Conference Program/Sessions

• Learn about 3-step approach to supercharge your evidence with Rigor, Respect, Reach and Results (Stakeholder Mapping, Amplification Plan, Staying Plugged In)
• Roll up your sleeves and work with panelists to pull together a “Evidence Amplified” plan of action that elevates your evidence-generation function and achieves your company’s priority business goals

Premise: Structural changes in the markets for pharmaceuticals (genericization, increased focus on small populations and personalization, declining developed country reimbursements) have led to higher drug prices. In the US this has drawn more intense demand for rebates, more aggressive formulary and utilization management and higher patient cost-shares. In turn, these have led to suppression of even appropriate use of medicines and even higher prices. This state of affairs has also led to misunderstanding and resentment of both the pharmaceutical industry and pharmacy benefit managers and is rapidly becoming socially and politically unsustainable, thus threatening the sustainability of the US funding model for future innovation. Nonetheless, the industry actors remain focused on their blame game rather than crafting new solutions. If we truly care about access and affordability and future innovation, where should we go from here?

The global life sciences industry is undergoing fundamental transformation. Getting innovative medical technologies to patients has never been more difficult.

To meet our commitment to bringing the best and brightest patient access luminaries together to discuss and develop solutions for the modern access and commercial landscape, ACCESS Forum has created The Titan's Table. 

Access in the Face of Uncertainty:

What is the Way Forward?

The IRA lays the groundwork for a new US pricing system.

The prescription drug pricing landscape and patient access in Medicare will be affected by the new manufacturer rebate requirement under IRA, which goes into effect on October 1, 2022, for drugs in Medicare Part D whose price increases surpass inflation.

To lessen the blow of the IRA and the industry's current precarious situation, pharmaceutical companies should do several things. Nevertheless, the complete picture has not yet been established, so it is premature to forecast the precise effects of the IRA on the pharmaceutical sector.

Given this situation, one potential course of action is to expand internationally and investigate potential opportunities in other jurisdictions. On the other hand, this presents an opportunity; the most important markets in Europe and Latin America face a challenging price control situation.

This section will be run in a workshop format, where participants will be asked to discuss this and other market possibilities, as well as how they can learn from other countries about running a business in a price control scenario

• The need for multi-stakeholder approach to value in MedTech
• The need for fit-for-all MedTech-specific frameworks for value assessment
• The opportunity to learn from one another’s experiences and best practices

The End of the Phase 2 is a critical inflection point in drug development.

We’ve identified 8 reasons why new drugs fall short of their launch sales goals. Effective cross-functional planning and execution at the end of Phase 2 can ensure that pitfalls are avoided, and the new brand achieves its access and sales objectives.

ICON’s Strategy Summit is an essential element in a three-step process that guides the product development team in understanding:

1.Current situation: Where are we now?

2. Brand vision: Where do we want to be by launch?

3. Roadmap: How do we get there?

The ICON team will share their insights and experience and describe the actions we can take at the end of Phase 2 to ensure a new product’s acceptance by payers, HTAs, governments, clinicians, and patients.

Presenters:

Mark McCoy, Director, Client Engagement

Joe Brown, Principal ICS, Pricing, Market Access & Reimbursement

Tanja Obradovic, VP, Scientific Affairs

Angela Lawrence, Senior Director, Domain Consulting

• State of the Union: What’s keeping payers up at night?
• Overview of US Healthcare System: Meet the Players; Understand their Roles and Rules
• Healthcare in Action: Follow the Dollar
• Planning for Success: Considerations for Launch Optimization
• Building a Go-To-Market Strategy (Case Study)

Join our interactive session on the new challenges of IRA Medicare Drug Price Negotiation. We will discuss the experiences and lessons learned from countries that have implemented centralized drug price negotiation. The session aims to draw learnings from global examples and draw actionable insights for consideration of market access and pricing strategies in this rapidly evolving IRA landscape in the U.S.

· Overview on Maximum Fair Price negotiations – what we know, what is unknown?

· Global learnings of central government price negotiation (e.g., EU, China) - how are these similar, and how are they unique?

· What can companies do to prepare to be successful with CMS drug price negotiation?

In this session, attendees will gain stakeholder perspectives and data insights from market access, policy and actuarial experts on the evolving PBM landscape and implications for pharmaceutical manufacturers. The session will consist of three topics: 

• Know your customers: understanding PBMs and their customers 
• How do PBMs and Part D plan sponsors utilize CMS data to inform formulary strategies? 
• PBM Reform Act and state-level legislative efforts  

A next generation of more accurate analytics is driving faster, better market access. Hear from customers and how they benefited in their launch and decisions using NAVLIN to:

• Forecast share-shift trade-offs around market access better
• Understand impacts from GPOs/PBMs on downstream accounts
• Drive market access penetration and uptake faster at launch
• Predict launch price and market access potential earlier and more accurately

EVERSANA will present successful case studies in oncology, CNS, rare/orphan and more about how this technology is revolutionizing US market access.

Unlock the future of Market Access strategy with ValueGen.AI, a groundbreaking platform redefining the landscape designed to accelerate your Market Access journey with precision  and unparalleled speed.

This cutting-edge AI-powered platform empowers users to:

• Seamlessly delve into, analyze, and interpret value assessment reports and publications within your chosen therapeutic area.
• Harness quick, actionable insights from pertinent Health Technology Assessment (HTA) evaluations and publications. 
• Pinpoint strategic gaps for augmented evidence generation, strategically amplifying value creation opportunities.
• Expedite the creation of early economic models tailored to your selected therapeutic area and conduct early product scenario analyses with ease and unparalleled speed.
• Create downloadable reports encapsulating the holistic value propositions of your product across diverse scenarios.

ValueGen.AI isn't just a platform; it's a game-changer. In this session, the ValueGen.AI team will demonstrate salient features of the platform and showcase how ValueGen.AI is revolutionizing market access strategy.

Topics Covered:
 

• Differential Pricing of New Medicines: Theory and Background
• Differential Pricing of New Pharmaceuticals in Emerging Market: Global Perspective
• Differential Pricing of New Pharmaceuticals in Latin America: The case for innovative vaccines

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.

Access Hub revolutionises global drug launches by empowering teams to make informed decisions, learn from past experiences, benchmark against competition, and showcase the success of their brands.

In this session our Head of Sales, Russ Leslie, will walk through Access Hub and how it’s supporting the most successful pharma companies to transform how they track market access performance.

• C-Suite survey results and what this may mean for the future sequencing of EU, UK, US, and other markets
• The value of European market – complex, but a worthwhile prize – market size and influence in other markets
• Overview of EU HTA Regulations, what we know, what we do not know, what we need to do now
• Other supranational initiatives in Europe
• Translating the outputs from Joint Clinical Assessments into national processes – insight on how this is likely to work, e.g.
  • PICOs,
  • Assessing value
  • Commercial negotiations
• Influence of UK post-Brexit, what role is NICE playing?
• EU legal framework, the pharma package, how unmet medical need, and orphan designation may impact assessment

• Preparing for EU JCA, what should be clear steps a company may need to take
• Overview of the Results of survey on preparedness of manufacturers for EU Joint Clinical Assessment (JCA)
• Panel session: How prepared are pharma and biotech companies for EU JCA? A discussion with pharma executives