10^th EPP Life Sciences Pricing Forum

• Analysing the outcomes of greater Net Price Transparency for innovative medicines in Europe. What outcomes can be highlighted from the implementation of the Pricing and Reimbursement Decree in Italy?
• Exploring how cross-border collaboration on HTA and pricing can boost market access to new medicines
• To which extent is an open and early dialogue with HTAs needed to achieve a timely market access?
• Assessing the long-term effect of the EU Pharmaceutical Strategy for increased price transparency and accessibility

• Understanding why Pricing & Market Access teams should establish early collaboration with payers to model and negotiate the most efficient contracting solutions
• Debating why optimising the organization and operations of the Pricing & Market Access function must be a priority for Life Sciences companies navigating a challenging payer environment
• In which ways can P&MA and Health Economics and Outcomes Research (HEOR) professionals cooperate in order to maximise early access to new drugs?
• Bridging the digital skills gap in Life Sciences: from resistance to change to talent attraction

Panelists:

• George Boretos, Founder and CMO, Cube RM
• Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome

• Medical Device Regulation: What has been achieved during the first five months of application?
• How are regulatory, technology, and marketplace trends converging to create new opportunities for manufacturers?
• Developing innovative pricing strategies in a highly competitive market by leveraging product value in a customer-centric approach
• Value-Based Procurement in MedTech – a tangible, cost-effective reality?
• Overcoming barriers to develop a successful reimbursement strategy

• Boosting innovation by preventing a late start of market access assessment and a lack of evidence requirements
• To which extent will a mature and refreshed framework be paramount to tackle price settings and reimbursements as ATMPs enter the market more often?
• How are national public health systems working to achieve affordable reimbursement of cell gene therapies?
• How can ATMPs clinical assessments coordinate at the EU level, while adapting HTA, pricing and reimbursement processes to capture and value long-term benefits and risks?
• Improving patient access and reimbursement schemes by tackling barriers such as uncertainty in patient volume, high costs, and new delivery models

• Recent developments and processes so far
• Reimbursement: Contracting models and implementations
• Data-requirements / registries – an outlook

• Volatility: Fluctuation of competitor offerings, price changes
• Uncertainty: Impact of of local and macro variables to KPIs
• Complexity: Multichannel supply chain, bundled offerings
• Ambiguity: Influencing decision makers, lifetime customer value

• Delving into the key role of Real World Evidence (RWE) research in value-based pricing. How can RWE be leveraged to design and support new, innovative value-based contracting programmes?
• Pursuing valid and reliable measures of value – how should value metrics be designed to avoid risks but adding truly beneficial outcomes?
• Assessing key considerations for stakeholders. What are the main challenges and barriers to value-based agreements adoption?
• What capabilities and technologies should be harnessed to tackle the challenging match between Value and Costs?

• How to make reimbursable combination of biologics? To which extent doubling the cost of the therapy thus increasing the efficacy and improving the clinical outcome represents a feasible strategy?
• Analysing the challenges in the value assessment, pricing and funding of targeted combination therapies in oncology
• Indication-based pricing: what are the opportunities and challenges in oncology medicines? How is it actually applicable in practice?
• How should the value of CAR T-Cell Therapy be determined? Exploring innovative pricing models and strategies to make CAR-T Therapy affordable

• Defining the concept of fair pricing for medicines. What makes a fair price for both buyers and sellers?
• Delving into the price transparency conundrum. Does price transparency undermine fair prices? To which extent can the transparency of prices paid, R&D costs, production costs and profit margins represent key factors to assess the fairness of medicines prices?
• What can and should governments do to lower prices and improve patient access to innovative, costly and life-changing medicines? In which ways can industry, regulators and governments collaborate to achieve a fair and actionable pricing model?
• Building a European model for the calculation of fair prices for medicines – a realistic approach?
• Fair prices for vaccines – lessons learnt during the COVID-19 pandemic

Panelists:

Aleš Bourek, Head Centre for Healthcare Quality, Medical Faculty, Masaryk University

Neil Palmer, Principal Consultant, WN Palmer & Co

• Overview and history of IRP
• IRP, absence of price transparency, role of confidential agreements & patient access schemes
• Impact of IRP on launch sequencing & patient access
• Case Study: Canada: new basket of 11 reference countries intended to lower drug prices to OECD median
• USA: Overview of US IRP regulatory proposals, potential for implementation in current political environment
• Outlook and implications

• How to deliver the right value proposition
• How do you ensure pricing visibility and control at the corporate level?
• Gaining clarity on how the value of a product is assessed

• Reviewing the dynamics of markets to increase access and availability to patients across international markets
• Assessing the Pricing and Reimbursement pathway
• Adopting measures to rationalise and streamline the pricing negotiation procedure for generics and biosimilars

• Analysing the added value of customer service and digitisation. How is this shift affecting MedTech pricing strategies?
• Exploring innovative contracting models without risk sharing, such as device-as-a-service models
• From ownership model to access model: subscription-based pricing in MedTech

• The role of the pricing leader within the organization
• The importance of involving Executive Leadership
• Growing pricing advocates
• Driving long-term information gathering to commit to evidence-based decision making
• Bridging the gap between the sales team and the pricing team
• Developing an organizationally engaged and collaborative value model

• Lagging behind digital transformation – what main barriers need overcome to embrace the swift to digital?
• Why a strategic approach is key to digital transformation: from the adoption and implementation of advanced technologies, to organisational changes, collaboration and supportive leadership
• How is big data and AI technology driving market access strategy and practice? How can AI and machine learning help maximise clinical trial data, identify RWE gaps and generation of evidence to meet HTA requirements?
• Assessing how predictive analytics can be deployed to inform pricing strategies, determine appropriate launch sequences and optimise discounts
• Getting the right people and the right skills – pros and cons of hiring for digital transformation

• From real-world data to real-world evidence: Leveraging Big Data to boost market access of innovative medicines
• How can AI be utilised to generate the right pricing to respond to the market?
• To which extent can disruptive technologies such as AI, blockchain and big data optimise drug prices and improve patient access?
• Exploring latest developments of the DARWIN EU (Data Analytics and Real World Interrogation Network) scheme

Exploring new and innovative digital solutions in market access, pricing and evidence generation to allow patients gaining access to life saving solutions

• How are payers in Europe embracing digital tools such as connected devices and telemedicine?
• Exploring reimbursement models of digital health apps around Europe: examples in Germany and France.
• eHealth Stakeholder Group: latest developments and outcomes in Europe

Discovering this new shared information system implemented within the Spanish National Health System to assess the real therapeutic value of drugs with digitisation at the forefront of the scheme.

• Using complex analytical models to analyse patterns in raw data and predict future results
• Modeling in price prediction: Testing and using the best model for each market behaviour
• Evidence-based algorithms with machine learning for best price prediction results

1. Analysing Instalment payments for Gene Therapy linked to outcomes-based agreements
2. External Reference Pricing – Impact of ERP on launch sequencing & patient access
3. How to show clinical value? Setting the price for gene therapies and manage the price for long-term efficacy

Facilitator: Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome

1. Approach to clinical evidence generation across the entire lifecycle of high-risk implantable Medical Devices. Are manufacturers and rest of stakeholders ready?
2. How do you empower your commercial teams in this current post-pandemic world?
3. Assessing the true cost of Digital Transformation in Healthcare

Facilitator: Aleš Bourek, Head Centre for Healthcare Quality, Medical Faculty, Masaryk University

• What Does a Biden Administration Mean for the Life Sciences pricing industry?
• Analysing the current status of the ‘favored nation status’ executive orders from the Trump’s administration. How is it impacting the industry both in US and Europe?
• How is the COVID-19 pandemic long-lasting effect changing the economic strength of the life sciences industry? How is the tender market in the EU evolving in the current post-pandemic climate?
• Analysing the effect of Brexit in life sciences and pricing
• How can the Life Sciences industry keep the momentum going after the achievements in diagnostics, therapies and vaccines to address coronavirus through collaboration, rapid adaptation and innovation? What lessons can the pricing community extract and leverage from these unprecedent accomplishments?

Panelists:

Eric M. Wirth, Global Pricing Leader | Global Commercial Excellence, PerkinElmer

Since China initiated a trial of the centralised drug procurement programme in 2019, three rounds of the procurement have covered 112 varieties of medicine, with their average price down 54 percent, including those widely prescribed for diabetes, high blood pressure, infections and cancers. China’s shift in its healthcare strategy means the second largest economy has increased its healthcare public spending and revamped its drug approval system, with some foreign drugs and medical trials now approved quicker than in the US. How can multinationals compete with domestic manufacturers in China’s expanding centralised drug procurement programme? With a target price in the negotiation table set up at or below the lowest ERP, in which ways will global market access and HEOR teams have to collaborate with their Chinese affiliates to maximise value realisation in negotiations?