious concerns about how to manage the considerable costs while ensuring equitable access.

Independent watchdog organization, ICER (Institute for Clinical and Economic Review), is helping to push the movement toward fair pricing and fair access forward—and it’s been shown that cell and gene therapies can be cost-effective. However, for this value proposition to become a universally accepted practice, payers must adopt a view that systematically incorporates the concept of value-based pricing. Traditional methods of reimbursement won’t work. As a consequence, payers will need to implement value-based pricing arrangements, such as pay-for-performance schemes or warranty programs, in which evidence is gathered and analyzed to assess whether cell and gene therapies prove their worth and are durable over time. Policymakers will need to turn to value-based contracting solutions, such as the ones Lyfegen offers.

Both pharma companies and payers are faced with the complex challenge of navigating the uncertainties of drug pricing agreements for cell and gene therapies. Lyfegen is an independent resource that provides powerful tools and resources for pharma and payers to leverage so that the right type of reimbursement model can be identified for a specific cell and gene therapy. The Lyfegen Model & Agreement Library contains more than 2,000 real-world, value-based agreements and 18 drug pricing models from around the world. And the Lyfegen Platform leverages intelligent algorithms to capture and analyze patient-level drug cost data that can then be run through a platform-based simulator to help customers negotiate the best agreements possible.

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

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

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



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

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

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

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

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

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

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

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

About Lyfegen

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

Read the official Press Release

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

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

EGK uses the Lyfegen Platform to handle complex pricing models of on and off-label usage of more than 80 drugs

 

Basel, Switzerland - November 29, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, announced today that EGK-Gesundheitskasse is joining its portfolio of insurer partners to execute all of their value-based pricing contracts for high-cost drugs efficiently, securely, and transparently.

Switzerland, with the fourth-highest pharmaceutical spending per capita, spent CHF 8 Billion (8.1 billion euro) on drugs prescribed for specific diseases in the first nine months of 2022. In an effort to combat the high drug spending, Switzerland has implemented an increasing number of discount models for on and off-label drug usage over the last five years. While intending to ensure accessibility to patients at sustainable prices, the complexity of the price models leads to millions spent by insurers to monitor and adjudicate the price models, resulting in an estimated CHF two- to three-digit million range of missed rebates.

Lyfegen's software enables EGK to identify and claim rebates from 141 drug price models with 32 manufacturers, with minimal effort and maximum transparency. This includes cases of rare or chronic illnesses, promising therapies that may be used outside the approved indication, or new drugs not yet available or approved in Switzerland. Lyfegen's platform addresses the needs of Swiss health insurers for cost efficiency and digitalization, helps solve existing complexities in the system, and does its utmost to counteract high insurance premiums.

"We are delighted to support EGK and take an active role in addressing the growing complexity of drug pricing models to support sustainable access to innovative drugs and therapies in Switzerland,” said Nico Mros, CXO and Co-Founder of Lyfegen. “By focusing on making the implementation of the platform as easy as possible and being responsive to EGK, we were able to quickly present results and kickoff the collaboration to a successful start!"

“With the Lyfegen Platform, EGK is further expanding its focus on sustainability and efficiency for the benefit of our policyholders”, said Carolina Pirelli, Head of Benefits and Deputy CEO at EGK. “The ever-increasing number of pricing models for medications poses challenges for insurance companies in terms of resources and processes. With the automated processing of pricing models through the Lyfegen Platform, we are able to perfectly meet our current needs and with Lyfegen's flexibility, focus and understanding, we see ourselves in good hands.”

 

About Lyfegen

Lyfegen is a global healthtech SaaS analytics company providing a value-based agreement platform for drugs, therapies and devices. Health insurances, pharma, medtech companies & hospitals use the secure platform for thousands of payment models throughout Switzerland, Europe, the Middle East and North America. The Lyfegen Platform supports the negotiation and automated execution of value-based payment models cost-effectively and at scale using real-world data and machine learning. Globally renowned health insurances, hospitals, pharma & medtech companies have already implemented Lyfegen’s patent-pending platform to scale value-based payment models for drugs, therapies and devices, improving access to treatments and patient outcomes.

Lyfegen was founded by individuals with decades of experience in healthcare, pharma and technology, pioneering the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.

About EGK-Gesundheitskasse

EGK-Gesundheitskasse is an SME health insurer based in Laufen (BL), Switzerland. The EGK Group comprises EGK Grundversicherungen AG (basic insurance in accordance with KVG), EGK Privatversicherungen AG (supplementary insurance in accordance with VVG) and EGK Services AG (administration). It insures around 100,000 people in basic insurance throughout Switzerland, 80% of them also have EGK supplementary insurance.

Naturalness and sustainability are part of EGK's values. It is considered a pioneer in providing unrestricted access to excellent complementary medicine. It launches and supports activities throughout Switzerland to strengthen health in a natural way.

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

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

Lyfegen’s value-based contracting software is used by healthcare payers and leading pharma companies, including Novartis, Roche, MSD, Bristol Myers Squibb (BMS) and Johnson & Johnson

 

New York, NY - September 20, 2022 - Lyfegen, a global healthtech SaaS company driving the world’s transition from volume to value-based healthcare for high-cost drugs, today announced an oversubscribed $8 million Series A financing round led by aMoon, with additional participation from APEX Ventures and others.

Currently, less than 2% of the health insurance population requiring specialty drugs is responsible for 51% of drug spending. The cost of specialty drugs in the US is spiraling out of control, increasing 12% from 2020 to 2021 alone, with no sign of slowing down due to the increase of cell and gene therapies expected to come to market. As a result, value-based contracting is becoming a more viable alternative for healthcare payers to only pay for drugs that actually work.

By 2025, total net spending on medicine in the US is expected to reach up to $400B. Additionally, new drugs regularly enter the market, but when pharmaceutical companies fail to agree on commercial terms with payers, patients are at risk of being denied access to life saving therapies. Lyfegen’s platform helps regulators, pharma companies and payers more easily adopt value-based payment models by digitizing the end-to-end process of data collection, anonymization and contract negotiations for all parties to agree upon drug pricing and reimbursement.

“We are excited to be announcing this funding round and to have this vote of confidence from aMoon, APEX and our other investors who understand the shift in healthcare that we are experiencing, and are supporting our efforts to expand the Lyfegen platform,” said Girisha Fernando, CEO and founder of Lyfegen. “We currently work with leading government payers, health insurance companies in Europe, the US and the Middle East, and some of the world’s largest pharma companies. Our plan now is to further expand our presence in the US, partnering with both private and public healthcare insurance companies. The move away from volume-based healthcare has never been more needed, and we are happy to play an important role in the shift to value-based contracting.”

“Lyfegen is addressing a significant market need in an industry that is changing dramatically and rapidly, and we are thrilled to help validate their efforts through our investment,” said Moshic Mor, General Partner at aMoon, and former Partner at Greylock and Greylock Israel. “During a time of healthcare budget pressures and recessions, the world needs Lyfegen’s solution now more than ever. We look forward to seeing the company, led by an incredible executive team, continue to enhance access to new drugs as they drive value-based healthcare to become increasingly mainstream.”

 

About Lyfegen

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

Lyfegen is based in the USA & Switzerland, and was founded by individuals with decades of experience in healthcare, pharma and technology to enable the shift away from volume-based and fee-for-service healthcare to value-based healthcare. For more information, visit www.lyfegen.com.

Media Contact

Yael Hart

GK for Lyfegen

yael@gkpr.com

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

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

The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment.



Official Communication by KPMG on 26.10.2020

KPMG addresses the most pressing challenges the healthcare sector is facing today and in the future. Society’s desire to obtain value from the wider healthcare system is not new, however recent experience shows that there is a need to rethink and move healthcare into a new age.

Two current megatrends are: 1) the redesign of pricing for health solutions, and 2) the value of data and the importance of patient access. It is important to address both elements within the Life Sciences ecosystem, including how to innovate, how to develop successful digitalization strategies, and how to get the most out of data.

How outcome-based contracts benefit healthcare

The pricing of services and products based on outcomes or value created is another intrinsic element of the future of healthcare. Rising healthcare costs impact patient budgets and hinder access to treatments. Incentivizing positive outcomes can only benefit patients, while payers gain confidence that they are only reimbursing effective treatments. Manufacturers and providers that buy into the outcome-based model are taking an important step towards making their business more sustainable while contributing to the wider interest of the healthcare ecosystem.

One of the key issues has always been defining the factors that represent value and deciding how to measure them. To give an example, how do you measure if a patient is symptom-free and how long should the observation period last? How is the impact on those caring for an individual considered and how is the societal or economic impact assessed, e.g., can the individual go back to pursuing a career? These questions are key in any reimbursement of pricing arrangements.

Helping the healthcare community

Teaming up with Lyfegen, a healthtech company facilitating access to innovative therapies, KPMG recently published a joint whitepaper (see link below) on the application of outcome-based contracting. Girisha Fernando (CEO and Founder of Lyfegen HealthTech AG) and Martin Rohrbach (Head of Life Sciences for KPMG Switzerland) discuss how this approach can deliver value for healthcare payers, providers and patients.

The whitepaper is a joint initiative to share with healthcare stakeholders some of Lyfegen and KPMG’s expertise and experience in the development and implementation of value and data-driven agreements in an evolving healthcare environment. The combination of knowledge, reach, and technology specific to value-based healthcare, together with proven practical experience, brings unique insights into value and data-driven pricing agreements for healthcare stakeholders. The whitepaper focuses on why outcome-based contracting can address drug access and reimbursement challenges, and how such contracts can be enabled by innovative technology. There are some clear takeaways, serving as building blocks and opportunities to engage in outcome-based contracting for the benefit of healthcare systems.

READ THE WHITEPAPER

 

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Lyfegen raises CHF 750‘000 in Seed Capital

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Lyfegen raises CHF 750‘000 in Seed Capital

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

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

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

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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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How could Donald Trump change US healthcare?

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How could Donald Trump change US healthcare?

Introduction

Donald Trump has been elected as the 47th President of the United States. With healthcare remaining a critical issue, it’s valuable to revisit some of Trump’s past healthcare reforms and examine a particularly controversial policy that could significantly impact drug pricing in the U.S. From efforts to lower out-of-pocket costs to transparency initiatives aimed at increasing competition, Trump’s past healthcare policies reveal a complex approach to improving accessibility and affordability. Here, we also explore how these initiatives have evolved under the Biden-Harris administration and what their potential implications could mean for the future of American healthcare.

Let’s examine some of his past reforms to improve healthcare and discuss a controversial policy that could greatly alter drug pricing.

  1. The No Surprises Act, enacted by Donald Trump on December 27th 2020, was designed to lower out-of-pocket healthcare costs for Americans in the case they were covered by an out-of-network provider. In these cases, medical bills are more expensive than they would be if care was received in-network. The Biden-Harris administration expanded upon this legislation by improving the payment dispute process.
  1. Americans don’t have a reliable way of estimating their healthcare costs. The Trump administration issued an Executive Order leading to CMS establishing rules requiring hospitals to disclose upfront costs of their services. Another aim of this initiative was to encourage greater competition among hospitals, group health plans, and health insurance issuers. This initiative was rolled out by the Biden-Harris administration but is still in its early stages.  
  1. One controversial Trump policy was his “most favored nations” Executive Order, which aimed to price-match drugs with that of the lowest price among other wealthy nations. Many were fearful this effort would stifle competition and hinder pharmaceutical development in the United States. Trump said he would not plan to revive the policy if re-elected.
  1. One of the most groundbreaking changes made by the Biden-Harris Administration was to allow Medicare to negotiate drug prices directly with manufacturers, as part of the Inflation Reduction Act. The second round of negotiations involves 15 additional drugs to the 10 included in the first round and will be announced by February 1st next year. However, several Republicans have expressed interest in repealing these negotiations.  

Conclusion

The evolving landscape of American healthcare policy, influenced by both Trump and Biden’s administrations, reflects an ongoing effort to address cost, transparency, and access to treatment. Trump’s initiatives laid the groundwork for healthcare cost transparency and patient protections, while the Biden-Harris administration has expanded these initiatives and introduced groundbreaking policies like Medicare drug price negotiation. As these changes continue to unfold, the healthcare industry, patients, and policymakers alike will need to adapt to new dynamics, shaping the future of healthcare in the United States.

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Canada: Investing in RWE for rare diseases

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Canada: Investing in RWE for rare diseases

Introduction

Canada’s Drug Agency has recently awarded funding to multiple rare disease registries to enhance the “pan-Canadian evidence landscape.” This funding is aimed at bolstering the quality and accessibility of data that can guide regulatory and reimbursement decisions for rare disease therapies. As Canada focuses on building a comprehensive evidence base, pharmaceutical companies, payers, and stakeholders must adapt to the evolving landscape for market access and contracting. Lyfegen’s Agreements Library and Drug Contracting Simulator offer vital tools to navigate these complexities with greater precision and transparency.

Key Takeaways for Pharma and Payers

1. Strengthening Data Quality and Accessibility

What’s Changing: The new funding will support initiatives to improve data accuracy, completeness, and accessibility within rare disease registries across Canada. This enriched data landscape will play a crucial role in guiding therapeutic decisions for rare diseases.

Impact: With access to more comprehensive data, pharma companies and payers can make more informed decisions regarding therapy efficacy and patient outcomes. This data-driven approach is essential for adapting market strategies to address the specific needs of rare disease populations in Canada.

2. Supporting Regulatory and Reimbursement Decisions

What’s Changing: The funding will enable the development of evidence needed to meet Health Canada’s regulatory requirements and the Canadian Agency for Drugs and Technologies in Health (CADTH) reimbursement criteria for rare disease treatments.

Impact: A robust evidence base will accelerate the approval and reimbursement process for rare disease therapies. Pharma and payers can benefit from shorter timelines for market entry and more predictable pricing models aligned with outcomes-based agreements, ensuring that patient needs are met in a timely manner.

3. Advancing Outcome-Based Metrics and Digital Health Solutions

What’s Changing: Emphasis on outcome-based evidence and digital health transformation within rare disease registries will promote a transparent, efficient healthcare ecosystem for these high-cost therapies.

Impact: Outcome-based metrics provide pharma and payers the opportunity to structure contracts that reflect real-world patient outcomes, supporting more sustainable pricing models that align with the health outcomes valued by Canadian healthcare providers.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library, a vast digital repository of drug pricing agreements, offers valuable insights into historical trends and pricing models that support evidence-based contracting decisions. By leveraging over 6,000 agreements and diverse pricing models, pharma and payers can develop contracts that align with Canada’s specific regulatory and reimbursement frameworks.

2. Drug Contracting Simulator: Lyfegen’s Drug Contracting Simulator enables teams to model various pricing scenarios, allowing them to understand potential outcomes and financial risks associated with rare disease therapies. By simulating real-world conditions, stakeholders can make informed contracting decisions that support the Canadian healthcare system’s goal of data-driven, sustainable solutions for rare diseases.

Conclusion

Canada’s initiative to strengthen its rare disease data landscape marks a significant step forward in improving access to and affordability of rare disease therapies. For pharma companies, payers, and other stakeholders, this shift provides opportunities to develop innovative contracts that align with Canadian healthcare goals. Lyfegen’s Agreements Library and Drug Contracting Simulator offer the tools needed to support evidence-based decision-making, enabling healthcare players to navigate Canada’s evolving market access landscape confidently.

Book your demo today to discover how our tools can transform your approach to rare disease therapy access in Canada: https://www.lyfegen.com/demo

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FDA Launches a new program to speed patient access

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FDA Launches a new program to speed patient access

Introduction

The FDA has launched an innovative pilot program to expedite patient access to essential therapies: the Split Real Time Application Review (STAR). Starting December 2, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will begin accepting a limited number of marketing applications under this new initiative. By focusing on early and continuous review processes, the STAR program aims to minimize the time between final submission and the FDA’s action date, providing faster access to treatments for patients with unmet medical needs.

Key Takeaways for Pharma and Healthcare Providers

1. Accelerated Review Process for Unmet Needs

What’s Changing: The STAR program is designed to review applications in segments, allowing FDA reviewers to assess data in real time as it becomes available. This continuous review approach differs from traditional methods, where applications are evaluated in full only after complete submission.

Impact: For pharmaceutical companies, this streamlined process could mean faster paths to market, particularly for therapies targeting critical, unmet needs. It emphasizes the FDA’s commitment to addressing patient needs more swiftly, which could reduce financial burdens on developers facing lengthy approval processes.

2. Collaboration Between CDER and CBER

What’s Changing: The STAR program is a collaborative effort involving both CDER and CBER, expanding its applicability to a broad range of therapies, including new drugs and biologics. This joint approach signals the FDA’s intention to standardize and extend this model across diverse therapeutic areas.

Impact: By involving multiple FDA centers, the STAR program encourages broader participation from biotech and pharmaceutical companies developing biologics, vaccines, and innovative therapies. For patients, it represents a promising step toward quicker access to a wider array of advanced treatment options.

3. Focus on Real-Time Data and Incremental Submissions

What’s Changing: Unlike traditional application reviews that rely on fully completed submissions, STAR’s approach allows the FDA to review segments as they are completed. This real-time data review supports a more dynamic evaluation process and could accelerate decision-making.

Impact: For the pharma industry, this shift may lead to shorter regulatory timelines and a more predictable approval process. By providing early feedback on submitted data, the FDA enables companies to address potential issues proactively, ultimately supporting faster market access for breakthrough therapies.

Conclusion

The FDA’s STAR program represents a transformative approach to regulatory review, one that aligns with the needs of modern healthcare. By focusing on continuous, real-time reviews, the FDA is paving the way for faster patient access to treatments that address critical health needs. For pharmaceutical companies and healthcare providers, this new pathway offers a chance to bring innovations to patients more swiftly and efficiently. As the STAR program unfolds, its success could shape the future of regulatory review, setting a new standard for timely patient access in the U.S. healthcare system.

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Switzerland. Improving the fast-track process and anti-migraine drugs

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Switzerland. Improving the fast-track process and anti-migraine drugs

Introduction

Switzerland has taken steps to streamline drug approvals and make essential therapies more accessible by revising Swissmedic’s fast-track and temporary authorization procedures, effective as of October 15, 2024. These changes aim to expedite market access for crucial treatments, especially for those addressing urgent healthcare needs. Recently, the Federal Office of Public Health (FOPH) conducted a Health Technology Assessment (HTA) on Calcitonin gene-related peptide (CGRP) receptor antagonists, a class of anti-migraine drugs. The analysis determined that these drugs are more cost-effective for chronic migraine sufferers than for those with episodic migraines, influencing how they may be priced and reimbursed.

Key Takeaways for Pharma and Payers

1. Revised Fast-Track and Temporary Authorization Processes

What’s Changing: Swissmedic has updated its fast-track and temporary authorization procedures, intended to speed up drug approval times. This revision allows for quicker access to therapies that address significant healthcare needs, supporting patients in receiving timely treatments.

Impact: For pharmaceutical companies, these changes open up opportunities to bring their innovations to market faster, particularly for therapies that address chronic and complex conditions. With the fast-track pathway, companies can achieve quicker regulatory approval, which could help with meeting demand and advancing critical treatments for conditions like chronic migraine.

2. Pricing Adjustments Based on Cost-Effectiveness Analysis

What’s Changing: The FOPH’s recent HTA on CGRP receptor antagonists for migraines concluded that these drugs offer higher cost-effectiveness for chronic versus episodic migraine patients. As a result, FOPH has proposed a price reduction to align with the value provided, ensuring that patients benefit from more affordable access to these treatments.

Impact: For payers and pharma, this emphasis on value-based pricing represents a growing trend in Switzerland. Drug prices are being set based on real-world evidence and cost-effectiveness, pushing the industry towards more sustainable, outcome-driven pricing models.

3. Inclusion in the List of Pharmaceutical Specialities (LS)

What’s Changing: FOPH re-evaluates drug prices every three years and decides if they should remain on the List of Pharmaceutical Specialities (LS), which comprises all drugs covered by basic insurance. For certain treatments, such as CGRP receptor antagonists, drugs may be included with limitations—meaning they will only be reimbursed under specific conditions.

Impact: This conditional reimbursement approach supports more targeted healthcare spending, benefiting patients who meet specific criteria. For pharmaceutical companies, meeting these requirements is essential to ensure ongoing reimbursement and access to Switzerland’s market.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library offers a comprehensive resource of pricing agreements, enabling pharma and payers to explore pricing models that align with Switzerland’s emphasis on cost-effectiveness. With access to over 6,000 agreements, pharma teams can develop flexible, outcome-based pricing strategies that meet Swiss regulatory and reimbursement requirements.

2. Drug Contracting Simulator: The Drug Contracting Simulator provides a powerful tool for modeling various pricing scenarios. By simulating real-world conditions, stakeholders can assess the financial and clinical outcomes of fast-track approved therapies, enabling them to create tailored, data-driven agreements that reflect the FOPH’s cost-effectiveness criteria.

Conclusion

Switzerland’s recent adjustments to its fast-track drug approval processes and value-based approach to anti-migraine drug pricing underscore the country’s commitment to accessible, cost-effective healthcare. For pharmaceutical companies and payers, these changes represent an opportunity to align market access strategies with Switzerland’s evolving regulatory landscape. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential support for navigating these complexities, helping stakeholders design effective, outcome-driven agreements that meet Switzerland’s regulatory standards.

Book a personalized demo today to see how Lyfegen can transform your market access strategy under Switzerland’s new reforms: https://www.lyfegen.com/demo

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Spain: Reducing unnecessary care and improving HTA education

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Spain: Reducing unnecessary care and improving HTA education

Introduction

Spain is making strides in healthcare by prioritizing education, innovation, and cost-effective care. Recently, the Spanish Council of Ministers allocated over 44 million euros from pharmaceutical sales to support various public health initiatives, focusing on two critical areas: reducing unnecessary care and enhancing Health Technology Assessment (HTA) education for healthcare professionals. These investments are aimed at improving the efficiency of healthcare delivery, reducing costs, and supporting more informed decision-making around drug use and preventive care.

Key Takeaways for Pharma and Payers

1. Funding for HTA Education and Training

What’s Changing: Part of the allocated funds will go toward continuing education programs for healthcare professionals, specifically to improve their understanding of Health Technology Assessment (HTA). By deepening professionals’ knowledge of HTA, Spain aims to ensure that drug evaluation and therapeutic positioning are guided by evidence-based practices.

Impact: For pharmaceutical companies, this initiative means greater scrutiny of drug effectiveness and cost-effectiveness, especially as healthcare providers become more proficient in HTA principles. Payers may also benefit, as a well-informed healthcare workforce can make better use of resources, potentially lowering overall costs.

2. De-prescription of Unnecessary Drugs and Promotion of Preventive Care

What’s Changing: The initiative will also fund programs aimed at de-prescribing unnecessary medications to reduce healthcare costs. Alongside this, Spain is placing a stronger emphasis on preventive care, which not only improves patient outcomes but also curtails spending on unnecessary treatments.

Impact: For pharma, this push towards de-prescription may affect demand for certain drugs, particularly those deemed low-value or non-essential. However, it also presents an opportunity to align with Spain’s focus on value-based care, potentially promoting medications that are supported by strong evidence of efficacy. For payers, preventive care investments mean a healthier population with fewer costs linked to chronic diseases, reducing the financial burden on the healthcare system.

3. Supporting Innovation Through Therapeutic Positioning Reports

What’s Changing: Another portion of the funding will support the consolidation of therapeutic positioning reports. These reports will help evaluate and position drugs more effectively within the healthcare system, ensuring that innovative treatments are assessed rigorously before they reach patients.

Impact: Pharmaceutical companies may see a more streamlined and transparent pathway for introducing new drugs to the Spanish market. This approach promotes fair competition and emphasizes innovation, aligning with Spain’s broader goals of delivering cost-effective, impactful healthcare solutions.

How Lyfegen’s Solutions Can Support Your Strategy

1. Agreements Library: Lyfegen’s Agreements Library provides access to an extensive collection of value-based agreements that can help pharma companies align with Spain’s focus on cost-effective treatments. This resource allows pharma to explore agreements and pricing models suited to Spain’s HTA-driven environment, improving the chances of successful market access.

2. Drug Contracting Simulator: With the Drug Contracting Simulator, stakeholders can simulate pricing models that reflect Spain’s emphasis on evidence-based evaluation. By assessing various pricing scenarios and outcomes, pharma companies can design agreements that align with Spain’s value-based healthcare priorities, supporting successful negotiations and reimbursement strategies.

Conclusion

Spain’s recent investments in HTA education, de-prescription, and preventive care reflect the country’s commitment to a sustainable, efficient healthcare system. For pharmaceutical companies and payers, these changes highlight the need to align market access strategies with Spain’s goals of evidence-based care and cost containment. Lyfegen’s Agreements Library and Drug Contracting Simulator offer essential tools to navigate these shifts, enabling stakeholders to create outcome-driven agreements that support Spain’s healthcare objectives.

Book a personalized demo today to see how Lyfegen can empower your market access strategy in Spain’s evolving healthcare landscape: https://www.lyfegen.com/demo

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