The affordability of newly approved innovative health technologies (IHTs) is challenging for many health systems. Health care payers and pharmaceutical companies across European Union (EU) have explored different ways of defining payment for new products that ensure quick access of patients to new health technologies that provide adequate incentives to R&D efforts (both in rewarding R&D and guiding efforts to areas of higher social value) and that keeps health systems financially sustainable. For example, the 2000 Pharmaceutical Strategy for Europe has also put one pillar on ensuring and enhancing the affordability of medicines, including those that address an unmet medical need. However, substantial differences in access to IHTs, including medicines and patient outcomes still exist across different countries in the EU. This has significant implications for patient access for low-income countries as medicines are offered months and years later despite being worse population health. With reference to the official list prices of first launch countries, it relates to higher prices, which are frequently not the real prices paid, since the latter have been negotiated down in confidential deals, commonly known as managed entry agreements (MEA). This contradicts the idea of “Equal access to health care” in the member states. Furthermore, uncertainty on the effectiveness and costeffectiveness of IHTs is increasing as the number of medicines approved by the European Medicine Agency (EMA) in the absence of phase III randomised controlled trial (RCT) data is increasing. A new aim is EU’s strategic approach in 2019 to reduce the significant risks of pharmaceutical residues in the environment. From the payer’s perspective to create incentives to green manufacturing, it is also desirable to be aware of the environmental impact medical products may have and to include this data, e.g., in new cost-effectiveness models.

Developing a policy support tool für decision-makers

In ASCERTAIN, we will co-create and develop a cloud-based publicly accessible ASCERTAIN policy support tool for decision-makers to improve access to IHTs, including medicines. It will include new models (pricing, (cost-)effectiveness, and reimbursement). Another target is to have data related to the environmental impact of health technologies’ entire life cycle. This includes, e.g., drug/product discovery, production, supply chain and logistics, packaging and how products are disposed of at the end of product life7. We will test the models with three use cases (UCs) precision cancer medicine (PCM), cell- and gene therapy and medical devices (class IIb and III) or in vitro diagnostic (IVD) class D. We will follow the FAIR (findable, accessible, interoperable, and reusable) data principles, recognised across the EU. ASCERTAIN consortium will pro-actively collaborate with stakeholders, e.g., industry, clinicians, patients, policy makers, government, academia, regulatory bodies, and payers to ensure quality, awareness, and acceptance of developed models.

ASCERTAIN will contribute to better anticipating and calculating pricing, health technology assessment (HTA) and reimbursement conditions for IHTs. ASCERTAIN policy tool features essential elements for long-term planning and incentives for economic entrepreneurship and takes into account the stakeholder preferences, e.g., faster and broader access for patients, transparency in methodology and decision-support structures. Furthermore, it’s an open-access tool reducing uncertainties for all stakeholders, reward for innovation and investing in areas of unmet need. It has both value- and cost-based elements, elements to stimulate a “greener” production, adaptable to country-specific conditions.