Evolving Healthcare Landscape: Cell and Gene Therapy, Part 1

ADVI expert Alicia Silver, director of market access, cell and gene therapy, discusses the current focus on Medicare and Medicaid, specifically high launch prices, NTAP, and the upcoming Cell and Gene Therapy Access Model. She highlights the importance of Medicare modernization and the logistical challenges of launching therapies across all 50 states while ensuring patient access and adapting to new outcomes-based agreements.

Learn more about ADVI’s Cell and Gene expertise and meet up with our experts at Meeting on the Mesa from from October 7-9, 2024.

“Several clients are seeking ways to approach Medicare to discuss program improvements that would better accommodate one-time, high-cost therapies. This is both exciting and challenging.”

Panelists

Alicia Silver

Director, Market Access, Cell and Gene Therapy

Alicia leads ADVI’s cell and gene therapy commercialization efforts, assisting clients with market access and policy activities across solid organ transplant, autologous, allogeneic transplant, and novel cell therapies.

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Full Transcript

Alicia Silver: When I think about what we’re working on with clients, I find it most exciting right now to consider two things in the Medicare space. First, we’re seeing relatively high launch prices, particularly in relation to NTAP (New Technology Add-On Payments) on the inpatient side. The recent major denial of an NTAP application for a cell and gene therapy manufacturer, based on the substantial clinical improvement criterion, has prompted us to focus on how best to communicate with payers, especially Medicare. Additionally, we’re thinking about Medicare modernization as a key area where we can play a significant role. Several clients are seeking ways to approach Medicare to discuss program improvements that would better accommodate one-time, high-cost therapies. This is both exciting and challenging.

This work is very much connected to what’s happening with the IRA (Inflation Reduction Act), particularly regarding Medicare drug price negotiations in Part D and Part B. Medicare is certainly considering the future implications of these developments for cell and gene therapies, so we’re staying vigilant and carefully reviewing all related rules.

On the Medicaid front, we are working with multiple clients who are facing logistical challenges as they launch their products across all 50 states. Developing a strategy to ensure that no patient is left without access at the time of launch is crucial. This is particularly exciting because it is underpinned by the increasing prevalence of outcomes-based agreements in Medicaid, as well as the upcoming Cell and Gene Therapy Access Model. We expect this model to launch early next year, with more details about the participating manufacturers and states to be revealed later this year, specifically for gene therapy for sickle cell disease.

We will continue to monitor developments closely and plan to provide more information on the Cell and Gene Therapy Access Model in late September or early October, as more details become available. It’s essential to consider the impact of these decisions on our clients and the patients they serve.

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