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

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

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

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

 

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

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

The rebates of the Medicaid Best Price Policy

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

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

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

Outcome-based drug pricing can affect rebates

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

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

The new Multiple Best Price policy

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

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

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

Critique of the Multiple Best Price policy

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

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

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

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

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

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

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

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

The Lyfegen Solution

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

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

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

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

BOOK A DEMO

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

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Value-based drug agreements are easier when drug manufacturers and payers follow FDA communication guidelines

When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare...

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Value-based drug agreements are easier when drug manufacturers and payers follow FDA communication guidelines

When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare their budgets and formularies to launch value-based drug pricing arrangements as soon as a new treatment receives FDA approval. Pre-approval data sharing between manufacturers and payers gives patients quicker access to newly approved treatments.

 

As the healthcare system in the U.S. continues its transition from fee-for-service to value-based care, the sharing of healthcare economic information (HCEI) is becoming increasingly important to pharmaceutical manufacturers and healthcare payers seeking to enter value-based drug pricing arrangements.

In the past, drug manufacturers were hesitant to share HCEI and other pre-approval information with payers because regulations were unclear about the legal limits of this type of communication. But payers want HCEI from drug manufacturers for planning, formulary design, budgeting, and purchasing decisions. And lawmakers want to eliminate legislative barriers that inhibit the sharing of HCEI and the increased adoption of value-based healthcare.

The history of legislation surrounding manufacturer/payer communications

Policymakers and regulators, like the Food and Drug Administration (FDA), recognize the importance of big data and the sharing of HCEI for promoting value-based payment arrangements. Their first attempts to remove the legislative barriers to the exchange of HCEI between drug and device manufacturers and population healthcare managers did not produce the desired effects.

The first U.S. federal consumer protection law, the Food and Drugs Act, was enacted in 1906. This law’s consumer protections and law enforcement capabilities were strengthened by the 1938 Food, Drug, and Cosmetic Act (FD&C). Section 502(a) of the FD&C introduced and defined HCEI, giving the pharmaceutical industry their first instructions about what kind of economic data promotion could be communicated and with whom. But manufacturers refused to share information, fearing the penalties of accidentally disseminating off-label information.

Section 114 of the FDA Modernization Act (FDAMA) of 1997, amended FD&C Section 502(a) and provided a safe harbor for HCEI sharing. But manufacturers continued to resist sharing economic data because they felt the guidelines were still too vague about some topics, such as the definition of reliable scientific evidence and who was authorized to receive HCEI. The FDA failed to issue guidance on how to interpret the law.

The industry-wide push towards value-based care after the Affordable Care Act passed made clarification of Section 114 a priority again. In 2016, policymakers issued clarifying guidance about communications and transparency of HCEI, both pre- and post- FDA approval. The 21st Century Cures Act, Section 3037 further defined what types of HCEI and analyses could be used for drug promotion and to whom the HCEI should be communicated. The FDA published a draft payer guidance document in 2017 and then final guidance documents in 2018 suggesting ways to operationalize communications between pharmaceutical manufacturers and payers.

Current FDA guidance

An FDA press statement from June 2018 emphasizes that the 2018 guidance documents are meant to help pharmaceutical manufacturers provide payers with truthful, non-misleading background and contextual information about their products. Furthermore, manufacturers are encouraged to share both clinical data and HCEI payers need to make informed decisions about formulary management, cost effectiveness and reimbursement; this may be more and different data than the safety and efficacy data submitted by the manufacturer to the FDA for drug approval decisions.

The guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities–Questions and Answers, expands upon the sources of scientific evidence for HCEI as defined under Section 502(a). And the guidance clarifies who can receive HCEI, including public and private sector payers, formulary committees, technology assessment panels, third-party administrators, and other multidisciplinary parties.

This first guidance also addresses manufacturers’ communications with payers regarding unapproved uses of FDA-approved products. The FDA does not object to the sharing of this type of information as long as the manufacturer makes it abundantly clear in its communications what uses the product is not approved for.

The second guidance introduced in the FDA press statement is titled Medical Product Communications That Are Consistent With FDA-Required Labeling–Questions and Answers. It pertains to information not included in a drug’s labeling but information that a manufacturer may want to share with payers. Examples can include data from pre- and post-market studies or surveillance of patient compliance that can affect the measurement of a drug’s benefits to health outcomes in value-based contracts. (The first guidance offers safe harbor for communications related to the negotiations or implementation of value-based drug pricing agreements.)

Timing of information exchanges

Payers prefer to receive information regularly from manufacturers during the latter part of the FDA drug approval process. Annual budgets and formulary planning are more difficult to forecast if payers don’t have data in advance to prepare for the coverage of a new drug. Payers are more likely to make a newly approved treatment available to patients without delay when manufacturers share the clinical data and HCEI needed to make formulary and pricing decisions during pre-approval.

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Under the FDA’s accelerated approval process, therapies sometimes become available to patients even before the publication of clinical trial data is complete. Payers say, ideally, they would like clinical and HCEI data about new products 12 to 18 months before the projected FDA approval date.

Many manufacturers wait to begin communications with payers until just 6 to 12 months before their product’s expected approval date. Recognizing the importance of HCEI in negotiating value-based drug pricing arrangements, some manufacturers have included HCEI in their FDA product dossier and promotional materials for payers.

The FDA guidance recommends increased transparency about cost data, including price range, price parity with competitors, price premiums, discounts, and inflation adjustments. Some manufacturers and payers prefer to wait for final clinical trial data before discussing pricing. Post-approval data-sharing of real-world evidence must continue between manufacturers and payers to implement value-based drug pricing agreements.

The Lyfegen solution

With most regulatory barriers removed and value-based contract communications exempted from FDA reporting, policymakers hope to see an increase in value-based drug pricing arrangements. Manufacturers and payers can partner with third-party vendors like Lyfegen to employ technology that facilitates easy, continued data-sharing for innovative pricing agreements.

Lyfegen is an independent, global analytics company that offers a value-based contracting platform for healthcare insurances, pharma, and medtech companies wanting to implement value-based drug pricing arrangements with greater efficiency and transparency. 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.

BOOK A DEMO

When pharmaceutical manufacturers share clinical and economic data about their products in the pipeline, payers can prepare...

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Who does it better? Assessing a value-based drug price in Europe vs the US

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Who does it better? Assessing a value-based drug price in Europe vs the US

U.S. and European healthcare payers are increasing their utilization of value-based drug pricing agreements to hold down drug costs, bring better value and improvements to health outcomes, and determine a fair price for new drugs. The question of who does the assessments to determine a drug’s fair price is answered differently in the EU than in the U.S.

 

National healthcare leaders have a common problem to solve and a common goal to achieve. The problem is how to protect national healthcare budgets from overwhelming drug costs without discouraging pharmaceutical manufacturers from developing new products. The goal is to provide populations with equitable access to innovative, safe, clinically effective, and cost-effective healthcare therapies.

In the U.S., payers and policymakers are trying to control drug expenditures and determine the value of new drugs in an opaque, free-market environment. In Europe, government price controls and centralized clinical and economic evaluations of new drugs are standard. For both these pharmaceutical markets, drug pricing agreements based on value instead of volume are gaining traction.

The problem: drug prices keep rising

Pharmaceutical sales in Europe are almost a quarter of all drug sales globally. From 2015 to 2020, the top five European markets–the UK, Germany, France, Italy, and Spain–accounted for 17.4% of sales of new drug therapies. These top five markets are predicted to increase spending by $51 billion through 2026.

North America is the largest pharmaceutical market, accounting for almost half of the total global sales. From 2015 through 2020, the U.S. purchased 63.7% of all the new medicines introduced. The U.S. is expected to increase drug spending by an estimated $119 billion through 2026.

According to IQVIA, a leading healthcare consulting firm, the change in drug spending in the U.S. and European markets through 2026 will be due, in large part, to new brands.

The goal: access to new, high-quality drug treatments at a fair price

Healthcare payers don’t want to take on the financial risk and clinical uncertainty of a new, high-cost pharmaceutical product. Payers want to provide patients with equitable access to innovative treatments that improve health outcomes, especially in therapeutic areas with unmet health needs.

Value-based drug pricing arrangements address these concerns with evidence-driven, outcome-based agreements. The payer and manufacturer share the risks of a new drug not performing as expected. In both the U.S. and the EU, payers and manufacturers are engaged in more finance-based drug pricing contracts than performance-based contracts–but this trend is shifting.

Assessing a drug’s value in the EU healthcare system

Value-based drug pricing arrangements are called managed entry agreements (MEAs) in Europe. MEAs between drug manufacturers and healthcare payers can be finance-based (FBAs), performance-based (PBAs), or service-based agreements (SBAs).

Unlike the U.S., the EU has a centralized system for assessing a drug’s value. Each EU member state has an agency that uses an evidence-based data gathering process called health technology assessments (HTAs). HTAs include nine domains for assessment–four clinical and five non-clinical–that evaluate the efficacy and added value of a new drug compared to other treatment options already available on the market.

The work of the member states’ HTA bodies is coordinated by the European Network for Health Technology Assessment (EUnetHTA). However, conclusions and decisions related to drug pricing and reimbursement remain de-centralized.

Coverage with Evidence Development (CED) may be a part of an MEA and come after the HTA. CED is a way for urgently needed treatments to come to market under conditional approval while real-world evidence continues to be collected. This additional data should help payers decide about coverage. CED use varies by country, with the most CED found in the UK and the U.S. (through Medicare).

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

Assessing a drug’s value in the US healthcare system

The possibility of developing a centralized Health Technology Assessment for the U.S. Healthcare System was the focus and title of a white paper published in early 2020 by the University of Southern California Leonard D. Schaeffer Center for Health Policy & Economics.

The white paper describes the complexities of creating a national HTA organization in the U.S. It examines the difficult dynamics of the many stakeholders in the healthcare system; few are operating with enough transparency and coordination with other stakeholders to support value-based drug pricing. The authors conclude that in the current polarized legislative environment in the U.S., an attempt to develop a national HTA organization would be met with strong political resistance.

In the absence of the European-style centralized HTA body, U.S. payers look to alternative sources for the data they need for drug pricing negotiations. Private and public payers may find clinical and economic evaluations from various agencies that do HTAs on a limited scale. These include government and independent organizations, such as the Department of Veteran’s Affairs, Medicaid, the Patient-Centered Outcomes Research Institute (PCORI), and the Agency for Healthcare Research and Quality (AHRQ). One of the most influential organizations in this space is the independent, non-profit Institute for Clinical and Economic Review (ICER).

Unfortunately, these organizations don’t do value-based pricing evaluations for every drug that comes on the market, and some of their work is not publicly available. Even if analysis of a selected drug is available, it may not cover the key metrics a customized value-based drug pricing agreement needs to track.

When real-world data about a drug’s performance is limited, it’s often up to the manufacturer and payer entering the value-based contract to develop the framework and the data collection and analysis capability, either in-house or through a third-party vendor.

The Lyfegen Solution

The Lyfegen Platform is a customizable solution for healthcare payers, pharma, and medtech companies who need to gather and analyze real-world evidence about a drug’s performance for value-based drug pricing agreements. Lyfegen’s value-based contracting software collects real-world data and uses intelligent algorithms to provide valuable insights into clinical effectiveness and costs.

Lyfegen’s contracting platform helps implement and scale value-based drug pricing contracts with greater efficiency and transparency. By enabling the shift away from volume-based, fee-for-service healthcare to value-based healthcare, Lyfegen increases access to healthcare treatments and their affordability.

To learn more about Lyfegen’s software solutions, contact us to book a demo.

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Accelerating Drug Access: Lyfegen's Innovative Drug Contracting Simulator

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Accelerating Drug Access: Lyfegen's Innovative Drug Contracting Simulator

In the heart of innovation, where technology meets healthcare, Girisha Fernando, CEO of Lyfegen, stands as a beacon of transformation. We sat down with him to discuss the groundbreaking launch of the Lyfegen Drug Contracting Simulator, a tool set to revolutionize drug access, pricing and contracting.

Fernando begins by outlining the quintessential challenge that spurred the creation of this novel tool. “Drug access, pricing and contracting has been entangled in the complexities of payer negotiations for far too long. Traditional methods like manually modeling pricing and contracting scenarios are not just cumbersome; they’re archaic, in light of the innovative drugs we are seeing, such as gene therapies.”

On the quest for a solution that addresses the underlying issues such as uncertainties that prolong or event prevent access, and finding a win-win scenario that both pharma & payers are happy with, Lyfegen has developed a groundbreaking solution – the Lyfegen Drug Contracting Simulator. The innovation embodies Lyfegen’s ambition to streamline and revolutionize the drug pricing and contracting process.

“What we’ve created is not just a better Excel, but a solution - intuitive, real-time, limitless. It was made to close the gap between old practices and new innovations within the healthcare space. It’s the future of drug access.”

As we delve deeper into the conversation, Fernando's enthusiasm for the simulator's potential benefits becomes palpable. “It’s about accelerating strategies, saving time, and fostering better decision-making,” he asserts. “The Lyfegen Drug Contracting Simulator is a multi-faceted solution that combines drug pricing, contracting, and business case generation, all within a collaborative and innovative framework.” The uniqueness of the Lyfegen Drug Contracting Simulator lies in its features, as Fernando highlights.

“We’re talking about a simulator that not only runs real-world simulations but also provides data-driven insights to empower negotiations.” This level of sophistication, according to Fernando, addresses concerns beyond simple discounts and delves into the nuances of value-based and outcome-based contracting models. What strikes most about Fernando’s vision is incorporating AI to guide users on optimal pricing and rebate models. “In today’s world, the intelligent use of data is crucial. The simulator can help pharma and payers to become more efficient and successful.”

As our conversation nears its end, Fernando touches upon a crucial aspect – data security. “Data privacy is non-negotiable. Lyfegen is committed to rigorous adherence to international data privacy standards and state-of-the-art data security.” Fernando’s final thoughts encapsulate the essence of the Lyfegen Simulator. “The Lyfegen Simulator is a paradigm shift in how the pharmaceutical industry will approach drug pricing. It’s about turning uncertainty into understanding, and that’s a powerful change.”

As we part ways, it’s clear that the Lyfegen Drug Contracting Simulator isn’t just another product launch. It’s a vision brought to life, a testament to Fernando’s belief in the transformative power of technology in healthcare. With this launch, Lyfegen isn't just offering a solution; it's shaping the future of drug access and contracting.

Learn more about it here.

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A big win for value-based care: Medicare can now negotiate some drug prices

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A big win for value-based care: Medicare can now negotiate some drug prices

In a year marked by landmark legislative changes in support of value-based drug pricing, Medicare has recently received authorization to negotiate directly with drug manufacturers under the health provisions of the Inflation Reduction Act of 2022. Proponents of the law are hoping value-based pricing negotiations and inflation-based rate hike rebates for the country’s largest public healthcare payers will lower national drug costs and save U.S. taxpayers hundreds of billions over the next decade. Of course, pharmaceutical companies disagree.

In 2022, the pharmaceutical industry spent $187 million in lobbying funds fighting–unsuccessfully–to stop passage of a law that would grant Medicare negotiating authority for drug prices. The Inflation Reduction Act (IRA) of 2022 brought to life a legislative fix patient advocates, physician groups, and Democratic legislators have been trying to enact for decades as a tool to help lower prescription drug costs.

When the Medicare Part D retail prescription drug program was created in 2003, Republican legislators added the “noninterference clause” to the law to prevent Medicare from negotiating drug prices. Private health plans run the Medicare Part D drug program, but they set formularies and conduct drug price negotiations without Medicare’s input. The IRA establishes Medicare’s voice in drug price negotiations with drug manufacturers under the Drug Price Negotiation Program set to begin in 2023.

Medicare will be authorized to negotiate directly with manufacturers to find Maximum Fair Prices (MFPs) for a limited number of drugs that have no generic or biosimilar competition. The law also limits price increases year-over-year for Medicare Part D and Part B units sold (not for commercial units sold). Outside of a few product exceptions, drug makers who increase their prices more than the rate of inflation will have to pay rebates to Medicare.

Which drug prices can Medicare negotiate?

According to the new law, each year the Secretary of the Department of Health and Human Services (HHS) will select from a list of qualified single-source drugs with the highest total Medicare spending. The list of negotiation-eligible drugs will consist of the 50 costliest drugs from Medicare’s Part D program and (after 2028) the 50 costliest drugs from Medicare Part B (for drugs physician-administered on an outpatient basis).

A timeline for the changes enacted by the new legislation gives pharmaceutical manufacturers and health insurers time to adjust. The first step of the Drug Price Negotiation Program gives Medicare the authority to negotiate the 10 most expensive Part D drugs, with the negotiated price starting in 2026. The program expands to 15 eligible Part D drugs by 2027. Beginning in 2028, some Part B drugs may also be included in the list of 15 products that can be negotiated. From 2029 forward, Medicare can negotiate pricing for up to 20 Part D and Part B drugs. In total, Medicare will be able to negotiate prices on up to 60 eligible drugs by 2029.

The drugs for price negotiations under the IRA must meet certain standards, including the following:

·      The drug may not have a generic substitute.

·      For small-molecule drugs, it must be at least 7 years since FDA approval was granted.

·      For biologics, it must be at least 11 years since FDA approval was granted.

·      New drug formulations or treatments for rare diseases are excluded.

·      Treatments extracted or developed from human blood or plasma are not eligible for price negotiations.

·      A drug is excluded if Medicare’s total expenditures for the drug are no more than 1% of total Part D expenditures.

·      Most drugs developed by small biotechnology companies are excluded.

Not surprisingly, pharmaceutical companies see the passage of the IRA as an unfavorable development and view the Medicare negotiation process as price setting, not negotiations. The HHS and manufacturers are required to negotiate and agree on MFPs for negotiation-eligible drugs; negotiations are not optional. The drug manufacturer has 30 days to accept or counter the price offer Medicare makes. If a manufacturer refuses to cooperate with HHS or fails to negotiate in good faith, HHS can impose civil monetary penalties and an excise tax for non-compliance. It’s likely the pharma industry will challenge the law in court.

What analysts predict about industry impact and cost savings

In July 2022, the Congressional Budget Office (CBO) published the latest estimate of the budgetary effects of the health provisions in the IRA. The CBO expects Medicare’s ability to negotiate drug prices will save $102 billion in public sector healthcare costs over 10 years. During the same period, the CBO estimates an additional $62 billion in savings will result from the cap on drug price hikes at the rate of inflation.

The CBO expects manufacturers will increase launch prices for their new products to counteract the IRA’s inflation-rebate provision which slows the growth of prices over time. The analysts predict this will lead to an increase in Medicaid spending because Medicaid’s rebate program, triggered by the higher launch prices, would not fully offset the price increases. The CBO says Medicare Part B may also be affected by higher launch prices since that program uses the market’s average sales price of a drug to determine its reimbursement rate.

Analysts from Moody’s Investors Service expect there will be both price reductions for some drugs and limited price growth for other drugs. Moody’s analysts warn manufacturers that show high Medicare spending–due to their high prices, not patient consumption–will feel the impact of these regulatory changes the most.

Using the data from value-based drug purchasing arrangements

Proponents of Medicare’s authorization to negotiate drug prices believe the prescription drug provisions in the IRA are a suitable compromise that allows drug manufacturers to realize a reasonable profit while increasing the health benefits, accessibility, and affordability of prescription drugs for Medicare patients. Value-based purchasing arrangements will be an important tool at the core of this compromise.

Part of the criteria the HHS Secretary will consider when negotiating an MFP is the drug’s value to health outcomes and its cost-effectiveness compared with alternative treatments. Industry experts recognize that one of the best ways to gather insights into a drug’s performance is from the data collected in the implementation of value-based drug agreements. The data can either provide real-world evidence of a drug’s cost-effectiveness and benefit to patient health outcomes or reinforce the terms of a rebate for a drug’s underperformance.

Since negotiation-eligible drugs include those approved by the FDA at least 7 years ago, performance data may already be available from past value-based drug agreements for the first round of Medicare price negotiations. Manufacturers can prepare for future negotiations with Medicare by seeking value-based purchasing arrangements for their newer products as soon as possible after FDA approval.

The Lyfegen solution

Lyfegen, an independent global software analytics company, offers a contracting platform solution that helps health insurances, pharma, medtech, and hospitals implement value-based payment models with efficiency and transparency. Lyfegen’s Platform performs real-time, end-to-end, data collection and analysis through intelligent algorithms that can operationalize any value-based pharmaceutical purchasing arrangement and provide deep insights into a drug’s performance.

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.

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The importance of working with Johnson & Johnson: An interview with our Lyfegen CEO & Founder, Girisha Fernando

The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help...

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The importance of working with Johnson & Johnson: An interview with our Lyfegen CEO & Founder, Girisha Fernando

The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help patients around the world. We dived into a conversation with our CEO Girisha Fernando on why this partnership holds so much value for Lyfegen.


Girisha, why was the partnership with Johnson & Johnson such an important milestone for Lyfegen?

Girisha Fernando: Johnson & Johnson and Lyfegen share the same vision of sustainable & a value-based healthcare environment. Our goal is to help patients to receive the healthcare treatments they need and with this partnership, Lyfegen is proud to have been a key enabler for Johnson & Johnson and hospitals to deliver better health outcomes for patients.

How can this partnership be a blueprint for future collaborations?

Girisha Fernando: The increasing demand for healthcare measured against the limited financial resources is forcing the healthcare system to deliver innovative technologies to patients at sustainable costs. This can be done with value-based healthcare approaches and value-based agreements. The partnership between hospitals, Johnson & Johnson and Lyfegen shows how healthcare providers, manufacturers and an innovative tech company can deliver more value to patients whilst making efficient use of limited resources.

What would you suggest healthcare payers and hospitals to do if they are considering to implement value-based healthcare agreements with manufacturers?

Girisha Fernando: I believe it is important to focus on how to deliver better patient outcomes at lower cost. Value-based healthcare agreements can be used as a value-maximising method. It allows payers and hospitals to measure health outcomes and the adjacent cost to achieve these outcomes. Thus, hospitals can pivot on focusing their resources on value-adding healthcare treatments whilst addressing financial risk and uncertainty. It will take initial & minimal investment, but the return on investing in value-based healthcare and technology will be in the form of more value for money and better quality and patient health outcomes.

Why is Lyfegen the right platform for this?

Girisha Fernando: With over 120 value-based healthcare agreements running on the Lyfegen platform, we provide the necessary expertise, knowledge and technical competence to our customers. With these capabilities, we break down the complexity of implementing and managing value-based healthcare agreements. And lastly, we ensure that our customers can improve patient health outcomes by using value-based agreements at scale, efficiently.


Learn more about our platform by booking a demo today:


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The news are out: we are immensely proud to be partnering with Johnson & Johnson to advance value-based healthcare and help...

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The Health and Social Consortium of Catalonia to Develop New Value-Based Purchasing Models Incorporating New Tools for Negotiation with the Pharmaceutical Industry

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The Health and Social Consortium of Catalonia to Develop New Value-Based Purchasing Models Incorporating New Tools for Negotiation with the Pharmaceutical Industry

Barcelona, April 9, 2024
The Consortium of Health and Social Services of Catalonia has begun to work on value-based drug purchasing models by incorporating new tools for information management and negotiation with the pharmaceutical industry. This is an innovative project in collaboration with the health technology brand Lyfegen, which has developed the largest platform for managing public agreements in the world and a drug contracting simulator that allows for better deals by maximizing value in the purchasing process.

The goal of this innovative initiative is to increase the processes of value-based drug procurement, allowing CSC-affiliated health centers to focus on the evaluation of the clinical, economic, and social benefits that the drug can provide in relation to its cost.

For the design of these new procurement models, the "Lyfegen Agreements Library" database and the “Lyfegen Drug Contracting Simulator” were used, and work was done on the automation of administrative tasks and on improving interoperability among hospitals and health administrations. These tools allow the CSC to model various agreements and improve the drug management process in the central contracting office. The Health and Social Consortium of Catalonia thus becomes the first organization in Spain to incorporate these tools.

"From the Consortium, we are convinced that access to innovation and the sustainability of the health system relies on reaching innovative management agreements with pharmaceutical laboratories," says Josep Maria Guiu, director of the Pharmacy and Medication Area of the CSC. "The alliance with Lyfegen gives us a tool to work in this direction and to advance in the establishment of satisfactory agreements that facilitate access to innovation and contribute to the sustainability of the health system."

Girisha Fernando, CEO of Lyfegen, comments that "We are proud to help the Consortium lead access to innovation to improve patient care in Catalonia." "By using our advanced solutions, more than 100 health organizations throughout the region can research, model, and efficiently manage agreements, as well as value-based drug procurement," he adds.

“This allows professionals to really focus on what matters most: patient care.”

The collaboration with Lyfegen reflects the commitment of the Health and Social Consortium of Catalonia to value-based drug procurement and to access to pharmacological innovation, as well as the will to continue working for the implementation of solutions that ensure equity and sustainability of the health system.

The total contracting volume of the CSC, which acts as the purchasing center for the subsidized health sector of Catalonia, was 1.497 billion euros in 2023. Of this amount, 90% corresponded to medicines and 10% to sanitary products.

In recent years, the Consortium of Health and Social Services of Catalonia has incorporated social value aspects into the purchasing processes. For example, it has committed to ensuring that 100% of its drug and sanitary product tenders incorporate environmental clauses by 2024.

About Lyfegen

Lyfegen is an independent provider of rebate management software designed for the healthcare industry. Lyfegen solutions are used by health insurances, governments, hospital payers, and pharmaceutical companies around the globe to dramatically reduce the administrative burden of managing complex drug pricing agreements and to optimize rebates and get better value from those agreements. Lyfegen maintains the world’s largest digital repository of innovative drug pricing models and public agreements and offers access to a robust drug pricing simulator designed to dynamically simulate complex drug pricing scenarios to understand full financial impact. Headquartered in Basel, Switzerland, the company was founded in 2018 and has a market presence in Europe, North America, and the Middle East. Learn more at Lyfegen.com.

About CONSORCI

The Consortium of Health and Social of Catalonia (CSC) is a public entity with a local and associative basis, founded in 1983, which has its origin in the municipal movement. The CSC, a reference to the sector and with a clear vocation for service, has as a mission: to promote excellent and sustainable health and social models to improve the quality of life of the people, offering services of high added value to its partners. CSC wants to be the main reference for knowledge and capacity for cooperation, influence and anticipation in the face of the new challenges of the health and social system. All CSC associates are public or private non-profit bodies. For more information, please visit https://www.consorci.org/el-csc/en_index

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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

Read the Exclusive article with AXIOS

Read the Press Release on PR Newswire

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Lyfegen und die Schweizerische Krankenversicherung EGK-Gesundheitskasse kooperieren bei der Senkung der Preise für teure Medikamente

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Lyfegen und die Schweizerische Krankenversicherung EGK-Gesundheitskasse kooperieren bei der Senkung der Preise für teure Medikamente

EGK nutzt die Lyfegen-Plattform, um komplexe Preismodelle für die On- und Off-Label-Verwendung von mehr als 80 Medikamenten zu verwalten.

 

Basel, Schweiz - 29. November 2022 - Lyfegen, ein globales Healthtech-SaaS-Unternehmen, das den weltweiten Übergang von einer volumen- zu einer wertbasierten (value-based) Gesundheitsversorgung für hochpreisige Arzneimittel vorantreibt, gab heute bekannt, dass die EGK-Gesundheitskasse sich seinem Portfolio von Versicherungspartnern anschliesst, um alle ihre Verträge zur wertbasierten Preisgestaltung für hochpreisige Arzneimittel effizient, sicher und transparent auszuführen.

Die Schweiz, mit den vierthöchsten Arzneimittelausgaben pro Kopf, gab in den ersten neun Monaten des Jahres 2022 8 Milliarden Franken (8,1 Milliarden Euro) für Medikamente aus, die für bestimmte Krankheiten verschrieben wurden. Um die hohen Arzneimittelausgaben zu bekämpfen, hat die Schweiz in den letzten fünf Jahren eine wachsende Zahl von Rabattmodellen für den On- und Off-Label-Einsatz von Medikamenten eingeführt. Die Komplexität der Preismodelle führt jedoch dazu, dass die Versicherer Millionenbeträge für die Überwachung und Beurteilung der Preismodelle ausgeben, was zu entgangenen Rabatten in zwei- bis dreistelliger Millionenhöhe führt.

Mit der Software von Lyfegen kann die EGK mit minimalem Aufwand und maximaler Transparenz Rabatte aus 141 Medikamentenpreismodellen von 32 Herstellern identifizieren und einfordern. Dazu gehören Fälle von seltenen oder chronischen Krankheiten, vielversprechende Therapien, die ausserhalb der zugelassenen Indikation eingesetzt werden können, oder neue Medikamente, die in der Schweiz noch nicht erhältlich oder zugelassen sind. Die Plattform von Lyfegen adressiert die Bedürfnisse der Schweizer Krankenversicherer nach Kosteneffizienz und Digitalisierung. Sie hilft, bestehende Komplexitäten im System zu lösen und wirkt hohen Versicherungsprämien entgegen.

„Wir freuen uns, die EGK zu unterstützen und eine aktive Rolle bei der Bewältigung der zunehmenden Komplexität von Medikamentenpreismodellen zu übernehmen, um den nachhaltigen Zugang zu innovativen Medikamenten und Therapien in der Schweiz zu unterstützen“ sagte Nico Mros, CXO und Mitgründer von Lyfegen. „Indem wir uns darauf konzentrierten, die Implementierung der Plattform so einfach wie möglich zu gestalten und auf die EGK einzugehen, konnten wir schnell Ergebnisse präsentieren und die Zusammenarbeit erfolgreich starten!“

"Mit der Lyfegen-Plattform baut die EGK ihren Fokus auf Nachhaltigkeit und Effizienz zum Wohle ihrer Versicherten weiter aus", sagt Carolina Pirelli, Leiterin Leistungen und stv. Geschäftsleiterin bei der EGK. "Die immer grösser werdende Zahl von Preismodellen für Medikamente stellt die Versicherer vor Herausforderungen in Bezug auf Ressourcen und Prozesse. Mit der automatisierten Verarbeitung von Preismodellen über die Lyfegen-Plattform können wir unsere aktuellen Anforderungen perfekt erfüllen und sehen uns mit der Flexibilität, dem Fokus und dem Verständnis von Lyfegen in guten Händen."

 

Über Lyfegen

Lyfegen ist ein globales SaaS-Analyseunternehmen im Gesundheitsbereich, das eine Plattform für wert- und ergebnisbasierte Verträge für Medikamente, Therapien und Medizingeräte anbietet.

Krankenversicherungen, Pharma- und Medizintechnikunternehmen sowie Spitäler nutzen die sichere Plattform für Tausende von Preismodellen in der Schweiz, Europa, dem Nahen Osten und Nordamerika. Die Lyfegen Plattform unterstützt die Verhandlungen und ermöglicht die automatisierte Ausführung von wertbasierten Preismodellen durch die Analyse von real-world Daten durch intelligente, lernfähige Algorithmen.

Weltweit renommierte Krankenversicherungen, Spitäler, Pharma- und Medizintechnikunternehmen haben die zum Patent angemeldete Plattform von Lyfegen bereits implementiert, um wertbasierte Preismodelle für Medikamente, Therapien und Medizingeräte zu skalieren und damit den Zugang zu Behandlungen sowie Therapieergebnisse für Patienten zu verbessern.

Lyfegen wurde von Personen mit jahrzehntelanger Erfahrung in den Bereichen Gesundheitswesen, Pharma und Technologie gegründet und leistet Pionierarbeit bei der Umstellung von der volumenbasierten und kostenpflichtigen Gesundheitsversorgung auf die wertbasierten Gesundheitsversorgung. Weitere Informationen finden Sie unter www.lyfegen.com.

Über die EGK-Gesundheitskasse

Die EGK-Gesundheitskasse ist ein KMU-Krankenversicherer mit Sitz in Laufen (BL). Die EGK-Gruppe umfasst die EGK Grundversicherungen AG (Grundversicherung nach KVG), die EGK Privatversicherungen AG (Zusatzversicherung nach VVG) sowie die EGK Services AG (Verwaltung). Sie versichert schweizweit rund 100'000 Personen in der Grundversicherung, 80% von diesen verfügen auch über eine EGK-Zusatzversicherung.

Natürlichkeit und Nachhaltigkeit gehören zur Werthaltung der EGK. Sie gilt als Pionierin beim uneingeschränkten Zugang zu exzellenter Komplementärmedizin. Sie lanciert und unterstützt in der ganzen Schweiz Aktivitäten zur natürlichen Stärkung der Gesundheit.

Read on PR newswire in German

Read on PR newswire in English

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A message from our CEO as Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

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A message from our CEO as Lyfegen Raises $8 Million to Drive Down Drug Costs and Help Patients Access Life-Saving Medications

 

In light of today’s anticipated press release and exclusive article with AXIOS, we would like to extend a heartfelt thank you to our investors, customers, and team for sharing our vision to transform the healthcare system, helping patients to receive the healthcare treatments they need. The closing of our oversubscribed series A, led by aMoon Fund with additional participation from APEX Ventures and others, marks an important milestone.

Skyrocketing drug prices–especially for high-cost specialty drugs like cell and gene therapies–are accelerating the demand for value-based drug pricing. 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 a value-based future.

With the $8 million in funding, we will expand our presence in Europe and the U.S. to increase drug affordability for more customers and, more importantly, more patients.

Together, we save lives.

 

Read the official Press Release

Read the Exclusive article with AXIOS



[caption id="attachment_3253" align="aligncenter" width="200"]

Girisha Fernando
CEO & Founder[/caption]

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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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Principales Fabricantes y Pagadores en Brasil

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Principales Fabricantes y Pagadores en Brasil


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

Áreas Terapéuticas

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

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

Modelos de Precios

Nuevos modelos de precios de Brasil incluyen:

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

Acuerdos Destacados

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

Fibrosis Quística:

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


Atrofia Muscular Espinal Infantil:

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

Cáncer de Ovario:

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

Principales Fabricantes:

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

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

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

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

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

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

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

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


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

Trikafta (Elexacaftor-Tezacaftor-Ivacaftor, Vertex Pharmaceuticals)

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

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

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

Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals)

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

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

Kalydeco (ivacaftor, Vertex Pharmaceuticals)

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

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

Lynparza (Olaparib, AstraZeneca)

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

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

Zolgensma (onasemnogene abeparvovec, Novartis)

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

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

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

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How Spain is Preparing for Europe’s New Regulation

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How Spain is Preparing for Europe’s New Regulation


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

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

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

The 5 non-clinical domains include:  

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


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


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


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


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

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

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


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

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Medicare Part D’s 2025 Overhaul

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Medicare Part D’s 2025 Overhaul


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

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

This brings us to another major development.  

Update to Medicare Drug Price Negotiation Program

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

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

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

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

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

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Brazil’s Key Manufacturers and Payers

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Brazil’s Key Manufacturers and Payers


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

Therapeutic Areas  

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

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

Pricing Models

New pricing models from Brazil include:  

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

Featured Agreements

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

Cystic Fibrosis:

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

Infantile Spinal Muscular Atrophy:

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

Ovarian Cancer:

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

Main Manufacturers:

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

Understanding the HTA Process for Drug Approval in Brazil

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

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

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

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

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