Insights & Articles

21.8.2024

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

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

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

Challenges for Specialty Drug Makers

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

Impact on Medicare Advantage Plans

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

How Lyfegen Can Help

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

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

Start Preparing Today

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

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

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The role of value-based care in patient access

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The role of value-based care in patient access

With rising healthcare costs around the world, value-based care (VBC) is a paradigm shift poised to make healthcare more accessible and affordable. It’s a departure from the traditional fee-for-service (FFS) model, which pays providers each time they perform a service. In this type of care model, providers are rewarded for the volume of care they provide, rather than the quality.  

Value-based care shifts the priority of healthcare to patient wellbeing and patient centeredness. Value-based care agreements incentivize healthcare stakeholders to achieve better outcomes, and may even penalize excessive spending or unnecessary procedures.  

There are many approaches to providing and paying for value-based care, and they will be the subject of this article. Let’s take a broad look at what VBC is, its benefits, its challenges, and future directions.  

Why value-based care is needed

Healthcare costs are rising across the globe, and patients are bearing the brunt of it, with out-of-pocket healthcare costs rising faster than costs to insurers. Drugs are also becoming more expensive, and insurers and employers are concerned about high-cost claims. Many insurers are refusing to cover expensive treatments, like cell and gene therapies, or GLP-1 agonists.  

Although the fee-for-service model is still important, value-based care can fill the gaps to bring medicines to patients faster. Using cell and gene therapies as an example, VBC could prevent patients like Forrest VanPatten from dying during the process of jumping from insurer to insurer, hoping to find one that will cover the treatment.  

Alternative payment models (ABMs), a core element in the delivery of VBC, help these therapies get to market faster, by lowering the financial burden of expensive therapies. This could include installment payments, among several types of value-based contracts.  

Although pharmaceutical companies continue to improve patient outcomes by developing more effective medicines, healthcare costs include more than the price of the drugs. The total cost of care must also be managed and requires a close evaluation of how care is delivered to the patient.  

Ultimately, value-based care is a strategy to deliver a better healthcare experience to the patient while utilizing resources more effectively. It is feasible to reward healthcare practitioners for improving patient health, whether it be keeping them out of the hospital, reducing their reliance on medication, or becoming completely disease-free. But there are many challenges in implementing these models, as we’ll discuss.

The types of value-based care

There are many forms of value-based care, and different terms are used interchangeably. Use the glossary table below while reading this article to better understand.  

VBC can involve the following:  

  • Programs that work on delivering care more effectively
  • Payment models that involve sharing risk between the payer and the manufacturer  
  • Population-based payments to provider organizations
  • Patient-centered care: focusing on the needs and wants of the patient
  • Restricting access to medications only for those for whom it would be more effective

There are many ways medicine and care can be delivered to people in ways that support better outcomes. Let’s summarize the models above.  

Effective care delivery

The accountable care organization (ACO) is a group of clinical entities and providers that in synchronization, aim to deliver efficient and cost-effective healthcare to patients. If the efforts are successful, saved costs can be distributed, providing an incentive to avoid unnecessary procedures. A key component of ACOs is that financial responsibility lies on caregivers. ACOs were a central component of the Affordable Care Act in the United States, and generally describe the American healthcare system. However in several European countries, similar models providing integrative care do exist.  

This type of integrated care model may still rely on the fee-for-service model, but aim to reduce the volume of care.  

Risk-sharing agreements

Several value-based drug pricing agreements foster risk-sharing between the manufacturer of the drug and the payer. The following are examples:  

  • Pay-for-performance (P4P)
  • Coverage with evidence development (CED)
  • Outcomes guarantees
  • Installment payments
  • Managed entry agreements

Many of the above terms overlap with each other. What they have in common is that they can address clinical uncertainty—payers may be reluctant to reimburse therapies with limited clinical evidence from the pivotal trial. However, to ensure patient access, risk-sharing agreements are way to allow patients to be treated for a steep discount, while gathering real-world evidence.  

In a pay-for-performance agreement, payers will only have to pay for the treatment if anticipated patient outcomes are achieved. Several hybrid iterations of this type of agreement exist, including milestone payments, where payers receive rebates if disease progresses.  

You can find specific examples of these kinds of agreements in our Agreements Library.  

Population-based payments

Population-based payments facilitate integrative care delivery. They involve payments for either a specific condition, or for the care of an entire patient. However, unlike an ACO, population-based payments are value-based and are not based on the fee-for-service model.  

The Health Care Payment Learning & Action Network (HCP LAN) defines population-based payments as a “single payment that encompasses a broad array of services.” This is also more widely referred to as capitation. Capitation can apply to the care for a specific condition, or the entire continuum of care.  

NHS England defines capitation as “paying a provider or group of providers to cover the majority (or all) of the care provided to a specified population across different care settings. The regular payments are calculated as a lump sum per patient.”

Capitated payments typically involve a per-member-per-month fee. They provide predictable revenue for hospitals and providers while incentivizing them to provide quality care.  

Restricted access

Another way to address clinical uncertainty is to limit who can receive treatment as real-world evidence is being gathered. By refining the eligibility criteria, patients most-likely to benefit from the treatment can receive access.

What are some of the challenges of implementing value-based care?

There are several challenges to implementing value-based care. They include:  

  • Limiting who may receive care
  • Managing revenues
  • Integrating healthcare services  
  • Measuring clinical outcomes

One challenge with VBC is deciding on patient eligibility. Insurers may choose to cover a very select group of patients, denying others who may need treatment coverage, to ensure that they are incentivized accordingly. This leads to another challenge: choosing the right outcomes to measure. In the fee-for-service model, billing is tied to the condition and medication being prescribed, whereas in a value-based contract, financial incentives are tied to outcomes measured by a healthcare provider.

The chosen outcomes must be evidence-based and tracked accordingly. Collecting data, sharing it with various stakeholders, and integrating it into a patient’s care is another challenge. Great structural changes are needed to ensure the compliant sharing of this type of data.  

For manufacturers and hospitals alike, another challenge is to manage revenues. Pharmaceutical companies may be unclear for example on how drug profitability could vary with a performance-based or utilization cap contract. One of our solutions to this largely manual process was to create a drug price simulator. This tool helps manufacturers of health technologies compare and contrast different value-based contracts during the negotiation process.

For hospitals, it’s imperative to correctly track rebates, especially if they are warranted after upfront payments: our rebate management platform helps hospital systems identify up to 30% more rebates.  

Value-based care can balance innovation while lowering healthcare costs, but implementing it involves enhanced coordination of care delivery and significant organizational changes. VBC also involves innovative payment models that share risk with healthcare providers or place the burden of risk on them entirely to incentivize quality care.

Value-based payment models can reduce high upfront costs of expensive therapies while further evidence is gathered to justify the high costs. For providers, VBC may reduce burnout risk by incentivizing them to keep patients healthy.

The integration of value-based care in healthcare systems around the world requires data. At Lyfegen, we help pharma, MedTech, and providers understand the impact of value-based payment models with our innovative software. Let’s make this shift happen together.

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Drug Market Access Strategies in 2024: Key Considerations for Pharma Companies

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Drug Market Access Strategies in 2024: Key Considerations for Pharma Companies

The pharmaceutical industry and its drug market access strategies are continuing to evolve as we move through 2024, driven by mounting pricing pressures, aggressive regulatory shifts, and heightened payer demands. For pharma companies, refining market access strategies is no longer optional—it’s essential to securing rapid market entry and sustained patient access in an increasingly challenging environment. Let’s explore the key considerations for pharma companies within this space.

Evolving Drug Market Access Strategies

Pharmaceutical companies must adapt their drug market access strategies to address a rapidly evolving landscape shaped by policies and regulations across various regions, including the U.S. and Europe. New legislation, such as the Inflation Reduction Act (IRA), introduces more stringent reimbursement criteria, which could impact profitability and influence launch decisions for new drugs. To mitigate these challenges, companies need to prioritize earlier and broader data collection efforts, focusing on generating robust real-world evidence (RWE) and health economic outcomes research (HEOR). This comprehensive evidence base is essential for demonstrating the value of new therapies beyond the scope of traditional clinical trials, ultimately playing a critical role in payer negotiations and securing optimized reimbursement (NIH).

Global market variations also demand a tailored approach to launch strategies. In Europe, new regulations mandate shorter market exclusivity periods unless drugs are launched across all member states within two years, compelling pharma companies to align their launch timelines more closely with diverse national pricing schemes (European Parliament). Meanwhile, in markets like Japan, frequent price revisions are pushing companies to adopt dynamic pricing strategies to stay competitive.

The Role of Healthcare Technology Solutions in Market Access

With the industry pivoting towards value-based care and personalized treatments, healthcare technology solutions are essential in aligning stakeholder needs. Platforms like Lyfegen are pivotal in this shift. By offering a comprehensive Healthcare technology solution for outcome-based contracting, the Lyfegen platform supports the efficient implementation of value-based agreements between pharma companies, payers, and healthcare providers. Using platforms like Lyfegen means that the administration of complex pricing models can be simplified, patient outcomes can be tracked in real-time, and transparency can be increased, all of which are crucial for pharma to gain and maintain market access.

We continue to watch as the pharmaceutical industry is shaped by evolving regulations, mounting pricing pressures, and shifting payer demands. But to ensure market access, pharma companies must act now by building robust data portfolios early, integrating clinical trial data with real-world evidence (RWE), adapting to global pricing pressures, and leveraging digital solutions.

Lyfegen’s platform is at the forefront of helping pharma companies tackle these challenges. With Lyfegen’s Drug Contracting Simulator, you can model dynamic pricing strategies, optimize your market access plans, and streamline value-based agreements. Combined with the Lyfegen Library of real-world evidence and pricing models, you’ll be equipped to make data-driven decisions, ensuring faster patient access and successful contract negotiations.

Act Now – Book a demo of Lyfegen’s platform and discover how we can support your market access strategy: https://www.lyfegen.com/demo

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