Conference Program/Sessions

This session will cover:

• Current landscape of biosimilars in Europe vs the US
• Importance of Biosimilars to Improve Patient Access to Biologicals: the European Experience
• Future Reimbursement Challenges for Biosimilars

Pre-registration is required and seating is limited. There is no additional cost for these sessions. 

Session Objectives: 

• Unravel the complex interplay between innovative contracting arrangements and the uncertainties surrounding real-world data.

• Understand the drivers of contract uncertainties, from weight-based dosing to short-term clinical trial outcomes.

• Learn the importance of quantifying the impact of uncertainty on net revenue and effective net prices to ensure successful payer negotiations. 

• Unearth rapid techniques for assessing the value of innovative contracting arrangements.

• Arm yourself against common forecasting pitfalls to pave the way for successful contract negotiation and execution.

This pre-conference short course will be offered in-person at the ACCESS 2023 Europe Annual Meeting and Expo. Separate registration is required, although there is no fee to attend this session. Registration is limited to the first 60 participants. Please add this event to your main conference registration. 

Topics to include:

• General update on what we know today, including a summary of EU HTA regulations, and the EUnetHTA21 collaboration meetings
• Trends in supranational HTAs other than EUnetHTA – lessons learned
• Legal framework, the pharma package, how unmet medical need and orphan designation may impact assessment
• PICOS frameworks and challenges/opportunities in dealing with potentially large differences between member states
• C-Suite survey results and what this may mean for the future sequencing of EU, UK, US and other markets
• Registries and RWE – how these may influence and evolve with implementation of the EU HTA regulations

Patient involvement along the HTA process from scoping to deliberation and decision is done by many HTA agencies across Europe. However, the methods applied are highly variable. Under the new HTA-regulation in the European Union, a common process for patient input in the clinical assessment has been defined. In addition, patient involvement will continue within the national HTAs. 

As HTA systems harmonize their approaches, there is an opportunity to learn from the past and to promote best practices for patient involvement across European agencies. In this session, we will present some outcomes, learnings and recommendations resulting from past experiences of the different stakeholders in Europe. In the discussion among the panel and with the audience, we will explore what these recommendations and processes mean for patient organizations and industry, how these stakeholders can best prepare for patient relevant HTAs, and how stakeholders can support the more consistent use of good practices for patient involvement in HTA.

Check-in to receive your name badge, or if you need support from the events team. 

Check-in to receive your name badge, or if you need support from the events team. 

Check-in to receive your name badge, or if you need support from the events team. 

Session topics to include:

• Disparities due to shortages in lower-profitability countries, or due to parallel exports
• Disparities triggered indirectly due to no-launch in lower potential lower-price countries?

Session Overview:

Overview:

This workshop will focus on novel approaches to valuing health outcomes that are particularly relevant to innovative treatments for rare disease in order to support market access strategies. There are many challenges to measuring and valuing health outcomes using approaches currently recommended by Health Technology Assessment agencies when applied to emerging therapies for a wide range of conditions. Issues can include small patient numbers, clinical heterogeneity, limited content relevance of existing health utility measures, and inability to capture spillover effects on family. This workshop will examine some of the challenges to market access associated with demonstrating value for money and introduce several novel approaches to address those challenges that can help to support an evidence-based approach to market access.

Learning Objectives

• To demonstrate how patient reported outcomes data from a small trial in a rare disease were re-weighted by a general public sample in order to make the outcomes data suitable for cost-effectiveness analysis.
• To illustrate an approach to modifying existing health outcome measures to include content that captures aspects of disease relevant to patients.
• To examine an emerging construct and new measure that captures spillover effects of treatments for patients that improve caregiver quality of life/burden.

Questions around the value of healthcare innovation can be most meaningfully addressed in the real world as opposed to in controlled experiments. For this reason, payers around the globe have been a primary promotor and user of Real World Data (RWD) and Real World Evidence (RWE). Quantity and quality of RWD are skyrocketing, disparate data sources are linked, and advanced analytics are deployed to rapidly extract insights and evidence. This session will provide an overview of RWE use and its evolution by payers, with deeper dive into specific country examples in Europe and other regions.

In this session, our experts will present what keeps different stakeholders up at night about the IRA. We will learn about what payers, policy-makers, health economists, and large and small manufacturers are worried about and are preparing as the implementation of the law evolves. Topics we will touch on include the future of formularies, insufficiency of considering R&D costs, whether patients will see benefits from the price negotiation process, and how companies are working to “future-proof” their portfolios from the intended and unintended consequences of the law.

Artificial Intelligence—AI—brings the promise of individualized medicine:  Accurate matching of treatment to patient.  Today's approach is trial and error, prolonging suffering, amplifying costs, and harming patient trust in physicians and pharmaceuticals.  The solution is prediction, but mainstream AI and statistics continue to fail.  Patrick Lilley will illustrate in surprising, simple visuals why mainstream AI and statistical methods can't predict the complex interactions of biology, behavior, and drug compounds.  Claudio Fario will then provide a real-world example of how a different kind of AI yielded objective, biomarker-based prediction in immune-mediated diseases, where the first-line, step-restricted treatment has less than 40% efficacy.

Pre-registration is required and seating is limited. There is no additional cost for these sessions. 

Session Overview:
 

The process of launching a new drug globally is complex and time-consuming, involving negotiations and approvals in multiple countries. To support this endeavour, an often small Global Market Access team collaborate with their country counterparts to facilitate the launch around the world.  
 

Many companies continue to face challenges due to reliance on tools like Excel, PowerPoint, and email as the primary collaboration channels. These outdated methods result in delayed and inconsistent access to data, limited collaboration, and ineffective tracking of key metrics.

To address these issues we launched Access Hub, an all-in-one digital market access dashboard and performance tracking tool, that’s been designed specifically for market access teams.
 

Through extensive user research, we have built an innovative online platform that centralises launch activity tracking, streamlines communication, fosters information sharing and captures essential KPIs. 
 

In this session our Product Owner Thomas Gilboy will walk through Access Hub and how it’s supporting the most successful pharma companies to transform how they track market access performance.

Session Objectives:

• Assessing the current status of global access to innovative pharmaceuticals in LMICs
• Identifying the underlying factors contributing to inequitable access, such as pricing strategies, regulatory frameworks, health system capacities
• Addressing challenges and impact of inequitable access to innovative pharmaceuticals
• Exploring strategies to enhance equity and timely access to innovative pharmaceuticals, and the role of international collaborations and partnership
• Learning from China: the evolving landscape of biotech innovation and its influence on healthcare ecosystem in the context of pricing and reimbursement policy reform.

• HTAs for Digital/MedTech – progress made and continuing challenges
• Clinical and Economic Value of Molecular Diagnostics at Point of Care: Going Beyond Companion Diagnostics to Everyday Diagnostics

 

• MedTech’s role in value-based healthcare
• Time to rethink value?

Engage in a dynamic workshop of unparalleled-insight and peer-group discussion. Whether you’re already involved in building innovative contracts or new to the space, this is a session you won’t want to miss! Miami IMAS delegates scored the workshop 5 out of 5!
 

Innovative contracting is rapidly changing the ways in which we negotiate. This more sophisticated approach requires an elevation of both thought processes and execution capabilities. Join this workshop-style session where we will explore, as a group, three important themes:
 

1. The Landscape: Using cutting-edge market research based on over 700 published innovative contracts, we will discuss the latest global-to-local trends
    
2. The Possible in 2022/23: Post-pandemic, we see a 54% year-over-year increase in published contracts. What’s emerging that is exciting or innovative, and what do these contracts tell us about what is possible?
    
3. The Art of the Build: What does it take to create these types of contracts? Key considerations and best practice
   
    

Opening night reception featuring live entertainment, cocktails, hors d'oeuvres - a great opportunity to meet and network with fellow attendees and leadership before the conference begins

We will have coffee and tea available outside the grand ballroom during this time prior to the start of sessions. For those staying in the Corinthia hotel, you may enjoy your included breakfast in the hotel dining area on the lobby level. For those staying elsewhere, please enjoy breakfast at your hotel.

We will have coffee and tea available outside the grand ballroom during this time prior to the start of sessions. For those staying in the Corinthia hotel, you may enjoy your included breakfast in the hotel dining area on the lobby level. For those staying elsewhere, please enjoy breakfast at your hotel.

Timely workshops and small roundtable discussions that minimize didactic presentations and places attendees at the center of the discussion. Share best practices and learn from experts in the space. 

Timely workshops and small roundtable discussions that minimize didactic presentations and places attendees at the center of the discussion. Share best practices and learn from experts in the space. 

Featuring live entertainment, cocktails, food stations, and premiere networking opportunities.

Timely workshops and small roundtable discussions that minimize didactic presentations and places attendees at the center of the discussion. Share best practices and learn from experts in the space. 

Timely workshops and small roundtable discussions that minimize didactic presentations and places attendees at the center of the discussion. Share best practices and learn from experts in the space. 

See below for sessions available. These closed-door sessions present the latest solutions and insights from leading partners in the market access, pricing and reimbursement space. Lunch will be provided in the room for each session. 

Pre-registration is required and seating is limited. There is no additional cost for these sessions.