Conference Day Two
Conference Day Two
Thursday 27th June 2024
7:50 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
Reviewing One-Time Payment Mechanisms to Address the Misalignment with the Current Pay-for-Service Model to Improve Patient Access
9:00 am Analyzing the Disconnect Between High Product Costs & Manufacturer Profitability in the Pursuit of Business Model Enhancement & Sustainable Growth
Synopsis
- Why is it so hard to make money in this space right now as a manufacturer?
- What specific changes or adaptations are necessary within the current business model to ensure profitability in the space, given the longstanding challenge of finding a sustainable and profitable model?
- Navigating the lack of profitability and its impact on patients
9:30 am Assessing Value- & Cost-effectiveness: How to Compare Novel Cell and Gene Therapies with Current Standards of Care to Improve Decision-Making
Synopsis
- Developing a value framework to justify the benefits behind the pricing.
- Analyzing cost-effectiveness, i.e., balancing the therapy's cost relative to its benefits and outcomes achieved, considering factors like quality-adjusted life years gained
- How does each particular C&G treatment impact the overall treatment paradigm and economy?
10:00 am Evaluating Global Healthcare Budgeting Structures & Analyzing their Ability to Handle Large One-Time Payments to Better Allocate Funds
Synopsis
- What are the traditional valuation methods and payment methods in US and ex-US?
- Why these methods may not capture the sustained benefits or potential long-term effects adequately, and what are the hurdles to implementation?
- What should we consider when establishing payment structures based on the value these therapies deliver over the patient’s lifetime rather than a one-time fee, in times of limited/constrained healthcare budgets?
10:30 am Morning Break & Networking
Exploring Reimbursement Strategies for High-Cost Therapies to Promote Standardization & Roll Out Therapies Quicker
11:30 am Evaluating Inpatient Payment Systems to Address Under-Reimbursement Challenges & Enhance Access to Cell Therapies
Synopsis
- Inpatient delivery and profitability: why therapies are not profitable when delivered in the hospital setting
- Separating the drug from the service: the challenge of underpayment of services and offsetting the loss through the drug price
- Bundled payments in the inpatient delivery leading to inadequate reimbursement
12:00 pm Understanding Benefit Design to Evaluate the Suitability of Cell & Gene Therapies & Propose Novel Solutions
Synopsis
- Understanding the type of cell and gene therapy products that would meet the characteristics of a strong benefit design spread across commercial and public sectors
- Should the federal government propose a new standalone benefit for selling gene therapy products?
- Underscoring the importance of tailoring benefit designs for cell and gene therapies based on their specific characteristics
12:30 pm Roundtable Discussion: Exploring the Warranty Model for Reimbursement to Mitigate Potential Loss for Seamless Payment Implementation
Synopsis
- Distinguishing the difference between warranties and value-based agreements: what are the pros and cons? What are associated challenges?
- Evaluating how to implement warranties for cell and gene products
- Discussing the payer perspective: receptivity of the market and preference over other payment models
1:15 pm Lunch & Networking Break
Exploring Successful Strategies for Launching Therapies in a Dynamic Market by Delving into Early-Stage Commercial Strategy, Market Insights & Regulatory Policy
2:15 pm Launching Therapies into a Volatile Market & Strategies to Overcome Compounding Challenges for Successful Introduction & Market Adaptation for New Products
Synopsis
- Recognizing the increasing challenges arising from multiple cell and gene therapies competing for budgets
- Assessing the cumulative budget impact of these therapies collectively rather than individually
- Navigating access and pricing challenges in cell therapy beyond haematology indications to unlock new frontiers and explore opportunities for advancement and patient benefit
2:45 pm Roundtable Discussion: Examining Strategic Architectures for Global Gene Therapy Access through Insights in Cross-Functional Collaboration & Market Access for Crafting & Implementing Policy Strategies
Synopsis
- Facilitate a collaborative exchange of perspectives on market access intricacies and regulatory excellence
- Collaboratively generate actionable strategies for crafting and implementing robust regulatory and reimbursement public policies
- Engage in a dynamic discussion on the crucial role of cross-functional collaboration in shaping strategic architectures for optimal cell and gene therapy access
3:45 pm Reviewing Compassionate Use Regulations to Understand the Associated Challenges Required for Fast Delivery & Application to Cell & Gene Therapies
Synopsis
- Navigating the required regulations and walking through what they are
- Dissecting how to get regulatory approval for compassionate use
- How does the compassionate use apply to the cell and gene field and what are the challenges associated with that?