Meet with our experts in market access, evidence and strategy, and policy at Asembia. We will be presenting on the following panels:

First 100 Days: Key Insights on the New Administration and Congress – Monday, 4/28, 3–3:40 PM PT

The first 100 days of a new administration and a new Congress typically set the tone for the healthcare agenda and signal long-term priorities. The panelists will discuss the outlook for a range of health policy issues that may impact access to care and drug pricing, including the future direction for the Inflation Reduction Act (IRA). They will also examine the direction of policymakers’ interest in increased transparency in the drug supply chain, including through heightened oversight of Pharmacy Benefit Managers.

Avalere Health Panelists: 

• Megan West, Managing Director, Policy

• Ashley Flint, Principal, Policy

IRA Impact on Reimbursement, Access, and Distribution of Part B Drugs within Medicare and Beyond – Wednesday, 4/30, 11– 11:40 AM PT

In the spring of 2025, the Centers for Medicare and Medicaid Services (CMS) will release the draft guidance outlining key parameters of the negotiation process for initial price applicability year (IPAY) 2028. For the first time, the program will include Part B drugs. Panelists will discuss the specific considerations for buy-and-bill dynamics, contracting and distribution strategies, prescribing incentives and site of care for negotiated drugs, but also debate the outlook for key affected therapeutic areas, like oncology and immunology.

Avalere Health Panelists: 

• Milena Sullivan, Practice Director, Policy (Moderator)

• Omar Hafez, Practice Director, Market Access

Connect with us at Asembia to gain insights from our cross-functional experts on the following topics:

• Assessing the First 100 Days: Impacts and Directions: As the Trump administration reshapes HHS priorities and Congress debates 2025 legislative vehicles, stakeholders face a range of policy changes that could impact drug pricing and access to care (e.g., changes to Medicaid, provider payment, and pricing). Simultaneously, administrative efforts to streamline agency staffing, reprioritize federal funding, and impose tariffs could create additional disruption.
• Marketing to Payers and Planning for Commercial Launch: Manufacturers need pre-commercial strategies to demonstrate the value proposition of pipeline products. Strategies should address pharmacoeconomic value, access, and health policy considerations. Manufacturers should consider partners that not only provide strategic guidance but also communication execution.
• Navigating Challenges to Care Access and Affordability: Patients and providers may experience access challenges stemming from utilization management policies, copay adjustment and alternative funding programs, and care coordination policies that can inadvertently limit information sharing among specialists and settings. To navigate the evolving policy and market landscape, manufacturers need targeted strategies to support patients navigating these dynamics and to best support their customers.
• Understanding Changes in Utilization Patterns Due to Market Events: Market events such as vertical and horizontal consolidation in the drug channel and provider base, growth of Medicare Advantage, Part D redesign, and residual effects of COVID-19 on site-of-care decisions are all impacting how product moves from manufacturer to patient and how stakeholders behave. To support our clients, we continue to invest in our data and analytics capabilities, and we now have more timely access to 100% of medical and pharmacy claims with less lag time for Medicare Parts A, B, and D through CMS’s Virtual Research Data Center.
• Preparing for Impacts of Medicare Drug Price Negotiation: As manufacturers and CMS gain experience in Medicare drug price negotiation, evidence needs continue to grow for negotiated products and their competitors. Manufacturers need to begin preparing for selection years in advance to generate impactful evidence for maximum fair price (MFP) negotiations.
• Adapting to MFP Effectuation: Competitive Dynamics, Commercial Spillover: The first 10 MFPs are set to take effect on January 1, 2026 and 15 drugs have been selected for the second round of negotiations. As the impacts of negotiation become more tangible, manufacturers need to plan for stakeholder reactions, anticipate how they will influence market dynamics among impacted therapeutic alternatives, and prepare strategies to adapt to those changes.