Proceedings: DIA Europe 2019
Snapshot of DIA Europe 2019
paradigm shift in healthcare was evident at DIA Europe 2019 in Vienna. Well over a thousand attendees from industry, regulatory authorities, patient associations, and suppliers participated in multiple tracks and sessions over three exciting days. This is what we learned.
Healthcare System Transformation
Current healthcare systems are not sustainable: Over the last 100 years, our life expectancy grew by 35 years. This came at a cost that is outpacing GDP. This cost will double again in the next twenty years. High pressure on public spending will only grow.
Sustainable health systems need: 1) individual empowerment and responsibility, people making life choice decisions; 2) greater accountability of governments and healthcare providers to deliver effective, sustainable health services; 3) data-driven, evidence based value and outcomes.
In the future, therapies will be defined as synergistic interactions between different elements of care. Business models are needed to measure outcomes of healthcare intervention. Future healthcare systems require changes in incentive systems, and for people to value their health while they still have it. 45 percent of diseases are related to attitudes/behaviors.
Transformation Enabled by Digital Solutions
Many solutions for future healthcare systems relate to digital technology (such as robotics, telepresence, etc.), and come out of the private sector. They will impact jobs, market structure, and value proposition.
High precision tumor diagnosis is now possible thanks to innovative DNA/RNA sequencing techniques. Precision medicine techniques such as CMTA (comprehensive molecular tumor analysis) are available to stratify tumors. Predictive in silico modelling using a virtual twin concept can measure response to single drugs and combinations of drugs.
Data will become the main asset (the “new oil”). Access to healthcare data will become increasingly important. Access and ethical governance rules must be defined. The data ecosystem could adopt open sourcing for technologies and share data in a non-competitive space for the benefit of all.
New methodologies are being developed for clinical trials. Today’s gold standards were created 100 years ago! TransCelerate works on a new data sharing platform, DataCelerate, to augment a study with smaller placebo populations (placebo studies are major hurdle to getting patients enrolled) and accelerate clinical trials.
2018 was a record year for digital health M&A. Data vertical integration (mergers) will happen, and more collaboration between pharma and tech is expected. Regulation, social acceptance (cyber risk, trust, health system actors, etc.) and cost savings versus increased demand will challenge the digital transformation.
Increased Power of Patients
Europe’s Readiness to Face the Requirements of Future Therapies
Several warning signs point to the need to act quickly to make the EU an attractive place for innovation: The EU lags in fast track approvals and takes a longer time to approve. EU’s supply chains are under pressure; they are increasingly complex and not secure enough. Medicine availability is limited by pricing and reimbursement.
Regulatory Science on the rise
EU Patient Associations contribute to these efforts
EU Telematics Strategy implementation continues
EMA’s Innovation Task Force and the EU Innovation Network intend to catalyze innovation
The EU Innovation Network (EU-IN) fosters research and the uptake of innovative methods in the development of medicines. 24 national offices participate in the network. Horizon scanning helps to ensure that the network is able to regulate novel therapies and associated technologies such as nanomedicines, novel manufacturing strategies (such as 3D printing), and mobile/ digital apps in clinical trials.
The EU-IN also collaborates at the ICMRA level and encourages regulatory participation in Innovative Medicines Initiative (IMI) projects. EU regulators provide expertise and regulatory advice to IMI projects to develop new regulatory concepts and solutions. The latest IMI projects focus on digital and other innovative technologies.
New legislative framework for HTAs to reconcile innovation with access
Access to ATMPs in the European Union
Remaining challenges in the EU legislative framework
However, the EU legislative framework is not yet fully adapted to ATMPs and their inherent complexity. EMA is working on clarifying details related to genetically modified organism (GMO) legislation. The implementation of EU Medical Device Regulation (MDR) Article 117 for drug-device combination ATMPs must be defined. Finally, provisions in the legislation pertaining to the “hospital exemption” must be clarified.
Need for patient registries
Need for flexible pricing & reimbursement models
Flexible reimbursement models are also needed. The Institute for Clinical and Economic Review (ICER) has started a new project to develop and test alternative methods for evaluating potentially curative treatments and for translating the results of cost-effectiveness analyses into recommendations for value-based price benchmarks.
Finally, GDP variation between EU member states results in differential pricing for treatment coming from a single treatment center. A possible solution could be cross-region funding channels.
International Collaboration
ICH reforms successfully completed
Membership expansion has an impact on the size of expert working groups (EWG), an issue that ICH is addressing. These reforms, however, reduce industry’s influence in the ICH process: EWGs have more regulatory and therefore less industry representation, and industry is only involved up to Step 2a.
ICH will perform a survey on the implementation status of ICH guidelines in ICH regions, and share its results in June 2019. Multiple work streams have been launched to engage with training organizations and institutions