8:00 am Registration & Coffee
8:50 am Chair’s Opening Remarks
Exploring State and Federal Level Innovation
9:00 am A State Authority Perspective on Medicaid Reimbursement for Cell & Gene Therapies
Synopsis
- Sharing experiences on negotiating payment terms with manufacturers
- The new Medicaid Drug Rebate Program Final Rule & CMMI Access Models: how are these impacting CGT reimbursement at the state-level in 2025?
- Discussing CGT patient data evidence generation efforts
9:30 am State Medicaid Coverage and Reimbursement Landscape for CAR-T’s
Synopsis
- Current landscape for inpatient and outpatient coverage and reimbursement
- How it differs between Managed Medicaid and state-managed coverage
- CMS Final Rule for state Medicaid programs and impacts on CAR-T
- Additional future trends or considerations
10:00 am Roundtable Discussion: Driving Policy Reforms and Multistakeholder Actions to Progress the Field
Synopsis
Roundtables include a larger focus on group discussion. A moderator will introduce the session topic to attendees with a presentation, before they split into groups to work through a series of topic areas. At the end, all groups report back on their discussions, and findings are collated.
This roundtable will cover:
- Necessary steps for fair pricing mechanisms to both recoup manufacturing costs and reduce payer uncertainty
- Developing robust data infrastructures to support patient outcome tracking
- Suggesting policy reforms to improve equitable access across geographic regions and socioeconomic backgrounds
10:45 am Morning Break & Networking
Improving Value Demonstration & Evidence Generation
11:30 am Beyond the Price Tag: The Hidden Financial Dynamics of Cell and Gene Therapies Impacting Payers
Synopsis
- Using Milliman’s proprietary closed claims dataset: the payer’s perspective on the patient journey associated with cell and gene therapy treatment
- Exploring differences in treatment episodes and payer costs for ex vivo versus in vivo therapies and the potential impacts on the access ecosystem
- Unpacking the distinct roles of primary and secondary/re-insurers related to treatment costs to drive understanding of their perspectives and financial exposure
12:00 pm Hemgenix: Developing Methods to Model US Population Uptake
Synopsis
- Cross-functional design of a long-term impact study on Hemgenix adoption in the US, and resulting budget impact forecasts
- Fine-tuning the model to make it as predictive as possible
- Leveraging data to help payers understand the economic benefits of the therapy
Developing Effective Payer Engagement Strategies
12:30 pm Panel Discussion: Refining Drug Manufacturer-Payer Engagement Strategies
Synopsis
- Setting out a timeline through clinical development for touchpoints with payers
- Practical advice to develop meaningful relationships with both large, national; and small, regional payers
- Which areas of the CGT value demonstration story are often overlooked during payer interactions?
1:10 pm Lunch & Networking
2:10 pm Tailoring Value Propositions to Overcome Access Barriers in Cell & Gene Therapies
Synopsis
- Boosting the value proposition of commercial therapies through real-world evidence (RWE) and publications
- Navigating guidance on incorporating RWE into regulatory and HTA submissions
- Key considerations when working on commercial programmes with payer uncertainty over durability and therapeutic benefit
2:40 pm Navigating the Current Trends in Stop-Loss Insurance
Synopsis
- Clarifying these policies: their goals, methods, benefits and drawbacks in providing access to CGTs, particularly for self-insured plan sponsors
- How are reinsurance companies thinking about risk-based agreements for the success of these therapies?
- Is there an opportunity for manufacturers to directly contract with them?
- How can manufacturers work to ensure their therapies aren’t lasered out of plans?