n 2018, we focused our activities around three key areas to advance thought leadership in the value and access space: (1) sustainability of healthcare funding, (2) defining the concept of unmet medical need, and (3) supporting topics identified in the EMA-EUnetHTA (European Network for Health Technology Assessment) work plan to facilitate public discussions. Each project was proposed by DIA members and stakeholder groups as initiatives in which DIA should take a leading role.

• In partnership with the Boston Consulting Group (BCG) Market Access Roundtable, we further formalized the Sustainability of Healthcare Funding initiative into a project with leading academics to spearhead research streams on payment models, data and data infrastructure, and patient and cross-stakeholder collaboration.
• The European payer and regulator community initiated a working group to define unmet medical need and invited DIA to lead the discussion. The initiative was extended to trans-Atlantic stakeholders with the ambition to globalize some of the identified criteria.
• Organized for the second time in Europe, the Value, Access, and Regulatory Strategy workshop addressed areas that market access and regulatory strategies have in common. The discussion ranged from EMA-EUnetHTA Parallel Consultation (the process where scientific advice is sought from EMA and HTA bodies simultaneously) and increasing cooperation in health technology assessment to the various opportunities that digital health can offer and the use of real world evidence.
• DIA Japan hosted the 1^st DIA Health Economics and Outcomes Research (HEOR) Workshop to discuss the progress in HEOR area.

Why we care: There is an increasing need for non-political and non-commercial platforms to discuss optimization of patients’ access to affordable, high-quality medicines. With the incoming wave of modern technologies, such as AI and advanced gene editing, it’s becoming increasingly important to reevaluate the suitability of most value frameworks and payment models. As new technologies are entering the market, it’s time to develop better solutions to enable faster access to treatments that would benefit not only the patient but also the healthcare systems. At DIA, we are perfectly positioned to connect thought leaders to accelerate this change.

In 2018, we further increased our reach in the value and access space. Larger numbers of stakeholders were brought to DIA events, and more insights were shared through publications and other channels. DIA’s online magazine Global Forum, for example, has included articles ranging from FDA’s Payer Communication Guideline to Universal Healthcare in Asia.

With the Sustainability of Healthcare Funding initiative we are seeking solutions on how to start preparing healthcare systems for future funding challenges. In the US, for example, specialty medicines account for 50% of healthcare spending, and new solutions are urgently needed. Other elements of this initiative address, among others, the mismatch between care delivery and resource allocation, the move towards patient-relevant outcomes to reduce system inefficiencies, and the particular challenges of publicly funded healthcare systems.

Defining unmet medical need was set as a priority for the payer community in the EMA 2017 Annual Report, highlighting its importance in Europe. As the discussion progressed, it became clear the challenge is not only European but global; however, with different regulatory and reimbursement systems in place, the nuances of the discussion are differ across regions. At DIA Europe 2018, we hosted an open forum in which working group members and DIA Members shared their views. The discussion focused strongly on the willingness to pay for unmet medical needs and how these needs should be prioritized. To continue the discussion and provide a more global perspective on the issue, a DIA workshop series at the DIA Global Annual Meeting facilitated discussions from an international regulatory and patient organizations’ point of view. The outcomes of the DIA Europe working group and the Global Annual Meeting workshop series resulted in one published, non-peer-reviewed article in Clinical Leader and two peer-reviewed articles submitted to Value in Health and Therapeutic Innovation & Regulatory Science (TIRS).

The DIA Value, Access, and Regulatory Strategy workshop in Europe hosted several important discussions on the centralization of health technology assessment, with key policymakers presenting their perspectives. The platform also discussed the type of evidence package that is acceptable for both regulators and health technology assessment (HTA) bodies. This discussion was an attempt to emphasize the importance of parallel consultation to avoid additional studies for reimbursement purposes. The discussions at next year’s meeting will continue to advance the alignment of EMA, HTA bodies, and industry on these strategies.

The first health economic and outcomes research (HEOR) workshop in Japan highlighted different perspectives in HEOR from stakeholders such as clinicians, academics, industry, and patients. The overarching theme discussed in the workshop was the impact of HTA on policy reform.

At the DIA 2018 Global Annual Meeting and DIA Europe 2018, we hosted a number of value and access discussions on how to make value-based payment models the best practice, what constitutes fair pricing, whether we can streamline health technology assessment in Europe, and the impact of cell and gene therapy on the US payer system.

What’s Next?
In the coming year, our activities will focus on moving these developments forward, continuing to strengthen DIA’s role in the value and access landscape and bringing new insights and viewpoints to current and future challenges. Emergence of cell, gene, and digital therapies will shape the healthcare systems further. With our unique ability to bring healthcare professionals together from around the globe, DIA is uniquely positioned to unite the whole ecosystem to address these challenges together.